Page
|
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Prospectus
Summary
|
1
|
|
Risk
Factors
|
6
|
|
Forward-Looking
Statements
|
14
|
|
Use
of Proceeds
|
14
|
|
Market
Price and Dividends
|
15
|
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
16
|
|
Our
Business
|
23
|
|
Description
of Property
|
32
|
|
Legal
Proceedings
|
32
|
|
Management
|
33
|
|
Executive Compensation
|
35
|
|
Security
Ownership of Certain Beneficial Owners and Management
|
39
|
|
Certain
Relationships and Related Transactions, and Director
Independence
|
41
|
|
Description
of Common Stock
|
42
|
|
Selling
Stockholders
|
43
|
|
Plan
of Distribution
|
46
|
|
Disclosure
of Commission Position of Indemnification for Securities
Act Liabilities
|
48
|
|
Interests
of Named Experts and Counsel
|
48
|
|
Experts
|
48
|
|
Where
You Can Find More Information
|
48
|
|
Index
to Financial Statements
|
F-1
|
Issuer
|
Oramed
Pharmaceuticals Inc.
Hi-Tech
Park 2/5
Givat-Ram,
PO Box 39098
Jerusalem
91390, Israel
Telephone:
972-2-566-0001
|
|
Securities
offered by the Selling Stockholders
|
29,864,799
shares of common stock and 4,382,503 shares of common stock issuable upon
exercise of warrants and options.
|
|
Trading
Market
|
The
common stock offered in this prospectus is quoted on the OTCBB under the
symbol “ORMP.OB”.
|
|
Common
stock outstanding (as of August 24 2010)
|
57,565,321
shares1.
|
|
Use
of Proceeds
|
We
will not receive any of the proceeds from the sale of the shares of our
common stock being offered for sale by the selling stockholders. However,
we may receive up to approximately $3.3 million in proceeds upon exercise
of the warrants and options held by the selling stockholders, as the
warrants and options have an average exercise price of $0.74 per share and
are exercisable into 4,382,503 shares of our common stock. These
potential proceeds will be used for the research and development of our
products and for general working capital purposes. See “Use of
Proceeds.”
|
|
Plan
of Distribution
|
The
selling stockholders, and their pledgees, donees, transferees or other
successors in interest, may from time to time offer and sell, separately
or together, some or all of the common stock covered by this prospectus.
Registration of the common stock covered by this prospectus does not mean,
however, that those shares necessarily will be offered or sold. See “Plan of
Distribution.”
|
|
Risk
Factors
|
Please
read “Risk
Factors” and other information included in this prospectus for a
discussion of factors you should carefully consider before deciding to
invest in the securities offered in this
prospectus.
|
|
·
|
we
may be required to contribute additional funds to Entera to enable its
continued operations;
|
|
·
|
we
may have difficulties in retaining key employees who are necessary to
manage the new company; and
|
|
·
|
there
can be no assurance that Entera’s operations will ever result in profits
that are distributed to us as
shareholders.
|
|
·
|
Clinical
trial results and the timing of the release of such
results,
|
|
·
|
The
amount of cash resources and ability to obtain additional
funding,
|
|
·
|
Announcements
of research activities, business developments, technological innovations
or new products by companies or their
competitors,
|
|
·
|
Entering
into or terminating strategic
relationships,
|
|
·
|
Changes
in government regulation,
|
|
·
|
Departure
of key personnel,
|
|
·
|
Disputes
concerning patents or proprietary
rights,
|
|
·
|
Changes
in expense level,
|
|
·
|
Future
sales of our equity or equity-related
securities,
|
|
·
|
Public
concern regarding the safety, efficacy or other aspects of the products or
methodologies being developed,
|
|
·
|
Activities
of various interest groups or
organizations,
|
|
·
|
Media
coverage, and
|
|
·
|
Status
of the investment
markets.
|
|
·
|
Control
of the market for the security by one or a few
broker-dealers;
|
|
·
|
“Boiler
room” practices involving high-pressure sales
tactics;
|
|
·
|
Manipulation
of prices through prearranged matching of purchases and
sales;
|
|
·
|
The
release of misleading information;
|
|
·
|
Excessive
and undisclosed bid-ask differentials and markups by selling
broker-dealers; and
|
|
·
|
Dumping
of securities by broker-dealers after prices have been manipulated to a
desired level, which hurts the price of the stock and causes investors to
suffer loss.
|
High
|
Low
|
|||||||
Fiscal
Year Ending August 31, 2010
|
||||||||
First
Quarter
|
$ | 0.64 | $ | 0.43 | ||||
Second
Quarter
|
$ | 0.48 | $ | 0.37 | ||||
Third
Quarter
|
$ | 0.55 | $ | 0.41 | ||||
Fourth
Quarter (through August 26, 2010)
|
$ | 0.51 | $ | 0.36 | ||||
Year
Ended August 31, 2009
|
||||||||
First
Quarter
|
$ | 0.76 | $ | 0.36 | ||||
Second
Quarter
|
$ | 0.52 | $ | 0.25 | ||||
Third
Quarter
|
$ | 0.62 | $ | 0.20 | ||||
Fourth
Quarter
|
$ | 0.59 | $ | 0.40 | ||||
Year
Ended August 31, 2008
|
||||||||
First
Quarter
|
$ | 0.48 | $ | 0.23 | ||||
Second
Quarter
|
$ | 0.67 | $ | 0.21 | ||||
Third
Quarter
|
$ | 0.66 | $ | 0.45 | ||||
Fourth
Quarter
|
$ | 1.00 | $ | 0.60 |
Nine months ended
|
Three months ended
|
|||||||||||||||
Operating Data:
|
May 31, 2010
|
May 31, 2009
|
May 31, 2010
|
May 31, 2009
|
||||||||||||
Research
and development costs
|
$ | 833,498 | $ | 1,500,809 | $ | 346,716 | $ | 387,663 | ||||||||
General
and administrative expenses
|
981,861 | 879,518 | 459,242 | 144,145 | ||||||||||||
Financial
(income) expense, net
|
(4,136 | ) | (20,739 | ) | 261 | (18,518 | ) | |||||||||
Net
loss for the period
|
$ | 1,811,223 | $ | 2,359,588 | $ | 806,219 | $ | 513,290 | ||||||||
Loss
per common share – basic and diluted
|
$ | 0.03 | $ | 0.04 | $ | 0.01 | $ | 0.01 | ||||||||
Weighted
average common shares outstanding
|
57,349,130 | 56,546,323 | 57,466,907 | 56,802,562 |
Year ended
|
||||||||
Operating Data:
|
August 31, 2009
|
August 31, 2008
|
||||||
Research
and development expenses
|
$ | 1,522,188 | $ | 1,210,494 | ||||
General
and administrative expenses
|
1,261,930 | 1,469,517 | ||||||
Financial
income, net
|
(21,047 | ) | (72,904 | ) | ||||
Loss
before taxes on income
|
(2,763,071 | ) | (2,607,107 | ) | ||||
Taxes
on income
|
(2,597 | ) | 162,164 | |||||
Net
loss for the period
|
$ | (2,760,474 | ) | $ | (2,769,271 | ) | ||
Loss
per common share – basic and diluted
|
$ | (0.05 | ) | $ | (0.06 | ) | ||
Weighted
average common shares outstanding
|
56,645,820 | 48,604,889 |
|
·
|
On
November 23, 2009 we granted options under the 2008 Stock Incentive Plan
to purchase up to 100,000 shares of our common stock at an exercise price
of $0.76 to a consultant.
|
|
·
|
On
November 23, 2009 we granted options under the 2008 Stock Incentive Plan
to purchase up to 36,000 shares of our common stock at an exercise price
of $0.46 to an employee of our
subsidiary.
|
|
·
|
On
March 16, 2010, 50,000 options were granted to a consultant of our
subsidiary at an exercise price of $0.50 per share. The options vest in
three equal annual installments commencing on March 16, 2011 and will
expire on March 15, 2015.
|
|
·
|
On
March 16, 2010, 100,000 options were granted to a consultant of the
Company at an exercise price of $0.43 per share. The options vest in three
equal monthly installments commencing on March 30, 2010 and will expire on
March 15, 2015.
|
|
·
|
On
March 16, 2010, 13,200 options were granted to a consultant of the Company
at an exercise price of $0.43 per share. The options vest in six monthly
installments commencing on March 30, 2010 and will expire on March 15,
2015.
|
|
·
|
On
March 25, 2010, 100,000 options were granted to a consultant of the
Company at an exercise price of $0.50 per share. The options vest in four
equal quarterly installments commencing on May 17, 2010 and will expire on
March 24, 2015.
|
|
·
|
On
April 21, 2010, 864,000 options were granted to each of Nadav Kidron and
Miriam Kidron under the 2008 Stock Option Plan at an exercise price of
$0.49 per share, 108,000 of such options vested immediately on the date of
grant and the remainder will vest in twenty equal monthly installments,
commencing on May 31, 2010. The options have an expiration date of April
20, 2020.
