Delaware
|
33-0956433
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
Page
No.
|
||||
PART
I
|
||||
Item 1.
Business
|
1
|
|||
Item 2.
Properties
|
18
|
|||
Item 3.
Legal Proceedings
|
18
|
|||
Item 4.
Submission of Matters to a Vote of Security Holders
|
18
|
|||
PART
II
|
||||
Item 5.
Market for Common Equity and Related Stockholder Matters
|
19
|
|||
Item 6.
Management’s Discussion and Analysis of Financial Condition and Results of
Operation
|
20
|
|||
Item 7.
Financial Statements and Supplementary Data
|
29
|
|||
Item 8.
Change in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
54
|
|||
Item 8A.
Controls And Procedures
|
54
|
|||
Item
8B. Other Information
|
54
|
|||
PART
III
|
||||
Item 9.
Directors and Officers of the Registrant
|
55
|
|||
Item 10.
Executive Compensation
|
58
|
|||
Item 11.
Security Ownership of Certain Beneficial Owners and Management and
Related
Stockholder Matters
|
64
|
|||
Item 12.
Certain Relationships and Related Transactions
|
65
|
|||
Item 13.
Exhibits
|
66
|
|||
Item 14.
Principal Accountant Fees and Services
|
67
|
•
|
future
clinical trial results may show that IgG based
therapy
is not well tolerated by the recipients at its effective doses
or is not
efficacious as compared to placebo.
|
•
|
future
clinical trial results may be inconsistent with ARP's previous
preliminary
testing results. Data from our earlier studies may be inconsistent
with
clinical data.
|
•
|
even
if our IgG based therapies are shown to be safe and effective for
their
intended purposes, we may face significant or unforeseen difficulties
in
obtaining/manufacturing sufficient quantities at or at reasonable
prices.
|
•
|
our
ability to complete the development and commercialization of IgG
based
therapies for our intended use is significantly dependent upon
our ability
to obtain and maintain experienced and committed partners to assist
us
with obtaining clinical and regulatory approvals for, and the
manufacturing, marketing and distribution of IgGs on a worldwide
basis.
|
•
|
even
if IgG products are successfully developed, commercially produced
and
receive all necessary regulatory approvals, there is no guarantee
that
there will be market acceptance of the products.
|
•
|
our
competitors may develop therapeutics or other treatments which
are
superior or less costly than our own with the result that our products,
even if they are successfully developed, manufactured and approved,
may
not generate significant revenues
|
2006
|
2005
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
$
|
$
|
$
|
$
|
||||||||||
First
Quarter
|
1.75
|
1.01
|
2.20
|
1.50
|
|||||||||
Second
Quarter
|
1.72
|
1.05
|
1.92
|
1.45
|
|||||||||
Third
Quarter
|
1.69
|
0.71
|
1.85
|
0.90
|
|||||||||
Fourth
Quarter
|
1.20
|
0.53
|
1.45
|
0.85
|
Plan
Category
|
(a)
Number
of securities to be issued upon exercise of outstanding options,
warrants
and rights
|
(b)
Weighted-average
exercise price of outstanding options, warrants and rights
|
(c)
Number
of securities remaining available for future issuance under equity
compensation plans excluding securities reflected in column (a)
(1)
|
|||
Equity
compensation plans approved by security holders
|
2,930,000
|
$1.24
|
2,070,000
|
|||
Equity
compensation plans not approved by security holders (1),
(2)
|
||||||
Total
|
2,930,000
|
$1.24
|
1,570,000
|
·
|
Low-dose,
preventative therapy for disease-free, high-risk individuals,
|
·
|
Strong
dose for use in conjunction with surgery and other cancer treatments,
and
|
·
|
Maintenance
dose for use to prevent recurrence of cancer
growth.
|
·
|
Others
|
Year
ended September 30,
|
|||||||
2006
|
2005
|
||||||
Research
and development costs
|
$
|
802,254
|
$
|
545,928
|
|||
General
and administrative expenses
|
1,263,070
|
666,477
|
|||||
Financial
income, net
|
(29,151
|
)
|
(13,873
|
)
|
|||
Income
taxes
|
28,622
|
-
|
|||||
Net
loss for the period
|
$
|
(2,064,795
|
)
|
$
|
(1,198,532
|
)
|
Category
|
Amount
|
|||
Research
&Development
|
$
|
3,203,000
|
||
Marketing
and Business Development
|
378,000
|
|||
General
& Administrative Expenses
|
1,215,000
|
|||
Total
|
$
|
4,796,000
|
·
|
Summary
of pre-clinical data and collection of historical research
data.
|
·
|
Preparation
of clinical trial.
|
·
|
Oncologists
survey for cancer indication.
|
·
|
Survey
of complementary technologies
|
·
|
Survey
of potential IgG collaborators
|
·
|
Initiation
of contacts with potential
partners.
|
Page
|
||
REPORT
OF INDEPENDENT REGISTERED PUBLIC
|
||
ACCOUNTING
FIRM - Report of Kesselman & Kesselman
|
30
|
|
REPORT
OF INDEPENDENT AUDITORS -
|
||
Report
of Armando C. Ibarra
|
31
|
|
CONSOLIDATED
FINANCIAL STATEMENTS:
|
||
Balance
sheets
|
32
|
|
Statements
of operations
|
33
|
|
Statements
of changes in stockholders’ equity
|
34
|
|
Statements
of cash flows
|
35
|
|
Notes
to financial statements
|
36-53
|
Kesselman
& Kesselman
Certified
Public Accountants (Isr.)
