Nevada
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98-0376008
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(IRS Employer Identification No.)
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Large
accelerated filer ¨
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Accelerated
filer ¨
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Non-accelerated
filer ¨ (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
|
ITEM
3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
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22
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ITEM
4T - CONTROLS AND PROCEDURES
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22
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PART
II - OTHER INFORMATION
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23
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ITEM
1 - LEGAL PROCEEDINGS
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23
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ITEM
2 - UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
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23
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ITEM
6 - EXHIBITS
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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
|
7-12
|
May
31,
|
August
31,
|
|||||||
2010
|
2009
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 1,134,506 | $ | 1,716,866 | ||||
Short
term investments
|
500,000 | 1,000,000 | ||||||
Restricted
cash
|
16,008 | 16,000 | ||||||
Accounts
receivable - other
|
35,620 | 36,939 | ||||||
Prepaid
expenses
|
100,911 | 4,119 | ||||||
Grants
receivable from the Office of the Chief Scientist
|
266,215 | 400,405 | ||||||
Total
current assets
|
2,053,260 | 3,174,329 | ||||||
LONG
TERM DEPOSITS
|
10,729 | 12,161 | ||||||
PROPERTY AND EQUIPMENT,
net
|
51,552 | 75,361 | ||||||
Total
assets
|
$ | 2,115,541 | $ | 3,261,851 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 239,093 | $ | 321,344 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
286,345 | 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 May
31, 2010 and August 31, 2009; Issued and outstanding: 57,480,217 at May
31, 2010 and 56,456,710 shares at August 31, 2009,
respectively
|
57,480 | 56,456 | ||||||
Additional
paid-in capital
|
13,444,554 | 12,698,414 | ||||||
Deficit
accumulated during the development stage
|
(11,819,901 | ) | (10,008,678 | ) | ||||
Total
stockholders' equity
|
1,682,133 | 2,746,192 | ||||||
Total
liabilities and stockholders' equity
|
$ | 2,115,541 | $ | 3,261,851 |
Period
|
||||||||||||||||||||
from
April
|
||||||||||||||||||||
12,
2002
|
||||||||||||||||||||
(inception)
|
||||||||||||||||||||
Nine
months ended
|
Three
months ended
|
through
|
||||||||||||||||||
May
31,
|
May
31,
|
May
31,
|
May
31,
|
May
31,
|
||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES
|
$ | 833,498 | $ | 1,500,809 | $ | 346,716 | $ | 387,663 | $ | 5,978,357 | ||||||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
981,861 | 879,518 | 459,242 | 144,145 | 5,239,412 | |||||||||||||||
OPERATING
LOSS
|
1,815,359 | 2,380,327 | 805,958 | 531,808 | 11,652,645 | |||||||||||||||
FINANCIAL
INCOME
|
(15,897 | ) | (38,950 | ) | (4,981 | ) | (18,518 | ) | (152,005 | ) | ||||||||||
FINANCIAL
EXPENSE
|
11,761 | 18,211 | 5,242 | 159,694 | ||||||||||||||||
LOSS
BEFORE TAXES ON INCOME
|
1,811,223 | 2,359,588 | 806,219 | 513,290 | 11,660,334 | |||||||||||||||
TAXES
ON INCOME
|
- | - | - | - | 159,567 | |||||||||||||||
NET
LOSS FOR THE PERIOD
|
$ | 1,811,223 | $ | 2,359,588 | $ | 806,219 | $ | 513,290 | $ | 11,819,901 | ||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | 0.03 | $ | 0.04 | $ | 0.01 | $ | 0.01 | ||||||||||||
WEIGHTED
AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS
PER COMMON STOCK
|
57,349,130 | 56,546,323 | 57,466,907 | 56,802,562 |
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
|
2,428,014 | 2,428,014 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
381,764 | 381,764 | ||||||||||||||||||
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
|
453,620 | 454 | 211,546 | 212,000 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
423,795 | 423,795 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
108,533 | 108,533 | ||||||||||||||||||
IMPUTED
INTEREST
|
2,836 | 2,836 | ||||||||||||||||||
NET
LOSS
|
(1,811,223 | ) | (1,811,223 | ) | ||||||||||||||||
BALANCE
AS OF MAY 31, 2010 (unaudited)
|
57,480,217 | $ | 57,480 | $ | 13,444,554 | $ | (11,819,901 | ) | $ | 1,682,133 |
Nine months ended
|
Period from April
12, 2002
(inception date)
through
|
|||||||||||
May
31,
|
May
