Nevada
|
98-0376008
|
(State
or other jurisdiction of
incorporation
or organization)
|
(IRS
Employer Identification No.)
|
Large
accelerated filer
|
o
|
Accelerated
filer o
|
Non-accelerated
filer
|
o (Do not check if a smaller reporting company)
|
Smaller
reporting company x
|
1
|
||
ITEM 1 - FINANCIAL
STATEMENTS
|
1
|
|
ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
12
|
|
ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK
|
20
|
|
ITEM 4T - CONTROLS AND
PROCEDURES
|
20
|
|
PART
II - OTHER INFORMATION
|
23
|
|
ITEM 1 - LEGAL PROCEEDINGS
|
23
|
|
23
|
||
ITEM 6 - EXHIBITS
|
24
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Page
|
||
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS:
|
||
Balance
sheets
|
3
|
|
Statements
of operations
|
4
|
|
Statements
of changes in stockholders’ equity
|
5
|
|
Statements
of cash flows
|
6
|
|
Notes
to financial statements
|
7-11
|
February 28,
|
August 31,
|
|||||||
2010
|
2009
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 724,706 | $ | 1,716,866 | ||||
Short
term investments
|
1,400,000 | 1,000,000 | ||||||
Restricted
cash
|
16,000 | 16,000 | ||||||
Accounts
receivable - other
|
34,063 | 36,939 | ||||||
Prepaid
expenses
|
102,411 | 4,119 | ||||||
Grants
receivable from the Office of the Chief Scientist
|
179,132 | 400,405 | ||||||
Total
current assets
|
2,456,312 | 3,174,329 | ||||||
LONG
TERM DEPOSITS
|
11,814 | 12,161 | ||||||
PROPERTY AND EQUIPMENT,
net
|
59,605 | 75,361 | ||||||
Total
assets
|
$ | 2,527,731 | $ | 3,261,851 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 235,135 | $ | 321,344 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
282,387 | 368,596 | ||||||
PROVISION
FOR UNCERTAIN TAX POSITION
|
147,063 | 147,063 | ||||||
COMMITMENTS
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
stock of $ 0.001 par value - Authorized: 200,000,000 shares at
February 28, 2010 and August 31, 2009; Issued and outstanding: 57,454,707
at February 28, 2010 and 56,456,710 shares at August 31, 2009,
respectively
|
57,454 | 56,456 | ||||||
Additional
paid-in capital
|
13,054,509 | 12,698,414 | ||||||
Deficit
accumulated during the development stage
|
(11,013,682 | ) | (10,008,678 | ) | ||||
Total
stockholders' equity
|
2,098,281 | 2,746,192 | ||||||
Total
liabilities and stockholders' equity
|
$ | 2,527,731 | $ | 3,261,851 |
Period
|
||||||||||||||||||||
from April
|
||||||||||||||||||||
12, 2002
|
||||||||||||||||||||
(inception)
|
||||||||||||||||||||
Six months ended
|
Three months ended
|
through
|
||||||||||||||||||
February
28,
|
February
28,
|
February
28,
|
February
28,
|
February
28,
|
||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES
|
$ | 486,782 | $ | 1,113,146 | $ | 169,237 | $ | 274,970 | $ | 5,631,641 | ||||||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
522,619 | 735,373 | 222,663 | 371,508 | 4,780,170 | |||||||||||||||
OPERATING
LOSS
|
1,009,401 | 1,848,519 | 391,900 | 646,478 | 10,846,687 | |||||||||||||||
FINANCIAL
INCOME
|
(10,916 | ) | (30,700 | ) | (2,543 | ) | (8,556 | ) | (147,024 | ) | ||||||||||
FINANCIAL
EXPENSE
|
6,519 | 28,479 | 2,854 | 20,330 | 154,452 | |||||||||||||||
LOSS
BEFORE TAXES ON INCOME
|
1,005,004 | 1,846,298 | 392,211 | 658,252 | 10,854,115 | |||||||||||||||
TAXES
ON INCOME
|
- | - | - | - | 159,567 | |||||||||||||||
NET
LOSS FOR THE PERIOD
|