Trade
Tower, 25 Hamered Street
Tel
Aviv 68125 Israel
P.O
Box 452 Tel Aviv 61003
Telephone
+972-3-7954555
Facsimile
+972-3-7954556
|
Kesselman
& Kesselman
|
Tel-Aviv,
Israel
|
December
20, 2006
|
Armando
C. Ibarra, C.P.A.
|
Members
of the California Society of
|
Certified
Public Accountants
|
|
Armando
Ibarra, Jr., C.P.A., JD
|
Members
of the American Institute of
|
Certified
Public Accountants
|
|
Members
of the Better Business Bureau since
1997
|
September
30,
|
|||||||
2006
|
2005
|
||||||
A
s s e t s
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
538,738
|
$
|
713,342
|
|||
Prepaid
expenses
|
-
|
6,416
|
|||||
Other
|
12,494
|
22,029
|
|||||
T
o t a l current assets
|
551,232
|
741,787
|
|||||
FUNDS
IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT (Note
2)
|
21,071
|
7,528
|
|||||
LONG
TERM DEPOSITS (Note
3)
|
22,270
|
5,203
|
|||||
PROPERTY
AND EQUIPMENT, NET (Note
4)
|
25,247
|
10,269
|
|||||
T
o t a l assets
|
$
|
619,820
|
$
|
764,787
|
|||
Liabilities
and stockholders' equity
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
279,857
|
$
|
159,379
|
|||
Payroll
and related accruals
|
49,242
|
14,655
|
|||||
T
o t a l current liabilities
|
329,099
|
174,034
|
|||||
LIABILITY
FOR EMPLOYEE RIGHTS UPON RETIREMENT
(Note 2)
|
31,531
|
13,725
|
|||||
COMMITMENTS
(Note
5)
|
|||||||
STOCKHOLDERS’
EQUITY:
|
|||||||
Preferred
stock, $ 0.0001 par value (20,000,000 shares
|
|||||||
authorized;
none issued and outstanding)
|
|||||||
Common
stock, $ 0.0001 par value (100,000,000 authorized shares;
|
|||||||
28,453,732
and 26,231,510 shares issued and
|
|||||||
outstanding as of September 30, 2006 and 2005,
respectively)
|
2,845
|
2,622
|
|||||
Additional
paid-in capital
|
3,172,284
|
1,767,601
|
|||||
Warrants
|
861,474
|
519,423
|
|||||
Deficit
accumulated during the development stage
|
(3,777,413
|
)
|
(1,712,618
|
)
|
|||
T
o t a l stockholders' equity
|
259,190
|
577,028
|
|||||
T
o t a l liabilities and stockholders’ equity
|
$
|
619,820
|
$
|
764,787
|
Period
from
|
||||||||||
October
6,
|
||||||||||
Year
ended
|
1998*
to
|
|||||||||
September
30
|
September
30
|
|||||||||
2006
|
2005
|
2006
|
||||||||
RESEARCH
AND DEVELOPMENT COSTS (Note
8)
|
$
|
802,254
|
$
|
545,928
|
$
|
1,515,174
|
||||
GENERAL
AND ADMINISTRATIVE
|
||||||||||
EXPENSES
(Note
9)
|
1,263,070
|
666,477
|
2,288,711
|
|||||||
OPERATING
LOSS
|
2,065,324
|
1,212,405
|
3,803,885
|
|||||||
FINANCIAL
INCOME
|
(44,130
|
)
|
(20,703
|
)
|
(64,833
|
)
|
||||
FINANCIAL
EXPENSES
|
14,979
|
6,830
|
22,114
|
|||||||
LOSS
BEFORE TAXES ON INCOME
|
2,036,173
|
1,198,532
|
3,761,166
|
|||||||
TAXES
ON INCOME
|
28,622
|
-
|
28,622
|
|||||||
LOSS
FROM OPERATIONS OF THE COMPANY AND ITS CONSOLIDATED
SUBSIDIARY
|
2,064,795
|
1,198,532
|
3,789,788
|
|||||||
MINORITY
INTERESTS IN LOSSES OF A SUBSIDIARY
|
-
|
-
|
(12,375
|
)
|
||||||
NET
LOSS FOR THE PERIOD
|
$
|
(2,064,795
|
)
|
$
|
(1,198,532
|
)
|
$
|
(3,777,413
|
)
|
|
BASIC
AND DILUTED LOSS PER
|
||||||||||
COMMON
SHARES
|
$
|
(0.074
|
)
|
$
|
(0.046
|
)
|
||||
WEIGHTED
AVERAGE NUMBER OF COMMON
|
||||||||||
SHARES
USED IN COMPUTING BASIC AND
|
||||||||||
DILUTED
LOSS PER COMMON SHARE
|
28,052,065
|
26,099,260
|
Deficit
|
|||||||||||||||||||
accumulated
|
|||||||||||||||||||
Common
|
Additional
|
during
|
|||||||||||||||||
Number
of
|
Stock
|
paid-in
|
development
|
||||||||||||||||
Shares
|
Amount
|
Warrants
|
capital
|
stage
|
Total
|
||||||||||||||
Changes
during the period from
|
|||||||||||||||||||
October
6, 1998 (date of incorporation)
|
|||||||||||||||||||
to
September 30, 2004
|
|||||||||||||||||||
Common
stock and warrants
|
|||||||||||||||||||
issued for cash
|
57,506,498
|
$
|
5,750
|
$
|
139,494
|
$
|
782,141
|
$
|
-
|
$
|
927,385
|
||||||||
Contributed
capital
|
7,025
|
7,025
|
|||||||||||||||||
Cancellation
of shares at
|
|||||||||||||||||||
June
8, 2004
|
(32,284,988
|
)
|
(3,228
|
)
|
3,228
|
||||||||||||||
Gain
on issuance of subsidiary
|
|||||||||||||||||||
Stock to third party
|
86,625
|
86,625
|
|||||||||||||||||
Stock
based compensation
|
62,600
|
62,600
|
|||||||||||||||||
Net
loss
|
(514,086
|
)
|
(514,086
|
)
|
|||||||||||||||
Balance
at September 30, 2004
|
25,221,510
|
2,522
|
139,494
|
941,619
|
(514,086
|
)
|
569,549
|
||||||||||||
Common
stock and warrants
|
|||||||||||||||||||
issued for cash on November 11,
|
|||||||||||||||||||
2004, net of issuance costs
|
978,000
|
97
|
367,892
|
766,630
|
1,134,619
|
||||||||||||||
Common
stock and warrants
|
|||||||||||||||||||
issued for cash on January 25,
|
|||||||||||||||||||
2005, net of issuance costs
|
32,000
|
3
|
12,037
|
24,760
|
36,800
|
||||||||||||||
Issuance
of warrants to Consultants'
|
34,592
|
34,592
|
|||||||||||||||||
Net
loss
|
(1,198,532
|
)
|
(1,198,532
|
)
|
|||||||||||||||
Balance
at September 30, 2005
|
26,231,510
|
