x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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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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22
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23
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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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OHR PHARMACEUTICAL, INC.
|
(A Development Stage Company)
|
Balance Sheets
(Unaudited) |
March 31,
|
September 30,
|
|||||||
2013
|
2012
|
|||||||
|
||||||||
ASSETS | ||||||||
CURRENT ASSETS
|
|
|||||||
Cash
|
$ | 1,765,208 | $ | 2,632,413 | ||||
Prepaid expenses
|
208,838 | 218,242 | ||||||
Total Current Assets
|
1,974,046 | 2,850,655 | ||||||
EQUIPMENT, net
|
38,383 | 43,111 | ||||||
OTHER ASSETS
|
||||||||
Patent costs, net
|
584,866 | 623,654 | ||||||
TOTAL ASSETS
|
$ | 2,597,295 | $ | 3,517,420 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
CURRENT LIABILITIES
|
||||||||
Accounts payable and accrued expenses
|
$ | 314,293 | $ | 300,462 | ||||
Notes payable
|
3,643 | 22,037 | ||||||
Derivative liabilities
|
- | 768,696 | ||||||
Total Current Liabilities
|
317,936 | 1,091,195 | ||||||
TOTAL LIABILITIES
|
317,936 | 1,091,195 | ||||||
STOCKHOLDERS' EQUITY
|
||||||||
Preferred stock, Series B; 6,000,000 shares authorized, at $0.0001 par value, 5,444,447 and 5,583,336 shares issued and outstanding, respectively
|
544 | 558 | ||||||
Common stock; 180,000,000 shares authorized, at $0.0001 par value, 49,701,488 and 47,258,686 shares issued and outstanding, respectively
|
4,970 | 4,726 | ||||||
Additional paid-in capital
|
33,314,851 | 30,963,228 | ||||||
Stock subscription receivable
|
- | (11,891 | ) | |||||
Accumulated deficit
|
(21,628,748 | ) | (21,628,748 | ) | ||||
Deficit accumulated during the development stage
|
(9,412,258 | ) | (6,901,648 | ) | ||||
Total Stockholders' Equity
|
2,279,359 | 2,426,225 | ||||||
TOTAL LIABILITIES AND
|
||||||||
STOCKHOLDERS' EQUITY
|
$ | 2,597,295 | $ | 3,517,420 |
OHR PHARMACEUTICAL, INC.
|
(A Development Stage Company)
|
(Unaudited)
|
For the Three Months Ended
|
For the Six Months Ended
|
From Inception of the Development Stage on October 1, 2007 Through
|
||||||||||||||||||
March 31,
|
March 31,
|
March 31,
|
||||||||||||||||||
2013
|
2012
|
2013
|
2012
|
2013
|
||||||||||||||||
|
||||||||||||||||||||
REVENUES
|
$ | - | $ | - | $ | - | $ | - | $ | - | ||||||||||
COST OF SALES
|
- | - | - | - | - | |||||||||||||||
GROSS PROFIT
|
- | - | - | - | - | |||||||||||||||
OPERATING EXPENSES
|
||||||||||||||||||||
General and administrative
|
33,822 | 35,414 | 104,012 | 68,325 | 1,237,380 | |||||||||||||||
Professional fees
|
74,149 | 160,939 | 121,180 | 225,497 | 2,462,597 | |||||||||||||||
Research and development
|
433,789 | 351,165 | 1,012,302 | 687,320 | 3,438,517 | |||||||||||||||
Salaries and wages
|
