ORAMED PHARMACEUTICALS INC. - Quarter Report: 2009 May (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE
ACT OF 1934
For
the Quarterly Period Ended May 31, 2009
¨
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 5660001
(Registrant's
telephone number, including area code)
(Former
name, former address and former fiscal year, if changed since last
report)
Indicate
by check mark whether the registrant: (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
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 is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
|
¨
|
Accelerated
filer ¨
|
|
Non-accelerated
filer
|
¨
(Do not check if a smaller
reporting company)
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). Yes ¨ No x
APPLICABLE
ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS
DURING THE PRECEDING FIVE YEARS:
Indicate
by check mark whether the registrant has filed all documents and reports
required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act
of 1934 subsequent to the distribution of securities under a plan confirmed by a
court. Yes
¨ No ¨
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate
the number of shares outstanding of each of the issuer's classes of common
stock, as of the latest practicable date: 56,456,710 shares issued and
outstanding as of July 10, 2009.
ORAMED
PHARMACEUTICALS INC.
FORM
10-QSB
TABLE
OF CONTENTS
PART I – FINANCIAL
INFORMATION
|
1 | ||
ITEM
1 - FINANCIAL STATEMENTS
|
1 | ||
ITEM
2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
|
13 | ||
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
|
24 | ||
ITEM
4T - CONTROLS AND PROCEDURES
|
24 | ||
PART II – OTHER INFORMATION
|
26 | ||
ITEM
1 - LEGAL PROCEEDINGS
|
26 | ||
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 MAY
31, 2009
1
ORAMED
PHARMACEUTICALS INC.
(A
development stage company)
INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
AS OF MAY
31, 2009
TABLE OF
CONTENTS
Page
|
|
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS:
|
|
Balance
sheets
|
3
|
Statements
of operations
|
4
|
Statements
of changes in stockholders’ equity
|
5
|
Statements
of cash flows
|
6
|
Notes
to financial statements
|
7-12
|
2
ORAMED
PHARMACEUTICALS INC.
(A development stage
company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
U.S.
dollars
May
31,
|
August
31,
|
|||||||
2009
|
2008
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 3,217,986 | $ | 2,267,320 | ||||
Short
term investments
|
- | 2,728,000 | ||||||
Prepaid
expenses and other current assets
|
35,048 | 402,574 | ||||||
Total
current assets
|
3,253,034 | 5,397,894 | ||||||
LONG
TERM DEPOSITS
|
14,382 | 10,824 | ||||||
PROPERTY AND EQUIPMENT,
net
|
79,646 | 98,296 | ||||||
Total
assets
|
$ | 3,347,062 | $ | 5,507,014 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 427,776 | $ | 866,702 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
475,028 | 913,954 | ||||||
COMMITMENTS
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
stock of $ 0.001 par value - Authorized: 200,000,000 shares at May
31, 2009 and August 31, 2008; Issued and outstanding: 56,456,710 at May
31, 2009 and 56,252,806 shares at August
31, 2008, respectively
|
56,456 | 56,252 | ||||||
Additional
paid-in capital
|
12,423,370 | 11,785,012 | ||||||
Deficit
accumulated during the development stage
|
(9,607,792 | ) | (7,248,204 | ) | ||||
Total
stockholders' equity
|
2,872,034 | 4,593,060 | ||||||
Total
liabilities and stockholders' equity
|
$ | 3,347,062 | $ | 5,507,014 |
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)
|
||||||||||||||||||||
Nine months ended
|
Three months ended
|
through
|
||||||||||||||||||
May 31,
|
May 31,
|
May 31,
|
May 31,
|
May 31,
|
||||||||||||||||
2009
|
2008
|
2009
|
2008
|
2009
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES
|
$ | 1,448,466 | $ | 655,934 | $ | 374,097 | $ | 464,119 | $ | 5,036,300 | ||||||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
931,861 | 913,950 | 157,711 | 381,697 | 3,962,319 | |||||||||||||||
OPERATING
LOSS
|
2,380,327 | 1,569,884 | 531,808 | 845,816 | 9,433,495 | |||||||||||||||
INTEREST
INCOME
|
(38,950 | ) | (67,040 | ) | (18,518 | ) | (25,346 | ) | (146,724 | ) | ||||||||||
INTEREST
EXPENSE
|
18,211 | 6,034 | 1,051 | 158,857 | ||||||||||||||||
LOSS
BEFORE TAXES ON INCOME
|
2,359,588 | 1,508,878 | 513,290 | 821,521 | 9,445,628 | |||||||||||||||
TAXES
ON INCOME
|
- | - | - | - | 162,164 | |||||||||||||||
NET
LOSS FOR THE PERIOD
|
$ | 2,359,588 | $ | 1,508,878 | $ | 513,290 | $ | 821,521 | $ | 9,607,792 | ||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | 0.04 | $ | 0.03 | $ | 0.01 | $ | 0.02 | ||||||||||||
WEIGHTED
AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS
PER COMMON STOCK
|
56,546,323 | 47,041,387 | 56,802,562 | 47,059,078 |
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, 2007
(audited):
|
||||||||||||||||||||
SHARES
CANCELLED
|
(19,800,000 | ) | (19,800 | ) | 19,800 | - | ||||||||||||||
SHARES
ISSUED FOR INVESTMENT IN ISTI-NJ
|
1,144,410 | 1,144 | 433,732 | 434,876 | ||||||||||||||||
SHARES
ISSUED FOR OFFERING COSTS
|
1,752,941 | 1,753 | (1,753 | ) | - | |||||||||||||||
SHARES
ISSUED FOR CASH
|
27,181,228 | 27,181 | 2,095,800 | 2,122,981 | ||||||||||||||||
SHARES
ISSUED FOR SERVICES
|
125,000 | 125 | 98,625 | 98,750 | ||||||||||||||||
CONTRIBUTIONS
TO PAID IN CAPITAL
|
18,991 | 18,991 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
1,968,547 | 1,968,547 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
177,782 | 177,782 | ||||||||||||||||||
DISCOUNT
ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION
FEATURE
|
108,000 | 108,000 | ||||||||||||||||||
COMPREHENSIVE
LOSS
|
(16 | ) | (16 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
8,437 | 8,437 | ||||||||||||||||||
NET
LOSS
|
(4,478,917 | ) | (4,478,917 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2007 (audited)
|
45,231,779 | 45,231 | 4,946,833 | (4,478,933 | ) | 513,131 | ||||||||||||||
RECEIPTS
ON ACCOUNT OF SHARES AND
WARRANTS
|
6,061 | 6,061 | ||||||||||||||||||
SHARES
ISSUED FOR CONVERSION OF CONVERTIBLE NOTE
|
550,000 | 550 | 274,450 | 275,000 | ||||||||||||||||
SHARES
AND WARRANTS ISSUED FOR CASH – NET OF ISSUANCE EXPENSES
|
10,178,002 | 10,178 | 5,774,622 | 5,784,800 | ||||||||||||||||
SHARES
ISSUED FOR SERVICES
|
293,025 | 293 | 115,817 | 116,110 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
459,467 | 459,467 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
203,982 | 203,982 | ||||||||||||||||||
IMPUTED
INTEREST
|
3,780 | 3,780 | ||||||||||||||||||
NET
LOSS
|
(2,769,271 | ) | (2,769,271 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2008 (audited)
|
56,252,806 | 56,252 | 11,785,012 | (7,248,204 | ) | 4,593,060 | ||||||||||||||
