Delaware
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98-0376008
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(State or Other Jurisdiction of Incorporation or Organization)
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(I.R.S. Employer Identification No.)
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Hi-Tech Park 2/4 Givat Ram
PO Box 39098
Jerusalem, Israel
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91390
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(Address of Principal Executive Offices)
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(Zip Code)
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Large accelerated filer o | Accelerated filer o | |
Non-accelerated filer o | (Do not check if a smaller reporting company) | Smaller reporting company x |
1
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1
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2
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7
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7
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8 | |
8
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8
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Page
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CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:
|
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F-2
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F-3
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F-4 - F-6
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F-7
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F-8 - F-15
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November 30,
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August 31,
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|||||||
2013
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2013
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|||||||
A s s e t s
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||||||||
CURRENT ASSETS:
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||||||||
Cash and cash equivalents
|
$ | 1,370,753 | $ | 2,272,228 | ||||
Short term deposits
|
5,459,254 | 5,246,627 | ||||||
Marketable securities
|
962,392 | 956,376 | ||||||
Restricted cash
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16,000 | 16,000 | ||||||
Prepaid expenses and other current assets
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172,917 | 90,103 | ||||||
Related parties
|
5,097 | 4,530 | ||||||
Grants receivable from the chief scientist
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- | 58,412 | ||||||
T o t a l current assets
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7,986,413 | 8,644,276 | ||||||
LONG TERM DEPOSITS AND INVESTMENT
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4,593 | 4,593 | ||||||
AMOUNTS FUNDED IN RESPECT OF EMPLOYEE RIGHTS UPON RETIREMENT
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5,830 | 5,545 | ||||||
PROPERTY AND EQUIPMENT, NET
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8,792 | 5,768 | ||||||
T o t a l assets
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$ | 8,005,628 | $ | 8,660,182 | ||||
Liabilities and stockholders' equity
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued expenses
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$ | 621,274 | $ | 450,941 | ||||
Account payable with former shareholder
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47,252 | 47,252 | ||||||
T o t a l current liabilities
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668,526 | 498,193 | ||||||
LONG TERM LIABILITIES:
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||||||||
Employee rights upon retirement
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8,678 | 8,004 | ||||||
Provision for uncertain tax position
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23,210 | 23,210 | ||||||
31,888 | 31,214 | |||||||
COMMITMENTS (note 2)
|
||||||||
STOCKHOLDERS' EQUITY:
|
||||||||
Common stock, $ 0.012 par value (16,666,667 authorized shares; 7,947,872 and 7,937,872 shares issued and outstanding as of November 30, 2013 and August 31, 2013, respectively)
|
95,358 | 95,238 | ||||||
Accumulated other comprehensive income
|
334,173 | 303,403 | ||||||
Additional paid-in capital
|
30,123,592 | 29,855,723 | ||||||
Deficit accumulated during the development stage
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(23,247,909 | ) | (22,123,589 | ) | ||||
T o t a l stockholders' equity
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7,305,214 | 8,130,775 | ||||||
T o t a l liabilities and stockholders' equity
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$ | 8,005,628 | $ | 8,660,182 |
Period
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||||||||||||
from April
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||||||||||||
12, 2002 | ||||||||||||
(inception)
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||||||||||||
Three months ended
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through
|
|||||||||||
November 30,
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November 30,
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November 30,
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||||||||||
2013
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2012
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2013 | ||||||||||
RESEARCH AND DEVELOPMENT EXPENSES, NET
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$ | 750,510 | $ | 392,626 | $ | 12,554,998 | ||||||
IMPAIRMENT OF INVESTMENT
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- | - | 434,876 | |||||||||
GENERAL AND ADMINISTRATIVE EXPENSES
|
417,727 | 339,213 | 10,611,403 | |||||||||
OPERATING LOSS
|
1,168,237 | 731,839 | 23,601,277 | |||||||||
FINANCIAL INCOME
|
(46,123 | ) | (72,244 | ) | (433,776 | ) | ||||||
GAIN ON SALE OF INVESTMENT
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- | - | (1,033,004 | ) | ||||||||
IMPAIRMENT OF AVAILABLE- FOR-SALE SECURITIES
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- | - | 381,666 | |||||||||
FINANCIAL EXPENSE
|
2,206 | 299,158 | 696,032 | |||||||||
LOSS BEFORE TAXES ON INCOME
|
1,124,320 | 958,753 | 23,212,195 | |||||||||
TAXES ON INCOME
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- | - | 35,714 | |||||||||
NET LOSS FOR THE PERIOD
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$ | 1,124,320 | $ | 958,753 | $ | 23,247,909 | ||||||
SUBSEQUENT INCREASE IN THE FAIR VALUE OF AVAILABLE FOR SALE SECURITIES PREVIOUSLY WRITTEN DOWN AS IMPAIRED
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(5,322 | ) | (117,347 | ) | (136,167 | ) | ||||||
RECLASSIFICATION ADJUSTMENT TO FINANCIAL INCOME OF GAINS ON AVAILABLE-FOR-SALE SECURITIES
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18,454 | - | 108,824 | |||||||||
UNREALIZED GAIN ON AVAILABLE FOR SALE SECURITIES
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(43,902 | ) | (118,521 | ) | (306,830 | ) | ||||||
TOTAL OTHER COMPREHENSIVE INCOME
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(30,770 | ) | (235,868 | ) | (334,173 | ) | ||||||
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD
|
$ | 1,093,550 | $ | 722,885 | $ | 22,913,736 | ||||||
BASIC AND DILUTED LOSS PER COMMON SHARE
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$ | 0.14 | $ | 0.14 | ||||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES USED IN COMPUTING BASIC AND DILUTED LOSS PER COMMON STOCK*
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7,941,059 | 6,826,896 |
*
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See note 1a(3).
