ORAMED PHARMACEUTICALS INC. - Quarter Report: 2009 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, 2009
o 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)
(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 o
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 o
|
|
Accelerated filer
o
|
|
|
|||
Non-accelerated filer o
|
|
(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 o No x
APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS
DURING THE PRECEDING FIVE YEARS:
Indicate
by check mark whether the registrant has filed all documents and reports
required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act
of 1934 subsequent to the distribution of securities under a plan confirmed by a
court. Yes o No o
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date: 57,454,707 shares issued and
outstanding as of January 12, 2009.
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
4 – CONTROLS AND PROCEDURES
|
22
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ITEM
1 – LEGAL PROCEEDINGS
|
24
|
ITEM
2A – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
|
24
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ITEM
6 – EXHIBITS
|
25
|
PART I – FINANCIAL
INFORMATION
ITEM
1 – FINANCIAL STATEMENTS
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS OF
NOVEMBER 30, 2009
1
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS OF
NOVEMBER 30, 2009
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,
|
|||||||
2009
|
2009
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 1,146,128 | $ | 1,716,866 | ||||
Short
term investments
|
1,400,000 | 1,000,000 | ||||||
Restricted
cash
|
16,000 | 16,000 | ||||||
Accounts
receivable - other
|
34,154 | 36,939 | ||||||
Prepaid
expenses
|
23,610 | 4,119 | ||||||
Grants
receivable from the Office of the Chief Scientist
|
260,982 | 400,405 | ||||||
Total
current assets
|
2,880,874 | 3,174,329 | ||||||
LONG
TERM DEPOSITS
|
12,222 | 12,161 | ||||||
PROPERTY AND EQUIPMENT,
net
|
67,372 | 75,361 | ||||||
Total
assets
|
$ | 2,960,468 | $ | 3,261,851 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 364,332 | $ | 321,344 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
411,584 | 368,596 | ||||||
PROVISION
FOR UNCERTAIN TAX POSITION
|
147,063 | 147,063 | ||||||
COMMITMENTS
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
stock of $ 0.001 par value - Authorized: 200,000,000 shares at
November 30, 2009 and August 31, 2009; Issued and outstanding: 57,026,597
at November 30, 2009 and 56,456,710 shares at August 31, 2009,
respectively
|
57,026 | 56,456 | ||||||
Additional
paid-in capital
|
12,966,266 | 12,698,414 | ||||||
Deficit
accumulated during the development stage
|
(10,621,471 | ) | (10,008,678 | ) | ||||
Total
stockholders' equity
|
2,401,821 | 2,746,192 | ||||||
Total
liabilities and stockholders' equity
|
$ | 2,960,468 | $ | 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)
|
||||||||||||
Three
months ended
|
through
|
|||||||||||
November
30
|
November
30
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Unaudited
|
||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES, net
|
$ | 317,545 | $ | 818,680 | $ | 5,462,404 | ||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
299,956 | 383,361 | 4,557,507 | |||||||||
OPERATING
LOSS
|
617,501 | 1,202,041 | 10,454,787 | |||||||||
FINANCIAL
INCOME
|
(8,373 | ) | (22,144 | ) | (144,481 | ) | ||||||
FINANCIAL
EXPENSE
|
3,665 | 8,149 | 151,598 | |||||||||
LOSS
BEFORE TAXES ON INCOME
|
612,793 | 1,188,046 | 10,461,904 | |||||||||
TAXES
ON INCOME
|
- | - | 159,567 | |||||||||
NET
LOSS FOR THE PERIOD
|
$ | 612,793 | $ | 1,188,046 | $ | 10,621,471 | ||||||
BASIC
AND DILUTED LOSS PER
|
||||||||||||
COMMON
SHARE
|
$ | (0.01 | ) | $ | (0.02 | ) | ||||||
WEIGHTED
AVERAGE NUMBER OF COMMON
|
||||||||||||
STOCK
USED IN COMPUTING BASIC AND
|
||||||||||||
DILUTED
LOSS PER COMMON STOCK
|
57,158,865 | 56,363,714 |
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
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during
the
|
Total
|
||||||||||||||||||
Common
Stock
|
paid-in
|
development
|
stockholders'
|
|||||||||||||||||
Shares
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$
|
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
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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
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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
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2,605,796 | 2,605,796 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
203,982 | 203,982 | ||||||||||||||||||
DISCOUNT
ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION
FEATURE
|
108,000 | 108,000 | ||||||||||||||||||
COMPREHENSIVE
