ORAMED PHARMACEUTICALS INC. - Quarter Report: 2008 November (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the Quarterly Period Ended November 30, 2008
¨
TRANSITION REPORT UNDER 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 5660001
(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
past 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 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
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 ¨ No
¨
APPLICABLE
ONLY TO CORPORATE ISSUERS:
State the
number of shares outstanding of each of the registrant's classes of common
equity, as of the latest practicable date: 56,456,710 shares issued and
outstanding as of January 13, 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
|
11
|
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
21
|
ITEM
4T - CONTROLS AND PROCEDURES
|
21
|
PART
II – OTHER INFORMATION
|
23
|
ITEM
1 - LEGAL PROCEEDINGS
|
23
|
ITEM
6 - EXHIBITS
|
24
|
PART I – FINANCIAL
INFORMATION
ITEM
1 - FINANCIAL STATEMENTS
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS OF
NOVEMBER 30, 2008
TABLE OF
CONTENTS
Page
|
||
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS:
|
||
Balance sheets
|
2
|
|
Statements of
operations
|
3
|
|
Statements of changes in
stockholders’ equity
|
4
|
|
Statements of cash
flows
|
5
|
|
Notes to financial
statements
|
6-10
|
ORAMED
PHARMACEUTICALS INC.
(A development stage
company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
U.S.
dollars
November
30,
|
August
31,
|
|||||||
2008
|
2008
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 2,190,950 | $ | 2,267,320 | ||||
Short
term investments
|
1,728,000 | 2,728,000 | ||||||
Prepaid
expenses and other current assets
|
297,694 | 402,574 | ||||||
Total current
assets
|
4,216,644 | 5,397,894 | ||||||
|
||||||||
LONG
TERM DEPOSITS
|
11,776 | 10,824 | ||||||
PROPERTY AND EQUIPMENT,
net
|
92,268 | 98,296 | ||||||
Total assets
|
$ | 4,320,688 | $ | 5,507,014 | ||||
|
||||||||
Liabilities
and stockholders' equity
|
||||||||
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 612,902 | $ | 866,702 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total current
liabilities
|
660,154 | 913,954 | ||||||
|
||||||||
COMMITMENTS
|
||||||||
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
stock of $ 0.001 par value - Authorized: 200,000,000 shares at
November 30, 2008 and August 31, 2008; Issued and outstanding: 56,456,710
at November 30, 2008 and 56,252,806 shares at August 31, 2008,
respectively
|
56,456 | 56,252 | ||||||
Additional
paid-in capital
|
12,040,328 | 11,785,012 | ||||||
Deficit
accumulated during the development stage
|
(8,436,250 | ) | (7,248,204 | ) | ||||
Total stockholders'
equity
|
3,660,534 | 4,593,060 | ||||||
Total liabilities
and stockholders' equity
|
$ | 4,320,688 | $ | 5,507,014 |
The
accompanying notes are an integral part of the consolidated financial
statements.
2
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
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Unaudited
|
||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES
|
$ | 818,680 | $ | 95,674 | $ | 4,406,514 | ||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
383,361 | 266,296 | 3,413,819 | |||||||||
OPERATING
LOSS
|
1,202,041 | 361,970 | 8,255,209 | |||||||||
INTEREST
INCOME
|
(22,144 | ) | (17,145 | ) | (119,650 | ) | ||||||
INTEREST
EXPENSE
|
8,149 | 8,677 | 138,527 | |||||||||
LOSS
BEFORE TAXES ON INCOME
|
1,188,046 | 353,502 | 8,274,086 | |||||||||
TAXES
ON INCOME
|
- | - | 162,164 | |||||||||
NET
LOSS FOR THE PERIOD
|
$ | 1,188,046 | $ | 353,502 | $ | 8,436,250 | ||||||
BASIC
AND DILUTED LOSS PER
|
||||||||||||
COMMON
SHARE
|
$ | (0.02 | ) | $ | (0.01 | ) | ||||||
WEIGHTED
AVERAGE NUMBER OF COMMON
|
||||||||||||
STOCK
USED IN COMPUTING BASIC AND
|
||||||||||||
DILUTED
LOSS PER COMMON STOCK
|
56,363,714 | 45,609,417 |
The
accompanying notes are an integral part of the consolidated financial
statements.
