prem14a
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
SCHEDULE 14A
Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934
Filed by the Registrant þ
Filed by a Party other than the Registrant o
Check the appropriate box:
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Preliminary Proxy Statement |
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Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) |
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Definitive Proxy Statement |
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Definitive Additional Materials |
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Soliciting Material Under Rule 14a-12 |
Alteon Inc.
(Name of Registrant as Specified In Its Charter)
(Name of Person(s) Filing Proxy Statement, if other than the Registrant)
Payment of Filing Fee (Check the appropriate box):
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No fee required. |
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Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. |
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Title of each class of securities to which transaction applies:
Common Stock, $0.01 par value per share |
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Aggregate number of securities to which transaction applies:
37,399,065 |
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Per unit price or other underlying value of transaction computed pursuant to
Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and
state how it was determined): |
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$0.1950 Average of high and low prices reported on June 2, 2006 |
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Proposed maximum aggregate value of transaction:
$7,292,817.68 |
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Total fee paid:
$1,458.56 |
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Fee paid previously with preliminary materials. |
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Check box if any part of the fee is offset as provided by Exchange Act
Rule 0-11(a)(2) and identify the filing for which the offsetting fee
was paid previously. Identify the previous filing by registration
statement number, or the Form or Schedule and the date of its filing: |
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Amount previously paid:
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Form, Schedule or Registration Statement No: |
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Filing party: |
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Date Filed: |
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Alteon Inc.
6 Campus Drive
Parsippany, NJ 07054
(201) 934-5000
MERGER PROPOSED YOUR VOTE IS VERY IMPORTANT
The board of directors of Alteon Inc. has agreed to a merger of
Alteon and HaptoGuard, Inc. We believe the combined company will
be able to create substantially more stockholder value than
could be achieved by the companies individually.
It is presently expected that HaptoGuard stockholders and
warrant holders will receive an aggregate of
37,399,065 shares of Alteon common stock. The aggregate
number of shares of Alteon common stock to be issued and
transferred for the outstanding HaptoGuard common stock and
outstanding warrants will not be adjusted based upon changes in
the value of these shares. It is presently expected that each
holder of a HaptoGuard common share would receive
3,521 shares of Alteon common stock. The exchange ratios
are subject to adjustment depending upon the number of
outstanding shares and warrants to purchase HaptoGuard common
stock at the effective time of the merger. For a more detailed
discussion of the exchange ratios, see The
Merger The Merger Agreement Merger
Consideration on page I- .
Alteon common stock is currently listed on the American Stock
Exchange under the symbol ALT.
Based upon the outstanding shares of Alteon common stock
on ,
2006 and HaptoGuards outstanding shares of common stock
and warrants
on ,
2006, HaptoGuard stockholders will own approximately 31.37% of
Alteons then outstanding common stock after we complete
the merger. Based upon the fully-diluted capitalization of
Alteon and HaptoGuard
on ,
2006, immediately following the completion of the merger,
HaptoGuard security holders would own approximately 28.93% of
the combined company assuming (i) shares of Alteon common
stock outstanding following the cash exercise of all outstanding
Alteon warrants and stock options and (ii) shares of Alteon
common stock outstanding following the cash exercise of all
HaptoGuard stock options assumed by Alteon at the closing of the
merger. Genentech, Inc., an Alteon stockholder and party to the
merger agreement, would own approximately 11.99% of the combined
company after the merger.
We are asking stockholders of Alteon to approve the merger and
merger agreement and the issuance of shares of Alteon common
stock and the transfer and conversion of shares of Alteon common
stock contemplated thereby. In addition, in order to effect the
conversion of shares contemplated by the merger agreement, we
are asking Alteon stockholders will be asked to approve an
amendment to the Certificate of Designation of the Series G
Preferred Stock and an amendment to the Certificate of
Designation of the Series H Preferred Stock. As this will
be our annual meeting of stockholders, Alteon stockholders will
also be asked to vote on Alteon director nominees and to ratify
the selection of J.H. Cohn LLP as Alteons independent
registered public accounting firm.
We cannot complete the merger unless HaptoGuard stockholders
adopt the merger and the merger agreement, and Alteon
stockholders approve (i) the merger and the merger
agreement and (ii) the amendment to the Certificate of
Designation of the Series G Preferred Stock and the
amendment to the Certificate of Designation of the Series H
Preferred Stock in order to effect the conversion of shares
contemplated by the merger agreement.
This Proxy Statement provides you with detailed information
concerning Alteon, HaptoGuard and the merger. Please give all of
the information contained in the Proxy Statement your careful
attention. In particular, you should carefully consider the
discussion in the section entitled Risk Factors
beginning on page I- of this
Proxy Statement.
The date, time and place of the Alteon annual meeting is:
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2006
10:00 a.m., Eastern Time
The Hanover Marriott
1401 Route 10 East
Whippany, New Jersey 07981
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/s/ KENNETH I. MOCH |
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Kenneth I. Moch |
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Chairman of the Board |
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President and Chief Executive Officer |
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Alteon Inc. |
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NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES REGULATORS HAVE APPROVED OR DISAPPROVED THE ALTEON
COMMON STOCK TO BE ISSUED IN THE MERGER OR DETERMINED WHETHER
THIS PROXY STATEMENT IS ACCURATE OR ADEQUATE. ANY REPRESENTATION
TO THE CONTRARY IS A CRIMINAL OFFENSE.
Proxy Statement is
dated ,
2006 and is first being mailed to stockholders on or
around ,
2006.
Alteon will provide you with copies of important
information about Alteon from documents filed with the SEC that
are not included in or delivered with this Proxy Statement, free
of charge, upon request to:
Alteon Inc.
6 Campus Drive
Parsippany, NY 07054
Attention: Investor Relations
Telephone: (201) 934-5000
In order to receive timely delivery of the documents
before the Alteon annual meeting, you should make your request
no later
than ,
2006.
Please also see Where You Can Find More Information
on page VIII- .
HaptoGuard, Inc.
Park 80 West, Plaza II
Suite 200
Saddle Brook, NJ 07663
(201) 947-1270
MERGER PROPOSED YOUR VOTE IS VERY IMPORTANT
HaptoGuard, Inc. and Alteon Inc. have entered into an agreement
and plan of merger pursuant to which Alteon intends to acquire
HaptoGuard by way of a merger.
It is presently expected that HaptoGuard stockholders and
warrant holders will receive an aggregate of
37,399,065 shares of Alteon common stock. The aggregate
number of shares of Alteon common stock to be issued and
transferred for the outstanding HaptoGuard common stock and
outstanding warrants will not be adjusted based upon changes in
the value of these shares. It is presently expected that each
holder of a HaptoGuard common share would receive
3,521 shares of Alteon common stock. The exchange ratios
are subject to adjustment depending upon the number of
outstanding shares and warrants to purchase HaptoGuard common
stock at the effective time of the merger. For a more detailed
discussion of the exchange ratios, see The
Merger The Merger Agreement Merger
Consideration on
page I- .
Alteon common stock is currently listed on the American Stock
Exchange under the symbol ALT.
Based upon the outstanding shares of Alteon common stock
on ,
2006 and HaptoGuards outstanding shares of common stock
and warrants
on ,
2006, immediately following the completion of the merger,
HaptoGuard stockholders will own approximately 31.37% of
Alteons then outstanding common stock. Based upon the
fully-diluted capitalization of Alteon and HaptoGuard
on ,
2006, immediately following the merger HaptoGuard security
holders would own 28.93% of the combined company assuming
(i) shares of Alteon common stock outstanding following the
cash exercise of all outstanding Alteon warrants and stock
options and (ii) shares of Alteon common stock outstanding
following the cash exercise of all HaptoGuard stock options
assumed by Alteon at the closing of the merger. Genentech, Inc.,
an Alteon stockholder and party to the merger agreement, would
own 11.99% of the combined company after the merger.
We are asking stockholders of HaptoGuard to adopt the merger and
the merger agreement at a special meeting of HaptoGuard
stockholders. We cannot complete the merger unless HaptoGuard
stockholders adopt the merger and the merger agreement, and
Alteon stockholders approve (i) the merger and the merger
agreement and (ii) the amendment to the Certificate of
Designation of the Series G Preferred Stock and the
amendment to the Certificate of Designation of the Series H
Preferred Stock in order to effect the conversion of Alteon
shares contemplated by the merger agreement.
The date, time, and place of the HaptoGuard special meeting is:
[ ],
2006
[ ]
This Proxy Statement provides you with detailed information
concerning Alteon, HaptoGuard and the merger. Please give all of
the information contained in the Proxy Statement your careful
attention. In particular, you should carefully consider the
discussion in the section entitled Risk Factors
beginning on page I- of this Proxy
Statement.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE
SECURITIES REGULATORS HAVE APPROVED OR DISAPPROVED THE ALTEON
COMMON STOCK TO BE ISSUED IN THE MERGER OR DETERMINED WHETHER
THIS PROXY STATEMENT IS ACCURATE OR ADEQUATE. ANY REPRESENTATION
TO THE CONTRARY IS A CRIMINAL OFFENSE.
Proxy Statement is
dated ,
2006 and is first being mailed to stockholders on or
around ,
2006.
THIS PROXY STATEMENT IS NOT AN OFFER TO SELL SECURITIES AND
IT IS NOT SOLICITING AN OFFER TO BUY SECURITIES IN ANY STATE
WHERE THE OFFER OR SALE IS NOT PERMITTED.
Alteon will provide you with copies of important
information about Alteon from documents filed with the SEC that
are not included in or delivered with this Proxy Statement, free
of charge, upon request to:
Alteon Inc.
6 Campus Drive
Parsippany, NY 07054
Attention: Investor Relations
Telephone: (201) 934-5000
In order to receive timely delivery of the documents
before the Alteon annual meeting, you should make your request
no later
than ,
2006.
Please also see Where You Can Find More Information
on page VIII- .
Alteon Inc.
6 Campus Drive
Parsippany, NJ 07054
(201) 934-5000
NOTICE OF ANNUAL MEETING OF STOCKHOLDERS OF
ALTEON INC.
To Be Held
on ,
2006
To the Stockholders of Alteon Inc.:
The annual meeting of stockholders of Alteon Inc. will be held
on ,
2006, at 10:00 a.m., Eastern Time, at The Hanover Marriott,
1401 Route 10 East, Whippany, New Jersey 07981 for the following
purposes:
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1. To approve the merger, the Agreement and Plan of Merger,
dated as of April 19, 2006, by and among Alteon Inc.,
HaptoGuard, Inc., Alteon Merger Sub, Inc., and Genentech, Inc.,
and the issuance of shares, transfer and conversion of shares
contemplated thereby, as described in the attached Proxy
Statement; |
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2. To consider and vote upon an adjournment of the annual
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
Proposal No. 1; |
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3. To consider and vote upon a proposal to amend
Alteons Certificate of Designation of Series G
Preferred Stock, as described in the attached Proxy Statement,
in order to, among other related technical changes, change the
written notice requirements to Alteon for conversion of the
preferred stock in order to allow for the conversion pursuant to
the merger agreement; |
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4. To consider and vote upon a proposal to amend
Alteons Certificate of Designation of Series H
Preferred Stock, as described in the attached Proxy Statement,
in order to, among other related technical changes, change the
written notice requirements to Alteon for conversion of the
preferred stock in order to allow for the conversion pursuant to
the merger agreement; |
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5. To elect two directors to hold office until the
completion of the merger or, in the event the merger is not
completed, until the 2009 Annual Meeting of Stockholders and
until their successors have been duly elected and qualified; |
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6. To ratify the appointment of J.H. Cohn LLP as the
independent registered public accounting firm of Alteon for the
fiscal year ending December 31, 2006; and |
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7. To transact such other business as may properly come
before the meeting or any adjournment or postponement thereof. |
Only stockholders of record at the close of business
on ,
2006 are entitled to vote at the meeting or any adjournment or
postponement thereof. Only stockholders or their proxy holders
and Alteon guests may attend the meeting. A complete list of
those stockholders entitled to vote will be kept at the
principal executive offices of Alteon, 6 Campus Drive,
Parsippany, NJ 07054 for a period of ten days prior to the
meeting.
Your vote is important. The affirmative vote of the holders
of a majority of the votes cast in person or by proxy at the
Alteon annual meeting is required for approval of
Proposal No. 1 regarding the merger agreement and
issuance of shares of Alteon common stock in the merger. The
affirmative vote of the holders of a majority of the votes cast
in person or by proxy at the annual meeting is required for
approval of Proposal No. 2 regarding an adjournment of
the annual meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of Proposal No. 1. The affirmative vote of the
holders of a majority of the voting power of the shares of
Alteon common stock outstanding on the record date for the
Alteon annual meeting, as well as the affirmative vote of the
holders of two-thirds of the voting power of the shares of
Alteon Series G Preferred Stock outstanding on the record
date and the affirmative vote of the holders of two-thirds of
the voting power of the shares of Alteon Series H Preferred
Stock outstanding on the record date, respectively, is required
for approval of Proposal No. 3 and
Proposal No. 4, respectively, regarding the
amendment of Alteons certificates of designation. The
affirmative vote of the holders of a plurality of the votes cast
in person or by proxy at the Alteon annual meeting is required
for approval of Proposal No. 5 regarding the election
of directors. The affirmative vote of the holders of a majority
of the votes cast in person or by proxy at the Alteon annual
meeting is required for approval of Proposal No. 6
regarding the ratification of auditors. You are urged to attend
the annual meeting in person, but if you are unable to do so,
the board of directors would appreciate the prompt return of the
enclosed proxy card, dated and signed, or, if your proxy card or
voting instruction form so indicates, your prompt vote
electronically via the Internet or telephone. We strongly
encourage you to vote electronically if you have that
option.
,
2006
HaptoGuard, Inc.
Park 80 West, Plaza II
Suite 200
Saddle Brook, NJ 07663
(201) 947-1270
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS OF
HAPTOGUARD, INC.
To Be Held
on ,
2006
To the Stockholders of HaptoGuard Inc.:
A special meeting of stockholders of HaptoGuard Inc. will be
held
on ,
2006, at Park 80 West, Plaza II, Suite 200,
Saddle Brook, NJ 07663, (201) 947-1270, for the
following purposes:
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1. To consider and vote upon a proposal to adopt the
Agreement and Plan of Merger, dated as of April 19, 2006,
by and among Alteon Inc., HaptoGuard, Alteon Merger Sub, Inc.,
and Genentech, Inc. as described in the attached Proxy Statement; |
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2. To consider and vote upon an adjournment of the special
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
Proposal No. 1; and |
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3. To transact such other business as may properly come
before the meeting or any adjournment or postponement thereof. |
Only stockholders of record at the close of business
on ,
2006 may vote at the special meeting or any adjournment or
postponement thereof. A list of stockholders entitled to vote
will be kept at HaptoGuard, Inc. Park 80 West,
Plaza II, Suite 200, Saddle Brook, NJ 07663,
(201) 947-1270, for ten days before the special meeting.
Please do not send any certificates for your stock at this
time.
Your vote is important. The affirmative vote of the holders
of a majority of the shares of HaptoGuard common stock
outstanding on the record date for the HaptoGuard special
meeting is required for approval of Proposal No. 1
regarding adoption of the merger agreement. The affirmative vote
of the holders of a majority of the votes cast in person or by
proxy at the HaptoGuard special meeting is required to approve
Proposal No. 2 regarding an adjournment of the special
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
Proposal No. 1. You are urged to attend the special
meeting in person, but if you are unable to do so, the board of
directors would appreciate the prompt return of the enclosed
proxy card, dated and signed, or, if your proxy card or voting
instruction form so indicates, your prompt vote by telephone. If
you sign, date and mail your proxy card without indicating how
you wish to vote, your proxy will be counted as a vote in favor
of the adoption of the merger agreement and an adjournment of
the HaptoGuard special meeting, if necessary, if a quorum is
present, to solicit additional proxies if there are not
sufficient votes in favor of Proposal No. 1. If you fail to
return your proxy card or vote by telephone, the effect will be
a vote against the adoption of the merger agreement and your
shares will not be counted for purposes of determining whether a
quorum is present at the HaptoGuard special meeting. If you do
attend the HaptoGuard special meeting and wish to vote in
person, you may withdraw your proxy and vote in person.
,
2006
TABLE OF CONTENTS
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I-20 |
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I-31 |
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I-32 |
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I-52 |
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V-3 |
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VI-5 |
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VI-7 |
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VI-8 |
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VI-8 |
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VI-10 |
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VI-14 |
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VI-16 |
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VI-17 |
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VI-18 |
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VI-19 |
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VII-1 |
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VIII-1 |
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VIII-1 |
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VIII-1 |
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F-1 |
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CHAPTER ONE THE MERGER
SUMMARY
This summary highlights selected information from this Proxy
Statement and may not contain all of the information that is
important to you. To understand the merger fully and for a more
complete description of the legal terms of the merger, you
should read this Proxy Statement and the documents we have
referred you to carefully. See
Chapter Eight Additional Information for
Stockholders Where You Can Find More
Information.
The Companies
Alteon Inc.
6 Campus Drive
Parsippany, NY 07054
Attention: Investor Relations
Telephone: (201) 934-5000
Alteon is a product-based biopharmaceutical company engaged in
the development of small molecule drugs to treat and prevent
cardiovascular diseases and other diseases associated with aging
and diabetes. Alteon has identified promising product candidates
that it believes represent novel potential approaches to some of
the largest pharmaceutical markets. It has advanced one of these
products into Phase 2 clinical trials.
HaptoGuard Corporation
Park 80 West, Plaza II
Suite 200
Saddle Brook, NJ 07663
Telephone: (201) 947-1270
HaptoGuard, Inc. is a biopharmaceutical company developing and
commercializing therapeutics for inflammatory diseases,
particularly those that are present as a consequence of elevated
oxidized lipids in the blood. HaptoGuards portfolio
includes orally bioavailable, organoselenium mimics of
glutathione peroxidase that metabolize lipid peroxides. Its lead
compound, ALT-2074, is in Phase 2 clinical trials.
HaptoGuard also controls rights to a diagnostic assay that
identifies the large subset of diabetic patients at highest risk
for cardiovascular complications, because of a defect in
oxidized lipid metabolism that results in increased
cardiovascular inflammation.
Reasons for the Merger
Alteon and HaptoGuard are proposing the merger because, among
other things, the companies believe that combining the products
and technologies of the two companies will result in an
increased ability of the companies to raise capital to continue
product development and to offer a broader range of products.
The companies have complementary product platforms in the areas
of cardiovascular diseases, diabetes and other inflammatory
diseases.
Factors Considered by and Recommendation of, the Alteon
Board of Directors (see page
I- )
The Alteon board of directors approved the merger based on a
number of factors, including, among other factors, the following:
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The ability of Alteons stockholders to continue to
participate in the growth of the business conducted by Alteon
and HaptoGuard after the completion of the merger; |
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Anticipated improvements in the ability to raise capital; |
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The strategic fit between Alteon and HaptoGuard in the
cardiovascular and diabetes arenas; |
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The synergy of the board of directors and the management of the
combined company; |
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Anticipated synergies to be achieved by combining the management
of the development and commercialization of HaptoGuard and
Alteon products; |
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The likelihood that the combined company will have better
opportunities for future growth and increase the likelihood of
successful commercialization of HaptoGuard and Alteon
products; and |
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The potential to improve Alteons strategic position in the
potential markets it may serve. |
Factors Considered by, and Recommendation of, the
HaptoGuard Board of Directors (see page
I- )
The HaptoGuard board of directors approved the merger based on a
number of factors, including, among other factors, the following:
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Anticipated improvements in the ability to raise capital; |
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The belief that the merger represented the best value reasonably
available to HaptoGuards stockholders for their shares of
HaptoGuard; |
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The likelihood that the combined company will have better
opportunities for future growth by increasing the number of
potential candidates; |
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The ability of HaptoGuards stockholders to continue to
participate in the growth of the business conducted by Alteon
and HaptoGuard after the completion of the merger; |
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The strategic fit between Alteon and HaptoGuard in the
cardiovascular and diabetes arenas; |
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The importance of scale in the increasingly competitive market
environments in which both Alteon and HaptoGuard
operate; and |
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The belief that the combined company will be able to better
develop and commercialize its products. |
Recommendations to Stockholders
Recommendation of Alteons Board of Directors (see
page I- ):
The Alteon board of directors believes that the terms of the
merger are fair to you and in your best interest and recommends
that you vote FOR the merger and the merger agreement and
the issuance of the shares and the transfer and conversion of
shares contemplated thereby, FOR adjournment of the special
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
the merger and the merger agreement and the issuance of the
shares and the transfer and conversion of shares contemplated
thereby, FOR an amendment to the Certificate of Designation of
the Series G Preferred Stock, FOR an amendment to the
Certificate of Designation of the Series H Preferred Stock,
FOR the election of two directors to hold office until the
completion of the merger or, in the event the merger is not
completed, until the 2009 Annual Meeting of Stockholders and
until their successors have been duly elected and qualified and
FOR ratification of J.H. Cohn LLP as the independent registered
public accounting firm of Alteon.
Recommendation of HaptoGuards Board of Directors
(see page I- ):
The HaptoGuard board of directors believes that the merger is
fair to you and in your best interest and recommends that you
vote FOR the adoption of the merger and the merger
agreement and FOR adjournment of the special meeting, if
necessary, if a quorum is present, to solicit additional proxies
if there are not sufficient votes in favor of adoption of the
merger agreement.
Restructuring of Genentechs Preferred Stock Position
in Alteon
As of March 31, 2006, Genentech owned 1,418.41 shares
of Alteons Series G Preferred Stock and
4,260.52 shares of Alteons Series H Preferred
Stock. On the basis of the trading price of Alteon common stock
on March 31, 2006, such shares are convertible into
222,702,745.10 shares of common stock of Alteon, which
would be approximately 79.3% of the outstanding shares of Alteon
common stock as of March 31, 2006.
I-2
As part of the merger, Genentech will:
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convert a portion of its existing preferred Alteon stock to
13,492,349 shares of Alteon common stock, which number when
combined with prior shares owned would represent approximately
11.99% of the combined company after completion of the merger; |
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transfer to HaptoGuard shareholders a portion of
Genentechs preferred stock, which when converted to common
stock equals approximately $3.5 million in Alteon common
stock; |
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transfer to Alteon the remaining Alteon preferred stock it
holds, which will be cancelled; |
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as consideration for the conversion, transfer and cancellation
of Alteon preferred stock by Genentech, receive from the
combined company certain milestone payments and royalties on net
sales of alagebrium, Alteons lead compound, as well as a
right of first negotiation on ALT-2074, HaptoGuards lead
compound. This restructuring reduces Genentechs ownership
of Alteon and removes the substantial liquidation preference of
Genentechs stock which we anticipate will remove an
impediment to future financings of the combined company. |
Risks Relating to the Merger (see page
I- )
In evaluating the adoption of the merger agreement or the
issuance of shares of Alteon in the merger, you should carefully
read this Proxy Statement and especially consider the factors
discussed in the section titled Risk Factors,
starting on page I- , for a
description of risks relating to the merger, the combined
companys businesses, and the Alteon common stock.
The Merger Agreement(see page
I- )
The merger agreement is attached as Annex A to this Proxy
Statement. You should read the merger agreement as it is the
legal document that governs the merger.
Merger Consideration (see page
I- )
At the effective time of the merger:
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Genentech will convert a portion of the Alteon preferred stock
that it holds into shares of Alteon common stock, such that the
number of such shares of Alteon common stock to be issued will,
when added to the shares of Alteon common stock already owned by
Genentech, equal 19.99% of Alteons outstanding common
stock, as calculated after the conversion of such Alteon
preferred stock but prior to (i) the issuance of shares of
Alteon common stock in connection with the merger; (ii) the
issuance of Alteon common stock and warrants in connection with
the $2.6 million financing which occurred immediately after
signing of the merger agreement; and (iii) the conversion
of Alteon preferred stock to be transferred to HaptoGuard in
connection with the merger as described below; |
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Genentech will transfer to HaptoGuard a portion of Alteon
preferred stock held by it, in such an amount that will convert
to a number of shares of Alteon common stock, in accordance with
the terms of Alteons certificate of incorporation and the
terms of the merger agreement equal in value to $3,500,000 (the
value of the price per share of the Alteon common stock being
equal to $0.2353, based on the 20-trading day volume-weighted
average price of the per share selling prices on the American
Stock Exchange for the period immediately preceding the signing
of the merger agreement); |
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Genentech will transfer to Alteon all of the remaining shares of
Alteon preferred stock held by Genentech which are not either
converted or transferred, and such shares of Alteon preferred
stock shall be canceled and retired without payment of any
consideration therefor other than pursuant to the terms of the
merger agreement and cease to be outstanding; |
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every share of HaptoGuard common stock issued and outstanding
immediately prior to the effective time of the merger (other
than the dissenting shares) shall be converted into the right to
receive a number of shares of Alteon common stock equal to the
quotient of (i) the sum of (x) a number of |
I-3
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shares of Alteon common stock to be issued by Alteon to
HaptoGuard stockholders at the effective time with a value of
$5.3 million, which we refer to as the Alteon Shares, plus
(y) the number of shares of Alteon common stock to be
issued pursuant to the transfer of shares by Genentech to
HaptoGuard as noted above, the market value of (x) and
(y) to be equal to $8,800,000, divided by (ii) the sum
of (x) the number of outstanding shares of HaptoGuard
common stock at the effective time, and (y) the number of
Share Equivalents (as defined below). This quotient is referred
to as the exchange ratio; and |
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each share of HaptoGuard common stock held in the treasury of
HaptoGuard and each share of HaptoGuard common stock owned by
Alteon or by any direct or indirect wholly-owned subsidiary of
HaptoGuard or Alteon immediately prior to the effective time
shall, by virtue of the merger and without any action on the
part of the holder thereof, cease to be outstanding, be canceled
and retired without payment of any consideration therefor other
than pursuant to the terms of the merger agreement and cease to
exist. |
In consideration of the conversion, transfer and cancellation of
shares by Genentech, Genentech will receive from the combined
company certain milestone payments and royalties on net sales of
alagebrium, Alteons lead compound, as well as a right of
first negotiation on ALT-2074, HaptoGuards lead compound.
Alteon will assume each outstanding vested or unvested option to
purchase HaptoGuard common stock, which:
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will be exercisable following the merger for the number of
shares of Alteon common stock that is equal to the product of
the number of shares of HaptoGuard common stock that were
purchasable under such option immediately prior to the effective
time of the merger multiplied by the exchange ratio (rounded
down to the nearest whole number of shares of Alteon common
stock) and |
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the per share exercise price for the shares of Alteon common
stock issuable upon exercise of such assumed option will be
equal to the quotient determined by dividing the exercise price
per share of HaptoGuard common stock at which such option was
exercisable immediately prior to the effective time of the
merger by the exchange ratio (and rounding the resulting
exercise price up to the nearest whole cent). |
All outstanding warrants to purchase HaptoGuard common stock
will be exchanged for the right to receive a number of shares of
Alteon common stock (Share Equivalents) at the
effective time of the merger which will have a market value
equal to the difference between:
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the market value of the product of the number of shares of
HaptoGuard common stock that were purchasable under such
warrants immediately prior to the Effective Time multiplied by
the Exchange Ratio (rounded down to the nearest whole number of
shares of Alteon Common Stock) and |
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the total exercise price of such warrant. |
Listing of Alteon Common Stock (see page
I- )
The shares of Alteon common stock to be issued in the merger
will be listed on the American Stock Exchange under the symbol
ALT.
Ownership of Alteon After the Merger (see page
I- )
It is presently expected that HaptoGuard stockholders and
warrant holders will receive an aggregate of
37,399,065 shares of Alteon common stock. The aggregate
number of shares of Alteon common stock to be issued and
transferred for the outstanding HaptoGuard common stock and
outstanding warrants will not be adjusted based upon changes in
the value of these shares. It is presently expected that each
holder of a HaptoGuard common share would receive
3,521 shares of Alteon common stock. The exchange ratio is
subject to adjustment depending upon the number of outstanding
shares and warrants to purchase HaptoGuard common stock at the
effective time of the merger.
I-4
Based upon the outstanding shares of Alteon common stock
on ,
2006 and HaptoGuards outstanding shares of common stock
and warrants
on ,
2006, HaptoGuard stockholders will own approximately 31.37% of
Alteons outstanding common stock after we complete the
merger. Based upon the fully-diluted capitalization of Alteon
and HaptoGuard
on ,
2006, immediately following the completion of the merger,
HaptoGuard security holders would own approximately 28.93% of
the combined company assuming (i) shares of Alteon common
stock outstanding following the cash exercise of all outstanding
Alteon warrants and stock options and (ii) shares of Alteon
common stock outstanding following the cash exercise of all
HaptoGuard stock options assumed by Alteon at the closing of the
merger. Genentech, Inc., an Alteon stockholder and party to the
merger agreement, would own approximately 11.99% of the combined
company after the merger.
Vote Necessary to Approve Alteon and HaptoGuard Proposals
(see page II- )
For Alteon stockholders: Directors are elected by a
plurality vote, which means that the two nominees receiving the
most votes will be elected to fill the seats on the Board. The
amendment of Alteons Certificates of Designation of the
Series G Preferred Stock and the Series H Preferred
Stock must be approved by the affirmative vote of the holders of
at least a majority of the outstanding shares of our common
stock and the affirmative vote of the holders of at least
two-thirds of the outstanding shares of Series G Preferred
Stock and Series H Preferred Stock, respectively. All of
the other actions to be considered at the meeting, including an
adjournment, may be taken upon the favorable vote of a majority
of the votes present in person or represented by proxy at the
meeting.
For HaptoGuard stockholders: Adoption of the merger
agreement requires the vote of a majority of the outstanding
shares of HaptoGuard common stock voting as a single class.
Approval of the adjournment of the special meeting, if
necessary, if a quorum is present, to solicit additional proxies
if there are not sufficient voted in favor of adoption of the
merger agreement requires the vote of a majority of the votes
cast.
Voting Agreements (see page
I- )
All executive officers and directors of HaptoGuard, together
with their affiliates, own as a group approximately 53% of the
shares of HaptoGuard common stock entitled to vote to adopt the
merger agreement. A vote of a majority of the outstanding shares
of HaptoGuard common stock is required to adopt the merger
agreement.
The Chief Executive Officer of HaptoGuard, Dr. Noah
Berkowitz, and a family trust for the benefit of certain members
of his family, together representing approximately 41% of
HaptoGuard outstanding common stock, have entered into voting
agreements with Alteon, under which these persons have agreed to
vote their shares of HaptoGuard common stock:
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in favor of the adoption and approval of the merger agreement, |
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against any action or agreement that would reasonably be
expected to compete with, prevent, impede, interfere with,
attempt to discourage the Merger or inhibit the timely
consummation of the Merger, |
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against any action or agreement that, to such stockholders
knowledge, would result in a breach in any material respect of
any covenant, representation or warranty or any other obligation
of the Company under the Merger Agreement, and |
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except for the merger and the merger agreement, against any
merger, consolidation, business combination, reorganization,
recapitalization, liquidation or sale or transfer of any
material assets of HaptoGuard. |
Appraisal Rights (see page
I- )
The holders of Alteon common stock do not have any right to an
appraisal of the value of their shares in connection with the
merger under Delaware law. The holders of HaptoGuard common
stock do have a right to
I-5
an appraisal of the value of their shares in connection with the
merger if they do not vote for the merger and if they follow
certain procedures outlined on page
I- .
New Directors Following the Merger (see page
I- )
Upon completion of the merger, the Alteon board of directors
will consist of eight members, including four of the current
Alteon directors which shall initially consist of Kenneth I.
Moch, Thomas Moore, Marilyn Breslow, and George M. Naimark, plus
three nominees of HaptoGuard which shall initially consist of
Noah Berkowitz, Wayne Yetter and Mary Tanner and one independent
member to be designated by the board, who may be appointed to
the board after the completion of the merger. In the event that
the merger is not completed, Alteon will reevaluate the
composition of its board of directors.
Interest of Certain Persons in the Merger (see page
I- )
When you consider the recommendations of the Alteon board of
directors that the Alteon stockholders vote in favor of the
merger and the merger agreement and the issuance of shares and
the transfer and conversion of shares contemplated thereby and
the HaptoGuard board of directors that the HaptoGuard
stockholders adopt the merger agreement you should be aware that
certain Alteon directors and members of the management and
certain HaptoGuard directors and members of management may have
interests in the merger that may be different from, or in
addition to, the interests of Alteon or HaptoGuard stockholders.
Treatment of HaptoGuard Stock Options and Warrants (see
page I- )
Alteon will assume each outstanding vested or unvested option to
purchase HaptoGuard common stock, which will be exercisable
following the merger for a number of shares of Alteon common
stock that is equal to the product of the number of shares of
HaptoGuard common stock that were purchasable under such option
immediately prior to the effective time of the merger multiplied
by the exchange ratio (rounded down to the nearest whole number
of shares of common stock) and the per share exercise price for
the shares of Alteon common stock issuable upon exercise of such
assumed option will be equal to the quotient determined by
dividing the exercise price per share of HaptoGuard common stock
at which such option was exercisable immediately prior to the
effective time of the merger by the exchange ratio (and rounding
the resulting exercise price up to the nearest whole cent). All
outstanding warrants to purchase HaptoGuard common stock will be
exchanged for the right to receive a number of shares of Alteon
common stock at the effective time of the merger which will have
a market value equal to the difference between (i) the
market value of the product of the number of shares of
HaptoGuard common stock that were purchasable under such
warrants immediately prior to the effective time of the merger
multiplied by the exchange ratio (rounded down to the nearest
whole number of shares of Alteon common stock) and (ii) the
total exercise price of such warrant.
Accounting Treatment (see page
I- )
The merger will be accounted for as a purchase by Alteon under
accounting principles generally accepted in the United States.
Under the purchase method of accounting, the assets and
liabilities of HaptoGuard will be recorded, as of the completion
of the merger, at their respective fair values and added to
those of Alteon. The reported financial condition and results of
operations of Alteon issued after completion of the merger will
reflect HaptoGuards balances and results after completion
of the merger, but will not be restated retroactively to reflect
the historical financial position or results of operations of
HaptoGuard. Following the completion of the merger, the net loss
and balance sheet of the combined company will reflect purchase
accounting adjustments, including a one-time in-process research
and development charge.
Material U.S. Federal Income Tax Consequences of the
Merger (see page I- )
The companies expect the merger to be treated as a tax-free
reorganization pursuant to Section 368(a) of the Internal
Revenue Code of 1986, as amended, or the Code. If the merger is
treated as a tax-free reorganization, generally the stockholders
of HaptoGuard, for federal income tax purposes, will recognize
no gain or loss upon their receipt of Alteon common stock,
except with respect to cash received by HaptoGuard
I-6
stockholders instead of fractional shares of Alteon common
stock, or upon exercise of their dissenters rights. A
HaptoGuard stockholder who receives cash in lieu of fractional
shares will generally recognize capital gain or loss based on
the difference between the amount of the cash received and the
HaptoGuard stockholders aggregate adjusted tax basis in
the HaptoGuard stock surrendered. Tax matters are very
complicated, and the tax consequences of the merger to each
HaptoGuard stockholder will depend on the facts of that
stockholders particular situation. You are urged to
consult your own tax advisors regarding the specific tax
consequences of the merger, including tax return reporting
requirements, the applicability of federal, state, local and
foreign tax laws and the effect of any proposed changes in the
tax laws.
Conditions to the Completion of the Merger (see page
I- )
The completion of the merger depends upon the satisfaction or
waiver of a number of conditions, including the following:
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approval and adoption of the merger agreement and issuance of
shares pursuant to the merger agreement by the Alteon and
HaptoGuard stockholders; and |
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absence of all legal prohibition on completion of the merger. |
In addition, HaptoGuards obligation to complete the merger
is subject to, among other things, the following conditions:
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accuracy as of closing of the representations and warranties
made by Alteon to the extent specified in the merger agreement; |
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assumption by Alteon of all outstanding vested and unvested
options to purchase HaptoGuard common stock; |
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adoption of an employment agreement for Dr. Berkowitz in
form and substance reasonably identical to the proposed
employment agreement Dr. Berkowitz would have received from
HaptoGuard in the event of an acquisition transaction involving
HaptoGuard (where HaptoGuard remains the controlling
entity); and |
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performance by Alteon of the obligations required to be
performed by it at or prior to closing to the extent specified
in the merger agreement. |
In addition, Alteons obligation to complete the merger is
subject to, among other things, the following conditions:
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accuracy as of closing of the representations and warranties
made by HaptoGuard to the extent specified in the merger
agreement; |
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performance by HaptoGuard of the obligations required to be
performed by it at or prior to closing to the extent specified
in the merger agreement; and |
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HaptoGuard shall have received all consents and approvals to the
merger, if any, under certain material agreements, and such
agreements shall be in full force and effect. |
In addition, Genentechs obligation to consummate the
transaction contemplated by the merger agreement is subject to,
among other things, the following conditions:
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Alteon shall have filed an amendment to its Certificate of
Designations of its Series G Preferred Stock and
Series H Preferred Stock as described herein; |
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the shares of Alteon common stock issuable to Genentech upon
conversion of the shares of Series G Preferred Stock and
Series H Preferred Stock held by Genentech shall have been
approved for listing on the American Stock Exchange; |
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accuracy as of closing of the representations and warranties
made by Alteon and HaptoGuard to the extent specified in the
merger agreement; and |
I-7
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performance by Alteon and HaptoGuard of the obligations required
to be performed by it at or prior to closing to the extent
specified in the merger agreement except as would not have a
material adverse effect on such party. |
Regulatory Approvals (see page
I- )
Neither Alteon nor HaptoGuard is aware of any government
regulatory approval required to be obtained with respect to the
consummation of the merger, except for the filing of a
Certificate of Designations with respect to the Series G
Preferred Stock and the Series H Preferred Stock and a
certificate of merger with the office of the Secretary of State
of the State of Delaware, and compliance with all applicable
state securities laws regarding the offering and issuance of the
merger shares.
Interim Payments to HaptoGuard (see page
I- )
In order to allow HaptoGuard to continue its clinical
development programs and in consideration for HaptoGuards
agreement to provide Dr. Berkowitz and Dr. Malcolm MacNab,
HaptoGuards Chief Medical Officer, to provide advice and
counsel to Alteon during the period from the signing of the
merger agreement to the effective time of the merger with
respect to the clinical development of alagebrium, Alteon agreed
to pay HaptoGuard an amount equal to $140,000 per month,
subject to adjustment by agreement upon any material changes in
personnel or clinical development programs, to be applied by
HaptoGuard to payment of salaries and existing clinical
development programs or additional programs as may be agreed
upon by such parties going forward.
In consideration of HaptoGuards agreement to provide
advice and counsel to Alteon with respect to the corporate and
scientific development of certain Alteon technology for the
period from January 1, 2006 through the effective time of
the merger, as described in a consulting agreement between
Alteon and HaptoGuard, Alteon agreed to pay HaptoGuard an amount
equal to $125,000 to be applied by HaptoGuard to payment of
salaries and existing clinical development programs, or
additional programs as agreed upon by such parties going forward.
Termination of the Merger Agreement (see page
I- )
The merger agreement may be terminated by mutual written consent
of Alteon and HaptoGuard.
The merger agreement may be terminated by either Alteon or
HaptoGuard if:
(1) subject to certain exceptions set forth in the merger
agreement, the merger has not been completed by August 30,
2006, provided that the party terminating may not be the party
whose conduct was responsible for the failure of the merger to
occur before such date;
(2) Alteon or HaptoGuard stockholders fail to approve the
issuance of shares of Alteon common stock or adopt the merger
agreement, respectively, at a duly held meeting, provided that
the party terminating may not be the party whose conduct was
responsible for the failure to receive such vote;
(3) certain breaches of covenants of the other party,
respectively; or
(4) if any representation or warranty of the other party or
Genentech proves to be untrue prior to the effective time of the
merger, if such failure to be true would reasonably be likely to
have a material adverse effect, as defined in the merger
agreement, if the terminating party is not in material breach of
any of its obligation under the merger agreement and such
representation or warranty is not made true within ten
(10) business days of the date such representation or
warranty became untrue.
The merger agreement may be terminated by either Alteon,
HaptoGuard or Genentech if there is a permanent legal
prohibition, restraint or injunction to closing the merger.
In addition, the merger agreement may be terminated by Genentech
if:
(1) it is not in material breach of any of its obligations
under the merger agreement, if any representation or warranty of
Alteon or HaptoGuard set forth in the merger agreement proved to
have been untrue prior to
I-8
the effective time of the merger, if such failure to be true
would reasonably be likely to have a material adverse effect as
defined in the merger agreement and such representation or
warranty is not made true within ten (10) business days of
the date such representation or warranty became untrue; or
(2) upon a breach of any covenant or agreement on the part
of HaptoGuard or Alteon set forth in the merger agreement, in
either case, such that any of Genentechs conditions to
consummate the transactions contemplated by the merger agreement
would not be satisfied, provided that, if such breach is curable
prior to the expiration of ten (10) days from its
occurrence by Alteon or HaptoGuard, as the case may be, through
the exercise of its commercially reasonable efforts and for so
long as Alteon or HaptoGuard, as the case may be, continues to
exercise such commercially reasonable efforts, Genentech may not
terminate unless such
10-day period expires
without such breach having been cured.
Termination Fees (see page
I- )
HaptoGuard shall pay Alteon (x) a fee of $440,000 and
(y) the amount of any interim payments made by Alteon to
HaptoGuard pursuant to the merger agreement for payment of
salaries and existing clinical development programs (other than
those made pursuant to the consulting agreement), upon the
termination of the merger agreement by Alteon:
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in the event of the failure to receive HaptoGuard stockholder
approval of the merger agreement; |
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upon breach of any of HaptoGuards covenants or agreements
but only with respect to a termination for a breach of any
material covenant or agreement, (provided that at the time of
such termination Alteon is not in material breach of any of the
covenants or agreements set forth in the merger agreement that
are applicable to Alteon); or |
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if any representation or warranty of HaptoGuard proves to be
untrue prior to the effective time of the merger, if such
failure to be true would reasonably be likely to have a material
adverse effect, as defined in the merger agreement, if Alteon is
not in material breach of any of its obligation under the merger
agreement and such representation or warranty is not made true
within ten (10) business days of the date such
representation or warranty became untrue. |
Alteon shall pay HaptoGuard a fee of $440,000 upon the
termination of the merger agreement by HaptoGuard:
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in the event of the failure to receive Alteon stockholder
approval of the issuance of shares of Alteon common stock or
adoption of the merger agreement; |
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upon breach of any of Alteons covenants or agreements but
only with respect to a termination for a breach of any material
covenant or agreement, (provided that at the time of such
termination HaptoGuard is not in material breach of any of the
covenants or agreements set forth in this Agreement that are
applicable to HaptoGuard); or |
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if any representation or warranty of Alteon proves to be untrue
prior to the effective time of the merger, if such failure to be
true would reasonably be likely to have a material adverse
effect, as defined in the merger agreement, if HaptoGuard is not
in material breach of any of its obligation under the merger
agreement and such representation or warranty is not made true
within ten (10) business days of the date such
representation or warranty became untrue. |
Approval of Amendment to the Certificates of Designations
In order to effect the conversion of shares contemplated by the
merger agreement, the Alteon stockholders will be asked to
approve the amendments to the Certificates of Designations of
the Series G Preferred Stock and the Series H
Preferred Stock. The amendments, among other related technical
changes, change the written notice requirements to Alteon for
conversion of the preferred stock and the limitations on the
amount of preferred stock that may be converted in order to
allow for the conversion pursuant to the merger agreement.
I-9
Other Alteon Annual Meeting Matters
As this will be the annual meeting of Alteon stockholders,
Alteon stockholders will also be asked to elect two directors,
ratify the selection of J.H. Cohn LLP as Alteons
independent registered public accounting firm, and conduct other
business if properly presented.
I-10
SELECTED HISTORICAL AND PRO FORMA FINANCIAL DATA
How the Financial Statements Were Prepared
Alteon is providing the following information to aid you in your
analysis of the financial aspects of the merger. Alteon derived
this information from the audited financial statements of Alteon
as of December 31, 2005 and 2004 and each of the three
years in the period ended December 31, 2005, the unaudited
financial statements of Alteon as of March 31, 2006 and
2005 and for the three months then ended, the audited financial
statements of HaptoGuard as of December 31, 2005 and 2004
and the year ended December 31, 2005, and the period of
July 19, 2004 (inception) to December 31, 2004
and the unaudited financial statements of HaptoGuard as of
March 31, 2006 and 2005 and for the three months then
ended. This information is only a summary and you should read it
together with Alteons and HaptoGuards historical
financial statements and related notes attached to this Proxy
Statement. See Alteon Financial Statement and Annex G
attached to this Proxy Statement.
Accounting Treatment
The unaudited pro forma condensed combined statements of
operations and pro forma condensed combined balance sheet were
prepared by combining the historical amounts of each company in
addition to pro forma adjustments due to the merger. The
companies may have performed differently had they always been
combined. You should not rely on the unaudited pro forma
condensed combined financial information as being indicative of
the historical results that Alteon would have had or the future
results that Alteon will experience after the merger. See
Unaudited Pro Forma Condensed Combined Financial
Statements on
page I - .
Merger-Related Expenses
Alteon estimates that merger-related fees and expenses,
consisting primarily of SEC filing fees, fees and expenses of
investment bankers, attorneys and accountants, and financial
printing and other related charges, will be approximately
$800,000 (for Alteon and HaptoGuard in the aggregate) for the
merger. See note (iv) on
page I-97 and
note (4) on
page I- .
Periods Covered
The unaudited pro forma condensed combined balance sheet as of
March 31, 2006 gives effect to Alteons merger with
HaptoGuard as if the transaction had occurred on that date. The
pro forma condensed combined balance sheet is based on the
historical balance sheets of Alteon and HaptoGuard as of
March 31, 2006, in addition to the pro forma adjustments
due to the merger. The unaudited pro forma condensed combined
statements of operations for the three months ended
March 31, 2006 and for the year ended December 31,
2005 give effect to Alteons merger with HaptoGuard as if
it had occurred on January 1, 2005.
Selected Historical Financial Data of Alteon
The following selected historical financial data has been
derived from Alteons financial statements. This
information is only a summary and should be read together with
Alteons historical financial statements and related notes
attached to this Proxy Statement.
I-11
SELECTED FINANCIAL DATA FOR ALTEON AND HAPTOGUARD
Selected Historical Financial Data of Alteon Inc.
The following selected historical financial data as of and for
each of the fiscal years in the five-year period ended
December 31, 2005 and as of and for each of the three month
periods ending March 31, 2005 and March 31, 2006 has
been derived from Atleons audited financial statements and
the unaudited financial statements of Alteon as of
March 31, 2006 and 2005. This information is only a summary
and should be read together with Alteonss historical
financial statements and related notes attached to this Proxy
Statement.