$ | 1,005,004 | $ | 1,846,298 | $ | 392,211 | $ | 658,252 | $ | 11,013,682 | ||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | 0.02 | $ | 0.03 | $ | 0.01 | $ | 0.01 | ||||||||||||
WEIGHTED
AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS
PER COMMON STOCK
|
57,289,266 | 56,416,080 | 57,422,484 | 56,469,027 |
Deficit
|
||||||||||||||||||||
accumulated
|
||||||||||||||||||||
Additional
|
during
the
|
Total
|
||||||||||||||||||
Common
Stock
|
paid-in
|
development
|
stockholders'
|
|||||||||||||||||
Shares
|
$
|
capital
|
stage
|
equity
|
||||||||||||||||
BALANCE AS OF APRIL 12,
2002 (inception)
|
34,828,200 | $ | 34,828 | $ | 18,872 | $ | 53,700 | |||||||||||||
CHANGES DURING THE PERIOD FROM
APRIL 12, 2002 THROUGH AUGUST 31, 2008
(audited):
|
||||||||||||||||||||
SHARES
CANCELLED
|
(19,800,000 | ) | (19,800 | ) | 19,800 | - | ||||||||||||||
SHARES
ISSUED FOR INVESTMENT IN ISTI-NJ
|
1,144,410 | 1,144 | 433,732 | 434,876 | ||||||||||||||||
SHARES
ISSUED FOR OFFERING COSTS
|
1,752,941 | 1,753 | (1,753 | ) | - | |||||||||||||||
SHARES
ISSUED FOR CASH– NET OF ISSUANCE EXPENSES
|
37,359,230 | 37,359 | 7,870,422 | 7,907,781 | ||||||||||||||||
SHARES
ISSUED FOR SERVICES
|
418,025 | 418 | 214,442 | 214,860 | ||||||||||||||||
CONTRIBUTIONS
TO PAID IN CAPITAL
|
18,991 | 18,991 | ||||||||||||||||||
RECEIPTS
ON ACCOUNT OF SHARES AND
WARRANTS
|
6,061 | 6,061 | ||||||||||||||||||
SHARES
ISSUED FOR CONVERSION OF CONVERTIBLE NOTE
|
550,000 | 550 | 274,450 | 275,000 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
2,605,796 | 2,605,796 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
203,982 | 203,982 | ||||||||||||||||||
DISCOUNT
ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION
FEATURE
|
108,000 | 108,000 | ||||||||||||||||||
COMPREHENSIVE
LOSS
|
(16 | ) | (16 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
12,217 | 12,217 | ||||||||||||||||||
NET
LOSS
|
(7,248,188 | ) | (7,248,188 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2008 (audited)
|
56,252,806 | 56,252 | 11,785,012 | (7,248,204 | ) | 4,593,060 | ||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED
|
203,904 | 204 | 152,724 | 152,928 | ||||||||||||||||
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
203,699 | 203,699 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
436,025 | 436,025 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
117,174 | 117,174 | ||||||||||||||||||
IMPUTED
INTEREST
|
3,780 | 3,780 | ||||||||||||||||||
NET
LOSS
|
(2,760,474 | ) | (2,760,474 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2009 (audited)
|
56,456,710 | 56,456 | 12,698,414 | (10,008,678 | ) | 2,746,192 | ||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED IN PREVIOUS PERIOD
|
569,887 | 570 | (570 | ) | - | |||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED
|
361,443 | 361 | 179,139 | 179,500 | ||||||||||||||||
SHARES
ISSUED FOR SERVICES TO BE RENDERED
|
66,667 | 67 | 19,933 | 20,000 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
133,849 | 133,849 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
21,854 | 21,854 | ||||||||||||||||||
IMPUTED
INTEREST
|
1,890 | 1,890 | ||||||||||||||||||
NET
LOSS
|
(1,005,004 | ) | (1,005,004 | ) | ||||||||||||||||
BALANCE
AS OF FEBRUARY 28, 2010 (unaudited)
|
57,454,707 | $ | 57,454 | $ | 13,054,509 | $ | (11,013,682 | ) | $ | 2,098,281 |
Six months ended
|