2,622
|
519,423
|
1,767,601
|
(1,712,618
|
)
|
577,028
|
||||||||||||
Common
stock and warrants
|
|||||||||||||||||||
issued for cash on October 31,
|
|||||||||||||||||||
2005, net of issuance costs
|
666,666
|
67
|
72,410
|
365,670
|
438,147
|
||||||||||||||
Common
stock and warrants
|
|||||||||||||||||||
issued for cash on December 20,
|
|||||||||||||||||||
2005, net of issuance costs
|
1,555,556
|
156
|
269,641
|
804,998
|
1,074,795
|
||||||||||||||
Employees
and consultants stock based
compensation expenses
|
234,015
|
234,015
|
|||||||||||||||||
Net
loss
|
(2,064,795
|
)
|
(2,064,795
|
)
|
|||||||||||||||
Balance
at September 30, 2006
|
28,453,732
|
$
|
2,845
|
$
|
861,474
|
$
|
3,172,284
|
$
|
(3,777,413
|
)
|
$
|
259,190
|
Period
from
|
||||||||||
October
6,
|
||||||||||
Year
ended
|
1998*
to
|
|||||||||
September
30
|
September
30,
|
|||||||||
2006
|
2005
|
2006
|
||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||
Net
loss for the period
|
$
|
(2,064,795
|
)
|
$
|
(1,198,532
|
)
|
$
|
(3,777,413
|
)
|
|
Adjustments
required to reconcile net loss to net cash used
|
||||||||||
in
operating activities:
|
||||||||||
Income
and expenses not involving cash flows:
|
||||||||||
Depreciation
|
4,299
|
2,534
|
6,892
|
|||||||
Common
stock issued for services
|
-
|
-
|
3,000
|
|||||||
Minority
interests in losses of a subsidiary
|
-
|
-
|
(12,375
|
)
|
||||||
Write
off of in process research and development
|
-
|
-
|
100,000
|
|||||||
Employees
and consultants stock based compensation expenses
|
196,957
|
34,592
|
294,149
|
|||||||
Increase
in liability for employee rights upon retirement
|
17,806
|
13,725
|
31,531
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
Decrease
(increase) in prepaid expenses
|
6,416
|
4,613
|
-
|
|||||||
Decrease
(increase) in other current assets
|
9,535
|
(16,058
|
)
|
(12,494
|
)
|
|||||
Increase
in current liabilities
|
155,065
|
16,816
|
328,099
|
|||||||
Net
cash used in operating activities
|
(1,674,717
|
)
|
(1,142,310
|
)
|
(3,038,611
|
)
|
||||
CASH
FLOWS FROM INVESTING ACTIVITIES -
|
||||||||||
Increase
in long term deposits
|
(17,067
|
)
|
(5,203
|
)
|
(22,270
|
)
|
||||
Funds
in respect of employee rights upon retirement
|
(13,543
|
)
|
(7,528
|
)
|
(21,071
|
)
|
||||
Purchase
of property and equipment
|
(19,277
|
)
|
(8,904
|
)
|
(32,139
|
)
|
||||
Net
cash used in investing activities
|
(49,887
|
)
|
(21,635
|
)
|
(75,480
|
)
|
||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||
Issuance
of common stock and warrants net of issuance costs
|
1,550,000
|
1,171,419
|
3,652,829
|
|||||||
Net
cash provided by financing activities
|
1,550,000
|
1,171,419
|
3,652,829
|
|||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(174,604
|
)
|
7,474
|
538,738
|
||||||
BALANCE
OF CASH AND CASH EQUIVALENTS AT
|
||||||||||
BEGINNING
OF PERIOD
|
713,342
|
705,868
|
||||||||
BALANCE
OF CASH AND CASH EQUIVALENTS
|
||||||||||
AT
END OF PERIOD
|
$
|
538,738
|
$
|
713,342
|
$
|
538,738
|
a.
|
General:
|
b.
|
Accounting
principles
|
c.
|
Use
of estimates in the preparation of financial
statements
|
d.
|
Functional
currency
|
e.
|
Principles
of consolidation
|
f.
|
Property
and equipment
|
%
|
||
Computers
and peripheral equipment
|
33
|
|
Office
furniture and equipment
|
6-15
|
g.
|
Deferred
taxes
|
h.
|
Research
and development
|
i.
|
Cash
equivalents
|
j.
|
Comprehensive
loss
|
k.
|
Loss
per share
|
l.
|
Impairment
in value of long-lived
assets
|
m. |
Stock
based compensation
|
Year
ended
September
30,
|
|||||||
2006
|
2005
|
||||||
Net
loss as reported
|
$
|
(2,064,795
|
)
|
$
|
(1,198,532
|
)
|
|
Add
back: Stock based employee compensation expense
|
|||||||
included
in net loss as reported
|
163,517
|
-
|
|||||
Deduct:
pro forma stock based employee compensation
|
|||||||
expense
determined under fair value
|
|||||||
method
for all awards
|
(1,107,201
|
)
|
(153,287
|
)
|
|||
Recognize
the reversal of the pro forma stock based employee compensation
expense
determined under fair value method due to forfeiture of
awards
granted to employees
|
79,676
|
118,193
|
|||||
Pro
forma net loss
|
$
|
(2,928,803
|
)
|
$
|
(1,233,626
|
)
|
|
Net
loss per common shares:
|
|||||||
Basic
and diluted loss per shares - as reported
|
$
|
(0.074
|
)
|
$
|
(0.046
|
)
|
|
Basic
and diluted loss per shares - pro forma
|
$
|
(0.104
|
)
|
$
|
(0.047
|
)
|
For
options granted in
|
|||
Year
ended September 30,
|
|||
2006
|
2005
|
||
Expected
option life (years)
|
7.85
|
7.88
|
|
Expected
stock price volatility
|
80.0%-85.1%
|
71.9%-87.0%
|
|
Risk
free interest rate
|
4.5%
|
4.0%
|
|
Expected
dividend yield
|
0.0%
|
0.0%
|
n.
|
Recently
issued accounting
pronouncements:
|
1)
|
In
December 2004, the Financial Accounting Standards Board ("FASB")
issued
the revised Statement of Financial Accounting Standards ("FAS") No.
