Unassociated Document
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 10-Q

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

For the quarterly period ended November 30, 2010

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

For the transition period from _________ to _________

Commission file number: 000-50298

ORAMED PHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in its Charter)

Nevada
98-0376008
(State or Other Jurisdiction of
Incorporation or Organization)
(IRS Employer Identification
No.)

Hi-Tech Park 2/5 Givat Ram
PO Box 39098
Jerusalem, Israel
91390
(Address of Principal Executive
Offices)
(Zip Code)

+ 972-2-566-0001
(Registrant's Telephone Number, Including Area Code)

(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ¨           No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ¨
Accelerated filer ¨
Non-accelerated filer   ¨ (Do not check if a smaller reporting company)
Smaller reporting company x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes  ¨         No x

As of January 12, 2011 there were 65,262,784 shares of the issuer's Common Stock, $.001 par value, outstanding.
 
 
 

 

ORAMED PHARMACEUTICALS INC.

FORM 10-Q

TABLE OF CONTENTS

PART I – FINANCIAL INFORMATION
1
ITEM 1 - FINANCIAL STATEMENTS
1
ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
13
ITEM 3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
26
ITEM 4 - CONTROLS AND PROCEDURES
26
PART II - OTHER INFORMATION
 
ITEM 1 - LEGAL PROCEEDINGS
27
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
27
ITEM 6 - EXHIBITS
27
 
 
 

 

PART I – FINANCIAL INFORMATION
 
ITEM 1 - FINANCIAL STATEMENTS

 
ORAMED PHARMACEUTICALS INC.
 (A development stage company)

INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS OF NOVEMBER 30, 2010

 
1

 

ORAMED PHARMACEUTICALS INC.
 (A development stage company)

INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS OF NOVEMBER 30, 2010

TABLE OF CONTENTS

 
Page
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:
 
Balance sheets
3
Statements of operations
4
Statements of changes in stockholders’ equity
5
Statements of cash flows
6
Notes to financial statements
7-12
 
_________________________
________________________________
_________________________

 
2

 

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

   
November 30,
   
August 31,
 
   
2010
   
2010
 
   
Unaudited
   
Audited
 
Assets
           
             
CURRENT ASSETS:
           
Cash and cash equivalents
  $ 1,101,283     $ 1,199,638  
Short term investments
            100,000  
Restricted cash
    16,017       16,008  
Accounts receivable - other
    23,843       59,175  
Prepaid expenses
    24,097       1,859  
Related parties
    798       7,689  
Grants receivable from the Chief Scientist
    143,917       12,438  
Total current assets
    1,309,955       1,396,807  
                 
INVESTMENT IN A JOINT VENTURE
    1,535          
LONG TERM DEPOSITS
    10,967       10,582  
PROPERTY AND EQUIPMENT, net
    36,048       43,499  
Total assets
  $ 1,358,505     $ 1,450,888  
                 
Liabilities and stockholders' equity
               
                 
CURRENT LIABILITIES:
               
Accounts payable and accrued expenses
  $ 335,148     $ 411,330  
Account payable with former shareholder
    47,252       47,252  
Total current liabilities
    382,400       458,582  
                 
PROVISION FOR UNCERTAIN TAX POSITION
    162,034       162,034  
                 
COMMITMENTS
               
                 
STOCKHOLDERS' EQUITY:
               
Common stock of $ 0.001 par value - Authorized: 200,000,000 shares at November 30, 2010 and August 31, 2010; Issued and outstanding: 58,756,535 at November 30, 2010 and  57,565,321 shares at August 31, 2010, respectively
    58,757       57,565  
Additional paid-in capital
    14,344,152       13,758,761  
Deficit accumulated during the development stage
    (13,588,838 )     (12,986,054 )
Total stockholders' equity
    814,071       830,272  
Total liabilities and stockholders' equity
  $ 1,358,505     $ 1,450,888  

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

 
3

 

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

               
Period
 
               
from April
 
         
12, 2002
 
         
(inception)
 
   
Three months ended
   
through
 
   
November 30
   
November 30
 
   
2010
   
2009
   
2010
 
   
Unaudited
 
                     
RESEARCH AND DEVELOPMENT EXPENSES, net
  $ 286,488     $ 332,485     $ 6,979,028  
IMPAIRMENT OF INVESTMENT
                    434,876  
GENERAL AND ADMINISTRATIVE EXPENSES
    315,129       285,016       5,997,552  
OPERATING LOSS
    601,617       617,501       13,411,456  
FINANCIAL INCOME
    (2,189 )     (8,373 )     (162,989 )
FINANCIAL EXPENSE
    3,356       3,665       165,833  
LOSS BEFORE TAXES ON INCOME
    602,784       612,793       13,414,300  
TAXES ON INCOME
    -       -       174,538  
NET LOSS FOR THE PERIOD
  $ 602,784     $ 612,793     $ 13,588,838  
BASIC AND DILUTED LOSS PER
                       
COMMON SHARE
  $ (0.01 )   $ (0.01        
WEIGHTED AVERAGE NUMBER OF COMMON
                       
STOCK USED IN COMPUTING BASIC AND
                       
DILUTED LOSS PER COMMON STOCK
    57,932,597       57,158,865          

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

 
4

 

ORAMED PHARMACEUTICALS INC.
(A development stage company)
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
U.S. dollars
                     
Deficit
       
                     
accumulated
       
               
Additional
   
during the
   
Total
 
   
Common Stock
   
paid-in
   
development
   
stockholders'
 
   
Shares
   
$
   
capital
   
stage
   
equity
 
BALANCE AS OF APRIL 12, 2002 (inception)
    34,828,200     $ 34,828     $ 18,872           $ 53,700  
CHANGES DURING THE PERIOD FROM APRIL 12, 2002 THROUGH AUGUST 31, 2008 (audited):
                                     
SHARES CANCELLED
    (19,800,000 )     (19,800 )     19,800             -  
SHARES ISSUED FOR INVESTMENT IN ISTI-NJ
    1,144,410       1,144       433,732             434,876  
SHARES ISSUED FOR OFFERING COSTS
    1,752,941       1,753       (1,753 )           -  
SHARES ISSUED FOR CASH– NET OF ISSUANCE EXPENSES
    37,359,230       37,359       7,870,422             7,907,781  
SHARES ISSUED FOR  SERVICES
    621,929       622       367,166             367,788  
SHARES TO BE ISSUED FOR SERVICES RENDERED
                    203,699             203,699  
CONTRIBUTIONS TO PAID IN CAPITAL
                    18,991             18,991  
RECEIPTS ON ACCOUNT OF SHARES AND WARRANTS
                    6,061             6,061  
SHARES ISSUED FOR CONVERSION OF CONVERTIBLE NOTE
    550,000       550       274,450             275,000  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
                    2,864,039             2,864,039  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
                    498,938             498,938  
DISCOUNT ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION FEATURE
                    108,000             108,000  
COMPREHENSIVE LOSS
                            (16 )     (16 )
IMPUTED INTEREST
                    15,997               15,997  
NET LOSS
                            (10,008,662 )     (10,008,662 )
BALANCE AS OF AUGUST 31, 2009 (audited)
    56,456,710       56,456       12,698,414       (10,008,678 )     2,746,192  
SHARES ISSUED FOR  SERVICES RENDERED
    1,108,611       1,109       248,741               249,850  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
                    690,882               690,882  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
                    116,944               116,944  
IMPUTED INTEREST
                    3,780               3,780  
NET LOSS
                            (2, 977, 376 )     (2,977,376 )
BALANCE AS OF AUGUST 31, 2010 (audited)
    57,565,321     $ 57,565     $ 13,758,761     $ (12,986,054 )   $ 830,272  
SHARES ISSUED FOR  SERVICES RENDERED
    253,714       254       88,546               88,800  
RECEIPTS ON ACCOUNT OF SHARES AND WARRANTS
    937,500       938       299,062               300,000  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
                    188,966               188,966  
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
                    6,335               6,335  
OTHER COMPREHENSIVE INCOME
                    1,535               1,535  
IMPUTED INTEREST
                    947               947  
NET LOSS
                            (602,784 )     (602,784 )
BALANCE AS OF NOVEMBER 30, 2010 (unaudited)
    58,756,535     $ 58,757     $ 14,344,152     $ (13,588,838 )   $ 814,071  
 