|
|
·
|
On
July 8, 2010, 300,000 options were granted to a director at an exercise
price of $0.48 per share. The options vest in three equal annual
installments commencing on July 8, 2011 and will expire on July 7,
2020.
|
Category
|
Amount
|
|||
Research
& development, net of OCS funds
|
$ | 5,579,000 | ||
General
& administrative expenses
|
1,032,000 | |||
Financial
income, net
|
(8,000 | ) | ||
Taxes
on income
|
- | |||
Total
|
$ | 6,603,000 |
Name
|
Age
|
Position
|
||
Nadav
Kidron
|
36
|
President,
Chief Executive Officer and Director
|
||
Miriam
Kidron
|
69
|
Chief
Medical and Technology Officer and Director
|
||
Leonard
Sank
|
45
|
Director
|
||
Harold
Jacob
|
55
|
Director
and member of the Scientific Advisory Board
|
||
Michael
Berelowitz
|
66
|
Director
|
||
Yifat
Zommer
|
|
36
|
|
Chief
Financial Officer, Treasurer and
Secretary
|
Name and Principal
Position
|
Year
(1)
|
Salary
($)
|
Option Awards
($)
(2)
|
All Other
Compensation
($)
(3)
|
Total
($)
|
|||||||||||||
Nadav
Kidron
|
2009
|
155,359 | 153,855 | 15,474 | 324,688 | |||||||||||||
President
and CEO and director (4)
|
2008
|
151,037 | 216,504 | 14,511 | 382,053 | |||||||||||||
Miriam
Kidron
|
2009
|
154,983 | 153,855 | 11,539 | 320,377 | |||||||||||||
Chief
Medical and Technology Officer and director (5)(6)
|
2008
|
145,405 | 216,504 | 10,774 | 372,683 | |||||||||||||
Yifat
Zommer
|
2009
|
20,468 | 19,946 | 11,245 | 51,659 | |||||||||||||
CFO
and Secretary (7)
|
||||||||||||||||||
Chaime
Orlev
|
2009
|
59,300 | — | 25,544 | 84,844 | |||||||||||||
CFO
and Secretary (8)
|
2008
|
23,484 | — | 7,981 | 31,466 |
(1)
|
The
information is provided for each fiscal year which begins on September 1
and ends on August 31.
|
(2)
|
The
amounts reflect the compensation expense in accordance with FAS 123(R) of
these option awards. The assumptions used to determine the fair value of
the option awards for fiscal years ended August 31, 2009 and 2008 are set
forth in the notes to our audited consolidated financial statements
included in our Form 10-K for fiscal year ended August 31, 2009. Our Named
Executive Officers will not realize the value of these awards in cash
unless and until these awards are exercised and the underlying shares
subsequently sold.
|
(3)
|
See
All Other Compensation Table below.
|
(4)
|
Mr.
Kidron was appointed as our President, CEO and Director on March 8, 2006
and received compensation from our subsidiary through KNRY, an Israeli
entity owned by Mr. Kidron. See “Employment and Consulting
Agreements.”
|
(5)
|
Dr.
Kidron was appointed as our Chief Medical and Technology Officer and
Director on March 8, 2006 and received compensation from our subsidiary
through KNRY, an Israeli entity owned by Mr. Kidron. See “Employment and
Consulting Agreements.”
|
(6)
|
See
“Certain Relationships and Related Transactions and Director Independence”
for a description of management fees received by Dr. Kidron from
Hadasit.
|
(7)
|
Ms.
Zommer was appointed as our CFO and Secretary on April 19,
2009.
|
(8)
|
Mr.
Orlev served as our CFO and Secretary from May 1, 2008 through March 31,
2009.
|
Name
|
Year
|
Automobile
Related
Expenses
($)
|
Manager’s
Insurance *
($)
|
Education
Fund*
($)
|
Total
($)
|
|||||||||||||
Nadav
Kidron
|
2009
|
15,474 | — | — | 15,474 | |||||||||||||
Miriam
Kidron
|
2009
|
11,539 | — | — | 11,539 | |||||||||||||
Chaime
Orlev
|
2009
|
15,662 | 7,762 | 2,120 | 25,544 | |||||||||||||
Yifat
Zommer
|
2009
|
6,540 | 3,163 | 1,542 | 11,245 |
Name
|
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
|
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
|
Option
Exercise
Price
($)
|
Option
Expiration
Date
|
|||||||||
Nadav
Kidron
|
850,000 |
(1)
|
— | 0.45 |
08/01/12
|
||||||||
720,000 |
(2)
|
144,000 |
(2)
|
0.54 |
05/06/18
|
||||||||
Miriam
Kidron
|
3,361,360 |
(3)
|
— | 0.001 |
08/13/12
|
||||||||
850,000 |
(1)
|
— | 0.45 |
08/01/12
|
|||||||||
720,000 |
(2)
|
144,000 |
(2)
|
0.54 |
05/06/18
|
||||||||
Yifat
Zommer
|
— | 400,000 |
(4)
|
0.47 |
10/19/19
|
Name of Director
|
Fees Earned or
Paid in Cash
($)
|
Option Awards
(1)
($)
|
Total
($)
|
|||||||||
Nadav Kidron (2)
|
||||||||||||
Miriam Kidron (2)
|
||||||||||||
Leonard
Sank
|
8,000 | 45,206 | 53,206 | |||||||||
Harold
Jacob
|
8,000 | 45,206 | 53,206 |
(1)
|
The amounts reflect the
compensation expense in accordance with FAS 123(R) of these option awards.
The assumptions used to determine the fair value of the option awards are
set forth in Note 8 of our audited consolidated financial statements
included in this prospectus. Our directors will not realize the value of
these awards in cash unless and until these awards are exercised and the
underlying shares subsequently
sold.
|
(2)
|
Please refer to the summary
compensation table for executive compensation with respect to the named
individual.
|
Name and Address of
Beneficial Owner
|
Number of Shares
|
Percentage of Shares
Beneficially Owned
|
||||||
Nadav Kidron
†‡
|
||||||||
10 Itamar Ben Avi
St.
|
||||||||
Jerusalem,
Israel
|
12,373,735 |
(1)
|
20.77 | % | ||||
Zeev
Bronfeld
|
||||||||
6 Uri St.
|
||||||||
Tel-Aviv,
Israel
|
6,158,517 | 10.70 | % | |||||
Miriam Kidron
†‡
|
||||||||
2 Elza St.
|
||||||||
Jerusalem,
Israel
|
5,363,360 |
(2)
|
8.52 | % | ||||
Apollo Nominees
Inc
|
||||||||
One Financial Place Suite 100
Lower Collymore Rock
|
||||||||
St. Michael,
Barbados
|
3,577,501 |
(3)
|
6.09 | % | ||||
Hadasit Medical Research Services
& Development Ltd
|
||||||||
P.O. Box
12000
|
||||||||
Jerusalem,
Israel
|
4,141,532 | 7.19 | % | |||||
Leonard Sank
†
|
||||||||
3 Blair Rd Camps
Bay
|
||||||||
Cape Town, South
Africa
|
2,582,650 |
(4)
|
4.47 | % | ||||
Harold
Jacob
|
||||||||
Haadmur Mebuyon
26
|
||||||||
Jerusalem,
Israel
|
100,000 |
(5)
|
* | |||||
Michael
Berelowitz
|
||||||||
415
East 37th
Street
|
||||||||
New
York, NY,
USA
|
— | — | ||||||
Yifat
Zommer
|
||||||||
P.O. Box 39098,
|
||||||||
Jerusalem,
Israel
|
133,333 |
(6)
|
* | |||||
All current executive officers and
directors, as a group (five persons)
|
34,430,628
|
(7) | 58,16 | % |
*
|
Less than
1%
|
†
|
Indicates
Director
|
‡
|
Indicates
Officer
|
(1)
|
Includes 2,002,000 shares of
common stock issuable upon the exercise of outstanding stock
options.
|
(2)
|
Includes 5,363,360 shares of
common stock issuable upon the exercise of outstanding stock
options.
|
(3)
|
Includes 1,145,834 shares of
common stock issuable upon the exercise of warrants beneficially owned by
the referenced entity.
|
(4)
|
Includes 225,000 shares of common
stock issuable upon the exercise of warrants beneficially owned by the
referenced entity.
|
(5)
|
Consists of 100,000 shares of
common stock issuable upon the exercise of outstanding stock
options.
|
(6)
|
Consists of 133,333 shares of
common stock issuable upon the exercise of outstanding stock
options.
|
(7)
|
Includes 8,969,527 shares of
common stock issuable upon the exercise of outstanding stock
options.