126,383 | 359,954 | 245,400 | 423,513 | 1,476,274 | |||||||||||||||
Total Operating Expenses
|
668,143 | 907,472 | 1,482,894 | 1,404,655 | 8,614,768 | |||||||||||||||
OPERATING LOSS
|
(668,143 | ) | (907,472 | ) | (1,482,894 | ) | (1,404,655 | ) | (8,614,768 | ) | ||||||||||
OTHER INCOME (EXPENSE)
|
||||||||||||||||||||
Interest expense
|
- | - | (559 | ) | - | (52,099 | ) | |||||||||||||
Gain/(Loss) on derivative liabilities
|
285,481 | (504,870 | ) | (1,117,642 | ) | 322,032 | (1,801,871 | ) | ||||||||||||
Gain on sale of assets
|
- | - | - | - | 70,500 | |||||||||||||||
Gain on settlement of debt
|
- | - | - | 21,005 | 153,557 | |||||||||||||||
Other income and expense
|
90,404 | 25 | 90,485 | 38 | 154,010 | |||||||||||||||
Total Other Income (Expense)
|
375,885 | (504,845 | ) | (1,027,716 | ) | 343,075 | (1,475,903 | ) | ||||||||||||
LOSS FROM CONTINUING OPERATIONS BEFORE INCOME TAXES
|
(292,258 | ) | (1,412,317 | ) | (2,510,610 | ) | (1,061,580 | ) | (10,090,671 | ) | ||||||||||
PROVISION FOR INCOME TAXES
|
- | - | - | - | - | |||||||||||||||
LOSS BEFORE DISCONTINUED OPERATIONS
|
(292,258 | ) | (1,412,317 | ) | (2,510,610 | ) | (1,061,580 | ) | (10,090,671 | ) | ||||||||||
Income from discontinued operations (including gain on disposal of $606,000)
|
- | - | - | - | 678,413 | |||||||||||||||
Income tax benefit
|
- | - | - | - | - | |||||||||||||||
GAIN ON DISCONTINUED OPERATIONS
|
- | - | - | - | 678,413 | |||||||||||||||
NET LOSS
|
$ | (292,258 | ) | $ | (1,412,317 | ) | $ | (2,510,610 | ) | $ | (1,061,580 | ) | $ | (9,412,258 | ) | |||||
BASIC AND DILUTED INCOME (LOSS) PER SHARE
|
||||||||||||||||||||
Continuing operations
|
$ | (0.01 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.03 | ) | ||||||||
Discontinued operations
|
0.00 | 0.00 | 0.00 | 0.00 | ||||||||||||||||
$ | (0.01 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.03 | ) | |||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING:
|
||||||||||||||||||||
BASIC AND DILUTED
|
47,806,727 | 41,620,171 | 47,687,229 | 40,826,447 |
OHR PHARMACEUTICAL, INC.
|
|||||||||||
(A Development Stage Company)
|
|||||||||||
(Unaudited)
|
For the Six Months Ended
|
From Inception of the Development Stage on October 1, 2007 Through
|
|||||||||||
March 31,
|
March 31,
|
|||||||||||
2013
|
2012
|
2013
|
||||||||||
OPERATING ACTIVITIES
|
||||||||||||
Net loss
|
$ | (2,510,610 | ) | $ | (1,061,580 | ) | $ | (9,412,258 | ) | |||
Adjustments to reconcile net loss to net cash used by operating activities:
|
||||||||||||
Discontinued operations
|
- | - | (678,413 | ) | ||||||||
Common stock issued for services
|
- | - | 329,822 | |||||||||
Fair value of warrants issued for services
|
184,724 | 111,370 | 1,368,237 | |||||||||
Fair value of employee stock options
|
104,109 | 304,948 | 1,189,677 | |||||||||
Amortization of common stock and warrants issued in advance of services
|
- | 51,432 | - | |||||||||