3
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, 2007
(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
|
27,181,228 | 27,181 | 2,095,800 | 2,122,981 | ||||||||||||||||
SHARES
ISSUED FOR SERVICES
|
125,000 | 125 | 98,625 | 98,750 | ||||||||||||||||
CONTRIBUTIONS
TO PAID IN CAPITAL
|
18,991 | 18,991 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
1,968,547 | 1,968,547 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
177,782 | 177,782 | ||||||||||||||||||
DISCOUNT
ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION
FEATURE
|
108,000 | 108,000 | ||||||||||||||||||
COMPREHENSIVE
LOSS
|
(16 | ) | (16 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
8,437 | 8,437 | ||||||||||||||||||
NET
LOSS
|
(4,478,917 | ) | (4,478,917 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2007 (audited)
|
45,231,779 | 45,231 | 4,946,833 | (4,478,933 | ) | 513,131 | ||||||||||||||
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 | ||||||||||||||||
SHARES
AND WARRANTS ISSUED FOR CASH – NET OF ISSUANCE EXPENSES
|
10,178,002 | 10,178 | 5,774,622 | 5,784,800 | ||||||||||||||||
SHARES
ISSUED FOR SERVICES
|
293,025 | 293 | 115,817 | 116,110 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
459,467 | 459,467 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
203,982 | 203,982 | ||||||||||||||||||
IMPUTED
INTEREST
|
3,780 | 3,780 | ||||||||||||||||||
NET
LOSS
|
(2,769,271 | ) | (2,769,271 | ) | ||||||||||||||||
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
|
203,904 | 204 | 152,724 | 152,928 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
103,168 | 103,168 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
(1,521 | ) | (1,521 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
945 | 945 | ||||||||||||||||||
NET
LOSS
|
(1,188,046 | ) | (1,188,046 | ) | ||||||||||||||||
BALANCE
AS OF NOVEMBER 30, 2008 (unaudited)
|
56,456,710 | $ | 56,456 | $ | 12,040,328 | $ | (8,436,250 | ) | $ | 3,660,534 |
The
accompanying notes are an integral part of the consolidated financial
statements
4
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,
|
|||||||||||
2008
|
2007
|
2008
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (1,188,046 | ) | $ | (353,502 | ) | $ | (8,436,250 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
7,497 | 470 | 22,951 | |||||||||
Amortization
of debt discount
|
- | - | 108,000 | |||||||||
Exchange
differences on long term deposits
|
967 | (336 | ) | (675 | ) | |||||||
Stock
based compensation
|
101,647 | 82,552 | 2,911,425 | |||||||||
Common
stock issued for services
|
- | *- | 367,788 | |||||||||
Impairment
of investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
945 | 945 | 13,162 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
104,880 | (60,533 | ) | (297,694 | ) | |||||||
Accounts
payable and accrued expenses
|
(100,872 | ) | *(101,684 | ) | 612,902 | |||||||
Total net cash used in
operating activities
|
(1,072,982 | ) | (432,088 | ) | (4,263,515 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
(1,469 | ) | (7,221 | ) | (115,219 | ) | ||||||
Acquisition
of short-term investments
|
- | - | (2,728,000 | ) | ||||||||
Proceeds
from sale of Short term investments
|
1,000,000 | 1,000,000 | ||||||||||
Lease
deposits
|
(1,919 | ) | - | (11,101 | ) | |||||||
Total net cash provided by
(used in) in investing activities
|
996,612 | (7,221 | ) | (1,854,320 | ) | |||||||
CASH FLOWS FROM FINANCING
ACTIVITIES:
|
||||||||||||
Proceeds
from sales of common stocks and warrants
- net of issuance expenses
|
- | - | 7,967,542 | |||||||||
Proceeds
from convertible notes
|
- | - | 275,000 | |||||||||
Proceeds
from short term note payable
|
- | - | 120,000 | |||||||||
Payments
of short term note payable
|
- | - | (120,000 | ) | ||||||||
Shareholder
advances
|
- | - | 66,423 | |||||||||
Net cash provided by financing
activities
|
- | - | 8,308,785 | |||||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(76,370 | ) | (439,309 | ) | 2,190,950 | |||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
2,267,320 | 1,918,229 | - | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 2,190,950 | $ | 1,478,920 | $ | 2,190,950 | ||||||
Non
cash investing and financing activities:
|
||||||||||||
Shares
issued for offering costs
|
$ | 1,753 | ||||||||||
Contribution
to paid in capital
|
$ | 18,991 | ||||||||||
Stock
issued for receipts on account of shares issuance
|
$ | 255,000 | ||||||||||
Shares
issued for services rendered
|
$ | 152,928 | $ | 172,202 |
*
Reclassified
The
accompanying notes are an integral part of the consolidated financial
statements.
