UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

(Mark One)
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

For the Quarterly Period Ended February 28, 2010

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

For the Transition Period from _________ to _________

Commission file number: 000-50298

ORAMED PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)

Nevada
98-0376008
(State or other jurisdiction of
incorporation or organization)
(IRS Employer Identification No.)

Hi-Tech Park 2/5 Givat Ram
PO Box 39098
Jerusalem, Israel 91390
 (Address of principal executive offices)

+ 972 2 566 0001
(Registrant's telephone number, including area code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.         Yes x  No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).        Yes o  No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer
o
Accelerated filer o
Non-accelerated filer
o (Do not check if a smaller reporting company)
Smaller reporting company x
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o  No x

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date: 57,454,707 shares issued and outstanding as of April 11, 2010.

 
 

 

ORAMED PHARMACEUTICALS INC.

FORM 10-QSB

TABLE OF CONTENTS

1
     
 
ITEM 1 - FINANCIAL STATEMENTS
1
     
 
ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
12
     
 
ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
20
     
 
ITEM 4T - CONTROLS AND PROCEDURES
20
   
PART II - OTHER INFORMATION
23
     
 
ITEM 1 - LEGAL PROCEEDINGS
23
     
 
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 FEBRUARY 28, 2010

 
1

 

ORAMED PHARMACEUTICALS INC.
(A development stage company)

INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS OF FEBRUARY 28, 2010

TABLE OF CONTENTS

   
Page
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:
   
Balance sheets
 
3
Statements of operations
 
4
Statements of changes in stockholders’ equity
 
5
Statements of cash flows
 
6
Notes to financial statements
 
7-11
 


 
 
2

 

ORAMED PHARMACEUTICALS INC.
(A development stage company)
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars

   
February 28,
   
August 31,
 
   
2010
   
2009
 
   
Unaudited
   
Audited
 
Assets
           
             
CURRENT ASSETS:
           
Cash and cash equivalents
  $ 724,706     $ 1,716,866  
Short term investments
    1,400,000       1,000,000  
Restricted cash
    16,000       16,000  
Accounts receivable - other
    34,063       36,939  
Prepaid expenses
    102,411       4,119  
Grants receivable from the Office of the Chief Scientist
    179,132       400,405  
Total current assets
    2,456,312       3,174,329  
                 
LONG TERM DEPOSITS
    11,814       12,161  
PROPERTY AND EQUIPMENT, net
    59,605       75,361  
Total assets
  $ 2,527,731     $ 3,261,851  
                 
Liabilities and stockholders' equity
               
                 
CURRENT LIABILITIES:
               
Accounts payable and accrued expenses
  $ 235,135     $ 321,344  
Account payable with former shareholder
    47,252       47,252  
Total current liabilities
    282,387       368,596  
                 
PROVISION FOR UNCERTAIN TAX POSITION
    147,063       147,063  
                 
COMMITMENTS
               
                 
STOCKHOLDERS' EQUITY:
               
Common stock of $ 0.001 par value - Authorized: 200,000,000 shares at February 28, 2010 and August 31, 2009; Issued and outstanding: 57,454,707 at February 28, 2010 and  56,456,710 shares at August 31, 2009, respectively
    57,454       56,456  
Additional paid-in capital
    13,054,509       12,698,414  
Deficit accumulated during the development stage
    (11,013,682 )     (10,008,678 )
Total stockholders' equity
    2,098,281       2,746,192  
Total liabilities and stockholders' equity
  $ 2,527,731     $ 3,261,851  

The accompanying notes are an integral part of the consolidated financial statements.

 
3

 

ORAMED PHARMACEUTICALS INC.
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATION
U.S. dollars

                           
Period
 
                           
from April
 
                           
12, 2002
 
                           
(inception)
 
   
Six months ended
   
Three months ended
   
through
 
   
February 28,
   
February 28,
   
February 28,
   
February 28,
   
February 28,
 
   
2010
   
2009
   
2010
   
2009
   
2010
 
   
Unaudited
 
                                 
RESEARCH AND DEVELOPMENT EXPENSES
  $ 486,782     $ 1,113,146     $ 169,237     $ 274,970     $ 5,631,641  
IMPAIRMENT OF INVESTMENT
                                    434,876  
GENERAL AND ADMINISTRATIVE EXPENSES
    522,619       735,373       222,663       371,508       4,780,170  
OPERATING LOSS
    1,009,401       1,848,519       391,900       646,478       10,846,687  
FINANCIAL INCOME
    (10,916 )     (30,700 )     (2,543 )     (8,556 )     (147,024 )
FINANCIAL EXPENSE
    6,519       28,479       2,854       20,330       154,452  
LOSS BEFORE TAXES ON INCOME
    1,005,004       1,846,298       392,211       658,252       10,854,115  
TAXES ON INCOME
    -       -       -       -       159,567  
NET LOSS FOR THE PERIOD
  $ 1,005,004     $ 1,846,298     $ 392,211     $ 658,252     $ 11,013,682  
BASIC AND DILUTED LOSS PER COMMON SHARE
  $ 0.02     $ 0.03     $ 0.01     $ 0.01          
WEIGHTED AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER COMMON STOCK
    57,289,266       56,416,080       57,422,484       56,469,027          

The accompanying notes are an integral part of the consolidated financial statements.

