imm10q-110707.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934 for the quarterly period ended September 30,
2007
|
or
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934 for the transition period from _______ to
_______.
|
Commission
file number: 001-14907
|
IMMTECH
PHARMACEUTICALS, INC.
|
(Exact
name of registrant as specified in its
charter)
|
Delaware
|
|
39-1523370
|
(State
or other jurisdiction of incorporation or organization)
|
|
(I.R.S.
Employer Identification No.)
|
One
North End Avenue, New York, New York 10282
|
(Address
of principal executive offices)
|
(Zip
Code)
|
|
Registrant’s
telephone number: (212) 791-2911
|
|
Former
name, former address and former fiscal year, if changed since last
report
|
Indicate
by check mark whether the registrant (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes x No
o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer or a non-accelerated filer. See definition of
“accelerated filer and large accelerated filer” in Rule 12b-2.
Large
accelerated filer o Accelerated
filer x Non-accelerated
filer o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes o No
x
As
of
November 8, 2007, 15,498,253 shares of the Registrant’s common stock, par value
$0.01 per share (“Common Stock”), were outstanding.
|
Item
1.
|
Financial
Statements
|
1
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
21
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
25
|
|
Item
4.
|
Controls
and Procedures
|
25
|
PART
II.
|
OTHER
INFORMATION
|
26
|
|
Item
1.
|
Legal
Proceedings
|
26
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
27
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
28
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
28
|
|
Item
5.
|
Other
Information
|
28
|
PART
I. FINANCIAL
INFORMATION
Item
1.
|
Financial
Statements.
|
IMMTECH
PHARMACEUTICALS, INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
(A
Development Stage Enterprise)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS (UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
|
March
31,
|
|
ASSETS
|
|
2007
|
|
|
2007
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
9,839,925
|
|
|
$ |
12,461,795
|
|
Restricted
funds on deposit
|
|
|
693,731
|
|
|
|
3,118,766
|
|
Other
current assets
|
|
|
399,072
|
|
|
|
98,627
|
|
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
10,932,728
|
|
|
|
15,679,188
|
|
|
|
|
|
|
|
|
|
|
PROPERTY
AND EQUIPMENT - Net
|
|
|
104,226
|
|
|
|
140,263
|
|
|
|
|
|
|
|
|
|
|
PREPAID
RENT
|
|
|
3,271,777
|
|
|
|
3,309,240
|
|
|
|
|
|
|
|
|
|
|
OTHER
ASSETS
|
|
|
311,529
|
|
|
|
15,477
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
$ |
14,620,260
|
|
|
$ |
19,144,168
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$ |
1,426,738
|
|
|
$ |
2,585,395
|
|
Accrued
expenses
|
|
|
252,078
|
|
|
|
375,925
|
|
Deferred
revenue
|
|
|
2,791,043
|
|
|
|
1,726,673
|
|
|
|
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
4,469,859
|
|
|
|
4,687,993
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
4,469,859
|
|
|
|
4,687,993
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Preferred
stock, par value $0.01 per share, 3,913,000 shares authorized
and
|
|
|
|
|
|
|
|
|
unissued
as of September 30, 2007 and March 31, 2007.
|
|
|
|
|
|
|
|
|
Series
A convertible preferred stock, par value $0.01 per share, stated
value
|
|
|
|
|
|
|
|
|
$25
per share, 320,000 shares authorized, 54,500 and 55,500 shares
issued
|
|
|
|
|
|
|
|
|
and
outstanding as of September 30, 2007 and March 31, 2007,
respectively;
|
|
|
|
|
|
|
|
|
aggregate
liquidation preference of $1,399,817 as of September 30,
2007.
|
|
|
1,399,817
|
|
|
|
1,425,283
|
|
Series
B convertible preferred stock, par value $0.01 per share, stated
value
|
|
|
|
|
|
|
|
|
$25
per share, 240,000 shares authorized, 13,464 shares issued and
outstanding
|
|
|
|
|
|
|
|
|
as
of September 30, 2007 and March 31, 2007; aggregate liquidation
preference
|
|
|
|
|
|
|
|
|
of
$348,694 as of September 30, 2007.
|
|
|
348,694
|
|
|
|
348,621
|
|
Series
C convertible preferred stock, par value $0.01 per share, stated
value
|
|
|
|
|
|
|
|
|
$25
per share, 160,000 shares authorized, 45,536 shares issued and
outstanding
|
|
|
|
|
|
|
|
|
as
of September 30, 2007 and March 31, 2007; aggregate liquidation
preference
|
|
|
|
|
|
|
|
|
of
$1,180,594 as of September 30, 2007.
|
|
|
1,180,594
|
|
|
|
1,180,345
|
|
Series
D convertible preferred stock, par value $0.01 per share, stated
value
|
|
|
|
|
|
|
|
|
$25
per share, 200,000 shares authorized, 115,200 and 117,200 shares
issued
|
|
|
|
|
|
|
|
|
and
outstanding as of September 30, 2007 and March 31, 2007
respectively;
|
|
|
|
|
|
|
|
|
aggregate
liquidation preference of $2,960,007 as of September 30,
2007.
|
|
|
2,960,007
|
|
|
|
3,010,914
|
|
Series
E convertible preferred stock, par value $0.01 per share, stated
value
|
|
|
|
|
|
|
|
|
$25
per share, 167,000 shares authorized, 106,600 and 110,200 shares
issued
|
|
|
|
|
|
|
|
|
and
outstanding as of September 30, 2007 and March 31, 2007,
respectively;
|
|
|
|
|
|
|
|
|
aggregate
liquidation preference of $2,739,069 as of September 30,
2007.
|
|
|
2,739,069
|
|
|
|
2,831,116
|
|
Common
stock, par value $0.01 per share, 100,000,000 shares
|
|
|
|
|
|
|
|
|
authorized,
15,464,972 and 15,333,221 shares issued and outstanding
|
|
|
|
|
|
|
|
|
as
of September 30, 2007 and March 31, 2007, respectively
|
|
|
154,649
|
|
|
|
153,332
|
|
Additional
paid-in capital
|
|
|
108,158,007
|
|
|
|
106,031,851
|
|
Deficit
accumulated during the developmental stage
|
|
|
(106,790,436 |
) |
|
|
(100,525,287 |
) |
|
|
|
|
|
|
|
|
|
Total
stockholders' equity
|
|
|
10,150,401
|
|
|
|
14,456,175
|
|
|
|
|
|
|
|
|
|
|
TOTAL
|
|
$ |
14,620,260
|
|
|
$ |
19,144,168
|
|
|
|
|
|
|
|
|
|
|
See
notes to condensed consolidated financial statements
(unaudited).
|
|
|
|
|
|
|
|
|
IMMTECH
PHARMACEUTICALS, INC. AND SUBSIDIARIES
|
(A
Development Stage Enterprise)
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
|
|
|
|
|
|
|
|
|
|
October
15,
|
|
|
|
|
|
|
|
|
|
1984
|
|
|
|
Three
Months Ended
|
|
|
Six
Months Ended
|
|
|
(Inception)
to
|
|
|
|
September
30,
|
|
|
September
30,
|
|
|
September
30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REVENUES
|
|
$ |
1,030,333
|
|
|
$ |
491,330
|
|
|
$ |
1,856,682
|
|
|
$ |
2,432,939
|
|
|
$ |
26,939,435
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
2,282,839
|
|
|
|
1,755,326
|
|
|
|
4,200,651
|
|
|
|
4,224,162
|
|
|
|
64,314,584
|
|
General
and administrative
|
|
|
2,213,918
|
|
|
|
2,363,796
|
|
|
|
3,931,206
|
|
|
|
4,583,651
|
|
|
|
67,908,563
|
|
Other
(litigation settlement)
|
|
|
|
|
|
|
(1,874,454 |
) |
|
|
|
|
|
|
(1,874,454 |
) |
|
|
(1,874,454 |
) |
Equity
in loss of joint venture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
expenses
|
|
|
4,496,757
|
|
|
|
2,244,668
|
|
|
|
8,131,857
|
|
|
|
6,933,359
|
|
|
|
130,483,695
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS
FROM OPERATIONS
|
|
|
(3,466,424 |
) |
|
|
(1,753,338 |
) |
|
|
(6,275,175 |
) |
|
|
(4,500,420 |
) |
|
|
(103,544,260 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
132,242
|
|
|
|
132,334
|
|
|
|
280,005
|
|
|
|
282,695
|
|
|
|
1,754,036
|
|
Interest
expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,129,502 |
) |
Loss
on sales of investment securities - net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,942 |
) |
Cancelled
offering costs
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(584,707 |
) |
Gain
on extinguishment of debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,427,765
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income
|
|
|
132,242
|
|
|
|
132,334
|
|
|
|
280,005
|
|
|
|
282,695
|
|
|
|
1,464,650
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS
|
|
|
(3,334,182 |
) |
|
|
(1,621,004 |
) |
|
|
(5,995,170 |
) |
|
|
(4,217,725 |
) |
|
|
(102,079,610 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONVERTIBLE
PREFERRED STOCK DIVIDENDS AND CONVERTIBLE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
PREFERRED
STOCK PREMIUM DEEMED DIVIDENDS
|
|
|
(134,982 |
) |
|
|
(137,082 |
) |
|
|
(269,979 |
) |
|
|
(279,890 |
) |
|
|
(7,080,725 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
REDEEMABLE
PREFERRED STOCK CONVERSION, PREMIUM
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AMORTIZATION
AND DIVIDENDS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,369,899
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET
LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS
|
|
$ |
(3,469,164 |
) |
|
$ |
(1,758,086 |
) |
|
$ |
(6,265,149 |
) |
|
$ |
(4,497,615 |
) |
|
$ |
(106,790,436 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
AND DILUTED NET LOSS PER SHARE ATTRIBUTABLE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TO
COMMON STOCKHOLDERS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(0.22 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.30 |
) |
|
|
|
|
Convertible
preferred stock dividends and convertible
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
preferred
stock premium deemed dividends
|
|
|
(0.01 |
) |
|
|
(0.01 |
) |
|
|
(0.02 |
) |
|
|
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
AND DILUTED LOSS PER SHARE ATTRIBUTABLE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TO
COMMON STOCKHOLDERS
|
|
$ |
(0.23 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
WEIGHTED
AVERAGE SHARES USED IN COMPUTING
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BASIC
AND DILUTED NET LOSS PER SHARE
|
|
|
15,409,787
|
|
|
|
14,026,413
|
|
|
|
15,390,029
|
|
|
|
13,973,658
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See
notes to condensed consolidated financial statements
(unaudited).