123,
Share-Based
Payment (FAS 123R),
which addresses the accounting for share-based payment transactions
in
which the Company obtains employee services in exchange for (a) equity
instruments of the Company or (b) liabilities that are based on the
fair
value of the Company’s equity instruments or that may be settled by the
issuance of such equity instruments. In March 2005, the SEC issued
Staff
Accounting Bulletin No. 107 (SAB 107) regarding the SEC's interpretation
of FAS 123R. FAS 123R eliminates the ability to account for employee
share-based payment transactions using APB Opinion No. 25, Accounting
for Stock Issued to Employees,
and requires instead that such transactions be accounted for using
the
grant-date fair value based method. This Statement will be effective
as of
the beginning of the first annual reporting period that begins after
December 15, 2005, for small business issuers, which is October 1,
2006 for the Company.
|
2)
|
In
June 2005, the Financial Accounting Standards Board issued FAS No.
154,
"Accounting Changes and Error Corrections - a replacement of APB
Opinion
No. 20 and FASB Statement No. 3". This Statement generally requires
retrospective application to prior periods' financial statements
of
changes in accounting principle. Previously, Opinion No. 20 required
that
most voluntary changes in accounting principle were recognized by
including the cumulative effect of changing to the new accounting
principle in net income of the period of the change. FAS 154 apply
to all
voluntary changes in accounting principle. It also applies to changes
required by an accounting pronouncement in the unusual instance that
the
pronouncement does not include specific transition provisions. When
a
pronouncement includes specific transition provisions, those provisions
should be followed. This Statement shall be applied to accounting
changes
and corrections of errors made in fiscal years beginning after December
15, 2005, which is the year beginning October 1, 2006 for the company.
|
3)
|
In
July 2006, the FASB issued FASB Interpretation (FIN) No. 48 “Accounting
for Uncertainty in Income Taxes” (FIN 48). FIN 48 prescribes a
comprehensive model for recognizing, measuring, presenting and disclosing
in the financial statements tax positions taken or expected to be
taken on
a tax return, including a decision whether to file or not to file
in a
particular jurisdiction. FIN 48 is effective for fiscal years beginning
after December 15, 2006 (year beginning October 1, 2007 for the Company).
If there are changes in net assets as a result of application of
FIN 48
these will be accounted for as an adjustment to retained earnings.
In the
Company’s opinion, implementation of this standard is not expected to have
a material effect on its financial statements in future
periods.
|
4)
|
In
September 2006, the FASB issued Statement of Financial Accounting
Standard
(SFAS) No. 157, "Fair Value Measurements" (“FAS 157”). FAS 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 No. 157 will apply whenever another
standard requires (or permits) assets or liabilities to be measured
at
fair value. The standard does not expand the use of fair value to
any new
circumstances. SFAS No. 157 is effective for financial statements
issued
for fiscal years beginning after November 15, 2007, and interim periods
within those fiscal years, which is the year beginning October 1,
2008 for
the company.
|
5)
|
In
September 2006, the SEC issued Staff Accounting Bulletin No. 108,
Considering the Effects of Prior Year Misstatements when Quantifying
Misstatements in Current Year Financial Statements ("SAB No. 108").
SAB
No. 108 provides guidance on the consideration of the effects of
prior
year misstatements in quantifying current year misstatements for
the
purpose of a materiality assessment. SAB 108 establishes an approach
that
requires quantification of financial statement errors based on the
effects
of each of the company's balance sheet and statement of operations
and the
related financial statement disclosures. SAB No. 108 permits existing
public companies to record the cumulative effect of initially applying
this approach in the first year ending after
November 15, 2006 by recording the necessary correcting adjustments
to the
carrying values of assets and liabilities as of the beginning of
that year
with the offsetting adjustment recorded to the opening balance of
retained
earnings. Additionally, the use of the cumulative effect transition
method
requires detailed disclosure of the nature and amount of each individual
error being corrected through the cumulative adjustment and how and
when
it arose. The company does not expect this Statement to have a material
effect on the company’s financial statements or its results of
operations.
|
6)
|
In
September 2006, the Financial Accounting Standards Board (the "FASB")
issued Statement of Financial Accounting Standard No. 158, "Employers'
Accounting for Defined Benefit Pension and Other Postretirement Plans"
(FAS 158). FAS 158 requires employers to fully recognize the obligations
associated with single-employer defined benefit pension, retiree
healthcare and other postretirement plans in their financial statements.