|
Deficit
|
||||||||||||||||||||||||
Accumulated
|
accumulated
|
|||||||||||||||||||||||
Common Stock
|
Additional
|
Other
|
during the
|
Total
|
||||||||||||||||||||
paid-in
|
Comprehensive
|
development
|
stockholders'
|
|||||||||||||||||||||
Shares*
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$
|
capital
|
Income
|
stage
|
equity
|
|||||||||||||||||||
BALANCE AS OF APRIL 12, 2002 (inception)
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2,902,589 | $ | 34,828 | $ | 18,872 | - | - | $ | 53,700 | |||||||||||||||
CHANGES DURING THE PERIOD FROM APRIL 12, 2002 THROUGH AUGUST 31, 2007 :
|
||||||||||||||||||||||||
SHARES CANCELLED
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(1,650,000 | ) | (19,800 | ) | 19,800 | - | - | - | ||||||||||||||||
SHARES ISSUED FOR INVESTMENT IN ISTI-NJ
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95,368 | 1,144 | 433,732 | - | - | 434,876 | ||||||||||||||||||
SHARES ISSUED FOR OFFERING COSTS
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146,079 | 1,753 | (1,753 | ) | - | - | - | |||||||||||||||||
SHARES AND WARRANTS ISSUED FOR CASH– NET OF ISSUANCE EXPENSES
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2,265,514 | 27,181 | 2,095,800 | - | - | 2,122,981 | ||||||||||||||||||
SHARES ISSUED FOR SERVICES
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10,417 | 125 | 98,625 | - | - | 98,750 | ||||||||||||||||||
CONTRIBUTIONS TO PAID IN CAPITAL
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- | - | 18,991 | - | - | 18,991 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
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- | - | 1,968,547 | - | - | 1,968,547 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
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- | - | 177,782 | - | - | 177,782 | ||||||||||||||||||
DISCOUNT ON CONVERTIBLE NOTE RELATED TO BENEFICIAL CONVERSION FEATURE
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- | - | 108,000 | - | - | 108,000 | ||||||||||||||||||
OTHER COMPREHENSIVE LOSS
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- | - | - | (16 | ) | (16 | ) | |||||||||||||||||
IMPUTED INTEREST
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- | - | 8,437 | - | - | 8,437 | ||||||||||||||||||
NET LOSS
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- | - | - | - | (4,478,917 | ) | (4,478,917 | ) | ||||||||||||||||
BALANCE AS OF AUGUST 31, 2007
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3,769,967 | 45,231 | 4,946,833 | - | (4,478,933 | ) | 513,131 | |||||||||||||||||
RECEIPTS ON ACCOUNT OF SHARES
AND WARRANTS
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- | - | 6,061 | - | - | 6,061 | ||||||||||||||||||
SHARES ISSUED FOR CONVERSION OF CONVERTIBLE NOTE
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45,844 | 550 | 274,450 | - | - | 275,000 | ||||||||||||||||||
SHARES AND WARRANTS ISSUED FOR CASH - NET OF ISSUANCE EXPENSES
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848,288 | 10,178 | 5,774,622 | - | - | 5,784,800 | ||||||||||||||||||
SHARES ISSUED FOR SERVICES
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24,419 | 293 | 115,817 | - | - | 116,110 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
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- | - | 459,467 | - | - | 459,467 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
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- | - | 203,982 | - | - | 203,982 | ||||||||||||||||||
IMPUTED INTEREST
|
- | - | 3,780 | - | - | 3,780 | ||||||||||||||||||
NET LOSS
|
- | - | - | - | (2,769,271 | ) | (2,769,271 | ) | ||||||||||||||||
BALANCE AS OF AUGUST 31, 2008
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4,688,518 | $ | 56,252 | $ | 11,785,012 | - | $ | (7,248,204 | ) | $ | 4,593,060 |
*
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See note 1a(3).
