OHR Pharmaceutical Inc.

Ohr Pharmaceutical Reports Third Quarter 2016 Financial and Business Results

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NEW YORK, Aug. 09, 2016 (GLOBE NEWSWIRE) -- Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today reported results for its third quarter ended June 30, 2016.

“The start of the Phase 3 registration program for Squalamine during the quarter marked a significant milestone in our overall development program for our lead drug candidate,” said Jason Slakter, MD, Chief Executive Officer of Ohr. “There remains a significant need for new treatment options that can enhance visual acuity gains in wet AMD and provide a non-invasive treatment option. We believe that Squalamine, when administered as part of a combination therapy, meets these needs and has the potential to set a new standard of care. We look forward to an exciting second half of calendar 2016.”   

Third Quarter Highlights

  • Commenced enrollment in the Phase 3 clinical development program to investigate Squalamine lactate ophthalmic solution, 0.2% (“Squalamine”, also known as OHR-102) as a treatment to improve visual acuity 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 topically twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis® injections.
    • The primary endpoint in both studies is a measurement of visual acuity gain at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
  • Appointed David M. Brown, MD to serve as the chair of the Steering Committee for the Phase 3 clinical program of Squalamine in wet-AMD. 
    • Dr. Brown is Clinical Professor of Ophthalmology at Baylor College of Medicine, vice-chair for research at the Blanton Eye Institute, Houston Methodist Hospital, and partner at Retina Consultants of Houston.
  • Completed an in vivo study demonstrating sustained pharmacological anti-angiogenic activity of OHR3031, an angiogenesis inhibitor
    • Single intravitreal injection of microparticles containing OHR3031 produced clinically meaningful and statistically significant efficacy six weeks after dose administration in a rabbit model of laser-induced CNV. 
    • Dose response was observed in the reduction of average CNV lesion areas with OHR3031 compared to vehicle treatment, with the highest dose exhibiting a statistically significant effect at Week 6.
    • Magnitude of difference in average CNV lesion size for the high dose of OHR-3031 compared to vehicle treatment at 6 weeks was comparable to that seen at 2 weeks with a currently approved anti-VEGF agent conducted in a previous study.
    • OHR3031 was developed using SKS sustained release technology
  • Presented two posters on the Squalamine Phase 2 IMPACT study and OHR3031 in vivo studies at the Association for Research in Vision and Ophthalmology (ARVO) Conference in May.

Financial Results for Third Quarter ended June 30, 2016

  • For the third quarter ended June 30, 2016, the Company reported a net loss of approximately $7.7 million, or ($0.24) per share, compared to a net loss of approximately $3.3 million, or ($0.11) per share in the same period of 2015.
  • For the third quarter ended June 30, 2016, total operating expenses were approximately $7.6 million, consisting of approximately $1.7 million in general and administrative expenses, $5.6 million in research and development expenses, and $0.3 million in depreciation and amortization.  This compares to total operating expenses in the same period of 2015 of approximately $3.3 million, consisting of $1.6 million in general and administrative expenses, $1.5 million in research and development expenses, and $0.3 million in depreciation and amortization.
  • At June 30, 2016, the Company had cash and cash equivalents of approximately $17.6 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.

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

  • For the nine months ended June 30, 2016, the Company reported a net loss of approximately $19.1 million, or ($0.61) per share, compared to a net loss of approximately $11.3 million, or ($0.41) per share in the same period of 2015.
  • For the nine months ended June 30, 2016, total operating expenses were approximately $17.8 million, consisting of $5.8 million in general and administrative expenses, $11.8 million of research and development expenses, and $0.9 million in depreciation and amortization.  This compares to total operating expenses of $14.3 million in the same period of 2015, comprised of approximately $5.7 million in general and administrative expenses, $7.4 million in research and development expenses, and $0.9 million in depreciation and amortization.
   
Conference Call & Webcast   
Tuesday, August 9th at 5:00pm Eastern Time
 
Domestic:   877-407-0789  
International:   201-689-8562  
Conference ID:   13642605  
Webcast:   http://public.viavid.com/index.php?id=120651  
         
Replays – Available through August 16, 2016   
Domestic:   877-870-5176  
International:   858-384-5517  
Conference ID:   13642605  
       

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)
               
      June 30,   September 30,
      2016   2015
ASSETS
CURRENT ASSETS      
  Cash $    17,623,720     $    28,697,323  
  Prepaid expenses and other current assets      231,978          338,713  
               
    Total Current Assets      17,855,698          29,036,036  
               
EQUIPMENT, net      214,047          248,753  
               
OTHER ASSETS          
  Security deposit      12,243          12,243  
  Intangible assets, net      15,490,916          16,332,863  
  Goodwill      740,912          740,912  
               
    TOTAL ASSETS  $    34,313,816      $    46,370,807  
               
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES          
  Accounts payable and accrued expenses $    3,627,455     $    1,592,348  
  Notes payable      130,955          48,063  
  Contingent consideration      1,535,237          2,239,603  
               
    Total Current Liabilities      5,293,647          3,880,014  
               
    TOTAL LIABILITIES      5,293,647          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, 31,505,203 and 30,331,309 shares issued and outstanding, respectively      3,150          3,033  
  Additional paid-in capital      106,658,494          100,999,173  
  Accumulated deficit      (77,641,475 )        (58,511,413 )
               
    Total Stockholders' Equity      29,020,169          42,490,793  
    TOTAL LIABILITIES AND          
      STOCKHOLDERS' EQUITY $    34,313,816     $    46,370,807  
               


OHR PHARMACEUTICAL, INC.
Consolidated Statements of Operations
(Unaudited)
                           
      For the Three Months   For the Nine Months
      Ended   Ended
      June 30,   June 30,
      2016   2015   2016   2015
                           
OPERATING EXPENSES                      
                           
General and administrative $   1,664,882     $   1,554,997     $   5,849,374     $   5,706,831  
Research and development     5,637,602         1,496,768         11,757,741         7,416,745  
Depreciation and amortization     296,143         283,075         889,959         883,959  
Gain on settlement of accounts payable     -         -         (710,264 )       -  
Impairment of intangibles     -         -         -         338,906  
  OPERATING LOSS     7,598,627         3,334,840         17,786,810         14,346,441  
                           
OTHER INCOME (EXPENSE)                      
  Change in fair value of contingent consideration     (104,844 )       20,959         (1,356,770 )       3,123,766  
  Share in losses on investment in joint venture     -         (30,088 )       -         (97,949 )
  Other income     -         -         3,419         35,813  
  Interest income (expense), net     3,730         (2,028 )       10,099         (2,691 )
  Total Other Income (Expense)     (101,114 )       (11,157 )       (1,343,252 )       3,058,939  
                           
LOSS FROM OPERATIONS BEFORE                      
  INCOME TAXES     (7,699,741 )       (3,345,997 )       (19,130,062 )       (11,287,502 )
PROVISION FOR INCOME TAXES     -         -         -         -  
                           
NET LOSS $   (7,699,741 )   $   (3,345,997 )   $   (19,130,062 )   $   (11,287,502 )
BASIC AND DILUTED LOSS PER SHARE  (in dollars per share) $   (0.24 )   $   (0.11 )   $   (0.61 )   $   (0.41 )
WEIGHTED AVERAGE  NUMBER                      
OF SHARES OUTSTANDING:                      
  BASIC AND DILUTED     31,501,540         30,323,206         31,126,656         27,757,415  
                           

 

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.