ORAMED PHARMACEUTICALS INC. - Quarter Report: 2010 November (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 November 30, 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)
|
(Zip
Code)
|
+
972-2-566-0001
(Registrant's
Telephone Number, Including Area Code)
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last
Report)
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 (§232.405 of
this chapter) 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
As of
January 12, 2011 there were 65,262,784 shares of the issuer's Common Stock,
$.001 par value,
outstanding.
ORAMED
PHARMACEUTICALS INC.
FORM
10-Q
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
|
26
|
ITEM
4 - CONTROLS AND PROCEDURES
|
26
|
PART
II - OTHER INFORMATION
|
|
ITEM
1 - LEGAL PROCEEDINGS
|
27
|
ITEM
2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
27
|
ITEM
6 - EXHIBITS
|
27
|
PART I – FINANCIAL
INFORMATION
ITEM
1 - FINANCIAL STATEMENTS
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS OF
NOVEMBER 30, 2010
1
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS OF
NOVEMBER 30, 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
November 30,
|
August 31,
|
|||||||
2010
|
2010
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 1,101,283 | $ | 1,199,638 | ||||
Short
term investments
|
100,000 | |||||||
Restricted
cash
|
16,017 | 16,008 | ||||||
Accounts
receivable - other
|
23,843 | 59,175 | ||||||
Prepaid
expenses
|
24,097 | 1,859 | ||||||
Related
parties
|
798 | 7,689 | ||||||
Grants
receivable from the Chief Scientist
|
143,917 | 12,438 | ||||||
Total
current assets
|
1,309,955 | 1,396,807 | ||||||
INVESTMENT
IN A JOINT VENTURE
|
1,535 | |||||||
LONG
TERM DEPOSITS
|
10,967 | 10,582 | ||||||
PROPERTY AND EQUIPMENT,
net
|
36,048 | 43,499 | ||||||
Total
assets
|
$ | 1,358,505 | $ | 1,450,888 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 335,148 | $ | 411,330 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
382,400 | 458,582 | ||||||
PROVISION
FOR UNCERTAIN TAX POSITION
|
162,034 | 162,034 | ||||||
COMMITMENTS
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
stock of $ 0.001 par value - Authorized: 200,000,000 shares at
November 30, 2010 and August 31, 2010; Issued and outstanding: 58,756,535
at November 30, 2010 and 57,565,321 shares at August 31, 2010,
respectively
|
58,757 | 57,565 | ||||||
Additional
paid-in capital
|
14,344,152 | 13,758,761 | ||||||
Deficit
accumulated during the development stage
|
(13,588,838 | ) | (12,986,054 | ) | ||||
Total
stockholders' equity
|
814,071 | 830,272 | ||||||
Total
liabilities and stockholders' equity
|
$ | 1,358,505 | $ | 1,450,888 |
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)
|
||||||||||||
Three months ended
|
through
|
|||||||||||
November 30
|
November 30
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Unaudited
|
||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES, net
|
$ | 286,488 | $ | 332,485 | $ | 6,979,028 | ||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
315,129 | 285,016 | 5,997,552 | |||||||||
OPERATING
LOSS
|
601,617 | 617,501 | 13,411,456 | |||||||||
FINANCIAL
INCOME
|
(2,189 | ) | (8,373 | ) | (162,989 | ) | ||||||
FINANCIAL
EXPENSE
|
3,356 | 3,665 | 165,833 | |||||||||
LOSS
BEFORE TAXES ON INCOME
|
602,784 | 612,793 | 13,414,300 | |||||||||
TAXES
ON INCOME
|
- | - | 174,538 | |||||||||
NET
LOSS FOR THE PERIOD
|
$ | 602,784 | $ | 612,793 | $ | 13,588,838 | ||||||
BASIC
AND DILUTED LOSS PER
|
||||||||||||
COMMON
SHARE
|
$ | (0.01 | ) | $ | (0.01 | ) | ||||||
WEIGHTED
AVERAGE NUMBER OF COMMON
|
||||||||||||
STOCK
USED IN COMPUTING BASIC AND
|
||||||||||||
DILUTED
LOSS PER COMMON STOCK
|
57,932,597 | 57,158,865 |
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
|
621,929 | 622 | 367,166 | 367,788 | ||||||||||||||||
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
203,699 | 203,699 | ||||||||||||||||||
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
|
2,864,039 | 2,864,039 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
498,938 | 498,938 | ||||||||||||||||||
DISCOUNT
ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION
FEATURE
|
108,000 | 108,000 | ||||||||||||||||||
COMPREHENSIVE
LOSS
|
(16 | ) | (16 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
15,997 | 15,997 | ||||||||||||||||||
NET
LOSS
|
(10,008,662 | ) | (10,008,662 | ) | ||||||||||||||||
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
|
1,108,611 | 1,109 | 248,741 | 249,850 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
690,882 | 690,882 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
116,944 | 116,944 | ||||||||||||||||||
IMPUTED
INTEREST
|
3,780 | 3,780 | ||||||||||||||||||
NET
LOSS
|
(2, 977, 376 | ) | (2,977,376 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2010 (audited)
|
57,565,321 | $ | 57,565 | $ | 13,758,761 | $ | (12,986,054 | ) | $ | 830,272 | ||||||||||
SHARES