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|
|
(In thousands, except per share data) | |
CONSOLIDATED STATEMENTS OF OPERATIONS |
Income
|
|
$ |
60 |
|
|
$ |
99 |
|
|
$ |
458 |
|
|
$ |
334 |
|
|
$ |
179 |
|
|
$ |
410 |
|
|
$ |
452 |
|
Loss before income tax benefit
|
|
|
(1,621 |
) |
|
|
(4,741 |
) |
|
|
(12,941 |
) |
|
|
(14,345 |
) |
|
|
(14,797 |
) |
|
|
(17,528 |
) |
|
|
(12,770 |
) |
Preferred stock dividends
|
|
|
1,175 |
|
|
|
1,072 |
|
|
|
4,486 |
|
|
|
4,135 |
|
|
|
3,791 |
|
|
|
3,485 |
|
|
|
3,204 |
|
Net loss applicable to common stockholders
|
|
$ |
(2,797 |
) |
|
$ |
(5,714 |
) |
|
$ |
(17,100 |
) |
|
$ |
(18,094 |
) |
|
$ |
(18,243 |
) |
|
$ |
(20,366 |
) |
|
$ |
(14,997 |
) |
Basic/diluted net loss per share applicable to common
stockholders
|
|
$ |
(0.05 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.50 |
) |
|
$ |
(0.64 |
) |
|
$ |
(0.61 |
) |
Weighted average common shares used in computing basic/diluted
net loss per share
|
|
|
57,997 |
|
|
|
56,547 |
|
|
|
57,639 |
|
|
|
44,349 |
|
|
|
36,190 |
|
|
|
31,793 |
|
|
|
24,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
|
|
|
March 31, | |
|
As of December 31, | |
|
|
| |
|
| |
|
|
2006 | |
|
2005 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
|
|
(In thousands, except per share data) | |
CONSOLIDATED BALANCE SHEET DATA |
Cash, cash equivalents and short-term investments
|
|
$ |
4,469 |
|
|
$ |
6,583 |
|
|
$ |
6,583 |
|
|
$ |
11,176 |
|
|
$ |
16,679 |
|
|
$ |
17,439 |
|
|
$ |
10,726 |
|
Working capital
|
|
|
3,756 |
|
|
|
13,712 |
|
|
|
5,657 |
|
|
|
8,740 |
|
|
|
15,033 |
|
|
|
13,786 |
|
|
|
9,758 |
|
Total assets
|
|
|
5,157 |
|
|
|
7,134 |
|
|
|
7,134 |
|
|
|
11,642 |
|
|
|
17,255 |
|
|
|
18,099 |
|
|
|
13,233 |
|
Accumulated deficit
|
|
|
(225,610 |
) |
|
|
(222,813 |
) |
|
|
(222,813 |
) |
|
|
(205,713 |
) |
|
|
(187,619 |
) |
|
|
(169,376 |
) |
|
|
(149,009 |
) |
Total stockholders equity
|
|
|
4,370 |
|
|
|
5,992 |
|
|
|
5,992 |
|
|
|
9,047 |
|
|
|
15,384 |
|
|
|
14,303 |
|
|
|
10,871 |
|
I-12
Selected Historical Financial Data of HaptoGuard Inc.
The following selected historical financial data as of and for
the Period from July 19, 2004 (Inception) to
December 31, 2005 and as of and for each of the three month
periods ending March 31, 2005 and March 31, 2006, has
been derived from HaptoGuards audited financial statements
and the unaudited financial statements of HaptoGuard as of
March 31, 2006 and 2005 and for the three months then
ended. This information is only a summary and should be read
together with HaptoGuards historical financial statements
and related notes attached as an annex to this Proxy Statement.
See Annex G.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Period | |
|
|
For the | |
|
For the | |
|
from July 19, 2004 | |
|
|
Three Months Ended | |
|
Year Ended | |
|
(Inception) to | |
|
|
March 31, | |
|
December 31, | |
|
December 31, | |
|
|
2006 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
CONSOLIDATED STATEMENTS OF OPERATIONS |
Income
|
|
$ |
2 |
|
|
$ |
10 |
|
|
$ |
3 |
|
Net loss
|
|
$ |
(651 |
) |
|
$ |
(1,655 |
) |
|
$ |
(771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of | |
|
|
| |
|
|
March 31, | |
|
December 31, | |
|
December 31, | |
|
|
2006 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
CONSOLIDATED BALANCE SHEET DATA |
Cash and cash equivalents
|
|
|
3 |
|
|
|
101 |
|
|
|
582 |
|
Working capital
|
|
|
(238 |
) |
|
|
(267 |
) |
|
|
39 |
|
Total assets
|
|
|
33 |
|
|
|
115 |
|
|
|
587 |
|
Accumulated deficit
|
|
|
(3,076 |
) |
|
|
(2,425 |
) |
|
|
(771 |
) |
Total stockholders equity
|
|
|
(210 |
) |
|
|
(259 |
) |
|
|
40 |
|
Selected Unaudited Pro Forma Condensed Combined Financial
Data of Alteon and HaptoGuard
The following selected unaudited pro forma condensed combined
financial data has been derived from and should be read with the
Unaudited Pro Forma Condensed Combined Financial Statements and
related notes on
pages I- through I- .
This information is based on the historical combined balance
sheets and related historical combined statements of operations
of Alteon and HaptoGuard giving effect to the proposed merger.
The proposed merger will be accounted for under the purchase
method of accounting and is presented below as if the merger had
been completed on January 1, 2005 (the first day of
Alteons fiscal year) for income statement purposes, and on
March 31, 2006 for balance sheet purposes. The unaudited
pro forma condensed combined financial data is based on the
estimates and assumptions set forth in the notes to such
statements, which are preliminary and have been made solely for
the purposes of developing such pro forma information. This
information is for illustrative purposes only. The companies may
have performed differently had they always been combined. You
should not rely on the selected unaudited pro forma condensed
combined financial data as being indicative of the historical
results that would have been achieved had the companies always
been combined or the future results that the combined company
will experience after the merger.
I-13
UNAUDITED PRO FORMA SELECTED FINANCIAL DATA FOR ALTEON
Selected unaudited pro forma condensed combined Financial
Data of Alteon Inc.
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended | |
|
Year Ended | |
|
|
March 31, 2006 | |
|
December 31, 2005 | |
|
|
| |
|
| |
|
|
(In thousands, | |
|
(In thousands, | |
|
|
except per share | |
|
except per share | |
|
|
data) | |
|
data) | |
PRO FORMA CONDENSED COMBINED STATEMENT OF OPERATIONS |
Income
|
|
$ |
62 |
|
|
$ |
468 |
|
Loss before income tax benefit
|
|
$ |
(2,273 |
) |
|
$ |
(14,596 |
) |
Net loss applicable to common stockholders
|
|
$ |
(2,273 |
) |
|
$ |
(14,270 |
) |
Basic/diluted net loss per share applicable to common
stockholders
|
|
$ |
(0.02 |
) |
|
$ |
(0.12 |
) |
Weighted average common shares used in computing basic/diluted
net loss per share
|
|
|
119,848,525 |
|
|
|
119,491,069 |
|
|
|
|
|
|
|
|
As of March 31, 2006 | |
|
|
| |
|
|
(In thousands) | |
PRO FORMA CONDENSED COMBINED BALANCE SHEET DATA |
Cash and cash equivalents
|
|
$ |
6,972 |
|
Working capital
|
|
$ |
5,642 |
|
Total assets
|
|
$ |
7,266 |
|
Accumulated deficit
|
|
$ |
(235,738 |
) |
Total stockholders equity
|
|
$ |
5,862 |
|
I-14
COMPARATIVE PER SHARE BOOK VALUE AND DIVIDEND INFORMATION
Comparative Per Share Data
Alteon Inc. is providing the following comparative per share
information to aid you in your analysis of the financial aspects
of the merger. You should read this information in conjunction
with the historical financial statements and pro forma combined
financial statements of Alteon Inc. and HaptoGuard, Inc. and the
related notes that are included and incorporated elsewhere in
this Proxy Statement. The pro forma combined per share data
presented below reflects the purchase method of accounting in
accordance with Statement of Financial Accounting Standards
(SFAS) No. 141, Business
Combinations. The pro forma per share data is not
necessarily indicative of the results that would have occurred,
your financial interest in such results, or the future results
that will occur after the merger. Both Alteon Incs. and
HaptoGuard, Incs latest fiscal year ended on
December 31, 2005.
The historical book value per share is computed by dividing
total stockholders equity by the number of common shares
outstanding at the end of the period. The pro forma net loss per
share is computed by dividing the pro forma net loss by the pro
forma weighted average number of shares outstanding. The pro
forma combined book value per share is computed by dividing
total pro forma stockholders equity by the pro forma
number of common shares outstanding at the end of the period.
|
|
|
|
|
|
|
|
|
|
|
Year Ended | |
|
|
| |
|
|
March 31, | |
|
December 31, | |
|
|
2006 | |
|
2005 | |
|
|
| |
|
| |
Alteon Inc. Historical per share:
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$ |
(0.05 |
) |
|
$ |
(0.30 |
) |
Book value per share
|
|
$ |
0.08 |
|
|
$ |
0.10 |
|
HaptoGuard, Inc. Historical per share:
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$ |
(62.17 |
) |
|
$ |
(171.13 |
) |
Book value per share
|
|
$ |
(20.03 |
) |
|
$ |
(26.82 |
) |
Pro forma Combined Alteon Inc. per share:
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
$ |
(0.02 |
) |
|
$ |
(0.12 |
) |
Book value per share
|
|
$ |
0.05 |
|
|
|
|
|
Alteon and HaptoGuard have never paid cash dividends. If the
merger is not consummated, the boards of directors of Alteon and
HaptoGuard presently intend to continue a policy of retaining
all earnings to finance the expansion of the companies
respective businesses. Following the merger, it is expected that
the board of directors of Alteon will continue the policy of not
paying cash dividends in order to retain earnings for
reinvestment in the business of the combined companies.
I-15
QUESTIONS AND ANSWERS ABOUT THE MERGER
Q: Why are we proposing the
merger?
|
|
A: |
We are proposing the merger because, among other things, we
believe that combining the products and technologies of the two
companies will enhance the combined companies ability to
raise capital to continue its product development, and offer a
broader range of products, which could result in an increase in
stockholder value. For a full discussion of our reasons for the
merger, we urge you to read the sections entitled The
Merger Transaction Factors Considered by, and
Recommendation of, the Alteon Board of Directors beginning
on page I- . |
Q: What will happen in the
merger?
|
|
A: |
In the merger, HaptoGuard will become a wholly-owned subsidiary
of Alteon. Based upon the outstanding shares of Alteon common
stock
on ,
2006 and HaptoGuards outstanding shares of common stock
and warrants
on ,
2006, immediately following the completion of the merger,
HaptoGuard stockholders will own approximately 31.37% of
Alteons then outstanding common stock. Based upon the
fully-diluted capitalization of Alteon and HaptoGuard
on ,
2006, immediately following the completion of the merger,
HaptoGuard security holders would own approximately 28.93% of
the combined company assuming (i) shares of Alteon common
stock outstanding following the cash exercise of all outstanding
Alteon warrants and stock options and (ii) shares of Alteon
common stock outstanding following the cash exercise of all
HaptoGuard stock options assumed by Alteon at the closing of the
merger. Genentech, Inc., an Alteon stockholder and party to the
merger agreement, would own approximately 11.99% of the combined
company after the merger. |
Q: What will the HaptoGuard
stockholders and warrant holders receive in the merger?
|
|
A: |
We currently estimate that HaptoGuard stockholders and warrant
holders will receive an aggregate of 37,399,065 shares of
Alteon common stock. The aggregate number of shares of Alteon
common stock to be issued for the outstanding HaptoGuard common
stock and outstanding warrants will not be adjusted based upon
changes in the value of these shares. It is presently expected
that each holder of a HaptoGuard common share would receive
3,521 shares of Alteon common stock. The exchange ratios
are subject to adjustment depending upon the number of
outstanding shares and warrants to purchase HaptoGuard common
stock at the effective time of the merger. For a more detailed
discussion of the exchange ratios, see The
Merger The Merger Agreement Merger
Consideration on page I- . As
a result, the exact number of shares of Alteon common stock that
HaptoGuard security holders will receive in the merger will not
be known until immediately prior to the completion of the
merger. Moreover, the value of these shares and warrants will go
up or down as the market price of Alteon common stock goes up or
down. Neither party will be permitted to terminate its
obligations to complete the merger or fail to solicit the vote
of its stockholders based solely on changes in stock valuation
of either party. |
Q: When and where are the
stockholder meetings?
|
|
A: |
The Alteon annual meeting will take place
on ,
2006 at 10:00 a.m., Eastern Time at The Hanover Marriott,
1401 Route 10 East, Whippany, New Jersey 07981. |
The HaptoGuard special meeting will take place
on ,
2006 at
[ ].
Q: Do the board of directors
of Alteon and HaptoGuard recommend voting in favor of the
merger?
|
|
A: |
Yes, after careful consideration, Alteons board of
directors, by unanimous vote of those directors voting on such
matters, has determined the merger to be fair to Alteon
stockholders and in their best interests and declared the merger
advisable. Alteons board of directors approved the merger
agreement and recommends that Alteon stockholders approve the
merger and merger agreement and the issuance of shares of Alteon
common stock and the transfer and conversion of shares of Alteon
common stock |
I-16
|
|
|
contemplated thereby. In considering the recommendation of the
Alteon board of directors with respect to the merger agreement,
Alteon stockholders should be aware that certain directors of
Alteon have certain interests in the merger that are different
from, or are in addition to, the interests of Alteon
stockholders generally. We encourage you to read the section
titled Interests of Certain Persons in the Merger at
page I- for
a discussion of these interests. |
|
|
|
After careful consideration, HaptoGuards board of
directors has determined, by unanimous vote of those directors
voting on such matters, the merger to be fair to HaptoGuard
stockholders and in their best interests and declared the merger
advisable. HaptoGuards board of directors approved the
merger agreement and recommends the adoption of the merger
agreement by HaptoGuard stockholders. In considering the
recommendation of the HaptoGuard board of directors with respect
to the merger agreement, HaptoGuard stockholders should be aware
that certain directors and officers of HaptoGuard have certain
interests in the merger that are different from, or are in
addition to, the interests of HaptoGuard stockholders generally.
We encourage you to read the section titled Interests of
Certain Persons in the Merger at
page I- for
a discussion of these interests. |
Q: Who Can Vote?
|
|
A: |
Only stockholders who own Alteon common stock at the close of
business on
[ ]
are entitled to vote at the Alteon annual meeting. On this
record date, there were
[ ] shares
of Alteon common stock outstanding and entitled to vote. Each
share of stock of common stock is entitled to one vote on any
matter presented at the meeting. Alteon common stock is its only
class of voting stock. |
|
|
|
Only stockholders who own HaptoGuard common stock at the close
of business on
[ ]
are entitled to vote at the HaptoGuard annual meeting. On this
record date, there were
[ ] shares
of HaptoGuard common stock outstanding and entitled to vote.
Each share of stock of common stock is entitled to one vote on
any matter presented at the meeting. HaptoGuard common stock is
its only class of voting stock. |
Q: How do I vote?
|
|
A: |
You may vote by mail by completing, signing and dating your
proxy card and returning it in the enclosed, postage-paid and
addressed envelope. If you mark your voting instructions on the
proxy card, your shares will be voted: |
|
|
|
|
|
as you instruct, and |
|
|
|
according to the best judgment of the proxy holders if a
proposal comes up for a vote at the annual meeting that is not
on the proxy card. |
|
|
|
If you return a signed card, but do not provide voting
instructions, your shares will be voted: |
|
|
|
|
|
if you are an Alteon stockholder, FOR the merger and merger
agreement and the issuance of shares of Alteon common stock and
the transfer and conversion of shares of Alteon common stock
contemplated thereby, FOR the amendment to Alteons
Certificate of Designation of Series G Preferred Stock, FOR
the amendment to Alteons Certificate of Designation of
Series H Preferred Stock, FOR the election of two directors
to hold office until the completion of the merger or, in the
event the merger is not completed, until the 2009 Annual Meeting
of Stockholders and until their successors have been duly
elected and qualified, FOR the ratification of J.H. Cohn
LLP as Alteons independent registered public accounting
firm and FOR any proposal by the Alteon board of directors to
adjourn the meeting; |
|
|
|
if you are a HaptoGuard stockholder, FOR the adoption of the
merger and the merger agreement and FOR adjournment of the
special meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of adoption of the merger agreement; and |
|
|
|
according to the best judgment of the proxy holders if a
proposal comes up for a vote at the annual or special meeting
that is not on the proxy card or for the adjournment or
postponement of the special meeting. |
I-17
|
|
|
If you are a stockholder of record of Alteon, you may also vote
by telephone at the toll-free number
1-800-PROXIES or on the
Internet at www.voteproxy.com. If you are a beneficial owner of
Alteon, you may be able to vote electronically as well, if your
proxy card or voting instruction form so indicates. See the
instructions on your proxy card or voting instruction form.
You are strongly encouraged to vote electronically if you
are given that option. |
Q: What do I do if I want to
change my vote?
|
|
A: |
Just send in a later-dated, signed proxy or proxy card to your
companys Secretary before your meeting. Or, you can attend
your meeting in person and vote. You may also revoke your proxy
by sending a notice of revocation to your companys
Secretary at the address under The Companies on
page I- . If you voted by the
Internet or telephone, you can submit a later vote using those
same methods. |
|
|
Q: |
If my shares are held in street name by my
broker, bank or other nominee, will my broker, bank or other
nominee vote my shares for me? |
|
|
A: |
If you do not provide your broker, bank or nominee with
instructions on how to vote your street name shares,
your broker, bank or nominee will not be permitted to vote them
on the matters that are to be considered by the Alteon
stockholders and the HaptoGuard stockholders at their respective
meetings relating to the merger. You should therefore be sure to
provide your broker with instructions on how to vote your shares. |
|
|
|
If you wish to vote your shares in person, you must bring to the
meeting a letter from the broker, bank or nominee confirming
your beneficial ownership in the shares to be voted. |
Q: What happens if I do not
return a proxy card or otherwise provide proxy
instructions?
|
|
A: |
If you are a Alteon stockholder the failure to return your proxy
card or otherwise provide proxy instructions could be a factor
in establishing a quorum for the annual meeting of Alteon
stockholders for purposes of approving the merger and merger
agreement and the issuance of shares of Alteon common stock and
the transfer and conversion of shares of Alteon common stock
contemplated thereby, which is required to transact business at
the meeting. |
|
|
|
If you are a HaptoGuard stockholder, the failure to return your
proxy card or otherwise provide proxy instructions will have the
same effect as voting against the adoption of the merger
agreement and could be a factor in establishing a quorum for the
special meeting of HaptoGuard stockholders, which is required to
transact business at the meeting. |
Q: What are the costs of
soliciting these proxies?
|
|
A: |
Alteon will pay all of the costs of soliciting its proxies.
Alteon directors and employees may solicit proxies in person or
by telephone, fax or
e-mail. Alteon will pay
these employees and directors no additional compensation for
these services. Alteon will ask banks, brokers and other
institutions, nominees and fiduciaries to forward these proxy
materials to their principals and to obtain authority to execute
proxies. Alteon will then reimburse them for their expenses. |
|
|
|
HaptoGuard will pay all of the costs of soliciting its proxies.
HaptoGuard directors and employees may solicit proxies in person
or by telephone, fax or
e-mail. HaptoGuard will
not pay these employees additional compensation for these
services. |
Q: What Constitutes a Quorum
at the Meeting?
|
|
A: |
The presence, in person or by proxy, of the holders of a
majority of the outstanding shares of Alteons common stock
is necessary to constitute a quorum at the meeting. Votes of
stockholders of record who are present at the meeting in person
or by proxy, abstentions, and broker non-votes are counted for
purposes of determining whether a quorum exists. |
I-18
|
|
|
The presence, in person or by proxy, of the holders of a
majority of the outstanding shares of HaptoGuards common
stock is necessary to constitute a quorum at the meeting. Votes
of stockholders of record who are present at the meeting in
person or by proxy, abstentions, and broker non-votes are
counted for purposes of determining whether a quorum exists. |
Q: When do you expect the
merger to be completed?
|
|
A: |
We are working towards completing the merger as quickly as
possible. We hope to complete the merger
by ,
2006. However, the exact timing of completion of the merger
cannot be determined yet because completion of the merger is
subject to a number of conditions. |
|
|
Q: |
How many authorized but unissued shares of Alteon common
stock will exist after the closing of the merger? |
|
|
A: |
Following the closing of the merger, we anticipate that there
will be approximately 180,000,000 shares of authorized but
unissued Alteon common stock. In addition, Alteon will be
required to have reserved for future issuance following the
merger approximately 22,000,000 shares, including
approximately 18,600,000 shares pursuant to the exercise
and/or issuance of Alteon common stock as a result of
outstanding Alteon stock options and warrants and approximately
3,400,000 shares for issuance upon the exercise of
outstanding HaptoGuard options and warrants to be assumed in
connection with the merger. |
Q: What are the federal
income tax consequences of the merger?
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A: |
The companies expect the merger to be treated as a tax-free
reorganization pursuant to Section 368(a) of the Internal
Revenue Code of 1986, as amended, or the Code. If the merger is
treated as a tax-free reorganization, generally the stockholders
of HaptoGuard, for federal income tax purposes, will recognize
no gain or loss upon their receipt of Alteon common stock to
purchase Alteon common stock in the merger, except with respect
to cash received by HaptoGuard stockholders instead of
fractional shares of Alteon common stock or upon exercise of
their dissenters rights. A HaptoGuard stockholder who
receives cash in lieu of fractional shares will generally
recognize capital gain or loss based on the difference between
the amount of the cash received and the HaptoGuard
stockholders aggregate adjusted tax basis in the
HaptoGuard stock surrendered. |
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Tax matters are very complicated, and the tax consequences of
the merger to each HaptoGuard stockholder will depend on the
facts of that stockholders particular situation. See
The Merger Transaction Material
U.S. Federal Income Tax Consequences of the Merger
beginning on
page I- . |
Q: Who do I call if I have
questions about the meetings or the merger?
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A: |
Alteon stockholders may call Alteon Investor Relations at
201-934-5000.
HaptoGuard stockholders may call
201-947-1270. |
I-19
RISK FACTORS
You should consider the following risk factors in determining
how to vote at your stockholders meeting.
This Proxy Statement contains forward-looking statements.
These statements relate to future events or the future financial
performance of Alteon and HaptoGuard. In some cases, you can
identify forward-looking statements by terminology such as
may, should, expects,
plans, anticipates,
believes, estimated,
predicts, potential, or
continue or the negative of such terms and other
comparable terminology. These statements only reflect
managements expectations and estimates. Actual events or
results may differ materially. In evaluating these statements,
you should specifically consider various factors, including the
risks outlined below. The risks described below are the risks
that Alteon and HaptoGuard believe to be the most significant to
the merger, the business of the combined company, and Alteon
common stock at this time. These factors may cause Alteons
actual results to differ materially from any forward-looking
statements. Alteon and HaptoGuard are not undertaking any
obligations to update any forward-looking statements contained
in this Proxy Statement to reflect any future events or
developments.
The following factors should be considered carefully by
HaptoGuard stockholders in evaluating whether to adopt the
merger agreement and by Alteon stockholders in evaluating
whether to approve the issuance of shares of Alteon common stock
in the merger. These factors should be considered in conjunction
with any other information included or incorporated by reference
herein, including in conjunction with forward-looking statements
made herein. See Chapter Eight
Additional Information for Stockholders Where You
Can Find More Information on
page VIII- .
Risks Relating to the Merger
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Alteons ability to continue as a going concern is
dependent on future financing. |
J.H. Cohn LLP, our independent registered public accounting
firm, has included an explanatory paragraph in its report on our
financial statements for the fiscal year ended December 31,
2005, which expresses substantial doubt about our ability to
continue as a going concern. The inclusion of a going concern
explanatory paragraph in J.H. Cohn LLPs report on our
financial statements could have a detrimental effect on our
stock price and our ability to raise additional capital, either
alone or as a combined company.
Our financial statements have been prepared on the basis of a
going concern, which contemplates the realization of assets and
the satisfaction of liabilities in the normal course of
business. We have not made any adjustments to the financial
statements as a result of the outcome of the uncertainty
described above. Accordingly, the value of the combined company
in liquidation may be different from the values set forth in our
financial statements.
If the merger is not completed, the liquidation preference
associated with the shares of Alteon preferred stock owned by
Genentech and the substantial common stock ownership represented
by these preferred shares, on an
as-converted basis,
will make it unlikely that the combined company will be able to
obtain additional funding. The continued success of the combined
company will depend on its ability to continue to raise capital
in order to fund the development and commercialization of its
products.
Failure to raise additional capital may result in substantial
adverse circumstances, including delisting of our common stock
shares from the American Stock Exchange, which could
substantially decrease the liquidity and value of such shares,
or ultimately result in the liquidation of the combined company.
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Alteon and HaptoGuard have each historically incurred
operating losses and these losses will continue after the
merger. |
Alteon and HaptoGuard have each historically incurred
substantial operating losses due to their research and
development activities and expect these losses to continue after
the merger for the foreseeable future. As of December 31,
2005, Alteon and HaptoGuard had an accumulated deficit of
approximately $222,813,445 and $2,425,258, respectively.
Alteons fiscal year 2005, 2004 and 2003 net losses
were $12,614,459, $13,958,646, and $14,452,418, respectively.
HaptoGuards fiscal year 2005 and 2004 net losses were
I-20
$1,654,695 and $770,563, respectively. Alteons fiscal year
2005, 2004 and 2003 net losses applicable to common
stockholders were $17,100,795, $18,093,791 and $18,243,265,
respectively. The combined company currently expects to continue
its research and development activities at the same or at a more
rapid pace than prior periods. After the merger, the combined
company will expend significant amounts on research and
development programs for alagebrium and
ALT-2074. These
activities will take time and expense, both to identify
appropriate partners, to reach agreement on basic terms, and to
negotiate and sign definitive agreements. We will actively seek
new financing from time to time to provide financial support for
our research and development activities. Any partnering
agreements would required significant time and effort to
identify potential partners, to reach agreement on basic terms
and to negotiate and sign definitive agreements.
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The combined company will need additional capital in the
future, but its access to such capital is uncertain. |
At this time we are not able to assess the probability of
success in our fundraising efforts or the terms, if any, under
which we may secure financial support from strategic partners or
other investors. It is expected that we will continue to incur
operating losses for the foreseeable future. Alteons
current resources are insufficient to fund its own
commercialization efforts as well as the combined companys
commercialization efforts. As of March 31, 2006, Alteon had
cash on hand of $4,469,170. As described elsewhere in this
prospectus, in April, 2006 we closed on approximately
$2.6 million in financing. Prior to the financing, Alteon
was expending approximately $450,000 in cash per month.
Following the merger, including HaptoGuards cash spending
rate of approximately $110,000 in cash per month, the combined
company expects to spend approximately $560,000 in cash per
month. Our capital needs beyond the second quarter of 2006 will
depend on many factors, including our research and development
activities and the success thereof, the scope of our clinical
trial program, the timing of regulatory approval for our
products under development and the successful commercialization
of our products. Our needs may also depend on the magnitude and
scope of these activities, the progress and the level of success
in our clinical trials, the costs of preparing, filing,
prosecuting, maintaining and enforcing patent claims and other
intellectual property rights, competing technological and market
developments, changes in or terminations of existing
collaboration and licensing arrangements, the establishment of
new collaboration and licensing arrangements and the cost of
manufacturing scale-up
and development of marketing activities, if undertaken by the
combined company. Other than the recently completed financing
described in this prospectus, we do not have committed external
sources of funding and may not be able to secure additional
funding on any terms or on terms that are favourable to us. If
we raise additional funds by issuing additional stock, further
dilution to our existing stockholders will result, and new
investors may negotiate for rights superior to existing
stockholders. If adequate funds are not available, the combined
company may be required to:
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delay, reduce the scope of or eliminate one or more of its
development programs; |
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obtain funds through arrangements with collaboration partners or
others that may require it to relinquish rights to some or all
of its technologies, product candidates or products that it
would otherwise seek to develop or commercialize itself; |
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license rights to technologies, product candidates or products
on terms that are less favorable to it than might otherwise be
available; or |
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seek a buyer for all or a portion of its business, or wind down
its operations and liquidate its assets on terms not favorable
to it. |
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The success of the combined company will also depend on
the products and systems under development by HaptoGuard,
including ALT-2074, and
we cannot assure you that the efforts to commercialize
ALT-2074 will
succeed. |
ALT-2074,
HaptoGuards lead compound, is in development for the
treatment of heart complications in patients with diabetes. It
has demonstrated efficacy in mouse models.
I-21
ALT-2074 is still in
early clinical trials and any success to date should not be seen
as indicative of the probability of any future success. The
failure to complete clinical development and commercialize
ALT-2074 for any reason or due to a combination of reasons will
have a material adverse impact on the combined company.
We are dependent on the successful outcome of clinical trials
and will not be able to successfully develop and commercialize
products if clinical trials are not successful.
HaptoGuard received approval from Israels Ministry of
Health to conduct Phase II trials in diabetic patients
recovering from a recent myocardial infarction or acute coronary
syndrome. The purpose of the study is to evaluate the biological
effects on cardiac tissue in patients treated with
ALT-2074. HaptoGuard
has received Institutional Review Board (IRB)
approval for 3 sites in Israel. HaptoGuard recently
withdrew its submission to request approval to conduct
Phase 2 clinical trials in the Czech Republic, in order to
have the time to generate a response to the Czech
Republics request for additional data on drug stability.
The failure of either Alteon or HaptoGuard to obtain approvals
to conduct clinical trials would adversely affect the combined
companys business.
None of Alteons or HaptoGuards product candidates
are currently approved for sale by the FDA or by any other
regulatory agency in the world, and may never receive approval
for sale or become commercially viable. Before obtaining
regulatory approval for sale, each of the combined
companys product candidates will be subjected to extensive
preclinical and clinical testing to demonstrate safety and
efficacy for a particular indication for humans in addition to
meeting other regulatory standards. The combined companys
success will depend on the successful outcome of clinical trials
for one or more product candidates.
There are a number of difficulties and risks associated with
clinical trials. The possibility exists that:
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we may discover that a product candidate may cause, alone or in
combination with another therapy, harmful side effects; |
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we may discover that a product candidate, alone or in
combination with another therapy, does not exhibit the expected
therapeutic results in humans; |
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results from early trials may not be statistically significant
or predictive of results that may be obtained from large-scale,
advanced clinical trials; |
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we, the FDA, other similar foreign regulatory agencies or an
institutional review board may suspend clinical trials for any
reason whatsoever; |
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patient recruitment may be slower than expected; |
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patients may drop out of our clinical trials; and |
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we may be unable to produce sufficient supplies of products in a
timely fashion for clinical trials. |
Given the uncertainty surrounding the regulatory and clinical
trial process, we may not be able to develop safety, efficacy or
manufacturing data necessary for approval for any product
candidate. In addition, even if we receive approval, such
approval may be limited in scope and hurt the commercial
viability of such product. If the combined company is unable to
successfully obtain approval of and commercialize a product,
this would materially harm the business, impair our ability to
generate revenues and adversely impact our stock price.
The combined company is subject to significant government
regulation and failure to achieve regulatory approval of our
drug candidates would harm our business.
The FDA regulates the development, testing, manufacture,
distribution, labeling and promotion of pharmaceutical products
in the United States pursuant to the Federal Food, Drug, and
Cosmetic Act and related regulations. We must receive pre-market
approval by the FDA prior to any commercial sale of any drug
candidates. Before receiving such approval, we must provide
preclinical data and proof in human clinical trials of the
safety and efficacy of our drug candidates, which trials can
take several years. In addition, we must show that we can
produce any drug candidates consistently at quality levels
sufficient for administration in humans. Pre-market approval is
a lengthy and expensive process. We may not be able to obtain
FDA approval
I-22
for any commercial sale of any drug candidate. By statute and
regulation, the FDA has 180 days to review an application
for approval to market a drug candidate; however, the FDA
frequently exceeds the
180-day time period, at
times taking up to 18 months. In addition, based on its
review, the FDA or other regulatory bodies may determine that
additional clinical trials or preclinical data are required.
Except for any potential licensing or marketing arrangements
with other pharmaceutical or biotechnology companies, we will
not generate any revenues in connection with any of our other
drug candidates unless and until we obtain FDA approval to sell
such products in commercial quantities for human application.
Even if the combined companys products receive approval
for commercial sale, their manufacture, storage, marketing and
distribution are and will be subject to extensive and continuing
regulation in the United States by the federal government,
especially the FDA, and state and local governments. The failure
to comply with these regulatory requirements could result in
enforcement action, including, without limitation, withdrawal of
approval, which would have a material adverse effect on the
combined companys business. Later discovery of problems
with the combined companys products may result in
additional restrictions on the product, including withdrawal of
the product from the market. Regulatory authorities may also
require post-marketing testing, which can involve significant
uncontemplated expense. Additionally, governments may impose new
regulations, which could further delay or preclude regulatory
approval of the combined companys products or result in
significantly increased compliance costs.
In similar fashion to the FDA, foreign regulatory authorities
require demonstration of product quality, safety and efficacy
prior to granting authorization for product registration which
allows for distribution of the product for commercial sale.
International organizations, such as the World Health
Organization, and foreign government agencies including those
for the Americas, Middle East, Europe, and Asia and the Pacific,
have laws, regulations and guidelines for reporting and
evaluating the data on safety, quality and efficacy of new drug
products. Although most of these laws, regulations and
guidelines are very similar, each of the individual nations
reviews all of the information available on the new drug product
and makes an independent determination for product registration.
A finding of product quality, safety or efficacy in one
jurisdiction does not guarantee approval in any other
jurisdiction, even if the other jurisdiction has similar laws,
regulations and guidelines.
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Failure to integrate the companies operations
successfully could result in delays and increased expenses in
the companies clinical trial programs. |
Alteon and HaptoGuard have entered into the merger agreement
with the expectation that the merger will result in beneficial
synergies, including:
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improved ability to raise new capital through access to new
classes of investors focused on public companies engaged in
small molecule drug development; |
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shared expertise in developing innovative small molecule drug
technologies and the potential for technology collaboration; |
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a broader pipeline of products; |
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greater ability to attract commercial partners; |
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larger combined commercial opportunities; and |
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a broader portfolio of patents and trademarks. |
Achieving these anticipated synergies and the potential benefits
underlying the two companies reasons for the merger will
depend on a number of factors, some of which include:
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retention of scientific staff; |
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significant litigation, if any, adverse to Alteon and
HaptoGuard, including, particularly, product liability
litigation and patent and trademark litigation; and |
I-23
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the ability of the combined company to continue development of
Alteon and HaptoGuard product candidates; |
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success of our research and development efforts; |
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increased capital expenditures; |
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general market conditions relating to small cap biotech
investments; and |
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competition from other drug development companies. |
Achieving the benefits of the merger will depend in part on the
successful integration of Alteon and HaptoGuard in a timely and
efficient manner. The integration will require significant time
and efforts from each company, including the coordination of
research, development, regulatory, manufacturing, commercial,
administrative and general functions. Integration may be
difficult and unpredictable because of possible cultural
conflicts and different opinions on scientific and regulatory
matters. Delays in successfully integrating and managing
employee benefits could lead to dissatisfaction and employee
turnover. The combination of Alteons and HaptoGuards
organizations may result in greater competition for resources
and elimination of research and development programs that might
otherwise be successfully completed. If we cannot successfully
integrate our operations and personnel, we may not recognize the
expected benefits of the merger.
Even if the two companies are able to integrate their
operations, there can be no assurance that these anticipated
synergies will be achieved. The failure to achieve such
synergies could have a material adverse effect on the business,
results of operations and financial condition of the combined
company.
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Integrating Alteon and HaptoGuard may divert
managements attention away from our core research and
development activities. |
Successful integration of our operations, products and personnel
may place a significant burden on our management and our
internal resources. The diversion of managements attention
and any difficulties encountered in the transition and
integration process could result in delays in the
companies clinical trial programs and could otherwise
significantly harm our business, financial condition and
operating results.
We expect to incur significant costs integrating our operations,
product candidates and personnel, which cannot be estimated
accurately at this time. These costs include:
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severance; |
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conversion of information systems; |
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combining research, development, regulatory, manufacturing and
commercial teams and processes; |
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reorganization of facilities; and |
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relocation or disposition of excess equipment. |
We expect that Alteon and HaptoGuard will incur aggregate direct
transaction costs of approximately $800,000 associated with the
merger. If the total costs of the merger exceed our estimates or
benefits of the merger do not exceed the total costs of the
merger, the financial results of our combined company could be
adversely affected.
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Completion of, or the failure to complete, the merger
could adversely affect Alteons stock price and
Alteons and HaptoGuards future business and
operations. |
The merger is subject to the satisfaction of various closing
conditions, including the approval by both Alteon and HaptoGuard
stockholders, and there can be no assurance that the merger will
be successfully completed. In the event that the merger is not
consummated, Alteon and HaptoGuard will be subject to many
risks, including the costs related to the merger, such as legal,
accounting and advisory fees, which must be paid even if the
merger is not completed, or the payment of a termination fee
under certain circumstances. If the merger is not consummated
for any reason, the market price of Alteon common stock could
decline.
I-24
The shares of the combined company are publicly traded and we
cannot predict how the market will react to the merger of Alteon
and HaptoGuard. Even the successful completion of the merger may
negatively affect the stock price of the combined company, if
the market were to come to the view that Alteon would be in a
better position absent completion of the merger.
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The combined company will remain dependent on third
parties for research and development and manufacturing
activities necessary to commercialize certain of our
patents. |
We utilize the services of several scientific and technical
consultants to oversee various aspects of our protocol design,
clinical trial oversight and other research and development
functions. Alteon and HaptoGuard both contract out most of our
research and development operations, utilize third-party
contract manufacturers for drug inventory and shipping services
and third-party contract research organizations in connection
with preclinical and/or clinical studies in accordance with our
designed protocols, as well as conducting research at medical
and academic centers.
Because we rely on third parties for much our research and
development work and manufacturing, we have less direct control
over our research and development and manufacturing. We face
risks that these third parties may not be appropriately
responsive to our time frames and development needs and could
devote resources to other customers. In addition, certain of
these third parties may have to comply with FDA regulations or
other regulatory requirements in the conduct of this research
and development work, which they may fail to do.
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If the combined company does not successfully distinguish
and commercialize its technology, it may be unable to compete
successfully or to generate significant revenues. |
The biotechnology industry, including the field of small
molecule drugs to treat and prevent cardiovascular disease and
diabetes, is highly competitive and subject to significant and
rapid technological change. Accordingly, the combined
companys success will depend, in part, on its ability to
respond quickly to such change through the development and
introduction of new products and systems.
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The combined company will have substantial competition,
including competitors with substantially greater
resources. |
Many of the combined companys competitors or potential
competitors have substantially greater financial and other
resources than Alteon has and may also have greater experience
in conducting pre-clinical studies, clinical trials and other
regulatory approval procedures as well as in marketing their
products. Major competitors in the market for our potential
products include large, publicly-traded pharmaceutical
companies, public development stage companies and private
development stage companies. If the combined company or its
corporate partners commence commercial product sales, the
combined company or its corporate partners will be competing
against companies with greater marketing and manufacturing
capabilities.
The combined companys ability to compete successfully
against currently existing and future alternatives to its
product candidates and systems, and competitors who compete
directly with it in the small molecule drug industry will
depend, in part, on its ability to:
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attract and retain skilled scientific and research personnel; |
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develop technologically superior products; |
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develop competitively priced products; |
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obtain patent or other required regulatory approvals for the
combined companys products; |
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be early entrants to the market; and |
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manufacture, market and sell its products, independently or
through collaborations. |
I-25
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The success of the combined company is dependent on the
extent of third-party reimbursement for its products. |
Third-party reimbursement policies may also adversely affect the
combined companys ability to commercialize and sell its
products. The combined companys ability to successfully
commercialize its products depends in part on the extent to
which appropriate levels of reimbursement for its products and
related treatments are obtained from government authorities,
private health insurers, third party payers, and other
organizations, such as managed care organizations, or MCOs. Any
failure by doctors, hospitals and other users of the combined
companys products or systems to obtain appropriate levels
of reimbursement could adversely affect the combined
companys ability to sell these products and systems.
Federal legislation, enacted in December 2003, has altered the
way in which physician-administered drug programs covered by
Medicare are reimbursed, generally leading to lower
reimbursement levels. The new legislation has also added an
outpatient prescription drug benefit to Medicare, effective
January 2006. In the interim, the U.S. Congress has
established a discount drug card program for Medicare
beneficiaries. Both benefits will be provided through private
entities, which will attempt to negotiate price concessions from
pharmaceutical manufacturers. These negotiations may increase
pressures to lower prices. On the other hand, the drug benefit
may increase the volume of pharmaceutical drug purchases,
offsetting at least in part these potential price discounts.
While the new law specifically prohibits the
U.S. government from interfering in price negotiations
between manufacturers and Medicare drug plan sponsors, some
members of Congress are pursuing legislation that would permit
de facto price controls on prescription drugs. In addition, the
law triggers, for congressional consideration, cost containment
measures for Medicare in the event Medicare cost increases
exceed a certain level. These cost containment measures could
include limitations on prescription drug prices. This
legislation could adversely impact the combined companys
ability to commercialize any of its products successfully.
Significant uncertainty exists about the reimbursement status of
newly approved medical products and services. Reimbursement in
the United States or foreign countries may not be available for
any of the combined companys products, reimbursement
granted may not be maintained, and limits on reimbursement
available from third-party payers may reduce the demand for, or
negatively affect the price of, the combined companys
products. Alteon anticipates that the combined company will need
to work with a variety of organizations to lobby government
agencies for improved reimbursement policies for its products.
However, Alteon cannot guarantee that such lobbying efforts will
take place or that they will ultimately be successful.
Internationally, where national healthcare systems are
prevalent, little if any funding may be available for new
products, and cost containment and cost reduction efforts can be
more pronounced than in the United States.
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If the combined company is unable to protect its
intellectual property, it may not be able to operate its
business profitably. |
The combined companys success will depend on its ability
to develop proprietary products and technologies, to obtain and
maintain patents, to protect trade secrets, and to prevent
others from infringing on its proprietary rights. The combined
company has exclusive patents, licenses to patents or patent
applications covering critical components of its technologies,
including certain jointly owned patents. We also seek to protect
our proprietary technology and processes, in part, by
confidentiality agreements with our employees and certain
contractors. Patents, pending patent applications and licensed
technologies may not afford adequate protection against
competitors, and any pending patent applications now or
hereafter filed by or licensed to us may not result in patents
being issued. In addition, certain of the combined
companys technology relies on patented inventions
developed using university resources. Universities may have
certain rights, as defined by law or applicable agreements, in
such patents, and may choose to exercise such rights. To the
extent that employees, consultants or contractors of the
combined company use intellectual property owned by others,
disputes may arise as to the rights related to or resulting from
the know-how and inventions. In addition, the laws of certain
non-U.S. countries
do not protect intellectual property rights to the same
I-26
extent as do the laws of the United States. Medical technology
patents involve complex legal and factual questions and,
therefore, the combined company cannot predict with certainty
their enforceability.
The combined company is a party to various license agreements
that give it exclusive and partial exclusive rights to use
specified technologies applicable to research, development and
commercialization of its products, including alagebrium and
ALT-2074. The
agreements pursuant to which such technology is used permit the
licensors to terminate agreements in the event that certain
conditions are not met. If these conditions are not met and the
agreements are terminated, the combined companys product
development, research and commercialization efforts may be
altered or delayed.
Patents or patent applications, if issued, may be challenged,
invalidated or circumvented, or may not provide protection or
competitive advantages against competitors with similar
technology. Furthermore, competitors of the combined company may
obtain patent protection or other intellectual property rights
for technology similar to the combined companys that could
limit its ability to use its technology or commercialize
products that it may develop.
Litigation may be necessary to assert claims of infringement, to
enforce patents issued to the combined company, to protect trade
secrets or know-how or to determine the scope and validity of
the proprietary rights of others. Litigation or interference
proceedings could result in substantial additional costs and
diversion of management focus. If the combined company is
ultimately unable to protect its technology, trade secrets or
know-how, it may be unable to operate profitably. Although we
have not been involved with any threats of litigation or
negotiations regarding patent issues or other intellectual
property, or other related court challenges or legal actions, it
is possible that the combined company could be involved with
such matters in the future.
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If the combined company is unable to operate its business
without infringing upon intellectual property rights of others,
it may not be able to operate its business profitably. |
The combined companys success depends on its ability to
operate without infringing upon the proprietary rights of
others. We are aware that patents have been applied for and/or
issued to third parties claiming technologies for Advanced
Glycation End-Products or glutathione peroxidase mimetics that
may be similar to those needed by us. To the extent that planned
or potential products are covered by patents or other
intellectual property rights held by third parties, the combined
company would need a license under such patents or other
intellectual property rights to continue development and
marketing of its products. Any required licenses may not be
available on acceptable terms, if at all. If the combined
company does not obtain such licenses or it may not be able to
proceed with the development, manufacture or sale of its
products.
Litigation may be necessary to defend against claims of
infringement or to determine the scope and validity of the
proprietary rights of others. Litigation or interference
proceedings could result in substantial additional costs and
diversion of management focus. If the combined company is
ultimately unsuccessful in defending against claims of
infringement, it may be unable to operate profitably.
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HaptoGuards ALT-2074 and other HaptoGuard compounds
are licensed to HaptoGuard by third parties and if the combined
company is unable to continue licensing this technology our
future prospects may be materially adversely affected. |
HaptoGuard licenses technology, including technology related to
ALT-2074, from third parties. We anticipate that we will
continue to license technology from third parties in the future.
To maintain HaptoGuards license to ALT-2074 from Oxis
International, we are obligated to meet certain development and
clinical trial milestones and to make certain payments. There
can be no assurance that we will be able to meet any milestone
or make any payment required under the license with Oxis
International. While Oxis has not claimed a default under the
license agreement, it has indicated that its view as to whether
HaptoGuard satisfied the milestone to begin Phase II
clinical trials by May 28, 2006 differs from
HaptoGuards view. If we fail to meet any milestone or make
any payment, Oxis may terminate this license, and there can be
no assurance that we may be able to negotiate any continuation
or extension of the license agreement.
I-27
The technology HaptoGuard licenses from third parties would be
difficult or impossible to replace and the loss of this
technology would materially adversely affect our business,
financial condition and any future prospects.
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If the combined company loses or is unable to hire and
retain qualified personnel, it may not be able to develop its
products and technology. |
The combined company is highly dependent on the members of its
scientific and management staff. In particular, the combined
company will depend on Dr. Noah Berkowitz as the combined
companys Chief Executive Officer and Malcolm MacNab as the
combined companys Vice-President of Clinical Development.
We may not be able to attract and retain scientific and
management personnel on acceptable terms, if at all, given the
competition for such personnel among other companies and
research and academic institutions. Mary Phelan has resigned
from her position as our Director of Finance and Financial
Reporting effective May 31, 2006. If the combined company
loses an executive officer or certain key members of its
clinical or research and development staff or is unable to hire
and retain qualified management personnel, then its ability to
develop and commercialize its products and technology and to
raise capital and effect strategic opportunities may be
hindered. We have not purchased and do not anticipate purchasing
any key-man life insurance.
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The combined company may face exposure to product
liability claims. |
The combined company may face exposure to product liability and
other claims due to allegations that its products cause harm.
These risks are inherent in the clinical trials for
pharmaceutical products and in the testing, and future
manufacturing and marketing of, the combined companys
products. Although we currently maintain product liability
insurance, such insurance may not be adequate and the combined
company may not be able to obtain adequate insurance coverage in
the future at a reasonable cost, if at all. If the combined
company is unable to obtain product liability insurance in the
future at an acceptable cost or to otherwise protect against
potential product liability claims, it could be inhibited in the
commercialization of its products which could have a material
adverse effect on its business. We currently have a policy
covering $10 million of product liability for our clinical
trials. We do not have sales of any products. The coverage will
be maintained and limits reviewed from time to time as the
combined company progresses to later stages of its clinical
trials and as the length of the trials and the number of
patients enrolled in the trials changes. The combined company
intends to obtain a combined coverage policy that includes tail
coverage in order to cover any claims that are made for any
events that have occurred prior to the merger. Currently, our
annual premium for product liability insurance is approximately
$219,000.