SHARES
ISSUED FOR SERVICES
|
203,904 | 204 | 152,724 | 152,928 | ||||||||||||||||
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
109,590 | 109,590 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
295,230 | 295,230 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
77,980 | 77,980 | ||||||||||||||||||
IMPUTED
INTEREST
|
2,834 | 2,834 | ||||||||||||||||||
NET
LOSS
|
(2,359,588 | ) | (2,359,588 | ) | ||||||||||||||||
BALANCE
AS OF MAY 31, 2009 (unaudited)
|
56,456,710 | $ | 56,456 | $ | 12,423,370 | $ | (9,607,792 | ) | $ | 2,872,034 |
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
Nine months ended
|
Period from April
12, 2002
(inception date)
through
|
|||||||||||
May 31,
|
May 31,
|
May 31,
|
||||||||||
2009
|
2008
|
2009
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (2,359,588 | ) | $ | (1,508,878 | ) | $ | (9,607,792 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
22,760 | 7,078 | 38,214 | |||||||||
Amortization
of debt discount
|
- | 108,000 | ||||||||||
Exchange
differences on long term deposits
|
1,110 | 707 | (532 | ) | ||||||||
Stock
based compensation
|
373,210 | 246,679 | 3,182,988 | |||||||||
Common
stock issued for services
|
- | 172,101 | 214,860 | |||||||||
Impairment
of investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
2,834 | 2,835 | 15,051 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
367,526 | (50,033 | ) | (35,048 | ) | |||||||
Accounts
payable and accrued expenses
|
(176,408 | ) | (74,414 | ) | 690,294 | |||||||
Total
net cash used in operating activities
|
(1,768,556 | ) | (1,203,925 | ) | (4,959,089 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
(4,110 | ) | (98,415 | ) | (117,860 | ) | ||||||
Acquisition
of short-term investments
|
- | - | (2,728,000 | ) | ||||||||
Proceeds
from sale of Short term investments
|
2,728,000 | - | 2,728,000 | |||||||||
Lease
deposits
|
(4,668 | ) | (1,558 | ) | (13,850 | ) | ||||||
Total
net cash provided by (used in) investing activities
|
2,719,222 | (99,973 | ) | (131,710 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from sales of common stocks and warrants
- net of issuance expenses
|
- | 2,044,986 | 7,967,542 | |||||||||
Proceeds
from convertible notes
|
- | - | 275,000 | |||||||||
Proceeds
from short term note payable
|
- | - | 120,000 | |||||||||
Payments
of short term note payable
|
- | - | (120,000 | ) | ||||||||
Shareholder
advances
|
- | - | 66,243 | |||||||||
Net
cash provided by financing activities
|
- | 2,044,986 | 8,308,785 | |||||||||
INCREASE
IN CASH AND CASH EQUIVALENTS
|
950,666 | 741,088 | 3,217,986 | |||||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
2,267,320 | 1,918,229 | ||||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 3,217,986 | $ | 2,659,317 | $ | 3,217,986 | ||||||
Non
cash investing and financing activities:
|
||||||||||||
Shares
issued for offering costs
|
$ | 1,753 | ||||||||||
Contribution
to paid in capital
|
$ | 18,991 | ||||||||||
Stock
issued for receipts on account of shares issuance
|
$ | 1,036,060 | ||||||||||
Shares
issued for services rendered
|
$ | 152,928 | $ | 172,101 | ||||||||
Shares
to be issued for services rendered
|
$ | 109,590 | $ | 109,590 | ||||||||
Receipts
on account of shares issuance - reclassified from liability to
shareholder's equity
|
$ | 4,000 |
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 March 8, 2006, the
Company entered into an agreement with Hadasit Medical Services and
Development Ltd (“Hadasit”) (the “First Agreement”) to acquire the
provisional patent related to orally ingestible insulin pill to be used
for the treatment of individuals with diabetes, see also note
5.
|
The
Company has been in the development stage since its formation and has not yet
realized any revenues from its planned operations.
On May
14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed
Ltd. ("the Subsidiary"), which is engaged in research and
development.
|
2.
|
The
accompanying unaudited interim consolidated financial statements as of May
31, 2009 and for the nine and three months then ended, have been prepared
in accordance with accounting principles generally accepted in the United
States relating to the preparation of financial statements for interim
periods. Accordingly, they do not include all the information and
footnotes required for annual financial statements. In the opinion of
management, all adjustments (consisting of normal recurring accruals)
considered necessary for a fair presentation have been included. Operating
results for the nine and three months ended May 31, 2009, are not
necessarily indicative of the results that may be expected for the year
ending August 31, 2009.
|
|
3.
|
Going
concern considerations
|
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 May
31, 2009 of $9,607,792, 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 June 1, 2009. These factors raise
substantial doubt about the Company's ability to continue as a going concern.
Management is in the process of evaluating various financing alternatives as the
Company will need to finance future research and development activities and
general and administrative expenses through fund raising in
the public or private equity markets. Although there is no assurance that the
Company will be successful with those initiatives, management believes that it
will be able to secure the necessary financing as a result of ongoing financing
discussions with third party investors and existing
shareholders.
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.
|
Share-based
payment:
|
The
Company implements Statement of Financial Accounting Standards No. 123
(revised 2004) “Share-based Payment” (“FAS 123(R)”). FAS 123(R) requires awards
classified as equity awards be accounted for using the grant-date fair value
method. The fair value of share-based payment transactions is recognized as
expense over the requisite service period, net of estimated forfeitures. The
Company recognizes compensation cost for an award with only service conditions
that has a graded vesting schedule using the accelerated method of amortization
under FAS 123(R) over the requisite service period for the entire
awards.
In March
2005, the Securities and Exchange Commission issued Staff Accounting Bulletin
No. 107 (“SAB 107”). SAB 107 provides supplemental implementation guidance
on FAS 123(R), including guidance on valuation methods, inventory capitalization
of share-based compensation cost, income statement effects, disclosures and
other issues. SAB 107 requires share-based payment to be classified in the same
expense line items as cash compensation. The company has applied the provisions
of SAB 107 in its adoption of FAS 123(R).
