OPNT Opiant Pharmaceuticals Inc.

25.64
+0.42  (+2%)
Previous Close 25.22
Open 25.14
52 Week Low 8.88
52 Week High 37.7114
Market Cap $121,028,107
Shares 4,720,285
Float 4,500,040
Enterprise Value $90,607,967
Volume 36,813
Av. Daily Volume 69,686
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Upcoming Catalysts

Drug Stage Catalyst Date
OPNT003
Opioid Overdose
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
OPNT002
Alcohol Use Disorder
Phase 2
Phase 2
Phase 2 dosing initiated, noted January 20, 2022.
OPNT001
Bulimia Nervosa
Phase 2
Phase 2
Phase 2 data released February 21, 2019. Endpoints not met.
NARCAN (naloxone HCl) Nasal Spray
Opioid Overdose Reversal
Approved
Approved
FDA approved November 2015.

Latest News

    • Phase 2 trial to evaluate reduction in heavy drinking as measured by a change in the World Health Organization drinking risk levels1

    • Trial is informed by results from Phase 1 studies that showed pharmacokinetic properties of OPNT002 well suited for ‘as needed' administration, either in anticipation of drinking or once drinking has started2,3

    • Target enrollment of approximately 300 patients; Results anticipated in 2023

    • Alcohol Use Disorder is a chronic relapsing brain disease characterized by compulsive heavy drinking and is among the most prevalent mental health disorders globally4

    SANTA MONICA, Calif., Jan. 20, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT) today announced that the first patient has been dosed…

    • Phase 2 trial to evaluate reduction in heavy drinking as measured by a change in the World Health Organization drinking risk levels1



    • Trial is informed by results from Phase 1 studies that showed pharmacokinetic properties of OPNT002 well suited for ‘as needed' administration, either in anticipation of drinking or once drinking has started2,3



    • Target enrollment of approximately 300 patients; Results anticipated in 2023



    • Alcohol Use Disorder is a chronic relapsing brain disease characterized by compulsive heavy drinking and is among the most prevalent mental health disorders globally4

    SANTA MONICA, Calif., Jan. 20, 2022 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT) today announced that the first patient has been dosed in a Phase 2 clinical trial of OPNT002, nasal naltrexone, for the treatment of Alcohol Use Disorder ("AUD"). The trial will determine whether OPNT002 reduces heavy drinking as measured by a change in the World Health Organization ("WHO") drinking risk levels1.

    "The development of OPNT002 is predicated on modifying a patient's drinking behavior in order to reduce the harm of alcohol," said Phil Skolnick, Ph.D., D.Sc. (hon.), Chief Scientific Officer of Opiant. "Compelling clinical data have shown that reducing drinking from very high levels to more moderate levels can reduce long-term mortality and overall disease burden."

    Clinical and preclinical studies have shown that alcohol releases endorphins, which are the brain's endogenous opioids. These endorphins are thought to activate opioid receptors, which contribute to alcohol's reinforcing and addictive properties. Current naltrexone treatments work to block mu-opioid receptors when administered orally or through injection. However, converging lines of evidence indicate that activation of delta-opioid receptors also contributes to the reinforcing properties of alcohol. The effective blockade of delta‐opioid receptors requires much higher plasma naltrexone concentrations than is achieved by currently approved naltrexone products5.

    Opiant is developing OPNT002 to rapidly increase plasma concentrations of the drug following dosing and thereby block mu and delta-opioid receptors. In previous research, OPNT002 has demonstrated rapid nasal absorption, delivering high levels of naltrexone yet with a short half-life. Results from Phase 1 studies demonstrate that OPNT002 produces maximum plasma concentrations that are approximately 50% higher than orally administered naltrexone. This feature, along with a very rapid onset and a short plasma half-life, are characteristics ideally suited to developing OPNT002 for ‘as needed' nasal dosing in anticipation of drinking, or once drinking has started2,3. The primary end point will be the proportion of subjects showing an improvement in WHO Drinking Risk Level consisting of a 2-level reduction from Baseline to end of treatment. WHO Drinking Risk Level will be evaluated in the 28 days prior to the Baseline and end of treatment visits.

    The trial is a randomized, double-blind, placebo-controlled study that will enroll approximately 300 patients at sites within the European Union and the United Kingdom. The trial features a Sequential Parallel Comparison Study Design ("SPCD") aiming to reduce placebo response. Results from the trial are expected in 2023.