(Gain) loss on extinguishment of debt
|
- | (21,005 | ) | (89,592 | ) | |||||||
Gain on sale of asset
|
- | - | (70,500 | ) | ||||||||
(Gain) loss on derivative liability
|
1,117,642 | (322,032 | ) | 1,801,871 | ||||||||
Depreciation
|
4,728 | 4,728 | 20,038 | |||||||||
Amortization of patent costs
|
38,788 | 39,272 | 215,134 | |||||||||
Changes in operating assets and liabilities
|
||||||||||||
Prepaid expenses and deposits
|
9,404 | (134,417 | ) | (133,680 | ) | |||||||
Other receivables and other current assets
|
- | 184,358 | 85,025 | |||||||||
Accounts payable and accrued expenses
|
13,831 | 33,584 | 122,455 | |||||||||
Net Cash Used in Operating Activities
|
(1,037,384 | ) | (809,342 | ) | (5,252,184 | ) | ||||||
INVESTING ACTIVITIES
|
||||||||||||
Proceeds from sale of asset
|
- | - | 70,500 | |||||||||
Purchase of equipment
|
- | (33,403 | ) | (58,421 | ) | |||||||
Purchase of patents and other intellectual property
|
- | - | (300,000 | ) | ||||||||
Discontinued operations
|
- | - | 418,000 | |||||||||
Net Cash Provided by (Used in) Investing Activities
|
- | (33,403 | ) | 130,079 | ||||||||
FINANCING ACTIVITIES
|
||||||||||||
Proceeds from the sale of preferred stock and warrants
|
- | - | 1,005,000 | |||||||||
Proceeds from the sale of common stock and warrants
|
- | 1,100,000 | 2,150,000 | |||||||||
Proceeds from warrants exercised for cash
|
188,573 | - | 4,096,133 | |||||||||
Proceeds from related party payables
|
- | - | 125,453 | |||||||||
Repayments of related party payables
|
- | - | (125,453 | ) | ||||||||
Proceeds from short-term notes payable
|
- | 48,300 | 64,408 | |||||||||
Repayments of short-term notes payable
|
(18,394 | ) | - | (135,503 | ) | |||||||
Repayment of convertible debentures
|
- | - | (490,000 | ) | ||||||||
Net Cash Provided by Financing Activities
|
170,179 | 1,148,300 | 6,690,038 | |||||||||
NET CHANGE IN CASH
|
(867,205 | ) | 305,555 | 1,567,933 | ||||||||
CASH AT BEGINNING OF PERIOD
|
2,632,413 | 469,786 | 197,275 | |||||||||
CASH AT END OF PERIOD
|
$ | 1,765,208 | $ | 775,341 | $ | 1,765,208 | ||||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION CASH PAID FOR:
|
||||||||||||
Interest
|
$ | 559 | $ | - | $ | 72,299 | ||||||
Income Taxes
|
- | - | - | |||||||||
NON CASH FINANCING ACTIVITIES:
|
||||||||||||
Reclassification of derivative liability to permanent equity
|
$ | 1,886,338 | $ | - | $ | 5,340,432 | ||||||
Financing of insurance premiums through issuance of short term notes
|
- | - | 74,738 | |||||||||
Conversion of preferred for common stock
|
14 | - | 14 | |||||||||
Noncash exercise of options
|
33 | - | 33 | |||||||||
Transfer of investment for dividends payable
|
- | - | 186,000 | |||||||||
Purchase of patents for debenture
|
- | - | 500,000 | |||||||||
Conversion of debenture
|
- | - | 10,000 | |||||||||
Options issued to settle accounts payable
|
- | - | 3,991 |
Liabilities measured at fair value on a recurring
|
