ORAMED PHARMACEUTICALS INC. - Quarter Report: 2010 May (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For
the Quarterly Period Ended May 31, 2010
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For
the Transition Period from _________ to _________
Commission
file number: 000-50298
ORAMED
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
Nevada
|
98-0376008
|
|
(State or other jurisdiction of
incorporation or organization)
|
|
(IRS Employer Identification No.)
|
Hi-Tech
Park 2/5 Givat Ram
PO
Box 39098
Jerusalem,
Israel 91390
(Address
of principal executive offices)
+
972 2 566 0001
(Registrant's
telephone number, including area code)
Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days.
Yes x No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T during the
preceding 12 months (or for such shorter period that the registrant was required
to submit and post such files).
Yes ¨ No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
Non-accelerated
filer ¨ (Do not check if a smaller
reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes ¨ No x
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date: 57,480,217 shares issued and
outstanding as of July 13, 2010.
ORAMED
PHARMACEUTICALS INC.
FORM
10-QSB
TABLE
OF CONTENTS
PART
I – FINANCIAL INFORMATION
|
1
|
ITEM
1 - FINANCIAL STATEMENTS
|
1
|
ITEM
2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
|
13
|
ITEM
3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
22
|
ITEM
4T - CONTROLS AND PROCEDURES
|
22
|
PART
II - OTHER INFORMATION
|
23
|
ITEM
1 - LEGAL PROCEEDINGS
|
23
|
ITEM
2 - UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
23
|
ITEM
6 - EXHIBITS
|
24
|
PART I – FINANCIAL
INFORMATION
ITEM
1 - FINANCIAL STATEMENTS
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF MAY 31, 2010
1
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS OF MAY
31, 2010
TABLE OF
CONTENTS
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
|
2
ORAMED
PHARMACEUTICALS INC.
(A development stage
company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
U.S.
dollars
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 |
The
accompanying notes are an integral part of the consolidated financial
statements.
3
ORAMED
PHARMACEUTICALS INC.
(A development stage
company)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATION
U.S.
dollars
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 |
The
accompanying notes are an integral part of the consolidated financial
statements.
4
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
CONDENSED
STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
U.S.
dollars
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 |
The
accompanying notes are an integral part of the consolidated financial
statements
5
ORAMED
PHARMACEUTICALS INC.
(A development stage
company)
CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS
U.S.
dollars
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 |
The
accompanying notes are an integral part of the consolidated financial
statements.
6
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
1 - SIGNIFICANT ACCOUNTING POLICIES:
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
|
The
accompanying unaudited interim consolidated financial statements have been
prepared assuming that the Company will continue as a going concern. The Company
has net losses for the period from inception (April 12, 2002) through May
31, 2010 of $11,819,901 as well as negative cash flow from operating activities.
Presently, the Company does not have sufficient cash resources to meet its
requirements in the twelve months following May 31, 2010. These factors raise
substantial doubt about the Company's ability to continue as a going concern.
Management is in the process of evaluating various financing alternatives as the
Company will need to finance future research and development activities and
general and administrative expenses through fund raising in
the public or private equity markets. Although there is no assurance that the
Company will be successful with those initiatives, management believes that it
will be able to secure the necessary financing as a result of ongoing financing
discussions with third party investors and existing shareholders, as well as on
going funding from the Office of the Chief
Scientist ("OCS").
These
consolidated financial statements do not include any adjustments that may be
necessary should the Company be unable to continue as a going concern. The
Company's continuation as a going concern is dependent on its ability to obtain
additional financing as may be required and ultimately to attain
profitability.
7
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
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:
|
Certain
figures in respect of prior periods have been reclassified to conform to the
current period presentation.
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.
|
On
January 7, 2009, the Company entered into a second agreement with Hadasit (the
“Second Agreement”) which confirms that Hadasit has conveyed, transferred and
assigned all of its ownership rights in the patents acquired under the First
Agreement to the Company, and certain other patents filed by the Company after
the First Agreement as a result of the collaboration between the Company and
Hadasit.
