Nevada
|
98-0376008
|
(State
or other jurisdiction of
incorporation
or organization)
|
(IRS
Employer Identification
No.)
|
Large
accelerated filer
|
¨
|
Accelerated
filer ¨
|
|
Non-accelerated
filer
|
¨
(Do not check if a smaller
reporting company)
|
Smaller
reporting company x
|
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
|
24 | ||
ITEM
4T - CONTROLS AND PROCEDURES
|
24 | ||
PART II – OTHER INFORMATION
|
26 | ||
ITEM
1 - LEGAL PROCEEDINGS
|
26 | ||
ITEM
6 - EXHIBITS
|
27 |
Page
|
|
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS:
|
|
Balance
sheets
|
3
|
Statements
of operations
|
4
|
Statements
of changes in stockholders’ equity
|
5
|
Statements
of cash flows
|
6
|
Notes
to financial statements
|
7-12
|
May
31,
|
August
31,
|
|||||||
2009
|
2008
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 3,217,986 | $ | 2,267,320 | ||||
Short
term investments
|
- | 2,728,000 | ||||||
Prepaid
expenses and other current assets
|
35,048 | 402,574 | ||||||
Total
current assets
|
3,253,034 | 5,397,894 | ||||||
LONG
TERM DEPOSITS
|
14,382 | 10,824 | ||||||
PROPERTY AND EQUIPMENT,
net
|
79,646 | 98,296 | ||||||
Total
assets
|
$ | 3,347,062 | $ | 5,507,014 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 427,776 | $ | 866,702 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
475,028 | 913,954 | ||||||
COMMITMENTS
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
stock of $ 0.001 par value - Authorized: 200,000,000 shares at May
31, 2009 and August 31, 2008; Issued and outstanding: 56,456,710 at May
31, 2009 and 56,252,806 shares at August
31, 2008, respectively
|
56,456 | 56,252 | ||||||
Additional
paid-in capital
|
12,423,370 | 11,785,012 | ||||||
Deficit
accumulated during the development stage
|
(9,607,792 | ) | (7,248,204 | ) | ||||
Total
stockholders' equity
|
2,872,034 | 4,593,060 | ||||||
Total
liabilities and stockholders' equity
|
$ | 3,347,062 | $ | 5,507,014 |
Period
|
||||||||||||||||||||
from April
|
||||||||||||||||||||
12, 2002
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||||||||||||||||||||
(inception)
|
||||||||||||||||||||
Nine months ended
|
Three months ended
|
through
|
||||||||||||||||||
May 31,
|
May 31,
|
May 31,
|
May 31,
|
May 31,
|
||||||||||||||||
2009
|
2008
|
2009
|
2008
|
2009
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES
|
$ | 1,448,466 | $ | 655,934 | $ | 374,097 | $ | 464,119 | $ | 5,036,300 | ||||||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
931,861 | 913,950 | 157,711 | 381,697 | 3,962,319 | |||||||||||||||
OPERATING
LOSS
|
2,380,327 | 1,569,884 | 531,808 | 845,816 | 9,433,495 | |||||||||||||||
INTEREST
INCOME
|
(38,950 | ) | (67,040 | ) | (18,518 | ) | (25,346 | ) | (146,724 | ) | ||||||||||
INTEREST
EXPENSE
|
18,211 | 6,034 | 1,051 | 158,857 | ||||||||||||||||
LOSS
BEFORE TAXES ON INCOME
|
2,359,588 | 1,508,878 | 513,290 | 821,521 | 9,445,628 | |||||||||||||||
TAXES
ON INCOME
|
- | - | - | - | 162,164 | |||||||||||||||
NET
LOSS FOR THE PERIOD
|
$ | 2,359,588 | $ | 1,508,878 | $ | 513,290 | $ | 821,521 | $ | 9,607,792 | ||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | 0.04 | $ | 0.03 | $ | 0.01 | $ | 0.02 | ||||||||||||
WEIGHTED
AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS
PER COMMON STOCK
|
56,546,323 | 47,041,387 | 56,802,562 | 47,059,078 |
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 | ||||||||||||||||
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
109,590 | 109,590 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
295,230 | 295,230 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
77,980 | 77,980 | ||||||||||||||||||
IMPUTED
INTEREST
|
2,834 | 2,834 | ||||||||||||||||||
NET
LOSS
|
(2,359,588 | ) | (2,359,588 | ) | ||||||||||||||||
BALANCE
AS OF MAY 31, 2009 (unaudited)
|
56,456,710 | $ | 56,456 | $ | 12,423,370 | $ | (9,607,792 | ) | $ | 2,872,034 |
Nine months ended
|
Period from April
12, 2002
(inception date)
through
|
|||||||||||
May 31,
|
May 31,
|
May 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (2,359,588 | ) | $ | (1,508,878 | ) | $ | (9,607,792 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
22,760 | 7,078 | 38,214 | |||||||||
Amortization
of debt discount
|
- | 108,000 | ||||||||||
Exchange
differences on long term deposits
|
1,110 | 707 | (532 | ) | ||||||||
Stock
based compensation
|
373,210 | 246,679 | 3,182,988 | |||||||||
Common
stock issued for services
|
- | 172,101 | 214,860 | |||||||||
Impairment
of investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
2,834 | 2,835 | 15,051 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
367,526 | (50,033 | ) | (35,048 | ) | |||||||
Accounts
payable and accrued expenses
|
(176,408 | ) | (74,414 | ) | 690,294 | |||||||
Total
net cash used in operating activities
|
(1,768,556 | ) | (1,203,925 | ) | (4,959,089 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
(4,110 | ) | (98,415 | ) | (117,860 | ) | ||||||
Acquisition
of short-term investments
|
- | - | (2,728,000 | ) | ||||||||
Proceeds
from sale of Short term investments
|
2,728,000 | - | 2,728,000 | |||||||||
Lease
deposits
|
(4,668 | ) | (1,558 | ) | (13,850 | ) | ||||||
Total
net cash provided by (used in) investing activities
|