5
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. ("the Subsidiary"), which is engaged in research and
development.
|
|
2.
|
The
accompanying unaudited interim consolidated financial statements as of
November 30, 2008 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, 2008, are not necessarily
indicative of the results that may be expected for the year ending August
31, 2009.
|
|
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, 2008 of $8,436,250, 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 December 1, 2008. 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.
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.
6
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 1 - SIGNIFICANT ACCOUNTING
POLICIES (continued):
|
b.
|
Share-based
payment:
|
|
The
Company implements Statement of Financial Accounting Standards
No. 123 (revised 2004) “Share-based Payment” (“FAS 123(R)”). FAS
123(R) 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 expense over the requisite service period,
net of estimated forfeitures. The company recognizes compensation cost for
an award with only service conditions that has a graded vesting schedule
using the accelerated method of amortization under FAS 123(R) over the
requisite service period for the entire
awards.
|
On March
2005, the Securities and Exchange Commission issued Staff Accounting Bulletin
No. 107 (“SAB 107”). SAB 107 provides supplemental implementation guidance
on FAS 123(R), including guidance on valuation methods, inventory capitalization
of share-based compensation cost, income statement effects, disclosures and
other issues. SAB 107 requires share-based payment to be classified in the same
expense line items as cash compensation. The company has applied the provisions
of SAB 107 in its adoption of FAS 123(R).
The
Company accounts for equity instruments issued to third party service providers
(non-employees) in accordance with the fair value based on an option-pricing
model, pursuant to the guidance in EITF 96-18 “Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling Goods or Services”. The fair value of the options granted is revalued
over the related service periods and recognized over the vesting
period.
|
c.
|
Recently
Issued Accounting Pronouncements
|
|
1.
|
In
June 2007, the Emerging Issues Task Force (EITF) reached Issue No. 07-03,
"Accounting for
Nonrefundable Advance Payments for Goods or Services Received to Be Used
in Future Research and Development Activities" (EITF No.
07-03). EITF No. 07-03 requires that nonrefundable
advance payments for goods or services that will be used or rendered for
future research and development activities be deferred and amortized over
the period that the goods are delivered or the related services are
performed, subject to an assessment of recoverability. The
provisions of EITF 07-03 will be effective for financial statements issued
for fiscal years beginning after December 15, 2007, and interim periods
within those fiscal years (September 1, 2009, for the Company). The
provisions of this EITF are applicable for new contracts entered into on
or after the effective date. Earlier application is not
permitted.
|
7
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 1 - SIGNIFICANT ACCOUNTING
POLICIES (continued):
|
2.
|
In
December 2007, the FASB ratified EITF Issue No. 07-01, "Accounting for
Collaborative Arrangements" ("EITF 07-01"). EITF 07-01 defines
collaborative arrangements and establishes reporting requirements for
transactions between participants in a collaborative arrangement and
between participants in the arrangement and third parties. EITF 07-01 also
establishes the appropriate income statement presentation and
classification for joint operating activities and payments between
participants, as well as the sufficiency of the disclosures related to
these arrangements. EITF 07-01 is effective for fiscal years beginning
after December 15, 2008 (September 1, 2009, for the
Company). EITF 07-01 shall be applied using modified version of
retrospective transition for those arrangements in place at the effective
date. An entity should report the effects of applying this Issue as a
change in accounting principle through retrospective application to all
prior periods presented for all arrangements existing as of the effective
date, unless it is impracticable to apply the effects the
change retrospectively. The Company is currently assessing the impact that
EITF 07-01 may have on its results of operations and financial
position.
|
|
3.
|
In
April 2008, the FASB issued Staff Position No. FAS 142-3,
“Determination of the Useful Life of Intangible Assets. ("FSP FAS
142-3")”. FSP FAS 142-3 amends the factors that should be considered
in developing renewal or extension assumptions used to determine the
useful life of a recognized intangible asset under SFAS No. 142, “Goodwill
and Other Intangible Assets.” The intent of the position is to improve the
consistency between the useful life of a recognized intangible asset under
SFAS No. 142 and the period of expected cash flows used to measure the
fair value of the asset under FAS 141(R), and other U.S. generally
accepted accounting principles. The provisions of FSP FAS 142-3 are
effective for the fiscal year beginning September 1, 2009, early
adoption is prohibited. The Company is currently evaluating the impact of
the provisions of FSP FAS
142-3..