The accompanying notes are an integral part of the consolidated financial statements

 
5

 

ORAMED PHARMACEUTICALS INC.
(A development stage company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars
   
Three months ended
   
Period from April
12, 2002
(inception date)
through
 
   
November 30
   
November 30,
 
   
2010
   
2009
   
2010
 
   
Unaudited
 
CASH FLOWS FROM OPERATING ACTIVITIES:
                 
Net loss
  $ (602,784 )   $ (612,793 )   $ (13,588,838 )
Adjustments required to reconcile net loss to net cash used in operating activities:
                       
Depreciation
    7,451       7,989       85,255  
Amortization of debt discount
    -       -       108,000  
Exchange differences on long term deposits
    (385 )     (61 )     (1,051 )
Stock based compensation
    195,301       97,977       4,366,104  
Common stock issued for services
    -       -       706,438  
Common stock to be issued for services
    88,800       169,500       203,699  
Impairment of investment
    -       -       434,876  
Imputed interest
    947       945       20,724  
Changes in operating assets and liabilities:
                       
Prepaid expenses and other current assets
    (111,494 )     122,717       (192,655 )
Restricted cash
    (9 )     -       (16,017 )
Accounts payable and accrued expenses
    (76,182 )     42,988       335,148  
Provision for uncertain tax position
    -       -       162,034  
Total net cash used in operating activities
    (498,355 )     (170,738 )     (7,376,283 )
CASH FLOWS FROM INVESTING ACTIVITIES:
                       
Purchase of property and equipment
    -       -       (121,303 )
Acquisition of short-term investments
    -       (400,000 )     (3,728,000 )
Proceeds from sale of  Short term investments
    100,000       -       3,728,000  
Lease deposits
    -       -       (9,916 )
Total net cash provided by (used in) investing activities
    100,000       (400,000 )     (131,219 )
CASH FLOWS FROM FINANCING ACTIVITIES:
                       
Proceeds from sales of common stocks and warrants - net of issuance expenses
    300,000       -       8,261,481  
Receipts on account of shares issuances
    -       -       6,061  
Proceeds from convertible notes
    -       -       275,000  
Proceeds from short term note payable
    -       -       120,000  
Payments of short term note payable
    -       -       (120,000 )
Shareholder advances
    -       -       66,243  
Net cash provided by financing activities
    300,000       -       8,608,785  
                         
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
    (98,355 )     (570,738 )     1,101,283  
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
    1,199,638       1,716,866       -  
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 1,101,283     $ 1,146,128     $ 1,101,283  
Non cash investing and financing activities:
                       
  Shares issued for offering costs
                  $ 1,753  
  Contribution to paid in capital
                  $ 18,991  
Discount on convertible note related to beneficial
conversion feature
                  $ 108,000  
  Shares issued for services rendered
          $ 152,928          
 
The accompanying notes are an integral part of the consolidated financial statements.

 
6

 

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

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:

 
a.
  General:

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

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

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

 
2.
The accompanying unaudited interim consolidated financial statements as of November 30, 2010 and for the three months then ended, have been prepared in accordance with accounting principles generally accepted in the United States relating to the preparation of financial statements for interim periods. Accordingly, they do not include all the information and footnotes required for annual financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three months ended November 30, 2010, are not necessarily indicative of the results that may be expected for the year ending August 31, 2011.

 
3.
Going concern considerations
 
The accompanying unaudited interim consolidated financial statements have been prepared assuming that the Company will continue as a going concern. The Company has net losses for the period from inception (April 12, 2002) through November 30, 2010 of $13,588,838 as well as negative cash flow from operating activities. Presently, the Company does not have sufficient cash resources to meet its requirements in the twelve months following November 30, 2010. These factors raise substantial doubt about the Company's ability to continue as a going concern. Management is in the process of evaluating various financing alternatives as the Company will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets. Although there is no assurance that the Company will be successful with those initiatives, management believes that it will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders, as well as on going funding from the Office of the Chief Scientist of the Ministry of Industry, Trade and Labor of Israel ("OCS").  See also note 7b for sale of Securities Purchase Agreements to which the Company entered following November 30, 2010.

 
7

 

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

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
 
These consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to obtain additional financing as may be required and ultimately to attain profitability.

 
b.
Newly issued and recently adopted Accounting Pronouncements
 
 
1.
In February 2010, the FASB issued Accounting Standards Update No. 2010-09 ("ASU 2010-09"), "Subsequent Events (Topic 855): Amendments to Certain Recognition and Disclosure Requirements," which among other things amended ASC 855 to remove the requirement for an SEC filer to disclose the date through which subsequent events have been evaluated. This change alleviates potential conflicts between ASC 855 and the SEC's requirements. All of the amendments in this update are effective upon issuance of this update. Management has included the provisions of these amendments in the financial statements.
 
 
2.
In June 2009, the FASB updated accounting guidance relating to variable interest entities. As applicable to the Company, this will become effective as of the first annual reporting period that begins after November 15, 2009, for interim periods within that first annual reporting period, and for interim and annual reporting periods thereafter. As applicable to the Company, the adoption of the new guidance will not have a material impact on the consolidated financial statements.
 
 
c.
Reclassifications
Certain figures in respect of prior period have been reclassified to conform to the current period presentation.

NOTE 2 - INVESTMENT IN A JOINT VENTURE

a.
In June 2010, the subsidiary of the Company entered into an agreement with D.N.A Biomedical Solutions Ltd ("D.N.A"), for the establishment of a new company, Entera Bio Ltd. ("Entera"), ("the JV Agreement").
According to the JV Agreement, D.N.A will invest $600,000 in Entera, and Entera will be owned in equal parts by the subsidiary and D.N.A. In consideration for 50% of Entera's shares, the Subsidiary of the Company will enter into a Patent License Agreement with Entera, according to which, the subsidiary of the Company will out-license to Entera a technology for the development of oral delivery drugs for certain actions. Entera's Chief Executive Officer will be granted options to purchase ordinary shares of Entera, reflecting 9.9% of Entera's share capital.
In the event that Entera has not obtained third-party financing by June 1, 2011, or such other date mutually agreed upon by the parties, each of the subsidiary and D.N.A will be required to make a capital contribution to Entera in the amount of $150,000.
Mr. Zeev Bronfeld, who is one of D.N.A 's controlling shareholders, is also an affiliated shareholder of the Company.