LOSS
|
(16 | ) | (16 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
12,217 | 12,217 | ||||||||||||||||||
NET
LOSS
|
(7,248,188 | ) | (7,248,188 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2008 (audited)
|
56,252,806 | 56,252 | 11,785,012 | (7,248,204 | ) | 4,593,060 | ||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED
|
203,904 | 204 | 152,724 | 152,928 | ||||||||||||||||
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
203,699 | 203,699 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
436,025 | 436,025 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
117,174 | 117,174 | ||||||||||||||||||
IMPUTED
INTEREST
|
3,780 | 3,780 | ||||||||||||||||||
NET
LOSS
|
(2,760,474 | ) | (2,760,474 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2009 (audited)
|
56,456,710 | 56,456 | 12,698,414 | (10,008,678 | ) | 2,746,192 | ||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED IN PREVIOUS PERIOD
|
569,887 | 570 | (570 | ) | -,- | |||||||||||||||
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
169,500 | 169,500 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
81,316 | 81,316 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
16,661 | 16,661 | ||||||||||||||||||
IMPUTED
INTEREST
|
945 | 945 | ||||||||||||||||||
NET
LOSS
|
(612,793 | ) | (612,793 | ) | ||||||||||||||||
BALANCE
AS OF NOVEMBER 30, 2009 (unaudited)
|
57,026,597 | $ | 57,026 | $ | 12,966,266 | $ | (10,621,471 | ) | $ | 2,401,821 |
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,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (612,793 | ) | $ | (1,188,046 | ) | $ | (10,621,471 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
7,989 | 7,497 | 53,931 | |||||||||
Amortization
of debt discount
|
- | - | 108,000 | |||||||||
Exchange
differences on long term deposits
|
(61 | ) | 967 | (1,062 | ) | |||||||
Stock based
compensation
|
97,977 | 101,647 | 3,460,954 | |||||||||
Common stock issued for
services
|
- | - | 367,788 | |||||||||
Common stock to be issued for
services
|
169,500 | - | 373,199 | |||||||||
Impairment of
investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
945 | 945 | 16,942 | |||||||||
Changes in operating assets and
liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
122,717 | 104,880 | (318,746 | ) | ||||||||
Restricted
cash
|
- | - | (16,000 | ) | ||||||||
Accounts payable and accrued
expenses
|
42,988 | (100,872 | ) | 364,332 | ||||||||
Provision for uncertain tax
position
|
- | - | 147,063 | |||||||||
Total
net cash used in operating activities
|
(170,738 | ) | (1,072,982 | ) | (5,630,194 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
- | (1,469 | ) | (121,303 | ) | |||||||
Acquisition
of short-term investments
|
(400,000 | ) | - | (4,128,000 | ) | |||||||
Proceeds
from sale of Short term investments
|
- | 1,000,000 | 2,728,000 | |||||||||
Lease
deposits
|
- | (1,919 | ) | (11,160 | ) | |||||||
Total
net cash used in investing activities
|
(400,000 | ) | 996,612 | (1,532,463 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds from sales of common
stocks and warrants - net of issuance
expenses
|
- | - | 7,961,481 | |||||||||
Receipts on account of shares
issuances
|
6,061 | |||||||||||
Proceeds from convertible
notes
|
- | - | 275,000 | |||||||||
Proceeds from short term note
payable
|
- | - | 120,000 | |||||||||
Payments of short term note
payable
|
- | - | (120,000 | ) | ||||||||
Shareholder
advances
|
- | - | 66,243 | |||||||||
Net
cash provided by financing activities
|
- | - | 8,308,785 | |||||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(570,738 | ) | (76,370 | ) | 1,146,128 | |||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
1,716,866 | 2,267,320 | - | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 1,146,128 | $ | 2,190,950 | $ | 1,146,128 | ||||||
Non
cash investing and financing activities:
|
||||||||||||
Shares issued for offering costs
|
$ | 1,753 | ||||||||||
Contribution to paid in capital
|
$ | $18,991 | ||||||||||
Discount
on convertible note related to beneficial conversion
feature
|
$ | 108,000 | ||||||||||
Shares issued for services rendered
|
$ | 152,928 |
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, 2009 and for the three months then ended, have been prepared
in accordance with accounting principles generally accepted in the United
States relating to the preparation of financial statements for interim
periods. Accordingly, they do not include all the information and
footnotes required for annual financial statements. In the opinion of
management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. Operating
results for the three months ended November 30, 2009, are not necessarily
indicative of the results that may be expected for the year ending August
31, 2010.