|
NOTE
2 - COMMITMENTS:
|
a.
|
On
May 1, 2008, the Company entered into a consulting agreement with a third
party (“the Consultant”) for a period of twelve months, pursuant to which
the Consultant will assist the Company’s efforts to complete the FDA
approval process for its oral insulin capsule. On October 3, 2008 the
Company and the Consultant agreed to amend the agreement effective July 1,
2008. The Consultant is entitled to a fixed monthly fee of $16,666 (for
the period from May 1, 2008 through June 30, 2008 the monthly fee was
$8,333) and reimbursement of pre-approved out of pocket
expenses.
|
|
b.
|
On
September 8, 2008, the Company entered into Clinical Research agreement
with ETI Karle Clinical Pvt. Ltd. (“ETI”), pursuant to the agreement ETI
will be conducting clinical trials for the Company in India. In
consideration for the services provided under the agreement ETI will be
entitled to an estimated cash compensation of
$227,604.
|
8
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
3 - STOCK BASED
COMPENSATION:
The
following are stock issued for services, stock options and warrants transactions
made during the three months ended November 30, 2008:
|
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 FAS 150 "Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and
Equity".
|
On
October 17, 2008, the Company issued 203,904 shares of its common stock to Swiss
as remuneration for the services provided, in the amount of
$152,928.
|
b.
|
On
October 12, 2008, 828,000 options were granted to an employee of our
Subsidiary, at an exercise price of $0.47 per share (equivalent to the
traded market price on the date of grant), the options vest in three equal
annual instalments commencing on November 1, 2009 and expire on July 11,
2018. The fair value of these options on the date of grant was $330,699,
using the Black Scholes option-pricing model and was based on the
following assumptions: dividend yield of 0% for all years; expected
volatility of 113%; risk-free interest rates of 3.27%; and the remaining
contractual life of 6.00 years.
|
|
c.
|
On
October 12, 2008, 56,000 options were granted to an employee of our
Subsidiary, at an exercise price of $0.47 per share (equivalent to the
traded market price on the date of grant), the options vest in two equal
annual instalments commencing on May 1, 2009 and expire on July 11, 2018.
The fair value of these options on the date of grant was $21,988, using
the Black Scholes option-pricing model and was based on the following
assumptions: dividend yield of 0% for all years; expected volatility of
113%; risk-free interest rates of 2.77%; and the remaining contractual
life of 5.67 years.
|
The
Company recognized $101,647 of expense during the three months ended November
30, 2008 related to options granted, of which $75,407 relates to options granted
in prior years.
9
ORAMED
PHARMACEUTICULS, Inc.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
4 - FAIR VALUE:
On
September 1, 2008, the Company adopted the methods of fair value as
described in SFAS No. 157 (“SFAS 157”), which defines fair value,
establishes a framework for measuring fair value in accordance with GAAP and
expands disclosure about fair value measurements to value its financial assets
and liabilities. As defined in SFAS No. 157, fair value is based on the
price that would be received to sell an asset or paid to transfer a liability in
an orderly transaction between market participants at the measurement date. In
order to increase consistency and comparability in fair value measurements, SFAS
No. 157 establishes a fair value hierarchy that prioritizes observable and
unobservable inputs used to measure fair value into three broad levels, which
are described as follows:
|
Level
1:
|
Quoted
prices (unadjusted) in active markets that are accessible at the
measurement date for assets or liabilities. The fair value hierarchy gives
the highest priority to Level 1
inputs.
|
|
Level
2:
|
Observable
prices that are based on inputs not quoted on active markets, but
corroborated by market data.
|
|
Level
3:
|
Unobservable
inputs are used when little or no market data is available. The fair value
hierarchy gives the lowest priority to Level 3
inputs.
|
The
adoption of SFAS 157 did not have a material impact on the Company’s results of
operations and financial condition as the Company does not have any financial
assets and liabilities measured at fair value on a recurring basis subject to
the requirements of SFAS 157.
NOTE
5 – SUBSEQUENT EVENTS:
|
a.
|
On
January 7, 2009, the Company entered into an agreement with Hadasit (the
“Second Agreement”) to provide for the closing referenced in the First
Agreement. In the Second Agreement, Hadasit confirms that it has conveyed,
transferred and assigned all of its ownership rights in the patents
acquired under the First Agreement and certain other patents filed by the
Company after the First Agreement as a result of the collaboration between
the Company and Hadasit (the “Patents”). Hadasit further
acknowledges that the 4,141,532 shares of common stock issued to Hadasit
by the Company in connection with the First Agreement constitute complete
compensation for the Patents.
|
|
b.
|
On
January 11, 2009, an aggregate of 300,000 options were granted to three
Scientific Advisory Board members at an exercise price of $0.76 per share.