|
Deficit
|
||||||||||||||||||||||||
Accumulated
|
accumulated
|
|||||||||||||||||||||||
Additional
|
Other
|
during the
|
Total
|
|||||||||||||||||||||
Common Stock
|
paid-in
|
Comprehensive
|
development
|
stockholders'
|
||||||||||||||||||||
Shares*
|
$
|
capital
|
Income
|
stage
|
equity
|
|||||||||||||||||||
BALANCE AS OF AUGUST 31, 2008
|
4,688,518 | $ | 56,252 | $ | 11,785,012 | $ | - | $ | (7,248,204 | ) | $ | 4,593,060 | ||||||||||||
SHARES ISSUED FOR SERVICES
|
17,012 | 204 | 152,724 | - | - | 152,928 | ||||||||||||||||||
SHARES TO BE ISSUED FOR SERVICES
|
- | - | 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
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4,705,530 | $ | 56,456 | $ | 12,698,414 | - | $ | (10,008,678 | ) | $ | 2,746,192 | |||||||||||||
SHARES ISSUED FOR SERVICES
|
92,416 | 1,109 | 248,741 | - | - | 249,850 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
|
- | - | 690,882 | - | - | 690,882 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
|
- | - | 116,944 | - | - | 116,944 | ||||||||||||||||||
IMPUTED INTEREST
|
- | - | 3,780 | - | - | 3,780 | ||||||||||||||||||
NET LOSS
|
- | - | - | - | (2, 977, 376 | ) | (2,977,376 | ) | ||||||||||||||||
BALANCE AS OF AUGUST 31, 2010
|
4,797,946 | $ | 57,565 | $ | 13,758,761 | - | $ | (12,986,054 | ) | $ | 830,272 | |||||||||||||
SHARES ISSUED FOR SERVICES
|
60,887 | 731 | 226,838 | - | - | 227,569 | ||||||||||||||||||
SHARES AND WARRANTS ISSUED FOR CASH**
|
984,209 | 11,808 | 3,682,404 | - | - | 3,694,212 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
|
- | - | 502,593 | - | - | 502,593 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
|
- | - | 26,733 | - | - | 26,733 | ||||||||||||||||||
IMPUTED INTEREST
|
- | - | 3,782 | - | - | 3,782 | ||||||||||||||||||
NET LOSS
|
- | - | - | - | (1,561,245 | ) | (1,561,245 | ) | ||||||||||||||||
BALANCE AS OF AUGUST 31, 2011
|
5,843,042 | 70,104 | 18,201,111 | - | (14,547,299 | ) | 3,723,916 | |||||||||||||||||
SHARES ISSUED FOR SERVICES
|
29,084 | 349 | 107,511 | - | - | 107,860 | ||||||||||||||||||
SHARES AND WARRANTS ISSUED FOR CASH, INCLUDING RECLASSIFICATION OF WARRANTS
|
801,942 | 9,622 | 2,984,842 | - | - | 2,944,464 | ||||||||||||||||||
SHARES AND WARRANTS TO BE ISSUED FOR CASH
|
- | - | 25,093 | - | - | 25,093 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
|
- | - | 200,866 | - | - | 200,866 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
|
- | - | 70,292 | - | - | 70,292 | ||||||||||||||||||
NET LOSS
|
- | - | - | - | (3,344,478 | ) | (3,344,478 | ) | ||||||||||||||||
BALANCE AS OF AUGUST 31, 2012
|
6,674,068 | $ | 80,075 | $ | 21,589,715 | - | $ | (17,891,777 | ) | $ | 3,778,013 |
*
|
See note 1a(3).
|
**
|
Including 16,397 shares issued as finders' fee.