The
Company accounts for equity instruments issued to third party service providers
(non-employees) in accordance with the fair value based on an option-pricing
model, pursuant to the guidance in EITF 96-18 “Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling Goods or Services”. The fair value of the options granted is revalued
over the related service periods and recognized over the vesting
period.
c.
|
Recently
Issued Accounting
Pronouncements
|
|
1.
|
In
November 2007, the FASB ratified EITF Issue No. 07-01, "Accounting for
Collaborative Arrangements" ("EITF 07-01"). EITF 07-01 defines
collaborative arrangements and establishes reporting requirements for
transactions between participants in a collaborative arrangement and
between participants in the arrangement and third parties. EITF 07-01 also
establishes the appropriate income statement presentation and
classification for joint operating activities and payments between
participants, as well as the sufficiency of the disclosures related to
these arrangements. EITF 07-01 is effective for fiscal years beginning
after December 15, 2008 (September 1, 2009, for the Company). EITF 07-01
shall be applied using a modified version of retrospective transition for
those arrangements in place at the effective date. An entity should report
the effects of applying EITF 07-01 as a change in accounting principle
through retrospective application to all prior periods presented for all
arrangements existing as of the effective date, unless it is impracticable
to apply the effects of the change retrospectively. The Company is
currently assessing the impact that EITF 07-01 may have on its results of
operations and financial
position.
|
8
ORAMED
PHARMACEUTICULS INC.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 1 - SIGNIFICANT ACCOUNTING
POLICIES (continued):
|
2.
|
In
April 2008, the FASB issued Staff Position No. FAS 142-3,
“Determination of the Useful Life of Intangible Assets ("FSP FAS 142-3").
FSP FAS 142-3 amends the factors that should be considered in
developing renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under SFAS No. 142, “Goodwill and
Other Intangible Assets.” The intent of FSP FAS 142-3 is to improve
the consistency between the useful life of a recognized intangible asset
under SFAS No. 142 and the period of expected cash flows used to measure
the fair value of the asset under FAS 141(R), and other U.S.
generally accepted accounting principles. The provisions of FSP FAS
142-3 are effective for the fiscal year beginning September 1, 2009;
early adoption is prohibited. The Company is currently evaluating the
impact of the provisions of FSP FAS
142-3.
|
NOTE
2 - COMMITMENTS:
a.
|
On
September 8, 2008, the Company entered into Clinical Research agreement
with ETI Karle Clinical Pvt. Ltd. (“ETI”), pursuant to the agreement ETI
will be conducting clinical trials for the Company in India. In
consideration for the services provided under the agreement, ETI will be
entitled to estimated cash compensation of
$227,000.
|
b.
|
On
April 22, 2009, our subsidiary entered into a consulting service agreement
with ADRES
Advanced Regulatory Services Ltd. (“ADRES”) pursuant to which ADRES
will provide consulting services relating to quality assurance and
regulatory processes and procedures in order to assist the Subsidiary in
submission of a U.S. IND according to FDA regulations. In consideration
for the services provided under the agreement, ADRES will be entitled to a
total cash compensation of $211,000, of which the amount $110,000 will be
paid as a monthly fixed fee of $10,000 each month for 11 months commencing
May 2009, and the remaining $101,000 will be paid based on achievement of
certain milestones.
|
NOTE
3 - STOCK BASED COMPENSATION:
The
following are stock issued for services, stock options and warrants transactions
made during the nine months ended May 31, 2009:
|
a.
|
On
October 30, 2006 the Company entered into a Clinical Trial Manufacturing
Agreement with Swiss Caps AG (“Swiss”), pursuant to
which Swiss would manufacture and deliver the oral insulin capsule
developed by the Company. In consideration for the services being provided
to the Company by Swiss, the Company agreed to pay certain predetermined
amounts which are to be paid in common stock of the Company. The number of
shares to be issued is based on the invoice received from Swiss, and the
stock market price 10 days after the invoice was issued. The Company
accounted for the transaction with Swiss according to FAS 150 "Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and
Equity".
|
9
ORAMED
PHARMACEUTICULS INC.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE 3 - STOCK BASED
COMPENSATION (continued):
On
October 17, 2008, the Company issued 203,904 shares of its common stock to Swiss
as remuneration for the services provided, in the amount of
$152,928.
As of May
31, 2009 Swiss was entitled to receive 365,300 shares of the Company for
services provided, in the amount of $109,590.
b.
|
On
October 12, 2008, 828,000 options were granted to an employee of our
Subsidiary, at an exercise price of $0.47 per share (equivalent to the
traded market price on the date of grant). The options vest in three equal
annual instalments commencing on November 1, 2009 and expire on October
11, 2018. The fair value of these options on the date of grant was
$330,699, using the Black Scholes option-pricing model and was based on
the following assumptions: dividend yield of 0% for all years; expected
volatility of 113%; risk-free interest rates of 3.27%; and the remaining
contractual life of 6.00 years. On March 31, 2009 the employee ended his
services with the Company and the options were forfeited before they
had vested. The Company recognized an expense of $71,406 during the six
months ended February 28, 2009 and reverse that expense in the three
months ended May 31, 2009.
|
c.
|
On
October 12, 2008, 56,000 options were granted to an employee of our
Subsidiary, at an exercise price of $0.47 per share (equivalent to the
traded market price on the date of grant). The options vest in two equal
annual instalments commencing on May 1, 2009 and expire on October 11,
2018. The fair value of these options on the date of grant was $21,988,
using the Black Scholes option-pricing model and was based on the
following assumptions: dividend yield of 0% for all years; expected
volatility of 113%; risk-free interest rates of 2.77%; and the remaining
contractual life of 5.67
years.
|
d.
|
On
January 11, 2009, an aggregate of 600,000 options were granted to two
Board of Directors members and 150,000 options were granted to an employee
of our Subsidiary. All 750,000 options were granted at an exercise price
of $0.43 per share (equivalent to the traded market price on the date of
grant). The options vest in three equal annual instalments commencing on
January 1, 2010 and expire on January 10, 2019. The fair value of these
options on the date of grant was $285,028, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 126%; risk-free interest
rates of 1.51%; and the remaining contractual life of 6.00 years. On May
31, 2009 such employee left the Company and the options were forfeited
before they had vested. The Company recognized an expense of $4,354 during
the six months ended February 28, 2009 and reverse that expense in the
three months ended May 31,
2009.
|
e.
|
On
January 11, 2009, an aggregate of 300,000 options were granted to three
Scientific Advisory Board members, at an exercise price of $0.76 per share
(higher than the traded market price on the date of grant). The options
vest in four equal quarterly instalments commencing on April 1, 2009 and
expire on January 10, 2019. The fair value of the vested options was
$21,090 and the fair value of the unvested options as of May 31, 2009 was
$91,684, using the Black Scholes option-pricing model and was based on the
following assumptions: dividend yield of 0% for all years; expected
volatility of 128%; risk-free interest rates of 3.47%; and the remaining
contractual life of 9.62
years.
