“Adamis made significant advancements over the past year,” stated
Product and Pipeline Updates and Other Corporate Developments
October 18, 2021, Adamis announced that the U.S.FDA had approved the Company’s ZIMHI TM (naloxone HCL Injection, USP) 5 mg/0.5 mL product.
- ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose.
- According to the preliminary data from the
CDC, overdose deaths in the U.S.exceeded 100,000 for the twelve months ending April 2021.
- The Company’s
U.S.commercial partner, US WorldMedsis preparing to commercially launch ZIMHI in the first quarter of 2022.
October 2020, US WorldMedscompleted the transition of control of the commercial operations of SYMJEPI from Sandoz, Inc.
- The U.S. market for epinephrine exceeded
$1.7 billionin annual sales for the 12-month period ending September 30, 2021, according to Symphony Healthmarket data.
- Despite the marketing challenges posed by the pandemic and related lockdowns,
Symphony Healthdata indicates SYMJEPI unit sales increased approximately 98% for nine months ending September 30, 2021, versus the first nine months of 2020.
- Tempol has been shown to have antiviral, anti-inflammatory and antioxidant activity.
- Recently, the
National Institutes of Health(NIH) highlighted Tempol as a potential home treatment for COVID-19.
- In September, the first patient was enrolled into the Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19 and the Company is expanding the number of clinical study sites, including several potential sites outside the
- Adamis licensed exclusive worldwide rights under patents, patent applications and related know-how relating to Tempol for certain licensed fields including the treatment of respiratory diseases including asthma, respiratory syncytial virus infection, influenza and COVID-19.
- In addition to the work in COVID, the Company is exploring additional indications for the use of Tempol including, but not limited to the treatment of methamphetamine use disorder.
July 2021, the Company sold assets relating to its US Compounding human compounding pharmacy business. Under the terms of the sale, the Company expects to receive monthly payments over a 12-month period in an amount equal to one to two times the amount collected for sales of products to certain identified customers included in the sale.
- By the end of October,
USChad ceased manufacturing both human and veterinary pharmaceutical products and the employment of all USCemployees has ended.
- The Company is now engaged in a process of selling or otherwise disposing of the remaining assets of the business.
The business conducted through our
Reflecting these discontinued operations accounting principles, revenues for the nine months ended
Selling, general and administrative expenses for the nine months ending
Research and development expenses were approximately
Cash and equivalents as of
Adamis will host a conference call and live webcast today,
Conference ID: 13725311
A live audio webcast of the conference call will also be available via this link – https://viavid.webcasts.com/starthere.jsp?ei=1515468&tp_key=857fdc0361. If you are unable to participate in the live call, a replay will be available shortly after the live event. To listen to the replay please visit the events page of the Adamis investor relations section of the company website at http://ir.adamispharmaceuticals.com/presentations.
Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those that express plans, anticipation, intent, contingencies, goals, targets or future development and/or otherwise are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to the following statements: the Company's beliefs concerning the ability of its products and product candidates to compete successfully in the market; the Company's beliefs concerning the safety and effectiveness of SYMJEPI, ZIMHI or its other products and product candidates; the Company’s ability to successfully commercialize the products and product candidates, itself or through commercialization partners; the timing of the commercial launch of our ZIMHI product; future development and regulatory actions concerning the Company’s product candidates; the Company’s beliefs concerning the results of any future studies or clinical trials that the Company may conduct relating to Tempol or its other products or product candidates; the Company’s beliefs concerning the anticipated completion dates for clinical trials; the Company’s beliefs concerning the benefits, enforceability, and extent of intellectual property protection afforded by patents and patent applications that it owns or has licensed and its rights under applicable license agreements, and its ability to enforce its patents and other intellectual property rights against third parties; the Company’s expectations concerning future growth; expectations and statements about the Company’s strategies, objectives, future goals and achievements; and other statements concerning our future operations, activities and financial results. We may not achieve one or more of the target future milestones or achievements described in the press release either within the anticipated time periods or at all. In addition, forward-looking statements concerning our anticipated future activities assume that we have sufficient funding to support such activities and continue our operations and planned activities. Statements in this press release concerning future events depend on several factors beyond the Company's control, including the absence of unexpected developments or delays, market conditions, and the regulatory approval process. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, which may cause the Company’s actual results to be materially different from the results anticipated by such forward-looking statements. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and except as may be required by applicable law, we undertake no obligation to update or release publicly the results of any revisions to these forward-looking statements or to reflect events or circumstances arising after the date of this press release. Certain of these risks and additional risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the
Investor Relations at
(858) 997-2400 option 3
Source: Adamis Pharmaceuticals Corporation