2,719,222 | (99,973 | ) | (131,710 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from sales of common stocks and warrants
- net of issuance expenses
|
- | 2,044,986 | 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
|
- | - | 66,243 | |||||||||
Net
cash provided by financing activities
|
- | 2,044,986 | 8,308,785 | |||||||||
INCREASE
IN CASH AND CASH EQUIVALENTS
|
950,666 | 741,088 | 3,217,986 | |||||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
2,267,320 | 1,918,229 | ||||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 3,217,986 | $ | 2,659,317 | $ | 3,217,986 | ||||||
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
|
$ | 1,036,060 | ||||||||||
Shares
issued for services rendered
|
$ | 152,928 | $ | 172,101 | ||||||||
Shares
to be issued for services rendered
|
$ | 109,590 | $ | 109,590 | ||||||||
Receipts
on account of shares issuance - reclassified from liability to
shareholder's equity
|
$ | 4,000 |
a.
|
General:
|
|
1.
|
Oramed
Pharmaceuticals Inc. (the “Company”) was incorporated on April 12, 2002,
under the laws of the State of Nevada. From incorporation until March 3,
2006, the Company was an exploration stage company engaged in the
acquisition and exploration of mineral properties. On March 8, 2006, the
Company entered into an agreement with Hadasit Medical Services and
Development Ltd (“Hadasit”) (the “First Agreement”) to acquire the
provisional patent related to orally ingestible insulin pill to be used
for the treatment of individuals with diabetes, see also note
5.
|
|
2.
|
The
accompanying unaudited interim consolidated financial statements as of May
31, 2009 and for the nine and 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 nine and three months ended May 31, 2009, are not
necessarily indicative of the results that may be expected for the year
ending August 31, 2009.
|
|
3.
|
Going
concern considerations
|
b.
|
Share-based
payment:
|
c.
|
Recently
Issued Accounting
Pronouncements
|
|
1.
|
In
November 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 a modified version of retrospective transition for
those arrangements in place at the effective date. An entity should report
the effects of applying EITF 07-01 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 of the change retrospectively. The Company is
currently assessing the impact that EITF 07-01 may have on its results of
operations and financial
position.
|
|
2.
|
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 FSP FAS 142-3 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.
|
a.
|
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 estimated cash compensation of
$227,000.
|
b.
|
On
April 22, 2009, our 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.
|
|
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 certain predetermined
amounts which are to be paid in common stock of the Company. The number of
shares to be issued is based on the invoice received from Swiss, and the
stock market price 10 days after the invoice was issued. The Company
accounted for the transaction with Swiss according to FAS 150 "Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and
Equity".
|
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 October
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. On March 31, 2009 the employee ended his
services with the Company and the options were forfeited before they
had vested. The Company recognized an expense of $71,406 during the six
months ended February 28, 2009 and reverse that expense in the three
months ended May 31, 2009.
|
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 October 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.
|
d.
|
On
January 11, 2009, an aggregate of 600,000 options were granted to two
Board of Directors members and 150,000 options were granted to an employee
of our Subsidiary. All 750,000 options were granted at an exercise price
of $0.43 per share (equivalent to the traded market price on the date of
grant). The options vest in three equal annual instalments commencing on
January 1, 2010 and expire on January 10, 2019. The fair value of these
options on the date of grant was $285,028, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 126%; risk-free interest
rates of 1.51%; and the remaining contractual life of 6.00 years. On May
31, 2009 such employee left the Company and the options were forfeited
before they had vested. The Company recognized an expense of $4,354 during
the six months ended February 28, 2009 and reverse that expense in the
three months ended May 31,
2009.
|
e.
|
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
(higher than the traded market price on the date of grant). The options
vest in four equal quarterly instalments commencing on April 1, 2009 and
expire on January 10, 2019. The fair value of the vested options was
$21,090 and the fair value of the unvested options as of May 31, 2009 was
$91,684, using the Black Scholes option-pricing model and was based on the
following assumptions: dividend yield of 0% for all years; expected
volatility of 128%; risk-free interest rates of 3.47%; and the remaining
contractual life of 9.62
years.
|
|
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.
|
|
a.