|
|
3.
|
Going
concern considerations
|
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, 2009 of $10,621,471 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, 2009. 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
|
|
1.
|
In
April 2009, the Financial Accounting Standards Board (“FASB”) issued ASC
Topic 825 “Financial Instruments” (formerly FSP No. FAS 107-1
and APB 28-1, “Interim Disclosures about Fair Value of Financial
Instruments.” ASC 825 requires companies to disclose in interim
financial statements the fair value of financial instruments within the
scope of ASC Topic 820 “Fair Value Measurements and Disclosures” (formerly
FASB Statement No. 107, Disclosures about Fair Value of Financial
Instruments). However, companies are not required to provide in
interim periods the disclosures about the concentration of credit risk of
all financial instruments that are currently required in annual financial
statements. The fair-value information disclosed in the
footnotes must be presented together with the related carrying amount,
making it clear whether the fair value and carrying amount represent
assets or liabilities and how the carrying amount relates to what is
reported in the balance sheet.
|
|
ASC
825 also requires that companies disclose the method or methods and
significant assumptions used to estimate the fair value of financial
instruments and a discussion of changes, if any, in the method or methods
and significant assumptions during the period. The ASC shall be
applied prospectively and is effective for interim and annual periods
ending after June 15, 2009. To the extent relevant, the
Company adopted the disclosure requirements of this pronouncement for the
quarter ended November 30, 2009, in conjunction with the adoption of ASC
Topic 820 (formerly FSP FAS 157-4), ASC Topic 320 (formerly FSP
FAS 115-2) and ASC Topic 958 (formerly
FAS 124-2). The adoption of the new disclosure
requirements did not have a material impact on the Company’s financial
statements.
|
|
2.
|
In
May 2009, the FASB issued ASC Topic 855 “Subsequent Events”
(formerly SFAS No. 165, Subsequent Events). ASC 855 sets forth
the period after the balance sheet date during which management of a
reporting entity should evaluate events or transactions that may occur for
potential recognition or disclosure in the financial statements, the
circumstances under which an entity should recognize events or
transactions occurring after the balance sheet date in its financial
statements, and the disclosures that an entity should make about events or
transactions that occurred after the balance sheet date. ASC 855 is
effective for interim or annual periods ending after June 15, 2009 and
will be applied prospectively. The Company adopted the
provisions of ASC 855 for the quarter ended November 30,
2009. The adoption of ASC 855 did not have a material impact on
the Company’s condensed financial condition, results of operations or cash
flows.
|
|
3.
|
In
June 2009, the FASB issued Accounting Standards Update (“ASU”) No. 2009-1,
“Topic 105 — Generally
Accepted Accounting Principles” which amended ASC 105 “The “FASB
Accounting Standards Codification” and the Hierarchy of Generally Accepted
Accounting Principles (formerly SFAS No. 168 “The FASB Accounting
Standards Codification and the Hierarchy of Generally Accepted Accounting
Principles – A Replacement of FASB Statement No. 162”). ASU 2009-1
establishes the FASB Accounting Standards CodificationTM (Codification)
as the single source of authoritative U.S. generally accepted accounting
principles (U.S. GAAP) recognized by the FASB to be applied by
nongovernmental entities. Rules and interpretive releases of the SEC under
authority of federal securities laws are also sources of authoritative
U.S. GAAP for SEC registrants.