ISSUED FOR SERVICES RENDERED
|
253,714 | 254 | 88,546 | 88,800 | ||||||||||||||||
RECEIPTS
ON ACCOUNT OF SHARES AND WARRANTS
|
937,500 | 938 | 299,062 | 300,000 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
188,966 | 188,966 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
6,335 | 6,335 | ||||||||||||||||||
OTHER
COMPREHENSIVE INCOME
|
1,535 | 1,535 | ||||||||||||||||||
IMPUTED
INTEREST
|
947 | 947 | ||||||||||||||||||
NET
LOSS
|
(602,784 | ) | (602,784 | ) | ||||||||||||||||
BALANCE
AS OF NOVEMBER 30, 2010 (unaudited)
|
58,756,535 | $ | 58,757 | $ | 14,344,152 | $ | (13,588,838 | ) | $ | 814,071 |
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
Three months ended
|
Period from April
12, 2002
(inception date)
through
|
|||||||||||
November 30
|
November 30,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (602,784 | ) | $ | (612,793 | ) | $ | (13,588,838 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
7,451 | 7,989 | 85,255 | |||||||||
Amortization
of debt discount
|
- | - | 108,000 | |||||||||
Exchange
differences on long term deposits
|
(385 | ) | (61 | ) | (1,051 | ) | ||||||
Stock
based compensation
|
195,301 | 97,977 | 4,366,104 | |||||||||
Common
stock issued for services
|
- | - | 706,438 | |||||||||
Common
stock to be issued for services
|
88,800 | 169,500 | 203,699 | |||||||||
Impairment
of investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
947 | 945 | 20,724 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
(111,494 | ) | 122,717 | (192,655 | ) | |||||||
Restricted
cash
|
(9 | ) | - | (16,017 | ) | |||||||
Accounts
payable and accrued expenses
|
(76,182 | ) | 42,988 | 335,148 | ||||||||
Provision
for uncertain tax position
|
- | - | 162,034 | |||||||||
Total
net cash used in operating activities
|
(498,355 | ) | (170,738 | ) | (7,376,283 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
- | - | (121,303 | ) | ||||||||
Acquisition
of short-term investments
|
- | (400,000 | ) | (3,728,000 | ) | |||||||
Proceeds
from sale of Short term investments
|
100,000 | - | 3,728,000 | |||||||||
Lease
deposits
|
- | - | (9,916 | ) | ||||||||
Total
net cash provided by (used in) investing activities
|
100,000 | (400,000 | ) | (131,219 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from sales of common stocks and warrants - net of issuance
expenses
|
300,000 | - | 8,261,481 | |||||||||
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
|
300,000 | - | 8,608,785 | |||||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(98,355 | ) | (570,738 | ) | 1,101,283 | |||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
1,199,638 | 1,716,866 | - | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 1,101,283 | $ | 1,146,128 | $ | 1,101,283 | ||||||
Non
cash investing and financing activities:
|
||||||||||||
Shares
issued for offering costs
|
$ | 1,753 | ||||||||||
Contribution to paid in capital
|
$ | 18,991 | ||||||||||
Discount
on convertible note related to beneficial
conversion
feature
|
$ | 108,000 | ||||||||||
Shares issued for services rendered
|
$ | 152,928 |
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 pill to be used for the treatment of
individuals with diabetes. The Company has been in the development stage
since its formation and has not yet realized any revenues from its planned
operations.
|
|
On
May 14, 2007, the Company incorporated a wholly-owned subsidiary in
Israel, Oramed Ltd., which is engaged in research and development. Unless
the context indicates otherwise, the term “Group” refers to Oramed
Pharmaceuticals Inc. and its Israeli subsidiary, Oramed Ltd (the
“Subsidiary”).
|
|
The
Group is engaged in research and development in the biotechnology field
and is considered a development stage company in accordance with ASC Topic
915 (formerly FAS 7) “Development Stage
Entities”.
|
|
2.
|
The
accompanying unaudited interim consolidated financial statements as of
November 30, 2010 and for the three months then ended, have been prepared
in accordance with accounting principles generally accepted in the United
States relating to the preparation of financial statements for interim
periods. Accordingly, they do not include all the information and
footnotes required for annual financial statements. In the opinion of
management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. Operating
results for the three months ended November 30, 2010, are not necessarily
indicative of the results that may be expected for the year ending August
31, 2011.
|
|
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
November 30, 2010 of $13,588,838 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 November 30, 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 of the Ministry of
Industry, Trade and Labor of Israel ("OCS"). See
also note 7b for sale of Securities Purchase Agreements to which the Company
entered following November 30, 2010.