|
Name of
Selling
Stockholder
|
Shares Beneficially
Owned
Before the Offering
(excluding shares
issuable upon the
exercise of warrants
or options) (1)
|
Shares Beneficially
Owned Before the
Offering that are
Issuable Upon the
Exercise of
Warrants or
Options
|
Maximum Number
of Shares to be
Offered in the
Offering
|
Number of Shares
Beneficially
Owned Immediately
AfterSale of Maximum
Number of
Shares in the Offering
|
||||||||||||||||
# of Shares (2)
|
% of
Class
|
|||||||||||||||||||
Hargreave Hale Nominees Limited
A/C 060788 (3)
|
83,333 | 41,666 | 124,999 | — | — | |||||||||||||||
Hargreave Hale Nominees Limited
A/C 063717 (3)
|
1,666,667 | 833,334 | 2,500,001 | — | — | |||||||||||||||
Hargreave Hale Nominees Limited
(3)
|
1,500,000 | — | 1,500,000 | — | — | |||||||||||||||
Leonard Sank
(3)
|
774,317 | 83,334 | 250,001 | 607,650 | — | |||||||||||||||
Apollo Nominees
Incorporated
|
80,000 | — | 80,000 | — | — | |||||||||||||||
Apollo Nominees
Inc.
|
2,351,667 | 1,145,834 | 3,497,501 | — | — | |||||||||||||||
Laurie
Rubin
|
440,000 | - | 440,000 | - | - | |||||||||||||||
Swiss Caps AG
(4)
|
940,039 | — | 940,039 | — | — | |||||||||||||||
Mirabaud &
CIE
|
166,667 | 83,334 | 250,001 | — | — | |||||||||||||||
Joan Samson
|
166,667 | 83,334 | 250,001 | — | — | |||||||||||||||
Vered
Schimmel
|
100,000 | 50,000 | 150,000 | — | — | |||||||||||||||
Shikma A M R
Ltd
|
110,000 | 50,000 | 160,000 | — | — |
Name of
Selling
Stockholder
|
Shares Beneficially
Owned
Before the Offering
(excluding shares
issuable upon the
exercise of warrants
or options) (1)
|
Shares Beneficially
Owned Before the
Offering that are
Issuable Upon the
Exercise of
Warrants or
Options
|
Maximum Number
of Shares to be
Offered in the
Offering
|
Number of Shares
Beneficially
Owned Immediately
AfterSale of Maximum
Number of
Shares in the Offering
|
||||||||||||||||
# of Shares (2)
|
% of
Class
|
|||||||||||||||||||
Edward
Danehy
|
110,000 | 55,000 | 165,000 | — | — | |||||||||||||||
Oberdorf Finance
SA
|
80,000 | — | 80,000 | — | — | |||||||||||||||
Pnini David
Jerusalem
|
83,500 | 41,750 | 125,250 | — | — | |||||||||||||||
Vega Ventures
Limited
|
83,500 | 41,750 | 125,250 | — | — | |||||||||||||||
David
Lifscitz
|
70,000 | 35,000 | 105,000 | — | — | |||||||||||||||
Elhanan Noam Enterprising
Ltd.
|
102,642 | — | 102,642 | — | — | |||||||||||||||
Trevor
Garvin
|
107,329 | 33,334 | 100,001 | 40,662 | — | |||||||||||||||
Lawrence
Leigh
|
41,666 | 20,833 | 62,499 | — | — | |||||||||||||||
Ryan
Lazarus
|
40,000 | 20,000 | 60,000 | — | — | |||||||||||||||
Aviad
Freidman
|
43,333 | - | 43,333 | — | — | |||||||||||||||
Nadav Kidron
(5)
|
10,371,735 | 1,714,000 | 12,085,735 | — | — | |||||||||||||||
Zeev
Bronfeld
|
6,158,517 | — | 6,158,517 | — | — | |||||||||||||||
Hadasit Medical Services and Development
Ltd
|
4,141,532 | — | 4,141,532 | — | — | |||||||||||||||
Russel
Leigh
|
700,000 | 50,000 | 750,000 | — | — | |||||||||||||||
Total
|
30,513,111 | 4,382,503 | 34,247,302 | 648,312 | — |
·
|
in the over-the-counter
market;
|
·
|
in privately negotiated
transactions;
|
·
|
through broker-dealers, who may
act as agents or principals;
|
·
|
through one or more underwriters
on a firm commitment or best-efforts
basis;
|
·
|
in a block trade in which a
broker-dealer will attempt to sell a block of securities as agent but may
position and resell a portion of the block as principal to facilitate the
transaction;
|
·
|
directly to one or more
purchasers;
|
·
|
through agents;
or
|
·
|
in any combination of the
above.
|
|
·
|
purchases of the securities by a
broker-dealer as principal and resales of the securities by the
broker-dealer for its account pursuant to this
prospectus;
|
|
·
|
ordinary brokerage transactions;
or
|
|
·
|
transactions in which the
broker-dealer solicits purchasers on a best efforts
basis.
|
Page
|
||
CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS:
|
||
Balance
Sheets
|
F-4
|
|
Statements of
Operations
|
F-5
|
|
Statements of Changes in
Stockholders’ Equity
|
F-6
|
|
Statements of Cash
Flows
|
F-7
|
|
Notes to Financial
Statements
|
F-8
|
Page
|
||
REPORT OF INDEPENDENT REGISTERED
PUBLIC
|
||
ACCOUNTING FIRM - Report of
Kesselman & Kesselman
|
F-14
|
|
REPORT OF INDEPENDENT REGISTERED
PUBLIC
|
||
ACCOUNTING FIRM - Report of Malone
& Bailey, PC
|
F-15
|
|
CONSOLIDATED FINANCIAL
STATEMENTS:
|
||
Balance
Sheets
|
F-16
|
|
Statements of
Operations
|
F-17
|
|
Statements of Changes in
Stockholders’ Equity
|
F-18
|
|
Statements of Cash
Flows
|
F-20
|
|
Notes to Financial
Statements
|
F-21
|
Page
|
||
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS:
|
||
Balance
sheets
|
F-4
|
|
Statements
of operations
|
F-5
|
|
Statements
of changes in stockholders’ equity
|
F-6
|
|
Statements
of cash flows
|
F-7
|
|
Notes
to financial statements
|
F-8-F-13
|
May 31,
|
August 31,
|
|||||||
2010
|
2009
|
|||||||
Unaudited
|
Audited
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 1,134,506 | $ | 1,716,866 | ||||
Short
term investments
|
500,000 | 1,000,000 | ||||||
Restricted
cash
|
16,008 | 16,000 | ||||||
Accounts
receivable – other
|
35,620 | 36,939 | ||||||
Prepaid
expenses
|
100,911 | 4,119 | ||||||
Grants
receivable from the Office of the Chief Scientist
|
266,215 | 400,405 | ||||||
Total
current assets
|
2,053,260 | 3,174,329 | ||||||
LONG
TERM DEPOSITS
|
10,729 | 12,161 | ||||||
PROPERTY AND EQUIPMENT,
net
|
51,552 | 75,361 | ||||||
Total
assets
|
$ | 2,115,541 | $ | 3,261,851 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 239,093 | $ | 321,344 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
286,345 | 368,596 | ||||||
PROVISION
FOR UNCERTAIN TAX POSITION
|
147,063 | 147,063 | ||||||
COMMITMENTS
|
||||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
stock of $ 0.001 par value - Authorized: 200,000,000 shares at May
31, 2010 and August 31, 2009; Issued and outstanding: 57,480,217 at May
31, 2010 and 56,456,710 shares at August 31, 2009,
respectively
|
57,480 | 56,456 | ||||||
Additional
paid-in capital
|
13,444,554 | 12,698,414 | ||||||
Deficit
accumulated during the development stage
|
(11,819,901 | ) | (10,008,678 | ) | ||||
Total
stockholders' equity
|
1,682,133 | 2,746,192 | ||||||
Total
liabilities and stockholders' equity
|
$ | 2,115,541 | $ | 3,261,851 |
Period
|
||||||||||||||||||||
from April
|
||||||||||||||||||||
12, 2002
|
||||||||||||||||||||
(inception)
|
||||||||||||||||||||
Nine months ended
|
Three months ended
|
through
|
||||||||||||||||||
May 31,
|
May 31,
|
May 31,
|
May 31,
|
May 31,
|
||||||||||||||||
2010
|
2009
|
2010
|
2009
|
2010
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
RESEARCH
AND DEVELOPMENT EXPENSES
|
$ | 833,498 | $ | 1,500,809 | $ | 346,716 | $ | 387,663 | $ | 5,978,357 | ||||||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||||||||||
GENERAL
AND ADMINISTRATIVE EXPENSES
|
981,861 | 879,518 | 459,242 | 144,145 | 5,239,412 | |||||||||||||||
OPERATING
LOSS
|
1,815,359 | 2,380,327 | 805,958 | 531,808 | 11,652,645 | |||||||||||||||
FINANCIAL
INCOME
|
(15,897 | ) | (38,950 | ) | (4,981 | ) | (18,518 | ) | (152,005 | ) | ||||||||||
FINANCIAL
EXPENSE
|
11,761 | 18,211 | 5,242 | 159,694 | ||||||||||||||||
LOSS
BEFORE TAXES ON INCOME
|
1,811,223 | 2,359,588 | 806,219 | 513,290 | 11,660,334 | |||||||||||||||
TAXES
ON INCOME
|
- | - | - | - | 159,567 | |||||||||||||||
NET
LOSS FOR THE PERIOD
|