Period from April
12, 2002
(inception date)
through
|
|||||||||||
February 28,
|
February 28,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (1,005,004 | ) | $ | (1,846,298 | ) | $ | (11,013,682 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
15,756 | 15,111 | 61,698 | |||||||||
Amortization
of debt discount
|
- | - | 108,000 | |||||||||
Exchange
differences on long term deposits
|
347 | 1,804 | (654 | ) | ||||||||
Stock
based compensation
|
155,703 | 268,038 | 3,518,680 | |||||||||
Common
stock issued for services
|
199,500 | - | 567,288 | |||||||||
Common
stock to be issued for services
|
- | - | 203,699 | |||||||||
Impairment
of investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
1,890 | 1,890 | 17,887 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
125,857 | 226,549 | (315,606 | ) | ||||||||
Restricted
cash
|
- | - | (16,000 | ) | ||||||||
Accounts
payable and accrued expenses
|
(86,209 | ) | (217,225 | ) | 235,135 | |||||||
Provision
for uncertain tax position
|
- | - | 147,063 | |||||||||
Total
net cash used in operating activities
|
(592,160 | ) | (1,550,131 | ) | (6,051,616 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
- | (3,013 | ) | (121,303 | ) | |||||||
Acquisition
of short-term investments
|
(400,000 | ) | (4,128,000 | ) | ||||||||
Proceeds
from sale of Short term investments
|
- | 2,728,000 | 2,728,000 | |||||||||
Lease
deposits
|
- | (4,307 | ) | (11,160 | ) | |||||||
Total
net cash derived from (used in) investing activities
|
(400,000 | ) | 2,720,680 | (1,532,463 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from sales of common stock and warrants - net of issuance
expenses
|
- | - | 7,961,481 | |||||||||
Receipts
on account of shares issuances
|
6,061 | |||||||||||
Proceeds
from convertible notes
|
- | - | 275,000 | |||||||||
Proceeds
from short term note payable
|
- | - | 120,000 | |||||||||
Payments
of short term note payable
|
- | - | (120,000 | ) | ||||||||
Shareholder
advances
|
- | - | 66,243 | |||||||||
Net cash provided by financing activities
|
- | - | 8,308,785 | |||||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(992,160 | ) | 1,170,549 | 724,706 | ||||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
1,716,866 | 2,267,320 | - | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 724,706 | $ | 3,437,869 | $ | 724,706 | ||||||
Non
cash investing and financing activities:
|
||||||||||||
Shares
issued for offering costs
|
$ | 1,753 | ||||||||||
Contribution
to paid in capital
|
$ | $18,991 | ||||||||||
Discount
on convertible note related to beneficial conversion
feature
|
$ | 108,000 | ||||||||||
Shares
issued for services rendered
|
$ | 152,928 |
|
a.
|
General:
|
|
1.
|
Oramed
Pharmaceuticals Inc. (the “Company”) was incorporated on April 12, 2002,
under the laws of the State of Nevada. From incorporation until March 3,
2006, the Company was an exploration stage company engaged in the
acquisition and exploration of mineral properties. On February 17, 2006,
the Company entered into an agreement with Hadasit Medical Services and
Development Ltd (the “First Agreement”) to acquire the provisional patent
related to orally ingestible insulin pill to be used for the treatment of
individuals with diabetes. The Company has been in the development stage
since its formation and has not yet realized any revenues from its
operations.
