Nevada
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98-0376008
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(State
or other jurisdiction of
incorporation
or organization)
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(IRS
Employer Identification
No.)
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Large accelerated filer o
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Accelerated filer
o
|
|
|
|||
Non-accelerated filer o
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(Do not check if a smaller reporting company)
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Smaller reporting company x
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PART
I – FINANCIAL INFORMATION
|
1
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ITEM
1 – FINANCIAL STATEMENTS
|
1
|
ITEM
2 – MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
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13
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ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
22
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ITEM
4 – CONTROLS AND PROCEDURES
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22
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ITEM
1 – LEGAL PROCEEDINGS
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24
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ITEM
2A – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
24
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ITEM
6 – EXHIBITS
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25
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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
|
7-12
|
November
30,
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August
31,
|
|||||||
2009
|
2009
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 1,146,128 | $ | 1,716,866 | ||||
Short
term investments
|
1,400,000 | 1,000,000 | ||||||
Restricted
cash
|
16,000 | 16,000 | ||||||
Accounts
receivable - other
|
34,154 | 36,939 | ||||||
Prepaid
expenses
|
23,610 | 4,119 | ||||||
Grants
receivable from the Office of the Chief Scientist
|
260,982 | 400,405 | ||||||
Total
current assets
|
2,880,874 | 3,174,329 | ||||||
LONG
TERM DEPOSITS
|
12,222 | 12,161 | ||||||
PROPERTY AND EQUIPMENT,
net
|
67,372 | 75,361 | ||||||
Total
assets
|
$ | 2,960,468 | $ | 3,261,851 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 364,332 | $ | 321,344 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
411,584 | 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
November 30, 2009 and August 31, 2009; Issued and outstanding: 57,026,597
at November 30, 2009 and 56,456,710 shares at August 31, 2009,
respectively
|
57,026 | 56,456 | ||||||
Additional
paid-in capital
|
12,966,266 | 12,698,414 | ||||||
Deficit
accumulated during the development stage
|
(10,621,471 | ) | (10,008,678 | ) | ||||
Total
stockholders' equity
|
2,401,821 | 2,746,192 | ||||||
Total
liabilities and stockholders' equity
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$ | 2,960,468 | $ | 3,261,851 |
Period
|
||||||||||||
from
April
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||||||||||||
12,
2002
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||||||||||||
(inception)
|
||||||||||||
Three
months ended
|
through
|
|||||||||||
November
30
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November
30
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Unaudited
|
||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES, net
|
$ | 317,545 | $ | 818,680 | $ | 5,462,404 | ||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
299,956 | 383,361 | 4,557,507 | |||||||||
OPERATING
LOSS
|
617,501 | 1,202,041 | 10,454,787 | |||||||||
FINANCIAL
INCOME
|
(8,373 | ) | (22,144 | ) | (144,481 | ) | ||||||
FINANCIAL
EXPENSE
|
3,665 | 8,149 | 151,598 | |||||||||
LOSS
BEFORE TAXES ON INCOME
|
612,793 | 1,188,046 | 10,461,904 | |||||||||
TAXES
ON INCOME
|
- | - | 159,567 | |||||||||
NET
LOSS FOR THE PERIOD
|
$ | 612,793 | $ | 1,188,046 | $ | 10,621,471 | ||||||
BASIC
AND DILUTED LOSS PER
|
||||||||||||
COMMON
SHARE
|
$ | (0.01 | ) | $ | (0.02 | ) | ||||||
WEIGHTED
AVERAGE NUMBER OF COMMON
|
||||||||||||
STOCK
USED IN COMPUTING BASIC AND
|
||||||||||||
DILUTED
LOSS PER COMMON STOCK
|
57,158,865 | 56,363,714 |
Deficit
|
||||||||||||||||||||
accumulated
|
||||||||||||||||||||
Additional
|
during
the
|
Total
|
||||||||||||||||||
Common
Stock
|
paid-in
|
development
|
stockholders'
|
|||||||||||||||||
Shares
|
$
|
capital
|
stage
|
equity
|
||||||||||||||||
BALANCE AS OF APRIL 12,
2002 (inception)
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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
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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)
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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
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436,025 | 436,025 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
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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
TO BE ISSUED FOR SERVICES RENDERED
|
169,500 | 169,500 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
81,316 | 81,316 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
16,661 | 16,661 | ||||||||||||||||||
IMPUTED