|
On
June 3, 2009, 400,000 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
annual installments of 133,333, 133,333 and 133,334 on October 19, 2010,
October 19, 2011 and October 19, 2012, respectively, and expire on October
19, 2019. The fair value of these options on the date of grant was
$170,193, using the Black Scholes option-pricing model and was based on
the following assumptions: dividend yield of 0% for all years; expected
volatility of 130%; risk-free interest rates of 3.16%; and the remaining
contractual life of 6.19 years.
|
|
b.
|
On
July 8, 2009 the Company entered into a third agreement with Hadasit,
Prof. Itamar Raz and Dr. Miriam Kidron ("the Third Agreement"), to provide
consulting and clinical trial services. According to the Third Agreement,
Hadasit will be entitled to a total consideration of $400,000 to be paid
by Oramed. $200,000 of this amount was agreed in the terms of the First
Agreement, see note 5, and the remaining of $200,725 will be paid in ten
equal quarterly instalments commencing May 2009, in accordance with the actual
progress of the study.
|
Nine
months ended
|
Three
months ended
|
|||||||||||||||
Operating
Data:
|
May
31,
2009
|
May
31,
2008
|
May
31,
2009
|
May
31,
2008
|
||||||||||||
Research
and development costs
|
$ | 1,448,466 | $ | 655,934 | $ | 374,097 | $ | 464,119 | ||||||||
General
and administrative expenses
|
931,861 | 913,950 | 157,711 | 381,697 | ||||||||||||
Financial
(income) expense, net
|
(20,739 | ) | (61,006 | ) | (18,518 | ) | (24,295 | ) | ||||||||
Loss
before taxes on income
|
2,359,588 | 1,508,878 | 513,290 | 821,521 | ||||||||||||
Loss
per common share – basic and diluted
|
$ | 0.04 | $ | 0.03 | $ | 0.01 | $ | 0.02 | ||||||||
Weighted
average common shares outstanding
|
56,546,323 | 46,041,387 | 56,802,562 | 47,059,078 |
|
·
|
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.
|
|
·
|
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 March 31, 2009 Mr. Orlev
ended his services with the Company and the options were
forfeited before they had
vested.
|
|
·
|
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. In May 2009 such employee
left the Company and
the options were forfeited before they had
vested
|
|
·
|
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 members of our
Board of Directors.
|
Operating
Data:
|
Amount
|
|||
Research
and development costs
|
$ | 3,500,000 | ||
General
and administrative expenses
|
1,200,000 | |||
Financial
income, net
|
(11,000 | ) | ||
Total
|
$ | 4,692,000 |
|
·
|
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.
|
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, 2008 (incorporated by reference from our current report
on Form 8-K filed January 7, 2008).
|
|
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)
|
|
10.6
|
Amended and
Restated to Consulting Agreement, dated as of June 18,
2009, between Oramed Pharmaceuticals Inc. and Dr. Ehud
Arbit.
|
|
10.7
|
Employment
Agreement, dated as of April 19, 2009, by and between Oramed Ltd. and
Yifat Zommer (incorporated by reference from our current report on Form
8-K filed on April 22, 2009).
|
|
10.8
|
Indemnification
Agreement, dated as of April 19, 2009, by and between Oramed Ltd. and
Yifat Zommer (incorporated by reference from our current report on Form
8-K filed on April 22, 2009).
|
|
10.9
|
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).
|
|
10.10
|
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
|
ORAMED
PHARMACEUTICALS INC.
Registrant
|
||
Date: July
13, 2009
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: July
13, 2009
|
By:
|
/s/ Yifat
Zommer
|
Yifat
Zommer
|
||
Chief
Financial Officer
|
a)
|
designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this quarterly report is
being prepared;
|
b)
|
designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
c)
|
evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
d)
|
disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting;
|
Dated: July
13, 2009
|
By:
|
/s/ NADAV
KIDRON
|
||||
Nadav
Kidron
President,
Chief Executive Officer and
Director
|
|
a)
|
designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this quarterly report is
being prepared;
|
b)
|
designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
c)
|
evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period
covered by this report based on such evaluation;
and
|
d)
|
disclosed
in this report any change in the registrant’s internal control over
financial reporting that occurred during the registrant’s most recent
fiscal quarter that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting; and
|
Dated: July
13, 2009
|
By:
|
/s/ YIFAT
ZOMMER
|
||||
Yifat
Zommer,
Chief
Financial Officer
|
|
(1)
|
The
Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities and Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
Dated: July
13, 2009
|
By:
|
/s/ NADAV
KIDRON
|
|||
Nadav
Kidron
President,
Chief Executive Officer and
Director
|
|
(1)
|
The
Report fully complies with the requirements of section 13(a) or 15(d) of
the Securities and Exchange Act of 1934;
and
|
|
(2)
|
The
information contained in the Report fairly presents, in all material
respects, the financial condition and result of operations of the
Company.
|
Dated: July
13, 2009
|
By:
|
/s/ YIFAT
ZOMMER
|
||||
Yifat
Zommer,
Chief
Financial Officer
|