As of November 30, 2010, the Group holds 50% of the issued and outstanding share capital of Entera (45% - on fully diluted basis). As the Group did not obtain control in Entera, these consolidated financial statements do not include Entera's financial statements.

 
8

 

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

 
NOTE 2 - INVESTMENT IN A JOINT VENTURE (continued)

During the year ended August 31, 2010, the Group recognized deferred income at the amount of $300,000 (50% of $600,000) that is presented as a provision and deducted from investment account at the same amount. As of November 30, 2010, Entera's losses from operations are at the amount of $239,726.
 
Entera continued activities as a going concern are subject to additional financing until the completion of the development activities and the commencement of profit generating sales.
 
The Group has concluded Entera is a variable interest entity according to of the terms of the JV Agreement.  The Group reviewed several factors to determine whether the Company is the primary beneficiary of Entera, including the nature Entera's financing, its management structure, the nature of day-to-day operations and certain other factors.  Based on those factors, the Group determined that it is not the primary beneficiary of Entera.  The Group recognized its share of losses from this entity under the equity method, offset with a corresponding amount of revenue recognition on the out-license agreement.

b.       The investment in Entera is composed at follows:
   
November 30
   
August 31
 
   
2010
 
Share in Entera's shareholders equity
  $ 300,000     $ 200,000  
Currency translation adjustment
    1,535       (176 )
Less - equity losses
    (119,863 )     (67,025 )
      181,672       132,799  
Less - deferred income
    (180,137 )     (132,799 )
Net investment
  $ 1,535       -,-  
 
NOTE 3 - COMMITMENTS:
 
 
a.
Under the terms of the First Agreement with Hadasit (note 1a(1) above), the Company retained Hadasit to provide consulting and clinical trial services. As remuneration for the services provided under the agreement, Hadasit is entitled to $200,000. The primary researcher for Hadasit is Dr. Miriam Kidron, a director and officer of the Company. The funds paid to Hadasit under the agreement are deposited by Hadasit into a research fund managed by Dr. Kidron. Pursuant to the general policy of Hadasit with respect to its research funds, Dr. Kidron receives from Hadasit a management fee in the rate of 10% of all the funds deposited into this research fund.
 
On January 7, 2009, the Company entered into a second agreement with Hadasit (the “Second Agreement”) which confirms that Hadasit has conveyed, transferred and assigned all of its ownership rights in the patents acquired under the First Agreement to the Company, and certain other patents filed by the Company after the First Agreement as a result of the collaboration between the Company and Hadasit.

 
9

 

ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
 
NOTE 3 - COMMITMENTS (continued):

On July 8, 2009 the Company entered into a third agreement with Hadasit, Prof. Itamar Raz and Dr. Miriam Kidron ("the Third Agreement"), to provide consulting and clinical trial services. According to the Third Agreement, Hadasit will be entitled to a total consideration of $400,000 to be paid by Oramed. $200,000 of this amount was agreed in the terms of the First Agreement, and the remaining of $200,000 will be paid in accordance with the actual progress of the study. The total amount that was paid through November 30, 2010 was $359,255.

 
b.
As to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note 5 and 7a.

 
c.
On September 19, 2007 the Subsidiary entered into a lease agreement for its office facilities in Israel. The lease agreement is for a period of 51 months, and will end on December 31, 2011. The monthly lease payment is 2,396 NIS and is linked to the increase in the Israeli consumer price index, (as of November 31, 2010 the monthly payment in the Company's functional currency is $651, the future annual lease payments under the agreement for the years ending August 31, 2011 and 2012 are $7,532 and $2,512, respectively).
As security for its obligation under this lease agreement the Company provided a bank guarantee in an amount equal to three monthly lease payments.

 
d.
On April 21, 2009, the subsidiary entered into a consulting service agreement with ADRES Advanced Regulatory Services Ltd. (“ADRES”) pursuant to which ADRES will provide consulting services relating to quality assurance and regulatory processes and procedures in order to assist the subsidiary in submission of a U.S. IND according to FDA regulations. In consideration for the services provided under the agreement, ADRES will be entitled to a total cash compensation of $211,000, of which the amount $110,000 will be paid as a monthly fixed fee of $10,000 each month for 11 months commencing May 2009, and the remaining $101,000 will be paid based on achievement of certain milestones. $160,000 of the total amount was paid through November 30, 2010, of that $30,000 were paid for completing the three first milestones.

 
e.
On February 10, 2010, the subsidiary entered into an agreement with Vetgenerics Research G. Ziv Ltd, a clinical research organization (CRO), to conduct a toxicology trial on its oral insulin capsules. The total cost estimated for the studies is €107,100 ($139,138) of which €53,950 ($70,154) was paid through November 30, 2010.

 
f.
On May 2, 2010, the subsidiary entered into an agreement with SAFC Pharma, a division of the Sigma-Aldrich Corporation, to develop a process to produce one of its oral capsule ingredients, for a total estimated consideration of $269,600, of which $41,102 was paid through November 30, 2010.

 
g.
On July 5, 2010, the subsidiary of the Company entered into a Manufacturing Supply Agreement (MSA) with Sanofi-Aventis Deutschland GMBH ("sanofi-aventis"). According to the MSA, sanofi-aventis will supply the subsidiary with specified quantities of recombinant human insulin to be used for clinical trials in the USA.

 
10

 
 
ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
 
NOTE 3 - COMMITMENTS (continued):

 
h.
Grants from the Chief Scientist Office of the Ministry of Industry, Trade and Labor of Israel ("OCS")
 
The Subsidiary is obligated to pay royalties to the OCS on proceeds from the sale of products developed from research and development activities that were funded, partially, by grants from the OCS. In the case of failure of a project that was partly financed as described above, the Company is not obligated to pay any such royalties or repay funding received from the OCS.
 
Under the terms of the funding arrangements with the OCS, royalties of 3% to 3.5% are payable on the sale of products developed from projects funded by the OCS, which payments shall not exceed, in the aggregate, 100% of the amount of the grant received (dollar linked), plus interest at annual rate based on LIBOR. In addition, if the Company receives approval to manufacture the products developed with government grants outside the State of Israel, it will be required to pay an increased total amount of royalties (possibly up to 300% of the grant amounts plus interest), depending on the manufacturing volume that is performed outside the State of Israel, and, possibly, an increased royalty rate.
 
As of November 30, 2010, the subsidiary has not yet realized any revenues from the said project and did not incur any royalty liability.
 
For the three months period ended November 30, 2010 the research and development expenses are presented net of OCS Grants, in the total of $151,976. For the year ended August 31, 2010 the OCS Grants were $350,198.
 