|||||||||||||||
basis at September 30, 2012:
|
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||
Stock warrant derivative liabilities
|
$
|
—
|
$
|
—
|
$
|
768,696
|
$
|
768,696
|
|||||||
$
|
—
|
$
|
—
|
$
|
768,696
|
$
|
768,696
|
Stock Warrant
|
||||
Level 3 Reconciliation:
|
Derivative
|
|||
Level 3 assets and liabilities at September 30, 2012
|
$ | 768,696 | ||
Purchases, sales, issuances and settlements (net)
|
(1,886,338 | ) | ||
Mark to market adjustments
|
1,117,642 | |||
Total level 3 assets and liabilities at March 31, 2013
|
$ | — |
Date
|
Number
|
Exercise
|
Contractual
|
Expiration
|
Value if
|
|||||
Issued
|
Outstanding
|
Price
|
Life (Years)
|
Date
|
Exercised
|
|||||
Balance 10/1/08
|
13,509,857
|
1.18
|
5
|
Various
|
15,941,631
|
|||||
03/20/09
|
5,000,000
|
0.50
|
5
|
03/31/14
|
2,500,000
|
|||||
06/03/09
|
11,166,672
|
0.18
|
5
|
06/03/14
|
2,010,001
|
|||||
09/30/09
|
150,000
|
0.40
|
5
|
06/30/14
|
60,000
|
|||||
Expired
|
-
|
-
|
-
|
-
|
-
|
|||||
Balance 9/30/09
|
29,826,529
|
0.69
|
-
|
-
|
20,511,632
|
|||||
10/09/09
|
88,000
|
0.50
|
5
|
10/29/14
|
44,000
|
|||||
11/09/09
|
18,000
|
0.50
|
5
|
11/09/14
|
9,000
|
|||||
12/04/09
|
130,000
|
0.60
|
2
|
12/04/11
|
78,000
|
|||||
12/15/09
|
(5,583,336)
|
0.18
|
-
|
-
|
(1,005,000)
|
|||||
01/15/10
|
5,583,336
|
0.55
|
5
|
01/15/15
|
3,070,835
|
|||||
01/15/10
|
(5,583,336)
|
0.18
|
-
|
-
|
(1,005,000)
|
|||||
04/09/10
|
10,000
|
0.55
|
5
|
4/9/2015
|
5,500
|
|||||
07/23/10
|
93,000
|
0.50
|
3
|
07/23/13
|
46,500
|
|||||
Expired
|
-
|
-
|
-
|
-
|
-
|
|||||
Balance 9/30/10
|
24,582,193
|
0.89
|
-
|
-
|
21,755,467
|
|||||
12/30/10
|
2,520,000
|
0.55
|
5
|
12/30/15
|
1,386,000
|
|||||
05/12/11
|
55,000
|
0.50
|
5
|
05/12/16
|
27,500
|
|||||
06/13/11
|
300,000
|
0.50
|
2
|
06/13/13
|
150,000
|
|||||
07/15/11
|
100,000
|
0.54
|
5
|
07/15/16
|
54,000
|
|||||
07/15/11
|
120,000
|
0.54
|
5
|
07/15/16
|
64,800
|
|||||
08/23/11
|
50,000
|
0.67
|
3
|
08/23/14
|
33,500
|
|||||
Expired
|
(1,090,568)
|
1.19
|
-
|
-
|
(1,297,776)
|
|||||
Balance 9/30/11
|
26,636,625
|
0.83
|
-
|
-
|
22,173,491
|
|||||
12/16/11
|
916,678
|
0.65
|
5
|
12/16/16
|
595,841
|
|||||
12/21/12
|
3,125
|
0.65
|
5
|
12/21/12
|
2,031
|
|||||
03/03/12
|
350,000
|
0.65
|
5
|
03/03/17
|
227,500
|
|||||
04/10/12
|
(43,392)
|
0.60
|
-
|
-
|
(26,035)
|
|||||
04/12/12
|
15,000
|
0.90
|
3
|
4/12/2015
|
13,500
|
|||||
05/18/12
|
350,000
|
0.95
|
3
|
5/18/2015
|
332,500
|
|||||
06/28/12
|
(5,299,002)
|
0.55
|
-
|
-
|
(2,914,451)
|
|||||
06/28/12
|
3,179,410
|
1.20
|
5
|
06/28/17
|
3,815,292
|
|||||
07/11/12
|
50,000
|
0.95
|
3
|
07/11/15
|
47,500
|
|||||
07/17/12
|
(30,000)
|
0.50
|
-
|
-
|
(15,000)
|
|||||
09/07/12
|
75,000
|
1.00
|
5
|
09/07/17
|
75,000
|
|||||
Expired
|
(620,530)
|
0.79
|
-
|
-
|
(490,219)
|
|||||
Balance 9/30/12
|
25,582,914
|
0.93
|
-
|
-
|
23,836,950
|
|||||
10/24/2012
|
(200,000)
|
0.50
|
-
|
-
|
(100,000)
|
|||||
3/7/2013
|