Risks Related to Owning Alteons Common Stock
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Our stock price is volatile and you may not be able to
resell your shares at a profit. |
We first publicly issued common stock on November 8, 1991
at $15.00 per share in our initial public offering and it
has been subject to fluctuations. For example, during 2005, the
closing sale price of our common stock has ranged from a high of
$1.43 per share to a low of $0.17 per share. The
market price of our common stock could continue to fluctuate
substantially due to a variety of factors, including:
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quarterly fluctuations in results of operations; |
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the announcement of new products or services by the combined
company or competitors; |
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sales of common stock by existing stockholders or the perception
that these sales may occur; |
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adverse judgments or settlements obligating the combined company
to pay damages; |
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negative publicity; |
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loss of key personnel; |
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developments concerning proprietary rights, including patents
and litigation matters; and |
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clinical trial or regulatory developments in both the United
States and foreign countries. |
I-28
In addition, overall stock market volatility has often
significantly affected the market prices of securities for
reasons unrelated to a companys operating performance. In
the past, securities class action litigation has been commenced
against companies that have experienced periods of volatility in
the price of their stock. Securities litigation initiated
against the combined company could cause it to incur substantial
costs and could lead to the diversion of managements
attention and resources, which could have a material adverse
effect on revenue and earnings.
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We have a large number of authorized but unissued shares
of common stock, which our Board of Directors may issue without
further stockholder approval, thereby causing dilution of your
holdings of our common stock. |
After the closing of the merger and the financing, there are
expected to be approximately 180,000,000 shares of
authorized but unissued shares of our common stock. Our
management will continue to have broad discretion to issue
shares of our common stock in a range of transactions, including
capital-raising transactions, mergers, acquisitions, for
anti-takeover purposes, and in other transactions, without
obtaining stockholder approval, unless stockholder approval is
required for a particular transaction under the rules of the
American Stock Exchange, Delaware law, or other applicable laws.
We currently have no specific plans to issue shares of our
common stock for any purpose other than in connection with the
merger. However, if our management determines to issue shares of
our common stock from the large pool of such authorized but
unissued shares for any purpose in the future without obtaining
stockholder approval, your ownership position would be diluted
without your further ability to vote on that transaction.
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The sale of a substantial number of shares of our common
stock could cause the market price of our common stock to
decline and may impair the combined companys ability to
raise capital through additional offerings. |
We currently have outstanding warrants to purchase an aggregate
of 12,591,455 shares of our common stock, including
warrants to purchase 10,960,400 shares of our common
stock issued together with 10,960,400 shares of common stock all
of which such warrants and common stock we issued in connection
with a private equity financing completed in April 2006. Under
the terms of the financing we have agreed to register all of
such shares for resale. The resale of these shares of common
stock and the shares underlying the warrants may be effected at
any time once the resale registration statement is effective.
The shares issued in the private equity financing, together with
the shares underlying the warrants issued in such financing,
represent approximately 37.8% of the total number of shares of
our common stock outstanding immediately prior to the financing,
and not including shares to be issued in the merger with
HaptoGuard or shares to be issued upon conversion of preferred
stock upon transfer to HaptoGuard.
Sales of these shares in the public market, or the perception
that future sales of these shares could occur, could have the
effect of lowering the market price of our common stock below
current levels and make it more difficult for us and our
shareholders to sell our equity securities in the future.
Our executive officers, directors and holders of more than 5% of
our common stock and collectively beneficially own approximately
13.7% of the outstanding common stock as of March 31, 2006.
In addition, 6,403,464 shares of common stock issuable upon
exercise of vested stock options could become available for
immediate resale if such options were exercised.
Sale or the availability for sale, of shares of common stock by
stockholders could cause the market price of our common stock to
decline and could impair our ability to raise capital through an
offering of additional equity securities.
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Anti-takeover provisions may frustrate attempts to replace
our current management and discourage investors from buying our
common stock. |
We have entered into a Stockholders Rights Agreement
pursuant to which each holder of a share of common stock is
granted a Right to purchase our Series F Preferred Stock
under certain circumstances if a person or group acquires, or
commences a tender offer for, 20 percent of our outstanding
common stock. We
I-29
also have severance obligations to certain employees in the
event of termination of their employment after or in connection
with a change in control of the Company. In addition, the Board
of Directors has the authority, without further action by the
stockholders, to fix the rights and preferences of, and issue
shares of, Preferred Stock. The staggered board terms, Fair
Price Provision, Stockholders Rights Agreement, severance
arrangements, Preferred Stock provisions and other provisions of
our charter and Delaware corporate law may discourage certain
types of transactions involving an actual or potential change in
control.
I-30
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Proxy Statement and the documents incorporated by reference
herein contain forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, and
Section 21E of the Securities Exchange Act of 1934. These
statements relate to future events or our respective future
financial performance. Forward-looking statements are identified
by terminology denoting future events such as
anticipates, believes, can,
continue, could, estimates,
expects, intends, may,
plans, potential, predicts,
or should or the negative of these terms or other
comparable terminology. These statements are only predictions
and involve known and unknown risks, uncertainties and other
factors, including the risks pertaining to Alteon and the
combined entity outlined under the caption Risk
Factors.
Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee
future results, levels of activity, performance or achievements.
Alteons expectations are as of the date of this Proxy
Statement, and Alteon does not intend to update any of the
forward-looking statements after the date it files this Proxy
Statement to conform these statements to actual results, unless
required by law.
I-31
THE MERGER TRANSACTION
General
At the effective time, Alteon Merger Sub, Inc., a wholly-owned
subsidiary of Alteon, will merge with and into HaptoGuard.
HaptoGuard will be the surviving corporation. The parties
currently estimate that HaptoGuard stockholders and warrant
holders will receive an aggregate of 37,399,065 shares of
Alteon common stock. The aggregate number of shares of Alteon
common stock to be issued for the outstanding HaptoGuard common
stock and outstanding warrants will not be adjusted based upon
changes in the value of these shares. It is presently expected
that each holder of a HaptoGuard common share would receive
approximately 3,521 shares of Alteon common stock. The
exchange ratios are subject to adjustment depending upon the
number of outstanding shares and warrants to purchase HaptoGuard
common stock at the effective time of the merger.
Based upon the outstanding shares of Alteon common stock
on ,
2006 and HaptoGuards outstanding shares of common stock
and warrants
on ,
2006, HaptoGuard stockholders will own approximately 31.37% of
Alteons then outstanding common stock. Based upon the
fully-diluted capitalization of Alteon and HaptoGuard
on ,
2006, immediately following the completion of the merger,
HaptoGuard security holders would own approximately 28.93% of
the combined company assuming (i) shares of Alteon common
stock outstanding following the cash exercise of all outstanding
Alteon warrants and stock options and (ii) shares of Alteon
common stock outstanding following the cash exercise of all
HaptoGuard stock options assumed by Alteon at the closing of the
merger. Genentech, Inc., an Alteon stockholder and party to the
merger agreement, would own approximately 11.99% of the combined
company after the merger.
Background of the Merger
Alteon had originally been introduced to HaptoGuard in May 2004
by investment bankers at Rodman & Renshaw LLC. Although
Alteon had had an initial interest in the HaptoGuard technology
and a potential strategic transaction at that time, due to the
status of clinical activities at Alteon, these conversations did
not progress.
In May 2005, Dr. Berkowitz, President of HaptoGuard,
contacted Mr. Moch, President and Chief Executive Officer
of Alteon, suggesting that the companies consider merging
HaptoGuard into Alteon. No action was taken at that time.
In June 2005, the Alteon Board of Directors began to discuss the
implications of the results from the interim analysis of a
clinical trial relating to, and other potential avenues for use
of, the Alteons lead compound alagebrium, along with
Alteons other strategic options.
On June 28, 2005, the Board had a discussion of
Alteons strategic alternatives, including all available
strategic options with respect to Alteons technology in
general and alagebrium in particular. Members of the Board also
discussed and agreed upon the substantial impact that the
Genentech ownership position of convertible preferred stock of
Alteon would have on those strategic options.
The Board also established a Strategic Planning Committee, which
was authorized and directed to meet from time to time with
management of Alteon and to formulate a set of recommendations
for consideration by the full Board with respect to the
available strategic options for alagebrium and Alteon as a whole.
On July 12, 2005, the Strategic Planning Committee held its
first meeting at which it discussed and approved the engagement
of Aurora Capital to represent Alteon in discussions with a
specific list of compatible companies with respect to strategic
transactions. Aurora Capital joined the meeting and discussed
with the Committee the specific companies they had identified as
potential targets. The Committee also discussed the status of
conversations with a number of potential strategic advisors and
investment bankers and it was decided to pursue discussion with
such entities. Discussions with two of the identified companies
were held after such meeting but no basis for a transaction was
identified with either.
I-32
On July 19, 2005, the Committee discussed the status of
Alteons conversations with financial advisors and
investment bankers and the scope of the review of potential
strategic partners. The Board also discussed the ongoing
dialogue with Genentech regarding restructuring its convertible
preferred stock ownership position and the anticipated timeline
for Genentech to respond to Alteons initial proposal.
Members of the merchant banking group at Burrill &
Company then met with the Board and reviewed its proposal to act
as a strategic advisor to Alteon in partnering and merger
transactions. The Board voted that Alteon should engage
Burrill & Company.
On August 1, 2005, an initial meeting was held with
Burrill & Company and Alteon management in order to
discuss the initial strategy and timelines for discussions with
third parties with respect to strategic transactions.
During August 2005, approximately 185 companies were
contacted by Burrill & Company that broadly matched the
criteria Alteon was looking for. Of these companies, 6 expressed
interest, one of which had previously been contacted by Aurora.
A telephonic or
face-to-face meeting
was set up with each of these companies about a possible
combination with Alteon. Each of the companies contacted during
this process was invited to make a presentation for the Alteon
Board of Directors. As part of this process, Mr. Moch spoke
with Dr. Noah Berkowitz, President and CEO of HaptoGuard,
which was one of the 6 companies asked to make a
presentation. Discussions with such candidates continued through
early October.
On September 9, 2005, as a result of discussions with
HaptoGuard, Alteon and HaptoGuard entered into a Confidential
Disclosure and Non-Use Agreement.
On September 15, 2005, HaptoGuard submitted a presentation
to Alteon along with other company materials for Alteons
review.
On September 27, 2005, Mr. Moch discussed with the
Committee the recent letter received from Genentech and certain
parameters relating to evaluation of Genentechs proposal
relating to the convertible preferred stock held by Genentech.
On October 4, 2005, the Strategic Planning Committee spent
considerable time specifically discussing potential strategic
transactions and reviewing the interested parties in such
transactions.
On October 5, 2005, the Strategic Planning Committee
provided an update to the Board of Directors on the status of
discussion with third parties. Burrill & Company
presented a review of the actions which had been undertaken by
Burrill in conjunction with company management to identify
potential transaction partners for Alteon. At this point, it was
the consensus of the Alteon Board that HaptoGuard presented the
most promising candidate for a strategic transaction.
On October 14, 2005, the Senior Management team from Alteon
and HaptoGuard held a conference call during which HaptoGuard
management provided a detailed scientific presentation of the
HaptoGuard technology.
On October 14, 2005, Mr. Guggenheimer, acting Chief
Financial Officer of Alteon, resigned from Alteon to join the
investment banking firm of Dresdner Kleinwort Wasserstein. At
that time, Alteon agreed to engage Mr. Guggenheimer through
DKW as an advisory consultant to the merger process. This
agreement was formally signed on October 19, 2005.
On October 17, 2005, HaptoGuard submitted to Alteon an
offer letter for a merger transaction.
On October 18, 2005, Alteon initiated an internal
scientific and clinical and corporate due diligence review of
HaptoGuard and its technology and requested due diligence
materials from HaptoGuard. Due diligence meetings and review of
documents proceeded through December 2005.
On November 10, 2005, HaptoGuard submitted to Burrill on
behalf of Alteon, a revised merger proposal.
On November 15, 2005, the Strategic Planning Committee held
a meeting to discuss the revised proposal from HaptoGuard
relating to a combination with Alteon. Of the companies Alteon
was in discussion with, it was the consensus of the committee
members that HaptoGuard continued to present the most promising
I-33
strategic opportunity. It was resolved that Alteon should
proceed to complete due diligence, evaluate deal structure and
pricing and negotiate a strategic transaction with HaptoGuard.
At a November 22, 2005 Strategic Planning Committee
meeting, Burrill reviewed the status of the deal evaluation and
valuation process with respect to HaptoGuard and the companies
who were still in the discussion process with Alteon. Burrill
apprised the Committee of the ongoing due diligence process,
particularly issues that existed and that were being evaluated,
as well as the funding needs of the proposed relationships.
Burrill also apprised the Committee on the status of
conversations with Genentech relating to the restructuring of
its preferred stock ownership position.
On November 30, 2005, Alteon submitted to HaptoGuard a
memorandum of intent for a proposed transaction.
During December 2005, members of the HaptoGuard and Alteon
management teams held additional conference calls to discuss
valuation and deal parameters. Also during such period
discussions were held between Alteon and Genentech regarding the
restructuring of its convertible preferred stock.
On December 14, 2005, Alteon submitted to the American
Stock Exchange a document describing the proposed transaction
with HaptoGuard requesting their informal approval with respect
to the listing of shares.
During January and February, 2006, Alteon continued to discuss
with HaptoGuard and Genentech issues relating to the transaction
and with the American Stock Exchange the proposal for a deal
structure in order to secure its informal approval of the
listing of shares.
On January 18, 2006, Mintz Levin, Alteons legal
counsel, delivered to HaptoGuard merger agreement and related
document drafts.
On January 22, 2006, a memorandum of intent was sent to
Genentech by Alteon regarding a proposed restructuring of its
preferred stock ownership.
On February 1, 2006, Mr. Moch provided the Board with
an update on the companys ongoing discussions with
HaptoGuard, Genentech and the American Stock Exchange, as well
as the prospects relating to fund raising with their investment
banker, Rodman & Renshaw.
On February 12, 2006, Mintz Levin delivered a revised
merger agreement draft, reflecting changes to the structure of
the transaction to HaptoGuard. Alteon, HaptoGuard and their
respective legal counsel negotiated the agreement over the next
week.
On February 24, 2006, Mintz Levin delivered a memorandum of
intent to Genentech.
On February 28, 2006, Mintz Levin delivered a revised
merger agreement to HaptoGuard and Genentech. The agreements
were negotiated between such parties during March.
On March 1, 2006, Mr. Moch provided an update to
Alteons Board of Directors on the status of the
companys discussions with HaptoGuard, Genentech and the
American Stock Exchange. The Board discussed the potential for
entering into a consulting arrangement with HaptoGuard prior to
the execution of the transaction agreements. The Board approved
the consulting agreement.
Mr. Moch also discussed with the Board the need to initiate
fund raising with Rodman & Renshaw, to be completed
concurrent with the entering into the merger agreement with
HaptoGuard and Genentech. It was the sense of the Board that the
company should continue with such discussions at that time.
On March 3, 2006, AMEX provided informal approval for the
listing of shares to be issued in the transaction with
HaptoGuard.
On March 6, 2006, Mr. Moch, Mr. Guggenheimer,
Dr. Berkowitz and Ms. Tanner met with representatives
of Rodman & Renshaw to discuss potential financing
strategies for the proposed transaction. Such discussions
continued through March.
I-34
On April 4, 2006, Alteon engaged Rodman & Renshaw
to serve as the exclusive placement agent for the company in
connection with a proposed offer and private placement of common
stock and warrants of the company.
On April 13, 2006, the Alteon Board held a meeting during
which they approved the private placement through
Rodman & Renshaw and the proposed merger agreement with
HaptoGuard, including the restructuring of the Genentech
preferred stock relationship and authorized company management
to complete said transactions subject to legal review and
approval.
On April 19, 2006, the merger agreement between Alteon,
HaptoGuard and Genentech was signed by all parties and the
financing through Rodman & Renshaw was commenced.
On April 21, 2006, the financing through Rodman &
Renshaw was closed.
Factors Considered by, and Recommendation of, the Alteon
Board of Directors
Alteons board of directors has determined that the terms
of the merger and the merger agreement are fair to, and in the
best interests of, Alteon and its stockholders. Accordingly,
Alteons board of directors has approved the merger
agreement and the consummation of the merger and recommends that
you vote FOR approval of the merger and the merger
agreement and the issuance of shares and the transfer and
conversion of shares contemplated thereby. In reaching its
decision, Alteons board of directors consulted with and
received information and analyses from the management of Alteon
and its financial and legal advisors, and considered the
material factors described below.
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Reasons for the Merger Identified by the Alteon Board of
Directors |
Alteons board of directors has identified potential
benefits of the merger that they believe will contribute to the
success of the combined company, including the following:
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Anticipated improvements in revenue, cash flow and
profitability. Alteon believes that the merger will increase
the combined companys future revenues, accelerate profit
growth, and improve cash flow. |
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The strategic fit between Alteon and HaptoGuard in the
cardiovascular and diabetes arenas. Alteons lead
compound alagebrium is being developed for chronic
cardiovascular diseases and HaptoGuards lead compound,
ALT-2074, for acute
cardiovascular indications. The development program of both
companies is currently focused on cardiovascular disease of
diabetic patients. Each of Alteon and HaptoGuards lead
programs are based on different but complimentary inflammatory
mechanisms of action. |
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The synergy of the board of directors and the management of
the combined company. The board of directors and management
of the combined company will increase the experience and
expertise available to the company. |
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Anticipated synergies to be achieved by combining the
development and commercialization of HaptoGuard and Alteon
products. Alteon believes that the respective product
development strategies of HaptoGuard and Alteon complement each
other, potentially resulting in synergy between the two product
development and commercialization efforts of the companies.
Alteon believes that the combined products of Alteon and
HaptoGuard will result in synergies in the development of such
products in the cardiovascular and diabetes arenas. |
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Anticipated increase in ability to raise capital for
development and commercialization of products. Alteon
believes that the restructuring of the Genentech preferred stock
ownership and combined products of Alteon and HaptoGuard will
increase the ability of the combined company to raise capital
for the development and commercialization of its products. |
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The potential to improve Alteons strategic position in
the markets it serves. Alteon believes that the merger will
improve the strategic position of the combined company. |
I-35
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Other Factors Considered by the Alteon Board of
Directors |
In the course of deliberations, the Alteon board reviewed with
Alteon management and its legal and financial advisors a number
of additional factors relevant to the merger, including the
following:
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historical information concerning HaptoGuards and
Alteons respective businesses, financial performance and
condition, operations, management and competitive position,
including results of operations during the most recent fiscal
year for each company; |
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Alteon managements view of the financial condition,
results of operations and businesses of HaptoGuard and Alteon
before and after giving effect to the merger, based on
management due diligence; |
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current financial market conditions and historical market
prices, volatility and trading information with respect to
Alteon common stock; |
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Alteon managements view as to the potential for other
third parties to enter into strategic relationships with or to
acquire HaptoGuard; |
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certain terms of the merger agreement, including the provisions
that prohibit HaptoGuard from soliciting other acquisition
offers, the provisions that require HaptoGuard to pay Alteon a
termination fee if the merger agreement is terminated by
HaptoGuard for specified reasons, and the provisions that
require Alteon to pay HaptoGuard a termination fee if the merger
agreement is terminated by Alteon for specified reasons; |
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other terms of the merger agreement, including the parties
respective representations, warranties and covenants, and the
conditions to the parties respective obligations; |
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an assessment of alternatives to the merger, including
development opportunities and other possible acquisition
candidates, and the determination that the merger was a
strategic fit and presented a unique opportunity to enhance and
expand Alteons operations, product and service offerings
and position Alteon for future growth; and |
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the impact of the merger on Alteons stockholders and
employees. |
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Potentially Negative Factors Considered by the Alteon
Board of Directors |
Alteons board of directors also identified and considered
a variety of potentially negative factors in its deliberations
concerning the merger, including, but not limited to:
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the risk that the potential benefits sought in the merger might
not be fully realized; |
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the costs and timing of achieving the expected benefits may
exceed managements estimates; |
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the possibility that the merger might not be completed, and the
potential adverse effect of the public announcement of the
merger on Alteons reputation and ability to obtain
financing in the future; |
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the significant number of shares to be issued to HaptoGuard
stockholders; and |
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other risks described under Risk Factors beginning
on
page I- of
this Proxy Statement. |
Alteons board of directors believes that these risks were
outweighed by the potential benefits of the merger. The
foregoing discussion is not exhaustive of all factors considered
by Alteons board of directors, but it does describe all
material factors considered by the Alteon board of directors.
Individual members of Alteons board of directors may have
considered different factors, and Alteons board of
directors evaluated these factors as a whole and did not
quantify or otherwise assign relative weights to factors
considered. There can be no assurance that the potential
synergies or opportunities considered by the board of directors
of Alteon will be achieved through consummation of the offer.
See Risk Factors beginning on
page I- .
I-36
Recommendation of Alteons Board of Directors
After careful consideration, Alteons board of directors
has determined the merger to be fair to Alteons
stockholders and in the best interests of Alteons
stockholders and declared the merger advisable. Alteons
board of directors has approved the merger agreement and
recommends approval by Alteons stockholders of the
issuance of the shares pursuant to the merger agreement. In
considering the recommendation of the Alteon board of directors
with respect to the merger agreement, you should be aware that
certain directors and officers of Alteon have certain interests
in the merger that are in addition to the interests of Alteon
stockholders generally.
Factors Considered by, and Recommendation of, the HaptoGuard
Board of Directors
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Reasons for the Merger Identified by the HaptoGuard Board
of Directors |
In reaching its decision to approve the merger agreement,
HaptoGuards board of directors consulted with
HaptoGuards management and legal and financial advisors
regarding strategic, legal, operational and financial aspects of
the transaction. In the course of reaching its decision to
approve the merger agreement and the merger, the HaptoGuard
board of directors considered a variety of factors in favor of
the merger, including but not limited to, the following:
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Anticipated improvements in the ability to raise capital.
Because HaptoGuard does not contemplate generating significant
revenues in the near future, HaptoGuards board of
directors believe HaptoGuards ability to raise capital in
crucial to its viability. HaptoGuards board of directors
believes that a company with more potential drug candidates and
a larger infrastructure will be more likely to attract capital. |
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The belief of the HaptoGuard board of directors that the
merger represented the best value reasonably available to
HaptoGuards stockholders for their shares of
HaptoGuard. HaptoGuards board of directors concluded
that the merger represents the best value reasonably available
to HaptoGuards stockholders. The HaptoGuard board of
directors also determined that no other potential strategic
partner had expressed an interest in a merger, acquisition or
other business combination that would likely be on terms as
favorable to HaptoGuards stockholders as those of the
merger. |
|
|
|
The likelihood that the combined company will have better
opportunities for future growth through diversification and
growth of the number of potential drug candidates.
HaptoGuards board of directors and management analyzed the
technology, business, financial performance and condition,
prospects and products of each of Alteon and HaptoGuard as
separate entities and on a combined basis, and the HaptoGuard
board of directors considers it likely that the merger of Alteon
and HaptoGuard will provide the combined company with greater
opportunities for growth than are available to HaptoGuard as a
stand-alone company. HaptoGuards board of directors
considers the anticipated revenue growth of the combined company
to be greater than that achievable by HaptoGuard alone. |
|
|
|
The ability of HaptoGuards stockholders to continue to
participate in the growth of the business conducted by Alteon
and HaptoGuard after the completion of the merger.
HaptoGuards board of directors believes that
HaptoGuards stockholders will have the opportunity to
participate in the combined company, with the potential to
enhance stockholder value through share ownership in a larger,
more competitive company, through their receipt of Alteon common
stock in the merger, and to benefit from the potential
appreciation in value of Alteon common stock. |
|
|
|
The strategic fit between Alteon and HaptoGuard.
HaptoGuards board of directors determined that the
combination of Alteon and HaptoGuard represented a good
strategic fit. The combined company potentially could take
advantage of the complementary nature of its product platforms
in cardiovascular diseases, diabetes and other inflammatory
diseases. In addition, HaptoGuards board of directors
believes that the opportunities for the combined company to
market its products will exceed those currently available to
HaptoGuard. |
I-37
|
|
|
|
|
The importance of scale in the increasingly competitive
market environments in which both Alteon and HaptoGuard
operate. HaptoGuards board of directors believes that
the merger will enhance the ability of the combined company to
compete effectively in competitive market environments, because
the combined company will have greater financial resources and a
wider array of product offerings. |
|
|
|
The belief that the combined company will be able to better
develop and commercialize its products. Because of the
complementary nature of the markets in which Alteon and
HaptoGuard historically have focused their efforts,
HaptoGuards board of directors believes that the
opportunity for the combined company to better develop and
commercialize products is substantial. |
|
|
|
Other Factors Considered by the HaptoGuard Board of
Directors |
In the course of its consideration of the merger, the HaptoGuard
board of directors reviewed with HaptoGuard management and its
legal and financial advisors a number of additional factors
relative to the merger, including the following:
|
|
|
|
|
the strategic and financial alternatives available to
HaptoGuard, including the business, financial and execution
risks of remaining independent, continuing as a stand-alone
entity, seeking to acquire another company, seeking to engage in
one or more joint ventures, seeking to engage in a combination
with a company other than Alteon, or seeking to complete a
private placement of HaptoGuard common stock; |
|
|
|
the results of HaptoGuards due diligence investigation of
Alteon; |
|
|
|
historical and current information concerning HaptoGuards
and Alteons respective businesses, financial performance
and condition, operations, management, competitive positions,
and prospects, both before and after giving effect to the merger; |
|
|
|
that, by combining operations, the combined company will likely
have enhanced liquidity and access to capital markets; |
|
|
|
the terms and conditions of the merger agreement; |
|
|
|
the likely impact of the offer and the transaction on
HaptoGuards employees; and |
|
|
|
the qualification of the merger as a tax-free transaction for
United States federal income tax purposes. |
|
|
|
Potentially Negative Factors Considered by the HaptoGuard
Board of Directors |
HaptoGuards board of directors also identified and
considered potentially negative factors relating to the merger
in its deliberations, including but not limited to:
|
|
|
|
|
the fact that under the terms of the merger agreement,
HaptoGuard was required to terminate all discussions and
negotiations with other parties who might be interested in
negotiating a transaction with HaptoGuard, and that HaptoGuard
is restricted in its ability to solicit other acquisition
proposals; |
|
|
|
the challenges and costs of combining the operations of the two
companies and the substantial expenses to be incurred in
connection with the merger, including the risks that delays or
difficulties in completing the integration could adversely
affect the combined companys operating results and
preclude or delay the achievement of some or all of the benefits
anticipated from the merger; |
|
|
|
the potential disruption to partner relationships important to
either company as a result of the merger; |
|
|
|
the potential disruptions as a result of the integration process; |
|
|
|
the possibility that the reactions of existing and potential
competitors could adversely affect the competitive environment
in which either company currently operates, or the combined
company could operate; |
I-38
|
|
|
|
|
the termination fee payable by HaptoGuard to Alteon if the
merger agreement is terminated by HaptoGuard for specified
reasons, as well as the potential deterrence of other potential
acquirors resulting from the existence of that termination fee; |
|
|
|
the risk of diverting managements attention from other
strategic priorities to implement merger integration efforts, as
well as the fact that HaptoGuard officers and employees have and
will expend considerable efforts attempting to complete the
merger and have and will experience significant distractions
from their work during the pendency of the merger; |
|
|
|
the significant transaction costs that HaptoGuard will have
incurred in connection with the merger even if the merger is not
consummated; |
|
|
|
the interests that certain executive officers and directors of
HaptoGuard may have with respect to the merger in addition to
their interests as stockholders of HaptoGuard generally, as
described in Interests of Certain Persons in the
Merger on
page I- ; |
|
|
|
the risk that the merger might not be consummated in a timely
manner or at all; and |
|
|
|
various other applicable risks associated with the merger and
the combined company, including those described under Risk
Factors beginning on
page I- of
this Proxy Statement. |
HaptoGuards board of directors believes that these risks
were outweighed by the potential benefits of the merger. The
foregoing discussion of the information and factors considered
by the board of directors of HaptoGuard is not intended to be
exhaustive. In view of the wide variety of material factors
considered in connection with the evaluation of the offer, and
the complexity of these matters, the board of directors of
HaptoGuard did not find it practicable to, and did not, quantify
or otherwise attempt to assign any relative weight to the
various factors considered. In addition, the board of directors
of HaptoGuard did not undertake to make any specific
determination as to whether any particular factor, or any aspect
of any particular factor, was favorable or unfavorable to the
ultimate determination of the board of directors of HaptoGuard,
but rather the board of directors of HaptoGuard conducted an
overall analysis of the factors described above, including
discussions with and questioning of HaptoGuards senior
management and legal advisors. In considering the factors
described above, individual members of the board of directors of
HaptoGuard may have given different weight to different factors.
There can be no assurance that the potential synergies or
opportunities considered by the board of directors of HaptoGuard
will be achieved though consummation of the merger. See
Risk Factors beginning on page
I- .
Recommendation of HaptoGuards Board of Directors
After careful consideration, HaptoGuards board of
directors has determined, by unanimous vote of those directors
voting on such matters, the merger to be fair to the
stockholders of HaptoGuard and in the best interests of such
stockholders and declared the merger advisable.
HaptoGuards board of directors approved the merger
agreement and recommends adoption of the merger agreement by the
stockholders of HaptoGuard. In considering the
recommendation of the HaptoGuard board of directors with respect
to the merger agreement, you should be aware that certain
directors and officers of HaptoGuard have certain interests in
the merger that are different from, or are in addition to, the
interests of HaptoGuard stockholders generally. See
Interests of Certain Persons in the
Merger.
Accounting Treatment
The merger will be accounted for as a purchase by Alteon under
accounting principles generally accepted in the United States.
Under the purchase method of accounting, the assets and
liabilities of HaptoGuard will be recorded, as of the completion
of the merger, at their respective fair values and added to
those of Alteon. The reported financial condition and results of
operations of Alteon issued after completion of the merger will
reflect HaptoGuards balances and results after completion
of the merger, but will not be restated retroactively to reflect
the historical financial position or results of operations of
HaptoGuard. Following the completion of
I-39
the merger, the net loss and balance sheet of the combined
company will reflect purchase accounting adjustments, including
a one-time in-process research and development charge.
Material U.S. Federal Income Tax Consequences of the
Merger
The following is a summary of the material U.S. federal
income tax consequences of the merger that are generally
applicable to holders of HaptoGuard common stock. This
discussion is based upon the Internal Revenue Code of 1986, as
amended, which are referred to as the Code, the regulations
promulgated under the Code, Internal Revenue Service rulings,
and judicial and administrative rulings in effect as of the date
hereof, all of which are subject to change, possibly with
retroactive effect. Any such change could affect the accuracy of
the statements and conclusions discussed below and the tax
consequences of the merger. This discussion does not address all
aspects of federal income taxation that may be relevant to a
HaptoGuard stockholder in light of the stockholders
particular circumstances, or to those HaptoGuard stockholders
who are subject to special rules, such as:
|
|
|
|
|
financial institutions and mutual funds; |
|
|
|
banks; |
|
|
|
insurance companies; |
|
|
|
investment companies; |
|
|
|
retirement plans; |
|
|
|
tax-exempt organizations; |
|
|
|
dealers in securities; |
|
|
|
traders in securities that elect to use a
mark-to-market method; |
|
|
|
persons that hold their HaptoGuard common stock as part of a
straddle, a hedge against a currency risk or a constructive sale
or conversion transaction; |
|
|
|
persons that are or who hold their HaptoGuard common stock
through partnerships or other pass-through entities; |
|
|
|
persons who are not citizens or residents of the United States
or who are foreign corporations, foreign partnerships or foreign
estates or trusts for U.S. federal income tax purposes; |
|
|
|
persons whose functional currency is not the U.S. dollar; |
|
|
|
persons who hold HaptoGuard stock as qualified small business
stock within the meaning of Section 1202 of the Code; |
|
|
|
persons who are subject to the alternative minimum tax
provisions of the Code; or |
|
|
|
persons who acquired their HaptoGuard common stock in connection
with stock option or stock purchase plans or in some other
compensatory transaction. |
This discussion assumes that HaptoGuards stockholders hold
their shares of HaptoGuard common stock as capital assets. In
addition, the following discussion does not address the tax
consequences of the merger under foreign, state or local tax
laws. Furthermore, the discussion does not address the tax
consequences of transactions effected before, after, or at the
same time as the merger, whether or not they are in connection
with the merger, including, without limitation, transactions in
which persons acquired HaptoGuard common stock or disposed of
Alteon shares. HaptoGuard stockholders are urged to consult
their tax advisors as to the U.S. federal income tax
consequences of the merger and related reporting obligations, as
well as the effects of state, local and
non-U.S. tax laws
and U.S. tax laws other than income tax laws.
It is the opinion of Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., counsel to Alteon, that, subject to the
qualifications set forth herein, the material U.S. federal
income tax consequences of the merger are as set forth below,
such tax opinions are based on certain assumptions and subject
to certain limitations and
I-40
qualifications, including the assumptions that the merger will
be consummated as described in this Proxy Statement and the
merger agreement and that the factual representations contained
in letters delivered to counsel by Alteon in connection with the
tax opinions are true, correct and complete as of the date of
the letters and will remain true, correct and complete through
the effective time of the merger. An opinion of counsel only
represents counsels best judgment, and has no binding
effect or official status of any kind, and no assurance can be
given that contrary positions may not be taken by the IRS or a
court considering the issues. Neither Alteon nor HaptoGuard has
requested or will request a ruling from the IRS with regard to
any of the federal income tax consequences of the merger.
|
|
|
Tax Treatment of HaptoGuard Stockholders in Merger |
The following U.S. federal income tax consequences will
result to HaptoGuard stockholders who exchange their HaptoGuard
stock for Alteon stock:
|
|
|
|
|
Qualification as a Reorganization. The merger will be
treated as a reorganization within the meaning of
Section 368(a) of the United States federal income tax laws. |
|
|
|
No Gain or Loss. Subject to the discussion below
regarding cash received in lieu of fractional shares of Alteon
common stock, as well as cash received upon exercise of
appraisal rights, HaptoGuard stockholders receiving Alteon
common stock in the merger in exchange for HaptoGuard common
stock will not recognize any gain or loss as a result of the
receipt of Alteon common stock in the merger. |
|
|
|
Tax Basis and Holding Period. A HaptoGuard
stockholders aggregate tax basis in the Alteon common
stock, including any fractional shares deemed received, as
discussed below, will be equal to the aggregate tax basis of the
HaptoGuard common stock surrendered in the exchange. A
HaptoGuard stockholders holding period for the Alteon
common stock received will include the holding period for the
HaptoGuard common stock surrendered in the exchange. |
|
|
|
Cash Payments Received in Lieu of Fractional Shares and/or
Fractional Warrants. |
|
|
|
|
|
Gain or Loss. Cash payments received by HaptoGuard
stockholders in lieu of fractional shares of Alteon common stock
will be treated as if such fractional shares had been issued in
the merger and then redeemed by Alteon. A HaptoGuard stockholder
receiving such cash will generally recognize capital gain or
loss with respect to such payment equal to the difference, if
any, between such HaptoGuard stockholders tax basis in the
fractional share, and the amount of cash received. The capital
gain or loss will be long-term if the holding period for such
HaptoGuard common stock is more than one year as of the date of
the exchange. |
|
|
|
Tax Treatment of the Entities. |
|
|
|
|
|
No Gain or Loss. No gain or loss will be recognized by
HaptoGuard, Alteon or Alteon Merger Sub, Inc. as a result of
this merger. |
Other relevant tax considerations in connection with the merger
include the following:
Payments in connection with the merger may be subject to
backup withholding at a 28% rate. Backup withholding
generally applies if a holder: (a) fails to furnish his,
her or its taxpayer identification number, or TIN,
(b) furnishes an incorrect TIN, (c) fails to properly
include a reportable interest or dividend payment on his, her or
its United States federal income tax return or (d) under
certain circumstances, fails to provide a certified statement,
signed under penalties of perjury, that the TIN provided is its
correct number and that the stockholder is not subject to backup
withholding. Backup withholding is not an additional tax but
merely an advance payment, which may be refunded to the extent
it results in an overpayment of tax. Certain persons generally
are entitled to exemption from backup withholding, including
corporations, financial institutions and certain foreign
stockholders if such foreign stockholders submit a statement,
signed under penalties of perjury, attesting to their exempt
status. Certain penalties apply for failure to furnish correct
information and for failure to include reportable payments in
income. Each HaptoGuard stockholder should consult such
I-41
stockholders own tax advisor as to his, her or its
qualification for exemption from backup withholding and the
procedure for obtaining such exemption.
HaptoGuard stockholders receiving Alteon common stock in the
merger should file a statement with their U.S. federal
income tax returns for the year in which the merger occurs,
setting forth the tax basis in the HaptoGuard common stock
exchanged in the merger and the fair market values of the Alteon
common stock received in the merger.
The preceding discussion is intended only as a summary of the
material U.S. federal income tax consequences of the merger
and does not purport to be a complete analysis or discussion of
all potential tax effects relevant thereto. Thus, HaptoGuard
stockholders are urged to consult their own tax advisors as to
the specific tax consequences to them of the merger, including
tax return reporting requirements, the applicability and effect
of foreign, federal, state, local and other applicable tax laws
and the effect of any proposed changes in the tax laws.
Regulatory Approvals
Neither Alteon nor HaptoGuard is aware of any government
regulatory approvals required to be obtained with respect to the
consummation of the merger, except for the filing of a
certificate of merger with the office of the Secretary of State
of the State of Delaware, and compliance with all applicable
state securities laws regarding the offering and issuance of the
merger shares.
I-42
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL
STATEMENTS
Introduction to Unaudited Pro Forma Condensed Combined
Financial Statements
The following Unaudited Pro Forma Condensed Combined Financial
Statements combine the historical balance sheets and statements
of operations of Alteon and HaptoGuard giving effect to the
merger using the purchase method of accounting.
Unaudited Pro Forma Condensed Combined Financial Data
The Unaudited Pro Forma Condensed Combined Statements of
Operations for the three months ended March 31, 2006 and
the year ended December 31, 2005 and the Unaudited Pro
Forma Condensed Combined Balance Sheet as of March 31, 2006
are based on the historical financial statements of Alteon and
HaptoGuard, after giving effect to the acquisition of HaptoGuard.
The Unaudited Pro Forma Condensed Combined Statements of
Operations are presented as if the combination had taken place
on January 1, 2005. It is expected that following the
acquisition Alteon will incur additional costs in connection
with integrating the operations of the two companies. These
initiatives are expected to involve the termination of employees
and the elimination of redundant facilities. Plans with respect
to these restructuring activities are in the process of being
developed. As such, integration-related costs and the related
anticipated cost savings are not included in the accompanying
Unaudited Pro Forma Condensed Combined Financial Statements.
The Unaudited Pro Forma Condensed Combined Balance Sheet is
presented to give effect to the acquisition as if it occurred on
March 31, 2006, combines the balance sheet for Alteon as of
March 31, 2006 with the balance sheet of HaptoGuard as of
March 31, 2006 and reflects the allocation of the purchase
price to the HaptoGuard assets acquired and liabilities assumed.
The Unaudited Pro Forma Condensed Combined Financial Statements
are based on the estimates and assumptions set forth in the
accompanying notes to such statements. The Unaudited Pro Forma
Condensed Combined Financial Statements are prepared for
illustrative purposes only and are not necessarily indicative of
the results that would have been achieved had the transaction
been consummated as of the date indicated or that may be
achieved in the future.
The Unaudited Pro Forma Condensed Combined Financial Statements
should be read in conjunction with the historical financial
statements of Alteon and the historical financial statements of
HaptoGuard attached to this Proxy Statement. See Alteon
Financial Statements and Annex G attached to this Proxy
Statement.
I-43
DRAFT
UNAUDITED PROFORMA CONDENSED COMBINED BALANCE SHEET
March 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proforma | |
|
Proforma | |
|
|
Alteon Inc | |
|
HaptoGuard | |
|
Adjustments | |
|
Combined | |
|
|
| |
|
| |
|
| |
|
| |
|
|
Unaudited | |
|
|
(In 000s) | |
ASSETS |
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
4,469 |
|
|
$ |
3 |
|
|
|
2,600 |
(6) |
|
$ |
6,972 |
|
|
|
|
|
|
|
|
|
|
|
|
(100 |
)(6) |
|
|
|
|
Other current assets
|
|
|
73 |
|
|
|
1 |
|
|
|
|
|
|
|
74 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
4,542 |
|
|
|
4 |
|
|
|
2,500 |
|
|
|
7,046 |
|
PROPERTY AND EQUIPMENT, NET
|
|
|
41 |
|
|
|
5 |
|
|
|
|
|
|
|
46 |
|
RESTRICTED CASH
|
|
|
150 |
|
|
|
|
|
|
|
|
|
|
|
150 |
|
OTHER ASSETS
|
|
|
424 |
|
|
|
24 |
|
|
|
(424 |
)(4) |
|
|
20 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$ |
5,157 |
|
|
$ |
33 |
|
|
$ |
2,076 |
|
|
$ |
7,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
190 |
|
|
$ |
188 |
|
|
|
|
|
|
$ |
378 |
|
Accrued expenses
|
|
|
596 |
|
|
|
54 |
|
|
|
376 |
(4) |
|
|
1,026 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
786 |
|
|
|
242 |
|
|
|
376 |
|
|
|
1,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock
|
|
|
1 |
|
|
|
|
|
|
|
(1 |
)(7) |
|
|
(7 |
) |
Common stock
|
|
|
580 |
|
|
|
|
|
|
|
374 |
(3) |
|
|
1,199 |
|
|
|
|
|
|
|
|
|
|
|
|
110 |
(6) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135 |
(7) |
|
|
|
|
Additional paid in capital
|
|
|
229,400 |
|
|
|
2,897 |
|
|
|
(2,897 |
)(2) |
|
|
240,401 |
|
|
|
|
|
|
|
|
|
|
|
|
8,426 |
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,492 |
(6) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(100 |
)(6) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(135 |
)(7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
318 |
(5) |
|
|
|
|
Accumulated deficit
|
|
|
(225,610 |
) |
|
|
(3,106 |
) |
|
|
3,106 |
(2) |
|
|
(235,738 |
) |
|
|
|
|
|
|
|
|
|
|
|
(10,128 |
)(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
4,371 |
|
|
|
(209 |
) |
|
|
1,700 |
|
|
|
5,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS EQUITY
|
|
$ |
5,157 |
|
|
$ |
33 |
|
|
$ |
2,076 |
|
|
$ |
7,266 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I-44
DRAFT
UNAUDITED PROFORMA CONDENSED COMBINED STATEMENT OF
OPERATIONS
FOR THE 12 MONTHS ENDED DECEMBER 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proforma | |
|
Proforma | |
|
|
Alteon Inc | |
|
HaptoGuard | |
|
Adjustments | |
|
Combined | |
|
|
| |
|
| |
|
| |
|
| |
|
|
Unaudited | |
|
|
(In 000s except per share amounts) | |
INCOME:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTMENT INCOME
|
|
$ |
358 |
|
|
$ |
10 |
|
|
|
|
|
|
$ |
368 |
|
OTHER INCOME
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL INCOME
|
|
$ |
458 |
|
|
$ |
10 |
|
|
|
|
|
|
$ |
468 |
|
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RESEARCH AND DEVELOPMENT
|
|
|
9,074 |
|
|
|
916 |
|
|
|
|
|
|
|
9,990 |
|
GENERAL AND ADMINISTRATIVE
|
|
|
4,325 |
|
|
|
749 |
|
|
|
|
|
|
|
5,074 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL EXPENSES
|
|
|
13,399 |
|
|
|
1,665 |
|
|
|
|
|
|
|
15,064 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME TAX BENEFIT
|
|
|
(12,941 |
) |
|
|
(1,655 |
) |
|
|
|
|
|
$ |
(14,596 |
) |
INCOME TAX BENEFIT
|
|
|
326 |
|
|
|
|
|
|
|
|
|
|
|
326 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
|
(12,615 |
) |
|
|
(1,655 |
) |
|
|
|
|
|
|
(14,270 |
) |
PREFERRED STOCK DIVIDENDS
|
|
|
4,486 |
|
|
|
|
|
|
|
(4,486 |
)(7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS APPLICABLE TO COMMON SHAREHOLDERS
|
|
$ |
(17,101 |
) |
|
$ |
(1,655 |
) |
|
$ |
4,486 |
|
|
$ |
(14,270 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
|
|
$ |
(0.30 |
) |
|
$ |
|
|
|
|
|
|
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE SHARES
|
|
|
57,639,255 |
|
|
|
|
|
|
|
|
|
|
|
119,491,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calculation of pro forma adjustment for weighted average
shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALTEON INC WEIGHTED AVERAGE SHARES
|
|
|
57,639,255 |
|
|
|
|
|
|
|
|
|
|
|
|
|
add:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO HAPTOGUARD SHAREHOLDERS
|
|
|
37,399,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO PIPE SHAREHOLDERS
|
|
|
10,340,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO RODMAN AND RENSHAW (PIPE)
|
|
|
620,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO GENENTECH UPON CONVERSION
|
|
|
13,492,349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
|
119,491,069 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I-45
DRAFT
UNAUDITED PROFORMA CONDENSED COMBINED STATEMENT OF
OPERATIONS
FOR THE 3 MONTHS ENDED MARCH 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proforma | |
|
Proforma | |
|
|
Alteon Inc | |
|
HaptoGuard | |
|
Adjustments | |
|
Combined | |
|
|
| |
|
| |
|
| |
|
| |
|
|
Unaudited | |
|
|
(In 000s except per share amounts) | |
INCOME:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTMENT INCOME
|
|
$ |
60 |
|
|
$ |
2 |
|
|
|
|
|
|
$ |
62 |
|
OTHER INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL INCOME
|
|
$ |
60 |
|
|
$ |
2 |
|
|
|
|
|
|
$ |
62 |
|
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RESEARCH AND DEVELOPMENT
|
|
|
450 |
|
|
|
481 |
|
|
|
|
|
|
|
931 |
|
GENERAL AND ADMINISTRATIVE
|
|
|
1,232 |
|
|
|
172 |
|
|
|
|
|
|
|
1,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL EXPENSES
|
|
|
1,682 |
|
|
|
653 |
|
|
|
|
|
|
|
2,335 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME TAX BENEFIT
|
|
|
(1,622 |
) |
|
|
(651 |
) |
|
|
|
|
|
|
(2,273 |
) |
INCOME TAX BENEFIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
|
(1,622 |
) |
|
|
(651 |
) |
|
|
|
|
|
|
(2,273 |
) |
PREFERRED STOCK DIVIDENDS
|
|
|
1,175 |
|
|
|
|
|
|
|
(1,175 |
)(7) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS APPLICABLE TO COMMON SHAREHOLDERS
|
|
$ |
(2,797 |
) |
|
$ |
(651 |
) |
|
|
(1,175 |
) |
|
$ |
(2,273 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS PER SHARE APPLICABLE TO COMMON SHAREHOLDERS
|
|
$ |
(0.05 |
) |
|
$ |
|
|
|
|
|
|
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE SHARES
|
|
|
57,996,711 |
|
|
|
|
|
|
|
|
|
|
|
119,848,525 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calculation of pro forma adjustment for weighted average
shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALTEON INC WEIGHTED AVERAGE SHARES
|
|
|
57,996,711 |
|
|
|
|
|
|
|
|
|
|
|
|
|
add:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO HAPTOGUARD SHAREHOLDERS
|
|
|
37,399,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO PIPE SHAREHOLDERS
|
|
|
10,340,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO RODMAN AND RENSHAW (PIPE)
|
|
|
620,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
COMMON SHARES ISSUED TO GENENTECH UPON CONVERSION
|
|
|
13,492,349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
|
119,848,525 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
I-46
Notes to Unaudited Pro Forma Condensed Combined Financial
Statements
(1) Description of Transaction and Basis of Presentation
On April 19, 2006, Alteon entered into a definitive merger
agreement with HaptoGuard, Inc., Genentech, Inc. and Alteon
Merger Sub, Inc., a wholly-owned subsidiary of Alteon. The
merger agreement provides that upon the terms and subject to the
conditions set forth in the merger agreement, Merger Sub will
merge with and into HaptoGuard, with HaptoGuard becoming the
surviving corporation and a wholly-owned subsidiary of Alteon.