The options vest in four equal quarterly installments commencing on April
1, 2009 and will expire on January 10,
2019.
|
|
c.
|
On
January 11, 2009, 150,000 options were granted to an employee of the
subsidiary at an exercise price of $0.43 per share. The options vest in
three equal annual installments commencing on January 1, 2010 and will
expire on January 10, 2019.
|
|
d.
|
On
January 11, 2009, an aggregate of 600,000 options were granted to two
Board of Directors members at an exercise price of $0.43 per share. The
options vest in three equal annual installments commencing on January 1,
2010 and will expire on January 10,
2019.
|
10
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.
We
have included in this Quarterly Report certain “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995
concerning our business, operations and financial condition. “Forward-looking
statements” consist of all non-historical information, and the analysis of
historical information, including the references in this Quarterly Report to
future revenues, collaborative agreements, future expense growth, future credit
exposure, earnings before interest, taxes, depreciation and amortization, future
profitability, anticipated cash resources, anticipated capital expenditures,
capital requirements, and the Company’s plans for future periods. In addition,
the words “could”, “expects”, “anticipates”, “objective”, “plan”, “may affect”,
“may depend”, “believes”, “estimates”, “projects” and similar words and phrases
are also intended to identify such forward-looking statements.
Actual
results could differ materially from those projected in our forward-looking
statements due to numerous known and unknown risks and uncertainties, including,
among other things, unanticipated technological difficulties, the length, scope
and outcome of our clinical trial, difficulties or delays in obtaining
regulatory approval for our product candidates, competition from other
pharmaceutical or biotechnology companies, costs related to intellectual
property, cost of manufacturing and higher consulting costs, product demand,
changes in domestic and foreign economic, market and regulatory conditions, the
inherent uncertainty of financial estimates and projections, the uncertainties
involved in certain legal proceedings, instabilities arising from terrorist
actions and responses thereto, our ability to obtain additional funding required
to conduct our research, development and commercialization activities and other
considerations described as “Risk Factors” in other filings by the Company with
the SEC. Such factors may also cause substantial volatility in the market price
of our common stock. All such forward-looking statements are current only as of
the date on which such statements were made. We do not undertake any obligation
to publicly update any forward-looking statement to reflect events or
circumstances after the date on which any such statement is made or to reflect
the occurrence of unanticipated events.
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 in thousands unless otherwise
indicated.
Overview
We are a
pharmaceutical company engaged in the research and development of innovative
pharmaceutical solutions, including an orally ingestible insulin pill to be used
for the treatment of individuals with diabetes, rectal application of insulin,
flu vaccines, use of oral ingestible pills for delivery other polypeptides and
use of rectal application for delivery of other polypeptides.
11
Oramed
was incorporated on April 12, 2002, in the State of Nevada under the name
“Iguana Ventures Ltd” as 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”) and changed its name to Integrated Security
Technologies. 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 $.001 per
share. However, due to disappointing results, 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, the Company executed an agreement with Hadasit Medical Services and
Development Ltd. to acquire provisional patent application No.
60/718716 and
related intellectual property (the “First Agreement”). 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 for the
treatment of individuals with diabetes. Effective April 10,
2006, the Company changed its name from “Integrated Security Technologies, Inc.”
to “Oramed Pharmaceuticals Inc.” 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” on August 31,
2006.
On
January 7, 2009, the Company entered into an agreement with Hadasit (the “Second
Agreement”) to provide for the closing referenced in the First Agreement. In the
Second Agreement, Hadasit confirms that it has conveyed, transferred and
assigned all of its ownership rights in the patents acquired under the First
Agreement and certain other patents filed by the Company after the First
Agreement as a result of the collaboration between the Company and Hadasit (the
“Patents”). Hadasit further acknowledges that the 4,141,532 shares of
common stock issued to Hadasit by the Company in connection with the First
Agreement constitute complete compensation for the Patents.
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 Medical Services and Development Ltd.,
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
Application (“IND”) with the U.S. Food and Drug Administration (“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.
12
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.
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 II diabetic
volunteers at Hadassah Medical Center in Jerusalem. On August 6, 2008, we
announced the successful results of this trial.