$ | 1,811,223 | $ | 2,359,588 | $ | 806,219 | $ | 513,290 | $ | 11,819,901 | ||||||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | 0.03 | $ | 0.04 | $ | 0.01 | $ | 0.01 | ||||||||||||
WEIGHTED
AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS
PER COMMON STOCK
|
57,349,130 | 56,546,323 | 57,466,907 | 56,802,562 |
Deficit
|
||||||||||||||||||||
accumulated
|
||||||||||||||||||||
Additional
|
during the
|
Total
|
||||||||||||||||||
Common Stock
|
paid-in
|
development
|
stockholders'
|
|||||||||||||||||
Shares
|
$
|
capital
|
stage
|
equity
|
||||||||||||||||
BALANCE AS OF APRIL 12, 2002 (inception)
|
34,828,200 | $ | 34,828 | $ | 18,872 | $ | 53,700 | |||||||||||||
CHANGES
DURING THE PERIOD FROM APRIL 12, 2002 THROUGH AUGUST
31, 2008 (audited):
|
||||||||||||||||||||
SHARES
CANCELLED
|
(19,800,000 | ) | (19,800 | ) | 19,800 | - | ||||||||||||||
SHARES
ISSUED FOR INVESTMENT IN ISTI-NJ
|
1,144,410 | 1,144 | 433,732 | 434,876 | ||||||||||||||||
SHARES
ISSUED FOR OFFERING COSTS
|
1,752,941 | 1,753 | (1,753 | ) | - | |||||||||||||||
SHARES
ISSUED FOR CASH– NET OF ISSUANCE EXPENSES
|
37,359,230 | 37,359 | 7,870,422 | 7,907,781 | ||||||||||||||||
SHARES
ISSUED FOR SERVICES
|
418,025 | 418 | 214,442 | 214,860 | ||||||||||||||||
CONTRIBUTIONS
TO PAID IN CAPITAL
|
18,991 | 18,991 | ||||||||||||||||||
RECEIPTS
ON ACCOUNT OF SHARES AND
WARRANTS
|
6,061 | 6,061 | ||||||||||||||||||
SHARES
ISSUED FOR CONVERSION OF CONVERTIBLE NOTE
|
550,000 | 550 | 274,450 | 275,000 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
2,428,014 | 2,428,014 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
381,764 | 381,764 | ||||||||||||||||||
DISCOUNT
ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION
FEATURE
|
108,000 | 108,000 | ||||||||||||||||||
COMPREHENSIVE
LOSS
|
(16 | ) | (16 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
12,217 | 12,217 | ||||||||||||||||||
NET
LOSS
|
(7,248,188 | ) | (7,248,188 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2008 (audited)
|
56,252,806 | 56,252 | 11,785,012 | (7,248,204 | ) | 4,593,060 | ||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED
|
203,904 | 204 | 152,724 | 152,928 | ||||||||||||||||
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
203,699 | 203,699 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
436,025 | 436,025 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
117,174 | 117,174 | ||||||||||||||||||
IMPUTED
INTEREST
|
3,780 | 3,780 | ||||||||||||||||||
NET
LOSS
|
(2,760,474 | ) | (2,760,474 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2009 (audited)
|
56,456,710 | 56,456 | 12,698,414 | (10,008,678 | ) | 2,746,192 | ||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED IN PREVIOUS PERIOD
|
569,887 | 570 | (570 | ) | - | |||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED
|
453,620 | 454 | 211,546 | 212,000 | ||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
423,795 | 423,795 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
108,533 | 108,533 | ||||||||||||||||||
IMPUTED
INTEREST
|
2,836 | 2,836 | ||||||||||||||||||
NET
LOSS
|
(1,811,223 | ) | (1,811,223 | ) | ||||||||||||||||
BALANCE
AS OF MAY 31, 2010 (unaudited)
|
57,480,217 | $ | 57,480 | $ | 13,444,554 | $ | (11,819,901 | ) | $ | 1,682,133 |
Period from April
|
||||||||||||
12, 2002
|
||||||||||||
(inception date)
|
||||||||||||
Nine months ended
|
through
|
|||||||||||
May 31,
|
May 31,
|
|||||||||||
2010
|
2009
|
2010
|
||||||||||
Unaudited
|
||||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (1,811,223 | ) | $ | (2,359,588 | ) | $ | (11,819,901 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
|
23,809 | 22,760 | 69,751 | |||||||||
Amortization
of debt discount
|
- | - | 108,000 | |||||||||
Exchange
differences on long term deposits
|
317 | 1,110 | (684 | ) | ||||||||
Stock based
compensation
|
744,328 | 526,138 | 4,475,093 | |||||||||
Shares
to be issued for services rendered
|
109,590 | 203,699 | ||||||||||
Impairment of
investment
|
- | - | 434,876 | |||||||||
Imputed
interest
|
2,836 | 2,834 | 18,833 | |||||||||
Changes in operating assets and
liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
38,717 | 367,526 | (402,746 | ) | ||||||||
Restricted
cash
|
(8 | ) | - | (16,008 | ) | |||||||
Accounts payable and accrued
expenses
|
(82,251 | ) | (438,926 | ) | 239,093 | |||||||
Provision for uncertain tax
position
|
- | - | 147,063 | |||||||||
Total
net cash used in operating activities
|
(1,083,475 | ) | (1,768,556 | ) | (6,542,931 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
- | (4,110 | ) | (121,303 | ) | |||||||
Acquisition
of short-term investments
|
500,000 | - | (3,228,000 | ) | ||||||||
Proceeds
from sale of Short term investments
|
- | 2,728,000 | 2,728,000 | |||||||||
Lease
deposits
|
1,115 | (4,668 | ) | (10,045 | ) | |||||||
Total
net cash derived from (used in) investing activities
|
501,115 | 2,719,222 | (631,348 | ) | ||||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds from sales of common
stock and warrants - net of issuance
expenses
|
- | - | 7,961,481 | |||||||||
Receipts on account of shares
issuances
|
6,061 | |||||||||||
Proceeds from convertible
notes
|
- | - | 275,000 | |||||||||
Proceeds from short term note
payable
|
- | - | 120,000 | |||||||||
Payments of short term note
payable
|
- | - | (120,000 | ) | ||||||||
Shareholder
advances
|
- | - | 66,243 | |||||||||
Net
cash provided by financing activities
|
- | - | 8,308,785 | |||||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(582,360 | ) | 950,666 | 1,134,506 | ||||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
1,716,866 | 2,267,320 | - | |||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 1,134,506 | $ | 3,217,986 | $ | 1,134,506 | ||||||
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 |
|
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 capsule to be used for the treatment
of individuals with diabetes. The Company has been in the development
stage since its formation and has not yet realized any revenues from its
operations.
|
|
On
May 14, 2007, the Company incorporated a wholly-owned subsidiary in
Israel, Oramed Ltd., which is engaged in research and development. Unless
the context indicates otherwise, the term “Group” refers to Oramed
Pharmaceuticals Inc. and its Israeli subsidiary, Oramed Ltd. (the
“Subsidiary”).
|
|
The
group is engaged in research and development in the biotechnology field
and is considered a development stage company in accordance with ASC Topic
915 (formerly FAS 7) “Development Stage
Entities”.
|
|
2.
|
The
accompanying unaudited interim consolidated financial statements as of May
31, 2010 and for the nine 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 months ended May 31, 2010, are not necessarily
indicative of the results that may be expected for the year ending August
31, 2010.
|
|
3.
|
Going
concern considerations
|
|
b.
|
Newly
issued and recently adopted Accounting
Pronouncements
|
|
In
February 2010, the FASB issued Accounting Standards Update No. 2010-09
("ASU 2010-09"), "Subsequent Events (Topic 855): Amendments to Certain
Recognition and Disclosure Requirements," which among other things amended
ASC 855 to remove the requirement for an SEC filer to disclose the date
through which subsequent events have been evaluated. This change
alleviates potential conflicts between ASC 855 and the SEC's requirements.