INTEREST
|
945 | 945 | ||||||||||||||||||
NET
LOSS
|
(612,793 | ) | (612,793 | ) | ||||||||||||||||
BALANCE
AS OF NOVEMBER 30, 2009 (unaudited)
|
57,026,597 | $ | 57,026 | $ | 12,966,266 | $ | (10,621,471 | ) | $ | 2,401,821 |
Three
months ended
|
Period
from April
12, 2002 (inception date) through |
|||||||||||
November
30
|
November
30,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (612,793 | ) | $ | (1,188,046 | ) | $ | (10,621,471 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
7,989 | 7,497 | 53,931 | |||||||||
Amortization
of debt discount
|
- | - | 108,000 | |||||||||
Exchange
differences on long term deposits
|
(61 | ) | 967 | (1,062 | ) | |||||||
Stock based
compensation
|
97,977 | 101,647 | 3,460,954 | |||||||||
Common stock issued for
services
|
- | - | 367,788 | |||||||||
Common stock to be issued for
services
|
169,500 | - | 373,199 | |||||||||
Impairment of
investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
945 | 945 | 16,942 | |||||||||
Changes in operating assets and
liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
122,717 | 104,880 | (318,746 | ) | ||||||||
Restricted
cash
|
- | - | (16,000 | ) | ||||||||
Accounts payable and accrued
expenses
|
42,988 | (100,872 | ) | 364,332 | ||||||||
Provision for uncertain tax
position
|
- | - | 147,063 | |||||||||
Total
net cash used in operating activities
|
(170,738 | ) | (1,072,982 | ) | (5,630,194 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
- | (1,469 | ) | (121,303 | ) | |||||||
Acquisition
of short-term investments
|
(400,000 | ) | - | (4,128,000 | ) | |||||||
Proceeds
from sale of Short term investments
|
- | 1,000,000 | 2,728,000 | |||||||||
Lease
deposits
|
- | (1,919 | ) | (11,160 | ) | |||||||
Total
net cash used in investing activities
|
(400,000 | ) | 996,612 | (1,532,463 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds from sales of common
stocks 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
|
(570,738 | ) | (76,370 | ) | 1,146,128 | |||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
1,716,866 | 2,267,320 | - | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 1,146,128 | $ | 2,190,950 | $ | 1,146,128 | ||||||
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 planned
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
November 30, 2009 and for the three 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 three months ended November 30, 2009, are not necessarily
indicative of the results that may be expected for the year ending August
31, 2010.
|
|
3.
|
Going
concern considerations
|
b.
|
Newly
issued and recently adopted Accounting
Pronouncements
|
|
1.
|
In
April 2009, the Financial Accounting Standards Board (“FASB”) issued ASC
Topic 825 “Financial Instruments” (formerly FSP No. FAS 107-1
and APB 28-1, “Interim Disclosures about Fair Value of Financial
Instruments.” ASC 825 requires companies to disclose in interim
financial statements the fair value of financial instruments within the
scope of ASC Topic 820 “Fair Value Measurements and Disclosures” (formerly
FASB Statement No. 107, Disclosures about Fair Value of Financial
Instruments). However, companies are not required to provide in
interim periods the disclosures about the concentration of credit risk of
all financial instruments that are currently required in annual financial
statements. The fair-value information disclosed in the
footnotes must be presented together with the related carrying amount,
making it clear whether the fair value and carrying amount represent
assets or liabilities and how the carrying amount relates to what is
reported in the balance sheet.
|
|
ASC
825 also requires that companies disclose the method or methods and
significant assumptions used to estimate the fair value of financial
instruments and a discussion of changes, if any, in the method or methods
and significant assumptions during the period. The ASC shall be
applied prospectively and is effective for interim and annual periods
ending after June 15, 2009. To the extent relevant, the
Company adopted the disclosure requirements of this pronouncement for the
quarter ended November 30, 2009, in conjunction with the adoption of ASC
Topic 820 (formerly FSP FAS 157-4), ASC Topic 320 (formerly FSP
FAS 115-2) and ASC Topic 958 (formerly
FAS 124-2). The adoption of the new disclosure
requirements did not have a material impact on the Company’s financial
statements.
|
|
2.
|
In
May 2009, the FASB issued ASC Topic 855 “Subsequent Events”
(formerly SFAS No. 165, Subsequent Events). ASC 855 sets forth
the period after the balance sheet date during which management of a
reporting entity should evaluate events or transactions that may occur for
potential recognition or disclosure in the financial statements, the
circumstances under which an entity should recognize events or
transactions occurring after the balance sheet date in its financial
statements, and the disclosures that an entity should make about events or
transactions that occurred after the balance sheet date. ASC 855 is
effective for interim or annual periods ending after June 15, 2009 and
will be applied prospectively. The Company adopted the
provisions of ASC 855 for the quarter ended November 30,
2009. The adoption of ASC 855 did not have a material impact on
the Company’s condensed financial condition, results of operations or cash
flows.