NOTE 4 - STOCK HOLDERS’ EQUITY:
 
On November 16, 2010, the Company entered into a Securities Purchase Agreement with an accredited investor for the sale of 937,500 units at a purchase price of $0.32 per unit for total consideration of $300,000. Each unit consisted of one share of the Company's common stock and one common stock purchase warrant. Each warrant entitles the holder to purchase 0.35 a share of common stock exercisable for five years at an exercise price of $0.50 per share.

As to shares issued after November 30, 2010, see note 7.

 
11

 

ORAMED PHARMACEUTICULS, Inc.
(A development stage company)
NOTES TO INTERIM FINANCIAL STATEMENTS
 
NOTE 5 - STOCK BASED COMPENSATION:
 
The following are stocks issued for services, stock options and warrants transactions made during the three months ended November 30, 2010:
 
On October 30, 2006 the Company entered into a Clinical Trial Manufacturing Agreement with Swiss Caps AG (“Swiss”), pursuant to which Swiss would manufacture and deliver the oral insulin capsule developed by the Company. In consideration for the services being provided to the Company by Swiss, the Company agreed to pay a certain predetermined amounts which are to be paid in common stocks of the Company, the number of stocks to be issued is based on the invoice received from Swiss, and the stock market price 10 days after the invoice was issued. The Company accounted for the transaction with Swiss according to FASB ASC 480 "Distinguishing Liabilities from Equity" (formerly FAS 150).

On September 11, 2010, the Company issued 253,714 shares of its common stock to Swiss as remuneration for the services provided, for total of $88,800.
As to shares issued after November 30, 2010, see note 7a.
 
The Company recognized $195,301 of stock based compensation expense during the three months ended November 30, 2010 related to options granted to employees and consultants, all of which relates to options granted in prior years.
 
NOTE 6 - FAIR VALUE:
 
The fair value of the financial instruments included in the Company’s working capital is usually identical or close to their carrying value due to the short-term maturities of these instruments.
 
NOTE 7 - SUBSEQUENT EVENTS:

a.
On January 11, 2011, the Company issued 100,000 shares of its common stock to Swiss as remuneration for the services provided, in the amount of $31,000.

b.
In December 2010, the Company entered into a Securities Purchase Agreements with two accredited investors for the sale of 6,406,250 units at a purchase price of $0.32 per unit for total consideration of $2,050,000. Each unit consisted of one share of the Company's common stock and one common stock purchase warrant. Each warrant entitles the holder to purchase 0.35 a share of common stock exercisable for five years at an exercise price of $0.50 per share. 156,250 units were issued on December 23, 2010 and 6,250,000 units were issued on January 10, 2011.

 
12

 
 
ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
The following discussion and analysis of our financial condition and results of operations should be read together with the financial statements and the related notes included elsewhere herein and in our consolidated financial statements, accompanying notes and Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the year ended August 31, 2010.   
 
This Quarterly Report on Form 10-Q (including the section regarding Management's Discussion and Analysis of Financial Condition and Results of Operations) contains forward-looking statements regarding our business, financial condition, results of operations and prospects. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this Quarterly Report on Form 10-Q  Additionally, statements concerning future matters are forward-looking statements.
 
Although forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under "Item 1A – Risk Factors" in our Annual Report on Form 10-K for the year ended August 31, 2010, and filed with the Securities and Exchange Commission (the “SEC” or the “Commission”) on November 29, 2010, as well as those discussed elsewhere in our annual report and in this Quarterly Report on Form 10-Q. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. We undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Quarterly Report on Form 10-Q. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this Quarterly Report on Form 10-Q which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
 
As used in this Quarterly Report on Form 10-Q, the terms “we”, “us”, “our”, the “Company”, and “Oramed” mean Oramed Pharmaceuticals Inc. and our subsidiary, Oramed Ltd., unless otherwise indicated.
 
All dollar amounts refer to U.S. dollars unless otherwise indicated.
 
Overview of Operations
 
We are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions, including an orally ingestible insulin capsule or tablet to be used for the treatment of individuals with diabetes, use of orally ingestible capsules, tablets or pills for delivery of other polypeptides.
 
 
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Oramed was incorporated on April 12, 2002, in the State of Nevada under the name Iguana Ventures Ltd. Following the incorporation, the Company was an exploration stage company engaged in the acquisition and exploration of mineral properties. The Company was unsuccessful in implementing its business plan as a mineral exploration company. Accordingly, the Company decided to change the focus of its business by completing a share exchange with the shareholders of Integrated Security Technologies, Inc., a New Jersey private corporation (“ISTI”). On June 4, 2004, the Company changed its name to Integrated Security Technologies, Inc. by filing a Certificate of Amendment with the Nevada Secretary of State.  Effective June 14, 2004 the Company effected a 3.3:1 forward stock split, increasing the amount of authorized capital to 200,000,000 shares of common stock with the par value of $0.001 per share.  However, due to disappointing results of ISTI, on May 31, 2005, effective as of May 27, 2004 the Company terminated the share exchange agreement with the shareholders of ISTI.
 
On February 17, 2006, we executed an agreement with Hadasit Medical Services and Development Ltd. (“Hadasit”) to acquire provisional patent application No. 60/718716 and related intellectual property.  The provisional patent application No. 60/718716 relates to a method of preparing insulin so that it may be taken orally to be used in the treatment of individuals with diabetes.  On April 10, 2006, we changed our name from Integrated Security Technologies, Inc. to Oramed Pharmaceuticals Inc.  On August 31, 2006, based on provisional patent application No. 60/718716, we filed a patent application under the Patent Cooperation Treaty at the Israel Patent Office for “Methods and Compositions for Oral Administration of Proteins.”
 
Recent Business Developments
 
On December 21, 2010 we entered into a Securities Purchase Agreement with Attara Fund, Ltd. for the sale of 6,250,000 shares of our common stock ("Shares") and warrants to purchase up to 2,187,500 Shares, for a total purchase price of $2,000,000 in cash. The transaction closed on January 10, 2011.  The Shares and warrants were sold in units at a price per unit of $0.32, each unit consisting of one Share and a warrant to purchase 0.35 of a Share. The warrants have an exercise price of $0.50 per Share, subject to adjustment, and a term of five years commencing from January 11, 2010.
 
On December 23, 2010, our wholly owned Israeli subsidiary, Oramed Ltd., was awarded a government grant amounting to a total net amount of NIS 2.9 million (approximately $807,000), from the Office of the Chief Scientist of the Ministry of Industry, Trade and Labor of Israel (the "OCS"), which was designated for research and development expenses for the period of July 2010 to June 2011.  Oramed Ltd. plans to use the funds to support further research and development and clinical study of its oral insulin capsule and Oral GLP1-analog.