|
Deficit
|
||||||||||||||||||||||||
Accumulated
|
accumulated
|
|||||||||||||||||||||||
Additional
|
other
|
during the
|
Total
|
|||||||||||||||||||||
Common Stock
|
paid-in
|
Comprehensive
|
development
|
stockholders'
|
||||||||||||||||||||
Shares*
|
$ |
capital
|
Income
|
stage
|
equity
|
|||||||||||||||||||
BALANCE AS OF AUGUST 31, 2012
|
6,674,068 | $ | 80,075 | $ | 21,589,715 | - | $ | (17,891,777 | ) | $ | 3,778,013 | |||||||||||||
SHARES AND WARRANTS ISSUED FOR CASH, NET**
|
349,396 | 4,192 | 1,418,400 | - | - | 1,422,592 | ||||||||||||||||||
SHARES ISSUED FOR CASH, NET
|
658,144 | 7,897 | 4,230,992 | - | - | 4,238,889 | ||||||||||||||||||
SHARES ISSUED FOR MARKETABLE SECURITIES
|
199,172 | 2,390 | 626,240 | - | - | 628,630 | ||||||||||||||||||
SHARES ISSUED FOR SERVICES
|
33,709 | 404 | 244,053 | - | - | 244,457 | ||||||||||||||||||
EXCHANGE OF WARRANTS
|
- | - | 917,809 | - | - | 917,809 | ||||||||||||||||||
EXERCISE OF WARRANTS AND OPTIONS
|
23,383 | 280 | 109,295 | - | - | 109,575 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
|
- | - | 562,966 | - | - | 562,966 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
|
- | - | 156,253 | - | - | 156,253 | ||||||||||||||||||
NET LOSS
|
- | - | - | - | (4,231,812 | ) | (4,231,812 | ) | ||||||||||||||||
OTHER COMPREHENSIVE INCOME
|
- | - | - | 303,403 | - | 303,403 | ||||||||||||||||||
BALANCE AS OF AUGUST 31, 2013
|
7,937,872 | $ | 95,238 | $ | 29,855,723 | $ | 303,403 | $ | (22,123,589 | ) | $ | 8,130,775 | ||||||||||||
SHARES ISSUED FOR SERVICES ***
|
10,000 | 120 | 64,280 | - | - | 64,400 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO EMPLOYEES AND DIRECTORS
|
- | - | 200,858 | - | - | 200,858 | ||||||||||||||||||
STOCK BASED COMPENSATION RELATED TO OPTIONS GRANTED TO CONSULTANTS
|
- | - | 2,731 | - | - | 2,731 | ||||||||||||||||||
NET LOSS
|
- | - | - | - | (1,124,320 | ) | (1,124,320 | ) | ||||||||||||||||
OTHER COMPREHENSIVE INCOME
|
- | - | - | 30,770 | - | 30,770 | ||||||||||||||||||
BALANCE AS OF NOVEMBER 30, 2013
|
7,947,872 | $ | 95,358 | $ | 30,123,592 | 334,173 | $ | (23,247,909 | ) | $ | 7,305,214 |
*
|
See note 1a(3).
|
**
|
Including 13,872 shares issued as finders' fee.
|
***
|
See note 5.
|
Three months ended
|
Period from April 12, 2002 (inception date) through
|
|||||||||||
November 30,
|
November 30,
|
|||||||||||
2013
|
2012
|
2013
|
||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
Net loss
|
$ | (1,124,320 | ) | $ | (958,753 | ) | $ | (23,247,909 | ) | |||
Adjustments required to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Depreciation and amortization
|
1,871 | 2,271 | 128,094 | |||||||||
Amortization of debt discount
|
- | - | 108,000 | |||||||||
Exchange differences
|
(21,832 | ) | 18,782 |
28,384
|
||||||||
Stock based compensation
|
203,589 | 218,208 | 5,894,095 | |||||||||
Common Stock issued for services
|
64,400 | - | 1,464,813 | |||||||||
Gain on sale of investment
|
(18,454 | ) | - | (1,102,161 | ) | |||||||
Impairment of investment
|
- | - | 434,876 | |||||||||
Impairment of available for sale security
|
- | - | 381,666 | |||||||||
Imputed interest
|
- | - |
23,559
|
|||||||||
Exchange of warrants
|
- | 296,982 | 296,982 | |||||||||
Changes in fair value of warrant liabilities
|
- | (44,699 | ) | 98,005 | ||||||||
Changes in operating assets and liabilities:
|
||||||||||||
Prepaid expenses and other current assets
|
(24,969 | ) | (20,962 | ) | (188,222 | ) | ||||||
Restricted cash
|
- | - | (16,000 | ) | ||||||||
Accounts payable and accrued expenses
|
170,333 | (309,870 | ) | 621,274 | ||||||||
Liability of employee rights upon retirement
|
674 | 5,215 | 21,905 | |||||||||
Provision for uncertain tax position
|
- | - | 23,210 | |||||||||
Total net cash used in operating activities
|
(748,708 | ) | (792,826 | ) | (15,029,429 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
Purchase of property and equipment
|
(4,895 | ) | - | (136,886 | ) | |||||||
Purchase of short-term deposits
|
(4,300,000 | ) | - | (16,050,363 | ) | |||||||
Proceeds from sale of Short term deposits
|
4,100,000 | 454,381 | 10,582,011 | |||||||||
Proceeds from sale of investment and marketable securities
|
43,208 | - | 719,879 | |||||||||
Funds in respect of employee rights upon retirement
|
(500 | ) | (154 | ) | (9,485 | ) | ||||||
Lease deposits, net
|
- | - | (2,615 | ) | ||||||||
Total net cash provided (used in) investing activities
|
(162,187 | ) | 454,227 | (4,897,459 | ) | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
Proceeds from sales of common stock and
warrants - net of issuance expenses
|
- | 1,458,436 | 20,859,553 | |||||||||
Proceeds from exercise of warrants and options
|
109,575 | |||||||||||
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
|
- | 1,458,436 | 21,316,432 | |||||||||
EFFECT OF EXCHANGE RATE CHANGES ON CASH
|
9,420 | (19,502 | ) | (18,791 | ) | |||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
(901,475 | ) | 1,100,335 | $ | 1,370,753 | |||||||
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
2,272,228 | 4,430,740 | - | |||||||||
CASH AND CASH EQUIVALENTS AT END OF PERIOD
|
$ | 1,370,753 | $ | 5,531,075 | $ | 1,370,753 | ||||||
Non cash investing and financing activities:
|
||||||||||||
Shares and warrants issued as offering costs
|
- | - | $ | 77,779 | ||||||||
Contribution to paid in capital
|
- | - | $ | 18,991 | ||||||||
Discount on convertible note related to beneficial conversion feature
|
- | - | $ | 108,000 | ||||||||
Exchange of warrants
|
- | $ | 917,809 | $ | 917,809 | |||||||
Shares issued for marketable securities
|
- | $ | 628,630 | $ | 628,630 |
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
a.