The provisions of FAS 158 are effective as of the end of the fiscal
year
ending after December 15, 2006, which is the year beginning October
1,
2007 for the Company. In the Company’s opinion, implementation of this
standard is not expected to have a material effect on its financial
statements in future periods.
|
o.
|
Reclassifications
|
a.
|
Israeli
labor laws and agreements require payment of severance pay upon dismissal
of an employee or upon termination of employment in certain other
circumstances. The subsidiary's severance pay liability to its employees,
mainly based upon length of service and the latest monthly salary
(one
month’s salary for each year worked), is reflected by the balance sheet
accrual under the “liability for employee rights upon retirement”. The
Company records the liability as if it was payable at each balance
sheet
date on an undiscounted basis. The liability is partly funded by
purchase
of insurance policies. The amounts funded are included in the balance
sheet as “funds in respect of employee rights upon retirement”. The
policies are the Company’s assets and under labor agreements, subject to
certain limitations, they may be transferred to the ownership of
the
beneficiary employees.
|
b.
|
The
severance pay expenses for the years ended September 30, 2006 and
2005,
were $17,806 and $13,725
respectively.
|
c.
|
Cash
flow information regarding the Company’s liability for employee rights
upon retirement:
|
1.
|
The
Company expects to contribute to the insurance policies $20,694 in
respect
of severance pay for the year ended September 30,
2007.
|
2.
|
Due
to the relatively young age of the Company’s and its subsidiary's
employees, benefit payments to employees reaching retirement age
in the
next 10 years, are not material. The amounts were determined based
on the
employees’ current salary rates and the number of service years that will
accumulate upon their retirement date. These amounts do not include
amounts that might be paid to employees who will cease working for
the
subsidiary before their normal retirement age.
|
a.
|
Composition
of property and equipment, grouped by major classifications, is as
follows:
|
September
30,
|
|||||||
2006
|
2005
|
||||||
Cost:
|
|||||||
Office
furniture and equipment
|
$
|
14,287
|
$
|
7,400
|
|||
Computers
and peripheral equipment
|
17,852
|
5,462
|
|||||
32,139
|
12,862
|
||||||
Less
- accumulated depreciation
|
6,892
|
2,593
|
|||||
$
|
25,247
|
$
|
10,269
|
b.
|
Depreciation
expense totaled $4,299 and $2,534 in the years ended September 30,
2006
and 2005, respectively.
|
a.
|
On
May 18, 2006 the subsidiary entered into a new lease agreement for
its new
office facilities, to which it entered on August 10, 2006. The new
lease
agreement is for a period of 36 months with an option to renew the
lease
for an additional 36 month period. The monthly lease payment is $2,236
(the monthly lease payment per previous agreement was $679). The
future
lease payments under the lease are $26,827, 26,827 and 22,356 for
the
years ending September 30, 2007, 2008 and 2009
respectively.
|
b.
|
The
subsidiary has entered into operating lease agreements for vehicles
used
by its employees for a period of 3
years.
|
c.
|
On
December 13, 2005, the subsidiary entered into a Research and Licensing
Agreement with Tel Hashomer Medical Research Infrastructure and Services
Ltd. (“THM”), pursuant to which the subsidiary has agreed to provide THM
with $200,000 in funding for THM to conduct a research project relating
to
the mechanism of action for IVIg, hyper-immune IVIg and use of IVIg
as an
anti-cancer treatment. As of September 30, 2006 the subsidiary paid
a
total of $100,000 to THS under this agreement. According to the agreement
THM has granted the subsidiary an exclusive worldwide license to
any
resulting technology and know-how as described in the above mentioned
agreement.
|
a.
|
Capital
stock
|
b.
|
Summary
of the company’s stock options
plans
|
1.
|
On
the first anniversary commencing the grant date - 25% of the
options.
|
2.
|
On
the last day of each of the 36 months following the first anniversary
of
the grant date, the options shall vest in equal monthly
installments.
|
Year
ended September 30
|
|||||||||||||
2006
|
2005
|
||||||||||||
Weighted
|
Weighted
|
||||||||||||
Number
|
average
|
Number
|
average
|
||||||||||
exercise
|
exercise
|
||||||||||||
price
|
price
|
||||||||||||
$
|
$
|
||||||||||||
For
options granted to
|
|||||||||||||
employees:
|
|||||||||||||
Options
outstanding at
|
|||||||||||||
beginning
of year
|
350,000
|
$
|
1.17
|
1,450,000
|
$
|
1.30
|
|||||||
Changes
during the year:
|
|||||||||||||
Granted
- at market price
|
380,000
|
1.31
|
300,000
|
1.15
|
|||||||||
Granted
- at an exercise
|
|||||||||||||
price less then market
|
|||||||||||||
price
|
2,250,000
|
1.23
|
|||||||||||
Exercised
|
-
|
-
|
-
|
||||||||||
Forfeited
|
(150,000
|
)
|
1.20
|
(1,400,000
|
)
|
1.30
|
|||||||
Expired
|
-
|
-
|
-
|
||||||||||
Options
outstanding at end
|
|||||||||||||
of
year
|
2,830,000
|
1.24
|
350,000
|
1.17
|
|||||||||
Options
exercisable at end
|
|||||||||||||
of
year
|
82,292
|
-
|
|||||||||||
Weighted
average fair
|
|||||||||||||
value
of options granted
|
|||||||||||||
during
the year
|
$
|
1.19
|
$
|
0.90
|
Options
outstanding
|
Options
exercisable
|
|||||||||
Number
|
Weighted
|
Weighted
|
Number
|
Weighted
|
||||||
Range
|
outstanding
|
average
|
average
|
exercisable
|
average
|
|||||
of
|
at
|
remaining
|
exercise
|
at
|
exercise
|
|||||
exercise
|
September
30,
|
contractual
|
price
|
September
30,
|
price
|
|||||
prices
|
2006
|
life
|
2006
|
|||||||
$
|
Years
|
$
|
$
|
|||||||
0.93
to 1.37
|
2,830,000
|
9.36
|
1.24
|
82,292
|
1.15
|
a.
|
Deferred
income taxes:
|
September
30,
|
|||||||
2006
|
2005
|
||||||
In
respect of:
|
|||||||
Net
operating loss carryforward
|
$
|
431,165
|
$
|
268,935
|
|||
Research
and development expenses
|
145,840
|
-
|
|||||
Start-up
costs
|
142,932
|
-
|
|||||
Other
|
6,209
|
-
|
|||||
Less
- Valuation allowance
|
(726,146
|
)
|
(268,935
|
)
|
|||
Net
deferred tax assets
|
-,-
|
-,-
|
b.
|
Corporate
taxation in the U.S.
|
c.
|
Corporation
taxation in Israel
|
d.