Short Term Business Strategy

We plan to conduct further research and development on the technology covered by the patent application "Methods and Composition for Oral Administration of Proteins", which we acquired from Hadasit, as well as the other patents we have filed since.  Through our research and development efforts, we are seeking to develop an oral dosage form that will withstand the harsh chemical environment of the stomach or intestines and will be effective in delivering active insulin for the treatment of diabetes. The enzymes and vehicles that are added to the insulin in the formulation process must not modify chemically or biologically the insulin and the dosage form must be safe to ingest. We plan to continue to conduct clinical trials to show the effectiveness of our technology.  We intend to conduct the clinical trials necessary to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (the “FDA”). Additional clinical trials are planned in other countries such as Israel, India and South Africa, in order to substantiate our results as well as for purposes of making future filings for drug approval in these countries. We also plan to conduct further research and development by deploying our proprietary drug delivery technology for the delivery of other polypeptides in addition to insulin, and to develop other innovative pharmaceutical products, including an insulin suppository and use of rectal application for delivery of other polypeptides.
 
 
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Long Term Business Strategy
 
If our oral insulin capsule or other drug delivery solutions show significant promise in clinical trials, we plan to ultimately seek a strategic commercial partner, or partners, with extensive experience in the development, commercialization, and marketing of insulin applications and/or other orally digestible drugs. We anticipate such partner or partners would be responsible for, or substantially support, late stage clinical trials (Phase III) to ensure regulatory approvals and registrations in the appropriate markets in a timely manner. We further anticipate that such partner, or partners, would also be responsible for sales and marketing of our oral insulin capsule in these markets. Such planned strategic partnership, or partnerships, may provide a marketing and sales infrastructure for our products as well as financial and operational support for global clinical trials, post marketing studies, label expansions and other regulatory requirements concerning future clinical development in the United States and elsewhere. Any future strategic partner, or partners, may also provide capital and expertise that would enable the partnership to develop new oral dosage form for other polypeptides. While our strategy is to partner with an appropriate party, no assurance can be given that any third party would be interested in partnering with us. Under certain circumstances, we may determine to develop one or more of our oral dosage form on our own, either world-wide or in select territories.
 
Other Planned Strategic Activities
 
In addition to developing our own oral dosage form drug portfolio, we are, on an on-going basis, considering in-licensing and other means of obtaining additional technologies to complement and/or expand our current product portfolio. Our goal is to create a well-balanced product portfolio that will enhance and complement our existing drug portfolio.
 
Product Development
 
Orally Ingestible Insulin: During fiscal year 2007 we conducted several clinical studies of our orally ingestible insulin. The studies were intended to assess both the safety/tolerability and absorption properties of our proprietary oral insulin. Based on the pharmacokinetic and pharmacologic outcomes of these trials, we decided to continue the development of our oral insulin product.
 
On November 15, 2007, we successfully completed animal studies in preparation for the Phase 1B clinical trial of our oral insulin capsule (ORMD 0801).  On January 22, 2008, we commenced non-FDA approved Phase 1B clinical trials with our oral insulin capsule, in healthy human volunteers with the intent of dose optimization.  On March 11, 2008, we successfully completed our Phase 1B clinical trials.
 
On April 13, 2008, we commenced a non-FDA approved Phase 2A study to evaluate the safety and efficacy of our oral insulin capsule (ORMD 0801) in type 2 diabetic volunteers at Hadassah Medical Center in Jerusalem. On August 6, 2008, we announced the successful results of this trial.
 
 
15

 

In July 2008 we were granted approval by the Institutional Review Board Committee of Hadassah Medical Center in Jerusalem to conduct a non-FDA approved Phase 2A study to evaluate the safety and efficacy of our oral insulin capsule (ORMD 0801) on type 1 diabetic volunteers. On September 24, 2008, we announced the beginning of this trial. On July 21, 2009 we reported positive results from this trial. On September 14, 2010, we reported the successful results of an exploratory clinical trial testing the effectiveness of our oral insulin capsule (ORMD-0801) in type 1 diabetes patients suffering from uncontrolled diabetes. Unstable or labile diabetes is characterized by recurrent, unpredictable and dramatic blood glucose swings often linked with irregular hyperglycemia and sometimes serious hypoglycemia affecting type 1 diabetes patients.  This newly completed exploratory study was a proof of concept study for defining a novel indication for ORMD-0801. The encouraging results justify further clinical development of ORMD-0801 capsule application toward management of uncontrolled diabetes.   
 
On April 21, 2009, we entered into a consulting service agreement with ADRES Advanced Regulatory Services Ltd. (“ADRES”), pursuant to which ADRES will provide services for the purpose of filing an IND application with the FDA for a Phase 2 study according to the FDA requirements. The FDA approval process and, if approved, registration for commercial use as an oral drug can take several years.
 
In May 2009, we commenced a non-FDA approved Phase 2B study in South Africa to evaluate the safety, tolerability and efficacy of our oral insulin capsule (ORMD 0801) on type 2 diabetic volunteers. On May 6, 2010, we reported that the capsule was found to be well tolerated and exhibited a positive safety profile. No cumulative adverse effects were reported throughout this first study of extended exposure to the capsule. We are considering whether and when to conduct an additional non-FDA approved Phase 2B study in India.
 
On February 10, 2010, we entered into agreements with Vetgenerics Research G. Ziv Ltd., a clinical research organization (CRO), to conduct a toxicology trial on our oral insulin capsules.
 
GLP-1 Analog:
 
On September 16, 2008 we announced the launch of pre-clinical trials of ORMD 0901, a GLP-1 analog.  The pre-clinical trials include animal studies which suggest that the GLP-1 analog (exenatide -4) when combined with Oramed’s absorption promoters is absorbed through the gastrointestinal tract and retains its biological activity.
 
On September 9, 2009, we received approval from the Institutional Review Board (IRB) in Israel to commence human clinical trials of an oral GLP-1 analog. The approval was granted after successful pre-clinical results were reported. The trials are being conducted on healthy volunteers at Hadassah University Medical Center in Jerusalem. We anticipate that the results of these trials will be released in the near future.
 
 
16

 

Glucagon-like peptide-1 (GLP-1) is an incretin hormone - a type of gastrointestinal hormone that stimulates the secretion of insulin from the pancreas. The incretin concept was hypothesized when it was noted surprisingly that glucose ingested by mouth (oral) stimulated two to three times more insulin release than the same amount of glucose administered intravenously. In addition to stimulating insulin release, GLP-1 was found to suppress glucagon release (hormone involved in regulation of glucose) from the pancreas, slow gastric emptying to reduce the rate of absorption of nutrients into the blood stream, and increase satiety. Other important beneficial attributes of GLP-1 are its effects of increasing the number of beta cells (cells that manufacture and release insulin) in the pancreas and, possibly, protection of the heart.
 
Raw Materials:
 
Our oral insulin capsule is currently manufactured by Swiss Caps AG, under a Clinical Trail Manufacturing Agreement.
 
On July 5, 2010, our subsidiary entered into a Manufacturing Supply Agreement ("MSA") with Sanofi-Aventis Deutschland GMBH ("sanofi-aventis"). According to the MSA, sanofi-aventis will supply our subsidiary with specified quantities of recombinant human insulin to be used for clinical trials in the USA.
 