|
|
|
|
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IMMTECH
PHARMACEUTICALS, INC. AND SUBSIDIARIES
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(A
Development Stage Enterprise)
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CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
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October
15,
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1984
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Three
Months Ended
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Six
Months Ended
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(Inception)
to
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September
30,
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September
30,
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September
30,
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2007
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2006
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2007
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2006
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2007
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OPERATING
ACTIVITIES:
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Net
loss
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$ |
(3,334,182 |
) |
|
$ |
(1,621,004 |
) |
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$ |
(5,995,170 |
) |
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$ |
(4,217,725 |
) |
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$ |
(102,079,610 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
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Compensation
recorded related to issuance of common stock,common
stock options and warrants
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901,158
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557,307
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1,393,951
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1,233,387
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32,086,921
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Depreciation
and amortization of property and equipment
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36,387
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37,951
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73,500
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77,213
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1,262,194
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(Gain)/Loss
on disposal of fixed assets
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5,982
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|
Equity
in loss of joint venture
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|
|
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135,002
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Loss
on sales of investment securities - net
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2,942
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Amortization
of debt discounts and issuance costs
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134,503
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Gain
on extinguishment of debt
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(1,427,765 |
) |
Changes
in assets and liabilities:
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Other
current assets
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104,701
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(1,781,143 |
) |
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(300,445 |
) |
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(1,982,961 |
) |
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|
(399,072 |
) |
Other
assets
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(118,421 |
) |
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70,000
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(296,052 |
) |
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70,399
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|
(311,529 |
) |
Accounts
payable
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61,192
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|
(751,187 |
) |
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|
(1,158,657 |
) |
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|
(332,921 |
) |
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|
1,754,273
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|
Accrued
expenses
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|
(169,073 |
) |
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|
18,378
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|
(123,847 |
) |
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25,764
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915,091
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Deferred
revenue
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|
(1,099,412 |
) |
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|
(491,329 |
) |
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|
1,064,370
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3,215,968
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2,791,043
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Net
cash used in operating activities
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(3,617,650 |
) |
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(3,961,027 |
) |
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(5,342,350 |
) |
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(1,910,876 |
) |
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(65,130,025 |
) |
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INVESTING
ACTIVITIES:
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Purchase of property and equipment
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(5,659 |
) |
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(39,671 |
) |
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(1,617,249 |
) |
Restricted funds on deposit
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988,556
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557,628
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2,425,035
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(3,679,357 |
) |
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(693,731 |
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Advances to joint venture
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(135,002 |
) |
Proceeds from maturities of investment securities
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1,800,527
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Purchases of investment securities
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-
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-
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-
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-
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(1,803,469 |
) |
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Net
cash provided by (used in) investing activities
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988,556
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551,969
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2,425,035
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(3,719,028 |
) |
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(2,448,924 |
) |
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FINANCING
ACTIVITIES:
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Advances from stockholders and affiliates
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985,172
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Proceeds from issuance of notes payable
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2,645,194
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Principal payments on notes payable
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|
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|
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|
(218,119 |
) |
Payments for debt issuance costs
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
(53,669 |
) |
Payments for extinguishment of debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
(203,450 |
) |
Net proceeds from issuance of redeemable preferred stock
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
3,330,000
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|
Net
proceeds from issuance of convertible preferred stock and warrants
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|
|
|
|
|
|
|
|
|
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|
17,085,434
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Payments
of convertible preferred stock dividends and for fractional shares
of
common stock resulting from the conversions of convertible preferred
stock
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|
|
(17 |
) |
|
|
(2 |
) |
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|
(466 |
) |
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|
(407 |
) |
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|
(6,058 |
) |
Net proceeds from issuance of common stock
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|
|
295,911
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|
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|
30,000
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|
|
|
295,911
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|
29,994
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|
53,608,811
|
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|
|
|
|
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|
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|
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|
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Additional capital contributed by stockholders
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
245,559
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net
cash provided by financing activities
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|
|
295,911
|
|
|
|
29,998
|
|
|
|
295,445
|
|
|
|
29,587
|
|
|
|
77,418,874
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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NET INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
|
|
(2,333,200 |
) |
|
|
(3,379,060 |
) |
|
|
(2,621,870 |
) |
|
|
(5,600,317 |
) |
|
|
9,839,925
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
|
|
12,173,125
|
|
|
|
11,916,610
|
|
|
|
12,461,795
|
|
|
|
14,137,867
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
|
$ |
9,839,925
|
|
|
$ |
8,537,550
|
|
|
$ |
9,839,925
|
|
|
$ |
8,537,550
|
|
|
$ |
9,839,925
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
See
notes to condensed consolidated financial statements
(unaudited).
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IMMTECH
PHARMACEUTICALS, INC. AND SUBSIDIARies
(A
Development Stage Enterprise)
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
The
accompanying condensed consolidated financial statements have been prepared
by
Immtech Pharmaceuticals, Inc. and its subsidiaries (the “Company”) pursuant to
the rules and regulations of the Securities and Exchange Commission (“SEC”) and,
in the opinion of management, include all adjustments necessary for a fair
statement of results for each period shown (unless otherwise noted herein,
all
adjustments are of a normal recurring nature). Certain information
and footnote disclosures normally included in financial statements prepared
in
accordance with accounting principles generally accepted in the United States
of
America have been condensed or omitted pursuant to such SEC rules and
regulations. The Company, with a fiscal year ending March 31,
believes that the disclosures made are adequate to prevent the financial
information given from being misleading. It is suggested that these
financial statements be read in conjunction with the financial statements and
notes thereto included in the Company’s latest Annual Report on Form
10-K.
2.
|
COMPANY
BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
|
Description
of Business– Immtech Pharmaceuticals, Inc. (a development stage enterprise)
and its subsidiaries, is a pharmaceutical company working to commercialize
drugs
to treat infectious diseases, and the Company is expanding its targeted markets
by applying its proprietary pharmaceutical platform to treat other
disorders. The Company has advanced clinical programs that include
new treatments for Pneumocystis pneumonia (“PCP”), malaria, and trypanosomiasis
(“African sleeping sickness”), and a well-defined, expanding library of
compounds targeting fungal infections, hepatitis C virus (“HCV”) and other
serious diseases. Immtech holds an exclusive worldwide license to
certain patents and patent applications related to technology and products
derived from a proprietary pharmaceutical platform. The Company has
worldwide rights to commercialize and sublicense such patented technology,
including a large library of well-defined compounds from which a pipeline of
therapeutic products could be developed.
The
Company holds worldwide patents and patent applications, and licenses and rights
to license technology, primarily from a scientific consortium that has granted
to the Company exclusive rights to commercialize products from, and license
rights to the technology. The scientific consortium includes
scientists from The University of North Carolina at Chapel Hill (“UNC-CH”),
Georgia State University (“Georgia State”), Duke University (“Duke University”)
and Auburn University (“Auburn University”) (collectively, the “Scientific
Consortium”). The Company is a development stage enterprise and,
since its inception on October 15, 1984, has engaged in research and
development programs, expanded its network of scientists and scientific advisors
and licensing technology agreements, and worked to commercialize the aromatic
cation pharmaceutical technology platform (the Company acquired its rights
to
the aromatic cation technology platform in 1997 and promptly thereafter
commenced development of its current programs). The Company uses the
expertise and resources of strategic partners and third parties in a number
of
areas, including: (i) laboratory research, (ii) animal and
human trials and (iii) manufacture of pharmaceutical drugs.
The
Company does not have any products currently available for sale, and no products
are expected to be commercially available for sale until after March 31,
2008, if at all.
Since
inception, the Company has incurred accumulated net losses of approximately
$102,080,000. Management expects the Company will continue to incur
significant losses during the next several years as the Company continues
development activities, clinical trials and commercialization
efforts. In addition, the Company has various research and
development agreements with third parties and is dependent upon such parties’
abilities to perform under these agreements. There can be no
assurance that the Company’s activities will lead to the development of
commercially viable products. The Company’s operations to date have
consumed substantial amounts of cash. The negative cash flow from
operations is expected to continue in the foreseeable future. The
Company believes it will require substantial additional funds to commercialize
its drug candidates. The Company’s cash requirements may vary
materially from those now planned when and if the following become known:
results of research and development efforts, results of clinical testing,
responses to grant requests, formation and development of relationships with
strategic partners, changes in the focus and direction of development programs,
competitive and technological advances, requirements in the regulatory process
and other factors. Changes in circumstances in any of the above areas
may require the Company to allocate substantially more funds than are currently
available or than management intends to raise.
Management
believes the Company’s existing unrestricted cash and cash equivalents, and the
grants received or awarded and awaiting disbursement of, will be sufficient
to
meet the Company’s planned expenditures through at least the next twelve months,
although there can be no assurance the Company will not require additional
funds. Management may seek to satisfy future funding requirements
through public or private offerings of securities, by collaborative or other
arrangements with pharmaceutical or biotechnology companies or from other
sources or by issuance of debt.
The
Company’s ability to continue as a going concern is dependent upon its ability
to generate sufficient funds to meet its obligations as they become due,
complete the development and commercialization of drug candidates and,
ultimately, to generate sufficient revenues for profitable
operations. Management’s plans for the forthcoming year, in addition
to normal operations, include continuing financing efforts, obtaining additional
research grants and entering into research and development agreements with
other
entities.
Principles
of Consolidation– The consolidated financial statements include the
accounts of Immtech Pharmaceuticals, Inc. and its wholly owned
subsidiaries. All intercompany balances and transactions have been
eliminated.
Revenue
Recognition– Grants to perform research have been the Company’s primary
source of revenue and are generally granted to support research and development
activities for specific projects or drug candidates. Revenue related
to grants to perform research and development is recognized as earned based
on
the performance requirements of the specific grant. Upfront cash
payments from research and development grants are reported as deferred revenue
until such time as the research and development activities covered by the grant
are performed.