All of the amendments in this update are effective upon issuance of this
update. Management has included the provisions of these amendments in the
financial statements.
|
|
c.
|
Reclassification:
|
|
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.
|
|
b.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note
3a.
|
|
c.
|
On
April 22, 2009, the subsidiary entered into a consulting service agreement
with ADRES
Advanced Regulatory Services Ltd. (“ADRES”) pursuant to which ADRES
will provide consulting services relating to quality assurance and
regulatory processes and procedures in order to assist the subsidiary in
submission of a U.S. Investigational New Drug (“IND”) according to FDA
regulations. In consideration for the services provided under the
agreement, ADRES will be entitled to a total cash compensation of
$211,000, of which the amount $110,000 will be paid as a monthly
fixed fee of $10,000 each month for 11 months commencing May 2009, and the
remaining $101,000 will be paid based on achievement of certain
milestones. The Company has completed making the 11 monthly payments in
accordance with the agreement, and has made an additional payment of
$30,000 for the completion of certain
milestones.
|
|
d.
|
On
February 10, 2010, the subsidiary entered into agreements with Vetgenerics
Research G. Ziv Ltd, a clinical research organization (CRO), to conduct a
toxicology trial on its oral insulin capsules. The total cost estimated
for the studies is €107,100 ($133,040) of which €12,195 ($16,806) was paid
through May 31, 2010.
|
|
e.
|
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. The work commenced in June 2010, and no liability have
accrued through May 31, 2010.
|
|
f.
|
Grants
from the Chief Scientist Office
("OCS")
|
|
a.
|
On
October 30, 2006 the Company entered into a Clinical Trial Manufacturing
Agreement with Swiss Caps AG (“Swiss”), pursuant to
which Swiss would manufacture and deliver the oral insulin capsule
developed by the Company. In consideration for the services being provided
to the Company by Swiss, the Company agreed to pay a certain predetermined
amounts which are to be paid in common stocks of the Company, the number
of stocks to be issued is based on the invoice received from Swiss, and
the stock market price 10 days after the invoice was issued. The Company
accounted the transaction with Swiss according to FASB ASC 480
"Distinguishing Liabilities from Equity" (formerly FAS
150).
|
|
b.
|
On
November 23, 2009, 100,000 options were granted to a consultant, at an
exercise price of $0.76 per share (higher than the traded market price on
the date of grant), the options vest in three equal annual instalments
commencing November 23, 2010 and expire on November 23, 2014. The
engagement with the consultant has ended during the nine months period
ended May 31, 2010. The fair value of these options on the date of grant,
was $36,662, using the Black Scholes option-pricing model and was based on
the following assumptions: dividend yield of 0% for all years; expected
volatility of 123.30%; risk-free interest rates of 2.20%; and the
remaining contractual life of 5 years. The Company recorded all expenses
in respect of these options during that
period.
|
|
c.
|
On
November 23, 2009, 36,000 options were granted to an employee of the
Subsidiary, at an exercise price of $0.46 per share (equivalent to the
traded market price on the date of grant), the options vest in three equal
annual instalments commencing November 23, 2010 and expire on November 23,
2019. The fair value of these options on the date of grant was $14,565,
using the Black Scholes option-pricing model and was based on the
following assumptions: dividend yield of 0% for all years; expected
volatility of 123.55%; risk-free interest rates of 2.55%; and the
remaining contractual life of 6
years.
|
|
d.
|
On
December 29, 2009, the Company issued 100,000 shares of its common stock
to a third party as remuneration for services rendered and to be rendered
during the six month period commencing December 15, 2009. The fair value
of these shares on the date of issuance was
$37,000.
|
|
e.
|
On
March 16, 2010, 13,200 options were granted to a consultant, at an
exercise price of $0.43 per share (equivalent to the traded market price
on the date of grant), the options vest in six monthly instalments
commencing March 30, 2010 and expire on March 15, 2015. The fair value of
these options on the date of grant, was $4,747, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 121.61%; risk-free
interest rates of 2.37%; and the remaining contractual life of 5
years.
|
|
f.
|
On
March 16, 2010, 100,000 options were granted to a consultant, 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 monthly instalments
commencing March 30, 2010 and expire on March 15, 2015. The fair value of
these options on the date of grant, was $35,960, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 121.61%; risk-free
interest rates of 2.37%; and the remaining contractual life of 5
years.
|
|
g.
|
On
March 16, 2010, 50,000 options were granted to a consultant, at an
exercise price of $0.50 per share (higher than the traded market price on
the date of grant), the options vest in three equal annual instalments
commencing March 16, 2011 and expire on March 15, 2015. The fair value of
these options on the date of grant, was $17,702, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 121.61%; risk-free
interest rates of 2.37%; and the remaining contractual life of 5
years.
|
|
h.
|
On
March 25, 2010, 100,000 options were granted to a consultant, at an
exercise price of $0.50 per share (higher than the traded market price on
the date of grant), the options vest in four equal quarterly instalments
commencing May 17, 2010 and expire on March 24, 2015. The fair value of
these options on the date of grant, was $39,091, using the Black Scholes
option-pricing model and was based on the following assumptions: dividend
yield of 0% for all years; expected volatility of 121.21%; risk-free
interest rates of 2.65%; and the remaining contractual life of 5
years.
|
|
i.
|
On
April 21, 2010, an aggregate of 1,728,000 options were granted to Nadav
Kidron, the Company’s President, Chief Executive Officer and director, and
Miriam Kidron, the Company’s Chief Medical and Technology Officer and
director, both are related parties, at an exercise price of $0.49 per
share (equivalent to the traded market price on the date of grant),
216,000 of the options vested immediately on the date of grant and the
remainder will vest in twenty one equal monthly installments. These
options expire on April 20, 2020. The fair value of these options on the
date of grant was $807,392, using the Black Scholes option-pricing model
and was based on the following assumptions: dividend yield of 0% for all
years; expected volatility of 120.69%; risk-free interest rates of 3.77%;
and expected lives of 10 years.
|
|
a.
|
Related
parties transaction
|
|
b.
|
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.
|
c.
|
On July 8, 2010, 300,000 options
were granted to a director at an exercise price of $0.48 per share
(equivalent to the traded market price on the date of grant). The options
vest in three equal annual instalments commencing on July 8, 2011 and will
expire on July 7, 2020.
|
Kesselman
& Kesselman
|
Tel
Aviv, Israel
|
November
25, 2009
|
August 31
|
||||||||
2009
|
2008
|
|||||||
Assets
|
||||||||
CURRENT
ASSETS:
|
||||||||
Cash
and cash equivalents
|
$ | 1,716,866 | $ | 2,267,320 | ||||
Short
term investments (Note 2)
|
1,000,000 | 2,728,000 | ||||||
Restricted
cash (Note 1n)
|
16,000 | |||||||
Accounts
receivable - other
|
36,939 | 38,822 | ||||||
Prepaid
expenses
|
4,119 | 363,752 | ||||||
Grants
receivable from the Chief Scientist
|
400,405 | |||||||
Total
current assets
|
3,174,329 | 5,397,894 | ||||||
LONG TERM DEPOSITS (Note
6b)
|
12,161 | 10,824 | ||||||
PROPERTY AND EQUIPMENT, NET
(Note 4)
|
75,361 | 98,296 | ||||||
Total
assets
|
$ | 3,261,851 | $ | 5,507,014 | ||||
Liabilities
and stockholders' equity
|
||||||||
CURRENT
LIABILITIES:
|
||||||||
Accounts
payable and accrued expenses (note 9)
|
$ | 321,344 | $ | 736,052 | ||||
Account
payable with former shareholder
|
47,252 | 47,252 | ||||||
Total
current liabilities
|
368,596 | 783,304 | ||||||
PROVISION
FOR UNCERTAIN TAX POSITION (Note 12f)
|
147,063 | 130,650 | ||||||
COMMITMENTS (Note
6)
|
||||||||
STOCKHOLDERS’
EQUITY:
|
||||||||
Common
stock, $ 0.001 par value (200,000,000 authorized shares; 56,456,710 and
56,252,806 shares issued and outstanding as of August 31, 2009 and 2008,
respectively)
|
56,456 | 56,252 | ||||||
Additional
paid-in capital
|
12,698,414 | 11,785,012 | ||||||
Deficit
accumulated during the development stage
|
(10,008,678 | ) | (7,248,204 | ) | ||||
Total
stockholders' equity
|