On July
8, 2009 the Company entered into a third agreement with Hadasit, Prof. Itamar
Raz and Dr. Miriam Kidron ("the Third Agreement"), to provide consulting and
clinical trial services. According to the Third Agreement, Hadasit will be
entitled to additional of $200,000 to be paid by Oramed in accordance with the
actual progress of the study. The total amount that was paid through May 31,
2010, was $359,255.
|
b.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note
3a.
|
8
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 2 – COMMITMENTS
(continued):
|
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")
|
The
Subsidiary is obligated to pay royalties to the OCS on proceeds from the
sale of products developed from research and development activities that were
funded, partially, by grants from the OCS. In the case of failure of a project
that was partly financed as described above, the Subsidiary is not obligated to
pay any such royalties or repay funding received from the OCS.
Under the
terms of the funding arrangements with the OCS, royalties of 3% to 3.5% are
payable on the sale of products developed from projects funded by the OCS, which
payments shall not exceed, in the aggregate, 100% of the amount of the grant
received (dollar linked), plus interest at annual rate based on LIBOR. In
addition, if the Subsidiary receives approval to manufacture the products
developed with government grants outside the State of Israel, it will be
required to pay an increased total amount of royalties (possibly up to 300% of
the grant amounts plus interest), depending on the manufacturing volume that is
performed outside the State of Israel, and, possibly, an increased royalty
rate.
At May
31, 2010, the Company has not earned any revenues from the sale of products and
no royalty payments have accrued.
For the
nine and three months periods ended May 31, 2010, the research and development
expenses are presented net of OCS Grants, in the total of $450,717 and $158,160,
respectively.
9
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
3 - STOCK BASED
COMPENSATION:
The
following are stocks issued for services, stock options and warrants
transactions made during the nine months ended May 31, 2010:
|
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).
|
On
September 11, 2009, the Company issued 569,887 shares of its common stock to
Swiss as remuneration for the services provided, for total of
$203,699.
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.
On April
29, 2010, the Company issued 25,510 shares of its common stock to Swiss as
remuneration for the services provided, in the amount of $12,500.
|
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.
|
10
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 3 - STOCK BASED
COMPENSATION (continued):
|
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.
|
The
Company recognized $532,328 of stock based compensation expense during the nine
months ended May 31, 2010 related to options granted to employees and
consultants.
11
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
4 - FAIR VALUE:
The fair
value of the Company's financial instruments consisting of short term
investments, included in the Company’s financial statements is identical or
close to their carrying value due to the short-term maturities of these
instruments.
NOTE
5 - SUBSEQUENT EVENTS AND RELATED PARTIES TRANSACTION:
|
a.
|
Related
parties transaction
|
On June
1, 2010, the subsidiary of the Company entered into an agreement with Laser Detect Systems
Ltd. ("Laser
Detect"), an Israeli company, for the establishment of a new company,
Entera Bio Ltd. ("Entera").
According
to the agreement, Laser Detect will invest $600,000 in Entera, and Entera will
be owned in equal parts by the subsidiary and Laser Detect. As a remuneration,
the subsidiary of the Company will enter into a Patent License Agreement with
Entera, according to which, the subsidiary of the Company will out-license to
Entera a technology for the development of oral delivery drugs for certain
indications. The out-licensed technology differs from Oramed’s main
delivery technology that is used for oral insulin and is subject to a different
patent application. Entera's initial development effort will be an oral
formulation for the treatment of osteoporosis.
Entera's
Chief Executive Officer will be granted options to purchase ordinary shares of
Entera, reflecting 9.9% of the Entera's share capital.
In
the event that Entera has not obtained third-party financing by June 1, 2011, or
such other date mutually agreed upon by the parties, each of the subsidiary and
Laser Detect will be required to make a capital contribution to Entera in the
amount of $150,000. The agreement also contains customary provisions with
respect to preemptive rights, rights of first refusal, drag-along rights, veto
rights and information rights.
