OHR Pharmaceutical Inc.

Ohr Pharmaceutical Reports Second Quarter 2016 Financial and Business Results

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NEW YORK, May 10, 2016 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today reported results for its second quarter ended March 31, 2016.

“We achieved a number of important milestones in advancing our lead drug candidate, Squalamine, during the first few months of 2016,” said Jason S. Slakter, MD, Chief Executive Officer of Ohr.  “In commencing the enrollment of patients in our Phase 3 clinical program, we move closer to potentially providing a much-needed, safe and efficacious new treatment for patients with neovascular age-related macular degeneration or wet AMD.  Importantly, we are conducting the Phase 3 trials under an agreed upon Special Protocol Assessment (SPA) with the United States Food and Drug Administration.  The trials are designed to generate data to support regulatory approval of Squalamine in the United States and other major ophthalmic markets worldwide.”

Second Quarter and Recent 2016 Clinical and Pre-Clinical Highlights

  • Enrolled the first patient in the Phase 3 clinical development program to investigate Squalamine lactate ophthalmic solution, 0.2% (“Squalamine,” also known as OHR-102), when administered as part of a combination therapy, as a treatment to improve visual function for patients with wet AMD. 
    • The Phase 3 program includes two clinical trials designed as double-masked, placebo-controlled, multicenter, international studies of Squalamine administered twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis® injections.
    • The first of the two randomized trials will include approximately 165 centers in the United States and Canada and has a target enrollment of 650 treatment naïve subjects with wet AMD.   
    • The primary endpoint in both studies will be a measurement of visual acuity gains at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
  • Reached an agreement on a Special Protocol Assessment (SPA) with the United States Food and Drug Administration on the design of the Phase 3 trials for Squalamine.
  • Presented two posters at the Association for Research in Vision and Ophthalmology (ARVO) Conference, which took place May 1 through May 5 in Seattle, Washington.
    • CNV Lesion Characteristics as a Predictor of Visual Outcomes in Wet AMD Patients Receiving Combination Therapy with Ranibuzimab (Lucentis®) and topical Squalamine Lactate Ophthalmic Solution (David M. Brown et al). Included detailed analysis of lesion characteristics as predictors of visual outcome in the previously conducted Phase 2 IMPACT trial, and demonstrated that combination therapy with Squalamine was most effective in those patients whose occult component was less than 10mm2. These new data support the choice of the target population in the ongoing Phase 3 registration program.
    • Sustained Retinal Concentrations of OHR3031 Achieved with Intravitreal Injection of a Biodegradable Microparticle Formulation to Rabbits (Modi et al).  This poster discussed the use of Ohr’s proprietary sustained release technology to successfully deliver supratherapeutic concentrations of OHR3031, a novel small molecule anti-angiogenic compound, to target tissues in the back of the eye.

Financial Results for Second Quarter ended March 31, 2016

  • For the second quarter ended March 31, 2016, the Company reported a net loss of approximately $5.3 million, or ($0.17) per share, compared to a net loss of approximately $3.4 million, or ($0.12) per share in the same period of 2015.
  • For the second quarter ended March 31, 2016, total operating expenses were approximately $6.6 million, consisting of approximately $3.0 million in general and administrative expenses, $4.0 million in research and development expenses, $0.3 million in depreciation and amortization, and $0.7 million in gain on settlement of accounts payable.  This compares to total operating expenses in the same period of 2015 of approximately $6.8 million, consisting of $3.3 million in general and administrative expenses, $3.2 million in research and development expenses, and $0.3 million in depreciation and amortization.
  • At March 31, 2016, the Company had cash and cash equivalents of approximately $21.9 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.

Financial Results for the Six-Months ended March 31, 2016

  • For the six months ended March 31, 2016, the Company reported a net loss of approximately $11.4 million, or ($0.37) per share, compared to a net loss of approximately $7.9 million, or ($0.30) per share in the same period of 2015.
  • For the six months ended March 31, 2016, total operating expenses were approximately $10.2 million, consisting of $4.2 million in general and administrative expenses, $6.1 million of research and development expenses, $0.6 million in depreciation and amortization, and $0.7 million in gain on settlement of accounts payable. This compares to total operating expenses of $10.7 million in the same period of 2015, comprised of approximately $4.2 million in general and administrative expenses, $5.9 million in research and development expenses, and $0.6 million in depreciation and amortization.
 
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About Ohr Pharmaceutical, Inc.

Ohr Pharmaceutical, Inc. (Nasdaq:OHRP) is an ophthalmology research and development company. The company's lead drug candidate, Squalamine lactate ophthalmic solution, 0.2% (also known as OHR-102), is currently being studied using an eye drop formulation in a Phase 3 clinical program for the treatment of the wet form of age-related macular degeneration.  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 we undertake 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. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q 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)
               
      March 31,   September 30,
      2016   2015
ASSETS
CURRENT ASSETS      
  Cash $    21,881,370     $    28,697,323  
  Prepaid expenses and other current assets      456,514          338,713  
               
    Total Current Assets      22,337,884          29,036,036  
               
EQUIPMENT, net      229,363          248,753  
               
OTHER ASSETS          
  Security deposit      12,243          12,243  
  Intangible assets, net      15,770,541          16,332,863  
  Goodwill      740,912          740,912  
               