|
|
On
May 14, 2007, the Company incorporated a wholly-owned subsidiary in
Israel, Oramed Ltd., which is engaged in research and development. Unless
the context indicates otherwise, the term “Group” refers to Oramed
Pharmaceuticals Inc. and its Israeli subsidiary, Oramed Ltd. (the
“Subsidiary”).
|
|
The
group is engaged in research and development in the biotechnology field
and is considered a development stage company in accordance with ASC Topic
915 (formerly FAS 7) “Development Stage
Entities”.
|
|
2.
|
The
accompanying unaudited interim consolidated financial statements as of
February 28, 2010 and for the six months then ended, have been prepared in
accordance with accounting principles generally accepted in the United
States relating to the preparation of financial statements for interim
periods. Accordingly, they do not include all the information and
footnotes required for annual financial statements. In the opinion of
management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. Operating
results for the six months ended February 28, 2010, are not necessarily
indicative of the results that may be expected for the year ending August
31, 2010.
|
|
3.
|
Going
concern considerations
|
NOTE 1 -
|
SIGNIFICANT ACCOUNTING
POLICIES(continued):
|
b.
|
Newly
issued and recently adopted Accounting
Pronouncements
|
|
In
February 2010, the FASB issued Accounting Standards Update No. 2010-09
("ASU 2010-09"), "Subsequent Events (Topic 855): Amendments to Certain
Recognition and Disclosure Requirements," which among other things amended
ASC 855 to remove the requirement for an SEC filer to disclose the date
through which subsequent events have been evaluated. This change
alleviates potential conflicts between ASC 855 and the SEC's requirements.
All of the amendments in this update are effective upon issuance of this
update. Management has included the provisions of these amendments in the
financial statements.
|
c.
|
Reclassification:
|
NOTE 2 -
|
COMMITMENTS:
|
|
a.
|
Under
the terms of the First Agreement with Hadasit (note 1a(1) above), the
Company retained Hadasit to provide consulting and clinical trial
services. As remuneration for the services provided under the agreement,
Hadasit is entitled to $200,000. The primary researcher for Hadasit is Dr.
Miriam Kidron, a director and officer of the Company. The funds paid to
Hadasit under the agreement are deposited by Hadasit into a research fund
managed by Dr. Kidron. Pursuant to the general policy of Hadasit with
respect to its research funds, Dr. Kidron receives from Hadasit a
management fee in the rate of 10% of all the funds deposited into this
research fund.
|
|
b.
|
During
January and April 2008 the Company entered into agreements with OnQ
consulting, a clinical research organization (CRO) located in
Johannesburg, South Africa, to conduct Phase 1B and 2B clinical trials on
its oral insulin capsules. The total cost estimated for the studies is
$229,681 of which $182,187 was paid through February 28,
2010.
|
|
c.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note
3a.
|
NOTE 2 –
|
COMMITMENTS
(continued):
|
|
d.
|
On
April 22, 2009, the subsidiary entered into a consulting service agreement
with ADRES
Advanced Regulatory Services Ltd. (“ADRES”) pursuant to which ADRES
will provide consulting services relating to quality assurance and
regulatory processes and procedures in order to assist the subsidiary in
submission of a U.S. Investigational New Drug (“IND”) according to FDA
regulations. In consideration for the services provided under the
agreement, ADRES will be entitled to a total cash compensation of
$211,000, of which the amount $110,000 will be paid as a monthly
fixed fee of $10,000 each month for 11 months commencing May 2009, and the
remaining $101,000 will be paid based on achievement of certain
milestones. $120,000 of the total amount was paid through February 28,
2010.
|
|
e.
|
On
February 10, 2010, the subsidiary entered into agreements with Vetgenerics
Research G. Ziv Ltd, a clinical research organization (CRO), to conduct a
toxicology trial on its oral insulin capsules. The total cost estimated
for the studies is €107,100 of which €12,195 was paid through February 28,
2010.