Mr. Zeev
Bronfeld, who is one of Laser Detect's controlling shareholders, is also an
affiliated shareholder of the Company. Accordingly, the closing of the
transaction is subject to the approval of Laser Detect's
shareholders.
On June
27, 2010, Laser Detect changed its name to D.N.A Biomedical Solutions
Ltd.
|
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.
|
12
ITEM
2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following information should be read in conjunction with the financial
statements and notes thereto appearing elsewhere in this Quarterly
Report.
This
Quarterly Report on Form 10-Q (including the section regarding Management's
Discussion and Analysis of Financial Condition and Results of Operations)
contains forward-looking statements regarding our business, financial condition,
results of operations and prospects. Words such as “expects,” “anticipates,”
“intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or
variations of such words are intended to identify forward-looking statements,
but are not deemed to represent an all-inclusive means of identifying
forward-looking statements as denoted in this Quarterly Report on Form
10-Q Additionally, statements concerning future matters are
forward-looking statements.
Although
forward-looking statements in this Quarterly Report on Form 10-Q
reflect the good faith judgment of our management, such statements can only be
based on facts and factors currently known by us. Consequently, forward-looking
statements are inherently subject to risks and uncertainties and actual results
and outcomes may differ materially from the results and outcomes discussed in or
anticipated by the forward-looking statements. Factors that could cause or
contribute to such differences in results and outcomes include, without
limitation, those specifically addressed under "Item 1A – Risk Factors" in our
annual report on Form 10-K for the year ended August 31, 2009, and under "Risk
Factors" in our registration statement on Form S-1/A filed with the SEC on
February 24, 2010, as well as those discussed elsewhere in our annual report,
the registration statement and in this Quarterly Report on Form 10-Q.
Readers are urged not to place undue reliance on these forward-looking
statements, which speak only as of the date of this Quarterly Report on Form 10-Q. We
undertake no obligation to revise or update any forward-looking statements in
order to reflect any event or circumstance that may arise after the date of this
Quarterly Report
on Form 10-Q. Readers are urged to carefully review and consider the various
disclosures made throughout the entirety of this Quarterly Report on Form 10-Q
which attempt to advise interested parties of the risks and factors that may
affect our business, financial condition, results of operations and
prospects.
We file
reports with the Securities and Exchange Commission (the “SEC” or the
“Commission”). We make available on our website under “Investor Information/SEC
Filings,” free of charge, our annual reports on Form 10-K, quarterly reports on
Form 10-Q, current reports on Form 8-K and amendments to those reports as soon
as reasonably practicable after we electronically file such materials with or
furnish them to the SEC. Our website address is www.oramed.com. You can also
read and copy any materials we file with the SEC at the SEC's Public Reference
Room at 100 F Street, NE, Washington, DC 20549. You can obtain additional
information about the operation of the Public Reference Room by calling the SEC
at 1-800-SEC-0330. In addition, the SEC maintains an internet site (www.sec.gov)
that contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC, including
us.
As used
in this Quarterly Report, the terms "we," "us," "our," "Company" and "Oramed" mean Oramed
Pharmaceuticals Inc. and our subsidiary, Oramed Ltd., unless otherwise
indicated.
All
dollar amounts refer to U.S. dollars unless otherwise
indicated.
13
Overview
We are a
pharmaceutical company engaged in the research and development of innovative
pharmaceutical solutions, including an orally ingestible insulin capsule or
tablet to be used for the treatment of individuals with diabetes, rectal
application of insulin, use of orally ingestible capsules, tablets or pills for
delivery of other polypeptides and rectal application of other
polypeptides.