7
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 1 - SIGNIFICANT ACCOUNTING
POLICIES (continued):
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.
b.
|
Newly
issued and recently adopted Accounting
Pronouncements
|
1.
|
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.
|
2.
|
In June 2009, the FASB
updated accounting guidance relating to variable interest entities. As
applicable to the Company, this will become effective as of the first
annual reporting period that begins after November 15, 2009, for
interim periods within that first annual reporting period, and for interim
and annual reporting periods thereafter. As applicable to the Company, the
adoption of the new guidance will not have a material impact on the
consolidated financial
statements.
|
c.
|
Reclassifications
|
Certain
figures in respect of prior period have been reclassified to conform to the
current period presentation.
NOTE
2 - INVESTMENT IN A JOINT VENTURE
a.
|
In
June 2010, the subsidiary of the Company entered into an agreement with
D.N.A Biomedical Solutions Ltd ("D.N.A"), for the
establishment of a new company, Entera Bio Ltd. ("Entera"), ("the JV
Agreement").
|
According
to the JV Agreement, D.N.A will invest $600,000 in Entera, and Entera will be
owned in equal parts by the subsidiary and D.N.A. In consideration for 50% of
Entera's shares, 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 actions. Entera's Chief Executive Officer will be granted options to
purchase ordinary shares of Entera, reflecting 9.9% of 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
D.N.A will be required to make a capital contribution to Entera in the amount of
$150,000.
Mr. Zeev
Bronfeld, who is one of D.N.A 's controlling shareholders, is also an affiliated
shareholder of the Company.
As of
November 30, 2010, the Group holds 50% of the issued and outstanding share
capital of Entera (45% - on fully diluted basis). As the Group did not obtain
control in Entera, these consolidated financial statements do not include
Entera's financial statements.
8
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
2 - INVESTMENT IN A JOINT VENTURE (continued)
During
the year ended August 31, 2010, the Group recognized deferred income at the
amount of $300,000 (50% of $600,000) that is presented as a provision and
deducted from investment account at the same amount. As of November 30, 2010,
Entera's losses from operations are at the amount of $239,726.
Entera continued activities as a going concern
are subject to additional financing until the completion of the development
activities and the commencement of profit generating sales.
The Group
has concluded Entera is a variable interest entity according to of the terms of
the JV Agreement. The Group reviewed several factors to determine
whether the Company is the primary beneficiary of Entera, including the nature
Entera's financing, its management structure, the nature of day-to-day
operations and certain other factors. Based on those factors, the
Group determined that it is not the primary beneficiary of
Entera. The Group recognized its share of losses from this entity
under the equity method, offset with a corresponding amount of revenue
recognition on the out-license agreement.
b. The
investment in Entera is composed at follows:
November 30
|
August 31
|
|||||||
2010
|
||||||||
Share
in Entera's shareholders equity
|
$ | 300,000 | $ | 200,000 | ||||
Currency
translation adjustment
|
1,535 | (176 | ) | |||||
Less
- equity losses
|
(119,863 | ) | (67,025 | ) | ||||
181,672 | 132,799 | |||||||
Less
- deferred income
|
(180,137 | ) | (132,799 | ) | ||||
Net
investment
|
$ | 1,535 | -,- |
NOTE 3 - 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.
9
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 3 - COMMITMENTS
(continued):
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 a total consideration of $400,000 to be paid by Oramed. $200,000 of
this amount was agreed in the terms of the First Agreement, and the remaining of
$200,000 will be paid in accordance with the actual progress of the study. The
total amount that was paid through November 30, 2010 was $359,255.
|
b.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note 5
and 7a.
|
|
c.
|
On
September 19, 2007 the Subsidiary entered into a lease agreement for its
office facilities in Israel. The lease agreement is for a period of 51
months, and will end on December 31, 2011. The monthly lease payment is
2,396 NIS and is linked to the increase in the Israeli consumer price
index, (as of November 31, 2010 the monthly payment in the Company's
functional currency is $651, the future annual lease payments under the
agreement for the years ending August 31, 2011 and 2012 are $7,532 and
$2,512, respectively).
|
As
security for its obligation under this lease agreement the Company provided a
bank guarantee in an amount equal to three monthly lease payments.
|
d.
|
On
April 21, 2009, the subsidiary entered into a consulting service agreement
with ADRES
Advanced Regulatory Services Ltd. (“ADRES”) pursuant to which ADRES
will provide consulting services relating to quality assurance and
regulatory processes and procedures in order to assist the subsidiary in
submission of a U.S. IND according to FDA regulations. In consideration
for the services provided under the agreement, ADRES will be entitled to a
total cash compensation of $211,000, of which the amount $110,000
will be paid as a monthly fixed fee of $10,000 each month for 11 months
commencing May 2009, and the remaining $101,000 will be paid based on
achievement of certain milestones. $160,000 of the total amount was paid
through November 30, 2010, of that $30,000 were paid for completing the
three first milestones.
|
|
e.
|
On
February 10, 2010, the subsidiary entered into an agreement 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 ($139,138) of which €53,950
($70,154) was paid through November 30,
2010.
|
|
f.
|
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, of which $41,102 was paid through November 30,
2010.
|
|
g.
|
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.
|
10
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 3 - COMMITMENTS
(continued):
|
h.
|
Grants
from the Chief Scientist Office of the Ministry of Industry, Trade and
Labor of Israel ("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 Company 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 Company 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.