2,746,192 | 4,593,060 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 3,261,851 | $ | 5,507,014 |
Period
|
||||||||||||
from April
|
||||||||||||
12, 2002
|
||||||||||||
(inception)
|
||||||||||||
Year ended
|
through
|
|||||||||||
August 31
|
August 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
RESEARCH AND DEVELOPMENT
EXPENSES, NET (Note 10)
|
$ | 1,522,188 | $ | 1,210,494 | $ | 5,144,859 | ||||||
IMPAIRMENT
OF INVESTMENT
|
434,876 | |||||||||||
GENERAL AND ADMINISTRATIVE
EXPENSES (note 11)
|
1,261,930 | 1,469,517 | 4,257,551 | |||||||||
OPERATING
LOSS
|
2,784,118 | 2,680,011 | 9,837,286 | |||||||||
FINANCIAL
INCOME
|
(38,602 | ) | (83,185 | ) | (136,108 | ) | ||||||
FINANCIAL
EXPENSE
|
17,555 | 10,281 | 147,933 | |||||||||
LOSS
BEFORE TAXES ON INCOME
|
2,763,071 | 2,607,107 | 9,849,111 | |||||||||
TAXES ON INCOME (note
12)
|
(2,597 | ) | 162,164 | 159,567 | ||||||||
NET
LOSS FOR THE PERIOD
|
$ | 2,760,474 | $ | 2,769,271 | $ | 10,008,678 | ||||||
BASIC
AND DILUTED LOSS PER COMMON SHARE
|
$ | (0.05 | ) | $ | (0.06 | ) | ||||||
WEIGHTED
AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS
PER COMMON STOCK
|
56,645,820 | 48,604,889 |
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 | ||||||||||||||||
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 | ||||||||||||||||||
CONTRIBUTIONS
TO PAID IN CAPITAL
|
18,991 | 18,991 | ||||||||||||||||||
COMPREHENSIVE
LOSS:
|
||||||||||||||||||||
NET
LOSS
|
(4,478,917 | ) | (4,478,917 | ) | ||||||||||||||||
OTHER
COMPREHENSIVE LOSS
|
(16 | ) | (16 | ) | ||||||||||||||||
IMPUTED
INTEREST
|
8,437 | 8,437 | ||||||||||||||||||
BALANCE
AS OF AUGUST 31, 2007
|
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
|
56,252,806 | 56,252 | 11,785,012 | (7,248,204 | ) | 4,593,060 | ||||||||||||||
SHARES
ISSUED FOR SERVICES RENDERED
|
203,904 | 204 | 152,724 | 152,928 |
SHARES
TO BE ISSUED FOR SERVICES RENDERED
|
203,699 | 203,699 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND
DIRECTORS
|
436,025 | 436,025 | ||||||||||||||||||
STOCK
BASED COMPENSATION RELATED TO OPTIONS GRANTED TO
CONSULTANTS
|
117,174 | 117,174 | ||||||||||||||||||
IMPUTED
INTEREST
|
3,780 | 3,780 | ||||||||||||||||||
NET
LOSS
|
(2,760,474 | ) | (2,760,474 | ) | ||||||||||||||||
BALANCE
AS OF AUGUST 31, 2009
|
56,456,710 | $ | 56,456 | $ | 12,698,414 | $ | (10,008,678 | ) | $ | 2,746,192 |
Period from April
12, 2002
(inception date)
through
|
||||||||||||
Year ended August 31
|
August 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net
loss
|
$ | (2,760,474 | ) | $ | (2,769,271 | ) | $ | (10,008,678 | ) | |||
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
30,488 | 15,454 | 45,942 | |||||||||
Amortization
of debt discount
|
108,000 | |||||||||||
Exchange
differences on long term deposits
|
641 | (1,642 | ) | (1,001 | ) | |||||||
Stock
based compensation
|
553,199 | 663,449 | 3,362,977 | |||||||||
Common
stock issued for services
|
152,928 | 116,110 | 367,788 | |||||||||
Common
stock to be issued for services
|
203,699 | 203,699 | ||||||||||
Impairment
of investment
|
434,876 | |||||||||||
Imputed
interest
|
3,780 | 3,780 | 15,997 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
(38,889 | ) | (390,668 | ) | (441,463 | ) | ||||||
Restricted
cash
|
(16,000 | ) | (16,000 | ) | ||||||||
Accounts
payable and accrued expenses
|
(414,708 | ) | 395,180 | 321,344 | ||||||||
Provision
for uncertain tax position
|
16,413 | 130,650 | 147,063 | |||||||||
Total
net cash used in operating activities
|
(2,268,923 | ) | (1,836,958 | ) | (5,459,456 | ) | ||||||
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase
of property and equipment
|
(7,553 | ) | (112,014 | ) | (121,303 | ) | ||||||
Short
term investments
|
(1,000,000 | ) | (2,728,000 | ) | (3,728,000 | ) | ||||||
Proceeds
from sale of short term investments
|
2,728,000 | 2,728,000 | ||||||||||
Lease
deposits, net
|
(1,978 | ) | (3,738 | ) | (11,160 | ) | ||||||
Total
net cash provided by (used in) investing activities
|
1,718,469 | (2,843,752 | ) | (1,132,463 | ) | |||||||
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds
from sales of common stocks and warrants - net of issuance
expenses
|
5,029,801 | 7,961,481 | ||||||||||
Receipts
on account of shares issuances
|
6,061 | |||||||||||
Proceeds
from convertible notes
|
275,000 | |||||||||||
Proceeds
from short term note payable
|
120,000 | |||||||||||
Payments
of short term note payable
|
(120,000 | ) | ||||||||||
Shareholder
advances
|
66,243 | |||||||||||
Net
cash provided by financing activities
|
5,029,801 | 8,308,785 | ||||||||||
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(550,454 | ) | 349,091 | 1,716,866 | ||||||||
CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
2,267,320 | 1,918,229 | ||||||||||
CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 1,716,866 | $ | 2,267,320 | $ | 1,716,866 | ||||||
Non
cash investing and financing activities:
|
||||||||||||
Receipts
on account of shares issuance - reclassified from liability to
shareholder's equity
|
$ | 6,061 | ||||||||||
Stock
issued for receipts on account of shares issuance and convertible
notes
|
$ | 1,030,000 | ||||||||||
Discount
on convertible note related to beneficial conversion
feature
|
$ | 108,000 | ||||||||||
Shares
issued for offering costs
|
$ | 1,753 | ||||||||||
Contribution
to paid in capital
|
$ | 18,991 |
|
a.
|
General:
|
|
b.
|
Accounting
principles
|
|
The
consolidated financial statements have been prepared in accordance with
generally accepted accounting principles in the United States of America
(“U.S.
GAAP”).
|
|
c.
|
Use
of estimates in the preparation of financial
statements
|
|
d.
|
Functional
currency
|
|
e.
|
Principles
of consolidation
|
|
f.
|
Property
and equipment
|
%
|
|||
Computers
and peripheral equipment
|
33 | ||
Office
furniture and equipment
|
15-33
|
|
g.
|
Income
taxes
|
|
1.
|
Deferred
taxes
|
|
2.
|
Uncertainty
in income tax
|
|
h.
|
Research
and development
|
|
i.
|
Cash
equivalents
|
|
j.
|
Comprehensive
loss
|
|
The
Company has no other comprehensive loss components other than net loss for
the fiscal years of 2008 and 2009.
|
|
k.
|
Loss
per share
|
|
l.
|
Impairment
in value of long-lived assets
|
|
m.
|
Stock
based compensation
|
|
n.
|
Fair
value measurement:
|
|
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.
|
|
o.
|
Concentration
of credit risks
|
|
p.
|
Newly
issued and recently adopted accounting
pronouncements:
|
|
1.
|
In
May 2009, the FASB issued SFAS No. 165, “Subsequent Events” (“SFAS 165”).
SFAS 165 sets forth the period after the balance sheet date during which
management of a reporting entity should evaluate events or transactions
that may occur for potential recognition or disclosure in the financial
statements, the circumstances under which an entity should recognize
events or transactions occurring after the balance sheet date in its
financial statements, and the disclosures that an entity should make about
events or transactions that occurred after the balance sheet date. SFAS
165 will be effective for interim or annual periods ending after June 15,
2009 and will be applied prospectively. The Company adopted the provisions
of FAS 165. The adoption of SFAS No. 165 did not have a material impact on
the Company’s condensed financial condition, results of operations or cash
flows.
|
|
2.
|
In
June 2009, the FASB issued SFAS No. 168 “The FASB Accounting Standards
Codification and the Hierarchy of Generally Accepted Accounting Principles
— A Replacement of FASB Statement No. 162” (“SFAS 168”). Statement 168
establishes the FASB Accounting Standards CodificationTM (Codification) as
the single source of authoritative U.S. generally accepted accounting
principles (U.S. GAAP) recognized by the FASB to be applied by
nongovernmental entities. Rules and interpretive releases of the SEC under
authority of federal securities laws are also sources of authoritative
U.S. GAAP for SEC registrants. SFAS 168 and the Codification are effective
for financial statements issued for interim and annual periods ending
after September 15, 2009. When effective, the Codification will supersede
all existing non-SEC accounting and reporting standards. All other
nongrandfathered non-SEC accounting literature not included in the
Codification will become nonauthoritative. Following SFAS 168, the FASB
will not issue new standards in the form of Statements, FASB Staff
Positions, or Emerging Issues Task Force Abstracts. Instead, the FASB will
issue Accounting Standards Updates, which will serve only to: (a) update
the Codification; (b) provide background information about the guidance;
and (c) provide the bases for conclusions on the change(s) in the
Codification. The Company does not expect that the adoption of SFAS 168 to
have a material impact on the Company’s financial
statements.
|
|
q.
|
Reclassifications
|
|
a.