31,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (1,811,223 | ) | $ | (2,359,588 | ) | $ | (11,819,901 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
23,809 | 22,760 | 69,751 | |||||||||
Amortization
of debt discount
|
- | - | 108,000 | |||||||||
Exchange
differences on long term deposits
|
317 | 1,110 | (684 | ) | ||||||||
Stock
based compensation
|
744,328 | 526,138 | 4,475,093 | |||||||||
Shares
to be issued for services rendered
|
109,590 | 203,699 | ||||||||||
Impairment
of investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
2,836 | 2,834 | 18,833 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
38,717 | 367,526 | (402,746 | ) | ||||||||
Restricted
cash
|
(8 | ) | - | (16,008 | ) | |||||||
Accounts
payable and accrued expenses
|
(82,251 | ) | (438,926 | ) | 239,093 | |||||||
Provision
for uncertain tax position
|
- | - | 147,063 | |||||||||
Total
net cash used in operating activities
|
(1,083,475 | ) | (1,768,556 | ) | (6,542,931 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
- | (4,110 | ) | (121,303 | ) | |||||||
Acquisition
of short-term investments
|
500,000 | - | (3,228,000 | ) | ||||||||
Proceeds
from sale of Short term investments
|
- | 2,728,000 | 2,728,000 | |||||||||
Lease
deposits
|
1,115 | (4,668 | ) | (10,045 | ) | |||||||
Total
net cash derived from (used in) investing activities
|
501,115 | 2,719,222 | (631,348 | ) | ||||||||
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
|
(582,360 | ) | 950,666 | 1,134,506 | ||||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
1,716,866 | 2,267,320 | - | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 1,134,506 | $ | 3,217,986 | $ | 1,134,506 | ||||||
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 |
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 capsule 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 May
31, 2010 and for the nine 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 nine months ended May 31, 2010, 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
|
|
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:
|
|
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.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note
3a.
|
|
c.
|
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. The Company has completed making the 11 monthly payments in
accordance with the agreement, and has made an additional payment of
$30,000 for the completion of certain
milestones.
|
|
d.
|
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 ($133,040) of which €12,195 ($16,806) was paid
through May 31, 2010.
|
|
e.
|
On
May 2, 2010, the subsidiary entered into an agreement with SAFC Pharma, a
division of the Sigma-Aldrich Corporation, to develop a process to produce
one of its oral capsule ingredients, for a total estimated consideration
of $269,600. The work commenced in June 2010, and no liability have
accrued through May 31, 2010.
|
|
f.
|
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. The engagement with the consultant has ended during the
nine months period ended May 31, 2010. The fair value of these options on
the date of grant, was $36,662, using the Black Scholes option-pricing
model and was based on the following assumptions: dividend yield of 0% for
all years; expected volatility of 123.30%; risk-free interest rates of
2.20%; and the remaining contractual life of 5 years. The Company recorded
all expenses in respect of these options during that
period.
|
|
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.
|
|
e.
|
On
March 16, 2010, 13,200 options were granted to a consultant, at an
exercise price of $0.43 per share (equivalent to the traded market price
on the date of grant), the options vest in six monthly instalments
commencing March 30, 2010 and expire on March 15, 2015. The
fair value of these options on the date of grant, was $4,747, using the
Black Scholes option-pricing model and was based on the following
assumptions: dividend yield of 0% for all years; expected volatility of
121.61%; risk-free interest rates of 2.37%; and the remaining contractual
life of 5 years.
|
|
f.
|
On
March 16, 2010, 100,000 options were granted to a consultant, at an
exercise price of $0.43 per share (equivalent to the traded market price
on the date of grant), the options vest in three equal monthly instalments
commencing March 30, 2010 and expire on March 15, 2015. The
fair value of these options on the date of grant, was $35,960, using the
Black Scholes option-pricing model and was based on the following
assumptions: dividend yield of 0% for all years; expected volatility of
121.61%; risk-free interest rates of 2.37%; and the remaining contractual
life of 5 years.