    "Multiple medications are approved for the treatment of AUD, yet less than 10% of individuals with AUD currently receive treatment," said Roger Crystal MD, President and Chief Executive Officer of Opiant. "For those suffering from AUD, current therapies and treatments are built around an endpoint of abstinence, rather than harm reduction. The availability of a treatment option in the event a person craves alcohol, anticipates drinking or finds themselves in a high-risk situation such as a party or restaurant setting is an approach we believe could increase the number of people using medication."

    About Alcohol Use Disorder

    Alcohol Use Disorder is a chronic relapsing brain disease characterized by compulsive use of alcohol and the inability to control intake. It is the third leading preventable cause of death in the United States, and according to the World Health Organization, harmful use of alcohol is responsible for 5.1% of the global burden of disease6,7. A report by the Centers for Disease Control and Prevention, found that deaths from alcohol use increased by 43 percent from 2006 to 20188. Another study published in the JAMA network about changes in alcohol use during the COVID-19 pandemic said compared to 2019, American adults have increased their alcohol intake in 2020, by 14 percent9.

    About Opiant Pharmaceuticals, Inc. 

    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.

    For more information visit: www.opiant.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including the anticipated results of the Phase 2 study in 2023. 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, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 4, 2021, including under the caption titled "Risk 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.

    For Media and Investor Inquiries:

    Ben Atkins, Opiant

    (310) 598-5410

    Sources:

    1.   Witkiewitz, K et al. Drinking Risk Level Reductions Associated with Improvements in Physical Health and Quality of Life Among Individuals with Alcohol Use Disorder. Alcoholism: Clinical and Experimental Research 42(12):2453-2465, 2018



    2.   Krieter P, et al. Enhanced Intranasal Absorption of Naltrexone by Dodecyl Maltopyranoside: Implications for the Treatment of Opioid Overdose. Journal of Clinical Pharmacology, 2019 https://www.opiant.com/wp-content/uploads/2019/05/2019-IN-NTX-J-Clin-Pharm-1.pdf



    3.   Research & Development Meeting on Emerging Therapeutics for the Treatment of Addiction and Drug Overdose. Available at: http://ir.opiant.com/events/event-details/research-development-meeting-emerging-therapeutics-treatment-addiction-and



    4.   Carvalho AF, Heilig M, Perez A, Probst C, Rehm J. Alcohol use disorders. Lancet. 2019 Aug 31;394(10200):781-792. doi: 10.1016/S0140-6736(19)31775-1. PMID: 31478502.



    5.   Weerts E, Kim Y, Wand G, et al. Differences in δ and μ opioid receptor blockade measured by positron emission tomography in naltrexone-treated recently abstinent alcohol-dependent subjects. Neuropsychopharm. 2008;33:653-665.



    6.   National Institute on Alcohol Abuse and Alcoholism. Available at: https://www.niaaa.nih.gov/alcohol-health/overview-alcohol-consumption/alcohol-use-disorders

    7.   World Health Organization. Available at: https://www.who.int/health-topics/alcohol#tab=tab_1



    8.   Spencer, M et al. Rates of Alcohol-induced Deaths Among Adults Aged 25 and Over in Urban and Rural Areas: United States, 2000–2018, NCHS Data Brief No. 383, October 2020



    9.   Pollard, M et al. Changes in Adult Alcohol Use and Consequences During the COVID-19 Pandemic in the US. Jama Network doi: 10.1001/jamanetworkopen.2020.22942, Sept 2020



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  1. SHANGHAI and DURHAM, N.C., Jan. 17, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today the appointment of Richard John Daly ("Mr. Daly") as the President of CARsgen Therapeutics Corporation, a subsidiary of the Company in the United States. Mr. Daly will report to Dr. Zonghai Li, Founder, Chairman of the Board, CEO, CSO of CARsgen Therapeutics Holdings Limited.

    Mr. Daly will lead the CARsgen U.S. team for the international business activities of CARsgen outside of China, including clinical development, CMC operation, business development, commercialization, investor relations…

    SHANGHAI and DURHAM, N.C., Jan. 17, 2022 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced today the appointment of Richard John Daly ("Mr. Daly") as the President of CARsgen Therapeutics Corporation, a subsidiary of the Company in the United States. Mr. Daly will report to Dr. Zonghai Li, Founder, Chairman of the Board, CEO, CSO of CARsgen Therapeutics Holdings Limited.