|
8
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 1 - SIGNIFICANT ACCOUNTING
POLICIES (continued):
|
ASU
2009-1 and the Codification are effective for financial statements issued
for interim and annual periods ending after September 15, 2009. The
Codification supersedes all existing non-SEC accounting and reporting
standards. All other nongrandfathered non-SEC accounting literature not
included in the Codification will become nonauthoritative. Following ASU
2009-1, the FASB will not issue new standards in the form of Statements,
FASB Staff Positions, or Emerging Issues Task Force Abstracts. Instead,
the FASB will issue Accounting Standards Updates, which will serve only
to: (a) update the Codification; (b) provide background information about
the guidance; and (c) provide the bases for conclusions on the change(s)
in the Codification. The adoption of ASU 2009-1did not have a material
impact on the Company’s financial
statements.
|
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 November
30, 2009 was $279,255 which refers to all three agreements.
|
b.
|
During
January and April 2008 the Company entered into agreements with OnQ
consulting, a clinical research organization (CRO) located in
Johannesburg, South Africa, to conduct Phase 1B and 2B clinical trials on
its oral insulin capsules. The total cost estimated for the studies is
$229,681 of which $107,599 was paid through November 30,
2009.
|
|
c.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note
3a and 5a.
|
9
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 2 – COMMITMENTS
(continued):
|
d.
|
On
April 22, 2009, the subsidiary entered into a consulting service agreement
with ADRES Advanced Regulatory Services
Ltd. (“ADRES”) pursuant to which
ADRES will provide
consulting services
relating to quality assurance and regulatory processes and procedures in
order to assist the subsidiary in submission of a U.S.
IND according to FDA regulations. In consideration for the services
provided under the agreement, ADRES will be entitled to a total cash
compensation of $211,000, of which the amount $110,000 will
be paid as a monthly fixed fee of $10,000 each month for 11 months
commencing May 2009, and the remaining $101,000 will be paid based on
achievement of
certain milestones. $80,000 of the total amount was paid through
November 30, 2009.
|
|
e.
|
Grants
from the Chief Scientist Office
("OCS")
|
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.
At November 30, 2009, the Company has not earned any
revenues from the sale of products and no royalty payments have
accrued.
For the
three months period ended November 30, 2009 the research and development
expenses are presented net of OCS Grants, in the total of $147,590. For the year
ended August 31, 2009 the OCS Grants were $400,405.
10
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 three months ended November 30, 2009:
|
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.
|
b.
|
On
November 23, 2009, 100,000 options were granted to a consultant, at an
exercise price of $0.76 per share (higher than the traded market price on
the date of grant), the options vest in three equal annual instalments
commencing November 23, 2010 and expire on November 23,
2014.
|
|
c.
|
On
November 23, 2009, 36,000 options were granted to an employee of our
Subsidiary, at an exercise price of $0.46 per share (equivalent to the
traded market price on the date of grant), the options vest in three equal
annual instalments commencing November 23, 2010 and expire on November 23,
2019.
|
The
Company recognized $97,977 of stock based compensation expense during the three
months ended November 30, 2009 related to options granted to employees and
consultants, of which $97,332 relates to options granted in prior
years.
NOTE
4 - 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.
11
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
5 - SUBSEQUENT EVENTS:
The
Company has performed an evaluation of subsequent events through January 13,
2010, which is the date the financial statements were issued.
|
a)
|
On
December 29, 2009, the Company issued 328,110 shares of its common stock
to Swiss as remuneration for the services provided, in the amount of
$167,310.
|
|
b)
|
On
December 29, 2009, the Company issued 100,000 shares of its common stock
to a third party as remuneration for services that will be rendered
commencing December 15, 2009 for a period of six
months.
|
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 the heading “Risks Related to Our
Business” below, as well as those discussed elsewhere 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.
13
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 US dollars unless otherwise indicated.
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 oral ingestible capsules or tablets, use of oral
ingestible pills for delivery of other polypeptides and use of rectal
application for delivery 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 March
8, 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. Effective 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.”
14
Plan
of Operation
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 the chemically
or biologically 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 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, India and South Africa, 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.
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.
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 the 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.
15
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.
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 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. We are considering whether and when to conduct an
additional non-FDA approved Phase 2B study in India.
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 announced that we had concluded a
proof of concept study of the insulin suppositories.