|
|
3.
|
In
June 2009, the FASB issued Accounting Standards Update (“ASU”) No. 2009-1,
“Topic 105 — Generally
Accepted Accounting Principles” which amended ASC 105 “The “FASB
Accounting Standards Codification” and the Hierarchy of Generally Accepted
Accounting Principles (formerly SFAS No. 168 “The FASB Accounting
Standards Codification and the Hierarchy of Generally Accepted Accounting
Principles – A Replacement of FASB Statement No. 162”). ASU 2009-1
establishes the FASB Accounting Standards CodificationTM (Codification)
as the single source of authoritative U.S. generally accepted accounting
principles (U.S. GAAP) recognized by the FASB to be applied by
nongovernmental entities. Rules and interpretive releases of the SEC under
authority of federal securities laws are also sources of authoritative
U.S. GAAP for SEC registrants.
|
|
ASU
2009-1 and the Codification are effective for financial statements issued
for interim and annual periods ending after September 15, 2009. The
Codification supersedes all existing non-SEC accounting and reporting
standards. All other nongrandfathered non-SEC accounting literature not
included in the Codification will become nonauthoritative. Following ASU
2009-1, the FASB will not issue new standards in the form of Statements,
FASB Staff Positions, or Emerging Issues Task Force Abstracts. Instead,
the FASB will issue Accounting Standards Updates, which will serve only
to: (a) update the Codification; (b) provide background information about
the guidance; and (c) provide the bases for conclusions on the change(s)
in the Codification. The adoption of ASU 2009-1did not have a material
impact on the Company’s financial
statements.
|
|
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 $107,599 was paid through November 30,
2009.
|
|
c.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note
3a and 5a.
|
|
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.
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. $80,000 of the total amount was paid through
November 30, 2009.
|
|
e.
|
Grants
from the Chief Scientist Office
("OCS")
|
|
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.
|
|
c.
|
On
November 23, 2009, 36,000 options were granted to an employee of our
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.
|
|
a)
|
On
December 29, 2009, the Company issued 328,110 shares of its common stock
to Swiss as remuneration for the services provided, in the amount of
$167,310.
|
|
b)
|
On
December 29, 2009, the Company issued 100,000 shares of its common stock
to a third party as remuneration for services that will be rendered
commencing December 15, 2009 for a period of six
months.
|
Three months ended
|
||||||||
Operating Data:
|
November 30, 2009
|
November 30, 2008
|
||||||
Research
and development costs, net
|
$ | 317,545 | $ | 818,680 | ||||
General
and administrative expenses
|
299,956 | 383,361 | ||||||
Financial
income, net
|
(4,708 | ) | (13,995 | ) | ||||
Net
loss for the period
|
$ | 612,793 | $ | 1,188,046 | ||||
Loss
per common share – basic and diluted
|
$ | (0.01 | ) | $ | (0.02 | ) | ||
Weighted
average common shares outstanding
|
57,158,865 | 56,363,714 |
|
·
|
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
|
$ | 4,194,000 | ||
General
and administrative expenses
|
1,496,000 | |||
Financial
income, net
|
(10,000 | ) | ||
Taxes
on income
|
- | |||
Total
|
$ | 5,680,000 |
|
(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.
|
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
between our company and Hadasit Medical Services and Development Ltd.
dated February 17, 2006 (incorporated by reference from our current report
on Form 8-K filed February 17, 2006).
|
|
10.2
|
Agreement
between our company and Swiss Caps Ag dated October 30, 2006 (incorporated
by reference from our current report on Form 8-K filed October 26,
2006).
|
|
10.2
|
Agreement
between our company and Hadasit Medical Services and Development Ltd.
dated January 7, 2008 (incorporated by reference from our current report
on Form 8-K filed January 7, 2008).
|
|
10.3
|
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).
|
|
10.4
|
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: January
13, 2010
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: January
13, 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.
|
Dated: January
13, 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.
|
Dated: January
13, 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: January
13, 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: January
13, 2010
|
By:
|
/s/ YIFAT
ZOMMER
|
|
Name: Yifat
Zommer,
Title: Chief
Financial
Officer
|