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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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90-0577933
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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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Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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o
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Smaller reporting company
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x
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Do not check if smaller reporting company
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3
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3
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13
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17
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17
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18
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18
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18
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19
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19
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19
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19
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FINANCIAL INFORMATION
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Financial Statements.
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TABLE OF CONTENTS
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PAGE
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4
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5
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6
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7
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9
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Date
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Number
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Exercise
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Contractual
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Expiration
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Value if
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|||||||||||||||
Issued
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Outstanding
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Price
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Life (Years)
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Date
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Exercised
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Balance 10/1/08
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13,509,857 | 1.18 | 5 |
Various
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15,941,631 | |||||||||||||||
03/20/09
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5,000,000 | 0.50 | 5 |
03/31/14
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2,500,000 | |||||||||||||||
06/03/09
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11,166,672 | 0.18 | 5 |
06/03/14
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2,010,001 | |||||||||||||||
09/30/09
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150,000 | 0.40 | 5 |
06/30/14
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60,000 | |||||||||||||||
Expired
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— | — | — | — | — | |||||||||||||||
Balance 9/30/09
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29,826,529 | 0.69 | — | — | 20,511,632 | |||||||||||||||
10/09/09
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88,000 | 0.50 | 5 |
10/29/14
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44,000 | |||||||||||||||
11/09/09
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18,000 | 0.50 | 5 |
11/09/14
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9,000 | |||||||||||||||
12/04/09
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130,000 | 0.60 | 2 |
12/04/11
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78,000 | |||||||||||||||
12/15/09
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(5,583,336 | ) | 0.18 | — | — | (1,005,000 | ) | |||||||||||||
01/15/10
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5,583,336 | 0.55 | 5 |
01/15/15
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3,070,835 | |||||||||||||||
01/15/10
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(5,583,336 | ) | 0.18 | — | — | (1,005,000 | ) | |||||||||||||
04/13/10
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10,000 | 0.55 | 5 |
04/13/15
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5,500 | |||||||||||||||
07/23/10
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93,000 | 0.50 | 3 |
07/23/13
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46,500 | |||||||||||||||
Expired
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— | — | — | — | — | |||||||||||||||
Balance 9/30/10
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24,582,193 | 0.89 | — | — | 21,755,467 | |||||||||||||||
12/30/10
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2,520,000 | 0.55 | 5 |
12/30/15
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1,386,000 | |||||||||||||||
05/12/11
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25,000 | 0.50 | 5 |
5/12/2016
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12,500 | |||||||||||||||
05/12/11
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30,000 | 0.50 | 5 |
5/12/2016
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15,000 | |||||||||||||||
06/13/11
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25,000 | 0.50 | 2 |
6/13/2013
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12,500 | |||||||||||||||
Expired
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(1,090,568 | ) | 1.19 | — | — | (1,297,776 | ) | |||||||||||||
Balance 6/30/11
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26,091,625 | 0.84 | — | — | 21,883,691 |
Stock Price at Valuation Date
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$ | 0.40 | ||
Exercise (Strike) Price
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$ | 0.50 | ||
Dividend Yield
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0.00 | % | ||
Years to Maturity
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5.00 | |||
Risk-free Rate
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2.60 | % | ||
Volatility
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277 | % |
Date
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Number
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Exercise
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Contractual
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Expiration
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Value if
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Issued
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Outstanding
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Price
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Life (Years)
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Date
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Exercised
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Prior 10/1/2008
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— | $ | — | — | — | $ | — | |||||||||||||
04/09/09
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579,141 | 0.65 | 5 |
04/09/13
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376,442 | |||||||||||||||
Balance 09/30/09
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579,141 | 0.65 | — | — | 376,442 | |||||||||||||||
04/12/10
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1,000,000 | 0.50 | 5 |
04/12/15
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500,000 | |||||||||||||||
Balance 09/30/10
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1,579,141 | $ | 0.56 | — | — | $ | 876,442 | |||||||||||||
Issued
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— | — | — | — | — | |||||||||||||||
Expired
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(32,176 | ) | 0.65 | — | — | (20,914 | ) | |||||||||||||
Balance 6/30/11
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1,546,965 | $ | 0.55 | — | — | $ | 855,528 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
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●
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Ocular tolerance and toxicity: In a dose escalation safety study involving daily eye drop treatment in Dutch belted rabbits over a 28 day period, the formulation proved safe, and exhibited no signs of ocular toxicity or changes in intraocular pressure. Importantly, no macroscopic or histopathological changes to the ocular tissues were noted.