    Mr. Daly will lead the CARsgen U.S. team for the international business activities of CARsgen outside of China, including clinical development, CMC operation, business development, commercialization, investor relations and public relations. Mr. Daly will also contribute to the overall growth strategies and business planning of CARsgen, helping the Company to develop more innovative cell therapies to cancer patients worldwide and make cancer curable.

    Mr. Richard John Daly, President of CARsgen Therapeutics Corporation

    Mr. Daly brings approximately 30 years of experience in pharmaceutical industry, including leadership positions in multi-national corporations and biotech companies. Prior to joining CARsgen, Mr. Daly served as Chief Operating Officer of Beyond Spring, Inc. (NASDAQ:BYSI). From February 2016 to July 2018, Mr. Daly served as Chief Executive Officer, President and Chairman of Neuralstem, Inc. (NASDAQ:PALI). Mr. Daly served in AstraZeneca as the President of the U.S. Diabetes subsidiary (formerly BMS-AZ Diabetes Alliance). From 1998 to 2011, Mr. Daly served at Takeda and TAP Pharmaceuticals, a joint venture established between Takeda and Abbott Laboratories, holding several leadership positions, including the Executive Vice President at Takeda Pharmaceutical North America and the Senior Vice President of marketing at TAP Pharmaceuticals. Mr. Daly currently sits on the boards of directors of Catalyst Pharmaceuticals (NASDAQ:CPRX) and Opiant Pharmaceuticals (NASDAQ:OPNT).

    Mr. Daly holds an MBA from Kellogg School of Management at Northwestern University and a Bachelor of Science degree from University of Notre Dame.

    Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics Holdings Limited, said, "We warmly welcome Mr. Daly to join CARsgen. Mr. Daly is an industry veteran with approximately 30 years of successful experiences in pharmaceutical companies, including leadership positions in multi-national organizations such as Takeda, BMS, and AstraZeneca. The breadth of Mr. Daly's experiences in sales and marketing, business development, and operation management makes him an ideal fit to lead the team of our U.S. subsidiary. Mr. Daly joins us at an exciting time of the company's accelerating growth and development, and it resonates with our ambition for the global markets. The joining of Mr. Daly will further accelerate our international business activities, including clinical development, CMC operation, business development, etc. Together with Mr. Daly and the team, we are committed to developing more innovative cell therapies to cancer patients worldwide and make cancer curable."

    Mr. Daly, President of CARsgen Therapeutics Corporation, said, "The unique CARsgen scientific, clinical and manufacturing platform is incredibly exciting and has the potential to deliver improved therapeutic options for cancer patients. I am honored and thrilled to be joining the CARsgen team at this pivotal time and I look forward to working with our talented team to continue to build the platform that can deliver on the CARsgen promise of providing enhanced care for patients and, more importantly, making cancer curable."

    About CARsgen Therapeutics Holdings Limited

    CARsgen is a biopharmaceutical company with operations in China and the U.S. mainly focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. The company has built an integrated cell therapy platform with in-house capabilities that span target discovery, antibody development, clinical trials, and commercial-scale manufacturing. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. Our vision is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.

    Contact Us

    For more information, see https://www.carsgen.com/

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/carsgen-appoints-richard-john-daly-as-the-president-of-carsgen-therapeutics-corporation-301461816.html

    SOURCE CARsgen Therapeutics

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  2. SANTA MONICA, Calif., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three and nine months ended September 30, 2021, and provided a corporate update. Recent highlights include:

    Finance Update

    • Q3 revenues of $16.3 million, a 79% increase over the same period in 2020, driven by NARCAN® Nasal Spray royalties
    • Nine-month revenues of $34 million
    • $50.3 million in cash, cash equivalents and marketable securities (as of September 30, 2021)
    • Raises full-year 2021 revenue and cash guidance

      • Royalty revenue from the sale of NARCAN® Nasal Spray now anticipated to be approximately

    SANTA MONICA, Calif., Nov. 11, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a specialty pharmaceutical company developing medicines to treat addictions and drug overdose, today reported financial results for the three and nine months ended September 30, 2021, and provided a corporate update. Recent highlights include:

    Finance Update

    • Q3 revenues of $16.3 million, a 79% increase over the same period in 2020, driven by NARCAN® Nasal Spray royalties
    • Nine-month revenues of $34 million
    • $50.3 million in cash, cash equivalents and marketable securities (as of September 30, 2021)
    • Raises full-year 2021 revenue and cash guidance



      • Royalty revenue from the sale of NARCAN® Nasal Spray now anticipated to be approximately $38 million



      • Cash, cash equivalents and marketable securities now expected to be in the range of approximately $50 million to $52 million, an increase of approximately $8 million greater than 2nd quarter guidance

    Pipeline Update

    • OPNT003, nasal nalmefene, for opioid overdose:



      • Obtained U.S. Food and Drug Administration ("FDA") Fast-Track Designation for OPNT003



      • Enrollment and dosing of subjects in Pharmacodynamic ("PD") study is progressing. The PD study is designed as a non-inferiority study comparing OPNT003 to nasal naloxone to reverse the respiratory depression produced by the synthetic opioid remifentanil, by measuring change in minute ventilation. Company is on track to complete the clinical phase of the study by the end of 2021 with top-line data now anticipated in Q1 2022



      • Targeting NDA submission under Fast-Track designation during the first half of 2022, with commercial preparations underway for a potential launch in Q4 2022



    • OPNT002, nasal naltrexone, for Alcohol Use Disorder ("AUD"): Announces its plans to initiate patient recruitment for Phase 2 clinical study in Q4 2021

    Commenting, Roger Crystal, M.D., President and Chief Executive Officer of Opiant, said:

    "Opiant demonstrated strong performance again this quarter with continued positive momentum for OPNT003, nasal nalmefene, for opioid overdose. Following positive PK data, we were pleased this month to receive FDA Fast-Track designation. We are making good progress in our PD study and anticipate top-line results in the first quarter of 2022. In parallel, we continue to invest in and advance preparations for a potential commercial launch in 2022, if approved. We are also looking forward in Q4 this year to initiating our Phase 2 study of OPNT002, nasal naltrexone, for Alcohol Use Disorder, which we had put on hold due to COVID."

    David O'Toole, Chief Financial Officer of Opiant, said:

    "During Q3, we saw continued and strong revenue growth attributable to our royalties on significant net sales this quarter of NARCAN® Nasal Spray, a further indicator of the demand for opioid overdose treatment in the U.S. As we look forward to a potential launch of OPNT003 in the latter half of 2022, our expected strong cash position at the end of 2021, will support the commercial plan and the progression of the pipeline."

    Financial Results for the Three Months Ended September 30, 2021

    For the three months ended September 30, 2021, Opiant recorded approximately $16.3 million in revenue, compared to approximately $9.1 million during the corresponding period of 2020. For the three months ended September 30, 2021, the Company recorded approximately $14 million of revenue from its license agreement with Emergent BioSolutions, Inc. ("EBS") for the sale of NARCAN® Nasal Spray, compared to approximately $8.6 million in the same period of 2020. Third quarter 2021 sales of NARCAN® Nasal Spray were approximately $133.3 million, as reported by EBS. For the three months ended September 30, 2021, the Company recorded approximately $2.3 million in grant and contract revenue compared to approximately $0.5 million in the same period in 2020. The $5.4 million increase in revenue from our license agreement with EBS was primarily due to a $44.5 million increase in net NARCAN® Nasal Spray sales in the three months ended September 30, 2021, compared to the three months ended September 30, 2020. The $1.8 million increase in grant and contract revenue was due to the increased funding received from the National Institute of Drug Abuse ("NIDA") and Biomedical Advanced Research and Development Authority ("BARDA") for the development of OPNT003.

    For the three months ended September 30, 2021, general and administrative ("G&A") expenses were approximately $3.4 million, as compared to approximately $2.7 million in the comparable period in 2020.

    Research and development ("R&D") expenses for the three months ended September 30, 2021, were approximately $4.9 million, as compared to approximately $2.8 million in the comparable period in 2020. Development expense increased by $2.1 million primarily due to increased activity on OPNT003.

    Sales and marketing ("S&M") expenses for the three months ended September 30, 2021, were approximately $1.1 million for pre-commercialization efforts related to OPNT003. Sales and marketing expense during the three months ended September 30, 2020, were approximately $0.9 million.

    Royalty expense for the three months ended September 30, 2021, was approximately $3.1 million and $2.0 million for the comparable period of 2020. The $1.1 million increase was due to increased royalty revenue from net sales of NARCAN® Nasal Spray.

