OHR Pharmaceutical Inc.

Ohr Pharmaceutical Reports First Quarter 2016 Financial and Business Results

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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.

Consolidated Balance Sheets
      December 31,   September 30,
      2015   2015
  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  
  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  
  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  
      STOCKHOLDERS' EQUITY $    44,151,136     $    46,370,807  

Consolidated Statements of Operations
      For the Three Months Ended  
      December 31,  
      2015   2014  
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    
  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 )  
  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 )  
  BASIC AND DILUTED     30,472,493         25,259,154    

Consolidated Statements of Cash Flows
        For the Three Months Ended
        December 31,
        2015   2014
  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 )
    Purchase of property and equipment      (10,550 )        -  
      Net Cash Used in Investing Activities      (10,550 )        -  
  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  
  CASH PAID FOR:          
    Interest  $    406      $    433  
    Income Taxes      -          -  
    Common stock issued to settle accounts payable   $ -       $ 50,000  
    Settlement of contingent consideration     2,061,136         -  
Ohr Pharmaceutical Inc. 
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