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●
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Biodistribution study: A single eye drop was administered to the front of the eye in Dutch belted rabbits. At all evaluated timepoints, drug concentrations in the posterior sclera-choroid region behind the retina at the back of the eye exceeded the tissue concentrations of Squalamine that are known to block the choroidal neovascularization process in wet-AMD. The study results also demonstrated that the drug was undetectable in the anterior chamber of the eye (aqueous humor), confirming that it does not penetrate through all the layers of the cornea or contact the lens.
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2011
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2010
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Change
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Revenue
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$ | — | $ | — | $ | — | ||||||
Cost of sales
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— | — | — | |||||||||
General and administrative
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(228,387 | ) | (340,096 | ) | (111,709 | ) | ||||||
Research and development
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(73,144 | ) | (14,497 | ) | 58,647 | |||||||
Interest expense
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(84 | ) | (2,495 | ) | (2,411 | ) | ||||||
Gain (Loss) on derivative liability
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(2,835,983 | ) | 140,969 | 2,976,952 | ||||||||
Other income and expenses
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50 | 39,514 | 39,464 | |||||||||
Loss from operations
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(3,137,548 | ) | (176,605 | ) | 2,960,943 | |||||||
Discontinued operations
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— | — | — | |||||||||
Net Loss
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$ | (3,137,548 | ) | $ | (176,605 | ) | $ | 2,960,943 |
2011
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2010
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Change
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Revenue
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$ | — | $ | — | $ | — | ||||||
Cost of sales
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— | — | — | |||||||||
General and administrative
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(517,362 | ) | (613,544 | ) | (96,182 | ) | ||||||
Research and development
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(350,407 | ) | (73,399 | ) | 277,008 | |||||||
Interest expense
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(2,433 | ) | (19,288 | ) | (16,855 | ) | ||||||
Gain (Loss) on derivative liability
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(2,945,196 | ) | 140,969 | 3,086,165 | ||||||||
Other income and expenses
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72,162 | 68,101 | (4,061 | ) | ||||||||
Loss from operations
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(3,743,236 | ) | (497,161 | ) | 3,246,075 | |||||||
Discontinued operations
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— | — | — | |||||||||
Net Loss
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$ | (3,743,236 | ) | $ | (497,161 | ) | $ | 3,246,075 |
Quantitative and Qualitative Risk
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Controls and Procedures
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OTHER INFORMATION
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Legal Proceedings
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Unregistered Sales of Equity Securities and Use of Proceeds.
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On November 5, 2010 the Company issued 50,000 shares of common stock to a consultant for services. The shares were valued at $0.20 per share based on the market price of the shares on the date of issuance. The Company recorded the corresponding $10,000 expense to general and administrative expense. |
Defaults Upon Senior Securities.
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Removed and Reserved .
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Other Information
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Exhibits
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Exhibit
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Number
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10.21
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Form of consulting warrants
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31.1
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Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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31.2
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Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
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32.1
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Certification of Chief Executive Officer Pursuant to 18 U.S.C Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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32.2
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Certification of Chief Financial Officer Pursuant to 18 U.S.C Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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OHR PHARMACEUTICAL, INC.
(Registrant) |
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By: | /s/ Irach Taraporewala | ||
Irach Taraporewala | |||
Chief Executive Officer | |||
By: | /s/ Sam Backenroth | ||
Sam Backenroth | |||
Chief Financial Officer |
Warrant No. [ ] | [ ] Warrants |
Dated: | ||||||
OHR PHARMACEUTICAL, INC.
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By: | ||||||
Name: | ||||||
Title: | ||||||
Attest: |
(Signature must conform in all respects to the name of the Holder as specified on the face of the Warrant)
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(Address)
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Dated: | ||||
(Signature must conform in all respects to name of Holder as specified on the face of the Warrant)
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(Address)
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) for
the registrant
and have:
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a.
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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 report is being prepared;
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b.
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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;
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c.
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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
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d.
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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
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant
’s auditors and the audit committee of
the registrant
’s board of directors (or persons performing the equivalent functions):
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a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect
the registrant
’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in
the registrant
’s internal control over financial reporting.
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1.
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I have reviewed this report on Form 10-Q of Ohr Pharmaceutical, Inc
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) for
the registrant
and have:
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a.
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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 report is being prepared;
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b.
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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;
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c.
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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
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d.
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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
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5.
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The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant
’s auditors and the audit committee of
the registrant
’s board of directors (or persons performing the equivalent functions):
|
a.
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect
the registrant
’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in
the registrant
’s internal control over financial reporting.
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1.
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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2.
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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1.
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The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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2.
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|