    Net income for the three months ended September 30, 2021, was approximately $3.4 million, or income of $0.77 per basic share and $0.56 diluted share, compared to net income of approximately $0.7 million, or income of $0.17 per basic and $0.15 per diluted share, for the comparable period of 2020.

    Financial Results for the Nine Months Ended September 30, 2021

    For the nine months ended September 30, 2021, Opiant recorded approximately $34 million in revenue, compared to approximately $19.7 million during the corresponding period of 2020. For the nine months ended September 30, 2021, the Company recorded approximately $27.7 million of revenue from the sale of NARCAN® Nasal Spray, compared to approximately $19.1 million in the same period of 2020. Sales of NARCAN® Nasal Spray for the nine months ended September 30, were approximately $313.7 million, as reported by EBS. For the nine months ended September 30, 2021, the Company recorded approximately $6.3 million in grant and contract revenue compared to approximately $0.6 million in the same period in 2020. The $8.6 million increase in revenue from our license agreement with EBS was primarily due to a $80.0 million increase in net NARCAN® Nasal Spray sales in the nine months ended September 30, 2021, compared to the nine months ended September 30, 2020. The $5.7 million increase in grant and contract revenue was due to the increased funding received from NIDA and BARDA for the development of OPNT003.

    For the nine months ended September 30, 2021, G&A expenses were approximately $8.7 million, compared to approximately $8.1 million in the comparable period in 2020.

    R&D expenses for the nine months ended September 30, 2021, were approximately $12.1 million, as compared to approximately $4.8 million in the comparable period in 2020. Development expense increased by $7.3 million primarily due to increased activity on OPNT003.

    S&M expenses for the nine months ended September 30, 2021, were approximately $3.0 million compared to approximately $3.7 million in the comparable period in 2020.

    Royalty expense for the nine months ended September 30, 2021, was approximately $6.1 million, compared to approximately $4.3 million for the comparable period of 2020. The $1.8 million increase was due to increased royalty revenue from net sales of NARCAN®.

    Net income for the nine months ended September 30, 2021, was approximately $2.3 million, or income of $0.52 per basic share and income of $0.41 per diluted share, compared to net loss of approximately $1.2 million, or a loss of $0.28 per basic and diluted share, for the comparable period of 2020.

    As of  September 30, 2021, Opiant had $50.3 million in cash, cash equivalents, and marketable securities.

    Opiant is raising its 2021 financial guidance, reflecting higher than expected sales of NARCAN® Nasal Spray. Aligning its guidance to the upper-range of the full-year 2021 guidance for sales of NARCAN® Nasal Spray provided by EBS, of $420 million, Opiant expects full-year 2021 royalty revenue from the sale of NARCAN® Nasal Spray of approximately $38 million. The Company is also updating its guidance for ending cash and now expects to end 2021 with cash, cash equivalents and marketable securities in the range of approximately $50 million to $52 million, not including potential receipt of any additional tranches from the convertible debt deal.

    The OPNT003 development project has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No.

    HHSO100201800029C.

    Conference Call Details:

    Thursday, November 11th at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time

    Toll Free:877-407-0792
    International:201-689-8263
    Conference ID:13723604
    Webcast:http://ir.opiant.com/

    About Opiant Pharmaceuticals, Inc.

    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose.

    For more information visit: www.opiant.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including anticipated results and timing of the receipt of data from our PD study and timing of filing of an NDA and statements regarding updated royalty revenue guidance and ending cash target in 2021. 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, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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 same 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. Additional factors that could materially affect actual results can be found in our filed quarterly reports on Form 10-Q and our annual report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 4, 2021, including under the caption titled "Risk 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.



    Investor Relations Contacts:

    Ben Atkins

    VP of Corporate Communications and Investor Relations



    (310) 598-5410

       Opiant Pharmaceuticals, Inc. 
       Condensed Consolidated Balance Sheets
       (in thousands, except shares and per share amounts)
            
        As of September 30, As of December 31,

     
         2021   2020  
    Assets (unaudited)   
     Current assets     
      Cash & cash equivalents $35,285  $48,251  
      Marketable securities  15,045   -  
      Accounts receivable  15,426   8,911  
      Prepaid expenses and other current assets  2,121   1,937  
      Total current assets  67,877   59,099  
     Other assets     
      Property and equipment, net  93   171  
      Right of use assets - operating leases  998   279  
      Patents and patent applications, net  12   13  
      Other non-current assets  -   1,051  
      Total assets $68,980  $60,613  
            