 
4

 

ORAMED PHARMACEUTICALS INC.
(A development stage company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
U.S. dollars
 
                     
Deficit
       
                     
accumulated
       
               
Additional
   
during the
   
Total
 
   
Common Stock
   
paid-in
   
development
   
stockholders'
 
   
Shares
   
$
   
capital
   
stage
   
equity
 
BALANCE AS OF APRIL 12, 2002 (inception)
    34,828,200     $ 34,828     $ 18,872           $ 53,700  
CHANGES DURING THE PERIOD FROM APRIL 12, 2002 THROUGH AUGUST 31, 2008 (audited):
                                     
SHARES CANCELLED
    (19,800,000 )     (19,800 )     19,800             -  
SHARES ISSUED FOR INVESTMENT IN ISTI-NJ
    1,144,410       1,144       433,732             434,876  
SHARES ISSUED FOR OFFERING COSTS
    1,752,941       1,753       (1,753 )           -  
SHARES ISSUED FOR CASH– NET OF ISSUANCE EXPENSES
    37,359,230       37,359       7,870,422             7,907,781  
SHARES ISSUED FOR  SERVICES
    418,025       418       214,442             214,860  
CONTRIBUTIONS TO PAID IN CAPITAL
                    18,991             18,991  
RECEIPTS ON ACCOUNT OF SHARES AND WARRANTS
                    6,061             6,061  
SHARES ISSUED FOR CONVERSION OF CONVERTIBLE NOTE
    550,000       550       274,450             275,000  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
                    2,605,796             2,605,796  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
                    203,982             203,982  
DISCOUNT ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION FEATURE
                    108,000             108,000  
COMPREHENSIVE LOSS
                            (16 )     (16 )
IMPUTED INTEREST
                    12,217               12,217  
NET LOSS
                            (7,248,188 )     (7,248,188 )
BALANCE AS OF AUGUST 31, 2008 (audited)
    56,252,806       56,252       11,785,012       (7,248,204 )     4,593,060  
SHARES ISSUED FOR  SERVICES RENDERED
    203,904       204       152,724               152,928  
SHARES TO BE ISSUED FOR SERVICES RENDERED
                    203,699               203,699  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
                    436,025               436,025  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
                    117,174               117,174  
IMPUTED INTEREST
                    3,780               3,780  
NET LOSS
                            (2,760,474 )     (2,760,474 )
BALANCE AS OF AUGUST 31, 2009 (audited)
    56,456,710       56,456       12,698,414       (10,008,678 )     2,746,192  
SHARES ISSUED FOR  SERVICES RENDERED IN PREVIOUS PERIOD
    569,887       570       (570 )             -  
SHARES ISSUED FOR  SERVICES RENDERED
    361,443       361       179,139               179,500  
SHARES ISSUED FOR  SERVICES TO BE RENDERED
    66,667       67       19,933               20,000  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
                    133,849               133,849  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
                    21,854               21,854  
IMPUTED INTEREST
                    1,890               1,890  
NET LOSS
                            (1,005,004 )     (1,005,004 )
BALANCE AS OF FEBRUARY 28, 2010 (unaudited)
    57,454,707     $ 57,454     $ 13,054,509     $ (11,013,682 )   $ 2,098,281  
 
The accompanying notes are an integral part of the consolidated financial statements

 
5

 

ORAMED PHARMACEUTICALS INC.
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars
 
   
Six months ended
   
Period from April
12, 2002
(inception date)
through
 
   
February 28,
   
February 28,
 
   
2010
   
2009
   
2010
 
   
Unaudited
 
                   
CASH FLOWS FROM OPERATING ACTIVITIES:
                 
Net loss
  $ (1,005,004 )   $ (1,846,298 )   $ (11,013,682 )
Adjustments required to reconcile net loss to net cash used in operating activities:
                       
Depreciation
    15,756       15,111       61,698  
Amortization of debt discount
    -       -       108,000  
Exchange differences on long term deposits
    347       1,804       (654 )
Stock based compensation
    155,703       268,038       3,518,680  
Common stock issued for services
    199,500       -       567,288  
Common stock to be issued for services
    -       -       203,699  
Impairment of investment
    -       -       434,876  
Imputed interest
    1,890       1,890       17,887  
Changes in operating assets and liabilities:
                       
Prepaid expenses and other current assets
    125,857       226,549       (315,606 )
Restricted cash
    -       -       (16,000 )
Accounts payable and accrued expenses
    (86,209 )     (217,225 )     235,135  
Provision for uncertain tax position
    -       -       147,063  
Total net cash used in operating activities
    (592,160 )     (1,550,131 )     (6,051,616 )
                         
CASH FLOWS FROM INVESTING ACTIVITIES:
                       
Purchase of property and equipment
    -       (3,013 )     (121,303 )
Acquisition of short-term investments
    (400,000 )             (4,128,000 )
Proceeds from sale of  Short term investments
    -       2,728,000       2,728,000  
Lease deposits
    -       (4,307 )     (11,160 )
Total net cash derived from (used in) investing activities
    (400,000 )     2,720,680       (1,532,463 )
                         
CASH FLOWS FROM FINANCING ACTIVITIES:
                       
Proceeds from sales of common stock and warrants - net of issuance expenses
    -       -       7,961,481  
Receipts on account of shares issuances
                    6,061  
Proceeds from convertible notes
    -       -       275,000  
Proceeds from short term note payable
    -       -       120,000  
Payments of short term note payable
    -       -       (120,000 )
Shareholder advances
    -       -       66,243  
  Net cash provided by financing activities
    -       -       8,308,785  
                         
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
    (992,160 )     1,170,549       724,706  
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
    1,716,866       2,267,320       -  
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 724,706     $ 3,437,869     $ 724,706  
Non cash investing and financing activities:
                       
Shares issued for offering costs
                  $ 1,753  
Contribution to paid in capital
                  $ $18,991  
Discount on convertible note related to beneficial conversion feature
                  $ 108,000  
Shares issued for services rendered
          $ 152,928          
 
The accompanying notes are an integral part of the consolidated financial statements.

 
6

 

ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:

a.
General:

 
1.
Oramed Pharmaceuticals Inc. (the “Company”) was incorporated on April 12, 2002, under the laws of the State of Nevada. From incorporation until March 3, 2006, the Company was an exploration stage company engaged in the acquisition and exploration of mineral properties. On February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd (the “First Agreement”) to acquire the provisional patent related to orally ingestible insulin pill to be used for the treatment of individuals with diabetes. The Company has been in the development stage since its formation and has not yet realized any revenues from its operations.