Oramed
was incorporated on April 12, 2002, in the State of Nevada under the name Iguana
Ventures Ltd. Following the incorporation, the Company was an exploration stage
company engaged in the acquisition and exploration of mineral properties. The
Company was unsuccessful in implementing its business plan as a mineral
exploration company. Accordingly, the Company decided to change the focus of its
business by completing a share exchange with the shareholders of Integrated
Security Technologies, Inc., a New Jersey private corporation (“ISTI”). On
June 4, 2004, the Company changed its name to Integrated Security Technologies
by filing a Certificate of Amendment with the Nevada Secretary of State.
Effective June 14, 2004 the Company effected a 3.3:1 forward stock split,
increasing the amount of its authorized capital to 200,000,000 shares of common
stock with the par value of $.001 per share. However, due to disappointing
results of ISTI, on May 31, 2005, effective as of May 27, 2004 the Company
terminated the share exchange agreement with the shareholders of
ISTI.
On
February 17, 2006, we executed an agreement with Hadasit Medical Services and
Development Ltd. (“Hadasit”) to acquire provisional patent application No.
60/718716 and related intellectual property and agreed to retain Hadasit to
provide consulting and clinical trial services. The provisional patent
application No. 60/718716 relates to a method of preparing insulin so that it
may be taken orally to be used in the treatment of individuals with
diabetes. On April 10, 2006, the Company changed its name from Integrated
Security Technologies, Inc. to Oramed Pharmaceuticals Inc. On August 31,
2006, based on provisional patent application No. 60/718716, the Company filed a
patent application under the Patent Cooperation Treaty at the Israel Patent
Office for “Methods and Compositions for Oral Administration of
Proteins.”
Plan
of Operation
Short
Term Business Strategy
We plan
to continue to conduct clinical trials to show the effectiveness of our
technology. We intend to conduct studies and other tests necessary to file
an Investigational New Drug (“IND”) application with the U.S. Food and Drug
Administration (the “FDA”). Additional clinical trials are planned in other
countries such as Israel and India in order to substantiate our results as well
as for purposes of future filings for drug approval in these countries. We also
plan to conduct further research and development by deploying our proprietary
drug delivery technology for the delivery of other polypeptides in addition to
insulin, and to develop other innovative pharmaceutical products, flu vaccines,
and use of rectal application for delivery of other
polypeptides.
14
Long
Term Business Strategy
If our
oral insulin capsule or other drug delivery solutions show significant promise
in clinical trials, we plan to ultimately seek a strategic commercial partner,
or partners, with extensive experience in the development, commercialization,
and marketing of insulin applications and/or other orally digestible drugs. We
anticipate such partner or partners would be responsible for, or substantially
support, late stage clinical trials (Phase III) to ensure regulatory approvals
and registrations in the appropriate markets in a timely manner. We further
anticipate that such partner, or partners, would also be responsible for sales
and marketing of our oral insulin capsule in these markets. Such planned
strategic partnership, or partnerships, may provide a marketing and sales
infrastructure for our products as well as financial and operational support for
global clinical trials, post marketing studies, label expansions and other
regulatory requirements concerning future clinical development in the United
States and elsewhere. Any future strategic partner, or partners, may also
provide capital and expertise that would enable the partnership to develop new
oral dosage form for other polypeptides. We have not yet engaged in any
meaningful discussions with potential partners and no assurance can be given
that any third party would be interested in partnering with us. Under certain
circumstances, we may determine to develop one or more of our oral dosage form
on our own, either world-wide or in select territories.
Other
Planned Strategic Activities
In
addition to developing our own oral dosage form drug portfolio, we are, on an
on-going basis, considering in-licensing and other means of obtaining additional
technologies to complement and/or expand our current product portfolio. Our goal
is to create a well-balanced product portfolio that will enhance and complement
our existing drug portfolio.
Product
Development
Orally
Ingestible Insulin
During
fiscal years 2007 through 2009 we conducted several clinical studies of our
orally ingestible insulin. The studies were intended to assess both the
safety/tolerability and absorption properties of our proprietary oral insulin.