|
10
ORAMED
PHARMACEUTICULS INC.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
4 - FAIR VALUE
On
September 1, 2008, the Company adopted the methods of fair value as
described in SFAS No. 157 (“SFAS 157”), which defines fair value,
establishes a framework for measuring fair value in accordance with GAAP and
expands disclosure about fair value measurements to value its financial assets
and liabilities. As defined in SFAS No. 157, fair value is based on the
price that would be received to sell an asset or paid to transfer a liability in
an orderly transaction between market participants at the measurement date. In
order to increase consistency and comparability in fair value measurements, SFAS
No. 157 establishes a fair value hierarchy that prioritizes observable and
unobservable inputs used to measure fair value into three broad levels, which
are described as follows:
|
Level
1:
|
Quoted
prices (unadjusted) in active markets that are accessible at the
measurement date for assets or liabilities. The fair value hierarchy gives
the highest priority to Level 1
inputs.
|
|
Level
2:
|
Observable
prices that are based on inputs not quoted on active markets, but
corroborated by market data.
|
|
Level
3:
|
Unobservable
inputs are used when little or no market data is available. The fair value
hierarchy gives the lowest priority to Level 3
inputs.
|
The
adoption of SFAS 157 did not have a material impact on the Company’s results of
operations and financial condition as the Company does not have any financial
assets and liabilities measured at fair value on a recurring basis subject to
the requirements of SFAS 157.
NOTE
5 - RELATED PARTIES TRANSACTIONS
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, of which $199,255 was paid through May 31, 2009. 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 amount 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”) to provide for the closing referenced in the First
Agreement. In the Second Agreement, Hadasit confirms that it has conveyed,
transferred and assigned all of its ownership rights in the patents acquired
under the First Agreement and certain other patents filed by the Company after
the First Agreement as a result of the collaboration between the Company and
Hadasit.
See also
note 6(b) for information regarding a third agreement with
Hadasit.
11
ORAMED
PHARMACEUTICULS INC.
(A
development stage company)
NOTES TO
INTERIM FINANCIAL STATEMENTS
NOTE
6 - SUBSEQUENT EVENTS:
|
a.
|
On
June 3, 2009, 400,000 options were granted to an employee of our
Subsidiary, at an exercise price of $0.47 per share (equivalent to the
traded market price on the date of grant). The options vest in three
annual installments of 133,333, 133,333 and 133,334 on October 19, 2010,
October 19, 2011 and October 19, 2012, respectively, and expire on October
19, 2019. The fair value of these options on the date of grant was
$170,193, using the Black Scholes option-pricing model and was based on
the following assumptions: dividend yield of 0% for all years; expected
volatility of 130%; risk-free interest rates of 3.16%; and the remaining
contractual life of 6.19 years.
|
|
b.
|
On
July 8, 2009 the Company entered into a third agreement with Hadasit,
Prof. Itamar Raz and Dr. Miriam Kidron ("the Third Agreement"), to provide
consulting and clinical trial services. According to the Third Agreement,
Hadasit will be entitled to a total consideration of $400,000 to be paid
by Oramed. $200,000 of this amount was agreed in the terms of the First
Agreement, see note 5, and the remaining of $200,725 will be paid in ten
equal quarterly instalments commencing May 2009, in accordance with the actual
progress of the study.
|
12
ITEM
2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The
following information should be read in conjunction with the financial
statements and notes thereto appearing elsewhere in this Quarterly
Report.
We
have included in this Quarterly Report certain “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995
concerning our business, operations and financial condition. “Forward-looking
statements” consist of all non-historical information, and the analysis of
historical information, including the references in this Quarterly Report to
future revenues, collaborative agreements, future expense growth, future credit
exposure, earnings before interest, taxes, depreciation and amortization, future
profitability, anticipated cash resources, anticipated capital expenditures,
capital requirements, and the Company’s plans for future periods. In
addition, the words “could”, “expects”, “anticipates”, “objective”, “plan”, “may
affect”, “may depend”, “believes”, “estimates”, “projects” and similar words and
phrases are also intended to identify such forward-looking
statements.
Actual
results could differ materially from those projected in our forward-looking
statements due to numerous known and unknown risks and uncertainties, including,
among other things, unanticipated technological difficulties, the length, scope
and outcome of our clinical trials, difficulties or delays in obtaining
regulatory approval for our product candidates, competition from other
pharmaceutical or biotechnology companies, costs related to intellectual
property, cost of manufacturing and higher consulting costs, product demand,
changes in domestic and foreign economic, market and regulatory conditions, the
inherent uncertainty of financial estimates and projections, the uncertainties
involved in certain legal proceedings, instabilities arising from terrorist
actions and responses thereto, our ability to obtain additional funding
required to conduct our research, development and commercialization activities
and other considerations described as “Risk Factors” in other filings by the
Company with the SEC. Such factors may also cause substantial volatility in the
market price of our common stock. All such forward-looking statements are
current only as of the date on which such statements were made. We do not
undertake any obligation to publicly update any forward-looking statement to
reflect events or circumstances after the date on which any such statement is
made or to reflect the occurrence of unanticipated events.
As used
in this Quarterly Report, the terms "we", "us", "our", "Company" and "Oramed"
mean Oramed Pharmaceuticals Inc. and our subsidiary, Oramed Ltd., unless
otherwise indicated.
All
dollar amounts refer to U.S. dollars in thousands unless otherwise
indicated.
Overview
We are a
pharmaceutical company engaged in the research and development of innovative
pharmaceutical solutions, including an orally ingestible insulin pill to be used
for the treatment of individuals with diabetes, rectal application of insulin,
flu vaccines, use of oral ingestible pills for delivery of other
polypeptides and use of rectal application for delivery of other
polypeptides.
13
Oramed
was incorporated on April 12, 2002, in the State of Nevada under the name
“Iguana Ventures Ltd” as an exploration stage company engaged in the acquisition
and exploration of mineral properties. The Company was unsuccessful in implementing its
business plan as a mineral exploration company. Accordingly, the Company decided
to change the focus of its business by completing a share exchange with the
shareholders of Integrated Security Technologies, Inc., a private New Jersey
corporation (“ISTI”), and changed its name to Integrated Security
Technologies. Effective June 14, 2004 the Company effected a 3.3:1
forward stock split, increasing the amount of 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, the Company executed an agreement (the “First Agreement”)
with Hadasit Medical Services and
Development Ltd. (“Hadasit”) to acquire provisional patent application
No. 60/718716 and
related intellectual property and agreed to retain Hadasit to provide consulting
and clinical trial services. The provisional patent application
No. 60/718716 relates to a method of preparing
insulin so that it may be taken orally to be used in the treatment of
individuals with diabetes. Effective April 10, 2006, the
Company changed its name from “Integrated Security Technologies, Inc.” to
“Oramed Pharmaceuticals Inc.” Based on provisional patent application
No. 60/718716, the Company filed a patent application under the Patent
Cooperation Treaty at the Israel Patent Office for “Methods and Compositions for
Oral Administration of Proteins” on August 31, 2006.