At the effective time of the merger, (a) pursuant to the
terms of Alteons certificate of incorporation and the
merger agreement, Genentech will convert a portion of
Alteons preferred stock that it holds into shares of
Alteons common stock, such that the number of such shares
of common stock to be issued will, when added to the shares of
common stock already owned by Genentech, equal 19.99% of
Alteons outstanding common stock as calculated after the
conversion of the preferred stock; (b) Genentech will
transfer to HaptoGuard a portion of Alteon preferred stock held
by it, in such an amount that will convert to a number of shares
of Alteon common stock, in accordance with the terms of
Alteons certificate of incorporation and the terms of the
merger agreement equal in value to $3,500,000 (the price per
share of Alteon common stock based on the volume-weighted
average price of the per share selling prices on the American
Stock Exchange for the twenty (20) trading days immediately
preceding the signing of the merger agreement);
(c) Genentech will transfer to Alteon all of the remaining
shares of Alteon preferred stock held by Genentech which are not
either converted or transferred, and such shares of preferred
stock shall cease to be outstanding, be canceled and retired
without payment of any consideration therefor other than
pursuant to the terms of the merger agreement and cease to
exist; (d) every share of HaptoGuard common stock issued
and outstanding immediately prior to the effective time of the
merger (other than the dissenting shares) shall be converted
into the right to receive a number of shares of Alteon common
stock equal to the quotient of (i) the sum of (x) a
number of shares of Alteon common stock to be issued by Alteon
to HaptoGuard stockholders at the effective time with a value of
$5.3 million, plus (y) the number of shares of Alteon
common stock to be issued pursuant to
section (b) above at the effective time, the market
value of (x) and (y) to be equal to $8,800,000,
divided by (ii) the sum of (x) the number of
outstanding shares of HaptoGuard common stock at the effective
time, and (y) the number of Share Equivalents (as defined
below) (the Exchange Ratio); and (e) each share
of HaptoGuard common stock held in the treasury of HaptoGuard
and each share of HaptoGuard common stock owned by Alteon or by
any direct or indirect wholly-owned subsidiary of HaptoGuard or
Alteon immediately prior to the effective time shall, by virtue
of the merger and without any action on the part of the holder
thereof, cease to be outstanding, be canceled and retired
without payment of any consideration therefor other than
pursuant to the terms of the merger agreement and cease to
exist. Alteon will assume each outstanding vested or unvested
option to purchase HaptoGuard common stock, which will be
exercisable following the merger for the number of shares of
HaptoGuard common stock that were purchasable under such option
immediately prior to the effective time of the merger multiplied
by the Exchange Ratio (rounded down to the nearest whole number
of shares of common stock) and the per share exercise price for
the shares of HaptoGuard common stock issuable upon exercise of
such assumed option will be equal to the quotient determined by
dividing the exercise price per share of HaptoGuard common stock
at which such option was exercisable immediately prior to the
effective time of the merger by the Exchange Ratio (and rounding
the resulting exercise price up to the nearest whole cent). All
outstanding warrants to purchase HaptoGuard common stock will be
exchanged for the right to receive a number of shares of Alteon
common stock (Share Equivalents) at the effective
time of the merger which will have a market value equal to the
difference between (i) the market value of the product of
the number of shares of HaptoGuard common stock that were
purchasable under such warrants immediately prior to the
Effective Time multiplied by the Exchange Ratio (rounded down to
the nearest whole number of shares of Alteon common stock) and
(ii) the total exercise price of such warrant.
HaptoGuard has made customary representations, warranties and
covenants in the merger agreement, including, among others,
covenants (i) to conduct its business in the ordinary
course consistent with past practice during the interim period
between the execution of the merger agreement and consummation
of the
I-47
merger, (ii) not to engage in certain kinds of transactions
during such period, and (iii) not to solicit proposals
relating to alternative business combination transactions.
Alteon and Merger Sub have also made customary representations,
warranties and covenants in the merger agreement, including
covenants (i) to conduct its business in the ordinary
course consistent with past practice during the interim period
between the execution of the merger agreement and consummation
of the merger and (ii) not to engage in certain kinds of
transactions during such period.
Consummation of the merger is subject to certain conditions,
including (i) receipt of any necessary governmental
approvals, (ii) approval of the merger agreement and the
merger by the stockholders of Alteon and HaptoGuard,
(iii) absence of any law or order prohibiting the
consummation of the merger, and (iv) subject to certain
exceptions, the accuracy of the representations and warranties
made by HaptoGuard and by Alteon.
The merger agreement contains certain termination rights for
both HaptoGuard and Alteon. Upon termination of the merger
agreement under specified circumstances, the terminating party
would be required to pay the other party a termination fee of
$440,000 plus any payments already made pursuant to the merger
agreement.
The merger will be accounted for as a purchase by Alteon under
accounting principles generally accepted in the United States of
America. Under the purchase method of accounting, the net
liabilities of HaptoGuard will be recorded as of the acquisition
date, at their respective fair values, and combined with those
of Alteon. The reported financial condition and results of
operations of Alteon will reflect these values, but will not be
restated retroactively to reflect the historical financial
position or results of operations of HaptoGuard.
As required by FASB Interpretation No. 4,
Applicability of FASB Statement No. 2 to Business
Combinations Accounted for by the Purchase Method, the
Company will record a charge upon the closing of the transaction
of approximately $10,092,000 for the estimate of the portion of
the purchase price allocated to acquired IPRD (in-process
research and development).
A valuation using the guidance in SFAS NO. 141,
Business Combinations and the AICPA Practice Aid
Assets Acquired in a Business Combination to Be Used in
Research and Development Activities: A Focus on Software,
Electronic Devices and Pharmaceutical Industries was
performed to determine the fair value of research and
development projects of HaptoGuard which were in-process but not
yet completed.
(2) To eliminate the stockholders deficiency accounts
of HaptoGuard.
(3) To reflect the issuance of 37,399,065 shares of
common stock to HaptoGuard shareholders, including
22,524,437 shares from Alteon and 14,874,628 shares
from the conversion of Genentechs preferred stock
ownership in Alteon. The number of shares was calculated by
dividing the preliminary purchase price of $8,800,000 by the
20-day volume weighted average market price of the stock or
$0.2353.
The components of the preliminary purchase price, which we
anticipate will be charged to IPRD, are summarized as follows
(000s):
|
|
|
|
|
Common stock issued
|
|
$ |
8,800 |
|
Fair value of HaptoGuard vested options @ 3/31/06
|
|
|
318 |
|
Estimated transaction costs
|
|
|
800 |
|
|
|
|
|
|
|
|
9,918 |
|
Net liabilities assumed
|
|
|
210 |
|
|
|
|
|
Total purchase price
|
|
$ |
10,128 |
|
|
|
|
|
(4) To reflect estimated transaction costs.
(5) To reflect the fair value of vested HaptoGuard stock
options exchanged for Alteon options.
I-48
(6) To reflect the issuance of 10,960,400 shares of
common stock in connection with a PIPE to new investors at
signing of definitive merger agreement. Includes 620,400 common
shares issued to placement agent in lieu of cash fee. 10,340,000
sold for a price of $0.25 providing gross proceeds of $2,585,000
less approximately $100,000 in other cash expenses for net
proceeds to Alteon of $2,485,000.
(7) To reflect the partial conversion and cancellation of
all outstanding preferred stock to Genentech in exchange for
13,492,349 shares of common stock and certain rights and
royalties as noted in the definitive merger agreement.
I-49
INTERESTS OF CERTAIN PERSONS IN THE MERGER
Interests of Alteons Executive Officers and Directors
in the Merger
In considering the recommendation of the Alteon board of
directors that the Alteon stockholders vote FOR the merger
and the merger agreement and the issuance of shares and the
transfer and conversion of shares contemplated thereby, Alteon
stockholders should be aware that certain members of the
management and board of directors of Alteon have interests in
the merger that may be different from, or in addition to, the
interests of the Alteon stockholders generally. The board of
directors of Alteon was aware of these potential conflicts of
interest during its deliberations on the merits of the merger
and in making its decision to approve the merger, the merger
agreement and the related transactions.
Severance Arrangements
Alteon entered into a three-year amended and restated employment
agreement with Kenneth I. Moch as of December 15, 2004 as
clarified and supplemented by Alteons Board meetings dated
November 4, 2005 and December 7, 2005, pursuant to
which the Board agreed that Mr. Moch should also be paid an
amount equal to six months of his current annual salary upon the
closing of a strategic transaction or liquidation in a way to
maximize tax benefit to Mr. Moch and Alteon. Under the
terms of the amended and restated employment agreement,
Mr. Moch serves as Alteons Chief Executive Officer
and is entitled to an annual salary for the 2006 fiscal year of
$382,454 and a bonus of up to $150,000. Alteon entered into a
three-year amended and restated employment agreement with Judith
S. Hedstrom as of February 11, 2005 as clarified and
supplemented by Alteons Board meetings dated
November 4, 2005 and December 7, 2005, pursuant to
which the Board confirmed that Ms. Hedstrom would receive
one-years salary if terminated without cause prior to a
change in control transaction. Further, it was agreed that she
be offered a consulting contract for three months following
termination, that she would be available to Alteon for up to
15 days during this period, and that her compensation under
this agreement would be an extension of her right to exercise
her stock options for a 2 year period commencing on
April 30, 2006. It was also agreed that she would remain
entitled to receive her CIC Plan benefit upon a Change in
Control, offset by the amount of any payment received under her
consulting contract and upon the termination of her employment
without cause (i.e., total 1x salary benefit under the CIC Plan).
In February 1996, Alteon adopted the Alteon Inc. Change in
Control Severance Benefits Plan to protect and retain qualified
employees and to encourage their full attention, free from
distractions caused by personal uncertainties and risks in the
event of a pending or threatened change in control of Alteon.
The Change in Control Severance Plan provides for severance
benefits to certain employees upon certain terminations of
employment after or in connection with a change in control of
Alteon as defined in the Change in Control Severance Plan.
Following a qualifying termination that occurs as a result of a
change in control, our executive officers will be entitled to
continuation of (i) their base salary for a period of
24 months, and (ii) all benefit programs and plans
providing for health and insurance benefits for a period of up
to 18 months. In addition, upon a change in control of us,
all outstanding unexercisable stock options held by certain
employees that are participants in the Change in Control
Severance Plan will become exercisable. The Change in Control
Severance Plan was terminated in November 2005. However, such
provisions remain in effect for Mr. Moch and
Ms. Hedstrom pursuant to the terms of their employment
agreements.
The Alteon Severance Plan, which became effective June 1,
2005, provides for severance payments and benefits to certain
employees upon termination of their employment as a result of a
triggering event as defined in the Alteon Severance Plan. Upon a
triggering event, these employees will be entitled to
continuation of (i) their base salary for a period of up to
six months, and (ii) all benefit programs and plans
providing for health care coverage for a period of up to three
months. Our obligation to provide severance payments and
benefits to each employee ends if the employee secures
employment during such time periods. In the event the merger is
approved and all eligible employees are effected by a triggering
event, the cost of such benefits would be approximately
$1,429,764 in the aggregate.
I-50
Interests of HaptoGuards Executive Officers and
Directors in the Merger
In considering the recommendation of the HaptoGuard board of
directors that the HaptoGuard stockholders vote FOR the
adoption of the merger agreement, HaptoGuard stockholders should
be aware that certain members of the management and board of
directors of HaptoGuard have interests in the merger that may be
different from, or in addition to, the interests of the
HaptoGuard stockholders generally. The board of directors of
HaptoGuard was aware of these potential conflicts of interest
during its deliberations on the merits of the merger and in
making its decision to approve the merger, the merger agreement
and the related transactions.
|
|
|
Alteon Management and Board Membership |
Three members of the HaptoGuard board of directors will be
members of the Alteon board of directors, contingent upon
completion of the merger. Upon the effectiveness of the merger,
each new director will be entitled to receive cash compensation
and option grants. All members of the board of directors of
Alteon are eligible to receive cash compensation and option
grants as further set forth under
Chapter Three Other Information Regarding
Alteon Management Compensation of
Directors. In addition, upon the effectiveness of the
merger, Noah Berkowitz and Dr. Malcolm MacNab will hold
executive positions and be paid employees of the combined
company.
|
|
|
Indemnification; Directors and Officers
Insurance |
For a period of six years after the closing of the merger,
Alteon has agreed to indemnify the individuals who, on or before
the closing of the merger, were officers or directors of
HaptoGuard, with respect to all acts or omissions before the
closing of the merger by these individuals in these capacities.
HaptoGuard has agreed to use commercially reasonable efforts to
negotiate and secure a tail on its existing
directors, officers and company liability insurance policies
with a nationally recognized insurance carrier providing for
coverage at least as good as the coverage in its existing
policy, for a period of six years from the effective time of the
merger, provided however that such coverage shall not cost more
than $400,000 in the aggregate to be paid by Alteon. Alteon has
agreed that prior to the effective time of the merger, Alteon
will negotiate and acquire a tail effective at the
effective time of the merger, on its existing directors,
officers and company liability insurance policy for a period of
six years from the effective time of the merger, provided
however that such coverage shall not cost more than $800,000 in
the aggregate to be paid by Alteon. Alteon has further agreed to
honor all of HaptoGuards indemnification agreements in
existence prior to the closing of the merger.
I-51
THE MERGER AGREEMENT
The following summary of the merger agreement is qualified by
reference to the complete text of the merger agreement, which is
incorporated by reference and attached hereto as Annex A.
The merger agreement has been included to provide you with
information regarding its terms. You are encouraged to read the
entire merger agreement. The merger agreement is not intended to
provide any other factual information about us. Such information
can be found elsewhere in this Proxy Statement and in the other
public filings Alteon makes with the Securities and Exchange
Commission, which are available without charge at www.sec.gov.
Structure of the Merger
Under the merger agreement, Alteon Merger Sub, Inc., a wholly
owned subsidiary of Alteon, will merge into HaptoGuard, with
HaptoGuard becoming the surviving corporation.
Timing of Closing; Effective Time of the Merger
The closing will occur as promptly as practicable and in any
event within two business days after the day on which the last
of the conditions set forth in the merger agreement has been
satisfied or waived (in accordance with the terms of the merger
agreement), unless the parties to the merger agreement agree to
a different date or the merger agreement has been terminated
prior to such date. Alteon expects that, immediately upon the
closing of the merger, the parties will cause to be filed a
certificate of merger with the Secretary of State of Delaware,
at which time the merger will be effective.
Restructuring of Genentechs Preferred Stock Position in
Alteon
Genentech currently owns 1,418.41 shares of Alteons
Series G Preferred Stock and 4,260.52 shares of
Alteons Series H Preferred Stock. On the basis of the
trading price of Alteon common stock on March 31, 2006,
such shares are convertible into 222,702,745 shares of
common stock of Alteon, which would be approximately 79.3% of
the outstanding shares of Alteon common stock as of
March 31, 2006. Although Genentech is limited as to the
number of shares of common stock of Alteon which it may own, it
would be allowed to sell any shares converted and then convert
additional shares of preferred stock. As part of the merger,
Genentech will convert a portion of its existing preferred
Alteon stock to 13,492,349 shares of Alteon common stock,
which number after combined with prior shares owned would
represent approximately 11.99% of the combined company after
completion of the merger. A portion of the preferred stock held
by Genentech, which when converted to common stock equals
approximately $3.5 million in Alteon common stock, will be
transferred to HaptoGuard shareholders as part of the merger.
The remaining Alteon preferred stock held by Genentech will be
cancelled and there will be no shares of preferred stock of any
class outstanding. As consideration for the conversion, transfer
and cancellation of Alteon preferred stock by Genentech, it will
receive from the combined company certain milestone payments and
royalties on net sales of alagebrium, Alteons lead
compound, as well as a right of first negotiation on ALT-2074,
HaptoGuards lead compound. This restructuring reduces
Genentechs ownership of Alteon and removes the substantial
liquidation preference of Genentechs stock which will
remove an impediment to future financings of the combined
company.
Merger Consideration
At the effective time of the Merger, (a) pursuant to the
terms of Alteons certificate of incorporation and the
Merger Agreement, Genentech will convert a portion of the Alteon
preferred stock that it holds into shares of Alteon common
stock, such that the number of such shares of Alteon common
stock to be issued will, when added to the shares of Alteon
common stock already owned by Genentech, equal 19.99% of
Alteons outstanding common stock, as calculated after the
conversion of such Alteon preferred stock but prior to
(i) the issuance of shares of Alteon common stock in
connection with the merger; (ii) the issuance of Alteon
common stock and warrants in connection with the $2.6 financing
which occurred immediately after the signing of the merger
agreement; and (iii) the conversion of Alteon preferred
stock to be transferred to
I-52
HaptoGuard in connection with the merger as described in
clause (b); (b) Genentech will transfer to HaptoGuard
a portion of Alteon preferred stock held by it, in such an
amount that will convert to a number of shares of Alteon common
stock, in accordance with the terms of Alteons certificate
of incorporation and the terms of the Merger Agreement equal in
value to $3,500,000 (the value of the price per share of the
Alteon common stock referenced herein equal to $0.2353, based on
the volume-weighted average price of the per share selling
prices on the American Stock Exchange for the twenty
(20) trading days immediately preceding the signing of the
Merger Agreement); (c) Genentech will transfer to Alteon
all of the remaining shares of Alteon preferred stock held by
Genentech which are not either converted or transferred, and
such shares of Alteon preferred stock shall cease to be
outstanding, be canceled and retired without payment of any
consideration therefor other than pursuant to the terms of the
Merger Agreement and cease to exist; (d) every share of
HaptoGuard common stock (the Shares) issued and
outstanding immediately prior to the effective time of the
Merger (other than the dissenting shares) shall be converted
into the right to receive a number of shares of Alteon common
stock equal to the quotient of (i) the sum of (x) a
number of shares of Alteon common stock to be issued by Alteon
to HaptoGuard stockholders at the effective time with a value of
$5.3 million (the Alteon Shares), plus
(y) the number of shares of Alteon common stock to be
issued pursuant to section (b) above at the effective
time, the market value of (x) and (y) to be equal to
$8,800,000, divided by (ii) the sum of (x) the number
of outstanding Shares at the effective time, and (y) the
number of Share Equivalents (as defined below) (the
Exchange Ratio); and (e) each Share held in the
treasury of HaptoGuard and each Share owned by Alteon or by any
direct or indirect wholly-owned subsidiary of HaptoGuard or
Alteon immediately prior to the effective time shall, by virtue
of the Merger and without any action on the part of the holder
thereof, cease to be outstanding, be canceled and retired
without payment of any consideration therefor other than
pursuant to the terms of the Merger Agreement and cease to
exist. Alteon will not issue any fractional shares. HaptoGuard
stockholders will receive a check in the amount of (1) the
fractional share multiplied by the price per share as determined
by the volume-weighted average of the per share selling prices
on the American Stock Exchange for the twenty (20) trading
days immediately prior to the signing of the merger agreement.
In consideration of the conversion, transfer and cancellation of
shares by Genentech to HaptoGuard, Genentech will receive from
the combined company certain milestone payments and royalties on
net sales of alagebrium, Alteons lead compound, as well as
a right of first negotiation on ALT-2074, HaptoGuards lead
compound.
For example:
If you currently own 1,000 shares of HaptoGuard common
stock, then at the effective time of the merger, based upon an
assumed stock exchange ratio of approximately 3,521, you would
receive 3,521,000 shares of Alteon common stock, and a
check for any resulting fractional share of Alteon common stock.
The value of the stock that you will receive will fluctuate as
the price of Alteon common stock changes prior to the merger.
Treatment of HaptoGuard Stock Options and Warrants
Alteon will assume each outstanding vested or unvested option to
purchase HaptoGuard common stock, which will be exercisable
following the Merger for a number of shares of Alteon common
stock that is equal to the product of the number of shares of
HaptoGuard common stock that were purchasable under such option
immediately prior to the effective time of the merger multiplied
by the exchange ratio (rounded down to the nearest whole number
of shares of Alteon common stock) and the per share exercise
price for the shares of Alteon common stock issuable upon
exercise of such assumed option will be equal to the quotient
determined by dividing the exercise price per share of
HaptoGuard common stock at which such option was exercisable
immediately prior to the effective time of the merger by the
exchange ratio (and rounding the resulting exercise price up to
the nearest whole cent).
All outstanding warrants to purchase HaptoGuard common stock
will be exchanged for the right to receive a number of shares of
Alteon common stock (Share Equivalents) at the
effective time of the Merger which will have a market value
equal to the difference between (i) the market value of the
product of the number of shares of HaptoGuard common stock that
were purchasable under such warrants immediately
I-53
prior to the Effective Time multiplied by the Exchange Ratio
(rounded down to the nearest whole number of shares of Alteon
common stock) and (ii) the total exercise price of such
warrant.
Exchange of Shares
Promptly after the effective time of the merger, Alteon will
provide to each holder of HaptoGuard stock instructions
explaining how to surrender HaptoGuard stock certificates to
Alteon. Holders of HaptoGuard stock that surrender their
certificates to Alteon, together with a properly completed
letter of transmittal, will receive the appropriate merger
consideration. Holders of unexchanged shares of HaptoGuard stock
will not be entitled to receive any dividends or other
distributions payable by Alteon after the closing until their
certificates are surrendered.
Alteon will not issue any fractional shares. HaptoGuard
stockholders will receive a check in the amount of (1) the
fractional share multiplied by the price per share as determined
by the volume-weighted average of the per share selling prices
on the American Stock Exchange for the twenty (20) trading
days immediately prior to the signing of the merger agreement.
Alteon Board of Directors and Related Matters
Alteon has agreed to take the necessary corporate actions so
that, as of the closing of the merger, three nominees of
HaptoGuard will become directors of Alteon. Upon completion of
the merger, the board of directors will consist of eight
members, including four of the current Alteon directors which
shall initially consist of Kenneth I. Moch, Thomas Moore,
Marilyn Breslow, and George M. Naimark, plus three nominees of
HaptoGuard which shall initially consist of Noah Berkowitz,
Wayne Yetter and Mary Tanner and one independent member to be
designated by the board who may be appointed to the board after
the completion of the merger.
Certain Covenants
Each of Alteon and HaptoGuard has undertaken certain covenants
in the merger agreement. The following summarizes the most
significant of these covenants.
No Solicitation by HaptoGuard. HaptoGuard has agreed that
it and its officers, directors, employees, representatives or
agents will not take action to solicit or encourage an offer for
an acquisition proposal. An acquisition
proposal is any other proposal or offer regarding any
acquisition, merger, take-over bid, sale of substantial assets,
sale of shares of capital stock (including without limitation by
tender offer) or similar transactions. Restricted actions
include engaging in discussions or negotiations with any
potential bidder, or disclosing non-public information relating
to HaptoGuard. HaptoGuard must inform Alteon of the identity of
any potential bidder and the terms of any offer.
HaptoGuard Board of Directors Covenant to
Recommend. The HaptoGuard board of directors has agreed to
recommend the adoption of the merger agreement and the merger to
HaptoGuards stockholders.
Alteon Board of Directors Covenant to Recommend.
The Alteon board of directors has agreed to recommend the
approval of the merger agreement and the issuance of Alteon
common stock in connection with the merger to Alteons
stockholders.
Interim Operations of Alteon and HaptoGuard. Each of
Alteon and HaptoGuard has undertaken a separate covenant that
places restrictions on it until either the effective time of the
merger or until the merger agreement is terminated. In general,
HaptoGuard is required to conduct its business in the ordinary
course consistent with past practice and to use its commercially
reasonable efforts to preserve intact its business organization
and relationships with third parties. Alteon has agreed to
conduct its business in the ordinary course and consistent with
past practice.
I-54
The companies have also agreed to some specific restrictions
which are subject to exceptions described in the merger
agreement. The following table summarizes the most significant
of these restrictions, subject to certain exceptions, undertaken
by each company:
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|
Restriction |
|
HaptoGuard | |
|
Alteon | |
|
|
| |
|
| |
Amending its organizational documents
|
|
|
* |
|
|
|
* |
|
Acquire by merger, consolidation, or otherwise an interest in
any corporation, limited liability company or other business
|
|
|
* |
|
|
|
* |
|
Issuing or disposing of equity securities, options or other
securities convertible into or exercisable for equity securities
|
|
|
* |
|
|
|
* |
|
Splitting, combining or reclassifying its capital stock
|
|
|
* |
|
|
|
* |
|
Declaring, setting aside or paying dividends
|
|
|
* |
|
|
|
* |
|
Selling, transferring, or encumbering assets
|
|
|
* |
|
|
|
* |
|
Amending the terms of any outstanding stock options
|
|
|
* |
|
|
|
* |
|
Making significant capital expenditures, subject to certain
ordinary course exceptions
|
|
|
* |
|
|
|
* |
|
Increasing employee compensation or benefits, except for normal
ordinary course increases consistent with past practice, or
establishing, adopting, entering into or amending any employee
benefit plan
|
|
|
* |
|
|
|
* |
|
Changing its accounting policies
|
|
|
* |
|
|
|
* |
|
Reasonable Efforts Covenant. Alteon and HaptoGuard have
agreed to cooperate with each other and use all commercially
reasonable efforts to take all actions and do all things
necessary or advisable under the merger agreement and applicable
laws to complete the merger and the other transactions
contemplated by the merger agreement.
Indemnification and Insurance of HaptoGuard Directors and
Officers. For a period of six years after the closing of the
merger, Alteon has agreed to indemnify the individuals who, on
or before the closing of the merger, were officers or directors
of HaptoGuard, with respect to all acts or omissions before the
closing of the merger by these individuals in these capacities.
HaptoGuard has agreed to use commercially reasonable efforts to
negotiate and secure a tail on its existing
directors, officers and company liability insurance policies
with a nationally recognized insurance carrier providing for
coverage at least as good as the coverage in its existing
policy, for a period of six years from the effective time of the
merger, provided however that such coverage shall not cost more
than $400,000 in the aggregate to be paid by Alteon. Alteon has
agreed that prior to the effective time of the merger, Alteon
will negotiate and acquire a tail effective at the
effective time of the merger, on its existing directors,
officers and company liability insurance policy for a period of
six years from the effective time of the merger, provided
however that such coverage shall not cost more than $800,000 in
the aggregate to be paid by Alteon. Alteon has further agreed to
honor all of HaptoGuards indemnification agreements in
existence prior to the closing of the merger.
Representations and Warranties
The merger agreement contains representations and warranties
made by Alteon and HaptoGuard to each other with respect to each
partys:
|
|
|
|
|
organization and qualifications to do business in foreign
jurisdictions; |
|
|
|
subsidiaries; |
|
|
|
corporate authorization to enter into the merger; |
|
|
|
board consent to the transaction and stockholder votes required
to adoption of the merger agreement or the issuance of Alteon
shares pursuant to the merger agreement; |
|
|
|
SEC filings and certain compliance matters; |
I-55
|
|
|
|
|
governmental approvals required in connection with the merger; |
|
|
|
absence of any breach of organizational documents, law or
certain material agreements as a result of the merger; |
|
|
|
capitalization; |
|
|
|
absence of certain material changes since a specified balance
sheet date; |
|
|
|
intellectual property; |
|
|
|
tax matters; |
|
|
|
finders or advisors fees; |
|
|
|
absence of undisclosed material liabilities; |
|
|
|
compliance with laws; |
|
|
|
material permits; |
|
|
|
restrictions on business activities; |
|
|
|
employee benefits matters; |
|
|
|
insurance policies; |
|
|
|
environmental matters; and |
|
|
|
business practices. |
In addition, HaptoGuard has made representations and warranties
with respect to its:
|
|
|
|
|
information provided by it for inclusion in this Proxy Statement; |
|
|
|
financial statements; |
|
|
|
litigation; |
|
|
|
labor and employment matters; |
|
|
|
properties and assets; and |
|
|
|
material contracts. |
The representations and warranties in the merger agreement shall
survive the closing of the merger for a period of twelve
(12) months, except with respect to the representations
made by HaptoGuard with respect to its taxes and environmental
matters, which shall survive until the expiration of the
applicable statutes of limitation with respect to such claims.
Conditions to the Completion of the Merger
Mutual Closing Conditions. The obligations of Alteon and
HaptoGuard to complete the merger are subject to the
satisfaction or, to the extent legally permissible, waiver of
the following conditions:
|
|
|
|
|
approval of the merger and the merger agreement and the issuance
of Alteon stock and transfer and conversion of shares
contemplated thereby by the Alteon stockholders; |
|
|
|
approval and adoption of the merger agreement by the HaptoGuard
stockholders; |
|
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|
absence of legal prohibition on completion of the
merger; and |
|
|
|
all necessary governmental approvals shall have been obtained; |
I-56
Additional Closing Conditions for HaptoGuards
Benefit. HaptoGuards obligations to complete the
merger are subject to the following additional conditions:
|
|
|
|
|
accuracy as of closing of the representations and warranties
made by Alteon to the extent specified in the merger agreement; |
|
|
|
performance by Alteon of the obligations required to be
performed by it at or prior to closing to the extent specified
in the merger agreement; |
|
|
|
all material consents and approvals required to be obtained, and
all filings required to be made, by Alteon for the execution and
delivery of the merger agreement and the consummation of the
transactions contemplated thereby shall have been obtained and
made; |
|
|
|
no governmental actions or proceedings shall have been
instituted, pending or threatened seeking to prohibit or limit
HaptoGuard from exercising all material rights and privileges
pertaining to its ownership of the surviving corporation in the
merger or the ownership or operation by HaptoGuard of all or a
material portion of the business or assets of HaptoGuard, or
seeking to compel HaptoGuard to dispose of or hold separate all
or any material portion of the business or assets of HaptoGuard,
as a result of the merger or the transactions contemplated by
the merger agreement; |
|
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|
assumption by Alteon of all outstanding vested and unvested
options to purchase HaptoGuard Common Stock; and |
|
|
|
adoption of an employment agreement for Dr. Berkowitz in
form and substance reasonably identical to the proposed
employment agreement Dr. Berkowitz would have received from
HaptoGuard in the event of an acquisition transaction involving
HaptoGuard (where HaptoGuard remains the controlling entity). |
Additional Closing Conditions for Alteons Benefit.
Alteons obligations to complete the merger are subject to
the following additional conditions:
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|
|
accuracy as of closing of the representations and warranties
made by HaptoGuard to the extent specified in the merger
agreement; |
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|
|
performance by HaptoGuard of the obligations required to be
performed by it at or prior to closing to the extent specified
in the merger agreement; |
|
|
|
all consents and approvals, if any, relating to certain material
agreements have been obtained and such agreements are in full
force and effect; |
|
|
|
no governmental actions or proceedings shall have been
instituted, pending or threatened seeking to prohibit or limit
Alteon from exercising all material rights and privileges
pertaining to its ownership of the surviving corporation in the
merger or the ownership or operation by Alteon of all or a
material portion of the business or assets of Alteon, or seeking
to compel Alteon to dispose of or hold separate all or any
material portion of the business or assets of Alteon, as a
result of the merger or the transactions contemplated by the
merger agreement; and |
|
|
|
certain voting agreements and
lock-up agreements, as
specified, shall have been entered into and be in full force and
effect. |
Additional Closing Conditions for Genentechs
Benefit. Genentechs obligations to consummate the
transaction contemplated by the merger agreement are subject to
the following additional conditions:
|
|
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|
Alteon shall have filed an amendment to its Certificate of
Designations of its Series G Preferred Stock and
Series H Preferred Stock as described herein; |
|
|
|
the shares of Alteon common stock issuable to Genentech upon
conversion of the shares of Series G Preferred Stock and
Series H Preferred Stock held by Genentech shall have been
approved for listing on the American Stock Exchange; |
I-57
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accuracy as of closing of the representations and warranties
made by Alteon and HaptoGuard to the extent specified in the
merger agreement; and |
|
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|
performance by Alteon and HaptoGuard of the obligations required
to be performed by it at or prior to closing to the extent
specified in the merger agreement except as would not have a
material adverse effect on such party. |
Interim Payments to HaptoGuard
In order to allow HaptoGuard to continue its clinical
development programs and in consideration for HaptoGuards
agreement to provide Noah Berkowitz and Malcolm MacNab to
provide advice and counsel to Alteon during the period from the
signing of the merger agreement to the effective time of the
merger with respect to the clinical development of alagebrium,
Alteon agreed to pay HaptoGuard an amount equal to
$140,000 per month, subject to adjustment by agreement upon
any material changes in personnel or clinical development
programs, to be applied by HaptoGuard to payment of salaries and
existing clinical development programs or additional programs as
may be agreed upon by such parties going forward.
In consideration of HaptoGuards agreement to provide
advice and counsel to Alteon with respect to the corporate and
scientific development of certain Alteon technology for the
period from January 1, 2006 through the effective time of
the merger, as described in a consulting agreement between
Alteon and HaptoGuard, Alteon agreed to pay HaptoGuard an amount
equal to $125,000 to be applied by HaptoGuard to payment of
salaries and existing clinical development programs, or
additional programs as agreed upon by such parties going forward.
Termination of the Merger Agreement
Right to Terminate. The merger agreement may be
terminated at any time prior to the effective time of the merger
in any of the following ways:
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|
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By the mutual written consent of Alteon and HaptoGuard. |
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By Alteon or HaptoGuard if: |
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|
(1) subject to certain exceptions set forth in the
merger agreement, the merger has not been completed by
August 30, 2006; |
|
|
(2) Alteon or HaptoGuard stockholders fail to
approve the issuance of shares of Alteon common stock or adopt
the merger agreement, respectively, at a duly held meeting,
provided that the party terminating may not be the party whose
conduct was responsible for the failure to receive such vote; |
|
|
(3) certain breaches of covenants of the other
party, respectively; or |
|
|
(4) if any representation or warranty of the other
party or Genentech proves to be untrue prior to the effective
time of the merger, if such failure to be true would reasonably
be likely to have a material adverse effect, as defined in the
merger agreement, if the terminating party is not in material
breach of any of its obligation under the merger agreement and
such representation or warranty is not made true within ten
(10) business days of the date such representation or
warranty became untrue. |
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|
By either Alteon, HaptoGuard or Genentech if there is a
permanent legal prohibition to closing the merger. |
|
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By Genentech if: |
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|
|
(1) it is not in material breach of any of its
obligations under the merger agreement, if any representation or
warranty of Alteon or HaptoGuard set forth in the merger
agreement proved to have been untrue prior to the effective time
of the merger, if such failure to be true would reasonably be
likely to have a material adverse effect as defined in the
merger agreement and such representation or warranty is not made
true within ten (10) business days of the date such
representation or warranty became untrue; or |
I-58
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|
(2) upon a breach of any covenant or agreement on
the part of HaptoGuard or Alteon set forth in the merger
agreement, in either case, such that any of Genentechs
conditions to consummate the transactions contemplated by the
merger agreement would not be satisfied, provided that, if such
breach is curable prior to the expiration of ten (10) days
from its occurrence by Alteon or HaptoGuard, as the case may be,
through the exercise of its commercially reasonable efforts and
for so long as Alteon or HaptoGuard, as the case may be,
continues to exercise such commercially reasonable efforts,
Genentech may not terminate unless such
10-day period expires
without such breach having been cured. |
If the merger agreement is validly terminated, the agreement
will become void without any liability on the part of any party
unless such party is, prior to such termination, in breach
thereof. However, the provisions of the merger agreement
relating to termination fees will continue in effect
notwithstanding termination of the merger agreement.
Termination Fees
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Termination Fees Payable by HaptoGuard. |
HaptoGuard shall pay Alteon (x) a fee of $440,000 and
(y) the amount of any interim payments made by Alteon to
HaptoGuard pursuant to the merger agreement for payment of
salaries and existing clinical development programs, or
additional programs as agreed upon by such parties going forward
(other than those made pursuant to the consulting agreement),
upon the termination of the merger agreement by Alteon
(i) in the event of the failure to receive HaptoGuard
stockholder approval of the merger agreement; (ii) upon
breach of any of HaptoGuards covenants or agreements but
only with respect to a termination for a breach of any material
covenant or agreement, (provided that at the time of such
termination Alteon is not in material breach of any of the
covenants or agreements set forth in the merger agreement that
are applicable to Alteon), or (iii) if any representation
or warranty of HaptoGuard proves to be untrue prior to the
effective time of the merger, if such failure to be true would
reasonably be likely to have a material adverse effect, as
defined in the merger agreement, if Alteon is not in material
breach of any of its obligation under the merger agreement and
such representation or warranty is not made true within ten (10)
business days of the date such representation or warranty became
untrue.
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Termination Fees Payable by Alteon. |
Alteon shall pay HaptoGuard a fee of $440,000 upon the
termination of the merger agreement by HaptoGuard (i) in
the event of the failure to receive Alteon stockholder approval
of the issuance of shares of Alteon common stock or adoption of
the merger agreement, (ii) upon breach of any of
Alteons covenants or agreements but only with respect to a
termination for a breach of any material covenant or agreement,
(provided that at the time of such termination HaptoGuard is not
in material breach of any of the covenants or agreements set
forth in the merger agreement that are applicable to
HaptoGuard), or (iii) if any representation or warranty of
Alteon or Genentech proves to be untrue prior to the effective
time of the merger, if such failure to be true would reasonably
be likely to have a material adverse effect, as defined in the
merger agreement, if HaptoGuard is not in material breach of any
of its obligation under the merger agreement and such
representation or warranty is not made true within ten (10)
business days of the date such representation or warranty became
untrue.
Voting Agreements
All executive officers and directors of HaptoGuard, together
with their affiliates, own as a group
approximately % of the shares of
HaptoGuard common stock entitled to vote to adopt the merger
agreement. A vote of a majority of the outstanding shares of
HaptoGuard common stock is required to adopt the merger
agreement.
The Chief Executive Officer of HaptoGuard, Dr. Noah
Berkowitz, and a family trust for the benefit of certain members
of his family, together representing approximately 41% of
HaptoGuard outstanding common
I-59
stock, have entered into voting agreements with Alteon, under
which these persons have agreed to vote their shares of
HaptoGuard common stock:
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in favor of the adoption and approval of the merger agreement, |
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against any action or agreement that would reasonably be
expected to compete with, prevent, impede, interfere with,
attempt to discourage the merger or inhibit the timely
consummation of the merger, |
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against any action or agreement that, to Stockholders
knowledge, would result in a breach in any material respect of
any covenant, representation or warranty or any other obligation
of HaptoGuard under the merger agreement, and |
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except for the merger and the merger agreement, against any
merger, consolidation, business combination, reorganization,
recapitalization, liquidation or sale or transfer of any
material assets of HaptoGuard or its subsidiaries. |
Other Expenses
Except as described above or herein, all costs and expenses
incurred in connection with the merger agreement and related
transactions will be paid by the party incurring such costs or
expenses, whether or not the merger is consummated.
Alteon shall be responsible for all fees and expenses incurred
in relation to the preparation, printing, and distribution of
this Proxy Statement, including any amendments or supplements
thereto, provided that HaptoGuard shall pay the incremental
costs for distributing the Proxy Statement to the shareholders
of HaptoGuard and its costs in providing information for
inclusion in the proxy statement.
Within thirty (30) days of receiving an invoice from
Genentech with supporting documentation attached, Alteon shall
pay 100% of Genentechs legal fees up to an amount of
$50,000. In the event that such fees exceed $50,000, Alteon will
pay 50% of such excess, up to an additional $25,000 to be paid
by Alteon. In no case will Alteon pay more than $75,000 for such
legal fees.
Amendments and Waivers
Any provision of the merger agreement may be amended or waived
prior to closing if the amendment or waiver is in writing and
signed, in the case of an amendment, by HaptoGuard and Alteon
or, in the case of a waiver, by the party against whom the
waiver is to be effective. Notwithstanding the foregoing, no
amendment may be made with respect to Genentechs
representations and warranties, the indemnification provisions,
and certain other sections of the merger agreement without
Genentechs written consent. After the adoption of the
merger agreement by the stockholders of HaptoGuard and the
approval of the issuance of shares of Alteon common stock in the
merger by the stockholders of Alteon, no amendment or waiver
that by law requires further approval by stockholders may be
made without the further approval of such stockholders.
Appraisal Rights
By virtue of Section 262 of the Delaware General
Corporation Law, or the DGCL, if holders of HaptoGuard stock
exercise appraisal rights in connection with the merger, any
shares of HaptoGuard stock as to which such appraisal rights are
exercised will not be converted into the right to receive shares
of Alteon common stock but instead will be converted into the
right to receive such consideration as may be determined to be
due with respect to such dissenting shares pursuant to the DGCL.
THE FOLLOWING SUMMARY OF THE PROVISIONS OF SECTION 262
IS NOT INTENDED TO BE A COMPLETE STATEMENT OF SUCH PROVISIONS
AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO THE FULL TEXT
OF SECTION 262, A COPY OF WHICH IS ATTACHED HERETO AS
ANNEX D AND IS INCORPORATED HEREIN BY REFERENCE.
If the merger is approved by the required vote of
HaptoGuards stockholders, each holder of HaptoGuard stock
who (1) files written notice with HaptoGuard of his, her or
its intention to exercise his, her or its rights
I-60
to appraisal of his, her or its shares prior to the HaptoGuard
special meeting and (2) does not vote in favor of adoption
of the merger agreement and who follows the procedures set forth
in Section 262 will be entitled to have his, her or its
HaptoGuard stock purchased by the surviving corporation for cash
at the fair market value of the shares of HaptoGuard stock. The
fair market value of shares of HaptoGuard stock will be
determined by the Delaware Court of Chancery, exclusive of any
element of value arising from the merger. The shares of
HaptoGuard stock with respect to which holders have perfected
their appraisal demand in accordance with Section 262 and
have not effectively withdrawn or lost such appraisal rights are
referred to in this Proxy Statement as the dissenting
shares.
Within ten days after the effective date, HaptoGuard must mail a
notice to all stockholders who have complied with 1 and 2 above
notifying such stockholders of the effective date. Within
120 days after the effective date such holders of stock may
file a petition in the Delaware Court of Chancery for the
appraisal of their shares, provided such holders may within
60 days of the effective date withdraw their demand for
appraisal. Within 120 days of the effective time, the
holders of dissenting shares may also, upon written request,
receive from the surviving corporation a statement setting forth
the aggregate number of shares with respect to which demands for
appraisals have been received.
If any holder of HaptoGuard stock who demands the appraisal and
purchase of his, her or its shares under Section 262 fails
to perfect, or effectively withdraws or loses his, her or its
right to such purchase, the shares of such holder will be
converted into a right to receive a number of shares of Alteon
common stock in accordance with the terms of the merger
agreement. Dissenting shares lose their status as dissenting
shares if
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the merger is abandoned; |
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the shares are transferred prior to their submission for the
required endorsement; |
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the dissenting stockholder fails to make a timely written demand
for appraisal; |
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the dissenting shares are voted in favor of adoption of the
merger agreement; |
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neither Alteon nor the stockholder files a complaint or
intervenes in a pending action within 120 days after
mailing of the approval notice; or |
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the stockholder delivers to Alteon a written withdrawal of such
stockholders demand for appraisal of his, her or its
shares. |
FAILURE TO FOLLOW THE STEPS REQUIRED BY SECTION 262 FOR
PERFECTING APPRAISAL RIGHTS MAY RESULT IN THE LOSS OF SUCH
RIGHTS (IN WHICH EVENT A STOCKHOLDER WILL BE ENTITLED TO RECEIVE
THE CONSIDERATION RECEIVABLE WITH RESPECT TO SUCH DISSENTING
SHARES IN ACCORDANCE WITH THE MERGER AGREEMENT). IN VIEW OF THE
COMPLEXITY OF THE PROVISIONS OF SECTION 262, HAPTOGUARD
STOCKHOLDERS WHO ARE CONSIDERING OBJECTION TO THE MERGER SHOULD
CONSULT THEIR OWN LEGAL ADVISORS.
I-61
CHAPTER TWO INFORMATION ABOUT THE MEETING AND
VOTING
Alteons board of directors is using this Proxy Statement
to solicit proxies from the holders of Alteon common stock for
use at the Alteon annual meeting. We are first mailing this
Proxy Statement and accompanying form of proxy to Alteon
stockholders on or
about ,
2006.
Matters Relating to the Meetings
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Alteon Annual Meeting |
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HaptoGuard Special Meeting |
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Date, Time and Place:
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2006
10:00 a.m., Eastern Time
The Hanover Marriott
1401 Route 10 East
Whippany, New Jersey 07981 |
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2006
[ ] |
Purpose of Meeting is to Vote on the Following Items: |
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1. the merger and merger agreement and the issuance of
shares of Alteon common stock and the transfer and conversion of
shares of Alteon common stock contemplated thereby, described
under Chapter One The Merger The
Merger Transaction General on
page I- ; |
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1. adoption of the merger agreement as described under
Chapter One The Merger The Merger
Transaction General; and |
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2. the adjournment of the annual meeting, if necessary, if
a quorum is present, to solicit additional proxies if there are
not sufficient votes in favor of Proposal No. 1; |
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2. adjournment of the special meeting, if necessary, if a
quorum is present, to solicit additional proxies if there are
not sufficient votes in favor of Proposal No. 1; and |
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3. the amendment to Alteons Certificate of
Designation of Series G Preferred Stock, as described in
the attached Proxy Statement; as described under Chapter
Six Alteon Annual Meeting Proposals
Item 2 Amendment of Certificates of
Designation beginning on page VI- ; |
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3. such other matters as may properly come before the
HaptoGuard meeting, including the approval of any adjournment of
the meeting. |
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4. the amendment to Alteons Certificate of
Designation of Series H Preferred Stock, as described in
the attached Proxy Statement; as described under Chapter
Six Alteon Annual Meeting Proposals
Item 2 Amendment beginning on
page VI- ; |
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II-1
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Alteon Annual Meeting |
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HaptoGuard Special Meeting |
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5. the election of two directors to serve until the
completion of the merger or, in the event the merger is not
complete, the Annual Meeting of Stockholders to be held in 2009
and until their successors have been duly elected and qualified; |
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6. the ratification of the appointment by the Audit
Committee of the board of directors of J.H. Cohn LLP as the
independent registered public accounting firm of Alteon for the
fiscal year ending December 31, 2006; and |
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7. such other matters as may properly come before the
Alteon meeting, including the approval of any adjournment of the
meeting. |
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Record Date:
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The record date for shares entitled to vote is
[ ],
2006. |
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The record date for shares entitled to vote is
[ ],
2006. |
Outstanding Shares Held on Record Date: |
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As of
[ ],
2006, there were
[ ]
shares of Alteon common stock outstanding. As of
[ ],
2006, there were
[ ]
shares of Alteon Series G Preferred Stock and
[ ]
shares of Alteon Series H Preferred Stock outstanding. |
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As of
[ ],
2006, there were
[ ]
shares of HaptoGuard common stock outstanding. |
Shares Entitled to Vote: |
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Shares entitled to vote are Alteon common stock held at the
close of business on the record date,
[ ],
2006. |
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Shares entitled to vote are HaptoGuard common stock held at the
close of business on the record date,
[ ],
2006. |
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Each share of Alteon common stock that you own entitles you to
one vote. |
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Each share of HaptoGuard common stock that you own entitles you
to one vote. |
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Shares held by Alteon in its treasury, if any, are not voted. |
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Shares held by HaptoGuard in its treasury, if any, are not voted. |
II-2
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Alteon Annual Meeting |
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HaptoGuard Special Meeting |
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Quorum Requirement:
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A quorum of stockholders is necessary to hold a valid meeting.