Based on the pharmacokinetic and pharmacologic outcomes of these trials, we
decided to continue the development of our oral insulin product.
In
November 2007 we successfully completed animal studies in preparation for the
Phase 1B clinical trial of our oral insulin capsule (ORMD 0801). In
January 2008 we commenced the non-FDA approved Phase 1B clinical trials with our
oral insulin capsule, in healthy human volunteers with the intent of dose
optimization. In March 2008, we successfully completed our Phase 1B
clinical trials.
In April
2008 we commenced a non-FDA approved Phase 2A study to evaluate the safety and
efficacy of our oral insulin capsule (ORMD 0801) in type 2 diabetic volunteers
at Hadassah Medical Center in Jerusalem. In August 2008 we successfully
completed this trial.
In July
2008 we were granted approval by the Institutional Review Board Committee of
Hadassah Medical Center in Jerusalem to conduct a non-FDA approved Phase 2A
study to evaluate the safety and efficacy of our oral insulin capsule (ORMD
0801) on type 1 diabetic volunteers. On September 24, 2008, we commenced this
trial and in July 2009 we successfully completed this trial.
On April
21, 2009, we entered into a consulting service agreement with ADRES Advanced
Regulatory Services Ltd. (“ADRES”), pursuant to which ADRES will provide
services for the purpose of filing an IND application with the FDA for a Phase 2
study according to the FDA requirements. The FDA approval process and, if
approved, registration for commercial use as an oral drug can take several
years.
15
In May
2009 we commenced a non-FDA approved Phase 2B study in South Africa to evaluate
the safety, tolerability and efficacy of our oral insulin capsule (ORMD 0801) on
type 2 diabetic volunteers. On May 6, 2010, we reported that the capsule was
found to be well tolerated and exhibited a positive safety profile. No
cumulative adverse effects of extended exposure to the capsule were
reported throughout this first study. We are considering whether and when to
conduct an additional non-FDA approved Phase 2B study in India.
On
February 10, 2010, we entered into agreements with Vetgenerics Research G. Ziv
Ltd., a clinical research organization (CRO), to conduct a toxicology trial on
our oral insulin capsules.
Rectal
Application of Insulin and Other Polypeptides
We filed
two additional provisional patents for a suppository application to our
technology portfolio. The first patent focuses on a rectal application for
insulin. The second patent focuses on the usage of this rectal application to
other polypeptides that at present are only available in injection.
On
January 30, 2008, we entered into a master service agreement with OnQ
Consulting; a clinical research organization located in Johannesburg, South
Africa, to conduct non-FDA approved clinical trials for the rectal application
of insulin. On February 4, 2009, we concluded a proof of concept study of
the insulin suppositories.
In
October 2008 we commenced a non-FDA approved Phase 1A study to evaluate the
safety and efficacy of our insulin suppository (ORMD 0802) on healthy
volunteers, in South Africa.
As we
believe that the potential commercial market for our oral insulin products are
significantly greater than the potential commercial market for our rectal
application products, we have determined to use our limited resources to
research and develop our oral insulin capsules and tablets and have temporarily
suspended our development of our recital application products.
GLP-1
Analog
In
September 2008 we launched pre-clinical trials of ORMD 0901, a GLP-1
Analog. The pre-clinical trials include animal studies which suggest
that the GLP-1 Analog (exenatide -4) when combined with Oramed’s
absorption promoters is absorbed through the gastrointestinal tract
and retains its biological activity.
On
September 9, 2009, we received approval from the Institutional Review Board
(IRB) in Israel to commence human clinical trials of an oral GLP-1 Analog. The
approval was granted after successful pre-clinical results were reported. The
trials will be conducted on healthy volunteers at Hadassah University Medical
Center in Jerusalem. We anticipate that the
results of these trials will be released in the near future.