As
of November 30, 2010, the subsidiary has not yet realized any revenues
from the said project and did not incur any royalty liability.
For the
three months period ended November 30, 2010 the research and development
expenses are presented net of OCS Grants, in the total of $151,976. For the year
ended August 31, 2010 the OCS Grants were $350,198.
NOTE
4 - STOCK HOLDERS’ EQUITY:
On
November 16, 2010, the Company entered into a Securities Purchase Agreement with
an accredited investor for the sale of 937,500 units at a purchase price of
$0.32 per unit for total consideration of $300,000. Each unit consisted of one
share of the Company's common stock and one common stock purchase warrant. Each
warrant entitles the holder to purchase 0.35 a share of common stock exercisable
for five years at an exercise price of $0.50 per share.
As to
shares issued after November 30, 2010, see note 7.
11
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
5 - STOCK BASED
COMPENSATION:
The
following are stocks issued for services, stock options and warrants
transactions made during the three months ended November 30, 2010:
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 for the transaction with Swiss
according to FASB ASC 480 "Distinguishing Liabilities from Equity" (formerly FAS
150).
On
September 11, 2010, the Company issued 253,714 shares of its common stock to
Swiss as remuneration for the services provided, for total of
$88,800.
As to
shares issued after November 30, 2010, see note 7a.
The
Company recognized $195,301 of stock based compensation expense during the three
months ended November 30, 2010 related to options granted to employees and
consultants, all of which relates to options granted in prior
years.
NOTE
6 - FAIR VALUE:
The fair
value of the financial instruments included in the Company’s working capital is
usually identical or close to their carrying value due to the short-term
maturities of these instruments.
NOTE
7 - SUBSEQUENT EVENTS:
a.
|
On January 11, 2011, the Company
issued 100,000 shares of its common stock to Swiss as remuneration for the
services provided, in the amount of
$31,000.
|
b.
|
In
December 2010, the Company entered into a Securities Purchase Agreements
with two accredited investors for the sale of 6,406,250 units at a
purchase price of $0.32 per unit for total consideration of $2,050,000.
Each unit consisted of one share of the Company's common stock and one
common stock purchase warrant. Each warrant entitles the holder to
purchase 0.35 a share of common stock exercisable for five years at an
exercise price of $0.50 per share. 156,250 units were issued on December
23, 2010 and 6,250,000 units were issued on January 10,
2011.
|
12
ITEM
2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following discussion and analysis of our financial condition and results of
operations should be read together with the financial statements and the related
notes included elsewhere herein and in our consolidated financial statements,
accompanying notes and Management’s Discussion and Analysis of Financial
Condition and Results of Operations contained in our Annual Report on Form 10-K
for the year ended August 31, 2010.
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, 2010, and filed with
the Securities and Exchange Commission (the “SEC” or the “Commission”) on
November 29, 2010, as well as those discussed elsewhere in our annual report 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.
As used
in this Quarterly Report on Form 10-Q, the terms “we”, “us”, “our”, the “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.
Overview of
Operations
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, use of orally
ingestible capsules, tablets or pills for delivery of other
polypeptides.
13
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, Inc. 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 authorized
capital to 200,000,000 shares of common stock with the par value of $0.001 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. 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, we changed our name from Integrated
Security Technologies, Inc. to Oramed Pharmaceuticals Inc. On August
31, 2006, based on provisional patent application No. 60/718716, we filed a
patent application under the Patent Cooperation Treaty at the Israel Patent
Office for “Methods and Compositions for Oral Administration of
Proteins.”
Recent
Business Developments
On
December 21, 2010 we entered into a Securities Purchase Agreement with Attara
Fund, Ltd. for the sale of 6,250,000 shares of our common stock ("Shares") and
warrants to purchase up to 2,187,500 Shares, for a total purchase price of
$2,000,000 in cash. The transaction closed on January 10, 2011. The
Shares and warrants were sold in units at a price per unit of $0.32, each unit
consisting of one Share and a warrant to purchase 0.35 of a Share. The warrants
have an exercise price of $0.50 per Share, subject to adjustment, and a term of
five years commencing from January 11, 2010.
On
December 23, 2010, our wholly owned Israeli subsidiary, Oramed Ltd., was awarded
a government grant amounting to a total net amount of NIS 2.9 million
(approximately $807,000), from the Office of the Chief Scientist of the Ministry
of Industry, Trade and Labor of Israel (the "OCS"), which was designated
for research and development expenses for the period of July 2010 to June
2011. Oramed Ltd. plans to use the funds to support further
research and development and clinical study of its oral insulin capsule and
Oral GLP1-analog.
