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.
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.
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,|
|Cash and cash equivalents||$||1,281,556||$||434,217|
|Total current assets||1,308,639||467,360|
|Patents and patent applications (net of accumulated amortization of $7,701 at|
|January 31, 2016 and $7,015 at July 31, 2015)||19,749||20,435|
|Liabilities and Stockholders' Deficit|
|Accounts payable and accrued liabilities||$||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|
|Common stock; par value $0.001; 1,000,000,000 shares authorized;|
|1,886,890 shares issued and outstanding at January 31, 2016 and 1,841,866 shares|
|issued and outstanding at July 31, 2015||1,887||1,842|
|Additional paid-in capital||55,605,348||44,982,519|
|Total stockholders' deficit||(4,903,828||)||(8,386,725||)|
|Total liabilities and stockholders' deficit||$||1,328,388||$||487,795|
|Opiant Pharmaceuticals, Inc.|
|(formerly Lightlake Therapeutics Inc.)|
|Statements of Operations (Unaudited)|
|For the three and six months ended January 31, 2016 and 2015|
|For the||For the|
|Three Months Ended||Six Months Ended|
|January 31,||January 31,|
|General and administrative||2,485,578||2,138,609||13,276,958||2,846,622|
|Research and development||373,059||1,191,747||802,509||1,243,848|
|Total operating expenses||2,858,637||3,330,356||14,079,467||4,090,470|
|Income (loss) from operations||4,001,363||(2,770,356||)||(7,099,467||)||(3,530,470||)|
|Other income (expense)|
|Income (loss) on foreign exchange||(25,832||)||14,112||(29,191||)||7,101|
|Total other income (expense)||(31,323||)||(5,258||)||(40,510||)||(20,481||)|
|Income (loss) before provision for income taxes||3,970,040||(2,775,614||)||(7,139,977||)||(3,550,951||)|
|Provision for income taxes||-||-||-||-|
|Net income (loss)||$||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|
Source:Opiant Pharmaceuticals, Inc.