Glucagon-like
peptide-1 (GLP-1) is an incretin hormone - a type of gastrointestinal hormone
that stimulates the secretion of insulin from the pancreas. The incretin concept
was hypothesized when it was noted surprisingly that glucose ingested by mouth
(orally) stimulated two to three times more insulin release than the same amount
of glucose administered intravenously. In addition to stimulating insulin
release, GLP-1 was found to suppress glucagon release (a hormone involved in
regulation of glucose) from the pancreas, slow gastric emptying to reduce the
rate of absorption of nutrients into the blood stream, and increase satiety.
Other important beneficial attributes of GLP-1 are its effects of increasing the
number of beta cells (cells that manufacture and release insulin) in the
pancreas and, possibly, protection of the heart.
16
Raw
Materials
Our oral
insulin capsule is currently manufactured by Swiss Caps AG, under a Clinical
Trail Manufacturing Agreement.
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.
The raw
materials required for the manufacturing of the capsule are purchased from third
parties, under separate agreements. We generally depend upon a limited
number of suppliers for the raw materials. Although alternative sources of
supply for these materials are generally available, we could incur significant
costs and disruptions in changing suppliers. The termination of our
relationships with our suppliers or the failure of these suppliers to meet our
requirements for raw materials on a timely and cost-effective basis could
materially adversely affect our business, prospects, financial condition and
results of operations.
Licensing
We have
recently engaged in preliminary discussions with potential partners outside of
the United States regarding their management of clinical trials of our oral
insulin capsules. Such agreements could involve us granting exclusive
commercialization rights and profit interests in our products derived from
certain geographic areas outside the United States in exchange for payment of
the costs of running such clinical trials now. These discussions are in a very
early stage, however, and may not result in our being able to enter into any
such partnerships.
Out-licensing
technology
On June
1, 2010, the subsidiary of the Company, Oramed Ltd., entered into an agreement
with Laser Detect Systems Ltd. ("Laser Detect") (which changed its name to D.N.A
Biomedical Solutions Ltd. on June 27, 2010), for the establishment of a new
company to be called Entera Bio Ltd. ("Entera"). Under the terms of a license
agreement to be entered into at the closing between Oramed Ltd. and Entera,
Oramed Ltd. will out-license technology to Entera, on an exclusive basis, for
the development of oral delivery drugs for certain indications to be agreed upon
between the parties. The out-licensed technology differs from our main
delivery technology that is used for oral insulin and GLP-1 Analog and is
subject to a different patent application. Entera's initial development effort
will be an oral formulation for the treatment of osteoporosis.
17
Results
of Operations
Going
concern assumption
The
accompanying financial statements have been prepared assuming that we will
continue as a going concern. We have net losses for the period from inception
(April 12, 2002) through May 31, 2010 of $11,819,901, as well as negative cash
flow from operating activities. Based upon our existing spending commitments,
estimated at $6.6 million for the twelve months following June 1, 2010, and our
cash availability, we do not have sufficient cash resources to meet our
liquidity requirements through May 31, 2011. The ongoing global economic and
credit crisis makes it more difficult for the Company to raise financing.
Accordingly, these factors raise substantial doubt about our ability to continue
as a going concern. Management is in the process of evaluating various financing
alternatives as we will need to finance future research and development
activities and general and administrative expenses through fund raising in the
public or private equity markets. Although there is no assurance that we will be
successful with those initiatives, management believes that it will be able to
secure the necessary financing as a result of ongoing financing discussions with
third party investors and existing shareholders.
The
financial statements do not include any adjustments that may be necessary should
we be unable to continue as a going concern. Our continuation as a going concern
is dependent on our ability to obtain additional financing as may be required
and ultimately to attain profitability.
Critical
accounting policies
Our
significant accounting policies are more fully described in Note 1 to our
consolidated financial statements included in this Quarterly Report. We believe
that the accounting policies below are critical for one to fully understand and
evaluate our financial condition and results of operations.