 
On May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd., which is engaged in research and development. Unless the context indicates otherwise, the term “Group” refers to Oramed Pharmaceuticals Inc. and its Israeli subsidiary, Oramed Ltd. (the “Subsidiary”).

 
The group is engaged in research and development in the biotechnology field and is considered a development stage company in accordance with ASC Topic 915 (formerly FAS 7) “Development Stage Entities”.

 
2.
The accompanying unaudited interim consolidated financial statements as of February 28, 2010 and for the six 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 six months ended February 28, 2010, are not necessarily indicative of the results that may be expected for the year ending August 31, 2010.

 
3.
Going concern considerations
 
The accompanying unaudited interim consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company has net losses for the period from inception (April 12, 2002) through February 28, 2010 of $11,013,682 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 February 28, 2010. These factors raise substantial doubt about the Company's ability to continue as a going concern. Management is in the process of evaluating various financing alternatives as the Company will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets. Although there is no assurance that the Company will be successful with those initiatives, management believes that it will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders, as well as on going funding from the Office of the Chief Scientist  ("OCS").
 
These consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to obtain additional financing as may be required and ultimately to attain profitability.
 
7

 
ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS

NOTE 1 -
SIGNIFICANT ACCOUNTING POLICIES(continued):

b.
Newly issued and recently adopted Accounting Pronouncements

 
In February 2010, the FASB issued Accounting Standards Update No. 2010-09 ("ASU 2010-09"), "Subsequent Events (Topic 855): Amendments to Certain Recognition and Disclosure Requirements," which among other things amended ASC 855 to remove the requirement for an SEC filer to disclose the date through which subsequent events have been evaluated. This change alleviates potential conflicts between ASC 855 and the SEC's requirements. All of the amendments in this update are effective upon issuance of this update. Management has included the provisions of these amendments in the financial statements.
 
c.
Reclassification:
 
Certain figures in respect of prior periods have been reclassified to conform to the current period presentation.
 
NOTE 2 -
COMMITMENTS:
 
 
a.
Under the terms of the First Agreement with Hadasit (note 1a(1) above), the Company retained Hadasit to provide consulting and clinical trial services. As remuneration for the services provided under the agreement, Hadasit is entitled to $200,000. The primary researcher for Hadasit is Dr. Miriam Kidron, a director and officer of the Company. The funds paid to Hadasit under the agreement are deposited by Hadasit into a research fund managed by Dr. Kidron. Pursuant to the general policy of Hadasit with respect to its research funds, Dr. Kidron receives from Hadasit a management fee in the rate of 10% of all the funds deposited into this research fund.
 
On January 7, 2009, the Company entered into a second agreement with Hadasit (the “Second Agreement”) which confirms that Hadasit has conveyed, transferred and assigned all of its ownership rights in the patents acquired under the First Agreement to the Company, and certain other patents filed by the Company after the First Agreement as a result of the collaboration between the Company and Hadasit.
 
On July 8, 2009 the Company entered into a third agreement with Hadasit, Prof. Itamar Raz and Dr. Miriam Kidron ("the Third Agreement"), to provide consulting and clinical trial services. According to the Third Agreement, Hadasit will be entitled to additional of $200,000 to be paid by Oramed in accordance with the actual progress of the study. The total amount that was paid through February 28, 2010 was $309,255 which refers to all three agreements.

 
b.
During January and April 2008 the Company entered into agreements with OnQ consulting, a clinical research organization (CRO) located in Johannesburg, South Africa, to conduct Phase 1B and 2B clinical trials on its oral insulin capsules. The total cost estimated for the studies is $229,681 of which $182,187 was paid through February 28, 2010.

 
c.
As to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note 3a.

 
8

 
 
ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
 
NOTE 2 –
COMMITMENTS (continued):

 
d.
On April 22, 2009, the subsidiary entered into a consulting service agreement with ADRES Advanced Regulatory Services Ltd. (“ADRES”) pursuant to which ADRES will provide consulting services relating to quality assurance and regulatory processes and procedures in order to assist the subsidiary in submission of a U.S. Investigational New Drug (“IND”) according to FDA regulations. In consideration for the services provided under the agreement, ADRES will be entitled to a total cash compensation of $211,000, of which the amount $110,000 will be paid as a monthly fixed fee of $10,000 each month for 11 months commencing May 2009, and the remaining $101,000 will be paid based on achievement of certain milestones. $120,000 of the total amount was paid through February 28, 2010.

 
e.
On February 10, 2010, the subsidiary entered into agreements with Vetgenerics Research G. Ziv Ltd, a clinical research organization (CRO), to conduct a toxicology trial on its oral insulin capsules. The total cost estimated for the studies is €107,100 of which €12,195 was paid through February 28, 2010.

 
f.
Grants from the Chief Scientist Office ("OCS")
 
The Subsidiary is obligated to pay royalties to the OCS on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from the OCS. In the case of failure of a project that was partly financed as described above, the Subsidiary is not obligated to pay any such royalties or repay funding received from the OCS.
 
Under the terms of the funding arrangements with the OCS, royalties of 3% to 3.5% are payable on the sale of products developed from projects funded by the OCS, which payments shall not exceed, in the aggregate, 100% of the amount of the grant received (dollar linked), plus interest at annual rate based on LIBOR. In addition, if the Subsidiary receives approval to manufacture the products developed with government grants outside the State of Israel, it will be required to pay an increased total amount of royalties (possibly up to 300% of the grant amounts plus interest), depending on the manufacturing volume that is performed outside the State of Israel, and, possibly, an increased royalty rate.
 
At February 28, 2010, the Company has not earned any revenues from the sale of products and no royalty payments have accrued.
 
For the six and three months periods ended February 28, 2010, the research and development expenses are presented net of OCS Grants, in the total of $292,557 and $144,697, respectively. In the six and three months periods ended February 28, 2010, no OCS grants were recognized by the Company.

