“Also, during the last quarter we acquired rights to develop a novel drug compound, Tempol, for certain indications including COVID-19 infections. We believe Tempol could be a powerful therapeutic agent in combating COVID-19 and are committed to working with the FDA and other agencies with a goal to begin testing Tempol in patients as soon as practicable. I believe there are a number of exciting near-term milestones for Adamis and I am very excited about the second half of 2020 and beyond.”
SYMJEPI (epinephrine) Injection
In addition to the
ZIMHI (naloxone) Injection
In June, the company entered into a license agreement with
Since licensing this product, the company has submitted to the FDA a Pre-Investigational New Drug (IND) package, and the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled Phase II study examining Tempol in COVID-19 patients. The company’s goal is to apply for and obtain funding from certain government agencies and programs to enable the necessary trials to determine the efficacy of Tempol as a therapeutic treatment for COVID-19.
Drug Outsourcing Facility
Year to date, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), were adversely affected by slowing demand due to the novel coronavirus outbreak. Revenues decreased by approximately 19% year to date compared to the same period in the prior year.
Second Quarter Financial Results
Year to date revenues were approximately
Selling, general and administrative expenses (“SG&A”) for the six months ended
Research and development expenses were approximately
Cash and equivalents at the end of the second quarter was approximately
- Work with USWM to finalize transition of SYMJEPI commercial responsibility from Sandoz;
- FDA approval and
U.S.commercial launch of ZIMHI;
USCdivision back to pre-COVID-19 levels;
- Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
- Begin Phase 2 trial for Tempol in COVID-19 patients
Adamis will host a conference call and live webcast on Thursday, August 20, 2020 at 1:30 pm Pacific Time to discuss its financial and operating results for the second quarter of 2020 as well as provide an update on business developments and activities.
US Dial-in (Toll Free): 1-877-423-9813
Conference ID: 13708688
In addition, a telephone playback of the call will be available after approximately 4:30 pm PT on August 20, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 13708688.
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 impact of the recent COVID-19 outbreak and overall economic outlook on the company’s present and future operations, employees, suppliers, supply chain, manufacturers and commercial partners; the timing and results of the FDA’s review of the company’s resubmitted NDA for ZIMHI; the company’s beliefs concerning the results of studies or clinical trials that the company has conducted relating to ZIMHI or its other products or product candidates; the company’s beliefs concerning its ability to commercialize ZIMHI and its other products and product candidates; the company’s beliefs concerning the success of the transition of commercialization and marketing of its SYMJEPI products from Sandoz to USWM; the company's beliefs concerning the ability of its 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 beliefs concerning its commercialization strategies; the company’s beliefs concerning the anticipated timing of any commercial launch of its ZIMHI product; the company’s beliefs concerning the timing or outcome of discussions with the FDA and other agencies concerning the company’s pre-IND package, and any IND that the company may submit to the FDA, relating to a proposed Phase II study examining Tempol in COVID-19 patients, concerning the timing or outcome of discussions with government agencies or others regarding the design and funding for trials relating to use of Tempol as a therapeutic treatment for COVID-19, or the timing or outcome of any such trials; statements about strategies, objectives and our future goals and achievements; future financial results of the company and its subsidiaries; future development and regulatory actions concerning the company’s product candidates; the timing and progress of current and future clinical trials or studies; expectations and goals for future growth, including without limitation future growth in revenues from sales of compounded sterile pharmaceutical formulations; anticipated commencement and completion dates for clinical trials; product development timelines; anticipated dates for commercial introduction of products; guidance regarding future periods; and other statements concerning our future operations and activities. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis' actual results to be materially different from these forward-looking statements. There can be no assurances concerning the timing or outcome of future action by the FDA relating to our resubmitted NDA for ZIMHI. In addition, there can be no assurance that the FDA will conclude that the company’s resubmitted NDA satisfactorily responds to the matters raised in the FDA’s CRL or discussed in the Type A meeting, that the FDA will approve our resubmitted NDA relating to ZIMHI, or concerning the timing of any future action by the FDA on our resubmitted NDA. The FDA’s review processes can extend beyond, and in some cases significantly beyond, anticipated or target completion or action dates due to the timing of the FDA’s review process, FDA requests for additional data, information, materials or clarification, difficulties scheduling an advisory committee meeting, FDA workload issues, extensions resulting from the submission of additional information or clarification regarding information already in the submission, issues relating to the COVID-19 pandemic, or other reasons. We may not achieve one or more of the target future milestones 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 are able to obtain sufficient funding to support such activities and continue our operations and planned activities. As discussed in our filings with the
Senior Director, Investor Relations
& Corporate Communications
Source: Adamis Pharmaceuticals Corporation