Revenue
from licensing arrangements is recorded when earned based on the performance
requirements of the contract. Nonrefundable upfront license fees, for
product candidates where the Company is providing continuing services related
to
product development, are deferred and recognized as revenue over the development
period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes
from licenses, either from upfront fees or milestones where the Company is
providing continuing services related to product development, is dependent
upon
the Company’s estimates of filing dates. As product candidates move
through the development process, it is necessary to revise these estimates
to
consider
changes to the product development cycle, such as changes in the clinical
development plan, regulatory requirements, or various other factors, many of
which may be outside of the Company’s control. The impact on revenue
changes in the Company’s estimates and the timing thereof, is recognized
prospectively over the remaining estimated product development
period.
Net
Income (Loss) Per Share– Net income (loss) per share is calculated in
accordance with Statement of Financial Accounting Standard (“SFAS”) No. 128,
“Earnings Per Share.” Basic net income (loss) and diluted net income
(loss) per share are computed by dividing net income (loss) attributable to
common stockholders by the weighted average number of common shares
outstanding. Diluted net income per share, when applicable, is
computed by dividing net income attributable to common stockholders by the
weighted average number of common shares outstanding increased by the number
of
potential dilutive common shares based on the treasury stock
method. Diluted net loss per share was the same as the basic net loss
per share for the three and six month periods ended September 30, 2007 and
September 30, 2006, as none of the Company’s outstanding common stock options,
warrants and the conversion features of Series A, B, C, D and E Convertible
Preferred Stock were dilutive.
Stock-Based
Compensation– Effective April 1, 2006, the Company adopted SFAS No. 123(R),
“Share-Based Payment,” using the modified prospective
method. SFAS No. 123(R) requires entities to recognize the cost of
employee services in exchange for awards of equity instruments based on the
grant-date fair value of those awards (with limited exceptions). The
cost, based on the estimated number of awards that are expected to vest, will
be
recognized over the period during which the employee is required to provide
the
services in exchange for the award. No compensation cost is
recognized for awards for which employees do not render the requisite
service. Upon adoption, the grant-date fair value of employee share
options and similar instruments was estimated using the Black-Scholes valuation
model. The Black-Scholes valuation requires the input of highly
subjective assumptions, including the expected life of the stock-based award
and
stock price volatility. The assumptions used are management’s best
estimates, but the estimates involve inherent uncertainties and the application
of management’s judgment. As a result, if other assumptions had been
used, the recorded and pro forma stock-based compensation expense could have
been materially different from that depicted in the financial
statements.
Segment
Reporting– The Company is a development stage pharmaceutical company that
operates as one segment.
New
Accounting Standard– The Company adopted FASB Interpretation No. 48,
“Accounting for Uncertainty in Income Taxes,” (“FIN 48”) on April 1,
2007. The adoption of FIN 48 did not have an impact. At
the adoption date and as of September 30, 2007, the Company does not have a
liability for uncertain tax benefits. The Company does not presently
expect any reasonably possible material change to the estimated amount of
liability associated with its uncertain tax positions during the next twelve
months.
The
Company files income tax returns in the U.S. federal jurisdiction, and various
state jurisdictions. Periods subject to examination for the Company’s
federal tax return are the 1990 through 2006 tax years. In addition,
open tax years related to state jurisdictions remain subject to examination
but
are not considered material.
New
Accounting Standard– In September 2006, the FASB issued Statement No. 157
(“SFAS 157”), “Fair Value Measurements.” SFAS 157 defines
fair value, establishes a framework for measuring fair value in accordance
with
generally accepted accounting principles, and expands disclosures
about
fair value measurements. SFAS 157 is effective for us in fiscal year
2009. The Company is currently assessing the impact of the adoption
of this statement.
New
Accounting Standard– In February 2007, the FASB issued Statement No. 159
(“SFAS 159”), “Fair Value Option for Financial Assets and Financial
Liabilities.” SFAS 159 establishes the irrevocable option to
elect to carry certain financial assets and liabilities at fair value, with
changes in fair value recorded in earnings. SFAS 159 is effective for
us in fiscal year 2009. The Company is currently assessing the impact
of the adoption of this statement.
On
January 7, 2004, the stockholders of the Company approved an increase in the
number of authorized common stock from 30 million to 100 million
shares. On June 14, 2004, the Company filed with the Secretary of
State of the State of Delaware an Amended and Restated Certificate of
Incorporation implementing, among other things, the approved authorized 70
million share common stock increase from 30 million to 100 million shares of
common stock.
Series
A Convertible Preferred Stock - On February 14, 2002, the Company filed a
Certificate of Desigation with the Secretary of State of the State of Delaware
designating 320,000 shares of the Company’s 5,000,000 authorized shares of
preferred stock as Series A Convertible Preferred Stock, $0.01 par value, with
a
stated value of $25.00 per share. Dividends accrue at a rate of 6.0%
per annum on the $25.00 stated value per share and are payable semi-annually
on
April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in
cash or in equivalent shares of common stock, as defined. Included in
the carrying value of the Series A Convertible Preferred Stock in the
accompanying condensed consolidated balance sheets are $37,317 and $39,783
of
accrued preferred stock dividends at September 30, 2007 and March 31, 2007,
respectively. Each share of Series A Convertible Preferred Stock may
be converted by the holder at any time into shares of our common stock at a
conversion rate determined by dividing the $25.00 stated value, plus any accrued
and unpaid dividends (the “Liquidation Price”), by a $4.42 conversion price (the
“Conversion Price A”), subject to certain adjustments, as defined in the Series
A Certificate of Designation. On April 15, 2007, the Company issued
6,308 shares of common stock and paid $87 in lieu of fractional common shares
as
dividends on the preferred shares. On April 15, 2006, the Company issued 5,547
shares of common stock and paid $47 in lieu of fractional common shares as
dividends on the preferred shares. During the three and six month
periods ended September 30, 2007 and 2006 certain preferred stockholders
converted 1,000 and 2,400 shares of Series A Convertible Preferred Stock,
including accrued dividends, for 5,701 and 13,690 shares of common stock,
respectively.
The
Company may at any time require that any or all outstanding shares of Series
A
Convertible Preferred Stock be converted into shares of the Company’s common
stock, provided that the shares of common stock into which the Series A
Convertible Preferred Stock are convertible are registered pursuant to an
effective registration statement, as defined. The number of shares of
common stock to be received by the holders of the Series A Convertible Preferred
Stock upon a mandatory conversion by the Company is determined by (i) dividing
the Liquidation Price by the Conversion Price A, provided that the closing
bid
price for the Company’s common stock exceeds $9.00 for 20 consecutive trading
days within 180 days prior to notice of conversion, as defined, or (ii) if
the
requirements of (i) are not met, the number of shares of common stock is
determined by dividing 110% of the Liquidation Price by the Conversion Price
A. The Conversion Price A is subject to certain adjustments, as
defined in the Series A Certificate of Designation.
The
Company may at any time, upon 30 days’ notice, redeem any or all outstanding
shares of the Series A Convertible Preferred Stock by payment of the Liquidation
Price to the holder of such shares, provided that the holder does not convert
the Series A Convertible Preferred Stock into shares of common stock during
the
30 day period. The Series A Convertible Preferred Stock has a
preference in liquidation equal to $25.00 per share, plus any accrued and unpaid
dividends, over the common stock and is pari passu with all other outstanding
series of preferred stock. Each issued and outstanding share of
Series A Convertible Preferred Stock shall be entitled to 5.6561 votes (subject
to adjustment) with respect to any and all matters presented to the Company’s
stockholders for their action or consideration. Except as provided by
law or by the provisions establishing any other series of preferred stock,
Series A Convertible Preferred stockholders and holders of any other outstanding
preferred stock shall vote together with the holders of common stock as a single
class.
Series
B Convertible Preferred Stock - On September 25, 2002, the Company filed a
Certificate of Designation with the Secretary of State of the State of Delaware
designating 240,000 shares of the Company’s 5,000,000 authorized shares of
preferred stock as Series B Convertible Preferred Stock, $0.01 par value, with
a
stated value of $25.00 per share. Dividends accrue at a rate of 8.0%
per annum on the $25.00 stated value per share and are payable semi-annually
on
April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in
cash or in equivalent shares of common stock, as defined. Included in
the carrying value of the Series B Convertible Preferred Stock in the
accompanying condensed consolidated balance sheets are $12,095 and $12,021
of
accrued preferred stock dividends as of September 30, 2007 and March 31, 2007,
respectively. Each share of Series B Convertible Preferred Stock may
be converted by the holder at any time into shares of common stock at a
conversion rate determined by dividing the $25.00 stated value, plus any accrued
and unpaid dividends (the “Liquidation Price”), by a $4.00 conversion price (the
“Conversion Price B”), subject to certain adjustments, as defined in the Series
B Certificate of Designation. On April 15, 2007, the Company issued
2,040 shares of common stock and paid $30 in lieu of fractional common shares
as
dividends on the preferred shares. On April 15, 2006, the Company
issued 1,703 shares of common stock and paid $31 in lieu of fractional common
shares as dividends on the preferred shares. During the three and six
month periods ended September 2007 and 2006, there were no
conversions.
The
Company may at any time require that any or all outstanding shares of Series
B
Convertible Preferred Stock be converted into shares of the Company’s common
stock, provided that the shares of common stock into which the Series B
Convertible Preferred Stock are convertible are registered pursuant to an
effective registration statement, as defined. The number of shares of
common stock to be received by the holders of the Series B Convertible Preferred
Stock upon a mandatory conversion by the Company is determined by (i) dividing
the Liquidation Price by the Conversion Price B, provided that the closing
bid
price for the Company’s common stock exceeds $9.00 for 20 consecutive trading
days within 180 days prior to notice of conversion, as defined, or (ii) if
the
requirements of (i) are not met, the number of shares of common stock is
determined by dividing 110% of the Liquidation Price by the Conversion Price
B. The Conversion Price B is subject to certain adjustments, as
defined in the Series B Certificate of Designation.
The
Company may at any time, upon 30 days’ notice, redeem any or all outstanding
shares of the Series B Convertible Preferred Stock by payment of the Liquidation
Price to the holder of such shares, provided that the holder does not convert
the Series B Convertible Preferred Stock into shares of common stock during
the
30 day period. The Series B Convertible Preferred Stock has a
preference in liquidation equal to $25.00 per share, plus any accrued and unpaid
dividends over the common stock and is pari passu with all other outstanding
series of preferred stock. Each issued and outstanding share of
Series B Convertible Preferred Stock shall be entitled to 6.25 votes (subject
to
adjustment) with respect to any and all matters presented to the Company’s
stockholders for their
action
or
consideration. Except as provided by law or by the provisions
establishing any other series of preferred stock, Series B Convertible Preferred
stockholders and holders of any other outstanding preferred stock shall vote
together with the holders of common stock as a single class.