On
January 7, 2009, the Company entered into an agreement with Hadasit (the “Second
Agreement”) to provide for the closing referenced in the First Agreement. In the
Second Agreement, Hadasit confirms that it has conveyed, transferred and
assigned all of its ownership rights in the patents acquired under the First
Agreement and certain other patents filed by the Company after the First
Agreement as a result of the collaboration between the Company and Hadasit (the
“Patents”). Hadasit further acknowledges that the 4,141,532 shares of
common stock issued to Hadasit by the Company in connection with the First
Agreement constitute complete compensation for the Patents.
For
information regarding the third agreement with Hadasit see "Related Party
Transactions" below.
Plan
of Operation
Short
Term Business Strategy
We plan
to conduct further research and development on the technology covered by the
patent application "Methods and Composition for Oral Administration of
Proteins", which we acquired from Hadasit, as well as the other patents we have
filed since. Through our research and development efforts, we are
seeking to develop an oral dosage form that will withstand the harsh chemical
environment of the stomach or intestines and will be effective in delivering
active insulin for the treatment of diabetes. The enzymes and vehicles that are
added to the insulin in the formulation process must not modify the insulin
chemically or biologically and the dosage form must be safe to ingest. We plan
to continue to conduct clinical trials to show the effectiveness of our
technology. We intend to conduct the clinical trials necessary to
file an Investigational New Drug Application (“IND”) with the U.S. Food and Drug
Administration (“FDA”). Additional clinical trials are planned in other
countries such as Israel, South Africa and India, 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.
14
Orally Ingestible
Insulin: During
fiscal year 2007, we conducted several clinical studies of our orally ingestible
insulin. The studies were intended to assess both the safety/tolerability and
absorption properties of our proprietary oral insulin. Based on the
pharmacokinetic and pharmacologic outcomes of these trials, we decided to
continue the development of our oral insulin product.
On
November 15, 2007, we successfully completed animal studies in preparation for
the Phase 1B clinical trial of our oral insulin capsule (ORMD
0801). On January 22, 2008, we commenced the non-FDA approved Phase
1B clinical trials with our oral insulin capsule in healthy human volunteers
with the intent of dose optimization. On March 11, 2008, we
successfully completed our Phase 1B clinical trials.
On April
13, 2008, we commenced a non-FDA approved Phase 2A study to evaluate the safety
and efficacy of our oral insulin capsule (ORMD 0801) in Type II diabetic
volunteers at Hadassah Medical Center in Jerusalem. On August 6, 2008, we
announced the successful results of this trial.
During
July 2008, we were granted approval by the Institutional Review Board Committee
of Hadassah Medical Center in Jerusalem to conduct a non-FDA approved Phase 2A
study to evaluate the safety and efficacy of our oral insulin capsule (ORMD
0801) on Type I diabetic volunteers. On September 24, 2008, we announced the
beginning of this trail. The results of the trial have not yet been
published.
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 II diabetic volunteers. We also consider 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 available only via injection.
On
January 30, 2008, we entered into a master service agreement with OnQ
Consulting, a clinical research organization located in Johannesburg, South
Africa, to conduct non-FDA approved clinical trials for the rectal application
of insulin. The trials are expected to begin during the coming
months.
On
October 23, 2008, we commenced a non-FDA approved Phase 1A study to evaluate the
safety and efficacy of our insulin suppository (ORMD 0802) on healthy
volunteers, in South Africa. On February 4, 2009, we announced the completion of
this study.
15
GLP1
Analog: On September 16, 2008, we announced the launch of pre-clinical
trials of ORMD 0901, a GLP1-analog. The pre-clinical trials include a dog trial
which suggests that the GLP-1analog exenatide-4, when combined with
Oramed’s absorption promoters, is absorbed through the gastrointestinal tract
and retains its biological activity.
Glucagon-like
peptide-1 (GLP-1) is an incretin hormone - a type of gastrointestinal hormone
that stimulates the secretion of insulin from the pancreas. The incretin concept
was hypothesized when it was noted surprisingly that glucose ingested by mouth
(oral) stimulated two to three times more insulin release than the same amount
of glucose administered intravenously. GLP-1 was found in addition to stimulate
the release of insulin, to suppress the release of glucagon (a hormone involved
in the regulation of glucose) from the pancreas, to slow gastric emptying, to
reduce the rate of absorption of nutrients into the blood stream, and to
increases satiety. Other important beneficial attributes of GLP-1 are its
effects of increasing the number of beta cells (cells that manufacture and
release insulin) in the pancreas and possibly to protect the heart.
Licensing: We have recently engaged
in preliminary discussions with potential partners outside of the United States
regarding their management of clinical trials of our oral insulin capsules. Such
agreements could involve us granting exclusive commercialization rights and
profit interests in our products derived from certain geographic areas outside
the United States in exchange for payment of the costs of running such clinical
trials now. These discussions are in a very early stage, however, and may not
result in our being able to enter into any such partnerships.
Long
Term Business Strategy
If our
oral insulin capsule or other drug delivery solutions show significant promise
in clinical trials, we plan to ultimately seek a strategic commercial partner,
or partners, with extensive experience in the development, commercialization,
and marketing of insulin applications and/or other orally digestible drugs. We
anticipate such partner or partners would be responsible for, or substantially
support, late stage clinical trials (Phase III) to ensure regulatory approvals
and registrations in the appropriate markets in a timely manner. We further
anticipate that such partner, or partners, would also be responsible for sales
and marketing of our oral insulin capsule in these markets. Such planned
strategic partnership, or partnerships, may provide a marketing and sales
infrastructure for our products as well as financial and operational support for
global clinical trials, post marketing studies, label expansions and other
regulatory requirements concerning future clinical development in the United
States and elsewhere. Any future strategic partner, or partners, may also
provide capital and expertise that would enable the partnership to develop new
oral dosage form for other polypeptides. Under certain circumstances, we may
determine to develop one or more of our oral dosage form on our own, either
world-wide or in select territories.
Other
Planned Strategic Activities
In
addition to developing our own oral dosage form drug portfolio, we are, on an
on-going basis, considering in-licensing and other means of obtaining additional
technologies to complement and/or expand our current product portfolio. Our goal
is to create a well-balanced product portfolio that will enhance and complement
our existing drug portfolio.
16
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 May 31, 2009 of $9,607,792, as well as negative cash
flow from operating activities. Based upon our existing spending commitments,
estimated at $4.7 million for the twelve months following June 1, 2009, and our
cash availability, we do not have sufficient cash resources to meet our
liquidity requirements through May 31 2010. The ongoing global economic and
credit crisis makes it more difficult for the Company to raise financing.