On April
21, 2008, we entered into a service agreement with Encorium Group, Inc.
(“Encorium”) pursuant to which Encorium will provide services for the purpose of
filing an IND for a Phase 2 study as required by the FDA. The FDA approval
process and, if approved, registration for commercial use as an oral drug can
take several years.
During
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 I diabetic volunteers. On September 24, 2008, we announced the
beginning of this trail. The results of the trial have not yet been
published.
We plan
on conducing two additional non FDA approved Phase 2B study to evaluate the
safety and efficacy of our oral insulin capsule (ORMD 0801) on Type II diabetic
volunteers, in South Africa and India. The trials are scheduled to commence in
early 2009.
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. The trials are expected to begin during the coming
months.
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. The results of the trial have not yet been
published.
13
GLP1
Analog: On September 16, 2008 we announced the launch of pre-clinical
trials of ORMD 0901, a GLP1-analog. The pre-clinical trials includes a dog trial
which suggests that the GLP-1analog exenatide-4 when combined with Oramed’s
absorption promoters is absorbed through the gastrointestinal tract
and retains its biological activity.
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. GLP-1 was found in addition to stimulates
insulin release, to suppress glucagon release (hormone involved in regulation of
glucose) from the pancreas, it slows gastric emptying to reduce the rate of
absorption of nutrients into the blood stream, and it increases 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 to be hormone that protects the heart.
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 compliment our existing
drug portfolio.
14
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, 2008 of $8,436,250, as well as negative
cash flow from operating activities. Based upon our existing spending
commitments, estimated at $5.1 million for the twelve months following December
1, 2008, and our cash availability, we do not have sufficient cash resources to
meet our liquidity requirements through November 30, 2009. 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
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
fundraising.
Effective
March 1, 2006, the Company adopted Statement of Financial Accounting Standards
No. 123 (revised 2004), “Share-based Payment” (“FAS 123(R)”). FAS 123(R)
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 expense over the requisite service period, net of estimated
forfeitures. The Company estimated forfeitures based on historical experience
and anticipated future conditions.
In March
2005, the Securities and Exchange Commission issued Staff Accounting Bulletin
No. 107 (“SAB
107”). SAB 107 provides supplemental implementation guidance on FAS
123(R), including guidance on valuation methods, inventory capitalization of
share-based compensation cost, income statement effects, disclosures and other
issues. SAB 107 requires share-based payment to be classified in the same
expense line items as cash compensation. The Company has applied the provisions
of SAB 107 in its adoption of FAS 123(R).
The
Company elected to recognize compensation cost for an award with only service
conditions that has a
graded vesting schedule using the accelerated method based on multiple option
award approach.
The
Company elected to adopt
the modified prospective application transition method, as permitted by FAS
123(R). Under such transition method, upon the adoption of FAS 123(R), the
Company’s financial statements for periods prior to the effective date of the
Statement are not restated.
15
In
December 2007, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 110 (“SAB 110”) relating to the use of a “simplified” method
in developing an estimate of the expected term of “plain vanilla” share options.
SAB 107 previously allowed the use of the simplified method until
December 31, 2007. SAB 110 allows, under certain circumstances, to continue to accept the use of
the simplified method beyond December 31, 2007. The Company has applied the
provisions of SAB 110 in its financial statement.
The
Company accounts for equity instruments issued to third party service providers
(non-employees) in accordance with the fair value based on an option-pricing
model or when more reliability is based on the fair value of the services
received, pursuant to the guidance in EITF 96-18 “Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling Goods or Services”. The fair value of the options granted is
revalued over the related service periods and recognized using the accelerated
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. The Company has
provided a full valuation allowance with respect to its deferred tax
assets.
Regarding
Oramed, Ltd., paragraph 9(f) of FAS 109, “Accounting for Income Taxes”,
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.
As of
September 1, 2007, the Company adopted FASB Interpretation No. 48, ‘‘Accounting
for Uncertainty in Income Taxes - an Interpretation of FASB Statement No. 109’’
(‘‘FIN 48’’). FIN 48 specifies how tax benefits for uncertain tax positions are
to be recognized, measured and derecognized in financial statements; requires certain disclosures of
uncertain tax positions; specifies how reserves for uncertain tax positions
should be classified on the balance sheet; and provides transition and
interim-period guidance, among other provisions. On May 2, 2007, the FASB issued
FASB Staff Position No. FIN 48-1, ‘‘Definition of Settlement in FASB
Interpretation No. 48-1’’ (‘‘FSP FIN 48-1’’). FSP FIN 48-1 provides guidance
regarding how an entity should determine whether a tax position is effectively
settled for the purpose of recognizing previously unrecognized tax
benefits.
