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Ohr Pharmaceutical Reports First Quarter 2016 Financial and Business Results
Globe Newswire

Conference Call Today at 5:00pm Eastern Time

NEW YORK, Feb. 09, 2016 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today reported results for its first quarter ended December 31, 2015.

“I am excited by the ongoing progress we made in the first quarter of fiscal 2016,” said Jason S. Slakter, MD, Chief Executive Officer of Ohr.  “The positive data generated by our phase 2 IMPACT study of OHR-102 combination therapy in the wet form of age-related macular degeneration (wet-AMD) has set the stage for the phase 3 clinical program and supports our conviction that OHR-102 combination therapy has the potential to establish a new standard of care in wet AMD," continued Dr. Slakter.  “Importantly, we now have the data we need to optimize the design for our planned Phase 3 development program, in particular, the inclusion criteria for enrolling the patient population which has the highest likelihood of significant visual acuity gains. Our plan is to initiate the Phase 3 program upon completion of the Special Protocol Assessment (SPA) procedure, and begin enrolling patients in the first calendar quarter of 2016."

First Quarter 2016 Clinical Highlights

  • Submitted a Special Protocol Assessment (SPA) request to the FDA on the design of the Phase 3 clinical development program of OHR-102 for the treatment of wet-AMD.
    • The planned Phase 3 clinical trials are designed as double-masked, placebo-controlled, multicenter, international studies of OHR-102 administered twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis® injections.
    • The primary endpoint is visual acuity improvement at month 9.
    • Enrollment in the Phase 3 program is on track to begin in the first calendar quarter of 2016.
  • Presented new data on OHR-102 from Phase II IMPACT Study in Wet-AMD at American Academy of Ophthalmology (AAO) Annual Meeting in Las Vegas, NV.
    • The size of occult CNV at baseline, irrespective of a classic CNV component, was the strongest predictive factor of treatment success with the combination of OHR-102 plus Lucentis.
    • Occult CNV <10mm2 population represents a larger proportion of the subjects enrolled in the IMPACT study than the classic containing group and encompasses over 75% of patients seen in clinical practice today.
    • Phase 3 program will enroll an optimized patient population that has the greatest potential benefit from OHR-102 combination therapy.
  • Announced positive preclinical data from SKS sustained release ocular program
    • In an animal model used to evaluate ophthalmic compounds, sustained supratherapeutic levels of active drug were achieved in target ocular tissues.
    • Results serve as an important validation for Ohr's SKS sustained release technology which holds the promise of improving the standard of care in a number of ocular conditions.

Financial Results for First Quarter ended December 31, 2015

  • For the first quarter ended December 31, 2015, the Company reported a net loss of approximately $6.1 million, or ($0.20) per share, compared to a net loss of approximately $4.6 million, or ($0.18) per share in the same period of 2014.
  • For the first quarter ended December 31, 2015, total operating expenses were approximately $3.6 million, consisting of $1.2 million in general and administrative expenses, $2.1 million in research and development expenses, and 0.3 million in depreciation and amortization.  This compared to approximately $3.9 million in 2014, consisting of $0.8 million in general and administrative expenses, $2.8 million in research and development expenses, and $0.3 million in depreciation and amortization in the same period in 2015.
  • At December 31, 2015 the Company had cash and cash equivalents of approximately $25.3 million. This compares to cash and equivalents of approximately $10.4 million at December 31, 2014.

Conference Call
Tuesday, February 9 at 5:00pm Eastern Time

Domestic:                                877-407-0789
International:                           201-689-8562
Conference ID:                       13629898
Webcast:                                 http://public.viavid.com/index.php?id=118193

Replays – Available through February 16, 2016
Domestic:                                877-870-5176
International:                           858-384-5517
Conference ID:                       13629898

About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. (Nasdaq:OHRP) is an ophthalmology research and development company. The company's lead product, OHR-102 (Squalamine Lactate Ophthalmic Solution, 0.2%), is currently being studied as an eye drop formulation in clinical trials for back-of-the-eye diseases, including the wet form of age-related macular degeneration, retinal vein occlusion, and proliferative diabetic retinopathy. In addition, Ohr has a sustained release micro fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies, and protein drug delivery. Additional information on the company may be found at www.ohrpharmaceutical.com

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: 
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as the date thereof, and Ohr Pharmaceutical undertakes no obligation to update or revise the forward-looking statement whether as a result of new information, future events or otherwise. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the future success of our scientific studies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments, the financial resources available to us, and general economic conditions. Shareholders and prospective investors are cautioned that no assurance of the efficacy of pharmaceutical products can be claimed or assured until final testing; and no assurance or warranty can be made that the FDA will approve final testing or marketing of any pharmaceutical product. Ohr's most recent Annual Report and subsequent Quarterly Reports discuss some of the important risk factors that may affect our business, results of operations and financial condition.

Lucentis® is a registered trademark of Genentech, Inc.