|
General:
|
1)
|
Incorporation and operations
|
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
2)
|
Development and liquidity risks
|
|
3)
|
Reverse stock split
|
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
b.
|
Newly issued and recently adopted Accounting Pronouncements
|
|
c.
|
Condensed Consolidated Financial Statements Preparation
|
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
a.
|
On September 11, 2011, the Subsidiary entered into an agreement with Hadasit, Dr. Miriam Kidron and Dr. Daniel Schurr (the “Agreement”), to retain consulting and clinical trial services. According to the Agreement, Hadasit will be entitled to a consideration of $200,000 to be paid by the Company in accordance with the actual progress of the studies, $75,000 of which were paid and recognized through November 30, 2013. See also note 1a(1).
|
|
b.
|
On July 5, 2010, the Subsidiary of the Company entered into a Manufacturing Supply Agreement (“MSA”) with Sanofi-Aventis Deutschland GMBH (“Sanofi”). According to the MSA, Sanofi will supply the subsidiary with specified quantities of recombinant human insulin to be used for clinical trials in the United States.
|
|
c.
|
On February 15, 2011, the Subsidiary entered into a consulting agreement with a third party (the "Consultant”) for a period of five years, pursuant to which the Consultant will provide consultation on scientific and clinical matters. The Consultant is entitled to a fixed monthly fee of $8,000, royalties of 8% of the net royalties actually received by the Subsidiary in respect of the patent that was sold to Entera on March 31, 2011 (see note 1a(1)) and an option to purchase up to 20,834 shares of the Company at an exercise price of $6.00 per share. The option vests in five annual installments commencing February 16, 2012 and expires on February 16, 2021. The initial fair value of the option on the date of grant was $62,185, using the Black Scholes option-pricing model and was based on the following assumptions: dividend yield of 0% for all years; expected volatility of 78.65%; risk-free interest rates of 3.62%; and the remaining expected term of 10 years. The fair value of the option as of November 30, 2013 was $118,483, using the following assumptions: dividend yield of 0% and expected term of 7.21 years; expected volatility of 75.78%; and risk-free interest rate of 2.10%. The fair value of the option granted is remeasured at each balance sheet reporting date and is recognized over the related service period using the straight-line method.
|
|
d.
|
On March 18, 2012, the Subsidiary entered into a lease agreement for its facilities in Israel. The lease agreement was for a period of 57 months commencing January 1, 2012.
|
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
e.
|
On April 15, 2013, the Company entered into a consulting agreement with a third party advisor for a period of twelve months, pursuant to which such advisor will provide investor relations services and is entitled to receive a monthly cash fee and 15,000 shares of the Company issued in three equal installments, on each of May 1, 2013, August 1, 2013 and November 15, 2013. On July 11 and November 4, 2013 the Company issued to such advisor 5,000 and 10,000 shares, respectively. The fair value of the shares at these dates was $34,900 and 64,400, respectively. See also note 5.
|
|
f.
|
On April 29, 2013, the Subsidiary entered into a Clinical Research Organization Service Agreement with a third party, to retain it as a CRO, for its Phase 2a clinical trial for an oral insulin capsule. As consideration for its services, the subsidiary will pay the CRO a total amount of approximately $332,702 that will be paid during the term of the engagement and based on achievement of certain milestones, $196,304 of which were paid and $282,807 were recognized through November 30, 2013.
|
|
g.
|
On July 23, 2013, the Subsidiary entered into a Master Service Agreement with a vendor for the process development and production of one of its oral capsule ingredients in the amount of $102,280, of which $30,684 were paid and recognized through November 30, 2013.