Short
Term Business Strategy
We plan
to conduct further research and development on the technology covered by the
patent application "Methods and Composition for Oral Administration of
Proteins", which we acquired from Hadasit, as well as the other patents we have
filed since. Through our research and development efforts, we are
seeking to develop an oral dosage form that will withstand the harsh chemical
environment of the stomach or intestines and will be effective in delivering
active insulin for the treatment of diabetes. The enzymes and vehicles that are
added to the insulin in the formulation process must not modify chemically or
biologically the insulin and the dosage form must be safe to ingest. We plan to
continue to conduct clinical trials to show the effectiveness of our
technology. We intend to conduct the clinical trials 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, India and South Africa, in order to substantiate our
results as well as for purposes of making 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, including an insulin suppository 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. While our strategy is to partner with
an appropriate party, 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 year 2007 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.
On
November 15, 2007, we successfully completed animal studies in preparation for
the Phase 1B clinical trial of our oral insulin capsule (ORMD
0801). On January 22, 2008, we commenced non-FDA approved Phase 1B
clinical trials with our oral insulin capsule, in healthy human volunteers with
the intent of dose optimization. On March 11, 2008, we successfully
completed our Phase 1B clinical trials.
On April
13, 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. On August 6, 2008, we
announced the successful results of this trial.
15
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 announced the
beginning of this trial. On July 21, 2009 we reported positive results from this
trial. On September 14, 2010, we reported the successful results of an
exploratory clinical trial testing the effectiveness of our oral insulin capsule
(ORMD-0801) in type 1 diabetes patients suffering from uncontrolled
diabetes. Unstable or labile diabetes is characterized by recurrent,
unpredictable and dramatic blood glucose swings often linked with irregular
hyperglycemia and sometimes serious hypoglycemia affecting type 1 diabetes
patients. This newly completed exploratory study was a proof of
concept study for defining a novel indication for ORMD-0801. The encouraging
results justify further clinical development of ORMD-0801 capsule
application toward management of uncontrolled
diabetes.
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.
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 were reported throughout this first study of extended
exposure to the capsule. 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.
GLP-1
Analog:
On
September 16, 2008 we announced the launch of 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 are being 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.
16
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
(oral) 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 (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.
Our oral
insulin capsule is currently manufactured by Swiss Caps AG, under a Clinical
Trail Manufacturing Agreement.
On July
5, 2010, our subsidiary entered into a Manufacturing Supply Agreement ("MSA")
with Sanofi-Aventis Deutschland GMBH ("sanofi-aventis"). According to the MSA,
sanofi-aventis will supply our 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.
Patents
and Licenses
We
maintain a proactive intellectual property strategy which includes patent
filings in multiple jurisdictions, including the United States and other
commercially significant markets. We hold 34 patent applications currently
pending with respect to various compositions, methods of production oral
administration of proteins and exenatide. Expiration dates for pending patents
will in 2026 – 2028.
Consistent
with our strategy to seek protection in key markets worldwide, we have been and
will continue to pursue the patent applications and corresponding foreign
counterparts of such applications. We believe that our success will
depend on our ability to obtain patent protection for our intellectual
property.
Our
patent strategy is as follows:
·
Aggressively protect all current and
future technological developments to assure strong and broad protection by
filing patents and/or continuations in part as appropriate;
·
Protect technological developments at
various levels, in a complementary manner, including the base technology, as
well as specific applications of the technology; and
·
Establish comprehensive coverage in the
U.S. and in all relevant foreign markets in anticipation of future
commercialization opportunities.
17
The
validity, enforceability, written supports, and breadth of claims in our patent
applications involve complex legal and factual questions and, therefore, may be
highly uncertain. No assurance can be given that any patents based on pending
patent applications or any future patent applications filed by us will be
issued, that the scope of any patent protection will exclude competitors or
provide competitive advantages to us, that any of the patents that have been or
may be issued to us will be held valid or enforceable if subsequently
challenged, or that others will not claim rights in or ownership of the patents
and other proprietary rights held or licensed by us. Furthermore, there can be
no assurance that others have not developed or will not develop similar
products, duplicate any of our technology or design around any patents that have
been or may be issued to us. Since patent applications in the United States are
maintained in secrecy for the initial period of time following filing, we also
cannot be certain that others did not first file applications for inventions
covered by our pending patent applications, nor can we be certain that we will
not infringe any patents that may be issued to others on such
applications.
We also
rely on trade secrets and unpatentable know-how that we seek to protect, in
part, by confidentiality agreements. Our policy is to require our employees,
consultants, contractors, manufacturers, outside scientific collaborators and
sponsored researchers, board of directors, technical review board and other
advisors to execute confidentiality agreements upon the commencement of
employment or consulting relationships with us. These agreements provide that
all confidential information developed or made known to the individual during
the course of the individual's relationship with us is to be kept confidential
and not disclosed to third parties except in specific limited circumstances. We
also require signed confidentiality or material transfer agreements from any
company that is to receive our confidential information. In the case of
employees, consultants and contractors, the agreements provide that all
inventions conceived by the individual while rendering services to us shall be
assigned to us as the exclusive property of our company. There can be no
assurance, however, that all persons who we desire to sign such agreements will
sign, or if they do, that these agreements will not be breached, that we would
have adequate remedies for any breach, or that our trade secrets or unpatentable
know-how will not otherwise become known or be independently developed by
competitors.