 
9

 
 
ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
 
NOTE 3 -
STOCK BASED COMPENSATION:
 
The following are stocks issued for services, stock options and warrants transactions made during the six months ended February 28, 2010:
 
 
a.
On October 30, 2006 the Company entered into a Clinical Trial Manufacturing Agreement with Swiss Caps AG (“Swiss”), pursuant to which Swiss would manufacture and deliver the oral insulin capsule developed by the Company. In consideration for the services being provided to the Company by Swiss, the Company agreed to pay a certain predetermined amounts which are to be paid in common stocks of the Company, the number of stocks to be issued is based on the invoice received from Swiss, and the stock market price 10 days after the invoice was issued. The Company accounted the transaction with Swiss according to FASB ASC 480 "Distinguishing Liabilities from Equity" (formerly FAS 150).

On September 11, 2009, the Company issued 569,887 shares of its common stock to Swiss as remuneration for the services provided, for total of $203,699.

On December 29, 2009, the Company issued 328,110 shares of its common stock to Swiss as remuneration for the services provided, in the amount of $167,310.
 
b.
On November 23, 2009, 100,000 options were granted to a consultant, at an exercise price of $0.76 per share (higher than the traded market price on the date of grant), the options vest in three equal annual instalments commencing November 23, 2010 and expire on November 23, 2014.  The fair value of these options as of February 28, 2010, was $31,458, using the Black Scholes option-pricing model and was based on the following assumptions: dividend yield of 0% for all years; expected volatility of 122.49%; risk-free interest rates of 2.30%; and the remaining contractual life of 4.74 years.
 
c.
On November 23, 2009, 36,000 options were granted to an employee of the Subsidiary, at an exercise price of $0.46 per share (equivalent to the traded market price on the date of grant), the options vest in three equal annual instalments commencing November 23, 2010 and expire on November 23, 2019. The fair value of these options on the date of grant was $14,565, using the Black Scholes option-pricing model and was based on the following assumptions: dividend yield of 0% for all years; expected volatility of 123.55%; risk-free interest rates of 2.55%; and the remaining contractual life of 6 years.
 
d.
On December 29, 2009, the Company issued 100,000 shares of its common stock to a third party as remuneration for services rendered and to be rendered during the six month period commencing December 15, 2009. The fair value of these shares on the date of issuance was $37,000.
 
The Company recognized $155,703 of stock based compensation expense during the six months ended February 28, 2010 related to options granted to employees and consultants, of which $148,229 relates to options granted in prior years.

 
10

 
 
ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
 
NOTE 4 -
FAIR VALUE:
 
The fair value of the Company's financial instruments consisting of short term investments, included in the Company’s financial statements is identical or close to their carrying value due to the short-term maturities of these instruments.
 
NOTE 5 - SUBSEQUENT EVENTS:

 
a)
On March 16, 2010, 50,000 options were granted to a consultant of the subsidiary at an exercise price of $0.50 per share. The options vest in three equal annual instalments commencing on March 16, 2011 and will expire on March 15, 2015.
 
b)
On March 16, 2010, 100,000 options were granted to a consultant of the Company at an exercise price of $0.43 per share. The options vest in three equal monthly instalments commencing on March 30, 2010 and will expire on March 15, 2015.
 
c)
On March 16, 2010, 13,200 options were granted to a consultant of the Company at an exercise price of $0.43 per share. The options vest in six monthly instalments commencing on March 30, 2010 and will expire on March 15, 2015.
 
d)
On March 25, 2010, 100,000 options were granted to a consultant of the Company at an exercise price of $0.50 per share. The options vest in four equal quarterly instalments commencing on May 17, 2010 and will expire on March 25, 2015.
 
11

 
ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
The following information should be read in conjunction with the financial statements and notes thereto appearing elsewhere in this Quarterly Report.
 
This Quarterly Report on Form 10-Q (including the section regarding Management's Discussion and Analysis of Financial Condition and Results of Operations) contains forward-looking statements regarding our business, financial condition, results of operations and prospects. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this Quarterly Report on Form 10-Q  Additionally, statements concerning future matters are forward-looking statements.
 
Although forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under "Item 1A – Risk Factors" in our annual report on Form 10-K for the year ended August 31, 2009, and under "Risk Factors" in our registration statement on Form S-1/A filed with the SEC on February 24, 2010, as well as those discussed elsewhere in our annual report, the registration statement  and in this Quarterly Report on Form 10-Q. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. We undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Quarterly Report on Form 10-Q. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this Quarterly Report on Form 10-Q which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
 
We file reports with the Securities and Exchange Commission (the “SEC” or the “Commission”). We make available on our website under “Investor Information/SEC Filings,” free of charge, our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports as soon as reasonably practicable after we electronically file such materials with or furnish them to the SEC. Our website address is www.oramed.com. You can also read and copy any materials we file with the SEC at the SEC's Public Reference Room at 100 F Street, NE, Washington, DC 20549.  You can obtain additional information about the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains an internet site (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including us.
 
As used in this Quarterly Report, the terms "we," "us," "our," "Company" and "Oramed" mean Oramed Pharmaceuticals Inc. and our subsidiary, Oramed Ltd., unless otherwise indicated.
 
All dollar amounts refer to U.S. dollars unless otherwise indicated.
 
 
12

 
 
Overview
 
We are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions, including an orally ingestible insulin capsule or tablet to be used for the treatment of individuals with diabetes, rectal application of insulin, use of orally ingestible capsules, tablets or pills for delivery of other polypeptides and rectal application of other polypeptides.
 
Oramed was incorporated on April 12, 2002, in the State of Nevada under the name Iguana Ventures Ltd. Following the incorporation, the Company was an exploration stage company engaged in the acquisition and exploration of mineral properties. The Company was unsuccessful in implementing its business plan as a mineral exploration company. Accordingly, the Company decided to change the focus of its business by completing a share exchange with the shareholders of Integrated Security Technologies, Inc., a New Jersey private corporation (“ISTI”).  On June 4, 2004, the Company changed its name to Integrated Security Technologies by filing a Certificate of Amendment with the Nevada Secretary of State. Effective June 14, 2004 the Company effected a 3.3:1 forward stock split, increasing the amount of its authorized capital to 200,000,000 shares of common stock with the par value of $.001 per share.  However, due to disappointing results of ISTI, on May 31, 2005, effective as of May 27, 2004 the Company terminated the share exchange agreement with the shareholders of ISTI.
 