|
|
h.
|
Grants from Bio-Jerusalem
|
|
i.
|
Grants from the Chief Scientist Office ("OCS")
|
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
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 other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
|
|
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.
|
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
Level 1
|
||||
Marketable securities:
|
||||
November 30, 2013
|
$ | 962,392 | ||
August 31, 2013
|
$ | 956,376 |
ORAMED PHARMACEUTICALS Inc.
|
(A development stage company)
|
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
a.
|
On December 24, 2013, the Company entered into a Placement Agency Agreement with Aegis Capital Corp. (the "Placement Agent"), pursuant to which the Placement Agent agreed to use their reasonable best efforts to arrange for the sale of up to 1,580,000 shares of the Company’s common stock. In connection therewith, on December 24, 2013, the Company entered into a Securities Purchase Agreement, pursuant to which the Company agreed to sell an aggregate of 1,580,000 shares of common stock, at a price of $10.00 per share, to two institutional investors in a registered direct offering (the "Offering"). The Company had received all funds and issued all shares of common stock in connection with the Offering as of December 30, 2013. The net proceeds to the Company from the Offering were approximately $14,890,000, after deducting Placement Agent's commissions and estimated offering expenses of the Company.
|
|
b.
|
During January 2014, the Subsidiary sold in aggregate 600,000 of the D.N.A shares for a total of $36,747. As of January 9, 2014, the Group owns approximately 10.3% of D.N.A’s outstanding ordinary shares.
|
|
c.
|
During January 2014, 217,294 warrants were exercised for cash and resulted in the issuance of 217,294 shares of common stock. The cash consideration received for exercise of warrants was $1,303,764.
|
Three months ended
|
||||||||
Operations Data:
|
November 30,
|
|||||||
2013
|
2012
|
|||||||
Research and development expenses, net
|
$ | 750,510 | $ | 392,626 | ||||
General and administrative expenses
|
417,727 | 339,213 | ||||||
Financial expense (income), net
|
(43,917 | ) | 226,914 | |||||
Net loss for the period
|
$ | 1,124,320 | $ | 958,753 | ||||
Loss per common share – basic and diluted
|
$ | (0.14 | ) | $ | (0.14 | ) | ||
Weighted average common shares outstanding
|
7,941,059 |
6,826,896
|
Category
|
Amount
|
|||
Research and development, net of OCS funds
|
$ | 6,244,000 | ||
General and administrative expenses
|
1,849,000 | |||
Total
|
$ |
8,093,000
|
Number
|
|
Exhibit
|
10.1*
|
Agreement and Amendment No. 1 between the Company and Dr. Michael Berelowitz, dated November 26, 2013.
|
|
10.2
|
Form of Securities Purchase Agreement used in December 2013 registered direct offering (incorporated by reference from our current report on Form 8-K filed December 26, 2013).
|
|
31.1*
|
Certification Statement of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
|
|
31.2*
|
Certification Statement of Principal Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
|
|
32.1**
|
Certification Statement of Principal Executive Officer pursuant to 18 U.S.C. Section 1350.
|
|
32.2**
|
Certification Statement of Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
|
|
101.1*
|
The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended November 30, 2013, formatted in XBRL: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Comprehensive Loss, (iii) Condensed Consolidated Statements of Changes in Stockholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows and (v) the Notes to Condensed Consolidated Financial Statements, tagged as blocks of text and in detail.
|
*
|
Filed herewith
|
**
|
Furnished herewith
|
ORAMED PHARMACEUTICALS INC.
|
|||
Date: January 14, 2014
|
By:
|
/s/ Nadav Kidron
|
|
Nadav Kidron
|
|||
President and Chief Executive Officer
|
Date: January 14, 2014
|
By:
|
/s/ Yifat Zommer
|
|
Yifat Zommer
|
|||
Chief Financial Officer
|
|||
(principal financial and accounting officer)
|
1.
|
ENGAGEMENT
|
|
1.1
|
Engagement as Consultant. Subject to earlier termination of the Agreement as hereinafter provided, the Company hereby agrees to engage Berelowitz as a Consultant (the "Consultant") in accordance with the terms and provisions hereof.
|
|
1.2
|
Term. Unless terminated earlier in accordance with the provisions hereof, the term of engagement under this Agreement shall commence on December 1, 2013 (the ”Effective Date”) and shall continue for a period of six months (the “Term”).
|
|
1.3
|
Service.
|
|
(a)
|
Berelowitz will make himself available to the Company as much as reasonably possible and to the extent required by the Company and in accordance with his schedule, and will be actively involved in the Company's scientific decisions, taking part in negotiations regarding potential partnering with pharmaceutical companies, representing the Company in scientific conferences and investor presentations.