|
Reconciliation
of the theoretical tax expense to actual tax
expense
|
Year
ended
|
|||||||
September
30,
|
|||||||
2006
|
2005
|
||||||
Clinical
trials
|
$
|
390,717
|
$
|
239,200
|
|||
Consulting
|
142,404
|
127,082
|
|||||
Salaries
and related expenses
|
155,116
|
91,337
|
|||||
Costs
of registered patents
|
79,982
|
50,916
|
|||||
Compensation
costs in respect of warrants granted to
|
|||||||
consultants
|
33,440
|
34,590
|
|||||
Other
|
595
|
2,803
|
|||||
$
|
802,254
|
$
|
545,928
|
Year
ended
|
|||||||
September
30,
|
|||||||
2006
|
2005
|
||||||
Payroll
and related expenses
|
$
|
567,785
|
$
|
245,197
|
|||
Consulting
|
83,113
|
-
|
|||||
Travel
|
99,417
|
66,993
|
|||||
Professional
services
|
247,132
|
149,609
|
|||||
Insurance
|
57,481
|
56,162
|
|||||
Business
development
|
94,786
|
100,311
|
|||||
Other
|
113,356
|
48,205
|
|||||
$
|
1,263,070
|
$
|
666,477
|
a.
|
On
November 4, 2004, the Subsidiary entered into a consulting agreement
with
PBD Ltd. (the "Consultant"), a company controlled by a principal
shareholder of the Company. Pursuant to the terms of the agreement,
the
Subsidiary paid the Consultant a total fee of $50,000 for the services
provided as detailed in the agreement. Mainly the services
include summary
of pre-clinical data and collection of historical research data,
preparation of clinical trial, oncologist's survey for cancer indication,
a survey of complementary technologies, a survey of potential IVIg
collaborators and initiation of contacts with potential partners.
The
amount paid to the Consultant is included in "Research & development
costs" for the year ended September 30,
2005.
|
b.
|
On
March 1, 2005 the Company and its Subsidiary, entered into an agreement
appointing a principal shareholder as Vice President of Business
Development, in consideration of a salary of $4,000 per month, commencing
February 2005 and ended July 2,
2005.
|
c.
|
Effective
July 2, 2005, a related party served as the CEO of the Subsidiary
and as
acting CEO of the Company, devoting approximately 70% of her business
time
to the affairs of the Company and its subsidiary for a monthly salary
of
$6,475.
|
d.
|
On
April 15, 2006, the CEO of the subsidiary who also served as the
Acting
CEO of the company had resigned from its position as the acting CEO
of the
company, and continued as the CEO of the subsidiary.
|
e.
|
Payroll
and related expenses in respect of the related party, mentioned above
(b,c,d), for the year ended September 30, 2006 and 2005 was $111,610
and
$53,330 respectively.
|
f.
|
On
April 16, 2006, the Company entered into an employment agreement
(the
"Agreement") with its new CEO pursuant to which the new CEO will
serve as
CEO of the Company, effective April 15, 2006. The CEO shall receive
an
annual salary of $200,000 and an annual bonus of up to $200,000 upon
achieving certain objectives. Pursuant to a separate agreement between
the
company and the new CEO, the company agreed to indemnify the new
CEO for
substantially all liabilities he may incur as a result of his employment
by or service to the company.
|
a.
|
On
October 12, 2006 50,000 options were granted under the Stock Option
Plan
to a new member of the scientific advisory board, an outside party.
The
exercise price has been determined at $0.65 per share, which was
equivalent to the traded market price on the date of grant. As for
the
vesting period see note 6b above. The fair value of the above options
is
estimated by using Black Scholes option-pricing model as $27,055,
and was
based on the following assumptions: dividend yield of 0% for all
years;
expected volatility of 91%; risk-free interest rates of 4.65%; and
expected lives of 7.88 years.
|
b.
|
On
October 18, 2006 the Company entered into a Strategic Alliance Agreement
with UTEK Corporation (“UTEK”), pursuant to which UTEK would assist the
Corporation in identifying technology acquisition opportunities.
As
consideration for the services being provided to the Corporation
by UTEK,
the Corporation has agreed to issue UTEK an aggregate of 171,432
shares of
common stock, par value $0.0001 per share, of the Corporation, which
will
vest in 12 equal monthly instalments of 14,286
shares.
|
c.
|
On
November 13, 2006 150,000 options were granted under the Stock Option
Plan
to each of the Company’s two new board members (total - 300,000
options).
|
d.
|
On
November 20, 2006 the Company issued a convertible promissory note,
aggregate principal amount of $350,000, which bears interest at 8%
payable
on maturity of the note and matures on November 20, 2007. At the
discretion of the lender, in the event that the Company raises debt
or
equity financing during the 12 month period following the issuance
of the
note, the principal and interest due under the note is convertible
on the
same terms as such financing.
|
e.
|
On
December 5, 2006 50,000 options were granted under the Stock Option
Plan
to a new member of the scientific advisory board, an outside party.
The
exercise price has been determined at $0.50 per share, which was
equivalent to the traded market price on the date of grant. As for
the
vesting period see note 6b above. The fair value of the above options
is
estimated by using Black Scholes option-pricing model as $20,779,
and was
based on the following assumptions: dividend yield of 0% for all
years;
expected volatility of 91%; risk-free interest rates of 4.65%; and
expected lives of 7.88 years.
|
Name
|
Position
Held with our Company
|
Age
|
Date
First
Elected
or Appointed
|
Patrick
Schnegelsberg
|
Chief
Executive Officer of our company
|
42
|
April
16, 2006
|
Vered
Caplan
|
Chief
Executive Officer of GammaCan, Ltd.
|
38
|
March
1, 2005
|
Steven
Katz
|
Chairman
of the Board of our company
|
58
|
November
6, 2006
|
Albert
Passner
|
Director
of our company
|
68
|
November
6, 2006
|
Yair
Aloni
|
Director
of our company and GammaCan, Ltd.
|
56
|
August
17, 2004
|
Shmuel
Levi
|
Director
of our company and GammaCan, Ltd.
|
56
|
August
17, 2004
|
Josef
Neuhaus
|
Director
of our company and GammaCan, Ltd.
|
43
|
March
14, 2006
|
Chaime
Orlev
|
Chief
Financial Officer of our company and GammaCan, Ltd.
|
36
|
October
6, 2005
|
Prof.