On
October 23, 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.
GLP1
Analog: On September 16, 2008 we announced the launch of pre-clinical
trials of ORMD 0901, a GLP1-analog. The pre-clinical trials include
animal studies which suggest that the GLP-1analog (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.
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.
Raw
Materials: Our
oral insulin capsule is currently manufactured by Swiss Caps AG, under a
Clinical Trail Manufacturing Agreement. 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.
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. 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.
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 November 30, 2009 of $10,621,471, as well as negative
cash flow from operating activities. Based upon our existing spending
commitments, estimated at $5.7 million for the twelve months following December
1, 2009, and our cash availability, we do not have sufficient cash resources to
meet our liquidity requirements through November 30, 2010. 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 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.
The
following table summarizes
certain statements of operations data for the Company for the three month
periods ended November 30, 2009 and 2008:
18
Three months ended
|
||||||||
Operating Data:
|
November 30, 2009
|
November 30, 2008
|
||||||
Research
and development costs, net
|
$ | 317,545 | $ | 818,680 | ||||
General
and administrative expenses
|
299,956 | 383,361 | ||||||
Financial
income, net
|
(4,708 | ) | (13,995 | ) | ||||
Net
loss for the period
|
$ | 612,793 | $ | 1,188,046 | ||||
Loss
per common share – basic and diluted
|
$ | (0.01 | ) | $ | (0.02 | ) | ||
Weighted
average common shares outstanding
|
57,158,865 | 56,363,714 |
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 three months ended November 30, 2009 research and development expenses
totaled $317,545, compared to $818,680 for the three months ended November 30,
2008. The decrease is mainly attributable to a decrease in materials purchased
and an increase in grants received from the Office of Chief Scientist of the
Israeli Ministry of Industry, Trade and Labor, or the OCS. The research and
development costs include stock based compensation costs, which during the three
months ended November 30, 2009 totaled $31,552 as compared to $35,962 during the
three months ended November 30, 2008.
19
Government
Grants
In the
three months ended November 30, 2009, we recognized research and development
grants in an amount of $147,590. As of November 30, 2009, 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, 2009, general and administrative expenses
totaled $299,956 compared to $383,361 for the three months ended November 30,
2008. Costs incurred related to general and administrative activities during the
three months ended November 30, 2009 reflect a decrease of payroll and related
expenses and travel expenses as well as a decrease in general expenses such as
office and maintenance expenses. During the three months ended November 30,
2009, as part of our general and administrative expenses, we incurred $66,425
related to stock options granted to employees and consultants, as compared to
$65,685 during the three months ended November 30, 2008.
Financial
income/expense, net
During
the three months ended November 30, 2009 and 2008 we generated interest income
on available cash and cash equivalents which was offset by bank charges and
imputed interest.
Liquidity
and Capital Resources
Through
November 30, 2009, we incurred losses in an aggregate amount of $10,621,471. We
have financed our operations through the private placements of equity and debt
financing. Since inception through November 30, 2009, 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 November 30, 2009, we had
$1,146,128 of available cash as well as $1,400,000 in short term interest
bearing investments. We anticipate that we will require approximately $5.7
million to finance our activities during the twelve months following December 1,
2009.
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 activity during the three months ended November 30, 2009 included the
issuance of 569,887 shares of common stock on September 11, 2009, valued at
$203,699, to a third party for services rendered in the prior
year.
20
Employee's and Consultant’s Stock Options and
Warrants
Employee
and consultant stock
option grants and warrant issuance activities for the three months
ended November 30, 2009 included 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.
|
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, 2009 are as follows:
Operating:
|
Amount
|
|||
Research
and development costs, net of OCS funds
|
$ | 4,194,000 | ||
General
and administrative expenses
|
1,496,000 | |||
Financial
income, net
|
(10,000 | ) | ||
Taxes
on income
|
- | |||
Total
|
$ | 5,680,000 |
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, 2009.