Series
C Convertible Preferred Stock - On June 6, 2003, we filed a Certificate of
Designation with the Secretary of State of the State of Delaware designating
160,000 shares of the Company’s 5,000,000 authorized shares of preferred stock
as Series C Convertible Preferred Stock, $0.01 par value, with a stated value
of
$25.00 per share. Dividends accrue at a rate of 8.0% per annum on the
$25.00 stated value per share and are payable semi-annually on April 15 and
October 15 of each year while the shares are outstanding. The Company
has the option to pay the dividend either in cash or in equivalent shares of
common stock, as defined. Included in the carrying value of the
Series C Convertible Preferred Stock in the accompanying condensed consolidated
balance sheets are $42,194 and $41,945 of accrued preferred stock dividends
as
of September 30, 2007 and March 31, 2007, respectively. Each share of
Series C Convertible Preferred Stock may be converted by the holder at any
time
into shares of common stock at a conversion rate determined by dividing the
$25.00 stated value, plus any accrued and unpaid dividends (the “Liquidation
Price”), by a $4.42 conversion price (the “Conversion Price C”), subject to
certain adjustments, as defined in the Series C Certificate of
Designation. On April 15, 2007, the Company issued 6,900 shares of
common stock and paid $99 in lieu of fractional common shares as dividends
on
the preferred shares. On April 15, 2006, the Company issued 5,761
shares of common stock and paid $95 in lieu of fractional common shares as
dividends on the preferred shares. During the three and six month
periods ended September 30, 2007 and 2006, there were no
conversions.
The
Company may at any time require that any or all outstanding shares of Series
C
Convertible Preferred Stock be converted into shares of the Company’s common
stock, provided that the shares of common stock into which the Series C
Convertible Preferred Stock are convertible are registered pursuant to an
effective registration statement, as defined. The number of shares of
common stock to be received by the holders of the Series C Convertible Preferred
Stock upon a mandatory conversion by the Company is determined by (i) dividing
the Liquidation Price by the Conversion Price C provided that the closing bid
price for the Company’s common stock exceeds $9.00 for 20 consecutive trading
days within 180 days prior to notice of conversion, as defined, or (ii) if
the
requirements of (i) are not met, the number of shares of common stock is
determined by dividing 110% of the Liquidation Price by the Conversion Price
C. The Conversion Price C is subject to certain adjustments, as
defined in the Series C Certificate of Designation.
The
Company may at any time, upon 30 days’ notice, redeem any or all outstanding
shares of the Series C Convertible Preferred Stock by payment of the Liquidation
Price to the holder of such shares, provided that the holder does not convert
the Series C Convertible Preferred Stock into shares of common stock during
the
30 day period. The Series C Convertible Preferred Stock has a preference in
liquidation equal to $25.00 per share, plus any accrued and unpaid dividends,
over the common stock and is pari passu with all other outstanding series of
preferred stock. Each issued and outstanding share of Series C
Convertible Preferred Stock shall be entitled to 5.6561 votes (subject to
adjustment) with respect to any and all matters presented to the Company’s
stockholders for their action or consideration. Except as provided by
law or by the provisions establishing any other series of preferred stock,
Series C Convertible Preferred stockholders and holders of any other outstanding
preferred stock shall vote together with the holders of common stock as a single
class.
Series
D Convertible Preferred Stock– On January 15, 2004, the Company filed
a Certificate of Designation with the Secretary of State of the State of
Delaware designating 200,000 shares of the Company’s 5,000,000 authorized shares
of preferred stock as Series D Convertible Preferred Stock, $0.01 par value,
with a stated value of $25.00 per share. Dividends accrue at a rate
of 6.0% per
annum
on
the $25.00 stated value per share and are payable semi-annually on April 15
and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in
cash or in equivalent shares of common stock, as defined. Included in the
carrying value of the Series D Convertible Preferred Stock in the accompanying
condensed consolidated balance sheets are $80,007 and $80,914 of accrued
preferred stock dividends as of September 30, 2007 and March 31, 2007,
respectively. Each share of Series D Convertible Preferred Stock may
be converted by the holder at any time into shares of common stock at a
conversion rate determined by dividing the $25.00 stated value, plus any accrued
and unpaid dividends (the “Liquidation Price”), by a $9.00 conversion price (the
“Conversion Price D”), subject to certain adjustments, as defined in the Series
D Certificate of Designation. On April 15, 2007, the Company issued 13,334
shares of common stock and paid $95 in lieu of fractional common shares as
dividends on the preferred shares. On April 15, 2006, the Company
issued 11,134 shares of common stock and paid $79 in lieu of fractional common
shares as dividends on the preferred shares. During the three and six
month periods ended September 30, 2007 certain preferred stockholders converted
2,000 shares of Series D Convertible Preferred Stock, including accrued
dividends, for 5,653 shares of common stock, respectively. During the three
and
six month periods ended September 30, 2006 there were no
conversions.
The
Company may at any time, require that any or all outstanding shares of Series
D
Convertible Preferred Stock be converted into shares of our common stock,
provided that the shares of common stock into which the Series D Convertible
Preferred Stock are convertible are registered pursuant to an effective
registration statement, as defined. The number of shares of common
stock to be received by the holders of the Series D Convertible Preferred Stock
upon a mandatory conversion by the Company is determined by (i) dividing the
Liquidation Price by the Conversion Price D provided that the closing bid price
for the Company’s common stock exceeds $18.00 for 20 consecutive trading days
within 180 days prior to notice of conversion, as defined, or (ii) if the
requirements of (i) are not met, the number of shares of common stock is
determined by dividing 110% of the Liquidation Price by the Conversion Price
D. The Conversion Price D is subject to certain adjustments, as
defined in the Certificate of Designation.
The
Series D Convertible Preferred Stock has a preference in liquidation equal
to
$25.00 per share, plus any accrued and unpaid dividends, over the common stock
and is pari passu with all other series of preferred stock. Each
issued and outstanding share of Series D Convertible Preferred Stock shall
be
entitled to 2.7778 votes (subject to adjustment) with respect to any and all
matters presented to the Company’s stockholders for their action or
consideration. Except as provided by law or by the provisions establishing
any
other series of preferred stock, Series D Convertible Preferred stockholders
and
holders of any other outstanding preferred stock shall vote together with the
holders of common stock as a single class.
Series
E Convertible Preferred Stock–On December 13, 2005, the Company filed a
Certificate of Designation with the Secretary of State of the State of Delaware
designating 167,000 shares of the Company’s 5,000,000 authorized shares of
preferred stock as Series E Convertible Preferred Stock, $0.01 par value, with
a
stated value of $25.00 per share. Dividends accrue at a rate of 6.0%
per annum on the $25.00 stated value per share and are payable semi-annually
on
April 15 and October 15 of each year while the shares are
outstanding. The Company has the option to pay the dividend either in
cash or in equivalent shares of common stock, as defined. Included in
the carrying value of the Series E Convertible Preferred Stock in the
accompanying condensed consolidated balance sheets are $74,069 and $76,116
of
accrued preferred stock dividends as of September 30, 2007 and March 31, 2007,
respectively. Each share of Series E Convertible Preferred Stock may
be converted by the holder at any time into shares of common stock at a
conversion rate determined by dividing the $25.00 stated value, plus any accrued
and unpaid dividends (the
“Liquidation
Price”), by a $7.04 conversion price (the “Conversion Price E”), subject to
certain adjustments, as defined in the Series E Certificate of
Designation. On April 15, 2007, the Company issued 12,531 shares of
common stock and paid $132 in lieu of fractional common shares as dividends
on
the preferred shares. On April 15, 2006, the Company issued 8,819
shares of common stock and paid $135 in lieu of fractional common shares as
dividends on the preferred shares. During the three and six month
periods ended September 30, 2007, certain preferred stockholders converted
1,600
and 3,600 shares of Series E Convertible Preferred Stock, including accrued
dividends, for 5,813 and 12,972 shares of common stock,
respectively. During the three month period ended September 30, 2006
there were no conversions. During the six month period ended
September 30, 2006, certain preferred stockholders converted 46,000 shares
of
Series E Convertible Preferred Stock, including accrued dividends, for 163,847
shares of common stock.
The
Company may at any time, require that any or all outstanding shares of Series
E
Convertible Preferred Stock be converted into shares of our common stock,
provided that the shares of common stock into which the Series E Convertible
Preferred Stock are convertible are registered pursuant to an effective
registration statement, as defined. The number of shares of common
stock to be received by the holders of the Series E Convertible Preferred Stock
upon a mandatory conversion by us is determined by (i) dividing the Liquidation
Price by the Conversion Price E provided that the closing bid price for the
Company’s common stock exceeds $10.56 for 20 out of 30 consecutive trading days
within 180 days prior to notice of conversion, as defined, or (ii) if the
requirements of (i) are not met, the number of shares of common stock is
determined by dividing 110% of the Liquidation Price by the Conversion Price
E. The Conversion Price E is subject to certain adjustments, as
defined in the Certificate of Designation.
The
Series E Convertible Preferred Stock has a preference in liquidation equal
to
$25.00 per share, plus any accrued and unpaid dividends, over the common stock
and is parri passu with all other outstanding series of preferred
stock. Each issued and outstanding share of Series E Convertible
Preferred Stock is entitled to 3.5511 votes (subject to adjustment) with respect
to any and all matters presented to the Company’s stockholders for their action
or consideration. Except as provided by law or by the provisions establishing
any other series of preferred stock, Series E Convertible Preferred stockholders
and holders of any other outstanding preferred stock shall vote together with
the holders of common stock as a single class.
The
Company will, on December 13, 2008, at the Company’s election, (i) redeem the
Series E Convertible Preferred Stock plus any accrued and unpaid interest for
cash, (ii) convert the Series E Convertible Preferred Stock and any accrued
and
unpaid interest into common stock, or (iii) redeem and convert the Series E
Convertible Preferred Stock in any combination of (i) or (ii).