|
|
g.
|
On
March 16, 2010, 50,000 options were granted to a consultant, at an
exercise price of $0.50 per share (higher than the traded market price on
the date of grant), the options vest in three equal annual instalments
commencing March 16, 2011 and expire on March 15, 2015. The
fair value of these options on the date of grant, was $17,702, using the
Black Scholes option-pricing model and was based on the following
assumptions: dividend yield of 0% for all years; expected volatility of
121.61%; risk-free interest rates of 2.37%; and the remaining contractual
life of 5 years.
|
|
h.
|
On
March 25, 2010, 100,000 options were granted to a consultant, at an
exercise price of $0.50 per share (higher than the traded market price on
the date of grant), the options vest in four equal quarterly instalments
commencing May 17, 2010 and expire on March 24, 2015. The fair
value of these options on the date of grant, was $39,091, using the Black
Scholes option-pricing model and was based on the following assumptions:
dividend yield of 0% for all years; expected volatility of 121.21%;
risk-free interest rates of 2.65%; and the remaining contractual life of 5
years.
|
|
i.
|
On
April 21, 2010, an aggregate of 1,728,000 options were granted to Nadav
Kidron, the Company’s President, Chief Executive Officer and director, and
Miriam Kidron, the Company’s Chief Medical and Technology Officer and
director, both are related parties, at an exercise price of $0.49 per
share (equivalent to the traded market price on the date of grant),
216,000 of the options vested immediately on the date of grant and the
remainder will vest in twenty one equal monthly installments. These
options expire on April 20, 2020. The fair value of these
options on the date of grant was $807,392, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 120.69%; risk-free
interest rates of 3.77%; and expected lives of 10
years.
|
|
a.
|
Related
parties transaction
|
|
b.
|
On
July 5, 2010, the subsidiary of the Company entered into a Manufacturing
Supply Agreement (MSA) with Sanofi-Aventis Deutschland GMBH
("sanofi-aventis"). According to the MSA, sanofi-aventis will supply the
subsidiary with specified quantities of recombinant human insulin to be
used for clinical trials in the
USA.
|
|
c.
|
On
July 8, 2010, 300,000 options were granted to a director at an exercise
price of $0.48 per share (equivalent to the traded market price on the
date of grant). The options vest in three equal annual instalments
commencing on July 8, 2011 and will expire on July 7,
2020.
|
Nine months ended
|
Three months ended
|
|||||||||||||||
Operating Data:
|
May 31,
2010
|
May 31,
2009
|
May 31,
2010
|
May 31,
2009
|
||||||||||||
Research
and development costs
|
$ | 833,498 | $ | 1,500,809 | $ | 346,716 | $ | 387,663 | ||||||||
General
and administrative expenses
|
981,861 | 879,518 | 459,242 | 144,145 | ||||||||||||
Financial
(income) expense, net
|
(4,136 | ) | (20,739 | ) | 261 | (18,518 | ) | |||||||||
Net
loss for the period
|
$ | 1,811,223 | $ | 2,359,588 | $ | 806,219 | $ | 513,290 | ||||||||
Loss
per common share – basic and diluted
|
$ | 0.03 | $ | 0.04 | $ | 0.01 | $ | 0.01 | ||||||||
Weighted
average common shares outstanding
|
57,349,130 | 56,546,323 | 57,466,907 | 56,802,562 |
|
·
|
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
April 29, 2010, we issued 25,510 shares of common stock, valued at
$12,500, to a third party for services
rendered.
|
|
·
|
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.
|
|
·
|
On
March 16, 2010, 50,000 options were granted to a consultant of our
subsidiary at an exercise price of $0.50 per share. The options vest in
three equal annual installments commencing on March 16, 2011 and will
expire on March 15, 2015.
|
|
·
|
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 installments commencing on March 30, 2010 and will expire on
March 15, 2015.
|
|
·
|
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
installments commencing on March 30, 2010 and will expire on March 15,
2015.
|
|
·
|
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 installments commencing on May 17, 2010 and will expire on
March 24, 2015.