The raw materials required for the manufacturing of the capsule are purchased from third parties, under separate agreements.   We generally depend upon a limited number of suppliers for the raw materials.  Although alternative sources of supply for these materials are generally available, we could incur significant costs and disruptions in changing suppliers.  The termination of our relationships with our suppliers or the failure of these suppliers to meet our requirements for raw materials on a timely and cost-effective basis could materially adversely affect our business, prospects, financial condition and results of operations.
 
Patents and Licenses
 
We maintain a proactive intellectual property strategy which includes patent filings in multiple jurisdictions, including the United States and other commercially significant markets. We hold 34 patent applications currently pending with respect to various compositions, methods of production oral administration of proteins and exenatide. Expiration dates for pending patents will in 2026 – 2028.
 
Consistent with our strategy to seek protection in key markets worldwide, we have been and will continue to pursue the patent applications and corresponding foreign counterparts of such applications.  We believe that our success will depend on our ability to obtain patent protection for our intellectual property.
 
Our patent strategy is as follows:
 
·            Aggressively protect all current and future technological developments to assure strong and broad protection by filing patents and/or continuations in part as appropriate;
 
·            Protect technological developments at various levels, in a complementary manner, including the base technology, as well as specific applications of the technology; and
 
·            Establish comprehensive coverage in the U.S. and in all relevant foreign markets in anticipation of future commercialization opportunities.
 
 
17

 

The validity, enforceability, written supports, and breadth of claims in our patent applications involve complex legal and factual questions and, therefore, may be highly uncertain. No assurance can be given that any patents based on pending patent applications or any future patent applications filed by us will be issued, that the scope of any patent protection will exclude competitors or provide competitive advantages to us, that any of the patents that have been or may be issued to us will be held valid or enforceable if subsequently challenged, or that others will not claim rights in or ownership of the patents and other proprietary rights held or licensed by us. Furthermore, there can be no assurance that others have not developed or will not develop similar products, duplicate any of our technology or design around any patents that have been or may be issued to us. Since patent applications in the United States are maintained in secrecy for the initial period of time following filing, we also cannot be certain that others did not first file applications for inventions covered by our pending patent applications, nor can we be certain that we will not infringe any patents that may be issued to others on such applications.
 
We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements. Our policy is to require our employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, board of directors, technical review board and other advisors to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide that all confidential information developed or made known to the individual during the course of the individual's relationship with us is to be kept confidential and not disclosed to third parties except in specific limited circumstances. We also require signed confidentiality or material transfer agreements from any company that is to receive our confidential information. In the case of employees, consultants and contractors, the agreements provide that all inventions conceived by the individual while rendering services to us shall be assigned to us as the exclusive property of our company. There can be no assurance, however, that all persons who we desire to sign such agreements will sign, or if they do, that these agreements will not be breached, that we would have adequate remedies for any breach, or that our trade secrets or unpatentable know-how will not otherwise become known or be independently developed by competitors.
 
Our success will also depend in part on our ability to commercialize our technology without infringing the proprietary rights of others. No assurance can be given that patents do not exist or could not be filed which would have an adverse affect on our ability to market our technology or maintain our competitive position with respect to our technology. If our technology components, products, processes or other subject matter are claimed under other existing United States or foreign patents or are otherwise protected by third party proprietary rights, we may be subject to infringement actions. In such event, we may challenge the validity of such patents or other proprietary rights or we may be required to obtain licenses from such companies in order to develop, manufacture or market our technology. There can be no assurances that we would be able to obtain such licenses or that such licenses, if available, could be obtained on commercially reasonable terms. Furthermore, the failure to either develop a commercially viable alternative or obtain such licenses could result in delays in marketing our proposed technology or the inability to proceed with the development, manufacture or sale of products requiring such licenses, which could have a material adverse affect on our business, financial condition and results of operations. If we are required to defend ourselves against charges of patent infringement or to protect our proprietary rights against third parties, substantial costs will be incurred regardless of whether we are successful. Such proceedings are typically protracted with no certainty of success. An adverse outcome could subject us to significant liabilities to third parties and force us to curtail or cease our development and commercialization of our technology.
 
 
18

 

Partnerships and Collaborative Arrangements
 
We believe that working together with strategic partners will expedite product formulation, production and approval.
 
On February 17, 2006, we entered into an agreement with Hadasit to provide consulting and clinical trial services.
 
On October 30, 2006, we entered into a Clinical Trial Manufacturing Agreement with Swiss Caps AG (“Swiss”), pursuant to which Swiss currently manufactures the oral insulin capsule developed by us.
 
During April 2008, we entered into a five year master services agreement with SAFC, an operating division of Sigma-Aldrich, Inc., pursuant to which SAFC is providing services for individual projects, which may include strategic planning, expert consultation, clinical trial services, statistical programming and analysis, data processing, data management, regulatory, clerical, project management, central laboratory services, pre-clinical services, pharmaceutical sciences services, and other research and development services.
 
On April 21, 2009, we entered into a consulting service agreement with ADRES, pursuant to which ADRES will provide services for the purpose of filing an IND application with the FDA for a Phase 2 study in accordance with FDA requirements. The FDA approval process and, if approved, registration for commercial use as an oral drug can take several years.
 
On July 8, 2009 we entered into an additional agreement with Hadasit, to facilitate additional clinical trials to be performed at Hadassah Medical Center in Jerusalem.
 
On February 10, 2010, we entered into agreements with Vetgenerics Research G. Ziv Ltd., a clinical research organization (CRO), to conduct a toxicology trial on our oral insulin capsules.
 
On May 2, 2010, we entered into an additional agreement with SAFC Pharma, a division of the Sigma-Aldrich Corporation, to develop a process to produce one of our oral capsule ingredients.
 
As mentioned above, on July 5, 2010, our subsidiary entered into an MSA with sanofi-aventis. According to the MSA, sanofi-aventis will supply our subsidiary with specified quantities of recombinant human insulin to be used for clinical trials in the USA.
 
Out-Licensed Technology
 
On June 1, 2010, our subsidiary, Oramed Ltd., entered into an agreement with D.N.A Biomedical Solutions Ltd (formerly, Laser Detect Systems Ltd),, an Israeli company listed on the Tel Aviv Stock Exchange ("D.N.A"), for the establishment of a new company to be called Entera Bio Ltd. ("Entera").
 
Under the terms of a license agreement that was entered into between Oramed and Entera, we will out-license technology to Entera, on an exclusive basis, for the development of oral delivery drugs for certain indications to be agreed upon between the parties.  The out-licensed technology differs from our main delivery technology that is used for oral insulin and GLP-1 analog and is subject to different patent applications. Entera's initial development effort will be an oral formulation for the treatment of osteoporosis. The license will be royalty-free unless our ownership interest in Entera decreases to 30% or less of its outstanding share capital, in which case royalties will be payable with respect to revenues derived from certain indications. Under certain circumstances, Entera may receive ownership of the licensed technology, in which case we would receive a license back on the same terms.
 