The
discussion and analysis of our financial condition and results of operations is
based on our financial statements, which we prepared in accordance with U.S.
generally accepted accounting principles. The preparation of these financial
statements requires us to make estimates and assumptions that affect the
reported amounts of assets and liabilities and the disclosure of contingent
assets and liabilities at the date of the financial statements, as well as the
reported revenues and expenses during the reporting periods. We evaluate such
estimates and judgments on an ongoing basis. We base our estimates on
historical experience and on various other factors that we believe are
reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying value of assets and liabilities that are not
readily apparent from other sources. Actual results may differ from these
estimates under different assumptions or conditions.
Comparison
of nine month and three month periods ended May 31, 2010 and 2009
The
following table summarizes certain statements of operations data for the Company
for the nine month and three month periods ended May 31, 2010 and
2009:
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 |
18
Research
and development expenses
Research
and development expenses include costs directly attributable to the conduct of
research and development programs, including the cost of salaries, payroll
taxes, employee benefits, costs of registered patents materials, supplies, the
cost of services provided by outside contractors, including services related to
our clinical trials, clinical trial expenses, the full cost of manufacturing
drug for use in research, preclinical development. All costs associated with
research and development are expensed as incurred.
Clinical
trial costs are a significant component of research and development expenses and
include costs associated with third-party contractors. The Company outsources a
substantial portion of its clinical trial activities, utilizing external
entities such as contract research organizations, independent clinical
investigators, and other third-party service providers to assist the Company
with the execution of its clinical studies. For each clinical trial that the
Company conducts, certain clinical trial costs are expensed immediately, while
others are expensed over time based on the expected total number of patients in
the trial, the rate at which patients enter the trial, and the period over which
clinical investigators or contract research organizations are expected to
provide services.
Clinical
activities which relate principally to clinical sites and other administrative
functions to manage the Company’s clinical trials are performed primarily by
contract research organizations (“CROs”). CROs typically perform most of the
start-up activities for the Company’s trials, including document preparation,
site identification, screening and preparation, pre-study visits, training, and
program management.
During
the nine months ended May 31, 2010 research and development expenses totaled
$833,498, compared to $1,500,809 for the nine months ended May 31, 2009. The
decrease is mainly attributable to grants received from the Office of Chief
Scientist of the Israeli Ministry of Industry, Trade and Labor (the "OCS")
during the period ended May 31, 2010, in the amount of $450,717 as compared to
no grants at all during the nine months ended May 31, 2009. Additional decrease
was contributed by a decrease in materials purchased. The research and
development costs include stock based compensation costs, which during the nine
months ended May 31, 2010 totaled $212,385 as compared to $192,076 during the
nine months ended May 31, 2009.
The
decrease in research and development expenses during the three months ended May
31, 2010 as compared to the three months ended May 31, 2009 is attributable to
the same reasons mentioned above.
Government
Grants
In the
nine and three months ended May 31, 2010, we recognized research and development
grants in an amount of $450,717 and $158,160, respectively.
19
General
and administrative expenses
General
and administrative expenses include the salaries and related expenses of our
management, consulting costs, legal and professional fees, traveling, business
development costs, insurance expenses and other general costs.
For the
nine months ended May 31, 2010, general and administrative expenses totaled
$981,861 compared to $879,518 for the nine months ended May 31, 2009. Costs
incurred related to general and administrative activities during the nine months
ended May 31, 2010 reflect mainly an increase in investors and public relations
expenses and expenses related to stock options granted to employees and
consultants. During the nine months ended May 31, 2010, we incurred $319,943
related to stock options granted to employees and consultants, as compared to
$113,195 during the nine months ended May 31, 2009.
The
increase in general and administrative expenses during the three months ended
May 31, 2010 as compared to the three months ended May 31, 2009 is attributable
to the same reasons mentioned above.