|
|
f.
|
Grants
from the Chief Scientist Office
("OCS")
|
NOTE
3 -
|
STOCK BASED
COMPENSATION:
|
|
a.
|
On
October 30, 2006 the Company entered into a Clinical Trial Manufacturing
Agreement with Swiss Caps AG (“Swiss”), pursuant to
which Swiss would manufacture and deliver the oral insulin capsule
developed by the Company. In consideration for the services being provided
to the Company by Swiss, the Company agreed to pay a certain predetermined
amounts which are to be paid in common stocks of the Company, the number
of stocks to be issued is based on the invoice received from Swiss, and
the stock market price 10 days after the invoice was issued. The Company
accounted the transaction with Swiss according to FASB ASC 480
"Distinguishing Liabilities from Equity" (formerly FAS
150).
|
b.
|
On
November 23, 2009, 100,000 options were granted to a consultant, at an
exercise price of $0.76 per share (higher than the traded market price on
the date of grant), the options vest in three equal annual instalments
commencing November 23, 2010 and expire on November 23,
2014. The fair value of these options as of February 28, 2010,
was $31,458, using the Black Scholes option-pricing model and was based on
the following assumptions: dividend yield of 0% for all years; expected
volatility of 122.49%; risk-free interest rates of 2.30%; and the
remaining contractual life of 4.74
years.
|
c.
|
On
November 23, 2009, 36,000 options were granted to an employee of the
Subsidiary, at an exercise price of $0.46 per share (equivalent to the
traded market price on the date of grant), the options vest in three equal
annual instalments commencing November 23, 2010 and expire on November 23,
2019. The fair value of these options on the date of grant was $14,565,
using the Black Scholes option-pricing model and was based on the
following assumptions: dividend yield of 0% for all years; expected
volatility of 123.55%; risk-free interest rates of 2.55%; and the
remaining contractual life of 6
years.
|
d.
|
On
December 29, 2009, the Company issued 100,000 shares of its common stock
to a third party as remuneration for services rendered and to be rendered
during the six month period commencing December 15, 2009. The fair value
of these shares on the date of issuance was
$37,000.
|
NOTE
4 -
|
FAIR
VALUE:
|
|
a)
|
On
March 16, 2010, 50,000 options were granted to a consultant of the
subsidiary at an exercise price of $0.50 per share. The options vest in
three equal annual instalments commencing on March 16, 2011 and will
expire on March 15, 2015.
|
|
b)
|
On
March 16, 2010, 100,000 options were granted to a consultant of the
Company at an exercise price of $0.43 per share. The options vest in three
equal monthly instalments commencing on March 30, 2010 and will expire on
March 15, 2015.
|
|
c)
|
On
March 16, 2010, 13,200 options were granted to a consultant of the Company
at an exercise price of $0.43 per share. The options vest in six monthly
instalments commencing on March 30, 2010 and will expire on March 15,
2015.
|
|
d)
|
On
March 25, 2010, 100,000 options were granted to a consultant of the
Company at an exercise price of $0.50 per share. The options vest in four
equal quarterly instalments commencing on May 17, 2010 and will expire on
March 25, 2015.
|
Six months ended
|
Three months ended
|
|||||||||||||||
Operating Data:
|
February 28,
2010
|
February 28,
2009
|
February 28,
2010
|
February 28,
2009
|
||||||||||||
Research
and development costs
|
$ | 486,782 | $ | 1,113,146 | $ | 169,237 | $ | 274,970 | ||||||||
General
and administrative expenses
|
522,619 | 735,373 | 222,663 | 371,508 | ||||||||||||
Financial
(income) expense, net
|
(4,397 | ) | (2,221 | ) | 311 | 11,774 | ||||||||||
Net
loss for the period
|
1,005,004 | 1,846,298 | $ | 392,211 | $ | 658,252 | ||||||||||
Loss
per common share – basic and diluted
|
$ | 0.02 | $ | 0.03 | $ | 0.01 | $ | 0.01 | ||||||||
Weighted
average common shares outstanding
|
57,289,266 | 56,416,080 | 57,442,484 | 56,469,027 |
|
·
|
On
September 11, 2009, we issued 569,887 shares of common stock valued at
$203,699 to a third party, for services rendered in the prior
year.