|
|
·
|
On
April 21, 2010, 864,000 options were granted to each of Nadav Kidron and
Miriam Kidron under the 2008 Stock Option Plan at an exercise price of
$0.49 per share, 108,000 of such options vested immediately on the date of
grant and the remainder will vest in twenty equal monthly installments,
commencing on May 31, 2010. The options have an expiration date of April
20, 2020.
|
Operating:
|
Amount
|
|||
Research
and development costs, net of OCS funds
|
$ | 5,579,000 | ||
General
and administrative expenses
|
1,032,000 | |||
Financial
income, net
|
(8,000 | ) | ||
Taxes
on income
|
- | |||
Total
|
$ | 6,603,000 |
|
·
|
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 May 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.
|
|
·
|
On
April 29, 2010, we issued 25,510 shares of common stock, valued at
$12,500, to a third party for services
rendered.
|
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).
|
|
10.6
*
|
Joint
Venture Agreement dated June 1, 2010, between Oramed Ltd. and Laser Detect
Systems Ltd.
|
|
10.7
|
Manufacturing
Supply Agreement dated July 5, 2010, between Oramed Ltd. and
Sanofi-Aventis Deutschland GMBH (incorporated by reference from our
current report on Form 8-K filed July 14, 2010).
|
|
(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: July
14, 2010
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: July
14, 2010
|
By:
|
/s/ Yifat
Zommer
|
Yifat
Zommer
|
||
Chief
Financial
Officer
|
WHEREAS,
|
the
Founding Shareholders plan to establish an Israeli company to be named
Entera Ltd. (or such other name as may be approved by the Founding
Shareholders and the Companies Registrar) (the “Company”) and will at
inception be the sole shareholders of the Company;
and
|
WHEREAS,
|
the
Founding Shareholders desire to determine the principles, provisions,
terms and conditions required for the establishment, management, finance
and operation of the Company, all subject to the terms and conditions set
forth herein; and
|
WHEREAS,
|
Oramed
will provide the Company with a license pursuant to the License Agreement
(as defined below), and Laser will be responsible for the initial funding
the Company on the terms set forth
herein.
|
1.
|
General.
|
2.
|
Capitalization,
Closing and Share
Transfers.
|
4.
|
Corporate Governance;
Management.
|
5.
|
Covenants.
|
5.1
|
Best
Efforts. Between the date of this Agreement and the
Closing Date, each of the Parties shall use its best efforts to cause the
conditions in Section 9 to be satisfied as soon as practicable prior to
the Closing Date.
|
5.2
|
Publicity. No
Party shall issue a press release or cause any other publicity with
respect to the subject matter of this Agreement or the activities of the
Company without the consent of the Founding Shareholders or the Board of
Directors, except as required by applicable law or stock exchange rules,
in which case reasonable effort shall be made to coordinate the content
and timing of such publicity.
|
|
5.3
|
Confidentiality.
Each Shareholder shall hold in strict confidence and shall cause its
directors, employees, consultants and advisors to hold in strict
confidence, all documents and information in its possession concerning the
Company and its business, including financial information and the entering
into and content of this Agreement (the "Confidential
Information"), will use such Confidential Information only in
connection with its capacity as a Shareholder and shall not disclose the
same to any person; provided, however, that
in the event that a Shareholder is required by applicable law to disclose
any Confidential Information such Shareholder will first consult with the
Company and cooperate in an effort to minimize such disclosure of
Confidential Information to the greatest extent possible, and after such
consultation shall be entitled to disclose such Confidential Information
to the extent required. The obligations in this Section 5.3 will not apply
to any information which (i) is or becomes available to the public other
than by breach of this Agreement by the receiving party, (ii) is or has
been rightfully received by the receiving party from a third party, or
disclosed by the disclosing party to a third party, without any
restrictions as to its use or disclosure, (iii) is or has been
independently developed by the receiving party, or (iv) is published or
included in any publication in accordance to a regulatory or stock market
requirement or request.
