Adamis Pharmaceuticals Corporation

Greetings, and welcome to Adamus Pharmaceuticals' full year 2021 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Robert Uhl, with ICR Westwick.

Thank you, Operator, and good afternoon, everyone, and welcome to the Atomos Pharmaceuticals 2021 Financial Results and Corporate Update Conference Call. Thank you for joining us today for the update, and we welcome our shareholders, analysts, and anyone else interested in Atomos. Joining me today is Atomos' President and CEO, Dr. Dennis J. Carlo, Chief Medical Officer, Dr. Ron Moss, Chief Business Officer, David Margulio, and Chief Financial Officer David Benedicto. The format for this call will consist of prepared remarks from management followed by Q&A. This call is being webcast and will be available for replay in the Investors section of our website, atomuspharmaceuticals.com. In today's call, we will make certain forward-looking statements regarding our business based on current expectations and current information. Those statements speak only as of today and and except as required by law, we do not assume any duty to update in the future any forward-looking statement made today. Of course, any forward-looking statements involve risks and uncertainties, and our actual results could differ materially from those anticipated by any forward-looking statements that we make today. Additional information concerning factors that could affect our business and financial results is included in our most recent annual report on Form 10-K with the Securities and Exchange Commission, and in other subsequent filings that we make with the SEC. These are available at the SEC's website. With that, I will now hand the call over to Dr. Dennis Carlo, President and CEO.

Thank you, Robert, and thanks to all of you for joining us today. I want to begin with a review of how the company performed against our internal objectives for 2021. I want to start by introducing our five major corporate objectives for 21. Number one was to begin our clinical trial using Temple for the treatment of COVID-19. Obviously, this has been completed and is ongoing. The steps necessary, the steps we have taken to begin the trial included obtaining drug product, contracting with a major CRO and recruiting patients, finding a lead investigator, and putting together a quality DSMD. Our second objective was to meet and discuss with the FDA our planned responses to the agency's 2020 complete response letter regarding our naloxone, or Zimhi, NDA, and resubmitting the Zimhi new drug applications. This led to the third objective, which was to obtain approval for our Zimhi product, which we received on October 12th, 2021. The fourth objective was to complete an executed purchase agreement for the sale of assets relating to our U.S. compounding subsidiary. And the fifth and final objective was to file an IND to use Temple as a treatment for drug addiction. At this time, I am most pleased to report that we accomplished all of our major corporate goals for 2021. Additional accomplishments were, number one, we completed and published a Cyticon study with Stanford investigators, and we recently completed a COVID-19 hamster study in which animals were treated with Temple and received high doses of Omicron virus. The study was conducted at the University of Texas and shows significant reduction in inflammation. I would like to go back and say a little bit more about funding. We have and we will continue to explore options regarding funding and design a clinical study to examine the effects of Temple for other clinical indications but not limited to the treatment of COVID, methamphetamine and cocaine use disorder, long-term COVID or asthma. We are engaged in activities to support such development should we determine to proceed with such activities. To this end, we've applied for government grant for methamphetamine use disorder and have received a fundable score, but will not know if we receive funds until sometime in the second quarter of this year. In a few minutes, Dr. Moss will provide a detailed discussion of each of these product development programs. To summarize my opening remarks, at the beginning of 2021, we established what I believe were very ambitious corporate goals for the company the size of ours, I am pleased to say that we feel we achieved 100% of our objectives. This was with less than 15 full-time employees. Additionally, I've challenged my team to set ambitious goals for this year. With the commercial loss of Zimhi and increasing patient enrollment in our Phase III clinical trial in the first quarter of this year, I believe that 2022 is off to a very good start. With that, I'll turn it over to our CFO, David Benedicto, to provide some highlights from a recently filed client, David.