21
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
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, 2009. 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)
Management’s Annual
Report on Internal Control over Financial
Reporting
|
Our
management, under the supervision of our chief executive officer and chief
financial officer, is responsible for establishing and maintaining adequate
internal control over our financial reporting, as defined in Rules 13a-15(f) and
15d-15(f) of the Securities Exchange Act of 1934, as amended. The Company’s
internal control over financial reporting is defined as a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. Internal control over financial
reporting includes policies and procedures that:
|
·
|
pertain
to the maintenance of records that in reasonable detail accurately and
fairly reflect our transactions and asset
dispositions;
|
|
·
|
provide
reasonable assurance that transactions are recorded as necessary to permit
the preparation of our financial statements in accordance with generally
accepted accounting principles, and that our receipts and expenditures are
being made only in accordance with authorizations of our management and
directors; and
|
|
·
|
provide
reasonable assurance regarding the prevention or timely detection of
unauthorized acquisition, use or disposition of assets that could have a
material effect on our financial
statements.
|
22
Under the
supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we evaluated the
effectiveness of our internal control over financial reporting as of November
30, 2009 based on the framework for Internal Control-Integrated Framework set
forth by The Committee of Sponsoring Organizations of the Treadway Commission.
Due to the inherent limitations of our company, derived from our small size and
the limited number of employees, management evaluation concluded that there is a
material weakness with respect to segregation of duties that may not provide
reasonable assurance regarding the reliability of internal control over
financial reporting and may not prevent or detect misstatements. Specifically,
our CFO serves as our only qualified internal accounting and financial reporting
personnel and as such performs all accounting and financial reporting functions
without the benefit of independent checks, confirmations or backup other than
bookkeeping functions performed by an outside accounting firm. In addition,
projections of any evaluation of effectiveness to future periods are subject to
the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures may
deteriorate.
Based on
this evaluation, our management concluded that there is no reasonable assurance
regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted
accounting principles and that the Company’s internal controls over financial
reporting were not effective as of November 30, 2009.
As
previously reported in our Form 10-K filed on November 25, 2009, during the year
ended August 31, 2009, management started an extensive process of
documenting all major procedures related to financial reporting, in order to
strengthen our internal controls over financial reporting in order to reasonably
ensure the reliability of our financial statements.
This
management report on internal control over financial reporting shall not be
deemed to be filed for purposes of Section 18 of the Securities Exchange Act of
1934, as amended, or otherwise subject to the liabilities of that
Section.
(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 quarter ended
November 30, 2009 that have materially affected, or are reasonable likely to
materially affect our internal control over financial
reporting.
23
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
2A – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
(a) On
September 11, 2009, we issued 569,887 shares of our common stock to Swiss Cap AG
as remuneration for services rendered during 2009, in the amount of
$203,699. Since the transaction was not a public offering within the
meaning of Section 4(2) of the Securities Act, the issuance was deemed exempt
from registration.
24
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
between our company and Hadasit Medical Services and Development Ltd.
dated February 17, 2006 (incorporated by reference from our current report
on Form 8-K filed February 17, 2006).
|
|
10.2
|
Agreement
between our company and Swiss Caps Ag dated October 30, 2006 (incorporated
by reference from our current report on Form 8-K filed October 26,
2006).
|
|
10.2
|
Agreement
between our company and Hadasit Medical Services and Development Ltd.
dated January 7, 2008 (incorporated by reference from our current report
on Form 8-K filed January 7, 2008).
|
|
10.3
|
Agreement
dated April 22, 2009, between Oramed Ltd. and ADRES Advanced Regulatory
Services Ltd. (incorporated by reference from our current report on Form
8-K filed April 22, 2009).
|
|
10.4
|
Agreement
dated July 8, 2009, between our company and Hadasit Medical Services and
Development Ltd. (incorporated by reference from our current report on
Form 8-K filed July 9, 2009).
|
|
(31)
|
Section
302 Certification
|
|
31.1
*
|
Certification
Statement of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
31.2
*
|
Certification
Statement of the Principal Accounting Officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
(32)
|
Section
906 Certification
|
|
32.1
*
|
Certification
Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of
2002
|
|
32.2
*
|
Certification
Statement of the Principal Accounting Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
Of
2002
|
*
|
Filed
herewith
|
25
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, 2010
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: January
13, 2010
|
By:
|
/s/ Yifat
Zommer
|
Yifat
Zommer
|
||
Chief
Financial
Officer
|
26