Common
Stock–On May 26, 2006, restricted shares in the amount of 5,000 shares of
common stock were issued and expensed with a grant date value of approximately
$36,000 to Tulane University as part of the Tulane License Agreement granting
to
us an exclusive license to develop, manufacture and commercialize a group of
four – aminoquinoline drugs for treatment, prophylaxis and diagnosis of
infectious diseases.
On
May
26, 2006, restricted shares in the amount of 5,000 shares of common stock were
issued and expensed with a grant date value of approximately $36,000 to T.
Stephen Thompson as part of his retirement and consulting agreement dated May
1,
2006.
Warrants–
During the three and six month periods ended September 30, 2007, warrants to
purchase 48,312 shares of common stock were exercised, resulting in proceeds
to
the Company of $295,737.
During
the three and six month periods ended September 30, 2006, warrants to purchase
5,000 shares of common stock were exercised, resulting in proceeds to the
Company of $30,000.
In
connection with services rendered to us, effective July 17, 2007, the Company
issued to an investor relations firm, warrants to purchase 30,000 shares of
our
common stock. The warrants are exerciseable at $9.00 per
share. The warrants are exerciseable through July 17, 2011 as
follows: (i) 10,000 vest immediately, (ii) 10,000 vest upon the Company’s stock
trading at or above $10.00 per share for 20 consecutive trading days and (iii)
10,000 vest upon the Company’s stock trading at or above $12.00 per share for 20
consecutive trading days. The warrants have been expensed using a
grant date value as calculated using the Black-Scholes valuation model of
approximately $118,000.
In
connection with a consulting agreement, the Company issued warrants on September
10, 2007 to purchase 50,000 shares of common stock. The warrants are
exerciseable at $10.00 per share. The warrants are exerciseable
through September 10, 2010. The warrants have been expensed using a
grant date value as calculated using the Black-Scholes valuation model of
approximately $172,000.
Incentive
Stock Programs– At the stockholders’ meeting held November 12, 2004, the
stockholders approved the second amendment to the 2000 Stock Incentive Plan
which increased the number of shares of common stock reserved for issuance
from
1,100,000 shares to 2,200,000 shares. Options granted under the 2000
Stock Incentive Plan that expire are available to be reissued. During
the six month periods ended September 30, 2007 and 2006, 81,000 and 14,166
options, respectively, previously granted under the 2000 Stock Incentive Plan
expired and were available to be reissued. During the three month
period ended September 30, 2007, the Company issued 167,168 options to purchase
shares of common stock. During the three month period ended September
30, 2006, no options were issued. During the six month periods ended September
30, 2007 and 2006, the Company issued 174,668 and 56,000 options, respectively,
to purchase shares of common stock. Additionally, the Company granted
5,000 restricted stock awards in the three month period
ended June 30, 2006. As of September 30, 2007, there were a total of
345,845 shares available for grant. The purchase price of shares must be at
least equal to the fair market value of the common stock on the date of grant,
and the maximum term of an option is 10 years. The options generally
vest over periods ranging from 0 to 4 years.
The
Company recognized approximately $611,000 and $1,104,000 of compensation cost
for the three and six month periods ended September 30, 2007, and approximately
$557,000 and $1,162,000 for the three and six month periods ended September
30,
2006. During the three month period ended September 30, 2007, 19,119 options
were exercised on a cashless basis resulting in 18,000 common shares being
issued with an exercise price of $0.47. During the three and six
month periods ended September 30, 2006, 19,342 and 32,263 options were exercised
on a cashless basis resulting in 48,349 and 30,349 common shares being issued,
respectively, with an exercise price of $0.47.
The
fair
value of each stock option award is estimated on the date of grant using the
Black-Scholes valuation model. The Company uses historical data
regarding stock option exercise behaviors to estimate the expected term of
options granted (based on the period of time that options granted are expected
to be outstanding). Expected implied volatility is based on the
volatility of the Company’s exchange traded options for the Company’s common
stock. The risk-free interest rate is based on the U.S. treasury
security rate in effect over the estimated life of the option. There is no
dividend yield. The following weighted-average assumptions were used
in calculating the fair value of stock options granted during the three and
six
month periods ended September 30, 2007 and 2006.
|
Three
Months
|
|
Six
Months
|
|
Ended
September 30,
|
|
Ended
September 30,
|
|
2007
|
2006
|
|
2007
|
2006
|
|
|
|
|
|
|
Risk
free interest rate
|
4.67%
|
0%
|
|
4.69%
|
4.89%
|
Average
life of options (years)
|
10.0
|
0
|
|
10.0
|
6.0
|
Volatility
|
77%
|
0%
|
|
76%
|
69%
|
Dividend
yield
|
0
|
0
|
|
0
|
0
|
|
|
|
|
|
|
A
summary
of stock option activity as of and for the six month period ended September
30,
2007, is presented below:
|
|
Shares
|
|
|
Exercise
Price Per Share (*)
|
|
|
Remaining Contractual Term
(*) in Years
|
|
Outstanding
at March 31, 2007
|
|
|
1,800,609
|
|
|
$ |
8.92
|
|
|
|
|
Granted
|
|
|
174,668
|
|
|
|
6.94
|
|
|
|
|
Exercised
|
|
|
(19,119 |
) |
|
|
.47
|
|
|
|
|
Forfeited
or expired
|
|
|
(81,000 |
) |
|
|
10.95
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding
at September 30, 2007
|
|
|
1,875,158
|
|
|
|
8.73
|
|
|
|
6.79
|
|
Exercisable
at September 30, 2007
|
|
|
1,445,389
|
|
|
|
9.32
|
|
|
|
6.27
|
|
(*)
Weighted-average
The
weighted-average grant date fair value of options granted during the six month
periods ended September 30, 2007 and 2006 was $6.94 and $7.35,
respectively. The intrinsic value of options exercised during the six
month periods ended September 30, 2007 and 2006 was approximately $143,000
and
$121,000, respectively. The intrinsic value of stock options vested
during the six month periods ended September 30, 2007 and 2006 was approximately
$2,263,000 and $788,000, respectively. The intrinsic value of stock
options outstanding during the six month periods ended September 30, 2007 and
2006 was approximately $2,921,000 and $788,000, respectively.
As
of
September 30, 2007, there was approximately $1,985,000 of unrecognized
compensation cost related to non-vested stock option compensation arrangements
granted under the 2000 Plan that is expected to be recognized as a charge to
earnings over a weighted-average period of 0.6 years. As of September
30, 2007, 1,734,203 options have vested or are expected to vest with a
weighted-average exercise price of $10.52, a weighted-average remaining life
of
6.85 years, and with an intrinsic value of approximately
$2,755,000.
4.
|
COLLABORATIVE
RESEARCH AND DEVELOPMENT
ACTIVITIES
|
The
Company earns revenue under various collaborative research
agreements. Under the terms of these arrangements, the Company
generally has agreed to perform best efforts research and development and,
in
exchange, the Company may receive advanced cash funding, an allowance for
management overhead, and may also earn additional fees for the attainment of
certain milestones.
The
Company initially acquired its rights to the aromatic cation technology platform
developed by a consortium of universities consisting of UNC-CH, Georgia State
University, Duke University and Auburn University pursuant to an agreement,
dated January 15, 1997 (as amended, the “Consortium Agreement”) among the
Company, UNC-CH and a third-party (to which each of the other members of the
scientific consortium shortly thereafter joined) (the “original
licensee”). The Consortium Agreement commits the parties to
collectively research, develop, finance the research and development of,
manufacture and market both the technology and compounds owned by the scientific
consortium and previously licensed or optioned to the original licensee and
licensed to the Company in accordance with the Consortium Agreement (the
“Current Compounds”), and all technology and compounds developed by the
consortium scientists after January 15, 1997, through use of Company-sponsored
research funding or National Cooperative Drug Development grant funding made
available to the scientific consortium (the “Future Compounds” and, collectively
with the Current Compounds, the “Compounds”).
The
Consortium Agreement contemplated that upon the completion of our initial public
offering (“IPO”) of shares of its common stock with gross proceeds of at least
$10,000,000 by April 30, 1999, the Company, with respect to the Current
Compounds, and UNC-CH, (on behalf of the Scientific Consortium), with respect
to
Current Compounds and Future Compounds, would enter into license agreements
for
the intellectual property rights relating to the Compounds pursuant to which
the
Company would pay royalties and other payments based on revenues received for
the sale of products based on the Compounds.
The
Company completed an IPO on April 26, 1999, with gross proceeds in excess of
$10,000,000 thereby earning a worldwide license and exclusive rights to
commercially use, manufacture, have manufactured, promote, sell, distribute,
or
otherwise dispose of any products based directly or indirectly on all of the
Current Compounds and Future Compounds.
As
a
result of the closing of the IPO, the Company issued an aggregate of 611,250
shares of common stock, of which 162,500 shares were issued to the Scientific
Consortium and 448,750 shares were issued to the original licensee or persons
designated by the original licensee.
As
contemplated by the Consortium Agreement, on January 28, 2002, the Company
entered into a license agreement with the Scientific Consortium whereby the
Company received the exclusive license to commercialize the aromatic cation
technology platform and compounds developed or invented by one or more of the
Scientific Consortium scientists after January 15, 1997, and which also
incorporated into such license agreement the Company’s existing license with the
Scientific Consortium with regard to the Current Compounds (the “Consortium
License Agreement”). Also pursuant to the Consortium Agreement, the
original licensee transferred to the Company the worldwide license and exclusive
right to commercially use, manufacture, have manufactured, promote, sell,
distribute or otherwise dispose of any and all products based directly or
indirectly on aromatic cations developed by the Scientific Consortium on or
prior to January 15, 1997 and previously licensed (together with related
technology and patents) to the third-party.