(20,988)
|
1.19
|
-
|
-
|
(24,976)
|
|||||
3/11/2013
|
(5,037)
|
1.19
|
-
|
-
|
(5,994)
|
|||||
3/21/2013
|
120,000
|
1.44
|
5
|
3/21/2018
|
172,800
|
|||||
3/21/2013
|
50,000
|
1.44
|
3
|
3/21/2016
|
72,000
|
|||||
3/22/2013
|
(11,111)
|
0.55
|
-
|
-
|
(6,112)
|
|||||
3/27/2013
|
(2,520,000)
|
0.55
|
-
|
-
|
(1,386,000)
|
|||||
Expired
|
-
|
-
|
-
|
-
|
-
|
|||||
Balance 3/31/2013
|
22,995,778
|
0.98
|
-
|
-
|
22,558,668
|
Date Issued
|
Number Outstanding
|
Exercise Price
|
Contractual Life (Years)
|
Expiration Date
|
Value if Exercised
|
|||||||||||
Prior 10/1/2008
|
-
|
$
|
-
|
-
|
-
|
$
|
-
|
|||||||||
04/09/09
|
579,141
|
0.65
|
5
|
04/09/13
|
376,442
|
|||||||||||
Balance 09/30/2009
|
579,141
|
0.65
|
-
|
-
|
376,442
|
|||||||||||
04/12/10
|
1,000,000
|
0.50
|
5
|
04/12/15
|
500,000
|
|||||||||||
Expired
|
(32,176)
|
0.65
|
-
|
-
|
(20,914)
|
|||||||||||
Balance 9/30/2010
|
1,546,965
|
$
|
0.55
|
-
|
-
|
$
|
855,528
|
|||||||||
Issued
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Expired
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Balance 9/30/2011
|
1,546,965
|
$
|
0.55
|
-
|
-
|
$
|
855,528
|
|||||||||
03/09/12
|
1,700,000
|
0.57
|
-
|
3/9/2017
|
969,000
|
|||||||||||
Expired
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Balance 9/30/2012
|
3,246,965
|
$
|
0.56
|
-
|
-
|
$
|
1,824,528
|
|||||||||
Exercised
|
(546,965)
|
0.65
|
-
|
-
|
(355,527)
|
|||||||||||
Expired
|
-
|
-
|
-
|
-
|
-
|
|||||||||||
Balance 3/31/13
|
2,700,000
|
$
|
0.54
|
-
|
-
|
$
|
1,469,001
|
|
||||||||||||
March 31, 2013
|
Adjustments
|
Proforma March 31, 2013
|
||||||||||
ASSETS
|
||||||||||||
CURRENT ASSETS
|
||||||||||||
Cash
|
$ | 1,765,208 | $ | 5,056,337 | $ | 6,821,545 | ||||||
Prepaid expenses
|
208,838 | 208,838 | ||||||||||
Total Current Assets
|
1,974,046 | 7,030,383 | ||||||||||
EQUIPMENT, net
|
38,383 | 38,383 | ||||||||||
OTHER ASSETS
|
||||||||||||
Patent costs, net
|
584,866 | 584,866 | ||||||||||
TOTAL ASSETS
|
$ | 2,597,295 | $ | 7,653,632 | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||||
CURRENT LIABILITIES
|
||||||||||||
Accounts payable and accrued expenses
|
$ | 314,293 | $ | 314,293 | ||||||||
Notes payable
|
3,643 | 3,643 | ||||||||||
Total Current Liabilities
|
317,936 | 317,936 | ||||||||||
TOTAL LIABILITIES
|
317,936 | 317,936 | ||||||||||
STOCKHOLDERS' EQUITY
|
||||||||||||
Preferred stock, Series B
|
544 | 544 | ||||||||||
Common stock
|
4,970 | 424 | 5,394 | |||||||||
Additional paid-in capital
|
33,314,851 | 5,055,913 | 38,370,764 | |||||||||
Accumulated deficit
|
(21,628,748 | ) | (21,628,748 | ) | ||||||||
Deficit accumulated during the development stage
|
(9,412,258 | ) | (9,412,258 | ) | ||||||||
Total Stockholders' Equity
|
2,279,359 | 7,335,696 | ||||||||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$ | 2,597,295 | $ | 7,653,632 |
Management’s Discussion and Analysis of Financial Condition and Results of Operations.