Our
success will also depend in part on our ability to commercialize our technology
without infringing the proprietary rights of others. No assurance can be given
that patents do not exist or could not be filed which would have an adverse
affect on our ability to market our technology or maintain our competitive
position with respect to our technology. If our technology components, products,
processes or other subject matter are claimed under other existing United States
or foreign patents or are otherwise protected by third party proprietary rights,
we may be subject to infringement actions. In such event, we may challenge the
validity of such patents or other proprietary rights or we may be required to
obtain licenses from such companies in order to develop, manufacture or market
our technology. There can be no assurances that we would be able to obtain such
licenses or that such licenses, if available, could be obtained on commercially
reasonable terms. Furthermore, the failure to either develop a commercially
viable alternative or obtain such licenses could result in delays in marketing
our proposed technology or the inability to proceed with the development,
manufacture or sale of products requiring such licenses, which could have a
material adverse affect on our business, financial condition and results of
operations. If we are required to defend ourselves against charges of patent
infringement or to protect our proprietary rights against third parties,
substantial costs will be incurred regardless of whether we are successful. Such
proceedings are typically protracted with no certainty of success. An adverse
outcome could subject us to significant liabilities to third parties and force
us to curtail or cease our development and commercialization of our
technology.
18
Partnerships
and Collaborative Arrangements
We
believe that working together with strategic partners will expedite product
formulation, production and approval.
On
February 17, 2006, we entered into an agreement with Hadasit to provide
consulting and clinical trial services.
On
October 30, 2006, we entered into a Clinical Trial Manufacturing Agreement with
Swiss Caps AG (“Swiss”), pursuant to which Swiss currently manufactures the oral
insulin capsule developed by us.
During
April 2008, we entered into a five year master services agreement with SAFC, an operating division of
Sigma-Aldrich, Inc., pursuant to which SAFC is providing services for individual
projects, which may include strategic planning, expert consultation, clinical
trial services, statistical programming and analysis, data processing, data
management, regulatory, clerical, project management, central laboratory
services, pre-clinical services, pharmaceutical sciences services, and other
research and development services.
On April
21, 2009, we entered into a consulting service agreement with ADRES, pursuant to
which ADRES will provide services for the purpose of filing an IND application
with the FDA for a Phase 2 study in accordance with FDA requirements. The FDA
approval process and, if approved, registration for commercial use as an oral
drug can take several years.
On July
8, 2009 we entered into an additional agreement with Hadasit, to facilitate
additional clinical trials to be performed at Hadassah Medical Center in
Jerusalem.
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.
On May 2,
2010, we entered into an additional agreement with SAFC Pharma, a division of
the Sigma-Aldrich Corporation, to develop a process to produce one of our oral
capsule ingredients.
As
mentioned above, on July 5, 2010, our subsidiary entered into an MSA with
sanofi-aventis. According to the MSA, sanofi-aventis will supply our subsidiary
with specified quantities of recombinant human insulin to be used for clinical
trials in the USA.
Out-Licensed
Technology
On June
1, 2010, our subsidiary, Oramed Ltd., entered into an agreement with D.N.A Biomedical Solutions
Ltd (formerly,
Laser Detect Systems Ltd),, an Israeli company listed
on the Tel Aviv Stock Exchange ("D.N.A"), for the
establishment of a new company to be called Entera Bio Ltd.
("Entera").
Under the
terms of a license agreement that was entered into between Oramed and Entera, we
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 different patent applications. Entera's
initial development effort will be an oral formulation for the treatment of
osteoporosis. The license will be royalty-free unless our ownership interest in
Entera decreases to 30% or less of its outstanding share capital, in which case
royalties will be payable with respect to revenues derived from certain
indications. Under certain circumstances, Entera may receive ownership of the
licensed technology, in which case we would receive a license back on the same
terms.
19
D.N.A
invested $600,000 in Entera in two parts of $400,000 in August 2010 and $200,000
in November 2010, and Entera is owned in equal parts by Oramed and D.N.A,
subject to dilution by future issuances of shares. Entera's Chief Executive
Officer, Dr. Phillip Schwartz, will be granted options to purchase ordinary
shares of Entera, reflecting 9.9% of Entera's share capital, upon full exercise.
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 Oramed and D.N.A
will be required to make a capital contribution to Entera in the amount of
$150,000.
Mr. Zeev
Bronfeld, who is one of D.N.A's controlling shareholders, holds approximately
10.71% of our outstanding common stock (see "Securities Ownership of Certain
Beneficial Owners and Management").
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 November 30, 2010 of $13,588,838, as well as negative
cash flow from operating activities. Based upon our existing spending
commitments, estimated at $5.4 million for the twelve months following December
1, 2010, and our cash availability, we do not have sufficient cash resources to
meet our liquidity requirements through November 30, 2011. 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 appearing at the beginning of 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. On an ongoing
basis, we evaluate such estimates and judgments. 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.
20
Valuation of options and
warrants: We granted options to purchase shares of our common stock to
employees and consultants and issued warrants in connection with fund
raising.