|
|
5.4
|
Legal Representation;
Expenses. The Founding Shareholders acknowledge that attorneys at
the same law firm are representing both Founding Shareholders and the
Company in connection with this Agreement, the License Agreement and the
establishment of the Company. Accordingly, the fees of such
firm incurred in connection with such matters shall be borne by the
Founding Shareholders and the Company in three equal
parts. Such arrangement shall not apply to matters relating
specifically to one Founding Shareholder, such as the corporate approval
process of each Founding Shareholder. Except as otherwise
expressly provided herein, whether or not the transactions contemplated
herein are consummated, each Party shall bear and pay all fees, costs and
expenses (including legal fees and accounting fees) that have been
incurred or that are incurred by such Party in connection with this
Agreement and the transactions contemplated
herein.
|
|
5.5
|
Further
Assurances. At any time and from time to time after the Closing
Date, the Parties hereto agree to (i) furnish, execute, acknowledge and
deliver upon reasonable request to each other such further assurances,
documents, and information and (ii) do all such further acts and things,
all as the other Party may reasonably request for the purpose of carrying
out the intent of this Agreement and any document referred to
herein.
|
|
5.6
|
Notification.
Between the date of this Agreement and the Closing Date, each Party shall
promptly notify the other Party in writing if it becomes aware of any fact
or condition that causes or constitutes a breach of any of its
representations and warranties as of the date of this Agreement, or if it
becomes aware of the occurrence after the date of this Agreement of any
fact or condition that could (except as expressly contemplated herein)
cause or constitute a breach of any such representation or warranty had
such representation or warranty been made as of the time of occurrence or
discovery of such fact or condition. During the same period, each Party
shall promptly notify the other Party of the occurrence of any breach of
any covenant, agreement, undertaking or obligation of such Party or of the
occurrence of any event that may make the satisfaction of the conditions
in Section 9 impossible or not reasonably
likely.
|
6.
|
Non-Solicitation;
Specific Performance
|
7.
|
Representations and
Warranties.
|
8.
|
Term and
Termination.
|
9.
|
Conditions to
Closing.
|
9.1
|
Conditions to the
Obligations of Laser.
|
(i)
|
A
copy of the License Agreement duly executed by Oramed and the
Company;
|
|
(ii)
|
A
copy of the employment agreement duly executed by the Company and the
CEO;
|
|
(iii)
|
A
copy of the current and valid Articles;
and
|
|
(iv)
|
A
copy of a joinder agreement to this Agreement duly executed by the
Company.
|
9.2
|
Conditions to the
Obligations of Oramed.
|
|
(i)
|
A
copy of the License Agreement duly executed by the
Company;
|
|
(ii)
|
A
copy of the employment agreement duly executed by the Company and the
CEO;
|
|
(iii)
|
A
copy of the current and valid Articles;
and
|
|
(iv)
|
A
copy of a joinder agreement to this Agreement duly executed by the
Company.
|
10.
|
Miscellaneous.
|
If
to Laser:
|
Laser
Detect Systems Ltd.
11 Granit
St., Qiryat Arie
P.O.
Box 10168
Petach
Tikva 49514, Israel
Attention:
[_________]
Tel:
+972 3 927 7444
Fax:
+972 3 927 7543
E-mail:
[_________]
|
If
to Oramed:
|
Oramed
Ltd.
Hi-Tech
Park 2/5, Givat-Ram
PO
Box 39098
Jerusalem
91390, Israel
Attention:
Yifat Zommer, CFO
Tel:
+972 2 566 0001
Fax:
+972 2 566 0004
E-mail:
yifat@oramed.com
|
By:
|
_____________________________________
|
|
Name:
|
_____________________________________
|
|
Title:
|
_____________________________________
|
By:
|
_____________________________________
|
|
Name:
|
_____________________________________
|
|
Title:
|
_____________________________________
|
Shareholder
|
Amount
of Shares
|
Percentage
|
||||||
Laser
Detect Systems Ltd.
|
5,000 | 50 | % | |||||
Oramed
Ltd.
|
5,000 | 50 | % | |||||
TOTAL
|
10,000 | 100 | % |
|
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: July
14, 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: July
14, 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: July
14, 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: July
14, 2010
|
By:
|
/s/ YIFAT
ZOMMER
|
Name: Yifat
Zommer,
Title: Chief
Financial
Officer
|