The
Consortium Agreement provides that the Company is required to pay to UNC-CH
on
behalf of the Scientific Consortium reimbursement of patent and patent-related
fees, certain milestone payments and royalty payments based on revenue derived
from the Scientific Consortium’s aromatic cation technology
platform. Each month on behalf of the inventor scientist or
university, as the case may be, UNC-CH submits an invoice to the Company for
payment of patent-related fees related to current compounds or future compounds
incurred prior to the invoice date. The Company is also required to
make milestone payments in the form of the issuance of 100,000 shares of its
common stock to the Scientific Consortium when it files its first initial New
Drug Application (“NDA”) or an
Abbreviated
New Drug Application (“ANDA”) based on Scientific Consortium
technology. The Company is also required to pay to UNC-CH on behalf
of the Scientific Consortium (other than Duke University) (i) royalty
payments of up to 5% of our net worldwide sales of “current products” and
“future products” (products based directly or indirectly on current compounds
and future compounds, respectively) and (ii) a percentage of any fees the
Company receives under sublicensing arrangements. With respect to
products or licensing arrangements emanating from Duke University technology,
the Company is required to negotiate in good faith with UNC-CH (on behalf of
Duke University) royalty, milestone or other fees at the time of such event,
consistent with the terms of the Consortium Agreement.
Under
the
Consortium License Agreement, the Company must also reimburse the cost of
obtaining patents and assume liability for future costs to maintain and defend
patents so long as the Company chooses to retain the license to such
patents.
During
the three and six month periods ended September 30, 2007, the Company expensed
approximately $212,000 and $404,000, respectively, of other payments to UNC-CH
and certain other Scientific Consortium universities for patent related costs
and other contracted research. For the corresponding periods ended
September 30, 2006, the Company expensed approximately $393,000 and $635,000,
respectively. Included in accounts payable as of September 30, 2007 and
March 31, 2007, were approximately $90,000, and $174,000, respectively, due
to UNC-CH and certain other Scientific Consortium universities.
In
November 2000, The Bill & Melinda Gates Foundation (“Foundation”) awarded a
$15,114,000 grant to UNC-CH to develop new drugs to treat African sleeping
sickness and leishmaniasis (the “Foundation Grant”). On March 29,
2001, UNC-CH entered into a clinical research subcontract agreement with the
Company, whereby the Company was to receive up to $9,800,000, subject to certain
terms and conditions, over a five year period to conduct certain clinical and
research studies related to the Foundation Grant.
In
April
2003, the Foundation awarded a supplemental grant of approximately $2,700,000
to
UNC-CH for the expansion of phase IIB/III clinical trials to treat African
sleeping sickness and improved manufacturing processes. The Company
has received, pursuant to the clinical research subcontract with UNC-CH,
inclusive of its portion of the supplemental grant, a total amount of funding
of
approximately $11,700,000. Grant funds paid in advance of the
Company’s delivery of services are treated as restricted funds and must be
segregated from other funds and used for the purposes specified. In March 2006,
the Company amended and restated the clinical research subcontract with UNC-CH
and UNC-CH in turn obtained an expanded funding commitment for the Company
of
approximately $13,601,000 from the Foundation. Under the amended and
restated agreement, the Company received on May 24, 2006 the first payment
of
approximately $5,649,000 of the five year approximately $13,601,000
contract.
During
the three and six months ended September 30, 2007, approximately $626,000 and
$1,304,000 was utilized for clinical and research purposes conducted and
expensed, respectively. During the three and six months ended
September 30, 2006, approximately $379,000 and $1,208,000 was utilized for
clinical and research purposes conducted and expensed, respectively. The Company
has recognized revenues of approximately $626,000 and $1,304,000 during the
three and six months ended September 30, 2006, respectively. The
Company has recognized revenues of approximately $379,000 and $2,138,000 during
the three and six months ended September 30, 2006, respectively. The
remaining amount (approximately $423,000 as of September 30, 2007) has been
deferred and will be recognized as revenue over the term of the agreement as
the
services are performed.
On
November 26, 2003, the Company entered into a testing agreement with Medicines
for Malaria Venture (“MMV”), a foundation established in Switzerland, and
UNC-CH, pursuant to which the Company, with the support of MMV and UNC-CH,
conducted a proof of concept study of the dicationic first drug candidate
pafuramidine for the treatment of malaria (the “MMV Testing
Agreement”).
Under
the
terms of the MMV Testing Agreement, MMV committed to pay for human clinical
trials and, subject to certain milestones, regulatory preparation and filing
costs for the approvals to market pafuramidine to treat malaria. In return
for
MMV’s funding, the Company is required, when selling malaria drugs derived from
this research into “malaria-endemic countries,” as defined, to sell such drugs
at affordable prices. An affordable price is defined in the MMV
Testing Agreement to mean a price not to be less than the cost to manufacture
and deliver the drugs plus administrative overhead costs (not to exceed 10%
of
the cost to manufacture) and a modest profit. There are no price constraints
on
product sales into non-malaria-endemic countries. The Company must,
however, pay to MMV a royalty not to exceed 7% of net sales, as defined, on
product sales into non-malaria-endemic countries, until the amount funded under
the MMV Testing Agreement and amounts funded under a related discovery agreement
between MMV and UNC-CH is refunded to MMV at face value. The company
and MMV agreed to terminate the MMV Testing Agreement effective as of February
10, 2006. The Company has received approximately $5,636,000 under
this contract.
The
Company recognized revenues of approximately $112,000 and $294,000 during the
three and six month periods ended September 30, 2006, respectively, for expenses
incurred related to activities within the scope of the MMV Testing
Agreement.
On
June
8, 2007, the Company entered into an exclusive licensing agreement pursuant
to
which we have licensed to Par Pharmaceutical Companies, Inc. (“Par”)
commercialization rights in the United States of America to pafuramidine for
the
treatment of PCP in AIDS patients (the “Par License Agreement”). The Company and
Par may also collaborate on efforts to develop pafuramidine as a preventative
therapy for patients at risk of developing PCP, including people living with
HIV, cancer and other immunosuppressive conditions.
In
return, we received an initial payment of $3 million. Par will also
pay us as much as $29 million in development milestones if pafuramidine advances
through ongoing Phase III clinical trials and FDA regulatory review and
approval. In addition to royalties on sales, we may receive up to
$115 million in additional milestone payments on future sales and will retain
the right to co-market pafuramidine in the United States of
America. We have also granted Par a right of first offer to enter
into a license agreement with us if we determine that pafuramidine can be used
for the treatment and/or prophylaxis of malaria.
On
June
9, 2006, the International Court of Arbitration of the ICC notified the parties
that (i) the Arbitral Panel found that Neurochem breached the testing agreement
and awarded the Company approximately $1.9 million in damages and attorneys’
fees and costs, and (ii) denied all of Neurochem's claims against the Company.
On July 10, 2006, the Company requested that the Arbitral Panel make certain
corrections to the Award. On or about September 27, 2006, the Company received
an Addendum to the Final Award, which did not alter the substance or amount
of
the Arbitral Panel’s Award. Subsequent to September 30, 2006, Neurochem
disbursed funds representing the Final Award by the Arbitral Panel.
In
October 2003, Gerhard Von der Ruhr et al (the “Von der Ruhr Plaintiffs”) filed a
complaint in the United States District Court for the Northern District of
Illinois against the Company and certain officers and directors alleging
breaches of a stock lock-up agreement, option agreements and a technology
license agreement by the Company, as well as interference with the Von der
Ruhr
Plaintiffs’ contracts with the Company by its officers. The complaint
sought unspecified monetary damages and punitive damages, in addition to
equitable relief and costs. In 2005, one of the counts in the case
was dismissed upon the Company’s motion for summary judgment. A
preliminary pre-trial conference was held on October 26, 2006 and the court
granted the Company’s motions in limine to exclude plaintiffs’ claim for lost
profits damages and to prohibit plaintiff Gerhard Von der Ruhr from offering
expert testimony at trial. The court subsequently granted a motion to
sever the trial on Count V, regarding a technology license agreement, from
the
trial on the remaining counts. The final pre-trial
conference is scheduled for November 19, 2007 and the trial
is set to begin on December 3, 2007. At this time it is not
possible to predict the outcome of this matter or to estimate the possible
loss
or range of loss.
Pursuant
to the March 2006 amended and restated clinical research subcontract with
UNC-CH, on November 2, 2007, the Company received approximately
$5,123,000. The Foundation provided the funds to UNC-CH as part of
the approximately $22.6 million Foundation Grant to fund Phase III clinical
trials using the Company’s oral drug, pafuramidine maleate, to treat stage one
of African sleeping sickness.
*
* * * *
*
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
|
Forward
Looking Statements
Certain
statements contained in this quarterly report and in the documents incorporated
by reference herein constitute “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. All
statements other than statements of historical fact may be deemed to be
forward-looking statements. Forward-looking statements frequently,
but not always, use the words “may”, “intends”, “plans”, “believes”,
“anticipates” or “expects” or similar words and may include statements
concerning our strategies, goals and plans. Forward-looking
statements involve a number of significant risks and uncertainties that could
cause our actual results or achievements or other events to differ materially
from those reflected in such forward-looking statements. Such factors
include, among others described in this quarterly report, the following: (i)
we
are in an early stage of product development, (ii) the possibility that
favorable relationships with collaborators cannot be established or, if
established, will be abandoned by the collaborators before completion of product
development, (iii) the possibility that we or our collaborators will not
successfully develop any marketable products, (iv) the possibility that advances
by competitors will cause our product candidates not to be viable, (v)
uncertainties as to the requirement that a drug product be found to be safe
and
effective after extensive clinical trials and the possibility that the results
of such trials, if completed, will not establish the safety or efficacy of
our
drug product candidates, (vi) risks relating to requirements for approvals
by
governmental agencies, such as the Food and Drug Administration, before products
can be marketed and the possibility that such approvals will not be obtained
in
a timely manner or at all or will be conditioned in a manner that would impair
our ability to market our product candidates successfully, (vii) the risk that
our patents could be invalidated or narrowed in scope by judicial actions or
that our technology could infringe upon the patent or other intellectual
property rights of third parties, (viii) the possibility that we will not be
able to raise adequate capital to fund our operations through the process of
commercializing a successful product or that future financing will be completed
on unfavorable terms, (ix) the possibility that any products successfully
developed by us will not achieve market acceptance and (x) other risks and
uncertainties that may not be described herein. We undertake no
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.