|
|
·
|
Eye drops versus standard of care which is an intravitreal injection directly into the eye every 4-8 weeks on a chronic basis
|
|
·
|
Reduction or elimination of intravitreal injections has the potential to provide patients with improved safety by reducing or eliminating side effects associated with the intravitreal injection procedure
|
|
·
|
Inhibition of multiple growth factors may achieve superior visual acuity outcomes. Clinical evidence has demonstrated that inhibiting VEGF and PDGF together may provide patients with better visual acuity outcomes than anti-VEGF therapy alone
|
|
·
|
Cost advantage of manufacturing a small molecule when compared to large molecule proteins and antibodies
|
·
|
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.
|
|
·
|
Single Dose 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.
|
|
·
|
Multi Dose Biodistribution Study: Squalamine eye drops were administered once or twice daily in both eyes for up to 14 days in Dutch belted rabbits. The eyes were examined one full dosing interval (12 hours when given twice daily, 24 hours when given once daily) after the last administration of Squalamine eye drops to determine concentrations of Squalamine in the posterior ocular tissues (“Trough” level). At all time points and dosing regimens, Trough Squalamine concentrations exceeded tissue concentrations of Squalamine that are known to block the choroidal neovascularization process in Wet-AMD.
|
|
|
·
|
Long Term Ocular Tolerance and Toxicity: In a 26-week safety and toxicity study in male and female Dutch belted rabbits, Squalamine or placebo eye drops were administered via topical instillation twice a day in both eyes. Ophthalmoscopic examinations were conducted throughout the study period to assess ocular toxicity (irritation, redness, swelling, discharge). Blood and urine samples for clinical pathology evaluations were collected, and blood samples for determination of the plasma concentrations of squalamine eye drops and toxicokinetic evaluations were collected from all animals at designated time points. At study termination, necropsy examinations were performed, and organs and optical tissues were microscopically examined.
|
No adverse effects of treatment were observed in any of the parameters evaluated including clinical findings, body weights, food consumption, ocular irritation, hematology, coagulation, clinical chemistry, urinalysis and macroscopic pathology examinations. Importantly, ophthalmoscopic examinations indicated no signs of clouding of the lens, no corneal opacities or deposits, and no increase in intraocular pressure. In addition, microscopic histopathology evaluations on ocular tissues were normal. Squalamine also did not build up in plasma over long term administration, indicating reduced potential for systemic side effects.
|
2013
|
2012
|
Change
|
||||||||||
Operating Expenses
|
||||||||||||
General and administrative
|
$ | 33,822 | $ | 35,414 | $ | (1,592 | ) | |||||
Professional fees
|
74,149 | 160,939 | (86,790 | ) | ||||||||
Research and development
|
433,789 | 351,165 | 82,624 | |||||||||
Salaries and wages
|
126,383 | 359,954 | (233,571 | ) | ||||||||
Total Operating Expenses
|
668,143 | 907,472 | (239,329 | ) | ||||||||
Operating Income (Loss)
|
(668,143 | ) | (907,472 | ) | 239,329 | |||||||
Gain (loss) on derivative liability
|
285,481 | (504,870 | ) | 790,351 | ||||||||