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 the Company’s 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.
16
Clinical
trial costs are a significant component of research and development expenses and
include costs associated with third-party contractors. The Company out sources 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.
The
following table summarizes
certain statements of operations data for the Company for the three month
periods ended November 30, 2008 and 2007:
Three months ended
|
||||||||
Operating Data:
|
November 30, 2008
|
November 30, 2007
|
||||||
Research
and development costs
|
$ | 818,680 | $ | 95,674 | ||||
General
and administrative expenses
|
383,361 | 266,296 | ||||||
Financial
(income) expense, net
|
(13,995 | ) | (8,468 | ) | ||||
Net
loss for the period
|
$ | 1,188,046 | $ | 353,502 | ||||
Loss
per common share – basic and diluted
|
$ | (0.02 | ) | $ | (0.01 | ) | ||
Weighted
average common shares outstanding
|
56,363,714 | 45,609,417 |
Research
and development costs
Research
and development expenses are the costs incurred in the process of our
pre-clinical and our clinical trials. Clinical trial and pre-clinical 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.
During
the three months ended November 30, 2008 research and development expenses
totaled $818,680, compared to $95,674 for the three months ended November 30,
2007. The increase is
mainly attributable to increased clinical trials activities, materials and
patent related costs. The research and development costs include stock based
compensation costs, which during the three months ended November 30, 2008
totaled $35,962 as compared to $543 during the three months ended November 30,
2007.
17
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, 2008, general and administrative expenses
totaled $383,361 compared to $266,296 for the three months ended November 30,
2007. Costs incurred related to general and administrative activities during the
three months ended November 30, 2008 reflect an increase of payroll and related
expenses, professional, legal and consulting expenses and an increase in general
expenses such as office and maintenance expenses. During the three months ended
November 30, 2008, as part of our general and administrative expenses, we
incurred $65,685 related to stock options granted to employees and consultants,
as compared to $82,009 during the three months ended November 30,
2007.
Financial
income/expense, net
During
the three months ended November 30, 2008 and 2007 we generated interest income
on available cash and cash equivalents balance which were offset by bank
charges.
Liquidity
and Capital Resources
From
inception through November 30, 2008, we incurred losses in an aggregate amount
of $8,436,250. We have financed our operations through the private placements of
equity and debt financing.
Since inception through November 30, 2008, we raised a total of $8,308,785, net
of transaction costs, through private placements of equity and debt financing.
We anticipate that we will obtain additional financing through similar sources.
As of November 30, 2008 we had $2,190,950 of available cash as well as
$1,728,000 in short term interest bearing investments. The Company anticipates
it will require approximately $5.1 million to finance its activities during the
twelve months following December 1, 2008.
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.
Our financing activities during the
three months ended November 30, 2008 include the following:
|
·
|
On
October 17, 2008, Oramed issued 203,904 shares of common stock valued at
$152,928 to a third party, for services rendered in the prior
year.
|
18
Employee's and Consultant’s Stock Options and
Warrants
Employee
and consultant stock
options grants and warrant issuance activities for the three months ending
November 30, 2008 include the following:
|
·
|
On
October 12, 2008 we granted options under the 2008 Stock Incentive Plan to
purchase up to 828,000 shares of our common stock at an exercise price of
$0.47 to Chaime Orlev our Chief Financial
Officer.
|
|
·
|
On
October 12, 2008 we granted options under the 2008 Stock Incentive Plan to
purchase up to 56,000 shares of our common stock at an exercise price of
$0.47 to an employee of our
subsidiary.
|
|
·
|
On
January 11, 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 each of Dr. Nir Barzilai, Prof. Ele Ferrannini and Dr. Derek
LeRoith, three members of our Scientific Advisory
Board.
|
|
·
|
On
January 11, 2009 we granted options under the 2008 Stock Incentive Plan to
purchase up to 150,000 shares of our common stock at an exercise price of
$0.43 to an employee of our
subsidiary.
|
|
·
|
On
January 11, 2009 we granted options under the 2008 Stock Incentive Plan to
purchase up to 300,000 shares of our common stock at an exercise price of
$0.43 to each of Leonard Sank and Dr. Harold Jacob, two Board of Directors
members.
|
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, 2008 are as follows:
Operating
Data:
|
Amount
|
|||
Research
and development costs
|
$ | 3,650,000 | ||
General
and administrative expenses
|
1,505,000 | |||
Financial
income, net
|
(58,000 | ) | ||
Taxes
on income
|
35,000 | |||
Total
|
$ | 5,132,000 |
As
previously indicated, we are planning to conduct further clinical studies as
well as file an IND 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.