Yehuda Shoenfeld, M.D.
|
Chief
Scientist of GammaCan, Ltd.
|
57
|
August
17, 2004
|
Annual
Compensation
|
Long
Term
Compensation
|
Pay-
outs
|
||||||||||||||||||||
Name
and Principal
Position
|
Year
|
Salary
|
Bonus
|
Other
Annual
Compen-
sation
|
Securities
Under
Options/
SAR's
Granted
|
Restricted
Shares
or
Restricted
Share
Units
|
LTIP
Pay-
outs
|
|||||||||||||||
Patrick
Schnegelsberg Chief Executive Officer
|
2006
|
99,084
|
Nil
|
Nil
|
1,400,000
|
Nil
|
Nil
|
|||||||||||||||
Vered
Caplan, (1)
Active Chief Executive Officer
|
2006
|
96,385
|
Nil
|
15,225
|
Nil
|
Nil
|
Nil
|
|||||||||||||||
Vered
Caplan, (1)
Active
Chief Executive Officer
|
2005
|
49,538
|
Nil
|
3,792
|
Nil
|
Nil
|
Nil
|
|||||||||||||||
Dr.
Dan J. Gelvan, (2)
Former Chief Executive Officer
|
2005
|
102,283
|
Nil
|
12,594
|
Nil
|
Nil
|
Nil
|
|||||||||||||||
Dr.
Dan J. Gelvan, (2)
Former Chief Executive Officer
|
2004
|
14,620
|
Nil
|
2,290
|
1,400,000
|
Nil
|
Nil
|
Name
|
No.
of Securities Underlying Options Granted (#)
|
%
of Total Options Granted to Employees in
Fiscal
Year
|
Exercise
Price
($/Sh)
|
Expiration
Date
|
Shmuel
Levi
|
50,000
|
11.1
|
1.15
|
June
21, 2015
|
Yair
Aloni
|
50,000
|
11.1
|
1.15
|
June
21, 2015
|
Jean-Pierre
Elisha Martinez
|
50,000
|
11.1
|
1.15
|
June
21, 2015
|
Lior
Soussan-Gutman
|
50,000
|
11.1
|
1.15
|
June
21, 2015
|
Adi
Avidar *
|
100,000
|
22.3
|
1.15
|
June
21, 2015
|
David
Sidransky
|
50,000
|
11.1
|
1.15
|
June
21, 2015
|
Yosef
Yarden
|
50,000
|
11.1
|
1.15
|
June
21, 2015
|
Dan
Shochat**
|
50,000
|
11.1
|
1.15
|
June
21, 2015
|
Name
|
No.
of Securities Underlying Options Granted (#)
|
%
of Total Options Granted to Employees in
Fiscal
Year
|
Exercise
Price
($/Sh)
|
Expiration
Date
|
Chaime
Orlev
|
350,000
|
13.3
|
0.93
|
October
6, 2015
|
Liat
Ben David
|
30,000
|
1.1
|
1.35
|
October
20, 2015
|
Jacob
Nusbacher
|
250,000
|
9.5
|
1.34
|
December
20, 2015
|
Yaron
Cherny
|
50,000
|
1.9
|
1.10
|
January
12, 2016
|
Josef
Neuhaus
|
50,000
|
1.9
|
1.37
|
March
15, 2016
|
Patrick
Schnegelsberg
|
1,400,000
|
53.3
|
1.29
|
April
17, 2016
|
Shmuel
Levi
|
100,000
|
3.8
|
1.29
|
May
4, 2016
|
Yair
Aloni
|
100,000
|
3.8
|
1.29
|
May
4, 2016
|
Jean-Pierre
Elisha Martinez
|
100,000
|
3.8
|
1.29
|
May
4, 2016
|
Lior
Soussan-Gutman
|
100,000
|
3.8
|
1.29
|
May
4, 2016
|
Josef
Neuhaus
|
100,000
|
3.8
|
1.29
|
May
4, 2016
|
1.
|
we
have received an aggregate of $3,000,000 in equity investments by
unrelated third parties, who are not currently
our shareholders,
|
2.
|
we
have executed an agreement for a sufficient supply of Intra-Venous
Immunoglobulin in order to conduct a clinical trial regarding melanoma,
and
|
3.
|
we
have submitted a completed Investigational New Drug application to
the US
Food and Drug Administration, in connection with clinical trails
of
VitiGam.
|
1.
|
we
have received an aggregate of $10,000,000 in equity investments by
unrelated third parties, who are not currently
our shareholders,
|
2.
|
we
have begun phase 2 of our clinical trials of VitiGam, and
|
3.
|
we
have closed a merger or acquisition with another entity that has
technology which is complementary to
our.
|
Name
and Address of Beneficial Owner
|
Amount
and Nature of
Beneficial
Ownership (1)
|
Percentage
of
Class (1)
|
Yair
Aloni
Director
of our company
12A
Shabazy St.
Tel
Aviv, Israel
|
(2)306,047
common shares
|
1.07%
|
Yehuda
Shoenfeld
Chief
Scientist of GammaCan, Ltd.
26
Sapir St.
Ramat
Gen
Israel
|
699,996
common shares
|
2.45%
|
Zeev
Bronfeld
6
Uri St.
Tel
Aviv, Israel
|
3,900,006
common shares
|
13.62%
|
Vered
Caplan
Chief
Executive Officer of GammaCan, Ltd.
69
Deganya St.
Pardes
Hanna Karkur, Israel
|
3,900,006
common shares
|
13.62%
|
Shmuel
Levi
Director
of the company
14
Hanita St.