This means the holders of at least a majority of our common
stock must be represented at the meeting, either by proxy or in
person. Votes that are withheld, abstentions and broker
non-votes will be counted for purposes of determining the
presence or absence of a quorum. |
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A quorum of stockholders is necessary to hold a valid meeting.
This means the holders of at least a majority of our common
stock must be represented at the meeting, either by proxy or in
person. Votes that are withheld, abstentions and broker non-
votes will be counted for purposes of determining the presence
or absence of a quorum. |
Outstanding Shares Entitled to Vote and Owned by Alteon and
HaptoGuard Directors, Executive Officers and their Affiliates as
of ,
2006: |
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[ ]
shares of Alteon common stock outstanding and entitled to vote
at the Alteon annual meeting. These shares represent in total
approximately [ ]% of the voting power of
Alteons common stock outstanding and entitled to vote at
the Alteon meeting. |
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[ ] shares
of HaptoGuard common stock outstanding and entitled to vote at
the HaptoGuard special meeting. These shares represent in total
approximately [ ]% of the voting power of
HaptoGuards common stock outstanding and entitled to vote
at the HaptoGuard meeting. |
Vote Necessary to Approve Alteon and HaptoGuard Proposals
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Item |
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Vote Necessary |
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I.
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Merger Proposal |
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Alteon:
Approval of the merger and merger agreement and the issuance
of shares of Alteon common stock and the transfer and conversion
of shares of Alteon common stock contemplated thereby described
in Chapter One The Merger requires an
affirmative vote of a majority of the votes cast. Abstentions
will be counted towards the vote total for each proposal, and
will have the same effect as Against votes. Broker
non-votes have no effect and will not be counted towards the
vote total for any proposal. |
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HaptoGuard:
Adoption of the merger agreement described in
Chapter One The Merger requires an
affirmative vote of a majority of the issued and outstanding
shares of HaptoGuard common stock. |
II.
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Adjournment of the meeting, if necessary |
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Alteon:
Approval of the adjournment of Alteons annual meeting,
if necessary, if a quorum is present, to solicit additional
proxies if there are not sufficient vote to approve the issuance
of the shares of Alteon common stock pursuant to the merger
agreement requires the affirmative vote of a majority of the
votes cast, regardless of whether a quorum is present.
Abstentions will be counted towards the vote total for each
proposal, and will have the same effect as Against
votes. Broker non-votes have no effect and will not be counted
towards the vote total for any proposal. |
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HaptoGuard:
Approval of the adjournment of HaptoGuards special
meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient votes in favor of
adoption of the merger agreement requires the affirmative vote
of a majority of the votes cast, if a quorum is present. |
II-3
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Item |
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Vote Necessary |
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III.
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Amendment of Alteons Certificates of Designation |
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Alteon:
The amendment of Alteons certificates of designation
as described in Chapter Six Alteon Annual
Meeting Proposals Item 2
Amendment requires the affirmative vote of a majority of
the issued and outstanding common stock and two-thirds of the
issued and outstanding Series G Preferred Stock and
Series H Preferred Stock, respectively. Abstentions will be
counted towards the vote total for each proposal, and will have
the same effect as Against votes. Broker non-votes
have no effect and will not be counted towards the vote total
for any proposal. |
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HaptoGuard:
Not Applicable |
IV.
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Election of two directors to serve until the completion of
the merger or, in the event the merger is not completed, until
the Annual Meeting of Stockholders to be held in 2009 and until
their successors have been duly elected and qualified. |
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Alteon:
The election of two directors to Alteons board as
described in Chapter Six Alteon Annual
Meeting Proposals Item 3 Election
of Directors requires the affirmative vote of a plurality
of the votes cast. Abstentions will be counted towards the vote
total for each proposal, and will have the same effect as
Against votes. Broker non- votes have no effect and
will not be counted towards the vote total for any proposal. |
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HaptoGuard:
Not Applicable |
V.
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Ratification of the appointment by the Audit Committee of
J.H. Cohn LLP as the independent registered public accounting
firm of Alteon |
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Alteon:
The ratification of the appointment by the Audit Committee
of J.H. Cohn LLP as the independent registered public accounting
firm of Alteon as described in
Chapter Six Alteon Annual Meeting
Proposals Item 4 Ratification of
Selection of Independent Registered Public Accounting Firm
requires the affirmative vote of a majority of the votes cast.
Abstentions will be counted towards the vote total for each
proposal, and will have the same effect as Against
votes. Broker non-votes have no effect and will not be counted
towards the vote total for any proposal. |
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HaptoGuard:
Not Applicable |
Voting
Voting. You may vote in person at your meeting or by
proxy. We recommend you vote by proxy even if you plan to attend
your meeting. You can always change your vote at the meeting.
Voting instructions are included on your proxy or proxy card. If
you properly give your proxy and submit it in time to vote (or
vote electronically via the Internet or telephone), one of the
individuals named as your proxy will vote your shares as you
have directed. You may vote for or against the proposals or
abstain from voting. If you mark your proxy abstain
with respect to any proposal, you will be in effect voting
against the proposal. In addition, if you fail to send in your
proxy, this, too, will have the same negative effect. If your
shares are held in street name by a broker, bank or
other nominee, the broker cannot vote your shares on any
proposal without your instructions. This is a broker
non-vote. A broker non-vote with respect to a
proposal may have the effect of a vote against that proposal.
II-4
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Alteon |
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HaptoGuard |
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Complete, sign, date and return your proxy card in the enclosed
envelope. You may also vote electronically by Internet or
telephone if your proxy card so indicates. You are encouraged
to vote electronically if you have that option. |
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Complete, sign, date and return your proxy card in the enclosed
envelope. |
If you submit your proxy but do not make specific choices, your
proxy will follow the board of directors recommendations
and vote your shares:
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Alteon |
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HaptoGuard |
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FOR the merger and merger agreement and
the issuance of shares of Alteon common stock and the transfer
and conversion of shares of Alteon common stock contemplated
thereby; |
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FOR adoption of the merger agreement; |
FOR the adjournment of Alteons
annual meeting, if necessary, if a quorum is present, to solicit
additional proxies if there are not sufficient vote to approve
the merger and merger agreement and the issuance of shares of
Alteon common stock and the transfer and conversion of shares of
Alteon common stock contemplated thereby; |
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FOR the adjournment of HaptoGuards
special meeting, if necessary, if a quorum is present, to
solicit additional proxies if there are not sufficient votes in
favor of adoption of the merger agreement; and |
FOR the amendment of Alteons
certificates of designation of Series G Preferred Stock and
Series H Preferred Stock;
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In its discretion as to any other business that may
properly come before the HaptoGuard meeting. |
FOR the ratification of J.H. Cohn LLP as
the independent registered public accounting firm;
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FOR any proposal by the Alteon board of
directors to adjourn the meeting; and
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In its discretion as to any other business that may
properly come before the Alteon meeting.
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Revoking Your Proxy. You may revoke your proxy before it
is voted by:
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submitting a new proxy with a later date, |
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submitting a vote electronically via the Internet or by
telephone with a later date, if that was how the original vote
was submitted, |
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notifying your companys Secretary in writing before the
meeting that you have revoked your proxy, or |
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voting in person at the meeting. |
Voting in person. If you plan to attend a meeting and
wish to vote in person, we will give you a ballot at the
meeting. However, if your shares are held in the name of your
broker, bank or other nominee, and you are a Alteon stockholder,
you must bring an account statement or letter from the nominee
indicating that you are the beneficial owner of the shares on
[ ],
2006, the Alteon record date for shares entitled to vote at the
annual meeting. If your shares are held in the name of your
broker, bank or other nominee, and you are a HaptoGuard
stockholder, you must bring an account statement or letter from
the nominee indicating that you are the beneficial owner of the
shares on
[ ],
2006, the HaptoGuard record date for shares entitled to vote at
the special meeting.
People with disabilities. We can provide reasonable
assistance to help you participate in the meeting if you tell us
about your disability and your plan to attend. Please call or
write to the Secretary of your company at least two weeks before
your meeting at the number or address under The
Companies on
page I- .
II-5
Proxy solicitation. Alteon will pay its own costs, if
any, of soliciting proxies. Alteon reserves the right to retain
outside agencies for the purpose of soliciting proxies.
HaptoGuard will pay its own costs, if any, of soliciting proxies.
In addition to this mailing, Alteon and HaptoGuard employees may
solicit proxies personally, electronically or by telephone.
The extent to which these proxy soliciting efforts will be
necessary depends entirely upon how promptly proxies are
submitted. You should send in your proxy without delay. We also
reimburse brokers and other nominees for their expenses in
sending these materials to you and getting your voting
instructions.
Do not send in any stock certificates with your proxy.
Alteon will provide instructions for the surrender of stock
certificates for HaptoGuard common stock to HaptoGuard
stockholders immediately following the completion of the merger.
Other Business; Adjournments
We are not currently aware of any other business to be acted
upon at either meeting. Under the laws of Delaware, where Alteon
and HaptoGuard are each incorporated, no business other than
procedural matters may be raised at either the Alteon meeting or
the HaptoGuard meeting unless proper notice to the stockholders
has been given. If, however, other matters are properly brought
before either meeting, or any adjourned meeting, your proxies
will have discretion to vote or act on those matters according
to their best judgment, including to adjourn the meeting.
Adjournments may be made for the purpose of, among other things,
soliciting additional proxies. Any adjournment may be made from
time to time by approval of the holders of shares representing a
majority of the votes present in person or by proxy at the
meeting, whether or not a quorum exists, without further notice
other than by an announcement made at the meeting. Neither
Alteon nor HaptoGuard currently intends to seek an adjournment
of their meetings.
Appraisal Rights
Holders of Alteon common stock are not entitled to appraisal
rights under Delaware law in connection with any matters to be
voted on at the special meeting.
Holders of HaptoGuard common stock are entitled to appraisal
rights under Delaware law in connection with the merger. In
order to validly exercise their dissenters appraisal
rights under Delaware law, HaptoGuard stockholders shall
(1) file a written notice with HaptoGuard prior to the
HaptoGuard special meeting of the stockholders intent to
demand payment for fair value for such holders shares and
(2) not vote such shares in favor of adoption of the merger
agreement, as more fully described in The Merger
Agreement Appraisal Rights. See
Chapter Five Comparison of Stockholder
Rights Appraisal Rights.
II-6
CHAPTER THREE OTHER INFORMATION REGARDING
ALTEON
BUSINESS OF ALTEON
Overview
We are a product-based biopharmaceutical company engaged in the
development of small molecule drugs to treat and prevent
cardiovascular disease and diabetes. We identified several
promising product candidates that we believe represent novel
approaches to some of the largest pharmaceutical markets. We
have advanced one of these products into Phase 2 clinical
trials.
Our lead drug candidate, alagebrium chloride or alagebrium
(formerly ALT-711), is
a product of our drug discovery and development program.
Alagebrium has demonstrated potential efficacy in two clinical
trials in heart failure, as well as in animal models of heart
failure and nephropathy, among others. It has been tested in
approximately 1,000 patients in a number of Phase 1
and Phase 2 clinical trials. Our goal is to develop
alagebrium in diastolic heart failure (DHF). This disease
represents a rapidly growing market of unmet need, particularly
common among diabetic patients, and alagebrium has demonstrated
relevant clinical activity in two Phase 2 clinical trials.
We are in the process of preparing to submit an investigational
new drug application (IND) to the Division of Cardio-Renal
Drug Products (the Cardio-Renal division) specifically for
alagebrium in heart failure, in order to expand our clinical
program in this therapeutic area. However, any continued
development of alagebrium by us is contingent upon our entering
into strategic collaboration agreements for this product
candidate which, among other things, would be required to
include funding for product development.
In June 2005, our SPECTRA (Systolic Pressure Efficacy and Safety
Trial of Alagebrium) Phase 2b trial in systolic
hypertension was discontinued after an interim analysis found
that the data did not indicate a treatment effect of alagebrium
and we have ceased development of alagebrium for this indication.
Also, in June 2005, we announced that we had submitted
preclinical toxicity data on alagebrium to two divisions of the
United States Food and Drug Administrations, or
FDAs, Center for Drug Evaluation and Research (CDER),
specifically the Division of Cardio-Renal Drug Products and the
Division of Reproductive and Urologic Drug Products (the
Reproductive/ Urologic division). The preclinical toxicity data
were submitted in support of our view that liver alterations
previously observed in rats, and reported in December 2004, were
related to the male rat metabolism and not to genotoxic
pathways. Subsequent preliminary data on liver alterations in
rats had caused us to voluntarily suspend enrolling new patients
into all of our alagebrium clinical trials in February 2005.
Following review of the rat liver data, the Cardio-Renal
division allowed us to proceed with the development of
alagebrium in cardiovascular indications. The Reproductive/
Urologic division placed on clinical hold further enrollment in
the EMERALD (Efficacy and Safety of AlagebriuM in ERectile
Dysfunction in MALe Diabetics) study, our Phase 2a study of
alagebrium in diabetic patients with erectile dysfunction, and
requested further preclinical toxicity data, which we submitted
in August 2005. After review of these data, the Reproductive/
Urologic division decided to maintain the clinical hold pending
further preclinical testing. In January 2006, we announced that
we had withdrawn the IND for the EMERALD study. We decided
instead to commit our resources to the development of alagebrium
in cardiovascular diseases. There can be no assurance that we
will ever pursue the development of alagebrium for the ED
indication.
In November 2005, we announced that data presented at the
American Heart Association (AHA), Scientific Sessions from the
Phase 2a PEDESTAL (Patients with Impaired Ejection Fraction
and Diastolic Dysfunction: Efficacy and Safety Trial of
ALagebrium) study in diastolic dysfunction demonstrated the
ability of alagebrium to improve measures of diastolic function,
including a significant reduction in left ventricular mass.
Also in November 2005, in conjunction with a presentation at the
AHA, we announced positive findings from a Phase 2a study
to evaluate the potential effects of alagebrium on endothelial
dysfunction. Initiated in
III-1
February 2004, the study was conducted at Johns Hopkins
University (JHU) School of Medicine under grants from the
National Heart, Lung and Blood Institute and the Society of
Geriatric Cardiology.
As a result of having withdrawn the IND for the EMERALD study,
there is no clinical hold remaining on alagebrium from any
division of the FDA. The FDA has never placed a clinical hold on
our protocols in cardiovascular diseases, which are under the
oversight of CDERs Division of Cardio-Renal Drug Products.
We are primarily focused on fundraising activities and exploring
strategic relationships to support our development programs.
During 2005, as part of these efforts, we engaged an investment
banking firm to help us identify potential strategic options for
the company. On April 19, we entered into a definitive
Agreement and Plan of Merger with Alteon Merger Sub, Inc., a
Delaware corporation and wholly-owned subsidiary of Alteon,
HaptoGuard, Inc., a Delaware corporation, and Genentech, Inc., a
Delaware corporation. On April 21, 2006, we closed a
private placement of Units, consisting of common stock and
warrants, for gross proceeds of approximately $2.6 million.
At the present time, we have significantly curtailed all product
development activities of alagebrium due to the absence of
sufficient financial resources to continue its development.
We were incorporated in Delaware in October 1986. Our
headquarters are located at 6 Campus Drive, Parsippany, New
Jersey 07054. We maintain a web site at www.alteon.com and our
telephone number is
(201) 934-5000.
Our annual reports on
Form 10-K, our
quarterly reports on
Form 10-Q, our
current reports on
Form 8-K, and all
amendments to those reports, are available to you free of charge
through the Investor Relations section of our
website as soon as reasonably practicable after such materials
have been electronically filed with, or furnished to, the
Securities and Exchange Commission.
PATHWAYS
Advanced Glycation End-Products (A.G.E.) are glucose/protein
complexes and are formed by a reaction between circulating blood
glucose molecules and proteins. A.G.E.s have been
associated with protein crosslinking. These pathological
complexes affect the structural chemistry of tissues and organs,
resulting in increased stiffness and fibrosis, and compromised
function. The A.G.E. pathway may provide the scientific
explanation for how and why many of the medical complications of
the aging process occur with higher frequency and earlier in
life in diabetic patients. Diabetic individuals form excessive
amounts of A.G.E.s earlier in life than do non-diabetic
individuals, due primarily to higher levels of blood glucose.
For this reason, diabetes may be viewed as an accelerated form
of aging.
A.G.E.s and A.G.E. crosslinks are considered to be likely
causative factors in the development of many age-related and
diabetic disorders. For example, proteins in the body such as
collagen and elastin, which play an important role in
maintaining the elasticity of the cardiovascular system, are
prime targets for A.G.E. crosslinking. This stiffening process
can impair the normal function of contractile organs, such as
blood vessels, which depend on flexibility for normal function.
A loss of flexibility of the vasculature is associated with a
number of cardiovascular disorders, including diastolic
dysfunction, left ventricular hypertrophy (LVH) and heart
failure itself, as well as other diabetic complications.
In addition to their role in promoting the fibrosis and
stiffening of tissues and organs throughout the body, A.G.E.s
have been shown to contribute to disease by adversely altering
multiple inflammatory and metabolic pathways. A.G.E.s can lead
to pathologic alterations commonly associated with diabetic
nephropathy, retinopathy and processes that accelerate
atherosclerosis.
In recent years, our research and drug development activities
targeting the A.G.E. pathway have focused on the development of
A.G.E. Crosslink Breakers and A.G.E. Formation Inhibitors. We
believe that we were the first company to focus on the
development of compounds to treat diseases caused by A.G.E.
formation and crosslinking. Since our inception, we have created
an extensive library of novel compounds targeting the A.G.E.
pathway and have actively pursued patent protection for these
discoveries.
The primary focus of our research and development activities is
alagebrium, which is our lead product candidate, and we believe
it to be the only A.G.E. Crosslink Breaker to have entered
advanced human clinical
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testing. Alagebrium is the first rapidly-acting oral agent
designed to break A.G.E. crosslinks, the benefit of
which may be to restore structure and function to tissues and
organs, thereby potentially reversing the damage caused by aging
and diabetes.
OUR BUSINESS STRATEGY
Our strategy has been to develop drug candidates from our
proprietary portfolio of new chemical entities with a goal to
develop compounds to address large medical needs that are unmet
by existing therapies. We may seek, as appropriate, to
selectively in-license
clinical stage compounds and as appropriate to out-license or
co-develop some drug
candidates with corporate partners. Assuming we continue the
clinical development of alagebrium, we may elect to retain
development and marketing rights for one or several indications,
while at the same time continuing to evaluate potential
corporate partnerships for the further development and ultimate
marketing of the compound. In addition to these pipeline
products, we have identified compounds in multiple chemical
classes of A.G.E. Crosslink Breakers and A.G.E. Formation
inhibitors that may warrant further evaluation and potential
development.
In August 2005, in order to enable us to move forward with the
continued development of alagebrium, we announced that we had
engaged the services of Burrill & Company (Burrill) to
assist in developing and identifying options designed to
diversify our portfolio of product candidates and to enhance the
ability to raise financing in the future. Such options include
the acquisition of technologies and product programs, licensing
opportunities, the sale to or merger into another company, and
debt and equity financing.
MARKETS OF OPPORTUNITY
Our research and development efforts have led us to an initial
focus on cardiovascular and other vascular diseases, including
heart failure, retinopathy and nephropathy, as well as other
complications of diabetes. Therapeutic targeting of the A.G.E.
pathway may reverse the progressive fibrosis and stiffening of
tissues and organs thus potentially broadening our markets of
opportunity to include additional medical disorders related to
aging and diabetes. Importantly, there are currently no marketed
drugs of which we are aware that are known to work directly on
A.G.E.s and the structural stiffening of tissues and organs that
lead to diseases such as heart failure and renal failure.
Diastolic Dysfunction in Heart Failure/ Left Ventricular
Hypertrophy
Diastolic dysfunction is the impaired ability of the heart to
relax and fill properly after a contraction, in part due to the
stiffening of the heart tissue. It is characterized by higher
than normal pressures during the relaxing phase of the heart
cycle (diastole). If the heart tissue (interstitium) has
stiffened, the filling of the heart will be impaired. When the
ventricles (the hearts lower pumping chambers) do not
relax and fill normally, increased pressure and fluid in the
blood vessels of the lungs may be a result (pulmonary
congestion), resulting in shortness of breath. Diastolic
dysfunction can also cause increased pressure and fluid in the
blood vessels returning to the heart (systemic congestion).
Diastolic dysfunction is common to both systolic and diastolic
heart failure in a group that collectively numbers about five
million in the United States alone. DHF, which is estimated to
account for 30% to 50% of all heart failure cases, is an
especially poorly treated medical condition. Data presented from
the Phase 2a PEDESTAL study in diastolic dysfunction
demonstrated the ability of alagebrium to improve measures of
diastolic function.
Left ventricular hypertrophy, refers to the thickening of the
left ventricle that can occur progressively with hypertension
and DHF. It can lead to decreased cardiac output, the inability
to meet the circulatory needs of the body and to heart failure
itself. It is a condition associated with many cardiovascular
diseases and DHF. Patients who were treated with alagebrium have
experienced a rapid remodeling of the heart, resulting in a
statistically significant reduction of left ventricular mass, as
well as a marked improvement in the initial phase of left
ventricular diastolic filling. Additionally, in several
preclinical studies, alagebrium has been shown to reduce the
thickening of the left ventricle and induce a reverse remodeling
of the heart.
The endothelium, a single-cell lining of the arteries that acts
as an interface between the blood and arterial wall, is impaired
in many cardiovascular conditions. Endothelial damage, and the
resulting inability of
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smaller vessels to react to changes in blood pressure and flow,
can be a predictor of present and future cardiovascular disease.
Recent evidence suggests that when arteries become increasingly
stiff, endothelial function is worsened even when the
endothelial cells themselves are normal. The loss of vascular
tone, due to the interaction between arterial stiffening and
endothelial function, may be important in explaining why stiff
arteries are a major risk factor for cardiovascular disease.
Alagebrium has been shown to significantly improve endothelial
function.
Complications of Diabetes
A significant portion of diabetic individuals develop
cardiovascular diseases and other complications due to the high
levels of blood glucose and A.G.E.s within the body. According
to the American Diabetes Association, heart disease is the
leading cause of diabetes-related deaths. Heart disease death
rates are two to four times higher in adults with diabetes than
adults without diabetes. The risk of stroke is also two to four
times higher in those with diabetes.
The Diabetes Control and Complications Trial, a multi-center
clinical trial conducted by the National Institutes of Health,
demonstrated that elevated blood glucose levels significantly
increase the rate of progression of blood vessel, kidney, eye
and nerve complications from diabetes. More than 50% of people
with diabetes in the United States develop diabetic
complications that range from mild to severe.
Kidney Disease
Kidney disease is a significant cause of morbidity and mortality
in patients with Type 1 and Type 2 diabetes. It is a
chronic and progressive disease that affects approximately
one-third of patients with Type 1 diabetes and
approximately 10-15% of
patients with Type 2 diabetes. One of the early signs of
kidney damage is microalbuminuria (characterized by leakage of
small amounts of protein into the urine), which progresses to
overt nephropathy (characterized by leakage of large amounts of
protein into the urine) and ultimately to end-stage renal
disease. Diabetes is the leading cause of kidney failure in the
United States.
OUR TECHNOLOGY: THE A.G.E. PATHWAY IN AGING AND DIABETES
The harmful consequences of A.G.E. formation in man were
proposed in the 1980s by our scientific founders as an
outgrowth of a research effort focused on diabetes. The
foundation for our technology is the experimental evidence that
intervention along the A.G.E. pathway provides significant
benefit in slowing or reversing the development of serious
diseases in the diabetic and aging populations. We are the
pioneers in A.G.E. technology, and we have built an extensive
patent estate covering our discoveries and compounds.
A.G.E.s are permanent structures that form when simple sugars,
such as glucose, bind to the surface of proteins. As the body
ages, A.G.E. complexes form on proteins continuously and
naturally, though slowly throughout life, at a rate dependent
upon glucose levels and on the bodys natural ability to
clear these pathological structures. A.G.E. complexes
subsequently crosslink to other proteins. The A.G.E. crosslink
has been found to be unique in biology and is prevalent in
animal models of aging and diabetes. Scientific literature
suggests that the formation and subsequent crosslinking of
A.G.E.s is an inevitable part of the aging process and diabetes
that leads to the progressive loss of flexibility and function
in various tissues and organs.
The formation and crosslinking of A.G.E.s is a well-known
process in food chemistry called the Maillard Reaction. The
browning and toughening of food during the cooking process
occurs, in part, as a result of the formation of A.G.E.
complexes between sugars and the amino acids of proteins.
The A.G.E. pathway may provide the scientific explanation for
how and why many of the medical complications of the aging
process occur with higher frequency and earlier in life in
diabetic patients. Diabetic individuals form excessive amounts
of A.G.E.s earlier in life than do non-diabetic individuals, due
primarily to higher levels of blood sugar. For this reason,
diabetes may be viewed as an accelerated form of aging.
A.G.E.s and A.G.E. crosslinks are considered likely causative
factors in the development of many age-related and diabetic
disorders. For example, proteins in the body, such as collagen
and elastin, which play an important role in maintaining the
elasticity of the cardiovascular system, are prime targets for
A.G.E.
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crosslinking. This stiffening process can impair the normal
function of contractile organs, such as blood vessels, which
depend on flexibility for normal function. A loss of flexibility
of the vasculature is associated with a number of cardiovascular
disorders diastolic dysfunction, LVH and heart failure itself,
as well as ED and other diabetic complications.
In addition to their role in promoting fibrosis and stiffening
of tissues and organs throughout the body, A.G.E.s have been
shown to contribute to disease by adversely altering multiple
inflammatory and metabolic pathways. A.G.E.s can lead to
pathologic alterations commonly associated with diabetic
nephropathy, retinopathy and alterations in molecules that
accelerate atherosclerosis.
We incurred research and development expenditures of $9,074,000,
$10,147,000 and $9,930,000 for the years ended December 31,
2005, 2004 and 2003, respectively.
A.G.E. Crosslink Breakers
A.G.E. Crosslink Breakers have the potential to treat a number
of medical disorders where loss of flexibility or elasticity
leads to a loss in function. Our lead clinical candidate,
alagebrium, has demonstrated the ability to reverse tissue
damage and restore function to the cardiovascular system in
Phase 2 clinical studies in cardiovascular distensibility
and DHF. Additionally, we are evaluating the development of
several compounds in the breaker class for other indications
where A.G.E. crosslinking leads to abnormal function.
We have identified several potential chemical classes of A.G.E.
Crosslink Breakers, and have an extensive library of compounds.
Alagebrium
Alagebrium is a small, easily synthesized compound with a rapid
mode of action. It is well absorbed from an oral tablet
formulation. The compound has completed several Phase 2
studies and is being evaluated in various preclinical models to
assess its safety and potential in a number of other disease
states.
CURRENT CLINICAL STUDIES
CLINICAL AND PRECLINICAL DEVELOPMENT OF LEAD COMPOUND
ALAGEBRIUM
Our current priorities are to continue the Phase 2 clinical
development of alagebrium in heart failure. If we are able to
obtain sufficient funding to do so, through a collaboration or
otherwise, we hope to restart our clinical studies of alagebrium
in heart failure in late 2006 or early 2007.
ALAGEBRIUM: AN A.G.E. CROSSLINK BREAKER
We plan to pursue development of alagebrium in high potential
cardiovascular indications such as heart failure, after recent
data presented at the American Heart Association
(AHA) Scientific Sessions in November 2005 demonstrated
continued positive results of alagebrium in patients with
cardiovascular disease. The AHA presentations included data from
the Phase 2a PEDESTAL study in diastolic dysfunction in
heart failure with impaired ejection fraction, as well as
positive results from a Phase 2a study in endothelial
function.
In addition to these and other Phase 2 clinical studies, we
have also conducted a series of Phase 1 safety and dose
escalation studies of alagebrium. These studies have thus far
shown alagebrium to be safe and well tolerated in humans.
We are in the process of preparing an IND specifically in heart
failure in order to expand alagebriums clinical program in
this therapeutic area. Based on the previous positive data in
heart failure and endothelial dysfunction (see the discussions
of the PEDESTAL, Johns Hopkins and DIAMOND (Distensibility
Improvement And ReMOdeliNg in Diastolic Heart Failure) studies
set forth below), we are proposing an advanced
multi-institutional Phase 2 study involving
200 patients with diastolic heart failure and diabetes, and
hope to initiate this trial in late 2006 or early 2007. However,
any continued development of alagebrium by us is contingent upon
our entering into strategic collaboration agreements for this
product candidate which, among other things, would be required
to include funding for product development.
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As a result of having withdrawn the IND for our EMERALD study,
discontinued the SPECTRA trial and completed the PEDESTAL and
Johns Hopkins endothelial dysfunction studies, all of which are
described below, we have no subjects currently under protocol in
any clinical study of alagebrium.
We continue to evaluate potential preclinical and clinical
studies in other therapeutic indications in which alagebrium may
address significant unmet needs. In addition to our anticipated
clinical studies in heart failure, we have conducted early
research studies focusing on atherosclerosis; Alzheimers
disease; photoaging of the skin; eye diseases, including
age-related macular degeneration (AMD), and glaucoma; and other
diabetic complications, including renal diseases.
CLINICAL STUDIES
PEDESTAL
In November 2005, we announced that data presented at the
American Heart Association Scientific Sessions from the
Phase 2a PEDESTAL (Patients with Impaired Ejection Fraction
and Diastolic Dysfunction: Efficacy and Safety Trial of
ALagebrium) study in diastolic dysfunction demonstrated the
ability of alagebrium to improve measures of diastolic function,
including a significant reduction in left ventricular mass.
PEDESTAL was an open-label exploratory study to determine the
effects of alagebrium at two oral dosages (35 mg once a day
or 210 mg twice daily) for 6, 12, 16 and 24 weeks
on diastolic function and left ventricular mass in 20 patients
diagnosed with systolic heart failure and diastolic dysfunction.
Safety and quality of life were also evaluated. The study
included men and women at least 30 years of age with or
without diabetes, who were classified as having grade II
to IV heart failure under the New York Heart Association
guidelines. The primary endpoints, which include quantification
of left ventricular mass and complete Doppler evaluation of
changes in diastolic function, were designed to look at the
therapeutic remodeling capability of alagebrium. Secondary
endpoints include a quality of life assessment as measured by
the Minnesota Living With Heart Failure Questionnaire.
The PEDESTAL data indicated trends consistent with positive data
from our previous heart failure study, DIAMOND. While subjects
in PEDESTAL could not be compared directly with those from
DIAMOND, because those in PEDESTAL had impaired ejection
fraction, larger hearts and were sicker overall, treatment with
alagebrium appeared to have important and consistent effects in
both patient groups.
The AHA poster presentation, entitled Improvements in
Diastolic Function Among Patients with Advanced Systolic Heart
Failure Utilizing Alagebrium, an Oral Advanced Glycation
End-product Crosslink Breaker, describes the key findings
from PEDESTAL. Twenty-two subjects were treated at the Baylor
College of Medicine in an open-label, two-dose (35 mg and
210 mg bid) regimen and followed by echocardiography. The
data revealed significant improvements from a combined analysis
of both dose groups in Doppler measures of diastolic function,
including the early/late atrial filling phase ratio,
deceleration time, isovolumetric relaxation time and resulting
reduction of left atrial pressure. In addition, some patients
achieved regression of left ventricular mass and left
ventricular end-diastolic volume.
Johns Hopkins University Study in Endothelial Dysfunction
Also in November 2005, in conjunction with a presentation at the
AHA, we announced positive findings from a Phase 2a study
to evaluate the potential effects of alagebrium on endothelial
dysfunction. Initiated in February 2004, the study was conducted
at Johns Hopkins University (JHU) School of Medicine under
grants from the National Heart, Lung and Blood Institute and the
Society of Geriatric Cardiology.
The JHU endothelial study was designed to enroll male or female
subjects 50 years of age or more, with systolic
hypertension (defined as having systolic blood pressure of
greater than 140 mm Hg and a diastolic blood pressure of less
than 95 mm Hg). Subjects received 210 mg of alagebrium
twice daily for eight weeks, preceded by three weeks of twice
daily placebo run-in dosing. The primary purpose of the study
was to determine whether increasing arterial elasticity by
breaking A.G.E. crosslinks improves endothelial function as
assessed by evaluating vessel relaxation and biomarkers of
endothelial function.
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In the study, Improved Flow-Mediated Arterial Vasodilation
by Advanced Glycation Crosslink Breaker, Alagebrium Chloride
(ALT-711), in Older Adults with Isolated Systolic
Hypertension, 13 adults with isolated systolic
hypertension on stable antihypertensive therapy received a
2-week placebo run-in
followed by 8 weeks of oral alagebrium. Data measurements
were taken after placebo run-in and after 8 weeks of
therapy. Treatment with alagebrium reduced carotid augmentation
index (AI), a measure of arterial stiffness, by 37% and carotid
augmented pressure, whereas pulse wave velocity (PWV) was
unaltered. Thus, overall arterial stiffening, as reflected by
AI, was markedly reduced by alagebrium therapy. Heart rate,
brachial arterial pressures and brachial artery distensibility
measures were unaltered by alagebrium therapy. However,
alagebrium significantly improved flow-mediated dilation, a
measure of endothelial function, by 102%. Alagebrium therapy
improved peripheral artery endothelial function, independent of
changing local arterial distensibility, suggesting a new
mechanism through which alagebrium may act on A.G.E.s which
directly impair dynamic vascular function in addition to its
apparent effect on A.G.E.s impacting the structural aspects of
arteries.
SPECTRA
In June 2005, SPECTRA, a Phase 2b trial in systolic
hypertension, was discontinued after an interim analysis of data
from the first 190 out of an anticipated 400 patients in
the trial did not indicate a treatment effect of alagebrium.
Accordingly, we have ceased development of alagebrium for this
indication.
SAPPHIRE/ SILVER
The Phase 2b SAPPHIRE/ SILVER (Systolic And Pulse Pressure
Hemodynamic Improvement by Restoring Elasticity/ Systolic
Hypertension Interaction with Left VEntricular Remodeling) trial
evaluated the effectiveness of alagebrium in approximately
770 patients having elevated systolic blood pressure with
or without LVH. The trial was dose-ranging, double-blind,
placebo-controlled and conducted at over 60 sites in the United
States. In May 2004, the detailed findings from an analysis of
the SAPPHIRE/ SILVER trial were presented at the American
Society of Hypertension (ASH), Nineteenth Annual Scientific
Meeting. These data, which were subsequently published in a
supplement to the December 15, 2004 issue of the American
Journal of Hypertension, demonstrated that treatment with
alagebrium, as recorded by automatic blood pressure measurement
(ABPM), resulted in a significant reduction in systolic blood
pressure in patients that are traditionally difficult to treat.
The findings supported the hypothesis that alagebrium works best
in patients with more serious baseline hypertension via a
mechanism of action unlike any currently marketed high blood
pressure drug.
We announced the initial results of the SAPPHIRE/ SILVER trial
in July 2003. The pre-specified primary endpoint of this trial,
reduction of systolic blood pressure by office cuff pressure
measurement at the highest of the four active dose levels,
210 mg per day, did not demonstrate statistical
significance as compared to placebo. The data analysis was
confounded by a 6 to 10 mm Hg drop in systolic blood pressures
in all arms of the SAPPHIRE/ SILVER trial, including placebo,
during the first two weeks after patient randomization. However,
subjects in the SAPPHIRE
intent-to-treat
population demonstrated efficacy net of placebo, in the 2 to 3
mm Hg range by cuff pressure, at the lower end of the alagebrium
dosing range. As reported at that time, a pre-specified
secondary analysis of ABPM measurements in subjects who
completed the study demonstrated a blood pressure lowering
effect at lower doses of about 4 mm Hg net of placebo.
Importantly, there was no significant placebo effect noted in
the ABPM measurements, and that data were presented at the ASH
meeting in May 2004, as noted above.
DIAMOND
In January 2003, we announced positive results from an analysis
of the first 17 subjects in the Phase 2a DIAMOND
clinical study, evaluating the potential effects of alagebrium
in patients with diastolic dysfunction in diastolic heart
failure. The study was conducted at Wake Forest University
Baptist Medical Center and the Medical University of South
Carolina in subjects at least 60 years of age with isolated
DHF.
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In the DIAMOND study, 23 subjects received 210 mg of
alagebrium twice daily on an open-label outpatient basis for
16 weeks in addition to their current medications. Primary
endpoints included changes in exercise tolerance and aortic
stiffness. Effects on left ventricular hypertrophy, diastolic
filling and quality of life were also assessed. Those who
received alagebrium for 16 weeks experienced a rapid
remodeling of the heart, resulting in a statistically
significant reduction in left ventricular mass as well as a
marked improvement in the initial phase of left ventricular
diastolic filling. Additionally, the drug was well tolerated and
had a positive effect on quality of life. Measurements of
exercise tolerance and aortic distensibility proved to be more
variable than anticipated for a study of this size and were not
reportable.
EMERALD
In January 2005, we initiated a Phase 2a study to evaluate
the potential effects of alagebrium in ED. EMERALD was designed
to assess the ability of alagebrium to restore erectile function
in approximately 40 male diabetic subjects with moderate to
severe ED who achieve limited benefit from current treatment
with PDE5 inhibitors, the first class of orally-active compounds
approved for the treatment of ED. In a preclinical rat model of
diabetes, alagebrium had demonstrated an ability to restore
erectile function through what appeared to be a unique mechanism
of action that might offer significant potential as an
adjunctive treatment for diabetic ED.
In January 2006, we announced that we had withdrawn the IND for
the EMERALD study because the Reproductive/ Urologic Division
had required additional preclinical testing of the drug before
allowing phase 2a testing to proceed, and we decided
instead to commit resources to the development of alagebrium in
cardiovascular diseases. There can be no assurance that we will
ever pursue the development of alagebrium for the ED indication.
In June 2005, we announced that we had submitted pre-clinical
toxicity data on alagebrium to two divisions of the FDAs
Center for Drug Evaluation and Research, specifically the
Division of Cardio-Renal Drug Products and the Division of
Reproductive and Urologic Drug Products. The pre-clinical
toxicity data were submitted in support of our view that liver
alterations previously observed in rats, and reported in
December 2004, were related to the male rat metabolism and not
to genotoxic pathways. Preliminary data on liver alterations in
rats had caused us to voluntarily suspend enrolling new patients
into all of our alagebrium clinical trials, including EMERALD,
in February 2005.
Following review of the rat liver data, CDERs Division of
Reproductive and Urologic Drug Products placed on clinical hold
further enrollment in the EMERALD study, our Phase 2a study
of alagebrium in diabetic patients with erectile dysfunction,
and requested further pre-clinical toxicity data, which we
submitted in August 2005. After review of these data, the
Reproductive/ Urologic division decided to maintain the clinical
hold pending further pre-clinical data.
Phase 2a Cardiovascular Compliance Study
In January 2001, we announced successful results from a
Phase 2a clinical study of alagebrium evaluating the
effects of the compound on cardiovascular elasticity and
function. This study, conducted at nine United States clinical
sites, was a double-blind, placebo-controlled study evaluating
the safety, efficacy and pharmacology of alagebrium.
Study results showed that subjects who received alagebrium had a
statistically significant (p<0.02) and clinically meaningful
reduction in the arterial pulse pressure, defined as the
difference between systolic and diastolic blood pressure.
Results also showed a statistically significant increase in
large artery compliance (p<0.03), an indicator of greater
vascular flexibility and volume capacity, using a traditional
measurement of the ratio of stroke volume to pulse pressure.
Additionally, the drug was well tolerated.
PRECLINICAL STUDIES
Alagebrium efficacy data are consistent across species. Studies
in animal models in several laboratories around the world have
demonstrated rapid reversal of impaired cardiovascular functions
with alagebrium. In
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these preclinical models, alagebrium reverses the stiffening of
arteries, as well as the stiffening of the hearts that are
consequences of aging and diabetes.
Preclinical studies of alagebrium conducted by researchers from
the National Institute on Aging and Johns Hopkins Geriatric
Center demonstrated the ability of the compound to significantly
and rapidly reduce arterial stiffness in elderly Rhesus monkeys.
In a preclinical study of alagebrium in aged dogs,
administration of alagebrium for one month resulted in an
approximate 40% decrease in age-related ventricular stiffness,
or hardening of the heart, with an overall improvement in
cardiac function. Additionally, in several preclinical studies,
alagebrium has been shown to normalize the thickening of the
left ventricle and to have a beneficial, therapeutic effect on
reversing the pathologic remodeling of the heart. Preclinical
studies have also demonstrated the beneficial effects of
alagebrium on atherosclerosis, kidney disease, ED and certain
eye conditions.
MANUFACTURING
We have no manufacturing facilities for either production of
bulk chemicals or the manufacturing of pharmaceutical dosage
forms. We have relied in the past on third party contract
manufacturers to produce the raw materials and chemicals used as
the active drug ingredients in our products used in clinical
studies, nd we expect to rely on third parties to perform the
tasks necessary to process, package and distribute these
products in finished form.
We will inspect third party contract manufacturers and their
consultants to confirm compliance with current Good
Manufacturing Practice, or cGMP, required for pharmaceutical
products. Upon any resumption of activity in our clinical trial
program, we believe we will be able to obtain sufficient
quantities of bulk chemicals at reasonable prices to satisfy
anticipated needs.
MARKETING AND SALES
We retain worldwide marketing rights to our A.G.E. Crosslink
Breaker compounds. We believe that alagebrium may address the
cardiovascular, diabetes, ophthalmologic and primary care
physician markets. We plan to market and sell our products, if
and when they are successfully developed and approved, directly
or through co-promotion or other licensing arrangements with
third parties. Such arrangements may be exclusive or
nonexclusive and may provide for marketing rights worldwide or
in a specific market.
PATENTS, TRADE SECRETS AND LICENSES
Proprietary protection for our product candidates, processes and
know-how is important to our business. We aggressively file and
prosecute patents covering our proprietary technology, and, if
warranted, will defend our patents and proprietary technology.
As appropriate, we seek patent protection for our proprietary
technology and products in the United States and Canada and in
key commercial European and Asia/ Pacific countries. We also
rely upon trade secrets, know-how, continuing technological
innovation and licensing opportunities to develop and maintain
our competitive position. In addition to our own patent filings,
we have licensed or obtained technology and patent portfolios
from others relating to the
A.G.E.-formation and
crosslinking technology currently under development by us.
As of the date of this report, our patent estate of owned and/or
licensed patent rights consisted of 84 issued United States
patents and 15 pending patent applications in the United States,
Canada and Mexico, the majority of which are
A.G.E.-related. We also
own or have exclusive rights to over 40 issued patents in
Europe, Japan, Australia and Canada. These patents and
additional patent applications cover compounds, compositions and
methods of treatment for several chemical classes of crosslink
breaker compounds, including alagebrium.
We previously exclusively licensed from The Picower Institute
for Medical Research, or The Picower, certain patentable
inventions and discoveries relating to A.G.E. technology. The
Picower license agreement was terminated as of April 15,
2002, when we entered into a Termination Agreement, pursuant to
which The Picower assigned to us all of its patents, patent
applications and other technology related to A.G.E.s. We
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agreed to prosecute and maintain the patents and patent
applications and will pay to the trustee for The Picower
royalties on any sales of products falling within the claims of
these patents and patent applications until they expire or are
allowed to lapse.
We believe that our licensed and owned patents provide a
substantial proprietary base that will allow us and our
collaborative partners to commercialize products in this field.
We believe our research and development plans will expand and
broaden our rights within our technological and patent base. We
are also prepared to
in-license additional
technology that may be useful in building our proprietary
position. There can be no assurance, however, that pending or
future applications will issue, that the claims of any patents
which do issue will provide any significant protection of our
technology or that our directed discovery research will yield
compounds and products of therapeutic and commercial value.
Where appropriate, we utilize trade secrets and unpatentable
improvements to enhance our technology base and improve our
competitive position. We require all employees, scientific
consultants and contractors to execute confidentiality
agreements as a condition of engagement. There can be no
assurance, however, that we can limit unauthorized or wrongful
disclosures of unpatented trade secret information.
We believe that our estate of licensed and owned issued patents,
if upheld, and pending applications, if granted and upheld, will
be a substantial factor in our success. The patent positions of
pharmaceutical firms, including ours, are generally uncertain
and involve complex legal and factual questions. Consequently,
even though we are currently prosecuting such patent
applications in the United States and foreign patent offices, we
do not know whether any of such applications will result in the
issuance of any additional patents or, if any additional patents
are issued, whether the claims thereof will provide significant
proprietary protection or will be circumvented or invalidated.
Competitors or potential competitors have filed for or have
received United States and foreign patents and may obtain
additional patents and proprietary rights relating to compounds
or processes competitive with those of ours. Accordingly, there
can be no assurance that our patent applications will result in
patents being issued or that, if issued, the claims of the
patents will afford protection against competitors with similar
technology; nor can there be any assurance that others will not
obtain patents that we would need to license or circumvent. See
Competition.
Our success will depend, in part, on our ability to obtain
patent protection for our products, preserve our trade secrets
and operate without infringing on the proprietary rights of
third parties. There can be no assurance that our current patent
estate will enable us to prevent infringement by third parties
or that competitors will not develop competitive products
outside the protection that may be afforded by the claims of
such patents. To the extent we rely on trade secrets and
unpatented know-how to maintain our competitive technological
position, there can be no assurance that others may not develop
independently the same or similar technologies. Failure to
maintain our current patent estate or to obtain requisite patent
and trade secret protection, which may become material or
necessary for product development, could delay or preclude us or
our licensees or marketing partners from marketing their
products and could thereby have a material adverse effect on our
business, financial condition and results of operations.
GOVERNMENT REGULATION
We and our products are subject to comprehensive regulations by
the FDA and by comparable authorities in other countries. These
national agencies and other federal, state and local entities
regulate, among other things, the preclinical and clinical
testing, safety, effectiveness, approval, manufacturing,
labeling, marketing, export, storage, record keeping,
advertising and promotion of our products.
The process required by the FDA before our products may be
approved for marketing in the United States generally involves
(1) preclinical new drug laboratory and animal tests,
(2) submission to the FDA of an investigational new drug
application, or IND, which must become effective before clinical
trials may begin, (3) adequate and well-controlled human
clinical trials to establish the safety and efficacy of the drug
for its intended indication, (4) submission to the FDA of a
new drug application, or NDA, and (5) FDA review of the NDA
in order to determine, among other things, whether the drug is
safe and effective for its intended
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uses. There is no assurance that the FDA review process will
result in product approval on a timely basis, if at all.