    TOTAL ASSETS  $    39,090,943      $    46,370,807  
               
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES          
  Accounts payable and accrued expenses $    1,869,265     $    1,592,348  
  Notes payable      215,810          48,063  
  Contingent consideration      1,430,393          2,239,603  
               
    Total Current Liabilities      3,515,468          3,880,014  
               
    TOTAL LIABILITIES      3,515,468          3,880,014  
               
STOCKHOLDERS' EQUITY          
  Preferred stock, Series B; 6,000,000 shares authorized, $0.0001 par value, 0 shares issued and outstanding, respectively      -          -  
  Common stock; 180,000,000 shares authorized, $0.0001 par value, 31,496,869 and 30,331,309 shares issued and outstanding, respectively      3,150          3,033  
  Additional paid-in capital      105,514,059          100,999,173  
  Accumulated deficit      (69,941,734 )        (58,511,413 )
               
    Total Stockholders' Equity      35,575,475          42,490,793  
    TOTAL LIABILITIES AND          
      STOCKHOLDERS' EQUITY $    39,090,943     $    46,370,807  
               


OHR PHARMACEUTICAL, INC.
Consolidated Statements of Operations
(Unaudited)
                           
      For the Three Months Ended   For the Six Months Ended
      March 31,   March 31,
      2016   2015   2016   2015
                           
OPERATING EXPENSES                      
                           
General and administrative $   2,966,363      $    3,334,971      $   4,184,492      $   4,151,834  
                           
Research and development     4,043,859          3,175,855         6,120,139         5,919,977  
                           
Depreciation and amortization      296,077          295,262          593,816          600,884  
                           
Gain on settlement of accounts payable      (710,264 )        -          (710,264 )        -  
                           
    OPERATING LOSS      6,596,035          6,806,088          10,188,183          10,672,695  
                           
OTHER INCOME (EXPENSE)                      
  Change in fair value of contingent consideration      1,305,623          3,786,193          (1,251,926 )        3,102,807  
  Share in losses on investment in joint venture      -          (41,211 )        -          (67,861 )
  Other income      -          -          3,419          35,813  
  Interest income, net      5,553          (536 )        6,369          (663 )
  Impairment of intangibles      -          (338,906 )        -          (338,906 )
                           
    Total Other Income (Expense)      1,311,176          3,405,540          (1,242,138 )        2,731,190  
                           
LOSS FROM OPERATIONS BEFORE                      
  INCOME TAXES      (5,284,859 )        (3,400,548 )        (11,430,321 )        (7,941,505 )
                           
PROVISION FOR INCOME TAXES      -          -          -          -  
                           
NET LOSS $    (5,284,859 )   $    (3,400,548 )   $    (11,430,321 )   $    (7,941,505 )
                           
BASIC AND DILUTED LOSS PER SHARE   $   (0.17 )    $   (0.12 )    $   (0.37 )    $   (0.30 )
                           
WEIGHTED AVERAGE  NUMBER                      
  OF SHARES OUTSTANDING:                      
  BASIC AND DILUTED      31,344,424          27,713,410          30,906,114          26,479,538  
                           


Consolidated Statements of Cash Flows
(Unaudited)
                 
        For the Six Months Ended
        March 31,
        2016   2015
OPERATING ACTIVITIES          
  Net loss   $    (11,430,321 )   $    (7,941,505 )
  Adjustments to reconcile net loss to net cash          
    used by operating activities:          
    Common stock issued for services      715,952          353,876  
    Warrants issued for services      -          8,559  
    Stock option expense      1,724,375          2,269,785  
    Change in fair value of contingent consideration      1,251,926          (3,102,807 )
    Share in losses on investment in joint venture      -          67,861  
    Depreciation      31,494          24,866  
    Amortization of intangible assets      562,322          576,018  
    Impairment of Intangibles      -          338,906  
    Gain on settlement of accounts payable      (710,264 )        -  
  Changes in operating assets and liabilities          
    Prepaid expenses and deposits      98,009          (419,991 )
    Accounts payable and accrued expenses      987,180          1,018,156  
                 
      Net Cash Used in Operating Activities      (6,769,327 )        (6,806,276 )
                 
INVESTING ACTIVITIES          
    Investment in joint venture      -          (100,000 )
    Purchase of property and equipment      (12,103 )        (86,891 )
      Net Cash Used in Investing Activities      (12,103 )        (186,891 )
                 
FINANCING ACTIVITIES          
  Proceeds for issuance of common stock for cash      -          26,582,998  
  Proceeds from warrants exercised for cash      13,540          80,005  
  Repayments of short-term notes payable      (48,063 )        (67,068 )
                 
    Net Cash Provided by Financing Activities      (34,523 )        26,595,935  
                 
NET CHANGE IN CASH      (6,815,953 )        19,602,768  
CASH AT BEGINNING OF PERIOD      28,697,323          13,220,494  
                 
CASH AT END OF PERIOD $    21,881,370     $    32,823,262  
                 
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION          
  CASH PAID FOR:          
    Interest  $    -      $    1,533  
    Income Taxes      -          -  
                 
  NON CASH FINANCING ACTIVITIES:          
    Settlement of contingent consideration  $   2,061,136      $    -  
    Financing of insurance premiums through issuance of short term notes      215,810          212,400  
    Common stock issued to settle accounts payable      -          50,000  
                 
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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Source: Ohr Pharmaceutical, Inc.