Accordingly, these factors raise substantial doubt about our ability to continue
as a going concern. Management is in the process of evaluating various financing
alternatives as we will need to finance future research and development
activities and general and administrative expenses through fund raising in the
public or private equity markets. Although there is no assurance that we will be
successful with those initiatives, management believes that it will be able to
secure the necessary financing as a result of ongoing financing discussions with
third party investors and existing shareholders.
The
financial statements do not include any adjustments that may be necessary should
we be unable to continue as a going concern. Our continuation as a going concern
is dependent on our ability to obtain additional financing as may be required
and ultimately to attain profitability.
Critical
accounting policies
Valuation of options and
warrants: We have granted options to purchase shares of our common stock
to employees and consultants and issued warrants in connection with
fundraising.
Effective
March 1, 2006, the Company adopted Statement of Financial Accounting Standards
No. 123 (revised 2004), “Share-based Payment” (“FAS 123(R)”). FAS 123(R)
requires that awards classified as equity awards be accounted for using the
grant-date fair value method. The fair value of share-based payment transactions
is recognized as expense over the requisite service period, net of estimated
forfeitures. The Company estimated forfeitures based on historical experience
and anticipated future conditions.
In March
2005, the Securities and Exchange Commission issued Staff Accounting Bulletin
No. 107 (“SAB
107”). SAB 107 provides supplemental implementation guidance on FAS
123(R), including guidance on valuation methods, inventory capitalization of
share-based compensation cost, income statement effects, disclosures and other
issues. SAB 107 requires share-based payment to be classified in the same
expense line items as cash compensation. The Company has applied the provisions
of SAB 107 in its adoption of FAS 123(R).
The
Company elected to recognize compensation cost for an award with only service
conditions that has a
graded vesting schedule using the accelerated method based on multiple option
award approach.
The
Company elected to adopt
the modified prospective application transition method, as permitted by FAS
123(R). Under such transition method, upon the adoption of FAS 123(R), the
Company’s financial statements for periods prior to the effective date of the
Statement are not restated.
17
In
December 2007, the Securities and Exchange Commission issued Staff Accounting
Bulletin No. 110 (“SAB 110”) relating to the use of a “simplified” method
in developing an estimate of the expected term of “plain vanilla” share options.
SAB 107 previously allowed the use of the simplified method until
December 31, 2007. SAB 110 allows, under certain circumstances, to continue to accept the use of
the simplified method beyond December 31, 2007. The Company has applied the
provisions of SAB 110 in its financial statements.
The
Company accounts for equity instruments issued to third party service providers
(non-employees) in accordance with the fair value based on an option-pricing
model or, when more reliability is based on the fair value of the services
received, pursuant to the guidance in EITF 96-18 “Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling Goods or Services”. The fair value of the options granted is
revalued over the related service periods and recognized using the accelerated
method.
Taxes on
income: Deferred taxes are determined utilizing the asset and liability
method based on the estimated future tax effects of differences between the
financial accounting and tax bases of assets and liabilities under the
applicable tax laws. Deferred tax balances are
computed using the tax rates expected to be in effect when those differences
reverse. A valuation allowance in respect of deferred tax assets is provided if,
based upon the weight of available evidence, it is more likely than not that
some or all of the deferred tax assets will not be realized. The Company has
provided a full valuation allowance with respect to its deferred tax
assets.
Regarding
Oramed, Ltd., paragraph 9(f) of FAS 109, “Accounting for Income Taxes”,
prohibits the recognition of deferred tax liabilities or assets that arise from
differences between the financial reporting and tax bases of assets and
liabilities that are measured from the local currency into dollars using
historical exchange rates, and that result from changes in exchange rates or
indexing for tax purposes.
Consequently, the abovementioned differences were not reflected in the
computation of deferred tax assets and liabilities.
As of
September 1, 2007, the Company adopted FASB Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes - an Interpretation of FASB Statement No. 109” (“FIN 48”). FIN 48
specifies how tax benefits for uncertain tax positions are to be recognized,
measured and derecognized in financial statements, requires certain disclosures of
uncertain tax positions, specifies how reserves for uncertain tax positions
should be classified on the balance sheet, and provides transition and
interim-period guidance, among other provisions. On May 2, 2007, the FASB issued
FASB Staff Position No. FIN 48-1, “Definition of Settlement in FASB
Interpretation No. 48-1” (“FSP FIN 48-1”). FSP FIN 48-1 provides guidance
regarding how an entity should determine whether a tax position is effectively
settled for the purpose of recognizing previously unrecognized tax
benefits.
Research and
development expenses: Research and development expenses include costs
directly attributable to the conduct of research and development programs,
including the cost of salaries, payroll taxes, employee benefits, costs of registered patents materials,
supplies, the cost of services provided by outside contractors, including
services related to the Company’s clinical trials, clinical trial expenses, the
full cost of manufacturing drugs for use in research, preclinical development.
All costs associated with research and development are expensed as
incurred.
18
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.
The
following table summarizes certain statements of operations data for the Company
for the nine month periods ended May 31, 2009 and May 31, 2008:
Nine
months ended
|
Three
months ended
|
|||||||||||||||
Operating
Data:
|
May
31,
2009
|
May
31,
2008
|
May
31,
2009
|
May
31,
2008
|
||||||||||||
Research
and development costs
|
$ | 1,448,466 | $ | 655,934 | $ | 374,097 | $ | 464,119 | ||||||||
General
and administrative expenses
|
931,861 | 913,950 | 157,711 | 381,697 | ||||||||||||
Financial
(income) expense, net
|
(20,739 | ) | (61,006 | ) | (18,518 | ) | (24,295 | ) | ||||||||
Loss
before taxes on income
|
2,359,588 | 1,508,878 | 513,290 | 821,521 | ||||||||||||
Loss
per common share – basic and diluted
|
$ | 0.04 | $ | 0.03 | $ | 0.01 | $ | 0.02 | ||||||||
Weighted
average common shares outstanding
|
56,546,323 | 46,041,387 | 56,802,562 | 47,059,078 |
Research
and development costs
Research
and development expenses are the costs incurred in the process of our
pre-clinical and our clinical trials. Clinical trial and pre-clinical expenses
include regulatory and scientific consultants compensation and fees, research
expenses, purchase of
materials, cost of manufacturing of the oral insulin capsules, payments for
patient recruitment and treatment, costs related to the maintenance of our
registered patents, costs related to the filings of patent applications, as well
as salaries and related expenses of research and development
staff.
19
During
the nine months ended May 31, 2009, research and development expenses totaled
$1,448,466, compared to
$655,934 for the nine
months ended May 31, 2008. The increase is mainly attributable to increased
purchase of materials, clinical trials activities and patent related costs. The
research and development costs include stock based compensation costs, which
during the nine months ended May 31, 2009 totaled $192,076, as compared to
$80,183 during the nine months ended May 31, 2008.