On March 8, 2006, we executed an agreement with Hadasit Medical Services and Development Ltd. (“Hadasit”) to acquire provisional patent application No. 60/718716 and related intellectual property and agreed to retain Hadasit to provide consulting and clinical trial services.  The provisional patent application No. 60/718716 relates to a method of preparing insulin so that it may be taken orally to be used in the treatment of individuals with diabetes.  On April 10, 2006, the Company changed its name from Integrated Security Technologies, Inc. to Oramed Pharmaceuticals Inc.  On August 31, 2006, based on provisional patent application No. 60/718716, the Company filed a patent application under the Patent Cooperation Treaty at the Israel Patent Office for “Methods and Compositions for Oral Administration of Proteins.”
 
Plan of Operation
 
Short Term Business Strategy
 
We plan to continue to conduct clinical trials to show the effectiveness of our technology.  We intend to conduct studies and other tests necessary to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (the “FDA”). Additional clinical trials are planned in other countries such as Israel and India in order to substantiate our results as well as for purposes of future filings for drug approval in these countries. We also plan to conduct further research and development by deploying our proprietary drug delivery technology for the delivery of other polypeptides in addition to insulin, and to develop other innovative pharmaceutical products, flu vaccines, and use of rectal application for delivery of other polypeptides.
 
 
13

 

Long Term Business Strategy
 
If our oral insulin capsule or other drug delivery solutions show significant promise in clinical trials, we plan to ultimately seek a strategic commercial partner, or partners, with extensive experience in the development, commercialization, and marketing of insulin applications and/or other orally digestible drugs. We anticipate such partner or partners would be responsible for, or substantially support, late stage clinical trials (Phase III) to ensure regulatory approvals and registrations in the appropriate markets in a timely manner. We further anticipate that such partner, or partners, would also be responsible for sales and marketing of our oral insulin capsule in these markets. Such planned strategic partnership, or partnerships, may provide a marketing and sales infrastructure for our products as well as financial and operational support for global clinical trials, post marketing studies, label expansions and other regulatory requirements concerning future clinical development in the United States and elsewhere. Any future strategic partner, or partners, may also provide capital and expertise that would enable the partnership to develop new oral dosage form for other polypeptides. We have not yet engaged in any meaningful discussions with potential partners and no assurance can be given that any third party would be interested in partnering with us. Under certain circumstances, we may determine to develop one or more of our oral dosage form on our own, either world-wide or in select territories.
 
Other Planned Strategic Activities
 
In addition to developing our own oral dosage form drug portfolio, we are, on an on-going basis, considering in-licensing and other means of obtaining additional technologies to complement and/or expand our current product portfolio. Our goal is to create a well-balanced product portfolio that will enhance and complement our existing drug portfolio.
 
Product Development
 
Orally Ingestible Insulin
 
During fiscal years 2007 through 2009 we conducted several clinical studies of our orally ingestible insulin. The studies were intended to assess both the safety/tolerability and absorption properties of our proprietary oral insulin. Based on the pharmacokinetic and pharmacologic outcomes of these trials, we decided to continue the development of our oral insulin product.
 
In November 2007 we successfully completed animal studies in preparation for the Phase 1B clinical trial of our oral insulin capsule (ORMD 0801).  In January 2008 we commenced the non-FDA approved Phase 1B clinical trials with our oral insulin capsule, in healthy human volunteers with the intent of dose optimization.  In March 2008, we successfully completed our Phase 1B clinical trials.
 
In April 2008 we commenced a non-FDA approved Phase 2A study to evaluate the safety and efficacy of our oral insulin capsule (ORMD 0801) in type 2 diabetic volunteers at Hadassah Medical Center in Jerusalem. In August 2008 we successfully completed this trial.
 
In July 2008 we were granted approval by the Institutional Review Board Committee of Hadassah Medical Center in Jerusalem to conduct a non-FDA approved Phase 2A study to evaluate the safety and efficacy of our oral insulin capsule (ORMD 0801) on type 1 diabetic volunteers. On September 24, 2008, we commenced this trial and in July 2009 we successfully completed this trial.
 
On April 21, 2009, we entered into a consulting service agreement with ADRES Advanced Regulatory Services Ltd. (“ADRES”), pursuant to which ADRES will provide services for the purpose of filing an IND application with the FDA for a Phase 2 study according to the FDA requirements. The FDA approval process and, if approved, registration for commercial use as an oral drug can take several years.
 
 
14

 
 
In May 2009 we commenced a non-FDA approved Phase 2B study in South Africa to evaluate the safety, tolerability and efficacy of our oral insulin capsule (ORMD 0801) on type 2 diabetic volunteers. In March 2010 we completed this trial and we expect to report results from this study in the near future.
 
On February 10, 2010, we entered into agreements with Vetgenerics Research G. Ziv Ltd., a clinical research organization (CRO), to conduct a toxicology trial on our oral insulin capsules.
 
We are considering whether and when to conduct an additional non-FDA approved Phase 2B study in India.
 
Rectal Application of Insulin and Other Polypeptides
 
We filed two additional provisional patents for a suppository application to our technology portfolio. The first patent focuses on a rectal application for insulin. The second patent focuses on the usage of this rectal application to other polypeptides that at present are only available in injection.
 
On January 30, 2008, we entered into a master service agreement with OnQ Consulting; a clinical research organization located in Johannesburg, South Africa, to conduct non-FDA approved clinical trials for the rectal application of insulin.  On February 4, 2009, we concluded a proof of concept study of the insulin suppositories.
 
In October 2008 we commenced a non-FDA approved Phase 1A study to evaluate the safety and efficacy of our insulin suppository (ORMD 0802) on healthy volunteers, in South Africa.
 