|
Composition
of property and equipment, grouped by major classifications, is as
follows:
|
August
31
|
||||||||
2009
|
2008
|
|||||||
Cost:
|
||||||||
Leasehold
improvements
|
$ | 76,029 | $ | 76,029 | ||||
Office
furniture and equipment
|
19,941 | 17,684 | ||||||
Computers
and peripheral equipment
|
25,333 | 20,037 | ||||||
121,303 | 113,750 | |||||||
Less
- accumulated depreciation and amortization
|
45,942 | 15,454 | ||||||
$ | 75,361 | $ | 98,296 |
|
b.
|
Depreciation
expense totaled $30,488 and $15,454 in the years ended August 31, 2009 and
2008, respectively.
|
|
a.
|
Under
the terms of the First Agreement with Hadasit (note 1a 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.
|
b.
|
The
Subsidiary has entered into operating lease agreements for vehicles used
by its employees for a period of 3
years.
|
|
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 at 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 August 31, 2009 the monthly payment in the Company's
functional currency is $629, the future annual lease payment under the
agreement are $7,548).
|
|
d.
|
During
January and April 2008 the Company entered into agreements with OnQ
consulting, a clinical research organization (CRO) located in
Johannesburg, South Africa, to conduct Phase 1B and 2B clinical trials on
its oral insulin capsules. The total cost estimated for the studies is
$229,681 of which $107,599 was paid through August 31,
2009.
|
|
e.
|
As
to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see note
8a.
|
|
f.
|
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 $227,604, of
which $45,038 was paid though August 31,
2009.
|
|
g.
|
On
April 22, 2009, the subsidiary entered into a consulting service agreement
with ADRES
Advanced Regulatory Services Ltd. (“ADRES”) pursuant to which ADRES will
provide consulting services relating to quality assurance and regulatory
processes and procedures in order to assist the subsidiary in submission
of a U.S. 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. $50,000 of the total amount was paid though August 31,
2009.
|
|
h.
|
Grants
from the Chief Scientist Office
("OCS")
|
|
a.
|
On
July 14, 2008, the Company entered into a Securities Purchase Agreement
with twenty-nine accredited investors for the sale of 8,524,669 units at a
purchase price of $0.60 per unit for total consideration of $5,114,799.
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 half a share of common stock exercisable for three years at an
exercise price of $0.90 per share.
|
|
No
warrants were exercised throughout August 31,
2009.
|
|
b.
|
As
to shares issued as part of stock based compensation plan see Note
8.
|
|
c.
|
As to a Clinical Trial Manufacturing Agreement with Swiss Caps AG, see
note 8a.
|
|
a.
|
On
October 30, 2006 the Company entered into a Clinical Trial Manufacturing
Agreement with Swiss Caps AG (“Swiss”), pursuant to
which Swiss would manufacture and deliver the oral insulin capsule
developed by the Company. In consideration for the services being provided
to the Company by Swiss, the Company agreed to pay a certain predetermined
amounts which are to be paid in common stocks of the Company, the number
of stocks to be issued is based on the invoice received from Swiss, and
the stock market price 10 days after the invoice was issued. The Company
accounted the transaction with Swiss according to FAS 150 "Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and
Equity".
|
|
b.
|
On
September 4, 2007, 300,000 options were granted to two outside
consultants, at an exercise price of $0.45 per share (equivalent to the
traded market price on the date of grant), the options vest in twelve
equal monthly installments over the first year and those options expired
on September 4, 2009. On September 4, 2009, these options were
expired.
|
c.
|
On
October 30, 2007, 100,000 options were granted to an advisory board
member, at an exercise price of $0.76 per share (over the traded market
price on the date of grant), the options vest in eighteen equal monthly
installments from the date of grant and expire on October 30,
2010.
|
d.
|
On
May 7, 2008, an aggregate of 1,728,000 options were granted to Nadav
Kidron, the Company’s President, Chief Executive Officer and director, and
Miriam Kidron, the Company’s Chief Medical and Technology Officer and
director, both are related parties through KNRY Ltd. (see note 13c), at an
exercise price of $0.54 per share (equivalent to the traded market price
on the date of grant), 288,000 of the options vested immediately on the
date of grant and the remainder will vest in twenty equal monthly
installments. These options expire on May 7,
2018.
|
e.
|
On
July 17, 2008, 100,000 options were granted to an advisory board member,
at an exercise price of $0.62 per share (equivalent to the traded market
price on the date of grant), the options vest in four equal quarterly
installments commencing on September 17, 2008 and expire on July 17,
2011.
|
f.
|
On
October 12, 2008, 828,000 options were granted to an employee of the
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 installments commencing on November 1, 2009 and expire on October
11, 2018. 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 reversed that expense in the three months ended May 31, 2009.
|
|
g.
|
On
October 12, 2008, 56,000 options were granted to an employee of the
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 installments commencing on May 1, 2009 and expire on October 11,
2018.
|
|
h.
|
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 the 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 installments
commencing on January 1, 2010 and expire on January 10, 2019. 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
year and reversed that expense.
|
|
i.
|
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 installments commencing on April 1, 2009 and
expire on January 10, 2019.
|
|
j.
|
On
June 3, 2009, 400,000 options were granted to an employee of the
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 installments, commencing October 19, 2010, and expire on October
19, 2019.
|
|
k.
|
On
August 20, 2009, 100,000 options were granted to an employee of the
subsidiary, at an exercise price of $0.42 per share (equivalent to the
traded market price on the date of grant). The options vest in three equal
annual installments commencing August 20, 2010, and expire on August 20,
2019.
|
For options granted in
|
||||||
year ended August 31
|
||||||
2009
|
2008
|
|||||
Expected
option life (years)
|
1.0-9.8
|
1.0-5.4
|
||||
Expected
stock price volatility (%)
|
113.1-130.5
|
116.3-118.0
|
||||
Risk
free interest rate (%)
|
0.7-3.6
|
2.2-3.4
|
||||
Expected
dividend yield (%)
|
0.0
|
0.0
|
Year ended August 31,
|
||||||||||||||||
2009
|
2008
|
|||||||||||||||
Weighted
|
Weighted
|
|||||||||||||||
Number
|
average
|
Number
|
average
|
|||||||||||||
of
|
exercise
|
of
|
exercise
|
|||||||||||||
options
|
price
|
options
|
price
|
|||||||||||||
$
|
$
|
|||||||||||||||
Options
outstanding at
|
||||||||||||||||
beginning
of year
|
7,289,360 | 0.29 | 5,561,360 | 0.21 | ||||||||||||
Changes
during the year:
|
||||||||||||||||
Granted
– at market price
|
2,134,000 | 0.45 | 1,728,000 | 0.54 | ||||||||||||
Forfeited
|
(978,000 | ) | 0.46 | |||||||||||||
Options
outstanding at end
|
||||||||||||||||
of
year
|
8,445,360 | 0.31 | 7,289,360 | 0.29 | ||||||||||||
Options
exercisable at end
|
||||||||||||||||
of
year
|
7,001,360 | 6,137,360 | ||||||||||||||
Weighted
average fair
|
||||||||||||||||
value
of options granted
|
||||||||||||||||
during
the year
|
$ | 0.45 | $ | 0.45 |
Weighted
|
||||||||||||||||
Average
|
Weighted
|
|||||||||||||||
Range of
|
Remaining
|
average
|
||||||||||||||
exercise
|
Number
|
Contractual
|
exercise
|
Aggregate
|
||||||||||||
prices
|
outstanding
|
Life
|
price
|
intrinsic value
|
||||||||||||
$
|
Years
|
$
|
$
|
|||||||||||||
0.001
|
3,361,360 | 2.95 | 0.001 | 1,542,864 | ||||||||||||
0.45
to 0.62
|
4,584,000 | 6.80 | 0.43 | 39,000 | ||||||||||||
0.76
to 0.90
|