    Liabilities and stockholders' equity     
     Current liabilities     
      Accounts payable and accrued liabilities $2,581  $2,966  
      Accrued salaries and wages  1,347   909  
      Royalty payable  3,137   1,908  
      Deferred revenue  -   355  
      Operating leases  287   282  
      Total current liabilities  7,352   6,420  
     Long-term liabilities     
      Operating leases  716   -  
      Convertible debt, net of unamortized discount  18,906   18,701  
      Total long-term liabilities  19,622   18,701  
      Total liabilities  26,974   25,121  
     Stockholders' equity     
     Common stock, $0.001 par value, 200,000,000 shares     
      authorized, 4,618,221 and 4,258,105 shares     
      issued and outstanding at September 30, 2021     
      and December 31, 2020, respectively  5   4  
     Additional paid-in-capital  104,460   100,204  
     Accumulated other comprehensive loss  (27)  (27) 
     Accumulated deficit  (62,432)  (64,689) 
      Total stockholders' equity  42,006   35,492  
      Total liabilities and stockholders' equity $68,980  $60,613  
            



       Opiant Pharmaceuticals Inc.     
       Condensed Consolidated Statements of Operations     
       (in thousands, except shares and per share amounts)    
                 
                 
         Three months ended

     Three months ended

     Nine months ended Nine months ended
         September 30 September 30 September 30 September 30 
          2021   2020   2021   2020  
         (Unaudited) (Unaudited) (Unaudited) (Unaudited) 
    Revenues          
     Royalty revenue  $14,041  $8,601  $27,689  $19,057  
     Grant and contract revenue   2,298   505   6,296   644  
      Total Revenue   16,339   9,106   33,985   19,701  
                 
    Operating expenses          
     General and administrative   3,379   2,729   8,759   8,138  
     Research and development   4,881   2,784   12,119   4,763  
     Sales & marketing   1,060   914   3,080   3,738  
     Royalty expense   3,059   1,952   6,145   4,289  
      Total expenses   12,379   8,379   30,103   20,928  
                 
    Income (loss) from operations   3,960   727   3,882   (1,227) 
                 
    Other income (expense)          
     Interest income   4   4   10   92  
     Interest expense   (547)  -   (1,626)  -  
     Gain (loss) on foreign exchange   -   (6)  (10)  (2) 
      Total other income (expense)   (543)  (2)  (1,626)  90  
    Income (loss) before provision for income taxes  3,417   725   2,256   (1,137) 
     Income tax expense   -   -   -   39  
    Net income (loss)  $3,417  $725  $2,256  $(1,176) 
                 
    Other comprehensive income (loss):          
     Foreign currency translation adjustment   (8)  196   1   (115) 
    Comprehensive income (loss)  $3,409  $921  $2,257  $(1,291) 
                 
    Net income (loss) per common share          
     Basic  $0.77  $0.17  $0.52  $(0.28) 
     Diluted  $0.56  $0.15  $0.41  $(0.28) 
                 
    Weighted-average common shares outstanding:         
     Basic   4,462,236   4,258,105   4,359,759   4,247,045  
     Diluted   6,065,044   4,847,211   5,565,065   4,247,045  
                 


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  3. SANTA MONICA, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a company advancing medicines to better treat addictions and drug overdose, today announced that members of the company's senior management team will participate in the 12th Jefferies London Healthcare Conference virtually on Thursday, November 18 and Friday, November 19. Management will participate in investor 1x1 meetings on both days. A webcast of the event will be available from November 18, 2021, 8:00 AM GMT / 3:00 AM ET on the Opiant website.

    About Opiant Pharmaceuticals, Inc. 
    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and…

    SANTA MONICA, Calif., Nov. 10, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a company advancing medicines to better treat addictions and drug overdose, today announced that members of the company's senior management team will participate in the 12th Jefferies London Healthcare Conference virtually on Thursday, November 18 and Friday, November 19. Management will participate in investor 1x1 meetings on both days. A webcast of the event will be available from November 18, 2021, 8:00 AM GMT / 3:00 AM ET on the Opiant website.

    About Opiant Pharmaceuticals, Inc. 

    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.