As we believe that the potential commercial market for our oral insulin products are significantly greater than the potential commercial market for our rectal application products, we have determined to use our limited resources to research and develop our oral insulin capsules and tablets and have temporarily suspended our development of our recital application products.
 
GLP1 Analog
 
In September 2008 we launched pre-clinical trials of ORMD 0901, a GLP1-analog.  The pre-clinical trials include animal studies which suggest that the GLP-1analog (exenatide -4) when combined with Oramed’s absorption promoters is absorbed through the gastrointestinal tract and retains its biological activity.
 
On September 9, 2009, we received approval from the Institutional Review Board (IRB) in Israel to commence human clinical trials of an oral GLP-1 Analog. The approval was granted after successful pre-clinical results were reported. The trials will be conducted on healthy volunteers at Hadassah University Medical Center in Jerusalem. We anticipate that the results of these trials will be released in the near future.
 
Glucagon-like peptide-1 (GLP-1) is an incretin hormone - a type of gastrointestinal hormone that stimulates the secretion of insulin from the pancreas. The incretin concept was hypothesized when it was noted surprisingly that glucose ingested by mouth (orally) stimulated two to three times more insulin release than the same amount of glucose administered intravenously. In addition to stimulating insulin release, GLP-1 was found to suppress glucagon release (a hormone involved in regulation of glucose) from the pancreas, slow gastric emptying to reduce the rate of absorption of nutrients into the blood stream, and increase satiety. Other important beneficial attributes of GLP-1 are its effects of increasing the number of beta cells (cells that manufacture and release insulin) in the pancreas and, possibly, protection of the heart.
 
 
15

 
 
Raw Materials
 
Our oral insulin capsule is currently manufactured by Swiss Caps AG, under a Clinical Trail Manufacturing Agreement. The raw materials required for the manufacturing of the capsule are purchased from third parties, under separate agreements.  We generally depend upon a limited number of suppliers for the raw materials.  Although alternative sources of supply for these materials are generally available, we could incur significant costs and disruptions in changing suppliers.  The termination of our relationships with our suppliers or the failure of these suppliers to meet our requirements for raw materials on a timely and cost-effective basis could materially adversely affect our business, prospects, financial condition and results of operations.
 
Licensing
 
We have recently engaged in preliminary discussions with potential partners outside of the United States regarding their management of clinical trials of our oral insulin capsules. Such agreements could involve us granting exclusive commercialization rights and profit interests in our products derived from certain geographic areas outside the United States in exchange for payment of the costs of running such clinical trials now. These discussions are in a very early stage, however, and may not result in our being able to enter into any such partnerships.
 
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 February 28, 2010 of $11,013,682, as well as negative cash flow from operating activities. Based upon our existing spending commitments, estimated at $5.8 million for the twelve months following March 1, 2010, and our cash availability, we do not have sufficient cash resources to meet our liquidity requirements through February 28, 2011. The ongoing global economic and credit crisis makes it more difficult for the Company to raise financing.  Accordingly, these factors raise substantial doubt about our ability to continue as a going concern. Management is in the process of evaluating various financing alternatives as we will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets. Although there is no assurance that we will be successful with those initiatives, management believes that it will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders.
 
The financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. Our continuation as a going concern is dependent on our ability to obtain additional financing as may be required and ultimately to attain profitability.
 
 
16

 

Critical accounting policies
 
Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements included in this Quarterly Report. We believe that the accounting policies below are critical for one to fully understand and evaluate our financial condition and results of operations.
 
The discussion and analysis of our financial condition and results of operations is based on our financial statements, which we prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. We evaluate such estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
 
Comparison of six month and three month periods ended February 28, 2010 and 2009
 
The following table summarizes certain statements of operations data for the Company for the six month and three month periods ended February 28, 2010 and 2009:
 
   
Six months ended
   
Three months ended
 
Operating Data:
 
February 28, 
2010
   
February 28, 
2009
   
February 28, 
2010
   
February 28, 
2009
 
                         
Research and development costs
  $ 486,782     $ 1,113,146     $ 169,237     $ 274,970  
General and administrative expenses
    522,619       735,373       222,663       371,508  
Financial (income) expense, net
    (4,397 )     (2,221 )     311       11,774  
Net loss for the period
    1,005,004       1,846,298     $ 392,211     $ 658,252  
                                 
Loss per common share – basic and diluted
  $ 0.02     $ 0.03     $ 0.01     $ 0.01  
Weighted average common shares outstanding
    57,289,266       56,416,080       57,442,484       56,469,027  
 
Research and development expenses
 
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, costs of registered patents materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drug for use in research, preclinical development. All costs associated with research and development are expensed as incurred.
 
 
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Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company outsources a substantial portion of its clinical trial activities, utilizing external entities such as contract research organizations, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical studies. For each clinical trial that the Company conducts, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and the period over which clinical investigators or contract research organizations are expected to provide services.
 
Clinical activities which relate principally to clinical sites and other administrative functions to manage the Company’s clinical trials are performed primarily by contract research organizations (“CROs”). CROs typically perform most of the start-up activities for the Company’s trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management.
 
During the six months ended February 28, 2010 research and development expenses totaled $486,782, compared to $1,113,146 for the six months ended February 28, 2009. The decrease is mainly attributable to a decrease in materials purchased. Our research and development expenses were lower due to more grants received from the Office of Chief Scientist of the Israeli Ministry of Industry, Trade and Labor (the "OCS"). The research and development costs include stock based compensation costs, which during the six months ended February 28, 2010 totaled $42,508 as compared to $90,941 during the six months ended February 28, 2009.
 
The decrease in research and development expenses during the three months ended February 28, 2010 as compared to the three months ended February 28, 2009 is attributable to the same reasons mentioned above.
 
Government Grants
 
In the six and three months ended February 28, 2010, we recognized research and development grants in an amount of $292,557 and $144,967, respectively. As of February 28, 2010, we had no contingent liabilities to the OCS.
 