The
decrease in research and development expenses during the three months ended May
31, 2009 as compared to the three months ended May 31, 2008 is attributable to a
charge related to consulting expenses of $170,000 with a regulatory consultant
that was incurred in April 2008.
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
nine months ended May 31, 2009, general and administrative expenses totaled
$931,861, compared to $913,950 for the nine months ended May 31, 2008. Costs
incurred related to general and administrative activities during the nine months
ended May 31, 2009 reflect an increase of payroll and related expenses,
professional, legal and consulting expenses and an increase in general expenses
such as office and maintenance expenses. During the nine months ended May 31,
2009, as part of our general and administrative expenses, we incurred $181,134
related to stock options granted to employees and consultants, as compared to
$166,556 during the nine months May 31, 2008.
The
decrease in general and administrative expenses during the three months ended
May 31, 2009 as compared to the three months ended May 31, 2008 is mainly
attributable to extraordinary legal
and accounting expenses, that were incurred during the three months ended May
31, 2008 and related to replacing both legal and accounting services providers.
Another cause to the said decrease is derived from a decrease in stock based
compensation costs.
Financial
income/expense, net
During
the nine months ended May 31, 2009 and May 31, 2008, we generated interest
income on available cash and cash equivalents balance, which were offset by bank
charges as well as a devaluation of assets denominated in New Israeli Shekel
(NIS), due to the devaluation of the NIS as compared to the US$.
The
decrease in the interest income for the nine and three months period ending May
31, 2009 as compared with the corresponding periods in the preceding year is
attributable to the decrease in interest rates in both the United States and the
state of Israel, due to the current global financial crises.
Liquidity
and Capital Resources
From
inception through May 31, 2009, we incurred losses in an aggregate amount of
$9,607,792. We have financed our operations through the private placements of
equity and debt financing. Since inception through May 31, 2009, we raised a
total of $8,308,785, net of transaction costs, through private placements of
equity and debt financing. We anticipate that we will obtain additional
financing through similar sources. As of May 31, 2009, we had $3,217,986 of available cash. The
Company anticipates it will require approximately $4.7 million to finance its
activities during the twelve months following June 1, 2009.
20
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 or
though arrangements to out license our technology. Although there is no
assurance that we will be successful with those initiatives, management believes
that it will be able to secure the necessary financing as a result of ongoing
financing discussions with third party investors and existing
shareholders.
Our
financing activities during the nine months ended May 31, 2009 include the
following:
|
·
|
On
October 17, 2008, Oramed issued 203,904 shares of common stock valued at
$152,928 to a third party, for services rendered in the prior
year.
|
Employee's and Consultant’s Stock Options and
Warrants
Employee
and consultant stock options
grants and warrant issuance activities for the nine months ending May 31, 2009
include the following:
|
·
|
On
October 12, 2008, we granted options under the 2008 Stock Incentive Plan
to purchase up to 828,000 shares of our common stock at an exercise price
of $0.47 to Chaime Orlev our Chief Financial Officer. On March 31, 2009 Mr. Orlev
ended his services with the Company and the options were
forfeited before they had
vested.
|
|
·
|
On
October 12, 2008, we granted options under the 2008 Stock Incentive Plan
to purchase up to 56,000 shares of our common stock at an exercise price
of $0.47 to an employee of our
subsidiary.
|
|
·
|
On
January 11, 2009, we granted options under the 2008 Stock Incentive Plan
to purchase up to 100,000 shares of our common stock at an exercise price
of $0.76 to each of Dr. Nir Barzilai, Prof. Ele Ferrannini and Dr. Derek
LeRoith, three members of our Scientific Advisory
Board.
|
|
·
|
On
January 11, 2009, we granted options under the 2008 Stock Incentive Plan
to purchase up to 150,000 shares of our common stock at an exercise price
of $0.43 to an employee of our subsidiary. In May 2009 such employee
left the Company and
the options were forfeited before they had
vested
|
|
·
|
On
January 11, 2009, we granted options under the 2008 Stock Incentive Plan
to purchase up to 300,000 shares of our common stock at an exercise price
of $0.43 to each of Leonard Sank and Dr. Harold Jacob, two members of our
Board of Directors.
|
Off-Balance
Sheet Arrangements
We have
no off-balance sheet
arrangements.
21
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 June 1, 2008 are as follows:
Operating
Data:
|
Amount
|
|||
Research
and development costs
|
$ | 3,500,000 | ||
General
and administrative expenses
|
1,200,000 | |||
Financial
income, net
|
(11,000 | ) | ||
Total
|
$ | 4,692,000 |
As
previously indicated, we are planning to conduct further clinical studies as
well as file an IND with the FDA for our orally ingested insulin. Our ability
to proceed with these
activities is dependent on several major factors including the ability to
attract sufficient financing on terms acceptable to us.
Employment and Consulting
Agreements
On May 1,
2008, we entered into a consulting agreement with a Dr. Ehud Arbit for a period
of twelve months, pursuant to which Dr. Arbit will assist our efforts to
complete the FDA approval process for its oral insulin capsule. Dr. Arbit is
entitled to a fixed monthly fee of $8,333 effective from May 1, 2008, and
reimbursement of pre-approved out-of-pocket expenses. On October 3, 2008, we
amended the consulting agreement with Dr. Arbit. Pursuant to the amendment, Dr.
Arbit will perform his work under the contract on a full-time basis and his
compensation will be $16,666 per month, effective as of July 1, 2008. On June
18, 2009, the Company and Dr. Arbit agreed on a second amendment to the
agreement, according to which, Dr. Arbit will be entitled to a monthly fee of
$7,000 for a period of three months commencing May 1, 2009.
On April
19, 2009 we entered into an employment agreement with Yifat Zommer (the
“Employment Agreement”), pursuant to which Ms. Zommer was appointed as Chief
Financial Officer (“CFO”), Treasurer and Secretary of Oramed. Ms. Zommer’s
responsibilities include oversight of Oramed’s financial reporting and controls
and she will be employed on a part-time basis of 80%. The employment agreement
provides that for the period through October 19, 2009, Ms. Zommer will be
compensated a gross monthly amount of NIS 17,600. Beginning on October 20, 2009
and continuing until the employment agreement is terminated by either party
pursuant to the employment agreement, Ms. Zommer's monthly gross salary
compensation will be increased by 10%. Ms. Zommer has also agreed that during
the term of her employment with Oramed and for a 12 month period thereafter, she
will not compete with Oramed nor solicit employees of Oramed. On April 19, 2009,
Oramed and Ms. Zommer also entered into an indemnification agreement, pursuant
to which Oramed agrees to indemnify Ms. Zommer for any liability she may incur
by reason of the fact that she serves as Oramed’s CFO, to the maximum extent
permitted by law. On June 3, 2009, we granted options under the 2008 Stock
Incentive Plan to purchase up to 400,000 shares of our common stock at an
exercise price of $0.47 to Ms. Zommer.