We
account for share based payments in accordance with the guidance that requires
awards classified as equity awards be accounted for using the grant-date fair
value method. The fair value of share-based payment transactions is recognized
as an expense over the requisite service period, net of estimated forfeitures.
We estimated forfeitures based on historical experience and anticipated future
conditions.
We
elected to recognize compensation cost for an award with only service conditions
that has a graded vesting schedule using the accelerated method based on the
multiple-option award approach.
When
stock options are granted as consideration for services provided by consultants
and other non-employees, the transaction is accounted for based on the fair
value of the consideration received or the fair value of the stock options
issued, whichever is more reliably measurable, pursuant to the guidance. The
fair value of the options granted is measured on a final basis at the end of the
related service period and is recognized over the related service period using
the straight-line method.
Taxes on income: Deferred
taxes are determined utilizing the asset and liability method based on the
estimated future tax effects of differences between the financial accounting and
tax bases of assets and liabilities under the applicable tax laws. Deferred tax
balances are computed using the tax rates expected to be in effect when those
differences reverse. A valuation allowance in respect of deferred tax assets is
provided if, based upon the weight of available evidence, it is more likely than
not that some or all of the deferred tax assets will not be realized. We have
provided a full valuation allowance with respect to its deferred tax
assets.
Regarding
our subsidiary, Oramed Ltd., the guidance prohibits the recognition of deferred
tax liabilities or assets that arise from differences between the financial
reporting and tax bases of assets and liabilities that are measured from the
local currency into dollars using historical exchange rates, and that result
from changes in exchange rates or indexing for tax purposes. Consequently, the
abovementioned differences were not reflected in the computation of deferred tax
assets and liabilities.
The
following table summarizes
certain statements of operations data for the Company for the three month
periods ended November 30, 2010 and 2009:
Three months ended
|
||||||||
Operating Data:
|
November 30, 2010
|
November 30, 2009
|
||||||
Research
and development costs, net
|
$ | 286,488 | $ | 332,485 | ||||
General
and administrative expenses
|
315,129 | 285,016 | ||||||
Financial
expenses (income), net
|
1,167 | (4,708 | ) | |||||
Net
loss for the period
|
$ | 602,784 | $ | 612,793 | ||||
Loss
per common share – basic and diluted
|
$ | (0.01 | ) | $ | (0.01 | ) | ||
Weighted
average common shares outstanding
|
57,932,597 | 57,158,865 |
21
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. We outsource a
substantial portion of our clinical trial activities, utilizing external
entities such as contract research organizations, independent clinical
investigators, and other third-party service providers to assist us with the
execution of our clinical studies. For each clinical trial that we conduct,
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 our clinical trials are performed primarily by contract
research organizations ("CROs"). CROs typically perform most of the start-up
activities for our trials, including document preparation, site identification,
screening and preparation, pre-study visits, training, and program
management.
Clinical
trial and pre-clinical trial expenses include regulatory and scientific
consultants’ compensation and fees, research expenses, purchase of materials,
cost of manufacturing of the oral insulin capsules, payments for patient
recruitment and treatment, costs related to the maintenance of our registered
patents, costs related to the filings of patent applications, as well as
salaries and related expenses of research and development staff.
In August
2009, Oramed Ltd., our wholly owned Israeli subsidiary, was awarded a government
grant amounting to a total net amount of NIS 3.1 million (approximately
$813,000), from the Office of the Chief Scientist of the Ministry of Industry,
Trade and Labor of Israel (the "OCS"), which the OCS designated for
research and development expenses for the period of February 2009 to June
2010. The funds were used by Oramed Ltd. to support further
research and development and clinical study of its oral insulin capsule and
Oral GLP1-analog. In December 2010, Oramed Ltd., was awarded another grant
amounting to a total net amount of NIS 2.9 million (approximately $807,000) from
the OCS, which was designated for research and development expenses for the
period of July 2010 to June 2011. Oramed Ltd. plans to use the funds
to support further research and development and clinical study of its oral
insulin capsule and Oral GLP1-analog. Our grants from the OCS are subject
to repayment according to the terms determined by the OCS and applicable
law. See "Item 7 – Management's Discussion and Analysis of Financial
Condition and Results of Operations – Government Grants" in our Annual Report on
Form 10-K for the year ended August 31, 2010, and filed with the SEC on November
29, 2010.
22
During
the three months ended November 30, 2010 research and development expenses
totaled $286,488, compared to $317,545 for the three months ended November 30,
2009. The decrease is mainly attributable to a decrease in expenses relating to
manufacturing of capsules and a decrease in clinical trials costs. The research
and development costs include stock based compensation costs, which during the
three months ended November 30, 2010 totaled $94,669 as compared to $31,552
during the three months ended November 30, 2009.
Government
Grants
In the
three months ended November 30, 2010 and 2009, we recognized research and
development grants in an amount of $151,976 and $147,590, respectively. As of
November 30, 2010, we had no contingent liabilities to the OCS.