General and administrative expenses
 
General and administrative expenses include the salaries and related expenses of our management, consulting costs, legal and professional fees, traveling, business development costs, insurance expenses and other general costs.
 
For the six months ended February 28, 2010, general and administrative expenses totaled $522,619 compared to $735,373 for the six months ended February 28, 2009. Costs incurred related to general and administrative activities during the six months ended February 28, 2010 reflect a decrease of payroll and related expenses and professional fee expenses as well as a decrease in general expenses such as office and maintenance expenses. During the six months ended February 28, 2010, as part of our general and administrative expenses, we incurred $113,195 related to stock options granted to employees and consultants, as compared to $177,097 during the six months ended February 28, 2009.
 
 
18

 

The decrease in general and administrative expenses during the three months ended February 28, 2010 as compared to the three months ended February 28, 2009 is attributable to the same reasons mentioned above.
 
Financial income/expense, net
 
During the six months ended February 28, 2010 and 2009, we generated interest income on available cash and cash equivalents which was offset by bank charges and imputed interest.
 
Liquidity and Capital Resources
 
Through February 28, 2010, we incurred losses in an aggregate amount of $11,013,682. We have financed our operations through the private placements of equity and debt financing. Since inception through February 28, 2010, we have financed our operations through the private placements of equity and debt financings, raising a total of $8,308,785, net of transaction costs. We will seek to obtain additional financing through similar sources. As of February 28, 2010, we had $724,706 of available cash as well as $1,400,000 in short term interest bearing investments. We anticipate that we will require approximately $5.8 million to finance our activities during the twelve months following March 1, 2010.
 
Management is in the process of evaluating various financing alternatives as we will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets. Although there is no assurance that we will be successful with those initiatives, management believes that it will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders as well as receive additional funding from the OCS.
 
Our financing activities during the six months ended February 28, 2010 included the following:
 
 
·
On September 11, 2009, we issued 569,887 shares of common stock valued at $203,699 to a third party, for services rendered in the prior year.
 
 
·
On December 29, 2009, we issued 328,110 shares of common stock valued at $167,310 to a third party, for services rendered.
 
 
·
On December 29, 2009, we issued 100,000 shares of common stock valued at $30,000 to a third party, for services rendered and to be rendered during the six month period commencing December 15, 2009.
 
Employee's and Consultant’s Stock Options and Warrants
 
Employee and consultant stock options grant and warrant issuance activities for the six months ended February 28, 2010 include the following:
 
 
·
On November 23, 2009 we granted options under the 2008 Stock Incentive Plan to purchase up to 100,000 shares of our common stock at an exercise price of $0.76 to a consultant.
 
 
19

 
 
·
On November 23, 2009 we granted options under the 2008 Stock Incentive Plan to purchase up to 36,000 shares of our common stock at an exercise price of $0.46 to an employee of our subsidiary.
 
Off-Balance Sheet Arrangements
 
We have no off-balance sheet arrangements.
 
Planned Expenditures
 
The estimated expenses referenced herein are in accordance with our business plan. Since our technology is still in the development stage, it can be expected that there will be changes in some budgetary items. Our planned expenditures for the twelve months beginning March 1, 2010 are as follows:
 
Operating:
 
Amount
 
 
     
Research and development costs, net of OCS funds
  $ 4,760,000  
General and administrative expenses
    1,010,000  
Financial income, net
    (10,000 )
Taxes on income
    -  
Total
  $ 5,760,000  

As previously indicated, we are planning to conduct further clinical studies as well as file an IND application with the FDA for our orally ingested insulin. Our ability to proceed with these activities is dependent on several major factors including the ability to attract sufficient financing on terms acceptable to us.
 
ITEM 3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
We are a smaller reporting company, as defined by Rule 12b-2 of the Exchange Act of 1934, as amended and are not required to provide information under this item.
 
ITEM 4T - CONTROLS AND PROCEDURES
 
(a) 
Disclosure Controls and Procedures
 
Our management, including our chief executive officer and chief financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of February 28, 2010. Based on such review, our chief executive officer and chief financial officer have determined that in light of their conclusion with respect to the effectiveness of our internal control over our financial reporting as of such date, the weaknesses in controls and procedures described in our Form 10-K filed on November 25, 2009 continued this quarter and that the Company did not have in place effective controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure, and is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms.
 
20

 
(b) 
Management’s Annual Report on Internal Control over Financial Reporting
 
Our management, under the supervision of our chief executive officer and chief financial officer, is responsible for establishing and maintaining adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) of the Securities Exchange Act of 1934, as amended. The Company’s internal control over financial reporting is defined as a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Internal control over financial reporting includes policies and procedures that:
 
 
·
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;
 
 
·
provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
 
 
·
provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements.
 
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 February 28, 2010 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 February 28, 2010.
 
As previously reported in our Form 10-K filed on November 25, 2009, during the six months ended February 28, 2010, management, including our principal executive officer and principal financial officer, has started an extensive process of documenting all major procedures related to financial reporting, in order to strengthen our internal controls over financial reporting in order to reasonably ensure the reliability of our financial statements.
 
21

 
We have developed a comprehensive program designed to strengthen our internal controls over financial reporting in order to improve such reporting requirements.
 
This management report on internal control over financial reporting shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section.
 
(c) 
Changes in Internal Control over Financial Reporting
 
 There were no changes in our internal controls over financial reporting identified in connection with the evaluation thereof that occurred during the six months ended February 28, 2010 that have materially affected, or are reasonable likely to materially affect our internal control over financial reporting.

 
22

 

PART II – OTHER INFORMATION
 
ITEM 1 - LEGAL PROCEEDINGS
 
Except as previously disclosed, we know of no material, active or pending legal proceedings against us, nor are we involved as a plaintiff in any material proceedings or pending litigation.
 
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
 
·
On September 11, 2009, we issued 569,887 shares of common stock valued at $203,699 to a third party, for services rendered in the prior year.
 