|
|
·
|
On
December 29, 2009, we issued 328,110 shares of common stock valued at
$167,310 to a third party, for services
rendered.
|
|
·
|
On
December 29, 2009, we issued 100,000 shares of common stock valued at
$30,000 to a third party, for services rendered and to be rendered during
the six month period commencing December 15,
2009.
|
|
·
|
On
November 23, 2009 we granted options under the 2008 Stock Incentive Plan
to purchase up to 100,000 shares of our common stock at an exercise price
of $0.76 to a consultant.
|
|
·
|
On
November 23, 2009 we granted options under the 2008 Stock Incentive Plan
to purchase up to 36,000 shares of our common stock at an exercise price
of $0.46 to an employee of our
subsidiary.
|
Operating:
|
Amount
|
|||
|
||||
Research
and development costs, net of OCS funds
|
$ | 4,760,000 | ||
General
and administrative expenses
|
1,010,000 | |||
Financial
income, net
|
(10,000 | ) | ||
Taxes
on income
|
- | |||
Total
|
$ | 5,760,000 |
(a)
|
Disclosure
Controls and Procedures
|
(b)
|
Management’s
Annual Report on Internal Control over Financial
Reporting
|
|
·
|
pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect our transactions and asset
dispositions;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
the preparation of our financial statements in accordance with generally
accepted accounting principles, and that our receipts and expenditures are
being made only in accordance with authorizations of our management and
directors; and
|
|
·
|
provide
reasonable assurance regarding the prevention or timely detection of
unauthorized acquisition, use or disposition of assets that could have a
material effect on our financial
statements.
|
(c)
|
Changes
in Internal Control over Financial
Reporting
|
|
·
|
On
September 11, 2009, we issued 569,887 shares of common stock valued at
$203,699 to a third party, for services rendered in the prior
year.
|
|
·
|
On
December 29, 2009, we issued 328,110 shares of common stock valued at
$167,310 to a third party, for services
rendered.
|
|
·
|
On
December 29, 2009, we issued 100,000 shares of common stock valued at
$30,000 to a third party, for services rendered and to be rendered during
the six month period commencing December 15,
2009.
|
|
·
|
On
February 17, 2010, we entered into an agreement with a member of our
scientific advisory board, granting options to purchase 100,000 shares of
common stock at an exercise price per share of $0.50. The options vest in
four installments of 25,000 each, on each three-month anniversary
commencing February 17, 2010.
|
|
·
|
On
February 11, 2010, we entered into a consulting agreement for a six-month
term whereby the consultant was granted options to purchase 13,200 shares
of common stock at an exercise price per share of $0.43 vesting over the
consulting period.
|
|
·
|
On
April 11, 2010, we entered into a consulting agreement for a two-year term
whereby the consultant was granted options to purchase 50,000 shares of
common stock at an exercise price per share of $0.50. The
options vest in three equal installments, on each three-year anniversary
commencing March 16, 2011.
|
|
·
|
On
April 11, 2010, we entered into a consulting agreement for a three-month
term whereby the consultant was granted options to purchase 100,000 shares
of common stock at an exercise price per share of $0.43. The
options vest in three equal installments, on March 30, 2010, April 30,
2010 and May 30, 2010.
|
Number
|
Exhibit
|
|
(3)
|
Articles
of Incorporation and By-laws
|
|
3.1
|
Articles
of Incorporation (incorporated by reference from our Registration
Statement on Form S-1 file no. 333-164286 filed on January 11,
2010).