22
On April
22, 2009, the Company 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 Company 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. A
part of $110,000 will be paid as a monthly fixed fee of $10,000 for 11 months
commencing May 2009, and rest will be paid based on achievement of certain
milestones.
Related
Party Transactions
Under the
terms of the First Agreement with Hadasit, 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, of which $199,255
was paid through May 31, 2009. 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 amount of 10% of
all the funds deposited into this research fund.
On July
8, 2009 the Company entered into an 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 $200,725
will be paid in ten equal quarterly instalments commencing May 2009, in
accordance with the actual progress of the study.
23
ITEM
3 – QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4T - 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 May 31, 2009. Based on such
review, our chief executive officer and chief financial officer have determined
that in light of their conclusion with respect to the effectiveness of our
internal control over our financial reporting as of such date, the weaknesses in
controls and procedures described in our Form 10-KSB filed on November 26, 2008
continued this quarter and that the company did not have in place effective
controls and procedures designed to ensure that information required to be
disclosed by us in the reports that we file or submit under the Securities
Exchange Act of 1934, as amended, is accumulated and communicated to our
management, including our principal executive and principal financial officers,
or persons performing similar functions, as appropriate to allow timely
decisions regarding required disclosure, and is recorded, processed, summarized
and reported, within the time periods specified in the Commission’s rules and
forms.
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 May 31, 2009 based on the framework for
Internal Control-Integrated Framework set forth by The Committee of Sponsoring
Organizations of the Treadway Commission. Due to the inherent limitations of our
company, derived from our small size and the limited number of employees,
management evaluation concluded that there is a material weakness with respect
to segregation of duties that may not provide reasonable assurance regarding the
reliability of internal control over financial reporting and may not prevent or
detect misstatements. Specifically, our CFO serves as our only qualified
internal accounting and financial reporting personnel and as such performs all
accounting and financial reporting functions without the benefit of independent
checks, confirmations or backup other than bookkeeping functions performed by an
outside accounting firm. In addition, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
24
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 May 31, 2009.
As previously reported in our Form
10-KSB filed on November 26, 2008, during the nine month ended May 31, 2009,
management, including our principal executive officer and principal financial
officer, has started an extensive process of documenting all major procedures
related to the financial reporting, in order to strengthen our internal controls
over financial reporting in order to reasonably ensure that reliability of
financial reporting and the preparation of financial
statements.
This management report on internal
control over financial reporting shall not be deemed to be filed for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended or otherwise
subject to the liabilities of that Section.
There were no changes in our internal
controls over financial reporting identified in connection with the evaluation
thereof that occurred during the quarter ended May 31, 2009 that have materially
affected, or are reasonable likely to materially affect our internal control
over financial reporting.
25
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.
26
ITEM
6 - EXHIBITS
Number
|
Exhibit
|
|
(3)
|
Articles
of Incorporation and By-laws
|
|
3.1
|
Articles
of Incorporation (incorporated by reference from our Registration
Statement on Form SB-2, filed on November 29, 2002).
|
|
3.2
|
Bylaws
(incorporated by reference from our Current Report on Form 8-K filed on
April 10, 2006).
|
|
3.3
|
Articles
of Merger filed with the Nevada Secretary of State on March 29, 2006
(incorporated by reference to our Current Report on Form 8-K filed on
April 10, 2006).
|
|
(4)
|
Instruments
defining rights of security holders, including
indentures
|
|
4.1
|
Specimen
Stock Certificate (incorporated by reference from our Registration
Statement on Form SB-2, filed on November 29, 2002).
|
|
4.2
|
Form
of warrant certificate (incorporated by reference from our current report
on Form 8-K filed on June 18, 2007)
|
|
(10)
|
Material
Contracts
|
|
10.1
|
Agreement
between our company and Hadasit Medical Services and Development Ltd.
dated February 17, 2006 (incorporated by reference from our current report
on Form 8-K filed February 17, 2006).
|
|
10.2
|
Agreement
between our company and Hadasit Medical Services and Development Ltd.
dated January 7, 2008 (incorporated by reference from our current report
on Form 8-K filed January 7, 2008).
|
|
10.3
|
Consulting
Agreement, dated May 1, 2008, between Oramed Pharmaceuticals Inc. and Dr.
Ehud Arbit (incorporated by reference from our annual report on Form
10-KSB filed November 26, 2008)
|
|
10.4
|
Amended
and Restated Consulting Agreement, dated as of May 1, 2008, between
Oramed Pharmaceuticals Inc. and Dr. Ehud Arbit (incorporated by reference
from our annual report on Form 10-KSB filed November 26,
2008)
|
|
10.5
|
Amended to
Consulting Agreement, dated as of October 3, 2008, between
Oramed Pharmaceuticals Inc. and Dr. Ehud Arbit (incorporated by reference
from our annual report on Form 10-KSB filed November 26,
2008)
|
|
10.6
|
Amended and
Restated to Consulting Agreement, dated as of June 18,
2009, between Oramed Pharmaceuticals Inc. and Dr. Ehud
Arbit.
|
|
10.7
|
Employment
Agreement, dated as of April 19, 2009, by and between Oramed Ltd. and
Yifat Zommer (incorporated by reference from our current report on Form
8-K filed on April 22, 2009).
|
|
10.8
|
Indemnification
Agreement, dated as of April 19, 2009, by and between Oramed Ltd. and
Yifat Zommer (incorporated by reference from our current report on Form
8-K filed on April 22, 2009).
|
|
10.9
|
Agreement
dated April 22, 2009, between Oramed Ltd. and ADRES Advanced Regulatory Services
Ltd. (incorporated by reference from our current report on Form 8-K
filed April 22, 2009).
|
|
10.10
|
Agreement
dated July 8, 2009, between our company and Hadasit Medical Services and
Development Ltd. (incorporated by reference from our current report on
Form 8-K filed July 9, 2009).
|
|
(31)
|
Section
302 Certification
|
|
31.1 *
|
Certification
Statement of the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
|
31.2 *
|
Certification
Statement of the Principal Accounting Officer pursuant to Section 302 of
the Sarbanes-Oxley Act of 2002
|
|
(32)
|
Section
906 Certification
|
|
32.1 *
|
Certification
Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section
1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act Of
2002
|
27
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
|
28
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: July
13, 2009
|
By:
|
/s/
Nadav
Kidron
|
Nadav
Kidron
|
||
President,
Chief Executive Officer and Director
|
||
Date: July
13, 2009
|
By:
|
/s/ Yifat
Zommer
|
Yifat
Zommer
|
||
Chief
Financial Officer
|
29