OHR PHARMACEUTICAL, INC.
Consolidated Balance Sheets
(Unaudited)
        
   December 31, September 30,
   2015 2015
ASSETS
CURRENT ASSETS   
 Cash$  25,325,809  $  28,697,323 
 Prepaid expenses and other current assets   1,777,746     338,713 
        
  Total Current Assets   27,103,555     29,036,036 
        
EQUIPMENT, net   244,261     248,753 
        
OTHER ASSETS     
 Security deposit   12,243     12,243 
       
 Intangible assets, net   16,050,165     16,332,863 
 Goodwill   740,912     740,912 
        
  TOTAL ASSETS $  44,151,136   $  46,370,807 
        
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES     
 Accounts payable and accrued expenses$  2,540,870  $  1,592,348 
 Notes payable   -     48,063 
 Contingent consideration   2,736,016     2,239,603 
        
  Total Current Liabilities   5,276,886     3,880,014 
        
  TOTAL LIABILITIES   5,276,886     3,880,014 
        
STOCKHOLDERS' EQUITY     
 Preferred stock, Series B; 6,000,000 shares authorized, $0.0001 par value, 0 and 500,000 shares issued and outstanding, respectively   -     - 
 Common stock; 180,000,000 shares authorized, $0.0001 par value, 30,956,112 and 30,331,309 shares issued and outstanding, respectively   3,096     3,033 
 Additional paid-in capital   103,528,029     100,999,173 
 Accumulated deficit   (64,656,875)    (58,511,413)
        
  Total Stockholders' Equity   38,874,250     42,490,793 
  TOTAL LIABILITIES AND     
    STOCKHOLDERS' EQUITY$  44,151,136  $  46,370,807 
        



OHR PHARMACEUTICAL, INC.
Consolidated Statements of Operations
(Unaudited)
         
   For the Three Months Ended 
   December 31, 
   2015 2014 
         
OPERATING EXPENSES      
         
General and administrative $ 1,218,128   $ 812,469  
         
Research and development  2,076,280    2,805,896  
         
Depreciation and amortization  297,740     305,622  
         
       
         
  OPERATING LOSS   3,592,148     3,923,987  
         
OTHER INCOME (EXPENSE)      
        
 Change in fair value of contingent consideration  (2,557,549)    (683,386) 
 Share in losses on investment in joint venture   -     (26,650) 
 Other income   3,419     35,813  
 Interest income (expense), net  816     (127) 
        
         
  Total Other Income (Expense)  (2,553,314)    (674,350) 
         
LOSS FROM OPERATIONS BEFORE      
 INCOME TAXES   (6,145,462)    (4,598,337) 
         
PROVISION FOR INCOME TAXES   -     -  
         
NET LOSS$ (6,145,462) $  (4,598,337) 
         
BASIC AND DILUTED LOSS PER SHARE $ (0.20)  $ (0.18) 
         
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING:      
 BASIC AND DILUTED  30,472,493    25,259,154  
         



OHR PHARMACEUTICAL, INC.
Consolidated Statements of Cash Flows
(Unaudited)
         
    For the Three Months Ended
    December 31,
    2015 2014
OPERATING ACTIVITIES     
 Net loss $  (6,145,462) $  (4,540,958)
 Adjustments to reconcile net loss to net cash     
   used by operating activities:     
  Common stock issued for services   137,424     28,760 
  Warrants issued for services   -     8,559 
  Stock option expense   316,819     362,028 
  Change in fair value of contingent consideration   2,557,549     683,386 
  Share in losses on investment in joint venture   -     26,650 
  Depreciation   15,042     7,636 
  Amortization of intangible assets   282,698     297,986 
 Changes in operating assets and liabilities     
  Prepaid expenses and deposits   (1,439,033)    (445,523)
  Accounts payable and accrued expenses   948,522     834,605 
         
   Net Cash Used in Operating Activities   (3,326,441)    (2,736,871)
         
INVESTING ACTIVITIES     
  Purchase of property and equipment   (10,550)    - 
   Net Cash Used in Investing Activities   (10,550)    - 
         
FINANCING ACTIVITIES     
 Proceeds from warrants exercised for cash   13,540     3,000 
 Repayments of short-term notes payable   (48,063)    (43,899)
         
   Net Cash Used in Financing Activities   (34,523)    (40,899)
         
NET CHANGE IN CASH   (3,371,514)    (2,777,770)
CASH AT BEGINNING OF PERIOD   28,697,323     13,220,494 
         
CASH AT END OF PERIOD$  25,325,809  $  10,442,724 
         
SUPPLEMENTAL DISCLOSURES OF CASH FLOW    
INFORMATION   
 CASH PAID FOR:     
  Interest $  406   $  433 
  Income Taxes   -     - 
         
 NON CASH FINANCING ACTIVITIES:     
  Common stock issued to settle accounts payable $-   $50,000 
  Settlement of contingent consideration  2,061,136    - 
         
Contact:
Ohr Pharmaceutical Inc.	
Investor Relations		
888-388-2327			
ir@ohrpharmaceutical.com	
LifeSci Advisors, LLC
Michael Wood
646-597-6983
mwood@lifesciadvisors.com

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