Preclinical tests include laboratory evaluation of product
chemistry and formulation, as well as animal studies to assess
the potential safety and efficacy of the product. Certain
preclinical tests are subject to FDA regulations regarding
current Good Laboratory Practices. The results of the
preclinical tests are submitted to the FDA as part of an IND and
are reviewed by the FDA prior to the commencement of clinical
trials or during the conduct of the clinical trials, as
appropriate.
Clinical trials are conducted under protocols that detail such
matters as the objectives of the study, the parameters to be
used to monitor safety and the efficacy criteria to be
evaluated. Each protocol must be submitted to the FDA as part of
the IND. Further, each protocol must be reviewed and approved by
an IRB.
Clinical trials are typically conducted in three sequential
phases, which may overlap. During Phase 1, when the drug is
initially given to human subjects, the product is tested for
safety, dosage tolerance, absorption, metabolism, distribution
and excretion. Phase 2 involves studies in a limited
patient population to (1) evaluate preliminarily the
efficacy of the product for specific targeted indications,
(2) determine dosage tolerance and optimal dosage, and
(3) identify possible adverse effects and safety risks.
Phase 3 trials are undertaken in order to further evaluate
clinical efficacy and to further test for safety within an
expanded patient population. The FDA may suspend clinical trials
at any point in this process if it concludes that clinical
subjects are being exposed to an unacceptable health risk.
We will need FDA approval of our products, including a review of
the manufacturing processes and facilities used to produce such
products, before such products may be marketed in the United
States. The process of obtaining approvals from the FDA can be
costly, time-consuming and subject to unanticipated delays. We
have experienced such delays in the past, including in February
2005, when, based on initial findings from a preclinical
toxicity study that provided direction for further analysis, we
voluntarily and temporarily suspended enrollment of patients
into our ongoing clinical studies of alagebrium, pending receipt
of additional preclinical data and discussions with the FDA.
We cannot assure at this time when enrollment in our clinical
studies will resume, if ever. There can no assurance that the
FDA will grant approvals of our proposed products, processes or
facilities on a timely basis, if at all. Any delay or failure to
obtain such approvals would have a material adverse effect on
our business, financial condition and results of operations.
Moreover, even if regulatory approval is granted, such approval
may include significant limitations on indicated uses for which
a product could be marketed.
Among the conditions for NDA approval is the requirement that
the prospective manufacturers operating procedures conform
to cGMP requirements, which must be followed at all times. In
complying with these requirements, manufacturers, including a
drug sponsors third-party contract manufacturers, must
continue to expend time, money and effort in the area of
production and quality control to ensure compliance. Domestic
manufacturing establishments are subject to periodic inspections
by the FDA in order to assess, among other things, cGMP
compliance. To supply a product for use in the United States,
foreign manufacturing establishments must comply with cGMP and
are subject to periodic inspection by the FDA or by regulatory
authorities from other countries, as applicable.
Both before and after approval is obtained, a product, its
manufacturer and the holder of the NDA for the product are
subject to comprehensive regulatory oversight. Violations of
regulatory requirements at any stage, including the preclinical
and clinical testing process, the approval process, or
thereafter, including after approval, may result in various
adverse consequences, including the FDAs delay in
approving or refusal to approve a product, withdrawal of an
approved product from the market and/or the imposition of
criminal penalties against the manufacturer and/or NDA holder.
In addition, later discovery of previously unknown problems may
result in restrictions on the product, manufacturer or NDA
holder, including withdrawal of the product from the market.
Also, new government requirements may be established that could
delay or prevent regulatory approval of our products under
development.
For marketing outside of the United States, we will have to
satisfy foreign regulatory requirements governing human clinical
trials and marketing approval for drugs and diagnostic products.
The requirements
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governing the conduct of clinical trials, product licensing,
pricing and reimbursement vary widely from country to country.
We do not currently have any facilities or personnel outside of
the United States.
COMPETITION
A.G.E.s have been shown to contribute to many of the disorders
of aging and diabetes. Cardiovascular diseases and diabetic
complications are among the diseases that may be a consequence
of A.G.E. accumulation in the body. We are aware of many
companies pursuing research and development of compounds for
these indications. In addition, we are aware of companies, such
as Novartis AG, that currently have or previously have had
research and development activities in the A.G.E. field itself
and may have identified candidates for clinical development.
Our competition will be determined, in part, by the potential
indications for which our compounds are developed and ultimately
approved by regulatory authorities. An important factor in
competition may be the timing of market introduction of our or
our competitors products. Accordingly, the relative speed
with which we can develop products, complete the clinical trials
and approval processes and supply commercial quantities of the
products to the market are important competitive factors. We
expect that competition among any products that are approved for
sale will be based on, among other things, product efficacy,
safety, reliability, availability, price and patent position.
Our competitive position also depends upon our ability to obtain
sufficient capital resources, attract and retain qualified
personnel, and obtain protection for or otherwise develop
proprietary products or processes.
We are competing in an industry in which technologies can become
obsolete over time, thereby reducing or eliminating the market
for any pharmaceutical product. For example, competitive drugs
based on other therapeutic mechanisms are currently marketed and
are being developed to treat cardiovascular disease and diabetic
complications. The development by others of non-A.G.E.-related
treatment modalities could render any products that we develop
non-competitive. Therapeutic approaches being pursued by others
include treating cardiovascular disease and diabetic
complications via gene therapy and cell transplantation, as well
as pharmaceutical intervention with agents such as aldose
reductase inhibitors.
There are many drugs currently being used for the treatment of
heart failure including ACE inhibitors, angiotensin receptor
blockers, adrenergic alpha 1 receptor antagonists, aldosterone
inhibitors, beta-blockers and diuretics, among others.
Most of our competitors and potential competitors have
significantly greater financial resources than we have. Our
competitive position also depends on our ability to enter into a
collaboration agreement with respect to alagebrium, and we
cannot assure that we will be able to do so on reasonable terms,
or at all.
MEDICAL AND CLINICAL ADVISORS
Our Medical and Clinical Advisors are individuals with
recognized expertise in medical and pharmaceutical sciences and
related fields who advise us about present and long-term
scientific planning, research and development. These advisors
consult and meet with our management informally on a frequent
basis. All advisors are employed by employers other than us, who
may also be competitors of ours, and may have commitments to, or
consulting or advisory agreements with, other entities that may
limit their availability to us. The advisors have agreed,
however, not to provide any services to any other entities that
might conflict with the activities that they provide us. Each
member also has executed a confidentiality agreement for our
benefit.
The following persons are our Medical and Clinical Advisors:
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Daniel Burkhoff, M.D., PhD, Adjunct Associate Professor,
Medicine/ Cardiology, Columbia University and Cardiovascular
Research Foundation, Chief Medical Officer, Impulse Dynamics. |
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Norman K. Hollenberg, M.D., Ph.D., Professor of
Medicine, Harvard Medical School; Director of Physiologic
Research, Brigham and Womens Hospital, Boston; served as
an Editor of the New England Journal of Medicine. |
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Dalane Kitzman, M.D., Professor, Cardiology, Wake Forest
University Baptist Medical Center. |
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Peter R. Kowey, M.D., Full Professor, Medicine and Clinical
Pharmacology, Jefferson Medical College; President and Chief of
the Division of Cardiovascular Diseases, Main Line Health Heart
Center, Lankenau Hospital; Fellow of the American Heart
Association, the American College of Cardiology, the American
College of Physicians, the College of Physicians of
Philadelphia, the American College of Chest Physicians and the
American College of Clinical Pharmacology. |
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William Little, M.D., Section Head, Professor,
Cardiology, Wake Forest University Baptist Medical Center. |
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Craig M. Pratt, M.D., Professor of Medicine, Baylor College
of Medicine; Director of Research, Methodist DeBakey Heart
Center; Director, Coronary Intensive Care Unit, The Methodist
Hospital; Member, Continuing Medical Education Advisory Board,
Discovery International; Fellow, American College of Cardiology. |
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Vinay Thohan, M.D., Assistant Professor of Medicine,
Methodist DeBakey Heart Center. |
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Guillermo Torre, MD, PhD, Assistant Professor of Medicine/
Medical Director, Heart Transplant Service, Methodist DeBakey
Heart Center. |
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Susan Zieman, M.D., PhD, Assistant Professor, Dept. of
Medicine/ Cardiovascular, John Hopkins School of Medicine. |
As of March 1, 2006, we employed seven persons; one engaged
in research and development, and 6 engaged in
administration and management. One of those employed held a
Ph.D. We believe that we have been successful in the past in
attracting skilled and experienced personnel. Our employees are
not covered by collective bargaining agreements. All employees
are covered by confidentiality agreements. We believe that our
relationship with our employees is good. We have also engaged
consultants for certain administrative and scientific functions.
PROPERTIES
We lease 10,800 square feet of space in a building in
Parsippany, New Jersey, which contains our executive and
administrative offices. The lease, which commenced on
December 1, 2003, has a
37-month term. We
currently do not intend to renew this lease, which expires on
December 31, 2006. We believe that alternate commercial
space is available on reasonable terms.
LEGAL PROCEEDINGS
The lawsuit referred to in our
Form 10-K for the
fiscal year ended December 31, 2004 against Advanced
Biologics L.L.C. has settled and, pursuant to the terms of the
settlement, we and Advanced Biologics have dismissed outstanding
claims against each other and an undisclosed payment has been
received by Alteon.
III-13
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND
RESULTS OF OPERATIONS
OVERVIEW
We are a product-based biopharmaceutical company engaged in the
development of small molecule drugs to treat and prevent
cardiovascular disease and diabetes. We have identified several
promising product candidates that we believe represent novel
approaches to some of the largest pharmaceutical markets. We
have advanced one of these products into Phase 2 clinical
trials.
Our lead drug candidate, alagebrium, is a product of our drug
discovery and development program. Alagebrium has demonstrated
potential efficacy in two clinical trials in heart failure, as
well as in animal models of heart failure, nephropathy,
hypertension and erectile dysfunction. It has been tested in
approximately 1,000 patients in a number of Phase 1
and Phase 2 clinical trials. However, we have significantly
curtailed all product development activities of alagebrium due
to an absence of sufficient financial resources to continue its
development. As announced on February 1, 2006, while our
goal is to pursue development of alagebrium in high potential
cardiovascular indications such as diastolic heart failure, any
continued development of alagebrium by us is contingent upon our
entering into strategic collaboration agreements for this
product candidate which, among other things, would be required
to include funding for product development. We may not be able
to enter into a strategic collaboration agreement with respect
to alagebrium on reasonable terms, or at all. No enrollment or
other activity is taking place with respect to any of our
Phase 2 trials of alagebrium pending the resolution of our
financial resource issues.
We expect to utilize cash and cash equivalents to fund our
operating activities, including any continued development of our
lead compound, alagebrium. As a result of the discontinuation of
the Phase 2b SPECTRA trial in systolic hypertension, we
have undertaken curtailment actions and expect to have reduced
expenses in the first half of 2006. These actions include
evaluating clinical strategies before resuming clinical trials,
increased selectivity in preclinical programs and reduced
headcount. We have engaged third parties to assist in developing
and identifying options designed to diversify our portfolio of
product candidates. If we are unable to secure additional
financing on reasonable terms, unable to generate sufficient new
sources of revenue through collaborative arrangements or if the
level of cash and cash equivalents falls below anticipated
levels, we will not have the ability to continue as a going
concern after mid-2006.
We are in the process of preparing to submit an IND to the
FDAs Division of Cardio-Renal Drug Products specifically
for alagebrium in heart failure, in order to expand our clinical
program in this therapeutic area.
If we are able to continue the clinical development of
alagebrium, we will determine if it is appropriate to retain
development and marketing rights for one or several indications,
while at the same time continuing to evaluate potential
corporate partnerships for the further development and ultimate
marketing of the compound in other territories throughout the
world. We believe that alagebrium may address the
cardiovascular, diabetes, and primary care physician markets.
We cannot predict at this time when enrollment in our clinical
studies will resume, if ever. If we do not resume enrollment in
one or more of our clinical studies, we will evaluate moving
into more focused clinical trials in different indications or
returning to our pre-clinical library of compounds to identify
new compounds to bring forward for further evaluation. Should we
be unable to resume enrollment in our clinical studies, in a
timely manner, or at all, our business will be materially
adversely affected.
We continue to evaluate potential preclinical and clinical
trials in other therapeutic indications in which A.G.E.
Crosslink Breaker compounds may address significant unmet needs.
In addition to our clinical studies in heart failure and
endothelial dysfunction, we have early research studies focused
on atherosclerosis; Alzheimers disease; photoaging of the
skin; eye diseases, including AMD and glaucoma; and diabetic
complications, including renal diseases. However, the pursuit of
research or development in any of these areas is contingent upon
our ability to secure sufficient funding to proceed with these
programs.
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Since our inception in October 1986, we have devoted
substantially all of our resources to research, drug discovery
and development programs. To date, we have not generated any
revenues from the sale of products and do not expect to generate
any such revenues for a number of years, if at all. We have
incurred an accumulated deficit of $222,813,000 as of
December 31, 2005, and expect to incur net losses,
potentially greater than losses in prior years, for a number of
years.
We have financed our operations through proceeds from public
offerings of common stock, private placements of common and
preferred equity securities, revenue from former collaborative
relationships, reimbursement of certain of our research and
development expenses by our collaborative partners, investment
income earned on cash balances and short-term investments and
the sale of a portion of our New Jersey State net operating loss
carryforwards.
In April 2006, we announced the signing of a definitive merger
agreement with HaptoGuard, Inc., whereby the two companies will
combine operations. The companies have complementary product
platforms in cardiovascular diseases, diabetes and other
inflammatory diseases. We have begun working with the HaptoGuard
team in anticipation of the merger of the companies, and are
preparing a Phase 2 protocol for alagebrium in heart failure in
order to expand our clinical program in this therapeutic area.
However, any continued development of alagebrium by us is
contingent upon the successful completion of the merger and
adequate funding for product development.
Following the merger, the combined company will have two
products in Phase 2 clinical development:
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Alagebrium chloride (formally ALT-711), Alteons lead
compound, is an Advanced Glycation End-product Crosslink Breaker
being developed for heart failure. Data presented from two Phase
2 clinical studies at the American Heart Association meeting in
November 2005 demonstrated the ability of alagebrium to improve
overall cardiac function, including measures of diastolic and
endothelial function. In these studies, alagebrium also
demonstrated the ability to significantly reduce left
ventricular mass. The compound has been tested in approximately
1,000 patients, which represents a sizeable human safety
database, in a number of Phase 2 clinical trials. |
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ALT-2074 (formerly BXT-51072), HaptoGuards licensed lead
compound, is a glutathione peroxidase mimetic in development for
reduction of mortality in post-myocardial infarction patients
with diabetes. The compound has shown the ability to reduce
infarct size by approximately 85% in a mouse model of heart
attack called ischemia reperfusion injury. |
Additionally, HaptoGuard owns a license to a proprietary genetic
biomarker that has shown the potential to identify patients who
are most responsive to the HaptoGuard compound.
In April 2006, we also announced the signing of definitive
agreements for an equity financing which resulted in gross
proceeds to us of approximately $2.6 million. The PIPE
financing includes new and existing institutional investors, in
which we sold approximately 10.3 million Units, consisting
of common stock and warrants, for net proceeds after expenses
and fees of approximately $2.5 million. Each Unit consists
of one share of Alteon common stock and one warrant to purchase
one share of Alteon common stock. The Units were sold at a price
of $0.25 per Unit and the warrants are exercisable, commencing
six months from the date of issuance, for a period of five years
at an exercise price of $0.30 per share. The shares of common
stock and warrants that were offered and sold in the financing
were not registered under the Securities Act or state securities
laws pursuant to an exemption from registration provided by
Regulation D under the Securities Act. We have filed a
registration statement with the SEC for the resale of the shares
of common stock and the shares of common stock underlying the
warrants sold in the PIPE transaction. Rodman & Renshaw, LLC
served as placement agent in the transaction and received a 6%
placement fee which was paid in Units.
Our business is subject to significant risks including, but not
limited to, (1) our ability to obtain sufficient additional
funding in the near term, whether through a strategic
collaboration agreement or otherwise, to allow us to resume the
development of alagebrium and to continue operations,
(2) our ability to restructure our preferred stock
agreement with Genentech through completion of the merger with
HaptoGuard (3) our ability to resume enrollment in our
clinical studies of alagebrium should we have adequate financial
and other resources to do so, (4) the risks inherent in our
research and development efforts, including clinical trials and
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the length, expense and uncertainty of the process of seeking
regulatory approvals for our product candidates, (5) our
reliance on alagebrium, which is our only significant drug
candidate, (6) uncertainties associated with obtaining and
enforcing our patents and with the patent rights of others,
(7) uncertainties regarding government healthcare reforms
and product pricing and reimbursement levels,
(8) technological change and competition,
(9) manufacturing uncertainties, and (10) dependence
on collaborative partners and other third parties. Even if our
product candidates appear promising at an early stage of
development, they may not reach the market for numerous reasons.
These reasons include the possibilities that the products will
prove ineffective or unsafe during preclinical or clinical
studies, will fail to receive necessary regulatory approvals,
will be difficult to manufacture on a large scale, will be
uneconomical to market or will be precluded from
commercialization by proprietary rights of third parties. These
risks and others are discussed under the heading Risk
Factors.
RESULTS OF OPERATIONS
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Three Months ended March 31, 2006 and 2005 |
Total revenues for the three months ended March 31, 2006
and 2005, was $60,000 and $99,000, respectively. Revenues were
derived from interest earned on cash and cash equivalents. The
decrease from 2005 to 2006 was attributed to lower investment
balances and partially offset by higher interest rates.
Our total expenses were $1,682,000 for the three months ended
March 31, 2006, compared to $4,741,000 for the three months
ended March 31, 2005, and in each period consisted
primarily of research and development expenses. Research and
development expenses normally include third-party expenses
associated with pre-clinical and clinical studies, manufacturing
costs, including the development and preparation of clinical
supplies, personnel and personnel-related expenses and facility
expenses.
Research and development expenses were $450,000 for the three
months ended March 31, 2006, as compared to $3,641,000 for
the same period in 2005, a decrease of $3,191,000, or 87.6%.
This decrease was attributed to decreased clinical trial costs
and manufacturing expenses as a result of the discontinuation in
June 2005 of our Systolic Pressure Efficacy and Safety Trial of
Alagebrium (SPECTRA). In 2006, of the total amount
spent on research and development expenses, we incurred $233,000
in personnel and personnel-related expenses, $101,000 in product
liability insurance and $86,000 in third party consulting. In
2005, we incurred $1,275,000 in clinical trial expenses
primarily related to SPECTRA, $1,252,000 in personnel and
personnel-related expenses, $441,000 in pre-clinical expenses
and $284,000 related to manufacturing (packaging and
distribution).
General and administrative expenses were $1,232,000 for the
three months ended March 31, 2006, as compared to
$1,100,000 for the same period in 2005. Although general and
administrative expenses remained relatively flat, 2006 includes
increased severance costs and retention bonuses offset by
decreased corporate expenses.
Our net loss applicable to common stockholders was $2,797,000
for the three months ended March 31, 2006, compared to
$5,714,000 in the same period in 2005, a decrease of 51.1%. This
decrease was a result primarily of our significantly reduced
research and development expenses. Included in the net loss
applicable to common stockholders are preferred stock dividends
of $1,175,322 and $1,071,578 for the three months ended
March 31, 2006 and 2005 respectively.
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LIQUIDITY AND CAPITAL RESOURCES |
We had cash and cash equivalents at March 31, 2006, of
$4,469,000, compared to $6,583,000 at December 31, 2005.
The decrease is attributable to $1,912,000 of net cash used in
operating activities and $202,000 of cash used in investing
activities. At March 31, 2006 we had working capital of
$3,756,000.
We do not have any approved products and currently derive cash
from sales of our securities, sales of our New Jersey state net
operating loss carryforwards and interest on cash and cash
equivalents. We are highly susceptible to conditions in the
global financial markets and in the pharmaceutical industry.
Positive and negative movement in those markets will continue to
pose opportunities and challenges to us. Previous downturns in
the market valuations of biotechnology companies and of the
equity markets more generally have restricted our ability to
raise additional capital on favorable terms.
The Company has entered into a definitive merger agreement
whereby it plans to combine operations with HaptoGuard, Inc., a
privately-held biotechnology company. The merger and associated
preferred stock restructuring transactions are subject to the
approval of Alteon and HaptoGuard shareholders and are expected
to close early in the third quarter of 2006. See Note
6 Subsequent Events.
In addition, the Company has completed an equity financing that
resulted in net proceeds to Alteon of approximately
$2.5 million. The new financing, as well as the
Companys current cash and cash equivalents, will be used
to help fund future development efforts of the combined
companies, including studies for two Phase 2 clinical-stage
compounds focused on cardiovascular disease in diabetic
patients. See Note 6 Subsequent Events.
The Company may continue to pursue fund-raising possibilities
through the sale of its equity securities after the merger is
completed. If the Company is unable to complete the merger, is
unsuccessful in its efforts to raise additional funds through
the sale of additional equity securities or if the level of cash
and cash equivalents falls below anticipated levels, Alteon will
not have the ability to continue as a going concern after late
2006. As part of the merger, there are associated costs that
could result in the Company being required to make payment of
certain obligations in the amount of approximately
$2.0 million, including severance and other contractual and
regulatory requirements. In association with developing and
identifying strategic options, certain costs have been deferred
relating to the merger of $424,000.
The amount and timing of the Companys future capital
requirements will depend on numerous factors, including the
timing of resuming its research and development programs, if at
all, the timing of completion of the merger with HaptoGuard, the
number and characteristics of product candidates that it
pursues, the conduct of pre-clinical tests and clinical studies,
the status and timelines of regulatory submissions, the costs
associated with protecting patents and other proprietary rights,
the ability to complete strategic collaborations and the
availability of third-party funding, if any.
Selling securities to satisfy the Companys short-term and
long-term capital requirements may have the effect of materially
diluting the current holders of its outstanding stock. Alteon
may also seek additional funding through corporate
collaborations and other financing vehicles. There can be no
assurance that such funding will be available at all or on terms
acceptable to the Company. If adequate funds are not available,
the Company may be required to curtail significantly one or more
of its research and development programs. If funds are obtained
through arrangements with collaborative partners or others, the
Company may be required to relinquish rights to certain of its
technologies or product candidates. If Alteon is unable to
obtain the necessary funding, it may need to cease operations.
Even if the Company completes the merger with HaptoGuard, there
can be no assurance that the products or technologies acquired
in such transaction will result in revenues to the combined
company or any meaningful return on investment to its
stockholders.
III-17
RESULTS OF OPERATIONS
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Years Ended December 2005, 2004, and 2003 |
Total revenues for 2005, 2004 and 2003 were $458,000, $334,000,
and $179,000, respectively. Revenues were derived from interest
earned on cash and cash equivalents, other income, and
short-term investments. Investment income in 2005 was higher
than 2004 due to an increase in short-term interest rates,
partially offset by lower investment balances. In 2005, other
income included $100,000 received from a licensing agreement
with Avon Products, Inc. In 2004, other income included
approximately $52,000 derived from the sale of fully depreciated
laboratory equipment and supplies and a reimbursement of
$100,000 for improvements made to our former facility in Ramsey,
NJ. The increase in investment income in 2004 versus 2003 was
attributed to increased interest rates.
Total expenses decreased to $13,399,000 in 2005 from $14,679,000
in 2004 and from $14,976,000 in 2003 and consisted primarily of
research and development expenses. Research and development
expenses were $9,074,000 in 2005, $10,147,000 in 2004, and
$9,930,000 in 2003. These expenses consisted primarily of
third-party expenses associated with preclinical and clinical
studies, manufacturing costs, including the development and
preparation of clinical supplies, personnel and
personnel-related expenses and an allocation of facility expense.
Research and development expenses decreased to $9,074,000 in
2005 from $10,147,000 in 2004, a decrease of $1,073,000, or
10.6%. This was primarily related to decreased clinical trial
costs and manufacturing expenses as a result of the
discontinuation of the SPECTRA trial, partially offset by
additional preclinical toxicity testing. The 2005 results
include $3,796,000 in personnel and personnel-related costs,
$2,199,000 in clinical trial costs primarily related to SPECTRA,
$1,288,000 in preclinical expenses primarily associated with the
additional toxicity testing, $579,000 of manufacturing expenses
related to on-going drug stability studies, drug destruction and
storage, $425,000 in consulting expense, $396,000 in
trial-related insurance, and $351,000 in facility allocation.
Research and development expenses increased to $10,147,000 in
2004 from $9,930,000 in 2003, an increase of $218,000, or 2.2%.
This was primarily related to increased clinical trial costs and
manufacturing expenses and offset by lower facility cost. In
2004, $3,222,000 of the total research and development
expenditures related to SPECTRA. The 2004 results also included
$3,901,000 in personnel and personnel-related costs, $1,088,000
of manufacturing costs primarily related to tableting, packaging
and drug stability studies, $472,000 in facility allocation,
$459,000 in consulting expense, $392,000 in preclinical expenses
and $387,000 in trial-related insurance.
General and administrative expenses were $4,325,000 in 2005, a
decrease from $4,532,000 in 2004 and a decrease from $5,046,000
in 2003. The decrease in 2005 over 2004 includes a $397,000
reduction in business development and marketing that was
incurred in early 2004 related to the
start-up of SPECTRA,
$284,000 in reduced personnel costs due to reduced headcount,
and $123,000 in reduced patent expenses. This decrease was
offset by $597,000 in additional corporate expenses related to
Sarbanes-Oxley compliance and increased third-party consulting
expenses. The decrease in 2004 over 2003 included $266,000 in
patent expense as a result of higher expenses in 2003 associated
with changing patent counsel, $320,000 in reduced facility
expenses associated with the relocation to Parsippany, and
$137,000 in reduced marketing expenses related to the use of
consultants.
At December 31, 2005, we had available federal net
operating loss carryforwards of $159,565,000, which expire in
various amounts from the years 2006 through 2025, and state net
operating loss carryforwards of $56,141,000, which expire in the
years 2006 through 2012. In addition, at December 31, 2005,
we had federal research and development tax credit carryforwards
of $6,906,000 and state research and development tax credit
carryforwards of $1,646,000.
III-18
We had net losses of $12,614,000 in 2005, $13,959,000 in 2004
and $14,452,000 in 2003. Included in our net loss in 2005, 2004
and 2003 was the sale of $4,077,000, $3,456,000 and $2,083,000,
respectively, of our state net operating loss carryforwards and
$0, $123,000 and $209,000, respectively, of our state research
and development tax credit carryforwards. The proceeds from the
sale of these carryforwards in 2005, 2004 and 2003 were
$327,000, $386,000, and $345,000, respectively.
Included in the net loss applicable to common stockholders for
2005, 2004 and 2003 were preferred stock dividends of
$4,486,000, $4,135,000 and $3,791,000, respectively.
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LIQUIDITY AND CAPITAL RESOURCES |
We had cash and cash equivalents at December 31, 2005, of
$6,583,000 compared to $11,176,000 at December 31, 2004, a
decrease of $4,593,000. Cash used in operating activities for
the year ended December 31, 2005, totaled $14,033,000 (net
of $327,000 of cash received for the sales of our New Jersey
state net operating loss carryforwards) and consisted primarily
of research and development expenses, personnel and related
costs, and facility expenses. Cash used in investing activities
totaled $92,000 for the year ended December 31, 2005 and
included $13,000 of capital expenditures and $129,000 of
deferred acquisition costs offset by a decrease in restricted
cash of $50,000 required by our facility lease. Cash provided by
financing activities for the year ended December 31, 2005
was $9,532,000 and arose from a January 2005 public offering of
9,523,813 shares of common stock at $1.05 per share,
which provided net proceeds of $9,532,000.
In 2005, 2004 and 2003, we sold $4,077,000, $3,456,000 and
$2,083,000, respectively, of our gross state net operating loss
carryforwards and $0, $123,000 and $209,000, respectively, of
our state research and development tax credit carryforwards
under the State of New Jerseys Technology Business Tax
Certificate Transfer Program. This program allows qualified
technology and biotechnology businesses in New Jersey to sell
unused amounts of net operating loss carryforwards and defined
research and development tax credits for cash. Due to the
uncertainty at any time as to our ability to effectuate the sale
of our available New Jersey state net operating losses, and
since we have no control or influence over the tax certificate
transfer program, the benefits are recorded once the agreement
with the counterparty is signed and the sale is approved by the
State of New Jersey. The proceeds from the sales in 2005, 2004
and 2003 were $327,000, $386,000 and $345,000, respectively, and
such amounts were recorded as a tax benefit in the statements of
operations. As of December 31, 2005, we had state net loss
carryforwards and state research and development tax credit
carryforwards available for sale of $57,787,000. We cannot be
certain if we will be able to sell any or all of these
carryforwards under the tax certificate transfer program.
We do not have any approved products and currently derive cash
from sales of our securities, sales of our New Jersey state net
operating loss carryforwards and interest on cash and cash
equivalents. We are highly susceptible to conditions in the
global financial markets and in the pharmaceutical industry.
Positive and negative movement in those markets will continue to
pose opportunities and challenges to us. Previous downturns in
the market valuations of biotechnology companies and of the
equity markets more generally have restricted our ability to
raise additional capital on favorable terms.
We expect to utilize cash and cash equivalents to fund our
operating activities, including any continued development of our
lead compound, alagebrium. However, as a result of the
discontinuation of the Phase 2b SPECTRA trial in systolic
hypertension and a decrease in our financial resources, we have
significantly curtailed all product development activities of
alagebrium and expect to have further reduced expenses in the
first half of 2006. As announced on February 1, 2006, while
we intend to pursue development of alagebrium in high potential
cardiovascular indications such as heart failure, any continued
development of alagebrium by us is contingent upon our entering
into strategic collaboration agreements for this product
candidate which, among other things, would be required to
include funding for product development. We may not be able to
enter into a strategic collaboration agreement with respect to
alagebrium on reasonable terms, or at all. No enrollment or
other activity is taking place with respect to any of our
Phase 2 trials of alagebrium pending the resolution of our
financial resource issues.
III-19
In August 2005, in order to enable us to move forward with the
continued development of alagebrium, we announced that we had
engaged the services of Burrill & Company to assist in
developing and identifying strategic options designed to
diversify our portfolio of product candidates and to enhance our
ability to raise financing in the future. Potential transactions
include the acquisition of technologies and product programs,
licensing opportunities, the sale to or merger into another
company, and debt and equity financing.
The amount and timing of our future capital requirements will
depend on numerous factors, including the consummation of a
merger with HaptoGuard, the timing of resuming our research and
development programs, if at all, the number and characteristics
of product candidates that we pursue, the conduct of preclinical
tests and clinical studies, the status and timelines of
regulatory submissions, the costs associated with protecting
patents and other proprietary rights, the ability to complete
strategic collaborations and the availability of third-party
funding, if any.
Selling securities to satisfy our short-term and long-term
capital requirements may have the effect of materially diluting
the current holders of our outstanding stock. We may also seek
additional funding through corporate collaborations and other
financing vehicles. If the merger is not consummated, potential
financing sources may be dissuaded from investing in us in light
of the fact that Genentech, Inc., as the sole holder of the
outstanding shares of our Series G and Series H
Preferred Stock, currently has a significant liquidation
preference and voting position, on an as-converted to common
stock basis. If funds are obtained through arrangements with
collaborative partners or others, we may be required to
relinquish rights to our technologies or product candidates.
Even if we complete a merger, there can be no assurance that the
products or technologies acquired in such transaction will
result in revenues to the combined company or any meaningful
return on investment to our stockholders.
COMMITMENTS
The table below presents our contractual obligations as of
December 31, 2005:
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Payments Due by Period |
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After |
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5 Years |
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Contractual Obligations:
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Employment agreements(1)
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$ |
1,717,668 |
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$ |
1,717,668 |
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$ |
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$ |
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$ |
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Operating lease commitments
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345,464 |
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336,727 |
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8,737 |
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Total contractual obligations
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$ |
2,063,132 |
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$ |
2,054,395 |
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$ |
8,737 |
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$ |
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$ |
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(1) |
We have employment agreements with key executives, which provide
severance and/or change in control benefits. If we terminate all
of the agreements, we are subject to obligations totaling
$1,717,668. |
On January 31, 2006, Judith Hedstrom, our COO, resigned and
was paid one years salary in the amount of $300,000 and
COBRA benefits for up to 18 months. Under the terms of her
employment agreement with us, Ms. Hedstrom is entitled to
an additional one years salary upon a change in control.
CRITICAL ACCOUNTING POLICIES
In December 2001, the SEC issued a statement concerning its
views regarding the appropriate amount of disclosure by publicly
held companies with respect to their critical accounting
policies. In particular, the SEC expressed its view that in
order to enhance investor understanding of financial statements,
companies should explain the effects of critical accounting
policies as they are applied, the judgments made in the
application of these policies and the likelihood of materially
different reported results if different assumptions or
conditions were to prevail. We have since carefully reviewed the
disclosures included in our filings with the SEC. We believe the
effects of the following accounting policies are significant to
our results of operations and financial condition.
III-20
In December 2004, the Financial Accounting Standards Board
(FASB) issued Statement of Financial Accounting
Standards (SFAS) No. 123 (revised 2004),
Share-Based Payment (SFAS 123R), which
replaces Accounting for Stock-Based Compensation,
(SFAS 123) and supersedes Accounting Principles
Board (APB) Opinion No. 25, Accounting
for Stock Issued to Employees. SFAS 123R requires all
share-based payments to employees, including grants of employee
stock options, to be recognized in the financial statements
based on their fair values beginning with the first annual
reporting period that begins after December 15, 2005. Under
SFAS 123R, the pro forma disclosures previously permitted under
SFAS 123 are no longer an alternative to financial statement
recognition.
The Company accounts for employee stock-based compensation,
awards issued to non-employee directors, and stock options
issued to consultants and contractors in accordance with SFAS
123R, SFAS No. 148 Accounting for Stock-Based
CompensationTransition and Disclosure and Emerging
Issues Task Force Issue
No. 96-18,
Accounting for Equity Instruments that are Issued to Other
Than Employees for Acquiring or in Conjunction with Selling
Goods or Services.
The Company has adopted the new standard, SFAS 123R, effective
January 1, 2006 and has selected the Black-Scholes method
of valuation for share-based compensation. The Company has
adopted the modified prospective transition method which
requires that compensation cost be recorded, as earned, for all
unvested stock options and restricted stock outstanding at the
beginning of the first quarter of adoption of SFAS 123R, and is
recognized over the remaining service period after the adoption
date based on the options original estimate of fair value.
On December 15, 2005, the Compensation Committee of the
Board of Directors of the Company approved the acceleration of
the vesting date of all previously issued, outstanding and
unvested options, effective December 31, 2005. The
acceleration and the fact that no options were issued in the
three months ended March 31, 2006, resulted in the Company
not being required to recognize aggregate compensation expense
under SFAS 123R for the three months ended March 31, 2006.
Prior to adoption of SFAS 123R, the Company applied the
intrinsic-value method under APB Opinion No. 25,
Accounting for Stock Issued to Employees, and
related interpretations, under which no compensation cost
(excluding those options granted below fair market value) has
been recognized. SFAS 123, Accounting for Stock-Based
Compensation, established accounting and disclosure
requirements using a fair-value based method of accounting for
stock-based employee compensation plans. As permitted by SFAS
123, the Company elected to continue to apply the
intrinsic-value based method of accounting described above, and
adopted only the disclosure requirements of SFAS 123, as
amended, which were similar in most respects to SFAS 123R.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURE
Not applicable.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk for changes in interest rates
relates primarily to our investment in marketable securities. We
do not use derivative financial instruments in our investments.
In 2006, 2005 and 2004, all of our investments resided in money
market accounts. In 2003, our investments consisted primarily of
debt instruments of the United States government, government
agencies, financial institutions and corporations with strong
credit ratings.
Accordingly, we do not believe that there is any material market
risk exposure with respect to derivative or other financial
instruments that would require disclosure under this Item.
III-21
CHAPTER FOUR OTHER INFORMATION REGARDING
HAPTOGUARD
BUSINESS OF HAPTOGUARD
Brief Description of Business
HaptoGuard is a product-based biopharmaceutical company focused
on the development of small molecule drugs to treat and prevent
diseases associated with inflammation, initially targeting the
inflammatory components of cardiovascular disease in diabetic
patients. Its principal drug candidate,
ALT-2074, was
in-licensed from Oxis
International (Oxis), where it was previously
referred to as
BXT-50172.
HaptoGuard recently initiated Phase 2 clinical trials of
ALT-2074. HaptoGuard
also has strategic license agreements in place with
BIO-RAP Technologies
Ltd.
(BIO-RAP)
and UTI Limited Partnership , the technology transfer and
commercialization center of the University of Calgary
(UTI).
HaptoGuard is a Delaware corporation formed on November 3,
2003. Its offices are located in New Jersey although it
outsources most of its activities to third parties. HaptoGuard
currently has two employees, Dr. Noah Berkowitz, its
President and Chief Executive Officer, and Dr. Malcolm
MacNab, its Chief Medical Officer. HaptoGuard has engaged a
number of consultants and service providers to enable it to
execute on its strategic plans, including, among others, Ockham
Development Corporation, a clinical research organization that
is conducting the Phase 2 clinical trial of
ALT-2074, Oxis, which
in addition to licensing
ALT-2074 to HaptoGuard,
is providing the drug on a exclusive basis to HaptoGuard and UPM
Pharmaceuticals, Inc., a contract manufacturer that is producing
ALT-2074 in tablet form
for use in the Phase 2 clinical trial of
ALT-2074.
HaptoGuard licensed a family of compounds, including
ALT-2074, from Oxis on
an exclusive basis. Oxis previously conducted clinical trials
for ALT-2074 for an
alternative indication, inflammatory bowel disease. HaptoGuard
believes the clinical trial data Oxis produced suggests that
ALT-2074 could be safe
and biologically potent, subject to additional testing, in the
area of inflammation related to cardiovascular disease, more
specifically in reducing iron mediated oxidative damage.
HaptoGuards development plan includes a specialized
clinical diagnostic test (Hp Test) to choose high risk patients
that may benefit from treatment with
ALT-2074. The use of
the Hp Test to more quickly identify high risk patients may
allow HaptoGuard to perform efficacy studies with fewer patients
than otherwise would have been possible, in the absence of such
risk stratification. The Hp Test (also known as a qualitative
haptoglobin typing test) uses technology and reagents licensed
by HaptoGuard from
BIO-RAP Technologies
Ltd.
HaptoGuard also recently licensed a family of organoselenium and
organotelluriam compounds from UTI on a worldwide, exclusive
basis. These compounds, like the compounds HaptoGuard licensed
from Oxis, can convert oxidized lipids and hydrogen peroxide to
alcohols and water, respectively. This conversion process
reduces oxidative stress in cells and has been thought to reduce
inflammation. HaptoGuard believes these compounds may be used to
treat diseases such as acute ischemic injury as well as
autoimmune diseases such as Crohns disease and rheumatoid
arthritis, lupus, ulcerative colitis and psoriasis although the
research is in the early stages and significant development is
still required, including initial toxicity studies, before any
conclusions regarding the potential for commercialization of
such compounds may be made.
Diabetes is a therapeutic area that HaptoGuard believes has a
large market potential. Diabetes is characterized by a large
patient population, a small number of branded drugs, many
generics, and a widespread level of dissatisfaction with
treatment benefits. The number of patients suffering from
diabetes is growing rapidly in both the United States and
developing nations, particularly Asia. This coincides with an
epidemic of obesity, a syndrome that almost certainly
contributes to the increased risk of Type 2 diabetes. The
IV-1
increased incidence of diabetes is also a consequence of a
downward reclassification of fasting blood glucose levels.
Diabetes is the third leading cause of death from disease in the
United States far exceeding that of many well known cancers. The
World Health Organization (WHO) estimates that by year end
2000, there were approximately 150 million diabetics
worldwide, 7.5 million (5%) with Type 1 and an overwhelming
140 million (95%) with Type 2 diabetes. By the year
2025, WHO estimates that the overall number of people with
diabetes will have doubled to 300 million. Data from recent
years has supported these predictions, and has shown that
diabetes is growing into one of the most costly diseases on a
global basis in both human and economic terms.
Long term complications of diabetes, rather than the disease
itself, are the major causes of diabetes associated morbidity
and mortality. These complications include blindness
(retinopathy), kidney failure (nephropathy), nerve damage
(neuropathy) and cardiovascular disease. The second largest
diabetes related direct cost to the United States healthcare
system is the treatment of cardiovascular diseases by the
medical management of hypertension and hyperlipidemia and by
procedures such as coronary by pass surgery, coronary
angioplasty and amputations. A medical treatment for, and the
prevention of, diabetic cardiovascular complications would fill
an important unmet need in the repertoire of physicians treating
diabetics.
Cardiovascular Disease (CVD) and
ALT-2074
The relationship between diabetes mellitus (DM) and the
complications of CVD are well known. The Nurses Health Study,
which followed 117,000 individuals for 20 years, stated
that the overall incidence of myocardial infarction (MI) or
stroke was two and a half times higher in diabetic patients than
in the total population. In fact, statistics show that diabetes
confers the same degree of risk for future MI as having
established CVD. Additionally, CVD accounts for 75% of all
deaths in patients with DM. In patients presenting with acute
coronary syndromes, 30% have DM, whereas the prevalence of DM in
the general population is only about 7%. Finally, studies show
that the one year survival of patients with DM following first
MI is significantly lower than for patients without DM (57% vs.
70%, respectively). For 28 day survival, the death rate in
patients with DM following first MI is twice that of the non
diabetic population (14% vs. 7%, respectively). Thus, the
epidemiology of DM and CVD demonstrates a relationship between
these diseases and traditionally, tailoring medical treatment
has followed the same logic.
The primary medical treatment of diabetes consists of managing
blood glucose levels through diet modification, insulin
treatment or oral hypoglycemics. Diabetics often receive drugs
used for some CVD risk factors (such as ACE inhibitors for HTN
and statins for hyperlipidemia). Oxidative stress (the
physiological condition of inadequate oxygen supply) may worsen
atherosclerosis and make heart muscle more susceptible to
damage. Inflammation may induce the thrombosis that causes acute
coronary syndromes and may contribute to the remodeling of the
heart muscle seen after ischemic damage, often associated with
the development of congestive heart failure. Drugs that target
the inflammation caused by oxidative stress in some diabetics
may limit the severity of CVD.
The basis for a clinical development strategy that targets drugs
that reduce oxidative stress and inflammation to high risk
diabetics is supported by some well corroborated epidemiology
and some rapidly evolving basic science. Several studies have
observed that a genetic variant of haptoglobin (a ubiquitous
serum protein associated with inflammation and found commonly,
but not distributed evenly, in the human population as Hp
1 1, Hp 2 1 or Hp 2 2, see later section for
biology and genetics) may be associated with the rate of
vascular complications in diabetic patients. Those studies
include:
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The Strong Heart Study This longitudinal
survey of the healthcare of PIMA Indians focuses on CVD and
diabetes, and is particularly informative because of the high
incidence of diabetes in this patient population. An examination
of blood samples from several thousand patients enrolled in this
study revealed that haptoglobin type predicts cardiovascular
risk among diabetics but not non diabetics and the presence of a
Haptoglobin 2 allele seemed to be associated with risk in a
dose dependent fashion, such that Hp 2 2 diabetics were at
higher risk than Hp 2 1 diabetics who were at still higher
risk than Hp l 1 diabetics. |
IV-2
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The Munich Stent Study A group in Munich
followed 935 diabetic patients after an angioplasty and stent
placement for one year. When patients were segregated based on
haptoglobin type, it became apparent that the risk of MI and
death was highest in the Hp 2 2 and lowest in Hp l l. |
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The Rambam MI Study Dr. Andrew Levy, a
consultant to HaptoGuard, led a study at the Rambam Medical
Center in Haifa, Israel in which over 500 consecutive diabetics
who presented to the emergency room with a MI were followed for
at least 30 days. This study demonstrated that the risk of
30 day mortality in Hp 2 2 diabetics was 16%, while
the risk of mortality in the Hp l 1 group was less than 1%.
The risk of clinical heart failure was also much higher for
diabetics with Hp 2 2 as compared to those with other Hp
types. |
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The HOPE Study The Heart Outcomes Prevention
Study compared the ability of Ramipril (an ACE inhibitor), or
vitamin E, to prevent cardiovascular events in patients at
high risk for CVD. The study results were first reported in
2000. Ramipril was noted to reduce incidence of MI and death.
Vitamin E was ineffective. These findings were reported in
diabetics and non diabetics. In a 2003 collaboration, Hp type
predicted event rate in diabetics but not non diabetics,
confirming the Strong and Framingham observations. |
In short, Hp type correlates, in diabetic patients, with risk of
CVD, severity of disease, death and heart failure following
infarction and restenosis after angioplasty.
Oxidative Stress, the Glutathione Peroxidase Reaction and
CVD
During oxidative metabolism in the mitochondria, 02 is reduced
by the addition of 4 electrons. In the course of this reaction,
small quantities of reduced oxygen compounds, including 02, 0H
and H202 are produced. These substances, referred to as reactive
oxygen species (ROS) can initiate a cascade of reactions
whereby other cellular macromolecules undergo oxidation, and can
then function as ROS themselves, causing oxidation of additional
cellular components. The human organism has several ways of
detoxifying these ROS, but when there is an imbalance between
formation of ROS and their removal, a condition of oxidative
stress is said to exist. Under these conditions, lipids are
oxidized to create lipid peroxides and these peroxides are felt
to contribute to atherogenesis.
One of the defense mechanisms against the presence of ROS in
general and hydroperoxides, such as lipid peroxide, in
particular, is the enzyme glutathione peroxidase (GPx), which
inactivates the ROS hydrogen peroxide and other organic ROS by
the following reactions:
There is significant evidence that oxidative stress, due to
inadequate activity of detoxifying mechanisms such as the GPx
reaction, plays a role in the development of CVD. Animal models
including GPx knockouts have demonstrated the significant role
played by GPx in ischemic heart disease. Human epidemiology has
IV-3
implicated the same enzyme activity one group
elucidated a clear inverse relationship between GPx activity and
cardiac events. Also, GPx activity is significantly reduced in
diabetics.
Further, oxidized lipids (lipid peroxides) are
inflammatory signaling which increases sensitivity of blood
vessels, and possibly the heart muscle, to hypoxia (lack of
oxygen). Persons with high concentrations of lipid peroxides may
exhibit an increased risk for larger infarctions of the heart
and more severe heart failure.
The human body has developed protective mechanisms against the
accumulation of lipid peroxides. One such mechanism is
glutathione peroxidase, a seleno-enzyme that catalyzes the
reduction of hydroperoxides to less toxic species using
glutathione (GSH) as the reducing agent. In the case of
hydrogen peroxide (H2O2), water is the reduction product, while
organic hydroperoxides (ROOH) are reduced to the
corresponding alcohol (ROH) and water. The other product of
the reaction, oxidized glutathione (GSSG), is recycled back to
the reduced form via the enzyme NADPH-dependent glutathione
reductase.
ALT-2074 mimics the
activity of glutathione peroxidase, by catalyzing the conversion
of organic hydroperoxides to their presumably less toxic
alcohols. One reputable multinational research consortium has
elucidated a clear inverse relationship between GPx activity and
cardiac events. HaptoGuard believes that augmenting GPx activity
with ALT-2074,
particularly in diabetics at high risk for elevated lipid
hydroperoxides, will reduce oxidized lipid-induced
cardiovascular injury.