Gain on settlement of debt
|
- | - | - | |||||||||
Other income and expenses
|
90,404 | 25 | 90,379 | |||||||||
Income (loss) from operations
|
(292,258 | ) | (1,412,317 | ) | 1,120,059 | |||||||
Discontinued operations
|
- | - | - | |||||||||
Net Income (Loss)
|
$ | (292,258 | ) | $ | (1,412,317 | ) | $ | 1,120,059 |
2013
|
2012
|
Change
|
||||||||||
Operating Expenses
|
||||||||||||
General and administrative
|
$ | 104,012 | $ | 68,325 | $ | 35,687 | ||||||
Professional fees
|
121,180 | 225,497 | (104,317 | ) | ||||||||
Research and development
|
1,012,302 | 687,320 | 324,982 | |||||||||
Salaries and wages
|
245,400 | 423,513 | (178,113 | ) | ||||||||
Total Operating Expenses
|
1,482,894 | 1,404,655 | 78,239 | |||||||||
Operating Income (Loss)
|
(1,482,894 | ) | (1,404,655 | ) | (78,239 | ) | ||||||
Gain (loss) on derivative liability
|
(1,117,642 | ) | 322,032 | (1,439,674 | ) | |||||||
Gain on settlement of debt
|
- | 21,005 | (21,005 | ) | ||||||||
Other income and expenses
|
89,926 | 38 | 89,888 | |||||||||
Income (loss) from operations
|
(2,510,610 | ) | (1,061,580 | ) | (1,449,030 | ) | ||||||
Discontinued operations
|
- | - | - | |||||||||
Net Income (Loss)
|
$ | (2,510,610 | ) | $ | (1,061,580 | ) | $ | (1,449,030 | ) |
Quantitative and Qualitative Risk
|
Controls and Procedures
|
OTHER INFORMATION
|
Legal Proceedings
|
Unregistered Sales of Equity Securities and Use of Proceeds .
|
Defaults Upon Senior Securities.
|
Removed and Reserved.
|
Other Information
|
Exhibits
|
Exhibit
|
Number
|
||
OHR PHARMACEUTICAL, INC.
(Registrant)
|
||
By:
|
/s/ Irach Taraporewala
|
|
Irach Taraporewala
|
||
Chief Executive Officer
|
||
By:
|
/s/ Sam Backenroth
|
|
Sam Backenroth
|
||
Chief Financial Officer
|
1.
|
I have reviewed this report on Form 10-Q of Ohr Pharmaceutical, Inc;
|
|
2.
|
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;
|
|
3.
|
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;
|
|
4.
|
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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:
|
|
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 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
|
|
5.
|
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.
|
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
|
|
b.
|
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.
|
/s/ Irach Taraporewala
|
|
Irach Taraporewala
|
|
Chief Executive Officer
|
1.
|
I have reviewed this report on Form 10-Q of Ohr Pharmaceutical, Inc
|
|
2.
|
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;
|
|
3.
|
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;
|
|
4.
|
The registrants 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15(d)-15(f)) for the registrant and have:
|
|
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 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
|
|
5.
|
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.
|
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
|
|
b.
|
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.
|
/s/ Sam Backenroth
|
|
Sam Backenroth
|
|
Chief Financial Officer
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities 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.
|
/s/ Irach Taraporewala
|
|
Name: Irach Taraporewala
|
|
Title: Chief Executive Officer
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities 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.