|
|
3.2
|
Bylaws
(incorporated by reference from our Current Report on Form 8-K filed on
April 10, 2006).
|
|
3.3
|
Articles
of Merger filed with the Nevada Secretary of State on March 29, 2006
(incorporated by reference to our Current Report on Form 8-K filed on
April 10, 2006).
|
|
(4)
|
Instruments
defining rights of security holders, including
indentures
|
|
4.1
|
Specimen
Stock Certificate (incorporated by reference from our Registration
Statement on Form SB-2, filed on November 29, 2002).
|
|
4.2
|
Form
of warrant certificate (incorporated by reference from our current report
on Form 8-K filed on June 18, 2007)
|
|
(10)
|
Material
Contracts
|
|
10.1
|
Agreement
dated February 17, 2006, between our company and Hadasit Medical Services
and Development Ltd. (incorporated by reference from our current report on
Form 8-K filed February 17, 2006).
|
|
10.2
|
Agreement
dated October 30, 2006, between our company and Swiss Caps AG
(incorporated by reference from our current report on Form 8-K filed
October 26, 2006).
|
|
10.3
|
Agreement
dated January 7, 2008, between our company and Hadasit Medical Services
and Development Ltd. (incorporated by reference from our current report on
Form 8-K filed January 7, 2008).
|
|
10.4
|
Agreement
dated April 22, 2009, between Oramed Ltd. and ADRES Advanced Regulatory
Services Ltd. (incorporated by reference from our current report on Form
8-K filed April 22, 2009).
|
|
10.5
|
Agreement
dated July 8, 2009, between our company and Hadasit Medical Services and
Development Ltd. (incorporated by reference from our current report on
Form 8-K filed July 9, 2009).
|
|
(31)
|
Section
302 Certification
|
|
31.1
*
|
Certification
Statement of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
31.2
*
|
Certification
Statement of the Principal Accounting Officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
(32)
|
Section
906 Certification
|
|
32.1
*
|
Certification
Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of
2002
|
|
32.2
*
|
Certification
Statement of the Principal Accounting Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
Of
2002
|
*
|
Filed
herewith
|
ORAMED
PHARMACEUTICALS INC.
|
||
Registrant
|
||
Date: April
12, 2010
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: April
12, 2010
|
By:
|
/s/ Yifat
Zommer
|
Yifat
Zommer
|
||
Chief
Financial Officer
|
a)
|
designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this quarterly report is
being prepared;
|
b)
|
designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
c)
|
evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
d)
|
disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting.
|
a)
|
all
significant deficiencies and material weaknesses in the design or
operation of internal controls which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report
financial information; and
|
b)
|
any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting;
|
Dated: April
12, 2010
|
By:
|
/s/ NADAV
KIDRON
|
||
Name: Nadav
Kidron
|
||||
Title: President,
Chief Executive Officer
|
||||
and
Director
|
a)
|
designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this quarterly report is
being prepared;
|
b)
|
designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
c)
|
evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such
evaluation; and
|
d)
|
disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting.
|
|
a)
|
all
significant deficiencies and material weaknesses in the design or
operation of internal controls which are reasonably likely to adversely
affect the registrant’s ability to record, process, summarize and report
financial information; and
|
|
b)
|
any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting;
|
Dated: April
12, 2010
|
By:
|
/s/ YIFAT
ZOMMER
|
||
Name:
Yifat Zommer,
|
||||
Title: Chief
Financial Officer
|
|
(1)
|
The
Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities and Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
Dated: April
12, 2010
|
By:
|
/s/ NADAV
KIDRON
|
||
Name: Nadav
Kidron
|
||||
Title: President,
Chief Executive Officer
|
||||
and
Director
|
|
(1)
|
The
Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities and Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
Dated: April
12, 2010
|
By:
|
/s/ YIFAT
ZOMMER
|
||
Name: Yifat
Zommer,
|
||||
Title: Chief
Financial Officer
|