ALT-2074 has a variety
of special anti-inflammatory features that include:
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inhibition of ICAM1, VCAM-1, p-selectin; |
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inhibition of neutrophil attachment to endothelium, while
maintaining endothelial integrity; and |
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inhibition of neoiintimal formation in pig models of
balloon-inflation, endothelial injury. |
All clinical development prior to the Phase 2 clinical
trial was performed by Oxis.
ALT-2074 was tested in
a preclinical mouse model (high risk diabetic mice that have
been genetically engineered to model the human condition) of
ischemia reperfusion injury (i.e., a controlled heart attack) by
administering different doses of
ALT-2074. Results
demonstrated an approximate 85% reduction in infarct size
following a single oral administration of
ALT-2074. Doses of
0.5mg/kg to 5mg/kg of
ALT-2074 each yielded
similar results. After dosage testing,
ALT-2074 was
administered to over 40 patients and volunteers in one
Phase 1 study and a Phase 2a study involving patients
diagnosed with ulcerative colitis. No drug related serious
adverse events were reported and the drug was shown to be
rapidly absorbed by the oral route. In the Phase 2a trial,
20 patients with mild to moderate ulcerative colitis, who
had failed first line therapy
(5-ASA drugs), received
one of two dosage regimens of
ALT-2074 for
28 days. The primary end point was the Mayo Colitis
Activity Index (CAI), a well accepted composite
clinical disease activity score. A statistically significant
improvement in CAI from Day 1 to Day 28 was
demonstrated in both dose groups.
Diabetics are generally treated with insulin replacement and
oral hypoglycemics to reduce their elevated blood concentrations
of glucose (hyperglycemia). Despite readily available drugs,
glucose is imperfectly controlled even in well-managed diabetic
patients. Hence, ongoing hyperglycemia and possibly, the ensuing
state of high oxidative stress, lead to vascular complications
that persist in diabetics despite improvements in blood glucose
concentrations. HaptoGuard believes that direct treatment of CVD
in diabetics to prevent or reduce oxidative stress and
inflammation will:
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|
be most effective in preventing or delaying serious vascular
complications; |
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reduce the number of diabetics who are also diagnosed with
vascular disease; |
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|
improve the recovery rate for diabetics with vascular disease;
and |
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significantly reduce healthcare costs. |
IV-4
ALT-2074 currently has
an open IND in the CardioRenal Division of the FDA. HaptoGuard
recently initiated a Phase 2 clinical trial for
ALT-2074. HaptoGuard
plans to conduct the Phase 2 clinical trial for
ALT-2074 in Israel and
the Czech Republic over 8 separate sites and approximately
60 patients. The trial is a 5 day study in diabetic
patients undergoing urgent angioplasty in the brief aftermath of
a resolved, acute coronary syndrome. The clinical trial seeks to
test whether patients with biologically measurable cardiac
damage, as shown by the release of cardiac enzymes during the
interventional procedure, as a consequence of transient ischemia
from the brief occlusion of a coronary artery, will have less
cardiac damage if treated with
ALT-2074.
Personnel
HaptoGuard has two employees, each of who has substantial
expertise working with biopharmaceutical companies.
Noah Berkowitz, M.D., Ph.D. (Founder,
CEO)
Dr. Noah Berkowitz earned his B.A., M.D., and Ph.D.
from Columbia University and trained at the National Cancer
Institute in medical oncology. Prior to founding HaptoGuard, he
was vice-president of Clinical Development at IMPATH Inc., a
NASDAQ-traded, cancer information company where he
developed a division, IMPATH Predictive Oncology, focused on
biopharmaceutical partnerships supporting the discovery and
development of cancer-related targeted diagnostics and
therapeutics. Prior to IMPATH, Dr. Berkowitz was the
founder of Physician Choice, a biopharmaceutical strategic
consulting company.
Malcolm MacNab, M.D., Ph.D. (Vice President,
Clinical Development)
Dr. Malcolm MacNab was Vice President of
Cardiovascular & Metabolism, US Clinical Development
and Medical Affairs at Novartis Pharmaceuticals until
February 4, 2005. In his more than 20 years of
pharmaceutical industry experience, he assisted in all phases of
drug development. He contributed to the registration of Diovan,
a leading angiotensin receptor blocker used for the treatment of
hypertension and heart failure and Lotrel, a leading branded
combination product for the treatment of hypertension.
Dr. MacNab received his MD and PhD in vascular pharmacology
from Temple University in Philadelphia. He received
post-graduate training in Internal Medicine and Hematology at
the Medical College of Pennsylvania.
HaptoGuard also has an established scientific advisory board
consisting of recognized scholars in the fields of chemistry,
molecular biology, pharmacology and pre-clinical development.
Scientific advisors are reimbursed for participating on
HaptoGuards scientific advisory board. HaptoGuards
scientific advisors are:
Burton E. Sobel, M.D.
Dr. Sobel is E.L. Amidon Professor,
Physician-in-Chief and
Professor of Biochemistry at the University of Vermont and a
trustee of the Fletcher Allen Health Care Center, Burlington. He
is Editor of Circulation and Coronary Artery Disease.
Previously, he held senior academic and administrative positions
at Washington University School of Medicine from 1973 to 1994,
and at the University of California, San Diego, from 1968
to 1973. Dr. Sobel completed postgraduate training at the
Peter Bent Brigham Hospital, Boston and the National Institutes
of Health, Bethesda, and received an M.D. from Harvard
University and an A.B. from Cornell University.
Joseph Loscaizo, M.D., Ph.D.
Dr. Loscaizo is the Wade Professor and Chairman of the
Department of Medicine and Director of the Whitaker
Cardiovascular Institute at Boston University School of
Medicine. Author of over 450 articles and 20 books, he is
internationally recognized for his work on the vascular biology
of nitric oxide, platelet function, and atherothrombosis. He is
immediate past Chair of the Board of Scientific Counselors of
the NHLBI and the Cardiovascular Board of the American Board of
Internal Medicine, and current Director of the NHLBI-sponsored
Specialized Center of Research in Ischemic Heart Disease at
Boston University. He is also
Editor-in-Chief of the
premier cardiovascular journal, Circulation.
IV-5
Stanley Hazen, M.D., Ph.D.
Dr. Stanley Hazen is the Section Head of Preventive
Cardiology and Rehabilitation, and Director of the Center for
Cardiovascular Diagnostics and Prevention at the Cleveland
Clinic Foundation. A recipient of numerous honors and awards,
and frequent speaker at national and international meetings,
Dr. Hazen is an internationally recognized expert in
inflammation biochemistry and cardiovascular disease
pathogenesis. Dr. Hazen oversees a world-class research
program focusing on mechanisms of oxidant stress and
inflammatory diseases.
Recent Developments
In addition to entering into the merger agreement with Alteon,
HaptoGuard has undertaken numerous activities in the calendar
year 2006. In February 2006 HaptoGuard entered into a master
service agreement with Ockham Development Corporation to engage
Ockham to act as its contract research organization in
connection with the Phase 2 clinical trial of
ALT-2074. In March
2006, UPM Pharmaceutical, the contract manufacturer engaged by
HaptoGuard, completed manufacturing sufficient quantities of
ALT-2074 for the
Phase 2 clinical trial. In April 2006, HaptoGuard received
approval from the Israeli Ministry of Health regarding the
commencement of the Phase 2 clinical trial in Israel and
subsequently received IRB approval for 3 sites in Israel and has
contracted with these sites. Ockham Development Corporation,
HaptoGuards contract research organization, conducted
initiation visits and is screening patients at those sites.
HaptoGuard withdrew its request of the Czech Republic regulatory
agency to conduct a Phase 2 clinical trial at sites in the
Czech Republic because additional data regarding the duration of
drug stability was requested and at the time of submission was
unavailable. HaptoGuard plans to resubmit its application with
the Czech Republic Ministry of Health once such data can be
generated, which HaptoGuard believes will be later in 2006.
Intellectual Property
HaptoGuard currently has certain exclusive license rights under
certain issued patents and patent applications worldwide
covering technology licensed from BIO-RAP, certain patents
covering the compounds licensed from Oxis and one provisional
patent application covering the compounds licensed from UTI.
HaptoGuard also depends upon the skills, knowledge, and
experience of its scientific and technical personnel, as well as
that of its advisors, consultants, and other contractors, none
of which is patentable. To help protect its proprietary know-how
which is not patentable, and for inventions for which patents
may be difficult to enforce, HaptoGuard relies on trade secret
protection and confidentiality agreements to protect its
interests. To this end, HaptoGuard requires its employees,
consultants, advisors and other contractors to enter into
confidentiality agreements that prohibit the disclosure of
confidential information and, where applicable, require
disclosure and assignment to HaptoGuard of the ideas,
developments, discoveries and inventions important to its
business.
As part of the licensing agreement with Oxis covering
ALT-2074, HaptoGuard
controls the prosecution and maintenance of all licensed patents
and patent applications and HaptoGuard has the first right, but
not the obligation, to direct, bring and control any action or
proceedings with respect to any infringement in the United
States, Europe or any other territory of any patent or patent
application licensed to HaptoGuard. HaptoGuard has similar
rights with respect to the patents HaptoGuard licenses from
BIO-RAP and the Rappaport Institute of Medicine which cover the
insights and tests that will be used to determine the
haptoglobin phenotype of the patient. HaptoGuard also retains
the right and obligation under its agreement with UTI to
prosecute all patents relating to the compounds it licensed from
UTI and to protect such intellectual property against use by
non-licensees. In the event HaptoGuard elects not to prosecute
such patents, HaptoGuard will cease to have any rights to such
intellectual property.
As part of the licensing agreement with Oxis covering
ALT-2074, Oxis is
responsible for protecting the underlying intellectual property
against use by non-licensees and to use all legal methods to
defend the patents. BIO-RAP and the Rappaport Institute of
Medicine are similarly responsible for the patents HaptoGuard
licenses from them covering the insights and tests that will be
used to determine the haptoglobin
IV-6
phenotype of the patient. Conversely, HaptoGuard retains the
right and obligation under its agreement with UTI to prosecute
all patents relating to the compounds it licensed from UTI and
to protect such intellectual property against use by
non-licensees. In the event HaptoGuard elects not to prosecute
such patents, HaptoGuard will cease to have any rights to such
intellectual property.
|
|
|
Oxis Exclusive License and Supply Agreement |
On September 28, 2004, HaptoGuard entered into an exclusive
license and supply agreement with Oxis under which it received
an exclusive, worldwide, royalty-bearing license, with the right
to grant sublicenses, under certain patents, compounds, process,
know-how relating to
ALT-2074 and a family
of related compounds for therapeutic, diagnostic, preventative,
ameliorative and/or prognostic in certain defined cardiovascular
indications. Pursuant to the terms of the agreement, HaptoGuard
has already made aggregate payments to Oxis of approximately
$550,000 in cash as of May 31, 2006. These payments include
a $100,000 payment to Oxis in exchange for a 6 month
extension in complying with a stated milestone. HaptoGuard is
obligated to make future payments to Oxis upon achievement of
certain FDA-related milestones and to pay Oxis royalties on
sales of ALT-2074 upon
commercialization, net of various customary discounts,
attributable to certain licensed products. HaptoGuard is also
obligated to achieve certain development milestones in
accordance with the timelines set forth in the license
agreement. While Oxis has not claimed a default under the
license agreement, it has indicated that its view as to whether
HaptoGuard satisfied the milestone to begin Phase II
clinical trials by May 28, 2006 differs from
HaptoGuards view.
The license agreement with Oxis also requires HaptoGuard to
treat Oxis as the sole supplier of
ALT-2074, provided Oxis
meets its supply requirements under the agreement. The agreement
provides that all product purchased from Oxis shall be priced on
a cost plus basis. HaptoGuard has typical rights to inspect and
analyze representative samples of licensed products from batches
supplied by Oxis and to reject any non-conforming goods.
|
|
|
BlO-RAP License and Research Agreement |
On July 12, 2004 HaptoGuard entered into a license and
research agreement with BIO-RAP on its own and on behalf of the
Rappaport Family Institute for Research in the Medical Sciences.
Under the license, HaptoGuard received an exclusive, worldwide,
royalty-bearing license, with the right to grant sublicenses, to
certain technology, patents and technology relating to products
in the field of testing and/or measurement for diagnostic
predictive purposes of vascular or cardiac diseases. HaptoGuard
is currently negotiating such a sublicense with Oxis. Under the
agreement HaptoGuard is obligated to make annual research
funding payments to BIO-RAP plus a portion of BIO-RAPs
direct overhead costs. HaptoGuard is also obligated to make
future payments upon achievement of certain milestones including
FDA-related milestones as well as royalty payments on sales, net
of various customary discounts, attributable to therapeutic
products derived from the technology being licensed to
HaptoGuard by BIO-RAP. HaptoGuard has a first right to acquire a
license to any of the technology developed as part of the
research conducted pursuant to the agreement. If HaptoGuard
exercises this right but the parties acting in good faith fail
to reach an agreement in respect of such license then HaptoGuard
has a right of first refusal to license the research technology
on the same terms offered by BIO-RAP to a third party.
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|
|
UTI (University of Calgary) License Agreement |
On May 5, 2006, HaptoGuard entered into an exclusive
license agreement with UTI under which it received an exclusive,
worldwide, royalty-bearing license, with the right to grant
sublicenses, in and to certain organoselenium and tellurium
compounds described in the patent application, technology
relating to such compounds, and a provisional patent application
covering such compounds. Pursuant to the terms of the agreement,
HaptoGuard is obligated to make future annual payments to UTI as
well as a portion of the fees it receives on any sublicense of
compounds licensed under the agreement between HaptoGuard and
UTI. HaptoGuard is also obligated to pay UTI royalties on sales,
net of various customary discounts, attributable to certain
licensed products.
IV-7
Competition
The family of compounds licensed from Oxis (including
ALT-2074), can be
characterized as organoselenium compounds or mimics of
glutathione peroxidase. HaptoGuard is currently unaware of any
other companies actively developing organoselenium compounds for
treatment of oxidative stress and inflammation. A variety of
academic efforts to mimic glutathione peroxidase activity have
appeared in the scientific literature over the past few years
but none appear to be in clinical development. Although
HaptoGuard is not aware of any companies actively developing
such compounds, many large pharmaceutical companies have active
programs targeting the inflammatory aspects of CVD and numerous
companies are developing hypoglycemic medications or variants of
insulin that may promise tighter glucose control. As a
consequence, these approaches may deliver decreased oxidative
stress and fewer cardiovascular complications which may lessen
the need for treatment by a GPx mimic like
ALT-2074.
Possibly the most advanced antioxidant drug with similar
properties is AGI-1067,
which is being developed by Atherogenics. This probucol-like
compound has anti-inflammatory properties, some of which may be
mediated through its anti-oxidative.
Manufacturing
Oxis International is the sole supplier of the
ALT-2074 product to
HaptoGuard. Oxis supplies the product to HaptoGuard at cost plus
basis.
If Oxis is unable to supply
ALT-2074 as ordered by
HaptoGuard, for a period of sixty (60) or more days after
the agreed delivery time for any reason other than a delay
caused by HaptoGuard, then HaptoGuard may, at its option,
responsibility and expense, elect to manufacture or have a third
party manufacture
ALT-2074 until such
time as Oxis can demonstrate to HaptoGuards reasonable
satisfaction that Oxis is capable of resuming the manufacture of
the products.
HaptoGuard believes that there are several other manufacturers
that could produce
ALT-2074 but there
could be significant time loss and expense in changing
manufacturers.
Government Regulation
The FDA and comparable regulatory agencies in foreign countries
as well as pharmacy regulators in state and local jurisdictions,
impose substantial requirements upon the clinical development,
manufacture and marketing of pharmaceutical products. These
agencies and other federal, state and local entities regulate
research and development activities and the testing,
manufacture, quality control, safety, effectiveness, labeling,
storage, record keeping, approval, advertising, and promotion of
our products. These regulations are also subject to change from
time to time.
The current process required by the FDA under the drug
provisions of the United States Food, Drug, and Cosmetic Act
before HaptoGuards product candidates may be marketed in
the U.S. generally involves the following:
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Pre clinical laboratory and animal tests; |
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Submission of an IND, which must become effective before human
clinical trials may begin; |
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Adequate and well controlled human clinical trials to establish
the safety and efficacy of the product candidate for its
intended use; |
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Submission to the FDA of a NDA; and |
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|
FDA review and approval of a NDA. |
The testing and approval process requires substantial time,
effort, and financial resources, and there is no certainty that
any approval will be granted on a timely basis, if at all.
Pre-clinical tests include laboratory evaluation of the product
candidate, its chemistry, formulation and stability, as well as
animal studies to assess the potential safety and efficacy of
the product candidate. Certain
IV-8
pre clinical tests must be conducted in compliance with good
laboratory practice regulations. Violations of these regulations
can, in some cases, lead to invalidation of the studies,
requiring such studies to be replicated. In some cases, long
tern pre clinical studies are conducted while clinical studies
are ongoing.
An applicant then submit the results of the pre clinical tests,
together with manufacturing information and analytical data, to
the FDA as part of an IND, which must become effective before
beginning human clinical trials. The IND automatically becomes
effective 30 days after receipt by the FDA, unless the FDA,
within the 30 day time period, raises concerns or questions
about the conduct of the trials as outlined in the IND and
imposes a clinical hold. In such a case, the IND sponsor and the
FDA must resolve any outstanding concerns before clinical trials
can begin. Submission of an IND may not result in FDA
authorization to commence clinical trials. All clinical trials
must be conducted under the supervision of a qualified
investigator in accordance with good clinical practice
regulations. These regulations include the requirement that all
subjects provide informed consent. Further, an independent
Institutional Review Board (IRB) at each medical
center proposing to conduct the clinical trials must review and
approve any clinical study. The IRB also continues to monitor
the study and must be kept aware of the studys progress,
particularly as to adverse events and changes in the research.
Progress reports detailing the results of the clinical trials
must be submitted at least annually to the FDA and more
frequently if adverse events occur.
Human clinical trials are typically conducted in three
sequential phases that may overlap:
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Phase 1: The drug is initially introduced into healthy
human subjects or patients and tested for safety, dosage
tolerance, absorption, metabolism, distribution, and excretion. |
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|
Phase 2: The drug is studied in a limited patient
population to identify possible adverse effects and safety
risks, to determine the efficacy of the product for specific
targeted diseases and to determine dosage tolerance and optimal
dosage. |
|
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|
Phase 3: When Phase 2 evaluations demonstrate that a
dosage range of the drug is effective and has an acceptable
safety profile, Phase 3 trials are undertaken to further
evaluate dosage and clinical efficacy and to further test for
safety in an expanded patient population, often at
geographically dispersed clinical study sites. |
There is no certainty that HaptoGuard will successfully complete
Phase 1, Phase 2, or Phase 3 testing of its
product candidates within any specific time period, if at all.
Furthermore, the FDA or the Institutional Review Board or the
IND sponsor may suspend clinical trials at any time on various
grounds, including a finding that the subjects or patients are
being exposed to an unacceptable health risk.
Concurrent with clinical trials and pre clinical studies, we
also must develop information about the chemistry and physical
characteristics of the drug and finalize a process for
manufacturing the product in accordance with good manufacturing
practice (GMP) requirements. The manufacturing
process must be capable of consistently producing quality
batches of the product, and we must develop methods for testing
the quality, purity, and potency of the final products.
Additionally, appropriate packaging must be selected and tested
and chemistry stability studies must be conducted to demonstrate
that the product does not undergo unacceptable deterioration
over its shelf life.
The results of product development, pre clinical studies, and
clinical studies are submitted to the FDA as part of a NDA for
approval of the marketing and commercial shipment of the
product. The FDA reviews each NDA submitted and may request
additional information, rather than accepting the NDA for
filing. In this event, the application must be resubmitted with
the additional information. The resubmitted application is also
subject to review before the FDA accepts it for filing. Once the
FDA accepts the NDA for filing, the agency begins an in depth
review of the NDA. The FDA has substantial discretion in the
approval process and may disagree with interpretation of the
data submitted in the NDA. The review process may be
significantly extended by the FDA requests for additional
information or clarification regarding information already
provided. Also, as part of this review, the FDA may refer the
application to an appropriate advisory committee, typically a
panel of clinicians, for review, evaluation and a
recommendation. The FDA is not bound by the recommendation of an
advisory committee. Manufacturing establishments often also are
subject
IV-9
to inspections prior to NDA approval to assure compliance with
GMP and with manufacturing commitments made in the relevant
marketing application.
The FDA assigns a goal of ten months for standard NDA reviews
from acceptance of the application to the time the agency issues
its complete response, in which the FDA may approve
the NDA, deny the NDA if the applicable regulatory criteria are
not satisfied, or require additional clinical data. Even if
these data are submitted, the FDA may ultimately decide that the
NDA does not satisfy the criteria for approval. If the FDA
approves the NDA, the product becomes available for physicians
to prescribe. Even if the FDA approves the NDA, the agency may
decide later to withdraw product approval if compliance with
regulatory standards is not maintained or if safety problems
occur after the product reaches the market. The FDA may require
post marketing studies, also known as Phase IV studies, as
a condition of approval to develop additional information
regarding the safety of a product. In addition, the FDA requires
surveillance programs to monitor approved products that have
been commercialized, and the agency has the power to require
changes in labeling or to prevent further marketing of a product
based on the results of these post marketing programs.
Satisfaction of the above FDA requirements or requirements of
state, local and foreign regulatory agencies typically takes
several years, and the actual time required may vary
substantially based upon the type, complexity and novelty of the
pharmaceutical product. Government regulation may delay or
prevent marketing of potential products for a considerable
period of time and impose costly procedures upon our activities.
There is significant uncertainty as to whether FDA or any other
regulatory agency will grant approval for any of product
candidate under development on a timely basis, if at all.
Success in pre clinical or early stage clinical trials does not
assure success in later stage clinical trials. Data obtained
from pre clinical and clinical activities are not always
conclusive and may be susceptible to varying interpretations
that could delay, limit or prevent regulatory approval. Even if
a product receives regulatory approval, the approval may be
significantly limited to specific indications or uses. Further,
even after regulatory approval is obtained, later discovery of
previously unknown problems with a product may result in
restrictions on the product or even complete withdrawal of the
product from the market. Delays in obtaining, or failures to
obtain, regulatory approvals would have a material adverse
effect on our business.
HaptoGuard received approval from Israels Ministry of
Health to conduct Phase 2 clinical trials for its lead
product candidate,
ALT-2074, and has
received IRB approval for 3 sites in Israel and has contracted
with these sites. Ockham Development Corporation,
HaptoGuards contract research organization, conducted
initial visits and is screening patients at each of these sites.
HaptoGuard recently withdrew its submission to request approval
to conduct a Phase 2 clinical trial at sites in the Czech
Republic, in order to generate additional data regarding the
duration of drug stability . While HaptoGuard intends to
resubmit its application later in 2006, no assurance can be
given that such approval will be granted. The requirements for
approvals necessary to conduct clinical trials differ from
country to country as do the timelines for such approvals, and
additional delays and complications can arise from conducting
trials in multiple countries.
Market Price and Dividends on HaptoGuards Common Equity
and Related Stockholder Matters
There is no established public trading market for any of
HaptoGuards securities. Because there is no established
market for such securities, pricing information cannot be
readily provided.
As of May , 2006, HaptoGuard
had 24 holders of record of its common stock. Pursuant to
the merger agreement, at the effective time of the merger, each
holder of HaptoGuard common stock will receive approximately
3,521 shares of Alteon common stock for each one
(1) share of HaptoGuard common stock then held.
IV-10
HaptoGuard has never paid a cash dividend on its common stock
and has no present intention to declare or pay cash dividends on
the common stock at any time prior to the effective date of the
merger.
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(d) |
Securities Authorized for Issuance Under Equity
Compensation Plans |
The following table sets forth information concerning the number
of outstanding options and warrants, the weighted average
exercise price of those securities and the number of securities
remaining to be granted under existing equity plans, whether
approved or not approved by security holders, as of
December 31, 2005:
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|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
Weighted-Average | |
|
Number of Securities | |
|
|
to be Issued Upon | |
|
Exercise Price of | |
|
Remaining Available | |
|
|
Exercise of | |
|
Outstanding | |
|
for Future Issuance | |
|
|
Outstanding Options, | |
|
Options, Warrants | |
|
Under Existing Equity | |
Plan Category |
|
Warrants and Rights | |
|
and Rights | |
|
Compensation Plans | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders
|
|
|
[800 |
] |
|
$ |
[572.08 |
] |
|
|
[ |
] |
Equity compensation plans not approved by security holders
|
|
|
[509 |
] |
|
$ |
[572.08 |
] |
|
|
[0 |
] |
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
[1,309 |
] |
|
$ |
[572.08 |
] |
|
|
[ |
] |
In connection with entering into an exclusive license and supply
agreement with Oxis, HaptoGuard granted Oxis a warrant to
purchase 509 shares of common stock of HaptoGuard at a
price per share of $572.08. The warrant has a term of three
years and expires on February 1, 2008. The warrant may only
be exercised in whole, not in part. Pursuant to the Merger
Agreement, at the effective time of the merger, the warrant will
be canceled and exchanged for the right to receive approximately
551,800 shares of common stock of Alteon on the basis of
outstanding stock as of April 18, 2006.
IV-11
Managements Discussion and Analysis of Financial
Condition and Results of Operations
HaptoGuard is a product-based biopharmaceutical company focused
on the development of small molecule drugs to treat and prevent
diseases associated with inflammation, initially targeting the
inflammatory components of cardiovascular disease in diabetic
patients. HaptoGuards lead product,
ALT-2074, has recently
begun Phase 2 clinical trials. See Brief Discussion
of Business in this Chapter 4 for more information.
Since HaptoGuards inception in July 2004, it has devoted
substantially all of its resources to research, drug discovery
and development programs of
ALT-2074 and the
technology it licensed from
BIO-RAP. To date,
HaptoGuard has not generated any revenues from the sale of
products and does not expect to generate any such revenues for a
number of years, if at all. HaptoGuard has incurred an
accumulated deficit of $2,425,258 as of December 31, 2005
and of $3,075,881 as of March 31, 2006, and expects to
incur net losses, potentially greater than losses in prior
years, for a number of years.
RESULTS OF OPERATIONS
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Three months ended March 31, 2006 and 2005 |
Total revenues for three months ended March 31, 2006 were
$1,774 as compared to $3,006 for the three months ended
March 31, 2005. Revenues were derived from interest earned
on cash and cash equivalents.
Total expenses were $671,801 for the three months ended
March 31, 2006 and $682,328 for the three month ended
March 31, 2005. Research and development expenses were
$491,824 for the three month ended March 31, 2006 and
$375,458 for the period ending March 31, 2005. Research and
development expenses consisted primarily of third-party expenses
associated with preclinical and clinical studies, manufacturing
costs, including the development and preparation of clinical
supplies, personnel and personnel-related expenses. The $116,366
increase in R&D expenses for the three months ended
March 31, 2006 were related to contracting of a Contract
Research Organization for the management of a Phase II clinical
trial and the authorization of manufacturing of ALT-2074 for
that clinical trial.
General and administrative expenses were $179,977 for the three
months ended March 31, 2006 and $306,870 for the three
months ended March 31, 2005. The decrease in expenses were
primarily a consequence of one time legal expenses incurred in
an aborted merger transaction contemplated in the first quarter
of 2005.
HaptoGuard had net losses of $670,027 for the three months ended
March 31, 2006, $679,322 for the three months ended
March 31, 2005. Net losses are primarily due to the
research and development expenses and legal expenses relating to
the merger consideration.
LIQUIDITY AND CAPITAL RESOURCES
HaptoGuard had cash and cash equivalents of $2,805 at
March 31, 2006 and $833,178 at March 31, 2005. Cash
used in operating activities for the three months ended
March 31, 2006 totaled $562,931 and for the three months
ended March 31, 2005 totaled $373,483 and consisted
primarily of research and development expenses, personnel and
related costs. Cash provided by financing activities for the
three months ended March 31, 2006 totaled $464,646 and for
the three months ended March 31, 2005 totaled $837,849 and
arose from the sale of common stock.
HaptoGuard does not have any approved products or services that
it has commercialized and currently derives cash from sales of
securities and interest on cash and cash equivalents. HaptoGuard
expects to generate modest revenues in 2006 through various
consulting engagements. HaptoGuards ability to generate
IV-12
additional financing is highly susceptible to conditions in the
global financial markets and in the pharmaceutical industry.
On April 4, 2006, HaptoGuard entered into a consulting
agreement with Alteon Inc. This agreement called for HaptoGuard
to provide advisory services relating to clinical development
and receive in consideration $125,000 in two installments,
$75,000 at the time of signing of such agreement and $50,000 on
May 1, 2006.
In addition, upon signing the definitive merger agreement with
Alteon on April 19, 2006, HaptoGuard contracted to continue
the advancement of its Phase 2 clinical program for ALT-2074 and
will receive from Alteon $140,000/month until the time of the
shareholder vote.
The amount and timing of HaptoGuards future capital
requirements will depend on numerous factors, including the
timing its research and development activities and the Phase 2
clinical trial, the focus on one or more product candidates, the
conduct of preclinical tests and clinical studies, the status
and timelines of regulatory submissions, the costs associated
with protecting patents and other proprietary rights, the
ability to complete strategic collaborations and the
availability of third-party funding, if any.
RESULTS OF OPERATIONS
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Year Ended December 2005 and Period from July 19,
2004 (Inception) to December 31, 2004 |
Total revenues for the year ended December 31, 2005 and for
the period from July 19, 2004 (Inception) to
December 31, 2004 were $9,885 and $2,643 respectively.
Revenues were derived from interest earned on cash and cash
equivalents.
Total expenses increased to $1,664,580 for the year ended
December 31, 2005 from $773,206 for the period from
July 19, 2004 (Inception) to December 31, 2004 and
consisted primarily of research and development expenses.
Research and development expenses were $915,409 for the year
ended December 31, 2005 and $603,173 for the period from
July 19, 2004 (Inception) to December 31, 2004.
Research and development expenses consisted primarily of
third-party expenses associated with preclinical and clinical
studies, manufacturing costs, including the development and
preparation of clinical supplies, personnel and
personnel-related expenses.
Research and development expenses increased to $915,409 for the
year ended December 31, 2005 from $603,173 for the period
from July 19, 2004 (Inception) to December 31, 2004, a
change of $312,236, or 52%. The primary reasons for the change
were the filing of an IND with the FDA, an increase in patent
expenses for the licensed intellectual property, and the
submission of new patent applications.
General and administrative expenses increased to $749,171 for
the calendar year ended December 31, 2005 from $170,033 for
the period from July 19, 2004 (Inception) to
December 31, 2004, a change of $579,138, or 340%. The
primary reason for the change was the incurrence of considerable
legal expenses in consideration of a proposed merger transaction.
HaptoGuard had net losses of $1,654,695 for the year ended
December 31, 2005 and $770,563 for the period from
July 19, 2004 (Inception) to December 31, 2004. Net
loss increased primarily due to the increase in research and
development expenses and legal expenses relating to the proposed
merger. In addition, the period from July 19, 2004
(Inception) to December 31, 2004 was a shorter period than
the year ended December 31, 2005 (approximately five and
one-half months versus 12 months) which attributed to the
increase in net loss when comparing periods.
IV-13
LIQUIDITY AND CAPITAL RESOURCES
HaptoGuard had cash and cash equivalents at December 31,
2005, of $101,090, compared to $581,573 at December 31,
2004. Cash used in operating activities for the year ended
December 31, 2005, totaled $1,312,189 and consisted
primarily of research and development expenses, personnel and
related costs. Cash used in investing activities totaled $6,143
for the year ended December 31, 2005 and was for the
purchase of computers. Cash provided by financing activities for
the year ended December 31, 2005 was $837,849 and arose
from the sale of securities in a private placement.
HaptoGuard does not have any approved products or services that
it has commercialized and currently derives cash from sales of
securities and interest on cash and cash equivalents. HaptoGuard
expects to generate modest revenues in 2006 through various
consulting engagements. HaptoGuards ability to generate
additional financing is highly susceptible to conditions in the
global financial markets and in the pharmaceutical industry.
The amount and timing of HaptoGuards future capital
requirements will depend on numerous factors, including the
timing its research and development activities and the
Phase 2 clinical trial, the focus on one or more product
candidates, the conduct of preclinical tests and clinical
studies, the status and timelines of regulatory submissions, the
costs associated with protecting patents and other proprietary
rights, the ability to complete strategic collaborations and the
availability of third-party funding, if any.
CRITICAL ACCOUNTING POLICIES
In December 2004, the Financial Accounting Standards Board
(FASB) issued Statement of Financial Accounting
Standards (SFAS) No. 123 (revised 2004),
Share-Based Payment (SFAS 123R),
which replaces Accounting for Stock-Based
Compensation, (SFAS 123) and supersedes
Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to
Employees. SFAS 123R requires all share-based
payments to employees, including grants of employee stock
options, to be recognized in the financial statements based on
their fair values effective for the Company January 1,
2006. Under SFAS 123R, the pro forma disclosures previously
permitted under SFAS 123 are no longer an alternative to
financial statement recognition.
The Company accounts for employee stock-based compensation,
awards issued to non-employee directors, and stock options
issued to consultants and contractors in accordance with
SFAS 123R and Emerging Issues Task Force Issue
No. 96-18, Accounting for Equity Instruments that are
Issued to Other Than Employees for Acquiring or in Conjunction
with Selling Goods or Services.
The Company has adopted the new standard, SFAS 123R,
effective January 1, 2006 and has selected the
Black-Scholes method of valuation for share-based compensation.
The Company has adopted the modified prospective transition
method which requires that compensation cost be recorded, as
earned, for all unvested stock options and restricted stock
outstanding at the beginning of the first quarter of adoption of
SFAS 123R, and that such costs be recognized over the
remaining service period after the adoption date based on the
options original estimate of fair value.
There were no options that were issued in the three months ended
March 31, 2006, resulted in the Company not being required
to recognize aggregate compensation expense under SFAS 123R
for the three months ended March 31, 2006.
Prior to adoption of SFAS 123R, the Company applied the
intrinsic-value method under APB Opinion No. 25,
Accounting for Stock Issued to Employees, and
related interpretations, under which no compensation cost
(excluding those options granted below fair market value) had
been recognized. SFAS 123 established accounting and
disclosure requirements using a fair-value based method of
accounting for stock-based employee compensation plans. As
permitted by SFAS 123, the Company elected to continue to
apply the intrinsic-value based method of accounting described
above, and adopted only the disclosure requirements of
SFAS 123, as amended
IV-14
As with all pharmaceutical products, the probability of
commercial success for any one research and development project
is highly uncertain. The risks and uncertainties associated with
completing development within the projected completion dates and
realization of the anticipated return on our investment include
the inability to obtain and maintain access to intellectual
property, failure in clinical trials, the inability to obtain
required regulatory approvals, and the availability of
competitive products. If we fail to successfully advance our
clinical development of ALT-2074, we may not achieve the
currently anticipated return on any investment we have made or
will make. We currently are incurring costs for the development
of our portfolio of compounds. These costs are recognized as
expenses at the time they are incurred.
Quantitative and Qualitative Disclosures about Market Risk
HaptoGuards exposure to market risk for changes in
interest rates relates primarily to its investment in cash and
cash equivalents. HaptoGuard does not use derivative financial
instruments in making or holding its investments. Accordingly,
HaptoGuard does not believe that there is any material market
risk exposure with respect to derivative or other financial
instruments that would require additional disclosure.
IV-15
CHAPTER FIVE CERTAIN LEGAL INFORMATION
COMPARISON OF STOCKHOLDER RIGHTS
Both Alteon and HaptoGuard are incorporated in the state of
Delaware. If the merger is consummated, holders of HaptoGuard
preferred and common stock will become holders of Alteon common
stock, and the rights of former HaptoGuard stockholders will be
governed by Delaware law and Alteons certificate of
incorporation and by-laws. The rights of HaptoGuard stockholders
under HaptoGuards certificate of incorporation and by-laws
differ in limited respects from the rights of Alteon
stockholders under Alteons certificate of incorporation
and by-laws. These differences are summarized in the table below.
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Alteon Stockholder Rights |
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HaptoGuard Stockholder Rights |
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Corporate Governance:
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The rights of Alteon stockholders are currently governed by
Delaware law and the certificate of incorporation and by-laws of
Alteon. |
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The rights of HaptoGuard stockholders are currently governed by
Delaware law and the certificate of incorporation and by-laws of
HaptoGuard. |
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Upon consummation of the merger, the rights of Alteon
stockholders will continue to be governed by Delaware law and
the certificate of incorporation and by-laws of Alteon. |
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Upon consummation of the merger, the rights of HaptoGuard
stockholders will continue to be governed by Delaware law. They
will also be governed by the certificate of incorporation and
by-laws of Alteon. |
Authorized Capital Stock:
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The authorized capital stock of Alteon consists of
300,000,000 shares of Alteon common stock and
1,993,329 shares of Alteon preferred stock. |
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The authorized capital stock of HaptoGuard consists
of shares
of HaptoGuard common stock
and shares
of HaptoGuard preferred stock. |
Number of Directors:
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Alteons by-laws provide that the number of directors shall
be determined by the board of directors and shall be no less
than four (4) and no more than ten (10). |
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HaptoGuards by-laws provide that the number of directors
shall be determined by the board of directors. |
Classification of Board of Directors: |
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Alteons certificate of incorporation and by-laws provide
that the board of directors shall be divided into three classes,
with each class serving a staggered three-year term. |
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None |
Stockholder Action by Written Consent: |
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According to Alteons by-laws, stockholders may take any
action by written consent. |
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According to HaptoGuards by- laws, stockholders may take
any action by written consent. |
Notice of Business at Annual Meetings: |
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Under Alteons by-laws, written notice of stockholder
meetings, including annual meetings, must include a statement of
the purposes for which the meeting is called. Also,
stockholder-proposed business may only be transacted if the
proposing stockholder provides timely written notice to an
officer of the corporation. |
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Under HaptoGuards by-laws, all notices of meetings with
stockholders shall be in writing and shall be given not less
than ten (10) nor more than sixty (60) days before the date of
the meeting to each stockholder entitled to vote at such meeting. |
V-1
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Alteon Stockholder Rights |
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HaptoGuard Stockholder Rights |
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Liquidation Rights:
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Under Alteons certificate of incorporation, holders of
Alteon common stock are entitled to share ratably in the
remaining assets of the corporation, after payment to the
preferred stock holders of all amounts to which such preferred
holders are entitled. |
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Voting Rights:
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Each holder of Alteon common stock is entitled to one vote for
each share of Alteon common stock held of record on the
applicable record date on all matters submitted to a vote of
stockholders. There are no cumulative voting rights. |
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Dividend Rights:
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Under Alteons certificate of incorporation, holders of
common stock are not entitled to receive dividends. |
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Appraisal Rights:
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Alteon stockholders are not entitled to appraisal rights
Delaware law in connection with the merger. |
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HaptoGuard stockholders are entitled to appraisal rights under
the under the Delaware law in connection with the merger. |
V-2
DESCRIPTION OF ALTEON CAPITAL STOCK
The following summary of the current terms of the capital stock
of Alteon and the terms of the capital stock of Alteon to be in
effect after completion of the merger is not meant to be
complete and is qualified by reference to the Alteon certificate
of incorporation and Alteon by-laws. Copies of the Alteon
certificate of incorporation and Alteon by-laws are incorporated
by reference and will be sent to holders of shares of Alteon
common stock and HaptoGuard common stock upon request. See
Chapter Eight Additional Information for
Stockholders Where You Can Find More
Information.
Authorized Capital Stock
Under the Alteon certificate of incorporation, Alteons
authorized capital stock consists of 300,000,000 shares of
Alteon common stock, $0.01 par value per share, and
1,993,329 shares of preferred stock, $0.01 par value
per share.
Alteon Common Stock
Alteon Common Stock Outstanding. The outstanding shares
of Alteon common stock are, and the shares of Alteon common
stock issued pursuant to the merger will be, duly authorized,
validly issued, fully paid and nonassessable.
Voting Rights. Each holder of Alteon common stock is
entitled to one vote for each share of Alteon common stock held
of record on the applicable record date on all matters submitted
to a vote of stockholders. There are no cumulative voting rights.
Dividend Rights; Rights upon Liquidation. The holders of
Alteon common stock are not entitled to receive dividends. In
the event of liquidation, each share of Alteon common stock is
entitled to share pro rata in any distribution of Alteons
assets after payment or providing for the payment of liabilities
and the liquidation preference of any then outstanding Alteon
preferred stock.
Preemptive Rights. Holders of Alteon common stock have no
preemptive rights to purchase, subscribe for or otherwise
acquire any unissued or treasury shares or other securities.
Alteon Preferred Stock
Blank Check Preferred Stock. Under the Alteon certificate
of incorporation, the Alteon board of directors has the
authority, without stockholder approval, to create one or more
classes or series within a class of preferred stock, to issue
shares of preferred stock in such class or series up to the
maximum number of shares of the relevant class or series of
preferred stock authorized, and to determine the preferences,
rights, privileges, qualifications, limitations, and
restrictions of any such class or series, including the dividend
rights, dividend rates, voting rights, the rights and terms of
redemption, redemption prices, the rights and terms of
conversion, liquidation preferences, sinking fund terms, the
number of shares constituting any such class or series, and the
designation of such class or series. Alteon believes that the
power to issue preferred stock will provide flexibility in
connection with possible corporate transactions. The issuance of
preferred stock could adversely affect the voting power of the
holders of common stock and restrict their rights to receive
payment upon liquidation and could have the effect of delaying,
deferring or preventing a change of control of Alteon. See
Anti-Takeover Measures. Alteon has no
present plans to issue any shares of preferred stock.
Terms of Series G Preferred Stock and Series H
Preferred Stock. Alteon has outstanding shares of
Series G Preferred Stock and Series H Preferred Stock.
Both the Series G Preferred Stock and Series H
Preferred Stock have dividends which are payable quarterly in
shares of preferred stock at a rate of 8.5% of the accumulated
balance. The Series G and Series H Preferred Stock
each carry a liquidation preference, which means that the value
of that preferred stock would be required to be paid to the
holders of the Series G and Series H Preferred Stock
upon a sale or liquidation before any proceeds from such sale or
liquidation are paid to any other holders of equity securities,
including the common stock. The Series G and Series H
Preferred Stock have no voting rights. Each share of
Series G Preferred Stock and Series H Preferred Stock
is convertible, upon 70 days prior written notice,
into the number of shares of common stock determined by
V-3
dividing $10,000 by the average of the closing prices of our
common stock, as reported on the American Stock Exchange, for
the 20 business days immediately preceding the date of
conversion. On December 31, 2005, the Series G and
Series H Preferred Stock would have been convertible into
69,464,500 and 208,605,500 shares of common stock,
respectively, representing, in aggregate, approximately 83% of
our common stock outstanding on an as-converted basis as of that
date.
Stock Purchase Warrants
Alteon currently has outstanding warrants to purchase
12,591,455 shares of its common stock, expiring at various
dates through 2011, ranging from $.25 to $2.93 per share.
Anti-Takeover Measures
Alteons Certificate of Incorporation provides for
staggered terms for the members of the Board of Directors and
includes a provision (the Fair Price Provision) that
requires the approval of the holders of 80 percent of its
voting stock as a condition to a merger or certain other
business transactions with, or proposed by, a holder of
10 percent or more of its voting stock, except in cases
where certain directors approve the transaction or certain
minimum price criteria and other procedural requirements are
met. Alteon has entered into a Stockholders Rights
Agreement pursuant to which each holder of a share of common
stock is granted a Right to purchase our Series F Preferred
Stock under certain circumstances if a person or group acquires
or commences a tender offer for 20 percent of our
outstanding common stock. Alteon has also adopted a Change in
Control Severance Benefits Plan which provides for severance
benefits to employees upon certain events of termination of
employment after or in connection with a change in control as
defined in the Plan. In addition, the Board of Directors has the
authority, without further action by the stockholders, to fix
the rights and preferences of, and issue shares of, Preferred
Stock. The staggered board terms, Fair Price Provision,
Stockholders Rights Agreement, Change in Control Severance
Benefits Plan, Preferred Stock provision and other provisions of
Alteons charter and Delaware corporate law may discourage
certain types of transactions involving an actual or potential
change in control.
Transfer Agent
The transfer agent and registrar for Alteons common stock
is American Stock Transfer & Trust Co. Its telephone
number is 212-936-5100.
AMEX Listing
Alteon has agreed to use its best efforts to cause the shares of
its common stock issuable in the merger to be approved for
listing on AMEX prior to the closing.
V-4
CHAPTER SIX ALTEON ANNUAL MEETING PROPOSALS
ITEM 1 MERGER PROPOSAL
For summary and detailed information regarding the merger
proposal, see Chapter One The
Merger.
THE ALTEON BOARD OF DIRECTORS RECOMMENDS A VOTE IN FAVOR OF
THE MERGER AND MERGER AGREEMENT AND THE ISSUANCE OF SHARES OF
ALTEON COMMON STOCK AND THE TRANSFER AND CONVERSION OF SHARES OF
ALTEON COMMON STOCK CONTEMPLATED THEREBY.
ITEM 2 AMENDMENTS OF CERTIFICATES OF
DESIGNATION
At the Alteon meeting, holders of Alteon stock will be asked to
approve the amendment of Alteons Certificate of
Designation of Series G Preferred Stock and the amendment
of Alteons Certificate of Designation of Series H
Preferred Stock. The amendments, among other related technical
changes, change the written notice requirements to Alteon for
conversion of the preferred stock and the limitations on the
amount of the preferred stock that can be converted in order to
allow for the conversion of the preferred stock pursuant to the
merger agreement. See Annexes D and E.
Votes Required to Approve the Amendments of the Certificates
of Designation
The affirmative vote of the holders of a majority of the issued
and outstanding Alteon common stock and the holders of
two-thirds of the issued and outstanding Series G Preferred
Stock will be required to approve the amendment of Alteons
Certificate of Designation of Series G Preferred Stock; and
the affirmative vote of the holders of a majority of the issued
and outstanding Alteon common stock and the holders of
two-thirds of the issued and outstanding Series H Preferred
Stock will be required to approve the amendment of Alteons
Certificate of Designation of Series H Preferred Stock.
THE ALTEON BOARD OF DIRECTORS RECOMMENDS A VOTE FOR THE
APPROVAL OF ITEM 2.
ITEM 3 ELECTION OF DIRECTORS
At the meeting, two directors are to be elected to hold office
until the completion of the merger or, in the event the merger
is not completed, the Annual Meeting of Stockholders to be held
in 2009 and until their successors are elected and qualified.
The nominees for election to the Board of Directors are David K.
McCurdy and Mark Novitch, M.D. Their biographies appear
below.
Pursuant to Alteons certificate of incorporation, the
Board of Directors is divided into three classes, each of which
serves a term of three years. Class C consists of
Mr. McCurdy and Dr. Novitch, whose terms will expire
at the upcoming meeting. Class A consists of
Ms. Breslow, Mr. Dalby and Mr. Moore, whose terms
will expire at the Annual Meeting of Stockholders in 2007.
Class B consists of Mr. Moch, Dr. Bransome and
Dr. Naimark, whose terms will expire at the Annual Meeting
of Stockholders in 2008.
Proxies solicited by the Board of Directors will be voted for
the election of the nominees named above, unless otherwise
specified in the proxy. All of the persons whose names and
biographies appear below are present directors of Alteon. In the
event a nominee should become unavailable or unable to serve as
a director, it is intended that votes will be cast for a
substitute nominee designated by the Board of Directors. The
Board of Directors has no reason to believe that the nominees
named will be unable to serve if elected. The nominees have
consented to being named in this Proxy Statement and to serve if
elected.