Results
of Operations
With
the
exception of certain research funding agreements and certain grants, we have
not
generated any revenue from operations. For the period from inception
(October 15, 1984) to September 30, 2007, we incurred cumulative net losses
of approximately $102,080,000. We have incurred additional losses
since such date and we expect to incur additional operating losses for the
foreseeable future. We expect that our cash sources for at least the
next year will be limited to:
|
·
|
payments
from foundations and other collaborators under arrangements that
may be
entered into in the future;
|
|
·
|
payments
from license agreement milestones;
|
|
·
|
grants
from the United States government and other governments and entities;
and
|
|
·
|
the
issuance of securities or borrowing of
funds.
|
The
timing and amounts of grant and payment revenues, if any, will likely fluctuate
sharply and depend upon the achievement of specified milestones, and results
of
operations for any period may be unrelated to the results of operations for
any
other period.
Three
Month Period Ended September 30, 2007 Compared with the Three Month Period
Ended
September 30, 2006.
Revenues
under collaborative research and development, and license agreements were
approximately $1,030,000 and $491,000 for the three month periods ended
September 30, 2007 and September 30, 2006, respectively. For the
three month period ended September 30, 2007, we recognized revenues of
approximately $626,000 related to a clinical research subcontract agreement
between the Company and UNC-CH and approximately $404,000 related to the Par
License Agreement, while for the three month period ended September 30, 2006,
revenues recognized of approximately $379,000 related to the abovementioned
UNC-CH clinical research subcontract and $112,000 related to a grant from MMV
to
fund clinical studies and licensure of DB289 for treatment of malaria which
has
since lapsed.
The
clinical research subcontract agreement relates to a grant from the Foundation
to UNC-CH to develop new drugs to treat African sleeping sickness and
leishmaniasis. MMV also receives funding from the
Foundation. Grant and research and development agreement revenue is
recognized as completed under the terms of the respective agreements, according
to Company estimates. Grant and research and development funds
received prior to completion under the terms of the respective agreements are
recorded as deferred revenues.
Revenue
from licensing arrangements is recorded when earned based on the performance
requirements of the contract. Nonrefundable upfront license fees, for
product candidates where the Company is providing continuing services related
to
product development, are deferred and recognized as revenue over the development
period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes
from licenses, either from upfront fees or milestones where the Company is
providing continuing services related to product development, is dependent
upon
the Company’s estimates of filing dates.
Research
and development expenses increased to approximately $2,283,000 from $1,755,000
for the three month periods ended September 30, 2007 and September 30, 2006,
respectively. Expenses relating to the UNC-CH subcontract, increased
to approximately $626,000 in the three month period ended September 30, 2007
from approximately $379,000 in the three month period ended September 30, 2006
while expenses relating to the MMV Testing Agreement decreased over the same
periods to approximately $5,000 from $112,000. Contract services
relating to non-MMV supported malaria trials increased to approximately $322,000
in the three month period ended September 30, 2007 from approximately $12,000
in
the three month period ended September 30, 2006. Additionally, contract services
relating to trials for treatment of PCP decreased to approximately $529,000
from
approximately $620,000 in the same periods. Discovery contract
research expenses increased to approximately $408,000 in the three month period
ended September 30, 2007 from approximately $165,000 in the period ended
September 30, 2006. Non-cash options expense under research and development
decreased to approximately $115,000 in the three month period ended September
30, 2007 from approximately $174,000 in the three month period ended September
30, 2006. Other research and development expenses decreased
approximately $15,000 from the three month period ended September 30, 2006
to
the three month period ended September 30, 2007.
General
and administrative expenses decreased to approximately $2,214,000 from
approximately $2,364,000 during the three month periods ended September 30,
2007, and September 30, 2006, respectively. The decrease was partly
due to lower business development costs, which decreased to
approximately
$7,000 in the three month period ended September 30, 2007, from approximately
$319,000 in the three month period ended September 30, 2006. Patent
fees decreased to approximately $102,000 in the three month period ended
September 30, 2007 from approximately $343,000 in the three month period ended
September 30, 2006. Non-cash general and administrative expenses increased
to
approximately $786,000 in the three month period ended September 30, 2007,
which
includes (i) approximately $172,000 for 50,000 warrants issued to a consultant,
(ii) approximately $118,000 for 30,000 warrants issued to an investor relations
firm, and (iii) approximately $496,000 for expensing options, from approximately
$383,000 in the three month period ended September 30, 2006, which relates
to
the expensing of options.
Our
net
loss increased to approximately $3,334,000 from approximately $1,621,000 during
the three month periods ended September 30, 2007 and September 30, 2006,
respectively. The increase was primarily attributable to the
receivable of approximately $1,874,000 posted during the three month period
ended September 30, 2006 that related to the award from the Neurochem
litigation.
Six
Month Period Ended September 30, 2007 Compared with the Six Month Period Ended
September 30, 2006.
Revenues
under collaborative research and development agreements were approximately
$1,857,000 and $2,433,000 for the six month periods ended September 30, 2007
and
September 30, 2006, respectively. For the six month period ended
September 30, 2007, we recognized revenues of approximately $1,304,000 related
to a clinical research subcontract agreement between the Company and UNC-CH
and
approximately $553,000 related to the Par License Agreement, while for the
six
month period ended September 30, 2006, revenues recognized of approximately
$2,139,000 related to the abovementioned UNC-CH clinical research subcontract
and $294,000 related to a grant from MMV to fund clinical studies and licensure
of DB289 for treatment of malaria which has since lapsed.
The
clinical research subcontract agreement relates to a grant from the Foundation
to UNC-CH to develop new drugs to treat African sleeping sickness and
leishmaniasis. MMV also receives funding from the
Foundation. Grant and research and development agreement revenue is
recognized as completed under the terms of the respective agreements, according
to Company estimates. Grant and research and development funds
received prior to completion under the terms of the respective agreements are
recorded as deferred revenues.
Revenue
from licensing arrangements is recorded when earned based on the performance
requirements of the contract. Nonrefundable upfront license fees, for
product candidates where the Company is providing continuing services related
to
product development, are deferred and recognized as revenue over the development
period or as the Company provides services required under the
agreement. The timing and amount of revenue the Company recognizes
from licenses, either from upfront fees or milestones where the Company is
providing continuing services related to product development, is dependent
upon
the Company’s estimates of filing dates.
Research
and development expenses remained relatively the same by decreasing to
approximately $4,201,000 from $4,224,000 for the six month periods ended
September 30, 2007 and September 30, 2006, respectively. Expenses
relating to the UNC-CH subcontract, increased to approximately $1,221,000 in
the
six month period ended September 30, 2007 from approximately $1,208,000 in
the
three month period ended September 30, 2006 while expenses relating to the
MMV
Testing Agreement decreased over the same periods to approximately $15,000
from
$293,000. Contract services relating to non-MMV supported malaria
trials increased to approximately $782,000 in the six month period ended
September 30, 2007 from approximately $12,000 in the six month period ended
September 30, 2006. Additionally, contract services relating to trials for
treatment of PCP decreased to approximately
$795,000
from approximately $1,745,000 in the same periods. Discovery contract research
expenses increased to approximately $606,000 in the six month period ended
September 30, 2007 from approximately $172,000 in the period ended September
30,
2006. Non-cash options expense under research and development decreased to
approximately $233,000 in the six month period ended September 30, 2007 from
approximately $351,000 in the six month period ended September 30,
2006. Other research and development expenses increased approximately
$106,000 from the six month period ended September 30, 2006 to the six month
period ended September 30, 2007.
General
and administrative expenses decreased to approximately $3,931,000 from
approximately $4,584,000 during the six month periods ended September 30, 2007,
and September 30, 2006, respectively. The decrease was partly due to
lower business development costs, which decreased to approximately $9,000 in
the
six month period ended September 30, 2007, from approximately $662,000 in the
six month period ended September 30, 2006. Patent fees decreased to
approximately $173,000 in the six month period ended September 30, 2007 from
approximately $506,000 in the six month period ended September 30, 2006.
Non-cash general and administrative expenses increased to approximately
$1,161,000 in the six month period ended September 30, 2007, which includes
(i)
approximately $172,000 for the 50,000 warrants issued to a consultant, (ii)
approximately $118,000 for the 30,000 warrants issued to an investor relations
firm, and (iii) approximately $871,000 for expensing options, from approximately
$383,000 in the six month period ended September 30, 2006, which includes (i)
approximately $36,000 for the issuance of 5,000 common shares to Tulane
University, (ii) approximately $36,000 for the issuance of 5,000 common shares
as part of a retirement and consulting agreement, and approximately $811,000
for
expensing options. Other general and administrative expenses
decreased approximately $445,000 over the same periods.
Our
net
loss increased to approximately $5,995,000 from approximately $4,218,000 during
the six month periods ended September 30, 2007 and September 30, 2006,
respectively. The increase was primarily attributable to the
receivable of approximately $1,874,000 posted during the six month period ended
September 30, 2006 that related to the award from the Neurochem
litigation.
Liquidity
and Capital Resources
As
of
September 30, 2007, cash and cash equivalents were approximately
$9,840,000.
We
did
not make any equipment purchases during the six month period ended
September 30, 2007. We spent approximately $6,000 and $40,000,
respectively, on equipment purchases during the three and six month periods
ended September 30, 2006. No significant purchases of equipment are
anticipated by us during the year ending March 31, 2008.
We
periodically receive cash from the exercise of common stock options and
warrants. During the three and six month periods ended September 30,
2007 we received approximately $296,000 from the exercise of
warrants. During the three month period ended September 30, 2006, we
received $30,000 for the exercise of warrants.
We
believe our existing unrestricted cash and cash equivalents and the grants
we
have received or have been awarded and are awaiting disbursement of, will be
sufficient to meet our planned expenditures through at least November 2008,
although there can be no assurance we will not require additional
funds.
Through
September 30, 2007, we financed our operations with:
|
·
|
proceeds
from various private placements of debt and equity securities, an
initial
public offering, and other cash contributed from stockholders, which
in
the aggregate raised approximately
$77,419,000;
|
|
·
|
payments
from research agreements, license agreements, foundation grants,
and SBIR
grants and STTR program grants of approximately $26,939,000;
and
|
|
·
|
the
use of stock, options and warrants in lieu of cash
compensation.
|
Our
cash
resources have been used to finance, develop and begin commercialization of
drug
product candidates, including sponsored research, conduct of human clinical
trials, capital expenditures, expenses associated with development of product
candidates pursuant to the Consortium Agreement and, as contemplated by the
Consortium Agreement, under the Consortium License Agreement with the
Consortium, and general and administrative expenses. Over the next
several years we expect to incur substantial additional research and development
costs, including costs related to research in pre-clinical (laboratory) and
human clinical trials, administrative expenses to support our research and
development operations and marketing expenses to launch the sale of any
commercialized product that may be developed.