Financial
income/expense, net
During
the nine months ended May 31, 2010 and 2009, we generated interest income on
available cash and cash equivalents which was offset by bank charges and imputed
interest.
Liquidity
and Capital Resources
Through
May 31, 2010, we incurred losses in an aggregate amount of $11,819,901. Since
inception through May 31, 2010, we have financed our operations through the
private placements of equity and debt financings, raising a total of $8,308,785,
net of transaction costs. We will seek to obtain additional financing through
similar sources. As of May 31, 2010, we had $1,134,506 of available cash as well
as $500,000 in short term interest bearing investments. We anticipate that we
will require approximately $6.6 million to finance our activities during the
twelve months following June 1, 2010. In addition, according to an agreement
with Laser Detect to establish Entera, we may be required to make a capital
contribution to Entera in the amount of $150,000 by June 1, 2011.
Management
is in the process of evaluating various financing alternatives as we will need
to finance future research and development activities and general and
administrative expenses through fund raising in the public or private equity
markets. Although there is no assurance that we will be successful with those
initiatives, management believes that it will be able to secure the necessary
financing as a result of ongoing financing discussions with third party
investors and existing shareholders as well as receive additional funding from
the OCS.
Our
financing activities during the nine months ended May 31, 2010 included the
following:
|
·
|
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.
|
20
|
·
|
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.
|
Employee's and Consultant’s Stock Options and
Warrants
Employee
and consultant stock options grant and warrant issuance activities for the nine
months ended May 31, 2010 include the following:
|
·
|
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.
|
Off-Balance
Sheet Arrangements
We have
no off-balance sheet arrangements.
21
Planned
Expenditures
The
estimated expenses referenced herein are in accordance with our business plan.
Since our technology is still in the development stage, it can be expected that
there will be changes in some budgetary items. Our planned expenditures for the
twelve months beginning June 1, 2010 are as follows:
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 |
As
previously indicated, we are planning to conduct further clinical studies as
well as file an IND application with the FDA for our orally ingested insulin.
Our ability to proceed with these activities is dependent on several major
factors including the ability to attract sufficient financing on terms
acceptable to us.
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are a smaller reporting company, as
defined by Rule 12b-2 of the Exchange Act of 1934, as amended and are not
required to provide information under this item.
ITEM
4T - CONTROLS AND PROCEDURES
(a) Disclosure
Controls and Procedures
Our
management, including our chief executive officer and chief financial officer,
has evaluated the effectiveness of our disclosure controls and procedures as of
May 31, 2010. Based on such review, our chief executive officer and chief
financial officer have determined that in light of their conclusion with respect
to the effectiveness of our internal control over our financial reporting as of
such date, the weaknesses in controls and procedures described in our Form 10-K
filed on November 25, 2009 continued this quarter and that the Company did not
have in place effective controls and procedures designed to ensure that
information required to be disclosed by us in the reports that we file or submit
under the Securities Exchange Act of 1934, as amended, is accumulated and
communicated to our management, including our principal executive and principal
financial officers, or persons performing similar functions, as appropriate to
allow timely decisions regarding required disclosure, and is recorded,
processed, summarized and reported, within the time periods specified in the
Commission’s rules and forms.
(b) Changes
in Internal Control over Financial Reporting
There
were no changes in our internal controls over financial reporting identified in
connection with the evaluation thereof that occurred during the nine months
ended May 31, 2010 that have materially affected, or are reasonable likely to
materially affect our internal control over financial
reporting.
22
PART
II – OTHER INFORMATION
ITEM
1 - LEGAL PROCEEDINGS
Except as
previously disclosed, we know of no material, active or pending legal
proceedings against us, nor are we involved as a plaintiff in any material
proceedings or pending litigation.
ITEM
2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
·
|
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.
|
Since the
transactions were not public offerings within the meaning of Section 4(2) of the
Securities Act, these issuances were deemed exempt from registration.
23
ITEM
6 - EXHIBITS
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
|
24
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
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
|
25