|
|
(b)
|
Berelowitz agrees to faithfully, honestly and diligently serve the Company and to devote his attention and best efforts to further the business and interests of the Company during the period of this Agreement. Berelowitz agrees and undertakes to inform the Company’s Board immediately after becoming aware of any matter that may in any way raise a conflict of interest between Berelowitz and the Company. For the avoidance of doubt, nothing in this Section 1.3 shall derogate from Berelowitz's obligation to continue observing all of his undertakings under this Agreement in their entirety, including, without limitation, his obligations of confidentiality and non-disclosure.
|
|
(c)
|
Berelowitz and the Company shall be independent contracting parties under this Agreement and none of the provisions herein shall create or constitute an employer – employee relationship between the parties.
|
|
1.4
|
Indemnification. Oramed Pharmaceuticals, Inc. shall undertake to indemnify Berelowitz pursuant to its customary form of Indemnification Agreement.
|
|
1.5
|
Fiduciary Obligation. Berelowitz declares that his relationship to the Company is that of fiduciary, and he agrees to act towards the Company and otherwise behave as a fiduciary of the Company. The foregoing shall not derogate from Berelowitz's fiduciary duties under applicable law, including the corporate laws of Delaware.
|
|
1.6
|
Publicity. Berelowitz acknowledges that, and consents to, the Company making from time to time public announcements and producing materials and documents, whether required by applicable law or not, that will include his name, biography, description of his position in the Company and any other information that the Company deems necessary.
|
2.
|
COMPENSATION
|
|
2.1
|
Compensation. Berelowitz shall be entitled to receive remuneration for his service, as set forth in Appendix A hereto, to be paid monthly, shortly after the close of each month.
|
|
2.2
|
Expenses. Berelowitz shall be entitled to be reimbursed for all reasonable out-of-pocket expenses incurred in connection with board matters, as approved by the Board in advance and in writing.
|
|
2.3
|
Deductions. Berelowitz acknowledges that all payments by the Company in respect of the services provided by Berelowitz shall be subject to the deduction of any amount which the Company is required to deduct or withhold from any payments to a director in accordance with applicable law.
|
3.
|
CONFIDENTIALITY
|
|
3.1
|
Maintenance of Confidential Information. Berelowitz acknowledges that in the course of engagement hereunder he will, either directly or indirectly, have access to and be entrusted with information (whether oral, written or by inspection) relating to the Company, or its associates, strategic partners or customers that has not been made public (the “Confidential Information”). Accordingly, Berelowitz covenants and agrees that during the Term and thereafter until such time as all the Confidential Information becomes publicly known and made generally available through no action or inaction of Berelowitz, Berelowitz will keep in strict confidence the Confidential Information and shall not, without prior written consent of the Company, disclose, use or otherwise disseminate the Confidential Information, directly or indirectly, to any third party.
|
|
3.2
|
Exceptions. The general prohibition contained in Section 3.1 against the unauthorized disclosure, use or dissemination of the Confidential Information shall not apply in respect of any Confidential Information that:
|
|
(a)
|
is available to the public generally in the form disclosed;
|
|
(b)
|
becomes part of the public domain through no fault of Berelowitz;
|
|
(c)
|
is already in the lawful possession of Berelowitz at the time of receipt of the Confidential Information, as can be proven by written documentation; or
|
|
(d)
|
is compelled by applicable law to be disclosed, provided that Berelowitz gives the Company prompt written notice of such requirement prior to such disclosure and provides assistance in obtaining an order protecting the Confidential Information from public disclosure.
|
4.
|
NON-COMPETITION
|
|
4.1
|
Non Competition. Berelowitz agrees and undertakes that he will not, so long as he is engaged with the Company, directly or indirectly, as owner, partner, joint venture, stockholder, employee, broker, agent, principal, corporate officer, director, licensor or in any other capacity whatsoever, engage in, become financially interested in, be employed by, or have any connection with any business or venture that operates in the field of oral delivery of peptides; provided, however, that Berelowitz may own securities of any corporation which is engaged in such business and is publicly owned and traded but in an amount not to exceed at any one time one percent (1%) of any class of stock or securities of such company, so long as he has no active role in the publicly owned and traded company as director, employee, consultant or otherwise.
|
|
4.2
|
No Solicitation. Berelowitz agrees and undertakes that during the period of his engagement and for a period of 12 months following termination for any reason whatsoever, he will not, directly or indirectly, including personally or in any business in which he is an officer, director or shareholder, for any purpose or in any place, employ any person (as an employee or consultant) employed by the Company at such time or during the preceding twelve months, unless such person has been terminated by the Company, provided however, that such person who is terminated by the Company may be employed by Berelowitz as described above only after the expiration of twelve months after the effective date of such termination.