|
/s/ Sam Backenroth
|
|
Name: Sam Backenroth
|
|
Title: Chief Financial Officer
|
CAPITAL STOCK (Details Narrative) (USD $)
|
0 Months Ended | 1 Months Ended | 6 Months Ended | 66 Months Ended | 3 Months Ended | 0 Months Ended | 6 Months Ended | 0 Months Ended | 1 Months Ended | 6 Months Ended | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apr. 16, 2013
|
Apr. 05, 2013
|
Mar. 27, 2013
|
Oct. 05, 2012
|
Mar. 31, 2013
|
Mar. 31, 2013
|
Mar. 31, 2012
|
Mar. 31, 2013
|
Dec. 31, 2012
Stock Subscription Receivable
|
Nov. 30, 2012
Stock Options
|
Mar. 31, 2013
Stock Options
|
Mar. 31, 2013
Warrants
|
Mar. 27, 2013
Warrants
|
Mar. 23, 2013
Warrants
|
Mar. 11, 2013
Warrants
|
Mar. 07, 2013
Warrants
|
Oct. 24, 2012
Warrants
|
Jul. 17, 2012
Warrants
|
Apr. 10, 2012
Warrants
|
Dec. 15, 2009
Warrants
|
Mar. 31, 2013
Warrants
|
Mar. 31, 2013
Warrants
|
Sep. 07, 2012
Warrants
|
Jul. 11, 2012
Warrants
|
Jun. 28, 2012
Warrants
|
May 18, 2012
Warrants
|
Apr. 12, 2012
Warrants
|
Mar. 03, 2012
Warrants
|
Dec. 21, 2011
Warrants
|
Dec. 16, 2011
Warrants
|
Aug. 23, 2011
Warrants
|
Jul. 15, 2011
Warrants
|
Jun. 13, 2011
Warrants
|
May 12, 2011
Warrants
|
Dec. 30, 2010
Warrants
|
Jul. 23, 2010
Warrants
|
Apr. 09, 2010
Warrants
|
Jan. 15, 2010
Warrants
|
Dec. 04, 2009
Warrants
|
Nov. 09, 2009
Warrants
|
Oct. 09, 2009
Warrants
|
Sep. 30, 2009
Warrants
|
Jun. 03, 2009
Warrants
|
Mar. 20, 2009
Warrants
|
Mar. 31, 2013
Warrants
Lower Range
|
Mar. 31, 2013
Warrants
Upper Range
|
|
Conversion of Series B Preferred shares to common stock, preferred stock converted | 138,889 | 138,889 | ||||||||||||||||||||||||||||||||||||||||||||
Conversion of Series B Preferred shares to common stock, common stock | 138,889 | 138,889 | ||||||||||||||||||||||||||||||||||||||||||||
Exercise price, warrant | 0.55 | 0.55 | 1.19 | 1.19 | 0.50 | 0.50 | 0.60 | 0.18 | 1.00 | 0.95 | 1.20 | 0.95 | 0.90 | 0.65 | 0.65 | 0.65 | 0.67 | 0.54 | 0.50 | 0.50 | 0.55 | 0.50 | 0.55 | 0.55 | 0.60 | 0.50 | 0.50 | 0.40 | 0.18 | 0.50 | 0.55 | 1.19 | ||||||||||||||
Proceeds from warrants exercised for cash | $ 5,060,000 | $ 55,481 | $ 188,573 | $ 4,096,133 | $ 76,682 | $ 100,000 | ||||||||||||||||||||||||||||||||||||||||
Exercise of stock options, options exercised | 386,094 | 160,871 | 546,965 | |||||||||||||||||||||||||||||||||||||||||||
Exercise of awards, shares | 4,244,984 | 237,420 | 92,527 | (546,965) | 109,136 | (2,520,000) | (11,111) | (5,037) | (20,988) | (200,000) | (30,000) | (43,392) | (5,583,336) | 2,757,136 | 20,988 | |||||||||||||||||||||||||||||||
Collection of subscription receivable | $ 1,100,000 | $ 2,150,000 | $ 11,891 | |||||||||||||||||||||||||||||||||||||||||||
Exercise of cashless warrants, warrants | 2,448,000 | 2,448,000 | ||||||||||||||||||||||||||||||||||||||||||||
Exercise of cashless warrants, shares | 1,664,830 |
PATENT COSTS
|
6 Months Ended |
---|---|
Mar. 31, 2012
|
|
Patent Costs | |
PATENT COSTS | NOTE 3 – PATENT COSTS
Patent costs represent the capitalized purchase price of assets acquired in the secured party sale as part of the Company’s previously announced strategy to create a rollup of undervalued biotechnology companies and assets. As of March 31, 2013, the Company had purchased $800,000 worth of biotechnology patents and other intellectual property. In these acquisitions, the Company used approximately $300,000 in cash and issued a $500,000 convertible debenture for the remainder of the cost, which has been paid in full.
The Company amortizes its patents over the life of each patent. During the six months ended March 31, 2013 and 2012, the Company recognized $38,788 and $39,272 in amortization expense on the patents, respectively. The amortization expense has been included in research and development expense. |