500,000 | 0.23 | 0.76 | - | ||||||||||||
8,445,360 | 5.12 | 0.29 | 1,581,864 |
Weighted
|
||||||||||||||||
Average
|
Weighted
|
|||||||||||||||
Range of
|
Remaining
|
average
|
||||||||||||||
exercise
|
Number
|
Contractual
|
exercise
|
Aggregate
|
||||||||||||
prices
|
exercisable
|
Life
|
price
|
intrinsic value
|
||||||||||||
$
|
Years
|
$
|
$
|
|||||||||||||
0.001
|
3,361,360 | 2.95 | 0.001 | 1,542,864 | ||||||||||||
0.45
to 0.62
|
3,140,000 | 5.57 | 0.49 | 17,000 | ||||||||||||
0.76
to 0.90
|
500,000 | 0.23 | 0.76 | - | ||||||||||||
7,001,360 | 4.26 | 0.24 | 1,559,864 |
Year ended August 31
|
||||||||||||||||
2009
|
2008
|
|||||||||||||||
Weighted
|
Weighted
|
|||||||||||||||
Number
|
average
|
Number
|
average
|
|||||||||||||
of
|
exercise
|
of
|
exercise
|
|||||||||||||
options
|
price
|
options
|
price
|
|||||||||||||
$
|
$
|
|||||||||||||||
Options
outstanding at
|
||||||||||||||||
beginning
of year
|
900,000 | 0.65 | 750,000 | 0.76 | ||||||||||||
Changes
during the year:
|
||||||||||||||||
Granted
– at market price
|
150,000 | 0.71 | ||||||||||||||
Granted
– at an exercise
|
||||||||||||||||
price
above market
|
||||||||||||||||
Price
|
300,000 | 0.76 | 400,000 | 0.53 | ||||||||||||
Expired
|
(400,000 | ) | 0.76 | |||||||||||||
Options
outstanding at end
|
||||||||||||||||
of
year
|
1,200,000 | 0.68 | 900,000 | 0.65 | ||||||||||||
Options
exercisable at end
|
||||||||||||||||
of
year
|
900,000 | 733,333 |
Weighted
|
||||||||||||||||
Average
|
Weighted
|
|||||||||||||||
Range of
|
Remaining
|
average
|
||||||||||||||
exercise
|
Number
|
Contractual
|
exercise
|
Aggregate
|
||||||||||||
prices
|
outstanding
|
Life
|
price
|
intrinsic value
|
||||||||||||
$
|
|
Years
|
$
|
$
|
||||||||||||
0.45
to 0.62
|
400,000 | 0.48 | 0.49 | 3,000 | ||||||||||||
0.76
to 0.90
|
800,000 | 3.85 | 0.77 | - | ||||||||||||
1,200,000 | 2.73 | 0.68 | 3,000 |
Weighted
|
||||||||||||||||
Average
|
Weighted
|
|||||||||||||||
Range of
|
Remaining
|
average
|
||||||||||||||
exercise
|
Number
|
Contractual
|
exercise
|
Aggregate
|
||||||||||||
prices
|
exercisable
|
Life
|
price
|
intrinsic value
|
||||||||||||
$
|
Years
|
$
|
$
|
|||||||||||||
0.45
to 0.62
|
400,000 | 0.48 | 0.49 | 3,000 | ||||||||||||
0.76
to 0.90
|
500,000 | 0.55 | 0.77 | - | ||||||||||||
900,000 | 0.52 | 0.65 | 3,000 |
Year ended
|
||||||||
August 31,
|
||||||||
2009
|
2008
|
|||||||
Service
providers
|
$ | 274,291 | $ | 635,762 | ||||
Tax
provisions
|
12,504 | 31,514 | ||||||
Related
parties
|
28,062 | |||||||
Payroll
and related expenses
|
34,547 | 40,714 | ||||||
$ | 321,344 | $ | 736,052 |
Period from
April |
||||||||||||
12, 2002
|
||||||||||||
(inception)
|
||||||||||||
Year ended
|
through
|
|||||||||||
August 31,
|
August 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Clinical
trials
|
$ | 1,304,779 | $ | 538,056 | $ | 2,368,105 | ||||||
Payroll
and consulting fees
|
272,116 | 240,209 | 695,578 | |||||||||
Costs
for registration of patents
|
17,775 | 89,645 | 118,465 | |||||||||
Compensation
costs in respect of warrants granted to employees, directors and
consultants
|
264,861 | 285,336 | 2,216,663 | |||||||||
Other
|
63,062 | 57,248 | 146,453 | |||||||||
Less
– grants from the OCS
|
(400,405 | ) | (400,405 | ) | ||||||||
$ | 1,522,188 | $ | 1,210,494 | $ | 5,144,859 |
Period from
April |
||||||||||||
12, 2002
|
||||||||||||
(inception)
|
||||||||||||
Year ended
|
through
|
|||||||||||
August 31
|
August 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Compensation
costs in respect of warrants granted to employees, directors and
consultants
|
$ | 288,338 | $ | 378,113 | $ | 1,146,314 | ||||||
Professional
services
|
240,523 | 391,309 | 1,011,802 | |||||||||
Consulting
fees
|
155,359 | 151,037 | 480,678 | |||||||||
Travel
costs
|
132,531 | 141,862 | 410,704 | |||||||||
Write
off of debt
|
275,000 | |||||||||||
Business
development
|
73,286 | 154,357 | 227,643 | |||||||||
Payroll
and related expenses
|
205,122 | 95,244 | 300,366 | |||||||||
Insurance
|
25,068 | 23,630 | 48,698 | |||||||||
Other
|
141,703 | 133,965 | 356,346 | |||||||||
$ | 1,261,930 | $ | 1,469,517 | $ | 4,257,551 |
|
a.
|
Corporate
taxation in the U.S.
|
|
b.
|
Corporate
taxation in Israel:
|
|
c.
|
Deferred
income taxes:
|
August 31
|
||||||||
2009
|
2008
|
|||||||
In
respect of:
|
||||||||
Net
operating loss carryforward
|
$ | 1,507,587 | $ | 1,194,401 | ||||
Less
- Valuation allowance
|
(1,507,587 | ) | (1,194,401 | ) | ||||
Net
deferred tax assets
|
-,- | -,- |
|
d.
|
Income
loss before taxes on income and income taxes included in the income
statements:
|
Period from
April |
||||||||||||
12, 2002
|
||||||||||||
(inception)
|
||||||||||||
Year ended
|
through
|
|||||||||||
August 31
|
August 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Loss
before taxes on income:
|
||||||||||||
U.S.
|
$ | 248,890 | $ | 2,315,686 | $ | 7,134,126 | ||||||
Outside
U.S.
|
2,514,181 | 291,421 | 2,877,149 | |||||||||
2,763,071 | 2,607,107 | 10,011,275 | ||||||||||
Taxes
on income:
|
||||||||||||
Current:
|
||||||||||||
U.S.
|
16,664 | 39,799 | 56,463 | |||||||||
Outside
U.S.
|
(19,261 | ) | 122,365 | 103,104 | ||||||||
$ | (2,597 | ) | $ | 162,164 | $ | 159,567 |
|
e.
|
Reconciliation
of the theoretical tax expense to actual tax
expense
|
Period from
April |
||||||||||||
12, 2002
|
||||||||||||
(inception)
|
||||||||||||
Year ended
|
through
|
|||||||||||
August 31
|
August 31,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Loss
before income taxes as reported in the consolidated statement of
operations
|
$ | (2,763,071 | ) | $ | (2,607,107 | ) | $ | (9,849,111 | ) | |||
Computed
“expected” tax benefit
|
(967,075 | ) | (912,487 | ) | (3,447,189 | ) | ||||||
Increase
(decrease) in income taxes resulting from:
|
||||||||||||
Change
in the balance of the valuation allowance for deferred tax
losses
|
528,143 | 714,048 | 1,722,544 | |||||||||
Disallowable
deductions
|
149,043 | 200,916 | 1,431,509 | |||||||||
Increase
in taxes resulting from different tax rates applicable to non U.S.
subsidiary
|
270,879 | 29,037 | 305,640 | |||||||||
Uncertain
tax position
|
16,413 | 130,650 | 147,063 | |||||||||
Taxes
on income for the reported year
|
$ | (2,597 | ) | $ | 162,164 | $ | 159,567 |
|
f.
|
Uncertainty
in Income Taxes
|
|
a.
|
During
the fiscal years of 2008 and 2009 the Company paid to directors $15,000
and $16,000, respectively, for managerial
services.
|
|
b.
|
As
to the agreements with Hadasit, see note
6a.
|
|
c.
|
On
July 1, 2008, the subsidiary entered into a consulting agreement with KNRY
Ltd. (“KNRY”), an Israeli company owned by Nadav Kidron, whereby Mr. Nadav
Kidron, through KNRY, will provide services as President and Chief
Executive Officer of both Oramed and the subsidiary (the “Nadav Kidron
Consulting Agreement”). Additionally, on July 1, 2008, the
subsidiary entered into a consulting agreement with KNRY whereby Dr.
Miriam Kidron, through KNRY, will provide services as Chief Medical and
Technology Officer of both Oramed and the subsidiary (the “Miriam Kidron
Consulting Agreement” and together with the Nadav Kidron Consulting
Agreement, the “Consulting Agreements”). The Consulting
Agreements replaced the employment agreements entered into between the
Company and KNRY, dated as of August 1, 2007, pursuant to which Nadav
Kidron and Miriam Kidron, respectively, provide services to Oramed and the
subsidiary.
|
a.
|
On
September 11, 2009, the Company issued 569,887 shares of its common stock
to Swiss as remuneration for the services provided, in the amount of
$203,699.
|
b.
|
On
November 23, 2009, 100,000 options were granted to a consultant of the
subsidiary at an exercise price of $0.76 per share. The options vest in
three equal annual installments commencing on November 23, 2010 and will
expire on November 23, 2014.
|
c.
|
On
November 23, 2009, 36,000 options were granted to an employee of the
subsidiary at an exercise price of $0.46 per share. The options vest in
three equal annual installments commencing on November 23, 2010 and will
expire on November 23, 2019.
|