Our
future working capital requirements will depend upon numerous factors, including
the progress of research, development and commercialization programs (which
may
vary as product candidates are added or abandoned), results of pre-clinical
testing and human clinical trials, achievement of regulatory milestones, third
party collaborators fulfilling their obligations to us, the timing and cost
of
seeking regulatory approvals, the level of resources that we devote to the
engagement or development of manufacturing capabilities including the build-out
of our subsidiary’s facility in China, our ability to maintain existing and to
establish new collaborative arrangements with others to provide funding to
support these activities, and other factors. In any event, we will
require substantial additional funds in addition to our existing resources
to
develop product candidates and to otherwise meet our business
objectives.
Management’s
plans for the remainder of the fiscal year, in addition to normal operations,
include continuing their efforts to create joint ventures, obtain additional
grants and to develop and enter into research, development and/or
commercialization agreements with others.
Item
3.
|
Quantitative
and Qualitative Disclosures about Market
Risk.
|
The
exposure of market risk associated with risk-sensitive instruments is not
material, as our operations are conducted primarily in U.S. dollars and we
invest primarily in short-term government obligations and other cash
equivalents. We intend to develop policies and procedures to manage
market risk in the future if and when circumstances require.
Item
4.
|
Controls
and Procedures.
|
Disclosures
and Procedures
We
maintain controls and procedures designed to ensure that we are able to collect
the information we are required to disclose in the reports we file with the
United States Securities and Exchange Commission (the “SEC”), and to process,
summarize and disclose this information within the time periods specified in
the
rules of the SEC. Our Chief Executive Officer and Chief Financial
Officer are responsible for establishing and maintaining these procedures and,
as required by the rules of the SEC, evaluate their
effectiveness. Based on their evaluation of our disclosure controls
and procedures, our Chief Executive Officer and Chief Financial Officer have
concluded that these procedures were effective as of
the
end
of the period covered by this Quarterly Report on Form 10-Q to ensure that
we
are able to collect, process and disclose the information we are required to
disclose in the reports we file with the SEC within the required time
periods.
Internal
Controls
We
maintain a system of internal controls designed to provide reasonable assurance
that: (1) transactions are executed in accordance with management’s general
or specific authorization and (2) transactions are recorded as necessary to
(a) permit preparation of financial statements in conformity with generally
accepted accounting principles and (b) maintain accountability for
assets. Access to assets is permitted only in accordance with
management’s general or specific authorization and the recorded accountability
for assets is compared with the existing assets at reasonable intervals and
appropriate action is taken with respect to any differences.
Changes
in Internal Controls
We
have
not made any material changes in our internal control over financial reporting
during the quarter ended September 30, 2007 that have materially affected,
or
are reasonably likely to materially affect, our internal control over financial
reporting.
PART
II. OTHER
INFORMATION
Item
1.
|
Legal
Proceedings.
|
Gerhard
Von der Ruhr et al. v. Immtech International, Inc. et. al.
In
October 2003, Gerhard Von der Ruhr et al (the “Von der Ruhr Plaintiffs”) filed a
complaint in the United States District Court for the Northern District of
Illinois against the Company and certain officers and directors alleging
breaches of a stock lock-up agreement, option agreements and a technology
license agreement by the Company, as well as interference with the Von der
Ruhr
Plaintiffs’ contracts with the Company by its officers. The complaint
sought unspecified monetary damages and punitive damages, in addition to
equitable relief and costs. In 2005, one of the counts in the case
was dismissed upon the Company’s motion for summary judgment. A
preliminary pre-trial conference was held on October 26, 2006 and the court
granted the Company’s motions in limine to exclude plaintiffs’ claim for lost
profits damages and to prohibit plaintiff Gerhard Von der Ruhr from offering
expert testimony at trial. The court subsequently granted a motion to
sever the trial on Count V, regarding a technology license agreement, from
the
trial on the remaining counts. The final pre-trial
conference is scheduled for November 19, 2007 and the trial
is set to begin on December 3, 2007. At this time it is not
possible to predict the outcome of this matter or to estimate the possible
loss
or range of loss.
There
are
no material changes in risk factors previously disclosed in Item 1A to Part
I of
our Form 10-K for the fiscal year ended March 31, 2007.
Item
2.
|
Unregistered
Sales of Equity Securities and Use of
Proceeds.
|
Recent
Sales of Unregistered Securities.
All
such
shares of common stock herein described as issuances below were made pursuant
to
Section 4(2) of the Securities Act of 1933, as amended.
Option
Exercise
On
July
20, 2007, a consortium scientist exercised options on a cashless basis to
purchase 19,119 shares of Common Stock with an exercise price of $0.47 per
share. Common shares in the amount of 18,000 were
issued.
Warrant
Exercise
On
September 17, 2007, a warrant holder exercised warrants to purchase 5,000 shares
of Series B Convertible Preferred Stock, $0.01 par value ("Series B Preferred
Stock") with an exercise price of $6.125 per share, resulting in proceeds
to the Company of $30,625.
On
September 21, 2007, a warrant holder exercised warrants to purchase 5,000 shares
of Series B Preferred Stock with an exercise price of $6.125 per share,
resulting in proceeds to the Company of $30,625.
On
September 24, 2007, a warrant holder exercised warrants to purchase 36,000
shares of Series B Preferred Stock with an exercise price of $6.125 per share,
resulting in proceeds to the Company of $220,500.
On
September 25, 2007, an executive officer exercised warrants to purchase 2,312
shares of Series B Preferred Stock with an exercise price of $6.125 per share,
resulting in proceeds to the Company of $14,161.
Conversion
of Preferred Stock to Common Stock.
On
July
12, 2007, a holder of Series A Convertible Preferred Stock, $0.01 par value
(“Series A Preferred Stock”) converted 1,000 shares of Series A Preferred Stock
into 5,701 shares of our common stock.
On
July
18, 2007, a holder of Series D Convertible Preferred Stock, $0.01 par value
(“Series D Preferred Stock”) converted 2,000 shares of Series D Preferred Stock
into 5,653 shares of our common stock.
On
September 28, 2007, holders of Series E Convertible Preferred Stock, $0.01
par
value (“Series E Preferred Stock”) converted an aggregate of 1,600 shares of
Series E Preferred Stock into an aggregate of 5,813 shares of our common
stock.
Preferred
Stock Dividend Payment.
On
October 17, 2007, we issued 33,281 shares of common stock as payment of a
dividend earned on outstanding convertible preferred stock to the holders
thereof: holders of Series A Preferred Stock earned 5,106 shares of common
stock
on 54,500 outstanding shares; holders of Series B Preferred Stock earned 1,682
shares of common stock on 13,464 outstanding shares; holders of Series C
Convertible Preferred Stock, $0.01 par value, earned 5,694 shares of common
stock on 45,536 outstanding shares; holders of Series D Preferred Stock earned
10,804 shares of common stock on 115,200 outstanding shares; and holders of
Series E Preferred Stock earned 9,995 shares of common stock on 106,600
outstanding shares. We also paid holders of our outstanding
convertible preferred stock $507 in cash in lieu of fractional
shares.
Item
3.
|
Defaults
Upon Senior
Securities.
|
None
Item
4.
|
Submission
of Matters to a Vote of Security
Holders.
|
None
Item
5.
|
Other
Information.
|
None
Exhibit
Number Exhibit
Description
3.1
|
Amended
and Restated Certificate of Incorporation of the Company, dated June
14,
2004 (incorporated by reference from the Company's Form 10-K for
fiscal
year ended March 31, 2004) *
|
3.2
|
Certificate
of Correction to Certificate of Incorporation dated December 14,
2005
(incorporated by reference from the Company's Form 8-K, filed
December 14, 2005) *
|
3.3
|
Certificate
of Amendment (Name Change) to Certificate of Incorporation dated
March 22,
2006 (incorporated by reference from the Company's Form 8-K, filed
March 23, 2006) *
|
3.4
|
Certificate
of Amendment (Number of Members of the Board of Directors) to Certificate
of Incorporation dated April 17, 2007 (incorporated by reference
from the
Company's Form 10-K for fiscal year ended March 31, 2007) *
|
3.5
|
Certificate
of Designation for Series A Convertible Preferred Stock Private Placement,
dated February 14, 2002 (incorporated by reference from the Company's
Form
8-K, filed February 14, 2002) *
|
3.6
|
Certificate
of Designation for Series B Convertible Preferred Stock Private Placement,
dated September 25, 2002 (incorporated by reference from the Company's
Form 8-K, filed September 25, 2002) *
|
3.7
|
Certificate
of Designation for Series C Convertible Preferred Stock Private Placement,
dated June 6, 2003 (incorporated by reference from the Company's
Form
8-K, filed June 10, 2003) *
|
3.8
|
Certificate
of Designation for Series D Convertible Preferred Stock Private Placement,
dated January 15, 2004 (incorporated by reference from the Company's
Form
8-K, filed January 21, 2004) *
|
3.9
|
Certificate
of Designation for Series E Convertible Preferred Stock Private Placement,
dated December 13, 2005 (incorporated by reference from the Company's
Form
8-K, filed December 14, 2005) *
|
3.10
|
Amended
and Restated Bylaws of the Company effective as of June 8, 2007
(incorporated by reference from the Company's Form 8-K, filed June
12, 2007) *
|
31.1
|
Certification
of Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 **
|
31.2
|
Certification
of Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 **
|
32.1
|
Certification
of Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 **
|
32.2
|
Certification
of Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 **
|
*
|
These
items are hereby incorporated by reference from the exhibits of
the filing
or report indicated (Commission File No. 001-14907) and are hereby
made a
part of this Report.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
|
IMMTECH
PHARMACEUTICALS, INC.
|
|
|
|
|
|
|
|
|
By:
|
/s/
Eric L. Sorkin |
|
|
|
Eric
L. Sorkin
|
|
|
|
President
and Chief Executive Officer
|
|
|
|
|
|
|
|
|
By:
|
/s/
Gary C. Parks |
|
|
|
Gary
C. Parks
|
|
|
|
Treasurer,
Secretary and Chief Financial Officer
(Principal
Financial and Accounting Officer)
|
|