Naharia,
Isreal
|
(3)26,042
common shares
|
0.09%
|
Chaime
Orlev
Chief
Financial Officer of the Coampny and GammaCan, Ltd.
10
Hameyasdim St.
Kiryat-Ono,
Israel
|
(3)116,667
common shares
|
0.41%
|
Vantech
Securities Ltd.
1305
1090 West Georgia St.
Vancouver,
B.C. V6E 3V7 Canada
|
1,650,000
common shares
|
5.76%
|
Directors
and Executive Officers as a Group
|
(4)5,048,757
common shares
|
17.53%
|
·
|
Summary
of pre-clinical data and collection of historical research
data.
|
·
|
Preparation
of clinical trial.
|
·
|
Oncologists
survey for cancer indication.
|
·
|
Survey
of complementary technologies
|
·
|
Survey
of potential IgG collaborators
|
·
|
Initiation
of contacts with potential
partners.
|
Number
|
Exhibit
|
|
3.1
|
Certificate
of Incorporation, with amendments, filed as an exhibit to the Company’s
Registration Statement on Form 10SB, dated June 4, 2001, and incorporated
herein by reference.
|
|
3.2
|
By-Laws,
filed as an exhibit to the Company’s Registration Statement on Form 10SB,
dated June 4, 2001, and incorporated herein by
reference.
|
|
4.1
|
2004
Employees and Consultants Stock Compensation Plan, incorporated by
reference from Form 8-K, dated as of August 17, 2004
|
|
Stock
Purchase Warrant in the name of Bank Sal. Oppenheim jr. & Cie.
(Switzerland) Ltd. dated October 31, 2005,
incorporated by reference from Form 8-K, dated as of November
3, 2005
|
||
10.1
|
Sale
of Intellectual Property Agreement dated June 11, 2004 between GammaCan,
Ltd. and ARP Biomed, Ltd., incorporated by reference from the Company’s
Form 8-K, dated as of June 21, 2004
|
|
10.2
|
Employment
Agreement dated August 17, 2004 between GammaCan Ltd. and Dr. Dan
J.
Gelvan, incorporated by reference from Form 8-K, dated as of August
17,
2004.
|
|
10.3
|
Addendum
to Employment Agreement between GammaCan, Ltd. and Dr. Dan J.
Gelvan,
dated as of October 12, 2004, incorporated by reference from Form
8-K
dated as of October 12, 2004
|
|
10.4
|
Indemnity
Agreement between GammaCan International, Inc. and Dr. Dan J.
Gelvan,
dated as of October 12, 2004, incorporated by reference from Form
8-K
dated as of October 12, 2004
|
|
10.5
|
Employment
Agreement dated August 17, 2004 between GammaCan Ltd. and Ms. Tovi
Ben
Zeev, incorporated by reference from Form 8-K, dated as of August
17,
2004
|
|
10.6
|
Addendum
to Employment Agreement between GammaCan, Ltd. and Tovi
Ben-Zeev,
dated as of October 12, 2004, incorporated by reference from Form
8-K
dated as of October 12, 2004
|
|
10.7
|
Indemnity
Agreement between GammaCan International, Inc. and Tovi
Ben-Zeev,
dated as of October 12, 2004, incorporated by reference from Form
8-K
dated as of October 12, 2004.
|
|
10.8
|
Services
Agreement dated August 17, 2004 between GammaCan, Ltd. and Prof.
Yehuda
Shoenfeld, M.D., incorporated by reference from Form 8-K, dated as
of
August 17, 2004
|
|
10.9
|
Consulting
agreement between GammaCan Ltd. and PBD Ltd., dated as of November
4,
2004,
incorporated by reference to Form 8-K dated as of November 4,
2004
|
|
10.10
|
Employment
Agreement between GammaCan, Ltd. and Vered Caplan, dated as of June
21,
2005, incorporated by reference to Form 8-K dated as of June 27,
2005
|
|
10.11
|
Indemnity
Agreement between GammaCan International, Inc. and Vered Caplan,
dated as
of June 27, 2005.
|
|
10.12
|
Employment
Agreement between GammaCan, Ltd. and Chaime Orlev, dated as of September
6, 2005, incorporated by reference to Form 8-K dated as of September
12,
2005
|
|
10.13
|
Indemnity
Agreement between GammaCan International, Inc. and Chaime Orlev,
dated as
of September 12, 2005.
|
|
10.14
|
Indemnity
Agreement between GammaCan International, Inc. and Josef Neuhaus,
dated as
of March 15, 2006, incorporated by reference to Form 8-K dated as
of March
20, 2006
|
10.15
|
Employment
Agreement between GammaCan, Ltd. and Patrick Schnegelsberg, dated
as of
April 16, 2006, incorporated by reference to Form 8-K dated as of
April
19, 2006
|
|
10.16
|
Indemnity
Agreement between GammaCan International, Inc. and Patrick Schnegelsberg,
dated as of April 17, 2006, incorporated by reference to Form 8-K
dated as
of April 19, 2006
|
|
10.17
|
Form
of Addendum to Indemnity Agreement, incorporated by reference to
Form 8-K
dated as of April 26, 2006
|
|
10.18
|
Indemnity
Agreement between GammaCan International, Inc. and Steven Katz, dated
as
of November 13, 2006, incorporated by reference to Form 8-K dated
as of
November 13, 2006
|
|
10.19
|
Indemnity
Agreement between GammaCan International, Inc. and Albert Passner,
dated
as of November 13, 2006, incorporated by reference to Form 8-K dated
as of
November 13, 2006
|
|
14
|
Code
of Ethics
|
|
31.1
|
Certification
of Principal Executive Officer pursuant to Rule 13a-14 and Rule 15d-14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended
|
|
31.2
|
Certification
of Principal Financial Officer pursuant to Rule 13a-14 and Rule 15d
14(a),
promulgated under the Securities and Exchange Act of 1934, as
amended
|
|
32.1
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002 (Chief Executive
Officer)
|
|
32.2
|
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of
the Sarbanes-Oxley Act of 2002 (Chief Financial
Officer)
|