 
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D.N.A invested $600,000 in Entera in two parts of $400,000 in August 2010 and $200,000 in November 2010, and Entera is owned in equal parts by Oramed and D.N.A, subject to dilution by future issuances of shares. Entera's Chief Executive Officer, Dr. Phillip Schwartz, will be granted options to purchase ordinary shares of Entera, reflecting 9.9% of Entera's share capital, upon full exercise. In the event that Entera has not obtained third-party financing by June 1, 2011, or such other date mutually agreed upon by the parties, each of Oramed and D.N.A will be required to make a capital contribution to Entera in the amount of $150,000.
 
Mr. Zeev Bronfeld, who is one of D.N.A's controlling shareholders, holds approximately 10.71% of our outstanding common stock (see "Securities Ownership of Certain Beneficial Owners and Management").
 
Results of Operations
 
Going concern assumption
 
The accompanying financial statements have been prepared assuming that we will continue as a going concern. We have net losses for the period from inception (April 12, 2002) through November 30, 2010 of $13,588,838, as well as negative cash flow from operating activities. Based upon our existing spending commitments, estimated at $5.4 million for the twelve months following December 1, 2010, and our cash availability, we do not have sufficient cash resources to meet our liquidity requirements through November 30, 2011. Accordingly, these factors raise substantial doubt about our ability to continue as a going concern. Management is in the process of evaluating various financing alternatives as we will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets. Although there is no assurance that we will be successful with those initiatives, management believes that it will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders.
 
The financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern. Our continuation as a going concern is dependent on our ability to obtain additional financing as may be required and ultimately to attain profitability.
 
Critical accounting policies
 
Our significant accounting policies are more fully described in Note 1 to our consolidated financial statements appearing at the beginning of this Quarterly Report. We believe that the accounting policies below are critical for one to fully understand and evaluate our financial condition and results of operations.
 
The discussion and analysis of our financial condition and results of operations is based on our financial statements, which we prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis, we evaluate such estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
 
 
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Valuation of options and warrants: We granted options to purchase shares of our common stock to employees and consultants and issued warrants in connection with fund raising.
 
We account for share based payments in accordance with the guidance that requires awards classified as equity awards be accounted for using the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service period, net of estimated forfeitures. We estimated forfeitures based on historical experience and anticipated future conditions.
 
We elected to recognize compensation cost for an award with only service conditions that has a graded vesting schedule using the accelerated method based on the multiple-option award approach.
 
When stock options are granted as consideration for services provided by consultants and other non-employees, the transaction is accounted for based on the fair value of the consideration received or the fair value of the stock options issued, whichever is more reliably measurable, pursuant to the guidance. The fair value of the options granted is measured on a final basis at the end of the related service period and is recognized over the related service period using the straight-line method.
 
Taxes on income: Deferred taxes are determined utilizing the asset and liability method based on the estimated future tax effects of differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. We have provided a full valuation allowance with respect to its deferred tax assets.
 
Regarding our subsidiary, Oramed Ltd., the guidance prohibits the recognition of deferred tax liabilities or assets that arise from differences between the financial reporting and tax bases of assets and liabilities that are measured from the local currency into dollars using historical exchange rates, and that result from changes in exchange rates or indexing for tax purposes. Consequently, the abovementioned differences were not reflected in the computation of deferred tax assets and liabilities.
 
The following table summarizes certain statements of operations data for the Company for the three month periods ended November 30, 2010 and 2009:
 
   
Three months ended
 
Operating Data:
 
November 30, 2010
   
November 30, 2009
 
             
Research and development costs, net
  $ 286,488     $ 332,485  
General and administrative expenses
    315,129       285,016  
Financial expenses (income), net
    1,167       (4,708 )
Net loss for the period
  $ 602,784     $ 612,793  
                 
Loss per common share – basic and diluted
  $ (0.01 )   $ (0.01 )
Weighted average common shares outstanding
    57,932,597       57,158,865  
 
 
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Research and development expenses
 
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, costs of registered patents materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drug for use in research, preclinical development. All costs associated with research and development are expensed as incurred.
 
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as contract research organizations, independent clinical investigators, and other third-party service providers to assist us with the execution of our clinical studies. For each clinical trial that we conduct, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and the period over which clinical investigators or contract research organizations are expected to provide services.
 
Clinical activities which relate principally to clinical sites and other administrative functions to manage our clinical trials are performed primarily by contract research organizations ("CROs"). CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management.
 
Clinical trial and pre-clinical trial expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase of materials, cost of manufacturing of the oral insulin capsules, payments for patient recruitment and treatment, costs related to the maintenance of our registered patents, costs related to the filings of patent applications, as well as salaries and related expenses of research and development staff.
 
In August 2009, Oramed Ltd., our wholly owned Israeli subsidiary, was awarded a government grant amounting to a total net amount of NIS 3.1 million (approximately $813,000), from the Office of the Chief Scientist of the Ministry of Industry, Trade and Labor of Israel (the "OCS"), which the OCS designated for research and development expenses for the period of February 2009 to June 2010.  The funds were used by Oramed Ltd. to support further research and development and clinical study of its oral insulin capsule and Oral GLP1-analog. In December 2010, Oramed Ltd., was awarded another grant amounting to a total net amount of NIS 2.9 million (approximately $807,000) from the OCS, which was designated for research and development expenses for the period of July 2010 to June 2011.  Oramed Ltd. plans to use the funds to support further research and development and clinical study of its oral insulin capsule and Oral GLP1-analog. Our grants from the OCS are subject to repayment according to the terms determined by the OCS and applicable law.  See "Item 7 – Management's Discussion and Analysis of Financial Condition and Results of Operations – Government Grants" in our Annual Report on Form 10-K for the year ended August 31, 2010, and filed with the SEC on November 29, 2010.
 
 
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During the three months ended November 30, 2010 research and development expenses totaled $286,488, compared to $317,545 for the three months ended November 30, 2009. The decrease is mainly attributable to a decrease in expenses relating to manufacturing of capsules and a decrease in clinical trials costs. The research and development costs include stock based compensation costs, which during the three months ended November 30, 2010 totaled $94,669 as compared to $31,552 during the three months ended November 30, 2009.
 
Government Grants
 
In the three months ended November 30, 2010 and 2009, we recognized research and development grants in an amount of $151,976 and $147,590, respectively. As of November 30, 2010, we had no contingent liabilities to the OCS.
 
General and administrative expenses
 
General and administrative expenses include the salaries and related expenses of our management, consulting costs, legal and professional fees, traveling, business development costs, insurance expenses and other general costs.
 
For the three months ended November 30, 2010, general and administrative expenses totaled $315,129 compared to $299,956 for the three months ended November 30, 2009. Costs incurred related to general and administrative activities during the three months ended November 30, 2010 reflect an increase in consulting expenses and a decrease in legal and travel expenses. During the three months ended November 30, 2010, as part of our general and administrative expenses, we incurred $100,632 related to stock options granted to employees and consultants, as compared to $66,425 during the three months ended November 30, 2009.
 
Financial income/expense, net
 
During the three months ended November 30, 2010 and 2009 we generated interest income on available cash and cash equivalents which was offset by bank charges and imputed interest.
 