 
·
On December 29, 2009, we issued 328,110 shares of common stock valued at $167,310 to a third party, for services rendered.
 
 
·
On December 29, 2009, we issued 100,000 shares of common stock valued at $30,000 to a third party, for services rendered and to be rendered during the six month period commencing December 15, 2009.
 
 
·
On February 17, 2010, we entered into an agreement with a member of our scientific advisory board, granting options to purchase 100,000 shares of common stock at an exercise price per share of $0.50. The options vest in four installments of 25,000 each, on each three-month anniversary commencing February 17, 2010.
 
 
·
On February 11, 2010, we entered into a consulting agreement for a six-month term whereby the consultant was granted options to purchase 13,200 shares of common stock at an exercise price per share of $0.43 vesting over the consulting period.
 
 
·
On April 11, 2010, we entered into a consulting agreement for a two-year term whereby the consultant was granted options to purchase 50,000 shares of common stock at an exercise price per share of $0.50.  The options vest in three equal installments, on each three-year anniversary commencing March 16, 2011.
 
 
·
On April 11, 2010, we entered into a consulting agreement for a three-month term whereby the consultant was granted options to purchase 100,000 shares of common stock at an exercise price per share of $0.43.  The options vest in three equal installments, on March 30, 2010, April 30, 2010 and May 30, 2010.
 
Since the transactions were not public offerings within the meaning of Section 4(2) of the Securities Act, these issuances were deemed exempt from registration.

 
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ITEM 6 - EXHIBITS
 
Number
 
Exhibit
     
(3)
 
Articles of Incorporation and By-laws
     
3.1
 
Articles of Incorporation (incorporated by reference from our Registration Statement on Form S-1 file no. 333-164286 filed on January 11, 2010).
     
3.2
 
Bylaws (incorporated by reference from our Current Report on Form 8-K filed on April 10, 2006).
     
3.3
 
Articles of Merger filed with the Nevada Secretary of State on March 29, 2006 (incorporated by reference to our Current Report on Form 8-K filed on April 10, 2006).
     
(4)
 
Instruments defining rights of security holders, including indentures
     
4.1
 
Specimen Stock Certificate (incorporated by reference from our Registration Statement on Form SB-2, filed on November 29, 2002).
     
4.2
 
Form of warrant certificate (incorporated by reference from our current report on Form 8-K filed on June 18, 2007)
     
(10)
 
Material Contracts
     
10.1
 
Agreement dated February 17, 2006, between our company and Hadasit Medical Services and Development Ltd. (incorporated by reference from our current report on Form 8-K filed February 17, 2006).
     
10.2
 
Agreement dated October 30, 2006, between our company and Swiss Caps AG (incorporated by reference from our current report on Form 8-K filed October 26, 2006).
     
10.3
 
Agreement dated January 7, 2008, between our company and Hadasit Medical Services and Development Ltd. (incorporated by reference from our current report on Form 8-K filed January 7, 2008).
     
10.4
 
Agreement dated April 22, 2009, between Oramed Ltd. and ADRES Advanced Regulatory Services Ltd. (incorporated by reference from our current report on Form 8-K filed April 22, 2009).
     
10.5
 
Agreement dated July 8, 2009, between our company and Hadasit Medical Services and Development Ltd. (incorporated by reference from our current report on Form 8-K filed July 9, 2009).
     
(31)
 
Section 302 Certification
     
31.1 *
 
Certification Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
31.2 *
 
Certification Statement of the Principal Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
(32)
 
Section 906 Certification
     
32.1 *
 
Certification Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of 2002
     
32.2 *
 
Certification Statement of the Principal Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of 2002
 
*
Filed herewith 

 
24

 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
   
ORAMED PHARMACEUTICALS INC.
     
   
Registrant
     
Date: April 12, 2010
By:  
/s/ Nadav Kidron
     
   
Nadav Kidron
   
President, Chief Executive Officer and Director
     
Date: April 12, 2010
By:  
/s/ Yifat Zommer
     
   
Yifat Zommer
   
Chief Financial Officer

 
25

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
 
I, Nadav Kidron, certify that:
 
1.    I have reviewed this quarterly report on Form 10-Q of Oramed Pharmaceuticals Inc.;
 
2.    Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.    Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.    The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
 
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.
 
 
 

 
 
5.    The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):
 
a)
all significant deficiencies and material weaknesses in the design or operation of internal controls which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting;
 
Dated: April 12, 2010
 
By:
 
/s/    NADAV KIDRON
         
       
Name:  Nadav Kidron
       
Title:  President, Chief Executive Officer
       
           and Director

 
 

 

 CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE
SARBANES-OXLEY ACT OF 2002
 
I, Yifat Zommer, certify that:
 
1.    I have reviewed this quarterly report on Form 10-Q of Oramed Pharmaceuticals Inc.;
 
2.    Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.    Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.    The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
 
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.
 
5.    The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):
 
 
 

 
 
 
a)
all significant deficiencies and material weaknesses in the design or operation of internal controls which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
 
 
b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting;
 
Dated: April 12, 2010
 
By:
 
/s/    YIFAT ZOMMER
         
       
Name: Yifat Zommer,
       
Title:  Chief Financial Officer

 
 

 
 
Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of Oramed Pharmaceuticals Inc. (the “Company”) on Form 10-Q for the period ended February 28, 2010 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Nadav Kidron, President, Chief Executive Officer and Director of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that:

 
(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:  April 12, 2010
 
By:
 
/s/    NADAV KIDRON
         
       
Name:  Nadav Kidron
       
Title:  President, Chief Executive Officer
       
             and Director

 
 

 
   
Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of Oramed Pharmaceuticals Inc. (the “Company”) on Form 10-Q for the period ended February 28, 2010 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Yifat Zommer, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that:

 
(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: April 12, 2010
 
By:
 
/s/    YIFAT ZOMMER
         
       
Name:  Yifat Zommer,
       
Title:  Chief Financial Officer