|
5.
|
TERMINATION
|
|
5.1
|
Termination For Cause or Disability. This Agreement may be terminated at any time by Berelowitz or by the Company's Board for any reason whatsoever.
|
|
5.2
|
Effect of Termination. Articles 3 and 4 hereto and hereto shall remain in full force and effect after termination of this Agreement, for any reason whatsoever.
|
6.
|
MUTUAL REPRESENTATIONS
|
|
6.1
|
Berelowitz represents and warrants to the Company that the execution and delivery of this Agreement and the fulfillment of the terms hereof (i) will not constitute a default under or conflict with any agreement or other instrument to which he is a party or by which he is bound, and (ii) do not require the consent of any person or entity.
|
|
6.2
|
The Company represents and warrants to Berelowitz that this Agreement has been duly authorized, executed and delivered by the Company and that the fulfillment of the terms hereof (i) will not constitute a default under or conflict with any agreement of other instrument to which it is a party or by which it is bound, and (ii) do not require the consent of any person or entity.
|
|
6.3
|
Each party hereto warrants and represents to the other that this Agreement constitutes the valid and binding obligation of such party enforceable against such party in accordance with its terms, subject to applicable bankruptcy, insolvency, moratorium and similar laws affecting creditors' rights generally, and subject, as to enforceability, to general principles of equity (regardless if enforcement is sought in proceeding in equity or at law).
|
7.
|
NOTICES
|
|
7.1
|
Notices. All notices required or allowed to be given under this Agreement shall be made either personally by delivery to or by facsimile transmission to the address as hereinafter set forth or to such other address as may be designated from time to time by such party in writing:
|
|
(a)
|
in the case of the Company, to:
Oramed Pharmaceuticals Inc. and
Oramed Ltd.
2/4 High Tech Park
PO Box 39098
Givat Ram, Jerusalem
Israel 91390
Fax: +972 2 5660004
|
|
(b)
|
and in the case of Berelowitz, to his last residence address or facsimile number known to the Company.
|
|
7.2
|
Change of Address. Any party may, from time to time, change its address for notices hereunder by written notice to the other party in the manner aforesaid.
|
8.
|
GENERAL
|
|
8.1
|
Entire Agreement. As of from the date hereof, any and all previous agreements, written or oral between the parties hereto or on their behalf relating to the engagement of Berelowitz by the Company, including that certain Board Membership Agreement dated May 27, 2010, are null and void.
|
|
8.2
|
Waiver. No provision hereof shall be deemed waived and no breach excused, unless such waiver or consent excusing the breach is made in writing and signed by the party to be charged with such waiver or consent. A waiver by a party of any provision of this Agreement shall not be construed as a waiver of a further breach of the same provision.
|
|
8.3
|
Amendments in Writing. No amendment, modification or rescission of this Agreement shall be effective unless set forth in writing and signed by the parties hereto.
|
|
8.4
|
Assignment. Except as herein expressly provided, the respective rights and obligations of Berelowitz and the Company under this Agreement shall not be assignable by either party without the written consent of the other party.
|
|
8.5
|
Severability. In the event that any provision contained in this Agreement shall be declared invalid, illegal or unenforceable by a court or other lawful authority of competent jurisdiction, such provision shall be deemed not to affect or impair the validity or enforceability of any other provision of this Agreement, which shall continue to have full force and effect.
|
|
8.6
|
Governing Law. This Agreement shall be exclusively construed and interpreted in accordance with the laws of the state of New York applicable therein, and each of the parties hereto expressly agrees to the exclusive jurisdiction of the courts of the state of New York.
|
ORAMED PHARMACEUTICALS INC.
|
||||
Per: |
/s/ Nadav Kidron
|
/s/ Michael Berelowitz
|
||
MICHAEL BERELOWITZ M.D.
|
||||
Name: |
Nadav Kidron
|
|||
Title: |
Chief Executive Officer
|
ORAMED PHARMACEUTICALS INC.
|
||||
Per: |
/s/ Nadav Kidron
|
/s/ Michael Berelowitz
|
||
MICHAEL BERELOWITZ M.D.
|
||||
Name: |
Nadav Kidron
|
|||
Title: |
Chief Executive Officer
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
Dated: January 14, 2014
|
/s/ Nadav Kidron
|
Nadav Kidron
|
|
President and Chief Executive Officer
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
Dated: January 14, 2014
|
/s/ Yifat Zommer
|
Yifat Zommer
|
|
Chief Financial Officer
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities and Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Dated: January 14, 2014
|
/s/ Nadav Kidron
|
Nadav Kidron, President and Chief Executive Officer
|
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities and Exchange Act of 1934; and
|
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Dated: January 14, 2014
|
/s/ Yifat Zommer
|
Yifat Zommer, Chief Financial Officer
|