    For Media and Investor Inquiries:

    Ben Atkins, Opiant

    (310) 598-5410

     



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    • Fast Track Designation further underscores the potential for OPNT003 to represent a major advance in the treatment of opioid overdose as opioid overdose deaths surge1

    • This designation enables early and frequent communication with the FDA, in addition to the potential for a rolling submission of NDA application2

    SANTA MONICA, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a company advancing medicines to better treat addictions and drug overdose, today announced that the U.S. Food and Drug Administration ("FDA") has granted fast track designation for OPNT003, nasal nalmefene, its investigational treatment for opioid overdose.

    In July, the Company reported positive results from a confirmatory…

    • Fast Track Designation further underscores the potential for OPNT003 to represent a major advance in the treatment of opioid overdose as opioid overdose deaths surge1



    • This designation enables early and frequent communication with the FDA, in addition to the potential for a rolling submission of NDA application2

    SANTA MONICA, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Opiant Pharmaceuticals, Inc. ("Opiant") (NASDAQ:OPNT), a company advancing medicines to better treat addictions and drug overdose, today announced that the U.S. Food and Drug Administration ("FDA") has granted fast track designation for OPNT003, nasal nalmefene, its investigational treatment for opioid overdose.

    In July, the Company reported positive results from a confirmatory pharmacokinetic ("PK") study comparing OPNT003 to intramuscular nalmefene injection3. The characteristics OPNT003 exhibited in this study, coupled with nalmefene's five-fold higher affinity compared to naloxone4, demonstrate its promise as a potential new treatment. OPNT003 is currently being studied in an ongoing pharmacodynamic ("PD") study comparing it to nasal naloxone5. Both PK and PD data will form the basis of a New Drug Application ("NDA") submission using the 505(b)(2) regulatory pathway.

    "Opioid overdoses in the United States are a public health crisis with rates at the highest level in history and particularly powerful synthetic opioids like fentanyl, being the main driver," said Dr. Roger Crystal, President and CEO, Opiant. "The designation of Fast Track status by the FDA underscores the potential for OPNT003 to represent a major advance in opioid overdose treatment that can help communities better respond to this escalating crisis. Opiant is focused on advancing the OPNT003 development program as rapidly as possible and the granting of Fast Track designation represents significant additional support toward this objective."

    Synthetic opioids such as fentanyl are significantly more potent, have a very rapid onset, and a longer duration of action compared to heroin and prescription opioids. Synthetic opioids have created a much more dangerous environment for individuals that are using drugs, and not just those that use opioids. Fentanyl and related synthetic opioids have made their way into many substances sold illegally, including cocaine, methamphetamine and counterfeit pills, and is responsible for the deaths of thousands of Americans. Synthetic opioids have been found present in as many as 80% of overdose deaths1. Proving more resistant to reversal by standard doses of naloxone6, the public health threat posed by synthetic opioids prompted leadership at the National Institutes of Health (NIH) to call for the development of "…stronger, longer-acting formulations of antagonists7…"

    Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a potential rolling submission of the marketing application2. For more information on Fast Track designation, please visit the FDA's website, available at https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.

    About Opiant Pharmaceuticals, Inc. 

    Opiant Pharmaceuticals, Inc., the company that developed NARCAN® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements for OPNT003's potential as an opioid overdose reversal agent. 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, and among other things, our ability to maintain cash balances and successfully commercialize or partner our product candidates currently under development. 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. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on March 4, 2021, including under the caption titled "Risk 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.

    References:

    1. F. Ahmad et al. Provisional drug overdose death counts. National Center for Health Statistics (2021). https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
    2. U.S. Food and Drug Administration (FDA). Fast Track. Available from: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track.
    3. Opiant Press Release. Link.
    4. J. Cassel, et al. Alvimopan binding to the μ opioid receptor: Comparative binding kinetics of opioid antagonists. European Journal of Pharmacology, 520 (2005), pp. 29-36
    5. ClinicalTrials.gov (NCT04828005) Link.
    6. R. Moss, et al. Higher doses of naloxone are needed in the synthetic opioid era. Substance Abuse Treatment, Prevention, and Policy, 14 (2019), p. 6
    7. Volkow N & Collins F. The role of science in addressing the opioid crisis. N. Engl. J. Med 377, 391–394 (2017).

    For Media and Investor Inquiries:

    Ben Atkins, Opiant

    (310) 598-5410



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