19
Employment and Consulting
Agreements
On May 1,
2008 we entered into a consulting agreement with a Dr. Ehud Arbit (“Dr. Arbit”)
for a period of twelve months, pursuant to which Dr. Arbit will assist our
efforts to complete the FDA approval process for its oral insulin capsule. Dr.
Arbit is entitled to a fixed monthly fee of $8,333 effective from May 1, 2008, and reimbursement of
pre-approved out of pocket expenses. On October 3, 2008, we amended the
consulting agreement with Dr. Arbit. Pursuant to the amendment, Dr. Arbit will
perform his work under the contract on a full time basis and his compensation
will be $16,666 per month, effective as of July 1, 2008.
20
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act of
1934, as amended and are not required to provide information under this
item.
ITEM
4T - CONTROLS AND PROCEDURES
(a)
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, 2008. 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-KSB filed on November 26, 2008 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)
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.
|
21
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, 2008 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, 2008.
As
previously reported in our Form 10-KSB filed on November 26, 2008, during the
quarter ended November 30, 2008, management, including our principal executive
officer and principal financial officer, has started an extensive process, of
documenting all major procedures related to the financial reporting, in order to
strengthen our internal controls over financial reporting in order to reasonably
ensure that reliability of financial reporting and the preparation of 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.
To
improve our internal control over financial reporting, in the fourth quarter of
our fiscal year 2008, we began to develop a comprehensive program designed to
strengthen our internal controls over financial reporting. Among
other things, the program provides for the engagement of an outside consulting
accounting firm (separate from our independent auditing firm) to review the
Company’s financial reports on a quarterly basis and the implementation of an
improved documentation system underlying financial reports. We continue to
progress with the development of this program, although it has not yet been
implemented.
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)
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, 2008 that have materially affected, or are reasonable
likely to materially affect our internal control over financial
reporting.
22
PART
II – OTHER INFORMATION
ITEM
1 - LEGAL PROCEEDINGS
Except as
previously disclosed, we know of no material, active or pending legal
proceedings against us, nor are we involved as a plaintiff in any material
proceedings or pending litigation.
23
ITEM
6 - EXHIBITS
Number
|
Exhibit
|
|
(3)
|
Articles
of Incorporation and By-laws
|
|
3.1
|
Articles
of Incorporation (incorporated by reference from our Registration
Statement on Form SB-2, filed on November 29, 2002).
|
|
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 Hadasit Medical Services and Development Ltd.
dated January 7, 2009
|
|
10.3
|
Consulting
Agreement, dated May 1, 2008, between Oramed Pharmaceuticals Inc. and Dr.
Ehud Arbit (incorporated by reference from our annual report on Form
10-KSB filed November 26, 2008)
|
|
10.4
|
Amended
and Restated Consulting Agreement, dated as of May 1, 2008, between
Oramed Pharmaceuticals Inc. and Dr. Ehud Arbit (incorporated by reference
from our annual report on Form 10-KSB filed November 26,
2008)
|
|
10.5
|
Amended to
Consulting Agreement, dated as of October 3, 2008, between
Oramed Pharmaceuticals Inc. and Dr. Ehud Arbit (incorporated by reference
from our annual report on Form 10-KSB filed November 26,
2008)
|
|
(31)
|
Section
302 Certification
|
|
31.1
*
|
Certification
Statement of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
31.2
*
|
Certification
Statement of the Principal Accounting Officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
(32)
|
Section
906 Certification
|
|
32.1
*
|
Certification
Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of
2002
|
|
32.2
*
|
Certification
Statement of the Principal Accounting Officer pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act
Of
2002
|
*
|
Filed
herewith
|
24
SIGNATURES
In
accordance with the requirements of the Securities Exchange Act of 1934, the
registrant caused this report to be signed on its behalf by the undersigned,
hereunto duly authorized.
ORAMED
PHARMACEUTICALS INC.
Registrant
|
||
Date: January
13, 2009
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: January
13, 2009
|
By:
|
/s/ Chaime
Orlev
|
Chaime
Orlev
|
||
Chief
Financial Officer
|
25