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
three months ended November 30, 2010, general and administrative expenses
totaled $315,129 compared to $299,956 for the three months ended November 30,
2009. Costs incurred related to general and administrative activities during the
three months ended November 30, 2010 reflect an increase in consulting expenses
and a decrease in legal and travel expenses. During the three months ended
November 30, 2010, as part of our general and administrative expenses, we
incurred $100,632 related to stock options granted to employees and consultants,
as compared to $66,425 during the three months ended November 30,
2009.
Financial
income/expense, net
During
the three months ended November 30, 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
Since
inception through November 30, 2010, we incurred losses in an aggregate amount
of $13,588,838. Since inception through November 30, 2010, we have financed our
operations through the private placements of equity and debt financings, raising
a total of $8,608,785, net of transaction costs. We will seek to obtain
additional financing through similar sources. As of November 30, 2010, we had
$1,101,283 of available cash. We anticipate that we will require approximately
$5.4 million to finance our activities during the twelve months following
December 1, 2010.
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.
23
Our
financing activity during the three months ended November 30, 2010 included the
following:
|
·
|
On
September 11, 2010, we issued 253,714 shares of our common stock
("Shares"), valued at $88,800, to Swiss Caps AG as remuneration for the
services provided, for a total of
$88,800.
|
|
·
|
On November
16, 2010, we entered into a Securities Purchase Agreement with Vivid
Horizon Limited for the sale of 937,500 Shares and warrants to purchase up
to 328,125 Shares, for a total purchase price of $300,000 in
cash. The transaction closed on November 18,
2010. The Shares and warrants were sold in units at a price per
unit of $0.32, each unit consisting of one Share and a warrant to purchase
0.35 of a Share. The warrants have an exercise price of $0.50 per Share,
subject to adjustment, and a term of five years commencing from November
18, 2010. The sale of the units was not registered under the
Securities Act. The issuance of the units was a private
placement to an “accredited investor” as defined in Rule 501(a) of
Regulation D and is exempt from registration under Section 4(2) of
the Securities Act and Rule 504 of Regulation D promulgated
thereunder. There were no underwriting fees or commissions associated with
this transaction.
|
Employee's and Consultant’s Stock Options and
Warrants
No
options or warrants were granted to employees or consultants during the
three months ended November 30, 2010.
Off-Balance
Sheet Arrangements
We have
no off-balance sheet arrangements.
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 December 1, 2010 are as follows:
Category:
|
Amount
|
|||
Research
and development costs, net of OCS funds
|
$ | 4,263,000 | ||
General
and administrative expenses
|
1,131,000 | |||
Financial
expense, net
|
2,000 | |||
Taxes
on income
|
- | |||
Total
|
$ | 5,396,000 |
24
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.
Employment and Consulting
Agreements
We have
not engaged in any employment and consulting agreements in the three months
ended November 30, 2010.
25
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As a
smaller reporting company, we are not required to provide the information
required by this Item.
ITEM
4 - 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
November 30, 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, 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.
(c) 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 three months
ended November 30, 2010 that have materially affected, or are reasonable likely
to materially affect our internal control over financial
reporting.
26
PART
II – OTHER INFORMATION
ITEM
1 - LEGAL PROCEEDINGS
From time
to time we may become subject to litigation incidental to our business. We are
not currently a party to any material legal proceedings.
ITEM
2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
(a)
|
On
September 11, 2010, we issued 253,714 shares of our common stock
("Shares"), valued at $88,800, to Swiss Cap AG as remuneration for
services rendered. The transaction was not registered under the
Securities Act of 1933, as amended (the “Securities Act”). The
issuance of the Shares was not a public offering within the
meaning of Section 4(2) of the Securities Act, and was therefore deemed
exempt from registration. There were no underwriting fees or
commissions associated with this
transaction.
|
|
(b)
|
On
November 16, 2010, we entered into a Securities Purchase Agreement with
Vivid Horizon Limited for the sale of 937,500 Shares and warrants to
purchase up to 328,125 Shares, for a total purchase price of $300,000 in
cash. The transaction closed on November 18,
2010. The Shares and warrants were sold in units at a price per
unit of $0.32, each unit consisting of one Share and a warrant to purchase
0.35 of a Share. The warrants have an exercise price of $0.50 per Share,
subject to adjustment, and a term of five years commencing from November
18, 2010. The sale of the units was not registered under the
Securities Act. The issuance of the units was a private
placement to an “accredited investor” as defined in Rule 501(a) of
Regulation D and is exempt from registration under Section 4(2) of
the Securities Act and Rule 504 of Regulation D promulgated
thereunder. There were no underwriting fees or commissions associated with
this transaction.
|
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).
|
27
(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*
|
Securities
Purchase Agreement, between Oramed Pharmaceuticals Inc. and Attara Fund,
Ltd., dated as of December 21, 2010.
|
|
10.2*
|
Common
Stock Purchase Warrant issued to Attara Fund, Ltd. on January 10,
2011.
|
|
(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
|
28
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: January
13, 2011
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: January
13, 2011
|
By:
|
/s/ Yifat
Zommer
|
Yifat
Zommer
|
||
Chief
Financial
Officer
|
29