Liquidity and Capital Resources
 
Since inception through November 30, 2010, we incurred losses in an aggregate amount of $13,588,838. Since inception through November 30, 2010, we have financed our operations through the private placements of equity and debt financings, raising a total of $8,608,785, net of transaction costs. We will seek to obtain additional financing through similar sources. As of November 30, 2010, we had $1,101,283 of available cash. We anticipate that we will require approximately $5.4 million to finance our activities during the twelve months following December 1, 2010.
 
Management is in the process of evaluating various financing alternatives as we will need to finance future research and development activities and general and administrative expenses through fund raising in the public or private equity markets. Although there is no assurance that we will be successful with those initiatives, management believes that it will be able to secure the necessary financing as a result of ongoing financing discussions with third party investors and existing shareholders as well as receive additional funding from the OCS.
 
 
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Our financing activity during the three months ended November 30, 2010 included the following:
 
 
·
On September 11, 2010, we issued 253,714 shares of our common stock ("Shares"), valued at $88,800, to Swiss Caps AG as remuneration for the services provided, for a total of $88,800.
 
 
·
On November 16, 2010, we entered into a Securities Purchase Agreement with Vivid Horizon Limited for the sale of 937,500 Shares and warrants to purchase up to 328,125 Shares, for a total purchase price of $300,000 in cash.  The transaction closed on November 18, 2010.  The Shares and warrants were sold in units at a price per unit of $0.32, each unit consisting of one Share and a warrant to purchase 0.35 of a Share. The warrants have an exercise price of $0.50 per Share, subject to adjustment, and a term of five years commencing from November 18, 2010.  The sale of the units was not registered under the Securities Act.  The issuance of the units was a private placement to an “accredited investor” as defined in Rule 501(a) of Regulation D and is exempt from registration under Section 4(2) of the Securities Act and Rule 504 of Regulation D promulgated thereunder. There were no underwriting fees or commissions associated with this transaction.
 
Employee's and Consultant’s Stock Options and Warrants
 
No options or warrants were granted to employees or consultants during the three months ended November 30, 2010.
 
Off-Balance Sheet Arrangements
 
We have no off-balance sheet arrangements.
 
Planned Expenditures
 
The estimated expenses referenced herein are in accordance with our business plan. Since our technology is still in the development stage, it can be expected that there will be changes in some budgetary items. Our planned expenditures for the twelve months beginning December 1, 2010 are as follows:
 
Category:
 
Amount
 
       
Research and development costs, net of OCS funds
  $ 4,263,000  
General and administrative expenses
    1,131,000  
Financial expense, net
    2,000  
Taxes on income
    -  
Total
  $ 5,396,000  
 
 
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As previously indicated, we are planning to conduct further clinical studies as well as file an IND application with the FDA for our orally ingested insulin. Our ability to proceed with these activities is dependent on several major factors including the ability to attract sufficient financing on terms acceptable to us.
 
Employment and Consulting Agreements
 
We have not engaged in any employment and consulting agreements in the three months ended November 30, 2010.
 
 
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ITEM 3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
As a smaller reporting company, we are not required to provide the information required by this Item.
 
ITEM 4 - CONTROLS AND PROCEDURES
 
(a)      Disclosure Controls and Procedures
 
Our management, including our chief executive officer and chief financial officer, has evaluated the effectiveness of our disclosure controls and procedures as of November 30, 2010. Based on such review, our chief executive officer and chief financial officer have determined that in light of their conclusion with respect to the effectiveness of our internal control over our financial reporting as of such date, that the Company did not have in place effective controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure, and is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms.
 
(c)      Changes in Internal Control over Financial Reporting
 There were no changes in our internal controls over financial reporting identified in connection with the evaluation thereof that occurred during the three months ended November 30, 2010 that have materially affected, or are reasonable likely to materially affect our internal control over financial reporting.

 
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PART II – OTHER INFORMATION
 
ITEM 1 - LEGAL PROCEEDINGS
 
From time to time we may become subject to litigation incidental to our business. We are not currently a party to any material legal proceedings.
 
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 
 
(a)
On September 11, 2010, we issued 253,714 shares of our common stock ("Shares"), valued at $88,800, to Swiss Cap AG as remuneration for services rendered.  The transaction was not registered under the Securities Act of 1933, as amended (the “Securities Act”).  The issuance of the Shares was not a public offering within the meaning of Section 4(2) of the Securities Act, and was therefore deemed exempt from registration.  There were no underwriting fees or commissions associated with this transaction.
 
 
(b)
On November 16, 2010, we entered into a Securities Purchase Agreement with Vivid Horizon Limited for the sale of 937,500 Shares and warrants to purchase up to 328,125 Shares, for a total purchase price of $300,000 in cash.  The transaction closed on November 18, 2010.  The Shares and warrants were sold in units at a price per unit of $0.32, each unit consisting of one Share and a warrant to purchase 0.35 of a Share. The warrants have an exercise price of $0.50 per Share, subject to adjustment, and a term of five years commencing from November 18, 2010.  The sale of the units was not registered under the Securities Act.  The issuance of the units was a private placement to an “accredited investor” as defined in Rule 501(a) of Regulation D and is exempt from registration under Section 4(2) of the Securities Act and Rule 504 of Regulation D promulgated thereunder. There were no underwriting fees or commissions associated with this transaction.
 
ITEM 6 - EXHIBITS
 
Number
 
Exhibit
(3)
 
Articles of Incorporation and By-laws
     
3.1
 
Articles of Incorporation (incorporated by reference from our Registration Statement on Form S-1 file no. 333-164286 filed on January 11, 2010).
     
3.2
 
Bylaws (incorporated by reference from our Current Report on Form 8-K filed on April 10, 2006).
     
3.3
 
Articles of Merger filed with the Nevada Secretary of State on March 29, 2006 (incorporated by reference to our Current Report on Form 8-K filed on April 10, 2006).

 
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(4)
 
Instruments defining rights of security holders, including indentures
     
4.1
 
Specimen Stock Certificate (incorporated by reference from our Registration Statement on Form SB-2, filed on November 29, 2002).
     
4.2
 
Form of warrant certificate (incorporated by reference from our current report on Form 8-K filed on June 18, 2007)
     
(10)
 
Material Contracts
     
10.1*
 
Securities Purchase Agreement, between Oramed Pharmaceuticals Inc. and Attara Fund, Ltd., dated as of December 21, 2010.
     
10.2*
 
Common Stock Purchase Warrant issued to Attara Fund, Ltd. on January 10, 2011.
     
(31)
 
Section 302 Certification
     
31.1 *
 
Certification Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
31.2 *
 
Certification Statement of the Principal Accounting Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
(32)
 
Section 906 Certification
     
32.1 *
 
Certification Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of 2002
     
32.2 *
 
Certification Statement of the Principal Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of 2002
 
*
Filed herewith 
 
 
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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

   
ORAMED PHARMACEUTICALS INC.
     
   
Registrant
     
Date: January 13, 2011
By:
/s/ Nadav Kidron
     
   
Nadav Kidron
   
President, Chief Executive Officer and Director
     
Date: January 13, 2011
By:
/s/ Yifat Zommer
     
   
Yifat Zommer
   
Chief Financial Officer

 
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