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Opiant Pharmaceuticals, Inc., Reports Fiscal Second Quarter 2016 Financial Results and Provides Corporate Update

March 16, 2016 8:30 AM EDT

SANTA MONICA, Calif., March 16, 2016 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. (“Opiant”) (OTCQB: OPNT), a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders, today reported financial results for the fiscal second quarter ended January 31, 2016.

“The second quarter was a transformational one for Opiant as our first product, NARCAN® Nasal Spray, was approved by the U.S. Food and Drug Administration, and its launch by our commercial partner, Adapt Pharma Limited, occurring this quarter,” said Roger Crystal, M.D., Chief Executive Officer of Opiant. “On the heels of that significant progress, we are now focused toward advancing the rest of our pipeline.”

Second Quarter 2016 and Recent Highlights

  • NARCAN® Nasal Spray was approved by the U.S. Food and Drug Administration (FDA) for the emergency treatment of known or suspected opioid overdose. The treatment is being commercialized by Opiant’s partner, Adapt Pharma Limited (“Adapt”). Opiant received a $2 million milestone payment triggered by the FDA approval and a $2.5 million milestone payment following the first commercial sale of the treatment in the U.S.
  • Announced a collaboration with the National Institute on Drug Abuse (NIDA) to evaluate an opioid antagonist in patients with cocaine use disorder. The study is being conducted by the Department of Psychiatry at the Perelman School of Medicine at the University of Pennsylvania.
  • Initiated patient dosing of the NIDA-funded Phase II study to evaluate an opioid antagonist in patients with cocaine use disorder.
  • Announced the appointment of Mark Ellison, Ph.D., as Executive Vice President, Development, Manufacturing and Quality.
  • Announced the change of the company name to Opiant Pharmaceuticals, Inc., from Lightlake Therapeutics Inc.
  • Convened a medical advisory board to discuss the Opiant’s development programs in substance abuse, addictive and eating disorders.

Clinical Program Update

Opiant develops treatments for substance abuse, addictive and eating disorders.  Opiant expects the following events to occur during early fiscal year 2017:

  • 1Q17: Report top-line results of the Phase II study in patients with cocaine use disorder.
  • 1Q17: Initiate dosing in a Phase II study in patients with eating disorders.

Financial Results

Quarter ended January 31, 2016 compared to quarter ended January 31, 2015

For the quarter ended January 31, 2016, Opiant reported a net profit of $4.0 million, or $1.52 per fully-diluted share, compared to a net loss of $2.8 million, or $1.54 per basic and fully-diluted share, for the same period in 2015.  The increase was primarily due to the recognition of deferred revenue from prior sales of net profit interests in various treatments and the receipt of the $2 million milestone payment from Adapt triggered by FDA approval of NARCAN® Nasal Spray.

Research and development expense in the quarter ended January 31, 2016, was $0.4 million compared to $1.2 million for the quarter ended January 31, 2015. General and administrative expense was $2.5 million in the quarter ended January 31, 2016, compared to $2.1 million for the quarter ended January 31, 2015. The decrease in research and development expense was primarily due to decreased spending on research and development of Opiant’s opioid overdose reversal treatment. The increase general and administrative expense was primarily due a general increase in operational costs.

About Opiant Pharmaceuticals, Inc.

Opiant Pharmaceuticals, Inc., is a specialty pharmaceutical company developing pharmacological treatments for substance use, addictive and eating disorders. Over 45 million people in the U.S. have one of these disorders. The National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH), describes these disorders as chronic relapsing brain diseases which burden society at both the individual and community levels. With its innovative opioid antagonist nasal delivery technology, Opiant is positioned to become a leader in these treatment markets. Its first product, NARCAN® Nasal Spray, is approved for marketing in the U.S. by the company’s partner, Adapt Pharma Limited. Currently, Opiant is developing opioid antagonists for the treatment of substance use, addictive and eating disorders, with a near term focus on cocaine use disorder and binge eating disorder (BED). For more information please visit: www.opiant.com

Forward-Looking Statements

This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

Financial tables to follow

Opiant Pharmaceuticals, Inc.      
(formerly Lightlake Therapeutics Inc.)      
       
Balance Sheets (Unaudited)      
As of January 31, 2016 and July 31, 2015      
       
  January 31,  July 31, 
  2016  2015 
         
Assets        
Current assets        
Cash and cash equivalents $1,281,556  $434,217 
Prepaid insurance  27,083   33,143 
Total current assets  1,308,639   467,360 
         
Other assets        
Patents and patent applications (net of accumulated amortization of $7,701 at        
January 31, 2016 and $7,015 at July 31, 2015)  19,749   20,435 
         
Total assets $1,328,388  $487,795 
         
Liabilities and Stockholders' Deficit        
Liabilities        
Current liabilities        
Accounts payable and accrued liabilities $35,215  $315,460 
Accrued salaries and wages  3,863,501   3,129,060 
Due to related parties  -   130,000 
Total current liabilities  3,898,716   3,574,520 
         
Deferred revenue  2,333,500   5,300,000 
Total liabilities  6,232,216   8,874,520 
         
Stockholders' deficit        
Common stock; par value $0.001; 1,000,000,000 shares authorized;        
1,886,890 shares issued and outstanding at January 31, 2016 and 1,841,866 shares        
issued and outstanding at July 31, 2015  1,887   1,842 
Additional paid-in capital  55,605,348   44,982,519 
Accumulated deficit  (60,511,063)  (53,371,086)
Total stockholders' deficit  (4,903,828)  (8,386,725)
Total liabilities and stockholders' deficit $1,328,388  $487,795 

  

Opiant Pharmaceuticals, Inc.      
(formerly Lightlake Therapeutics Inc.)      
       
Statements of Operations (Unaudited)      
For the three and six months ended January 31, 2016 and 2015    
       
  For the  For the 
  Three Months Ended  Six Months Ended 
  January 31,  January 31, 
  2016  2015  2016  2015 
             
Revenue $6,860,000  $560,000  $6,980,000  $560,000 
                 
Operating expenses                
General and administrative  2,485,578   2,138,609   13,276,958   2,846,622 
Research and development  373,059   1,191,747   802,509   1,243,848 
Total operating expenses  2,858,637   3,330,356   14,079,467   4,090,470 
                 
Income (loss) from operations  4,001,363   (2,770,356)  (7,099,467)  (3,530,470)
                 
Other income (expense)                
Interest expense  (5,491)  (19,370)  (11,319)  (27,582)
Income (loss) on foreign exchange  (25,832)  14,112   (29,191)  7,101 
Total other income (expense)  (31,323)  (5,258)  (40,510)  (20,481)
                 
Income (loss) before provision for income taxes  3,970,040   (2,775,614)  (7,139,977)  (3,550,951)
                 
Provision for income taxes  -   -   -   - 
                 
Net income (loss) $3,970,040  $(2,775,614) $(7,139,977) $(3,550,951)
                 
                 
Basic income (loss) per common share $2.11  $(1.54) $(3.83) $(1.98)
Diluted income (loss) per common share $1.52  $(1.54) $(3.83) $(1.98)
                 
Basic weighted average common shares outstanding  1,880,279   1,806,303   1,865,230   1,797,032 
Diluted weighted average common shares outstanding  2,605,270   1,806,303   1,865,230   1,797,032 

 

CONTACT INFORMATION:

Corporate Contact:
[email protected]

Media Relations and Investor Relations:
Robert E. Flamm, Ph.D.
[email protected]
(212) 845-4226

Source: Opiant Pharmaceuticals, Inc.


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