VI-1
The current Board of Directors, including the nominees, is
comprised of the following persons:
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Served as a | |
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Name |
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Age | |
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Director Since | |
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Positions with Alteon |
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Kenneth I. Moch
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51 |
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1998 |
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Chairman of the Board, President and Chief Executive Officer |
Edwin D. Bransome, Jr., M.D.
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72 |
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1999 |
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Director |
Marilyn G. Breslow
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61 |
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1988 |
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Director |
Alan J. Dalby
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69 |
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1994 |
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Director |
David K. McCurdy(1)
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55 |
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1997 |
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Director |
Thomas A. Moore
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55 |
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2001 |
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Director |
George M. Naimark, Ph.D.
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81 |
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1999 |
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Director |
Mark Novitch, M.D.(1)
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73 |
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1994 |
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Director |
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(1) |
A nominee for election to the Board of Directors. |
The principal occupations and business experience, for at least
the past five years, of each director are as follows:
Kenneth I. Moch, Chairman of the Board, President and Chief
Executive Officer, joined the Company in February 1995, as
Senior Vice President, Finance and Business Development and
Chief Financial Officer. Mr. Moch became President, Chief
Executive Officer and a director of the Company in December
1998. In June 2001, he was named Chairman of the Board. From
1990 to 1995, Mr. Moch served as President and Chief
Executive Officer of Biocyte Corporation, a cellular therapy
company that pioneered the use of cord blood stem cells in
transplantation therapy. Mr. Moch was a founder and the
Managing General Partner of Catalyst Ventures, a seed venture
capital partnership, and was a founder of The Liposome Company,
Inc. in Princeton, New Jersey, where he served as Vice President
from 1982 to 1988. Previously, he was a management consultant
with McKinsey & Company, Inc. and a biomedical
technology consultant with Channing, Weinberg &
Company, Inc. Mr. Moch received an A.B. in Biochemistry
from Princeton University, and an M.B.A. with emphasis in
Finance and Marketing from the Stanford Graduate School of
Business.
Edwin D. Bransome, Jr., M.D., has been a director of
the Company since July 1999. Dr. Bransome has been a
consultant to CSRA Renal Services LLC since 2000. He is a
Professor of Medicine and Physiology Emeritus at the Medical
College of Georgia. He retired as Chief of the Section of
Endocrinology and Metabolism in 2000, is the Past-President of
the United States Pharmacopoeia Convention and has been a member
of the USP Board of Trustees since 1990. He served on the
Georgia Department of Medical Assistance (Medicaid) Drug
Utilization Board from 1992 to 2000 and was its first Chairman.
Currently, Dr. Bransome is in medical practice as a
consultant in Endocrinology. He is a member of the editorial
board of the journal, Diabetes Care. Dr. Bransome
has had faculty positions at the Scripps Clinic and Research
Foundation, MIT and the Harvard University School of Medicine.
He received his A.B. in 1954 from Yale University and received
his M.D. from Columbia University College of Physicians and
Surgeons in 1958. His post-graduate training in Internal
Medicine and Clinical Endocrinology fellowship was at the Peter
Bent Brigham Hospital in Boston and in Biochemistry at Columbia
University College of Physicians and Surgeons.
Marilyn G. Breslow has been a director of the Company since June
1988. She had been a Portfolio Manager/Analyst for W. P.
Stewart & Co., Inc., the research subsidiary of W. P.
Stewart & Co., Ltd., an investment advisory firm, since
1990, and was previously President of the New York office of
WPS, Inc. She was a General Partner of Concord Partners and a
Vice President of Dillon, Read & Co., Inc. from 1984 to
1990. Prior to Dillon, Read & Co., she worked at
Polaroid Corporation from 1973 to 1984 and was with Peat,
Marwick, Mitchell and Company from 1970 to 1972 and ICF, Inc.
from 1972 to 1973. Ms. Breslow holds a B.S. degree from
Barnard College and an M.B.A. from the Harvard Graduate School
of Business Administration.
VI-2
Alan J. Dalby has been a director of the Company since December
1994. He is the former Chairman of Reckitt Benckiser plc, a
household products company, and former Chairman, Chief Executive
Officer and a founder of Cambridge NeuroScience, Inc. He was
Executive Vice President and member of the Board of Directors
for SmithKline Beckman Corporation, retiring in 1987.
Mr. Dalby is a director of Acambis plc.
David K. McCurdy has been a director of the Company since June
1997. He is currently the President of Electronic Industries
Alliance (EIA), the premier trade organization
representing more than 2,100 of the worlds leading
electronics manufacturers. Before becoming President of EIA in
November 1998, Mr. McCurdy was Chairman and Chief Executive
Officer of the McCurdy Group L.L.C., a business consulting and
investment firm focused on high-growth companies in the fields
of healthcare, high technology and international business, which
he formed in 1995. Prior to forming the McCurdy Group,
Mr. McCurdy served for 14 years in the United States
House of Representatives from the fourth district of Oklahoma.
He attained numerous leadership positions, including Chairman of
the House Intelligence Committee and subcommittee chairs in both
the House Armed Services Committee and the Science and Space
Committee. He held a commission in the United States Air Force
Reserve attaining the rank of major and serving as a Judge
Advocate General (JAG). A 1972 graduate of the University of
Oklahoma, Mr. McCurdy received his J.D. in 1975 from the
University of Oklahoma College of Law. He also studied
international economics at the University of Edinburgh,
Scotland, as a Rotary International Graduate Fellow.
Thomas A. Moore has been a director of the Company since October
2001. He was President and Chief Executive Officer of Biopure
Corporation, a leading developer, manufacturer and marketer of
oxygen therapeutics for the treatment of anemia and other
applications, from 2002 to 2004. Prior to joining Biopure in
2002, Mr. Moore was President and Chief Executive Officer
of Nelson Communications Worldwide, one of the largest providers
of healthcare marketing services globally. From 1992 to 1996,
Mr. Moore was President of Procter & Gambles
worldwide prescription and
over-the-counter
healthcare products business, and Group Vice President of the
Procter & Gamble Company. Mr. Moore holds a B.A.
in History from Princeton University.
George M. Naimark, Ph.D., has been a director of the
Company since July 1999. He is President of Naimark &
Barba, Inc., a management consultancy, since September 1966, and
Naimark & Associates, Inc., a private healthcare
consulting organization, since February 1994. Dr. Naimark
has more than 30 years of experience in the pharmaceutical,
diagnostic and medical device industries. His experience
includes management positions in research and development, new
product development and quality control. In addition,
Dr. Naimark has authored books on patent law,
communications and business, as well as many articles that
appeared in general business, marketing, scientific and medical
journals and was the editor of a medical journal. He received
his Ph.D. from the University of Delaware in 1951, and received
a B.S. and M.S. from Bucknell University in 1947 and 1948,
respectively.
Mark Novitch, M.D., has been a director of the Company
since June 1994. He retired as Vice Chairman and Chief
Compliance Officer of the Upjohn Company in December 1993. Prior
to joining Upjohn in 1985, he was Deputy Commissioner of the
U.S. Food and Drug Administration. Dr. Novitch is a
Director of Guidant Corporation, a supplier of cardiology and
minimally invasive surgery products; Neurogen Corporation, a
biopharmaceutical firm focused on central nervous system
disorders; and Kos Pharmaceuticals, Inc., a developer of
pharmaceutical products for cardiovascular and respiratory
conditions. He graduated from Yale University and received his
M.D. from New York Medical College.
Committees and Meetings of the Board
The Board of Directors has a Compensation Committee, which
reviews incentive compensation for employees of and consultants
to Alteon, as well as salaries and incentive compensation of
executive officers; a Nominating Committee, which reviews the
qualifications of candidates and proposes nominees to serve as
directors on our Board of Directors and nominees for membership
on Board committees; and an Audit Committee, which oversees the
accounting and financial reporting processes and the audits of
our financial statements. In 2005, the Strategic Planning
Committee was formed to oversee all discussions relating to the
identification and implementation for the Alteons Advanced
Glycation End-product assets, as well as for
VI-3
Alteon itself. In 2005, the Audit, Nominating, Compensation and
Strategic Planning Committees were comprised of Edwin D.
Bransome, Jr., M.D., Marilyn G. Breslow, Alan J.
Dalby, David K. McCurdy, Thomas A. Moore, George M.
Naimark, Ph.D., and Mark Novitch, M.D. All of the
members of the Compensation Committee, the Nominating Committee,
the Strategic Planning Committee and the Audit Committee, are
independent, as such term is defined by Section 121.A of
the American Stock Exchange listing standards. The Board of
Directors does not currently have an audit committee
financial expert, within the meaning of applicable
regulations of the Securities and Exchange Commission, serving
on its Audit Committee. The Board of Directors believes that one
or more members of the Audit Committee satisfy the financial
sophistication requirement of the American Stock Exchange and
are capable of (i) understanding generally accepted
accounting principles (GAAP) and financial
statements; (ii) assessing the application of GAAP in
connection with our accounting for estimates, accruals and
reserves; (iii) analyzing and evaluating our financial
statements; (iv) understanding our internal controls and
procedures for financial reporting; and (v) understanding
audit committee functions, all of which are attributes of an
audit committee financial expert. However, the Board of
Directors believes that these members may not have obtained
these attributes through the experience specified in the
Securities and Exchange Commissions rules with respect to
audit committee financial experts, and therefore may not qualify
to serve in that role.
The Strategic Planning Committee held 17 meetings, the Audit
Committee held fourteen meetings, the Compensation Committee
held four meetings and the Nominating Committee held one meeting
during the year ended December 31, 2005. There were 18
meetings of the Board of Directors in 2005. Each of the
incumbent directors attended at least 75% of the aggregate of
(i) the total number of meetings of the Board of Directors
held during the year ended December 31, 2005 and
(ii) the total number of meetings held by all committees of
the Board on which he or she served during the year ended
December 31, 2005, except for Alan J. Dalby, who attended
12 of the 18 meetings of the Board and committees of the Board
held during 2005. The Board has adopted a written charter for
the Audit Committee, the Nominating Committee and the Strategic
Planning Committee. The written charter for the Nominating
Committee is available on our website at
www.alteon.com.
Director Nomination Process
The Nominating Committee reviews the qualifications of
candidates and proposes nominees to serve as directors on
Alteons Board of Directors and nominees for membership on
Board committees. It is the Nominating Committees policy
to consider potential candidates for Board membership
recommended by its members, management, stockholders and others.
The Nominating Committee has not established any specific
minimum qualifications that must be met for a recommendation for
a position on the Board of Directors. Instead, the Nominating
Committee conducts appropriate and necessary inquiries into the
backgrounds and qualifications of possible candidates for
nomination to the Board of Directors giving due consideration to
such criteria, including without limitation, diversity,
experience, skill set and the ability to act on behalf of
stockholders, as it believes appropriate and in the best
interests of Alteon and its stockholders. All potential director
candidates are evaluated based upon the same criteria, and the
Nominating Committee makes no distinction in its evaluation of
candidates based upon whether such candidates are recommended by
stockholders or others. Once the evaluation is complete, the
Nominating Committee recommends the nominees to the Board of
Directors, who makes the final determination. If a stockholder
wishes to nominate a candidate to be considered for election as
a director at the 2007 Annual Meeting of Stockholders using the
procedures set forth in Alteons amended and restated
by-laws, it must follow the procedures described in
Advance Notice of Stockholder Nominees for Director and
Other Stockholder Proposals set forth in Alteons
amended and restated by-laws. If a stockholder wishes simply to
propose a candidate for consideration as a nominee by the
Nominating Committee, it should follow the procedures set forth
in Appendix B, Procedures for Shareholders Submitting
Nominating Recommendations, to our Nominating Committee
Charter, which is available on our website at
www.alteon.com.
VI-4
Compensation of Directors
All of the directors are reimbursed for their expenses for each
Board meeting attended. Directors who are not also compensated
as our employees receive $1,500 per Board meeting attended
in person and $1,000 for each Board meeting attended by
telephone.
Pursuant to Alteons 2005 Stock Plan, non-employee
directors also receive, upon the date of their election or
re-election to the Board and on the dates of the next two Annual
Meetings of Stockholders (subject to their continued service on
the Board of Directors), a stock option to purchase
20,000 shares of common stock (subject to adjustment if
they received stock options upon appointment to the Board
between Annual Meetings of Stockholders to fill a vacancy or
newly created directorship) at an exercise price equal to the
fair market value of the common stock on the date of grant. Each
of these options will vest and become exercisable upon
completion of one full year of service and shall have a term of
ten years regardless of whether the director ceases to be a
director of the Company.
Stockholder Communication
Stockholders and other parties interested in communicating
directly with the Chairman or with the Board of Directors as a
group may do so by writing to Chairman, Alteon Inc.,
6 Campus Drive, Parsippany, New Jersey 07054. All
correspondence received by Alteon and addressed to the Chairman
is forwarded directly to the Board of Directors.
Director Attendance at Annual Meeting
All eight incumbent Directors attended Alteons Annual
Meeting of Stockholders in 2005. Each Director is expected to
dedicate sufficient time, energy and attention to ensure the
diligent performance of his or her duties, including attending
meetings of the stockholders, the Board and Committees of which
he or she is a member.
THE ALTEON BOARD OF DIRECTORS RECOMMENDS A VOTE FOR THE
APPROVAL OF ITEM 3.
|
|
ITEM 4 |
RATIFICATION OF THE APPOINTMENT OF INDEPENDENT REGISTERED
PUBLIC ACCOUNTING FIRM |
The Audit Committee of the Board has appointed, subject to
stockholder ratification, J.H. Cohn LLP
(J.H. Cohn) to serve as Alteons
independent registered public accounting firm for the fiscal
year ending December 31, 2006. As described below, KPMG LLP
(KPMG), our former independent registered accounting
firm, resigned effective August 10, 2004. The Board
recommends that our stockholders ratify this appointment.
J.H. Cohn served as our independent registered public
accounting firm for the fiscal years ended December 31,
2005 and December 31, 2004.
If the stockholders do not ratify the decision to appoint
J.H. Cohn, the Audit Committee may reconsider its
selection. The affirmative vote of a majority of the shares
voted at the Annual Meeting is required for ratification.
Representatives of J.H. Cohn are expected to be present at
the Annual Meeting to respond to appropriate questions from our
stockholders. They will be given the opportunity to make a
statement if they wish to do so.
VI-5
The following table summarizes the fees paid or payable to
J.H. Cohn for services rendered for the fiscal year ended
December 31, 2005:
|
|
|
|
|
|
|
|
Fiscal Year Ended | |
Type of Fees |
|
December 31, 2005 | |
|
|
| |
Audit Fees
|
|
$ |
288,966 |
|
Audit-Related Fees
|
|
|
7,150 |
|
Tax Fees
|
|
|
|
|
All Other Fees
|
|
|
|
|
|
|
|
|
|
Total Fees
|
|
$ |
296,116 |
|
|
|
|
|
The following table summarizes the fees paid or payable KPMG for
services rendered for the fiscal year ended December 31,
2005:
|
|
|
|
|
|
|
|
Fiscal Year Ended | |
Type of Fees |
|
December 31, 2005 | |
|
|
| |
Audit Fees
|
|
$ |
7,500 |
|
Audit-Related Fees
|
|
|
3,500 |
|
Tax Fees
|
|
|
|
|
All Other Fees
|
|
|
3,325 |
|
|
|
|
|
|
Total Fees
|
|
$ |
14,325 |
|
|
|
|
|
The following table summarizes the fees paid or payable J.H.
Cohn for services rendered for the fiscal year ended
December 31, 2004:
|
|
|
|
|
|
|
|
Fiscal Year Ended | |
Type of Fees |
|
December 31, 2004 | |
|
|
| |
Audit Fees
|
|
$ |
47,667 |
|
Audit-Related Fees
|
|
|
1,500 |
|
Tax Fees
|
|
|
|
|
All Other Fees
|
|
|
|
|
|
|
|
|
|
Total Fees
|
|
$ |
49,167 |
|
|
|
|
|
The following table summarizes the fees paid or payable KPMG for
services rendered for the fiscal year ended December 31,
2004:
|
|
|
|
|
|
|
|
Fiscal Year Ended | |
Type of Fees |
|
December 31, 2004 | |
|
|
| |
Audit Fees
|
|
$ |
83,000 |
|
Audit-Related Fees
|
|
|
|
|
Tax Fees
|
|
|
12,150 |
|
All Other Fees
|
|
|
26,828 |
|
|
|
|
|
|
Total Fees
|
|
$ |
121,978 |
|
|
|
|
|
Information set forth below the caption audit fees
relates to fees we paid the independent registered public
accountants for professional services for the audit of our
financial statements included in our
Form 10-K, review
of our financial statements included in our
Forms 10-Q and for
the issuance of comfort letters and/or consents in connection
with registration statements. 2005 Audit Fees to J.H. Cohn LLP
also include $196,239 for work related to the audit of our
internal controls over financial reporting and related
attestation to managements report on the effectiveness of
our internal controls over financial reporting required by
Section 404 of the Sarbanes-Oxley Act of 2002.
Audit-Related Fees are fees we paid for assurance
and related services by the independent registered public
accountants that are reasonably related to
VI-6
the performance of the audit or review of our financial
statements, including special procedures required to meet
certain regulatory requirements. All Other Fees are
fees paid to KPMG LLP for the year ended December 31, 2005
and December 31, 2004 related to an audit of a third-party
vendor. Tax fees are fees for tax compliance, tax
advice and tax planning.
THE ALTEON BOARD OF DIRECTORS RECOMMENDS A VOTE FOR THE
APPROVAL OF ITEM 4.
EXECUTIVE OFFICERS
The following table identifies Alteons current executive
officers:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In Current |
Name |
|
Age | |
|
Capacities in Which Served |
|
Positions Since |
|
|
| |
|
|
|
|
Kenneth I. Moch
|
|
|
51 |
|
|
Chairman of the Board President and Chief Executive Officer |
|
June 2001 December 1998 |
Mary Phelan(1)(2)
|
|
|
43 |
|
|
Director of Finance and Financial Reporting |
|
May 2005 |
|
|
(1) |
Mary Phelan has served as Alteons Director of Finance and
Financial Reporting since May 2005. Prior to that, she served as
Alteons Controller since October 2003. From July 2000 to
September 2003, Ms. Phelan served as Alteons
Assistant Controller. Prior to joining Alteon, Ms. Phelan
was accounting manager at Medicom Communications Corporation
from August 1999 to July 2000. Ms. Phelan is a Certified
Public Accountant who has held several accounting positions,
including Senior Accountant at KPMG, LLP. Ms. Phelan
received a BBA in Certified Public Accounting from Pace
University. |
|
(2) |
Mary Phelan has resigned from her position as Director of
Finance and Financial Reporting effective May 31, 2006. |
VI-7
EXECUTIVE COMPENSATION
The following table sets forth certain information concerning
the annual and long-term compensation for the fiscal years ended
December 31, 2005, 2004 and 2003, of Alteons Chief
Executive Officer and Alteons three other highly
compensated executive officers who were serving as executive
officers at December 31, 2005, or who served as executive
officers during the fiscal year ended December 31, 2005
(collectively, the Named Officers):
SUMMARY COMPENSATION TABLE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-Term | |
|
|
|
|
|
|
|
|
|
|
Compensation | |
|
|
|
|
|
|
Awards | |
|
|
|
|
Annual Compensation | |
|
Securities | |
|
|
|
|
| |
|
Underlying | |
|
All Other | |
|
|
|
|
Salary | |
|
Bonus | |
|
Options | |
|
Compensation | |
Name and Principal Position |
|
Year | |
|
($) | |
|
($) | |
|
(#) | |
|
($) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Kenneth I. Moch
|
|
|
2005 |
|
|
|
382,454 |
|
|
|
|
|
|
|
150,000 |
|
|
|
15,930 |
(1) |
|
President and Chief
|
|
|
2004 |
|
|
|
367,744 |
|
|
|
100,000 |
(2) |
|
|
600,000 |
|
|
|
13,619 |
(3) |
|
Executive Officer
|
|
|
2003 |
|
|
|
353,600 |
|
|
|
200,000 |
(4) |
|
|
100,000 |
|
|
|
3,000 |
(5) |
Judith S. Hedstrom(6)
|
|
|
2005 |
|
|
|
300,000 |
|
|
|
|
|
|
|
|
|
|
|
3,500 |
(5) |
|
Chief Operating Officer
|
|
|
2004 |
|
|
|
250,000 |
|
|
|
75,000 |
(2) |
|
|
400,000 |
|
|
|
3,250 |
(5) |
|
|
|
2003 |
|
|
|
223,600 |
|
|
|
78,333 |
(7) |
|
|
150,000 |
|
|
|
3,000 |
(5) |
Elizabeth A. ODell(8)
|
|
|
2005 |
|
|
|
101,667 |
|
|
|
|
|
|
|
|
|
|
|
3,500 |
(5) |
|
Vice President, Finance, Secretary and
|
|
|
2004 |
|
|
|
183,872 |
|
|
|
30,000 |
(2) |
|
|
63,000 |
|
|
|
3,250 |
(5) |
|
Treasurer
|
|
|
2003 |
|
|
|
176,800 |
|
|
|
30,000 |
(9) |
|
|
150,000 |
|
|
|
3,000 |
(5) |
Mary T. Phelan(10)
|
|
|
2005 |
|
|
|
131,667 |
|
|
|
32,500 |
|
|
|
44,000 |
|
|
|
2,400 |
(5) |
|
Director of Finance and Financial Reporting |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Represents expenses for a car allowance of $11,430 and matching
401(k) contributions of $4,500. |
|
|
(2) |
Represents a deferred performance bonus relating to the year
ended December 31, 2004, paid in 2005. |
|
|
(3) |
Represents expenses for a car allowance of $9,619 and matching
401(k) contributions of $4,000. |
|
|
(4) |
Includes a $100,000 deferred performance bonus relating to the
year ended December 31, 2003, paid in 2004. |
|
|
(5) |
Represents matching 401(k) contributions. |
|
|
(6) |
Ms. Hedstrom resigned effective January 31, 2006. |
|
|
(7) |
Includes a $45,000 deferred performance bonus relating to the
year ended December 31, 2003, paid in 2004. |
|
|
(8) |
Ms. ODell resigned effective May 18, 2005. |
|
|
(9) |
Includes a $20,000 deferred performance bonus relating to the
year ended December 31, 2003, paid in 2004. |
|
|
(10) |
Ms. Phelan became our Director of Finance and Financial
Reporting in May 2005. Ms. Phelan has resigned from her
position as Director of Finance and Financial Reporting
effective May 31, 2006. |
VI-8
The following tables set forth certain information concerning
grants and exercises of stock options during the fiscal year
ended December 31, 2005, to and by the Named Officers:
OPTION GRANTS IN LAST FISCAL YEAR
INDIVIDUAL GRANTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Potential Realizable | |
|
|
|
|
|
|
|
|
|
|
Value at Assumed | |
|
|
Number of | |
|
Percent of | |
|
|
|
|
|
Annual Rates of | |
|
|
Securities | |
|
Total Options | |
|
|
|
|
|
Stock Price | |
|
|
Underlying | |
|
Granted to | |
|
|
|
|
|
Appreciation For | |
|
|
Options | |
|
Employees in | |
|
Exercised | |
|
|
|
Option Term(1) | |
|
|
Granted | |
|
Fiscal Year | |
|
or Base | |
|
|
|
| |
Name |
|
(#) | |
|
(%) | |
|
Price ($/SH) | |
|
Expiration Date | |
|
5% ($) | |
|
10% ($) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Kenneth I. Moch
|
|
|
150,000 |
|
|
|
64.7 |
|
|
|
0.75 |
|
|
|
02/28/10 |
|
|
|
31,082 |
|
|
|
68,682 |
|
Mary T. Phelan
|
|
|
20,000 |
|
|
|
8.6 |
|
|
|
0.58 |
|
|
|
05/02/15 |
|
|
|
7,295 |
|
|
|
18,487 |
|
|
|
|
24,000 |
|
|
|
10.3 |
|
|
|
0.35 |
|
|
|
07/25/15 |
|
|
|
5,283 |
|
|
|
13,387 |
|
Judith S. Hedstrom
|
|
|
|
|
|
|
|
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
Mary T. Phelan
|
|
|
|
|
|
|
|
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
(1) |
The dollar amounts under these columns are the result of
calculations assuming that the price of Alteon common stock on
the date of the grant of the option increases at the
hypothetical 5% and 10% rates set by the Securities and Exchange
Commission and therefore are not intended to forecast possible
future appreciation, if any, of our stock price over the option
term of 10 years. |
AGGREGATED OPTION EXERCISES IN LAST FISCAL YEAR
AND FISCAL YEAR-END OPTION VALUES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Securities | |
|
|
|
|
Shares | |
|
|
|
Underlying Unexercised | |
|
Value of Unexercised In- | |
|
|
Acquired | |
|
|
|
Options at December 31, | |
|
The-Money Options | |
|
|
on | |
|
Value | |
|
2005 (#) | |
|
December 31, 2005(1) ($) | |
|
|
Exercise | |
|
Realized | |
|
| |
|
| |
Name |
|
(#) | |
|
($) | |
|
Exercisable | |
|
Unexercisable | |
|
Exercisable | |
|
Unexercisable | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Kenneth I. Moch
|
|
|
|
|
|
|
|
|
|
|
1,150,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Judith S. Hedstrom
|
|
|
|
|
|
|
|
|
|
|
825,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Elizabeth A. ODell
|
|
|
|
|
|
|
|
|
|
|
576,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Mary T. Phelan
|
|
|
|
|
|
|
|
|
|
|
81,730 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
No values are shown in these columns because none of the
reported exercisable options were
in-the-money at
December 31, 2005. |
VI-9
EQUITY COMPENSATION PLAN INFORMATION
The following table sets forth information concerning the number
of outstanding options, the weighted average exercise price of
those securities and the number of securities remaining to be
granted under existing equity plans, whether approved or not
approved by security holders, as of December 31, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- | |
|
|
|
|
Number of Securities | |
|
Average Exercise | |
|
|
|
|
to be Issued Upon | |
|
Price of | |
|
Number of Securities | |
|
|
Exercise of | |
|
Outstanding | |
|
Remaining Available | |
|
|
Outstanding | |
|
Options, | |
|
For Future Issuance | |
|
|
Options, Warrants | |
|
Warrants and | |
|
Under Existing Equity | |
Plan Category |
|
and Rights | |
|
Right | |
|
Compensation Plans | |
|
|
| |
|
| |
|
| |
Equity compensation plans approved by security holders(1)
|
|
|
6,486,665 |
|
|
$ |
2.12 |
|
|
|
4,807,978 |
|
Equity compensation plans not approved by security holders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
6,486,665 |
|
|
$ |
2.12 |
|
|
|
4,807,978 |
|
|
|
|
|
|
|
|
|
|
|
|
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(1) |
These plans consist of our Amended and Restated 1987 Stock
Option Plan, our Amended 1995 Stock Option Plan and our 2005
Stock Option Plan. |
Employment Contracts, Termination of Employment and
Change-in-Control
Arrangements
Alteon entered into a three-year amended and restated employment
agreement with Kenneth I. Moch as of December 15, 2004.
Under the terms of the amended and restated employment
agreement, Mr. Moch serves as Alteons Chief Executive
Officer and is entitled to an annual salary for the 2006 fiscal
year of $382,454. The term of his employment is for a three-year
period.
Alteon entered into a three-year amended and restated employment
agreement with Judith S. Hedstrom as of February 11, 2005.
Under the terms of the amended and restated employment
agreement, Ms. Hedstrom served as our Chief Operating
Officer and was entitled to an annual salary of
$300,000 per annum. The term of her employment was for a
three-year period. Ms. Hedstrom resigned effective
January 31, 2006.
By letter agreement dated December 22, 2003, Alteon entered
into an amended and restated employment agreement with Elizabeth
A. ODell for an additional three years. Pursuant to this
letter agreement, Ms. ODell received stock options to
purchase an aggregate of 100,000 shares of common stock and
was entitled to an annual salary of $182,872 (subject to annual
review by the Board of Directors) plus an annual bonus awarded
at the discretion of the Board of Directors. Based on the
provisions of her agreement, in December 2004, the Board of
Directors approved an increase in Ms. ODells
base salary to $191,227. Ms. ODell resigned effective
May 18, 2005.
In addition to provisions in the above-described agreements
requiring each individual to maintain the confidentiality of
Alteons information and assign inventions to Alteon, such
executive officers have agreed that during the terms of their
agreements and for one year thereafter, they will not compete
with Alteon by engaging in any capacity in any business that is
competitive with Alteons business. The employment
agreements with Mr. Moch and Ms. Hedstrom provide that
either party may terminate the agreement upon 30 days
prior written notice, subject to a salary continuation
obligation of Alteon if it terminates the agreements without
cause. Mr. Moch and Ms. Hedstrom will receive a
12-month salary
continuation under such circumstances. The employment agreements
with Mr. Moch and Ms. Hedstrom provide that they are
entitled to receive benefits upon a change in control of Alteon,
including payment of an amount equal to their base salary
payable each month for a period of 12 months following the
change in control. Mr. Moch and Ms. Hedstrom may elect
to receive this payment, if it is made, in a lump sum, subject
to a discount equal to the then applicable federal rate.
VI-10
On December 15, 2005, the Compensation Committee of the
Board of Directors of Alteon Inc. approved the acceleration of
the vesting date of all previously issued, outstanding and
unvested options, effective December 31, 2005.
Approximately 1.47 million options were accelerated, of
which approximately 1.3 million belong to executive
officers and non-employee members of the Board of Directors.
Change in Control Severance Benefits Plan
In February 1996, Alteon adopted the Alteon Inc. Change in
Control Severance Benefits Plan (the Change in Control
Severance Plan) to protect and retain qualified employees
and to encourage their full attention, free from distractions
caused by personal uncertainties and risks in the event of a
pending or threatened change in control of Alteon. The Change in
Control Severance Plan provides for severance benefits to
certain employees upon certain terminations of employment after
or in connection with a change in control of Alteon as defined
in the Change in Control Severance Plan. Following a qualifying
termination that occurs as a result of a change in control,
Alteons executive officers will be entitled to
continuation of (i) their base salary for a period of
24 months, and (ii) all benefit programs and plans
providing for health and insurance benefits for a period of up
to 18 months. In addition, upon a change in control of
Alteon, all outstanding unexercisable stock options held by
certain employees that are participants in the Change in Control
Severance Plan will become exercisable. The Change in Control
Severance Plan was terminated in November 2005.
Alteon Severance Plan
The Alteon Severance Plan, which became effective June 1,
2005, provides for severance payments and benefits to certain
employees upon termination of their employment as a result of a
triggering event as defined in the Alteon Severance Plan. Upon a
triggering event, these employees will be entitled to
continuation of (i) their base salary for a period of up to
six months, and (ii) all benefit programs and plans
providing for health care coverage for a period of up to three
months. Our obligation to provide severance payments and
benefits to each employee ends if the employee secures
employment during such time periods.
401(k) Plan
Alteon has a tax-qualified employee savings and retirement plan
(the 401(k) Plan) covering all of its employees.
Pursuant to the 401(k) Plan, employees may elect to reduce their
current compensation by up to the statutorily prescribed annual
limit ($15,000 in 2006) and have the amount of such reduction
contributed to the 401(k) Plan. The 401(k) Plan does not require
that Alteon make additional matching contributions to the 401(k)
Plan on behalf of participants in the 401(k) Plan. However, in
1998, we began making discretionary contributions at a rate of
25% of employee contributions up to a maximum of 5% of their
base salary. Contributions by employees to the 401(k) Plan and
income earned on such contributions are not taxable to employees
until the contributions are withdrawn from the 401(k) Plan. The
Trustees under the 401(k) Plan, at the direction of each
participant, invest the assets of the 401(k) Plan.
Compensation Committee Interlocks and Insider
Participation
The persons who served as members of the Compensation Committee
of the Board of Directors during 2005 were Alan J. Dalby, Edwin
D. Bransome, Jr., M.D., Marilyn G. Breslow, David K.
McCurdy, Thomas A. Moore, George M. Naimark, Ph.D., and
Mark Novitch, M.D. None of the members of the Compensation
Committee was an officer, former officer or employee of Alteon
or had any relationship with Alteon that requires disclosure
under Item 404 of the Securities and Exchange
Commissions
Regulation S-K.
Stockholder Return Performance Presentation
The following graph compares the cumulative total stockholder
return on our common stock over the five-year period ending
December 31, 2005, with the cumulative total return of
(i) the American Stock
VI-11
Exchange U.S. Index (Amex US) and
(ii) the Nasdaq Biotechnology Index (Nasdaq
Biotech). The graph assumes (i) an investment of $100
in our common stock and in each of the indices, and
(ii) reinvestment of all dividends. No cash dividends have
been declared on our common stock as of December 31, 2005.
The stock performance set forth below is not necessarily
indicative of future price performance.
VI-12
RELATIVE PERFORMANCE
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31-Dec-00 |
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31-Dec-01 |
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31-Dec-02 |
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31-Dec-03 |
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29-Dec-04 |
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31-Dec-05 |
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ALTEON
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100.00 |
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520.00 |
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234.29 |
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179.43 |
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149.71 |
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20.57 |
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AMEX US
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100.00 |
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86.34 |
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70.57 |
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95.52 |
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110.38 |
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119.47 |
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AMEX HP&S
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100.00 |
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112.77 |
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77.94 |
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136.53 |
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140.45 |
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121.47 |
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NASDAQ Biotech
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100.00 |
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103.06 |
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56.35 |
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82.12 |
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87.16 |
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89.63 |
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The preceding performance graph, the Compensation Committee
report and the Audit Committee report contained in this Proxy
Statement are not to be incorporated by reference into filings
Alteon has made or may make under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended,
that incorporate other filings Alteon has made or may make under
those statutes.
VI-13
COMPENSATION COMMITTEE REPORT
General Policies
The Compensation Committee (the Committee) of the
Board of Directors is responsible for reviewing and approving
Alteons general compensation policies and compensation
plans, as well as the specific compensation levels for officers
and highly compensated employees. The Committee also acts as the
Administrator under Alteons 2005 Stock Option Plan, and,
from time to time, grants options under such Plan.
Under the supervision of the Committee, Alteon has developed and
implemented compensation policies, plans and programs which
(i) provide a total compensation package which is intended
to be competitive within the industry so as to enable Alteon to
attract and retain high-caliber executive personnel, and
(ii) seek to align the financial interests of Alteons
employees with those of its stockholders by relying heavily on
long-term incentive compensation that is tied to performance.
The primary components of executive compensation include base
salary and long-term equity incentives in the form of stock
options. Alteon relies on long-term incentive compensation
(i.e., stock options) to motivate the executive officers and
other employees. This allows Alteon to retain cash for research
and development projects. In determining the size of stock
option grants to individual executives, the Committee considers
a number of factors, including the following: the level of an
executives job responsibilities; the executives past
performance; the size and frequency of grants by comparable
companies; the executives salary level; the need to
provide incentive for the purpose of retaining qualified
personnel in light of Alteons current conditions and
prospects; the size of any prior grants; and the achievement of
designated milestones by the executive. The Committee assigns no
specific weight to any of the foregoing factors (other than
achievement of designated milestones by the executive in cases
where the executives employment agreement provides for a
grant of a specific size upon achievement of the milestone) when
making determinations as to the size of stock option grants.
Executive officers are also eligible to earn an annual cash
incentive award, the amount of which is based upon (i) the
position level of the executive officer, and (ii) the
attainment of specific individual non-financial performance
objectives.
The Chief Executive Officer is responsible for the development
of the annual salary plan for executive officers other than
himself. The plan is based on industry and peer group
comparisons and national surveys and on performance judgments as
to the past and expected future contributions of the
individuals. To maintain a competitive level of compensation,
Alteon targets base salary at the upper percentiles of a
comparative group composed of other biotechnology companies of a
similar size and stage of business to Alteon. Base salary may
exceed this level as a result of individual performance. The
Committee reviews the annual plan and makes recommendations to
the Board of Directors, with any modifications it deems
appropriate. The Committee believes it has established executive
compensation levels which are competitive with companies in the
industry, taking into account individual experience, performance
of both Alteon and the individual, company size, location and
stage of development.
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Compensation of the Chief Executive Officer |
Mr. Mochs compensation was determined on the basis of
his expertise and experience, which include over 20 years
of experience in the biotechnology and venture capital fields.
Mr. Moch received a base salary of $382,454 in 2005. Based
on a review of the compensation of chief executive officers of
comparable biotechnology companies, the Committee believes that
Mr. Mochs compensation arrangements reflect the
compensation package necessary to retain his services for Alteon
in light of Alteons current condition and prospects and is
commensurate with his expertise and experience as well as with
compensation offered by comparable biotechnology companies.
It should be noted that when the Committee considers any
component of the Chief Executive Officers total
compensation, the aggregate amounts and mix of all the
components, including accumulated (realized and unrealized)
option gains are taken into consideration in the
Committees decisions. In addition, it is the
VI-14
Committees policy to make most compensation decisions in a
two-step process. At the first Committee meeting during the
year, the Chief Executive Officer and other executive
officers proposed compensation is presented, reviewed and
analyzed in the context of all the components of their total
compensation. Members then have additional time between meetings
to ask for additional information and to raise and discuss
further questions. The discussion is continued at a second
Committee meeting, after which a vote is taken.
Effective January 1, 1994, the Internal Revenue Code does
not permit corporations to deduct payment of certain
compensation in excess of $1,000,000 to the chief executive
officer and the four other most highly paid executive officers.
All compensation paid to our executive officers for 2005 will be
fully deductible, and the Committee anticipates that amounts
paid as cash compensation will continue to be fully deductible
because the amounts are expected to be less than the $1,000,000
threshold. Under certain circumstances, the executive officers
may realize compensation upon the exercise of stock options
granted under our stock option plans which would not be
deductible by Alteon. Alteon expects to take such action as is
necessary to qualify its stock option plans as
performance-based compensation, which is not subject
to the limitation, if and when the Committee determines that the
effect of the limitation on deductibility warrants such action.
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Compensation Committee |
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Alan J. Dalby |
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Edwin D. Bransome, Jr., M.D. |
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Marilyn G. Breslow |
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David K. McCurdy |
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Thomas A. Moore |
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George M. Naimark, Ph.D. |
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Mark Novitch, M.D. |
VI-15
AUDIT COMMITTEE REPORT
The Audit Committees powers and responsibilities and the
qualifications required of each of its members are set forth in
the Audit Committee Charter.
Responsibilities
The primary function of the Audit Committee is to oversee
Alteons accounting and financial reporting processes, the
audits of its financial statements and internal controls over
financial reporting. Management is solely responsible for the
financial statements and the financial reporting process,
including the system of internal controls, and has represented
to the Audit Committee and the Board of Directors that the
financial statements discussed below were prepared in accordance
with accounting principles generally accepted in the United
States of America appropriate in the circumstances and
necessarily include some amounts based on managements
estimates and judgments. Alteons independent registered
public accounting firm is responsible for auditing those
financial statements and expressing an opinion on the conformity
of these financial statements, in all material respects, with
accounting principles generally accepted in the United States of
America.
Independence
As required by Independence Standards Board Standard No. 1,
as currently in effect, Alteons independent registered
public accounting firm, J.H. Cohn LLP (J.H. Cohn)
has disclosed to the Audit Committee any relationships between
it (and its related entities) and Alteon (and its related
entities), which, in J.H. Cohns professional judgment, may
reasonably be thought to affect its ability to be independent.
In addition, J.H. Cohn has discussed its independence with the
Audit Committee and confirmed in a letter to the Audit Committee
that, in its professional judgment, it is independent of Alteon
within the meaning of the Securities Act of 1933, as amended,
and the Securities Exchange Act of 1934, as amended.
Recommendation
Acting pursuant to its Charter, the Audit Committee has reviewed
Alteons audited annual financial statements for the year
ended December 31, 2005 and the related report of J.H.
Cohn, and has discussed the audited financial statements and
report with management and with the independent registered
public accounting firm. The Audit Committee has also discussed
with management and the independent registered public accounting
firm the matters required to be discussed by Statement on
Auditing Standards No. 61, as currently in effect. These
matters include significant accounting policies, management
judgments and accounting estimates, managements
consultation with other accountants, and any difficulties
encountered in performing the audit, significant audit
adjustment or disagreements with management. Based on the review
and discussions described above, the Audit Committee recommended
to Alteons Board of Directors that the audited financial
statements be included in Alteons Annual Report on
Form 10-K for the
fiscal year ended December 31, 2005 for filing with the
Securities and Exchange Commission.
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Audit Committee |
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Marilyn G. Breslow |
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Edwin D. Bransome, Jr., M.D. |
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Alan J. Dalby |
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David K. McCurdy |
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Thomas A. Moore |
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George M. Naimark, Ph.D. |
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Mark Novitch, M.D. |
VI-16
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth certain information regarding the
beneficial ownership of our common stock as of May 15,
2006, except as otherwise set forth below, by (i) each
person who is known by us to own beneficially more than 5% of
the common stock, (ii) each Director, (iii) each
individual named in the Summary Compensation Table on
page [ ] hereof and
(iv) all current Directors and executive officers as a
group:
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Amount and Nature | |
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of Beneficial | |
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Percent of | |
Name of Beneficial Owner(1) |
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Ownership(1) | |
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Class(2) | |
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Kenneth I. Moch
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1,152,123 |
(3) |
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1.64 |
% |
Edwin D. Bransome, Jr., M.D
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132,500 |
(4) |
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* |
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Marilyn G. Breslow
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154,867 |
(5) |
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* |
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Alan J. Dalby
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154,867 |
(6) |
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* |
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David K. McCurdy
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166,067 |
(7) |
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* |
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Thomas A. Moore
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119,000 |
(8) |
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* |
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George M. Naimark, Ph.D
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142,337 |
(9) |
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* |
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Mark Novitch, M.D
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421,067 |
(10) |
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* |
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Mary T. Phelan
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82,590 |
(11) |
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* |
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Judith S. Hedstrom
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825,000 |
(12) |
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1.18 |
% |
Elizabeth A. ODell
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613,667 |
(13) |
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* |
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All current directors and officers as a group (9 persons)
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2,525,418 |
(14) |
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3.54 |
% |
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(1) |
Beneficial ownership is determined in accordance with the rules
of the Securities and Exchange Commission, and generally
includes voting or investment power with respect to securities.
Shares of common stock subject to stock options and warrants
currently exercisable or exercisable within 60 days are
deemed outstanding for computing the percentage ownership of the
person holding such options and the percentage ownership of any
group of which the holder is a member, but are not deemed
outstanding for computing the percentage ownership of any other
person. Except as indicated by footnote, and subject to
community property laws where applicable, the persons named in
the table have sole voting and investment power with respect to
all shares of common stock shown as beneficially owned by them. |
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(2) |
Applicable percentage of ownership is based on
68,957,111 shares of common stock outstanding. |
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(3) |
Includes 2,023 shares of common stock and
1,150,000 shares of common stock subject to options which
were exercisable as of May 15, 2006, and 100 shares
held by Mr. Mochs sons. Does not include options to
purchase 1,652,000 shares of common stock held in
trust for Mr. Mochs minor children, for which
Mr. Mochs wife is the trustee and Mr. Moch
disclaims beneficial ownership. |
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(4) |
Includes 10,000 shares of common stock held directly by
Dr. Bransome, 2,500 shares held by his wife and
120,000 shares of common stock subject to options that were
exercisable as of May 15, 2006. |
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(5) |
Includes 154,867 shares of common stock subject to options
that were exercisable as of May 15, 2006. |
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(6) |
Includes 12,467 shares of common stock held directly by
Mr. Dalby and 142,400 shares of common stock subject
to options which were exercisable as of May 15, 2006. |
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(7) |
Includes 166,067 shares of common stock subject to options
which were exercisable as of May 15, 2006. |
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(8) |
Includes 24,000 shares of common stock held directly by
Mr. Moore and 95,000 shares of common stock subject to
options which were exercisable as of May 15, 2006. |
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(9) |
Includes 5,000 shares of common stock held directly by
Dr. Naimark, 4,000 shares held jointly by
Dr. Naimark and his wife and 133,337 shares of common
stock subject to options which were exercisable as of
May 15, 2006. |
VI-17
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(10) |
Includes 5,000 shares of common stock held jointly by
Dr. Novitch and his wife and 416,067 shares of common
stock subject to options that were exercisable as of
May 15, 2006. |
|
(11) |
Includes 860 shares of common stock held directly by
Ms. Phelan and 81,730 shares of common stock subject
to options which were exercisable as of May 15, 2006. |
|
(12) |
Includes 825,000 shares of common stock subject to options
that were exercisable as of May 15, 2006. |
|
(13) |
Includes 37,500 shares of common stock held directly by
Ms. ODell and 576,167 shares of common stock
subject to options which were exercisable as of May 15,
2006. |
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(14) |
Includes 2,459,468 shares of common stock subject to
options which were exercisable as of May 15, 2006. |
Audit Committee Pre-Approval of Audit and Permissible
Non-Audit Services by Independent Accountants
The Audit Committee pre-approves all audit and legally
permissible non-audit services provided by the independent
accountants. The Audit Committee pre-approved all services
performed by the independent accountants during 2004 and 2005.
Change in Accountants
KPMG resigned as our principal accountants effective
August 10, 2004. The resignation was the sole decision of
KPMG and was neither approved nor recommended by our Audit
Committee. KPMGs reports on our financial statements, as
of and for the years ended December 31, 2003 and 2002, did
not contain an adverse opinion or a disclaimer of opinion and
were not qualified or modified as to uncertainty, audit scope or
accounting principles. During the years ended December 31,
2003 and 2002 and the period from December 31, 2003 to the
date of resignation of KPMG, (i) there were no
disagreements with KPMG on any matter of accounting principles
or practices, financial statement disclosure or auditing scope
or procedure, which disagreements, if not resolved to
KPMGs satisfaction, would have caused KPMG to make
reference to the subject matter of the disagreements in
connection with its report, and (ii) there were no
reportable events, as such term is defined in
Item 304(a)(1)(v) of
Regulation S-K. On
August 26, 2004, our Audit Committee engaged J.H. Cohn as
our principal accountant. During the years ended
December 31, 2003 and 2002, and the period from
December 31, 2003 to the date of engagement of J.H. Cohn,
neither Alteon nor anyone acting on its behalf consulted with
J.H. Cohn with respect to the application of accounting
principles to a specified transaction, either completed or
proposed, or the type of audit opinion that might be rendered on
Alteons financial statements or any matters or events set
forth in Items 304(a)(2)(i), and (ii) of
Regulation S-K.
KPMGs letter to the Securities and Exchange Commission
stating its agreement with the statements made herein is filed
as an exhibit to our current report on
Form 8-K filed
with the Securities and Exchange Commission on August 13,
2004.
SECTION 16(a) BENEFICIAL OWNERSHIP REPORTING
COMPLIANCE
Section 16(a) of the Securities Exchange Act of 1934, as
amended, requires our officers and directors, and persons who
own more than 10% of a registered class of our equity
securities, to file reports of ownership and changes in
ownership on Forms 3, 4 and 5 with the Securities and
Exchange Commission. Officers, directors and greater than 10%
stockholders are required by Securities and Exchange Commission
regulation to furnish us with copies of all Forms 3, 4
and 5, and any amendments thereto, they file.
Based solely on our review of the copies of such forms we have
received and written representations from certain reporting
persons that they were not required to file Forms 5 for
specified fiscal years, we believe that all of our officers,
directors, and greater than 10% beneficial owners complied with
all filing requirements applicable to them with respect to
transactions in our equity securities during fiscal year 2005.