Adamis Pharmaceuticals Corporation

Greetings. Welcome to the Atomos Pharmaceuticals Corp Q3 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. Please note, this conference is being recorded. I will now turn the conference over to your host, Mr. Robert Uhl. You may begin.

Thank you, Operator. Good afternoon, everyone, and welcome to the Atomos Pharmaceuticals Third Quarter 2021 Financial Results and Corporate Update Conference Call. Thank you for joining us today for the update, and welcome to our shareholders, analysts, and anyone 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 Adamus' recently named 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 investor section of our website, adamuspharmaceuticals.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 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. In addition, I would also like to say that if anyone would like to email questions in during the Q&A portion of the call or at any time during the call, please feel free to do so using the email address IR at AdamusPharma.com. With that, I will now hand the call over to Dr. Dennis Carlo, President and CEO.

Thank you, Robert. Well, obviously, a lot has happened since our last business update in June. And at that time, we were looking ahead to the following. Well, number one, FDA acceptance of the resubmitted new drug application for our Zinline Naloxone injection product Number two, enrolling of the first patient into our phase two, phase three clinical trial using TEMPL as a treatment for COVID-19. Number three, looking forward to increasing sales of our syngepi epinephrine injection product. Looking to get approval of our Zynhy treatment for opioid overdose and the subsequent commercial launch. And finally, following an IMD to enable the development of TEMPL for another indication at which time we were targeting radiation dermatitis. Well, I'm pleased to say we've made steady progress on each of these objectives, and with the exception of the commercial launch of Xenhyde, which will occur early in 2022, we have either already met or expect to meet by year-end each of these targeted milestones. Well, let me move forward now with an update on Xenhyde, our naloxone product. We submitted our NDA in May, and in June, the FDA indicated they had accepted it for review. In October, we received notice of approval, approximately one month ahead of the FDA's targeted action date. I'm only speculating that the alarming increase in overdose deaths and worsening opioid crisis may have contributed to the agency's expedited review. A recent New York Times article entitled, Overdose Deaths Reach Record High as the Pandemic Spreads, reported overdose deaths in the US top 100,000, according to the CDC data, for the 12 months ending April 2021. Our product, Zimhi, is the highest-dose naloxone product that is currently approved. It is differentiated from the currently available products in that naloxone enters the bloodstream faster and reaches higher concentrations than either of the competing nasal products. Every second matters during an overdose, and the higher levels are especially important when dealing with the highly toxic fentanyl substances. We and our commercial partners, U.S. World Meds, are very excited about introducing this product to the market, especially since they already are selling a complementary product in the area. They are already very familiar with this space. Now let me shift to Syngepi, our epinephrine product. Since taking over commercial responsibility for Syngepi in late 2020, U.S. World Meds has nearly doubled units sold during the same prior year period under Sandoz. Also, market penetration remains on an upward track. While we require continued growth before we approach our own sales expectations for Syngepi, we view the increase in quantity and availability of epinephrine products in the market as positive for those patients susceptible to severe allergic reactions. Additionally, we are very encouraged by the sales trajectory and U.S. worldwide strategy and commitment to make Syngepi a commercially successful product. David Mogulio will expand on this a little bit later in the call. Let me now move on to Temple. In early September, we enrolled the first patient into our ongoing Phase 2-3 clinical trial at Temple for the treatment of COVID-19. Dr. Moss will dwell into more specifics on the scope and timing of the trial, but I will say up until now, the combination of increasing numbers of vaccinated individuals and decreasing rates of COVID infections have presented challenges to patient enrollment. To address this challenge, though, we've begun a significant expansion on the number of clinical study sites, including potential sites outside the US. Now, lastly, some of you may have seen a webinar hosted by the NIH on Temple and its potential use in treating COVID-19. To date, which had been previously published by the NIH-demonstrated the antiviral properties of Temple that could be beneficial in a number of medical conditions, including COVID-19. We are aware of the NIH's recent activities related to Temple and its potential use in treating COVID-19, and we'll continue to monitor those activities. Now, I'd like to remind investors, Atomos licensed exclusive worldwide rights under patents, patents that have issued, patent applications and related know-how related to Temple for certain licensed fields, including the treatment of respiratory diseases, including asthma, respiratory syncytial virus, influenza, and COVID-19. Patents have already issued. In addition to our work in COVID, we continue to look for additional indications for the use of Temple and to explore options regarding funding and design of a clinical study to examine the effects of Temple for other clinical indications with the goal of being in a position to follow an IND. We initially explored radiation dermatitis, but because of the recent changes in treatment regimens, i.e. shorter treatment, the incidence of dermatitis has decreased and oncologists are seeing success treating the less severe cases of dermatitis with steward creams. We'll continue to monitor the area, but for now, we've decided to prioritize other potential uses. Now, with the recent approval of Zimhi, it made sense to look for other opportunities in the addiction space, Since multiple preclinical studies have suggested Temple could play a significant role in the treatment of methamphetamine and cocaine use disorder, we've decided to further explore this area. Now, lastly, I must address where things stand with the previously announced opinions that the company and our U.S. compounding subsidiary received from the U.S. Attorney's Office for the Southern District of New York in connection with an investigation by the U.S. Attorney's Office. The subpoenas requested a broad range of documents and materials relating to, among other things, certain veterinary products sold by USC, certain practices, agreements, and arrangements relating to products sold by USC, including veterinary products, and certain other matters relating to the company and USC. Also, as previously disclosed, our audit committee initiated an independent internal investigation, and now I am pleased that we have reached the stage where we are able to file our quarterly reports. As has been disclosed in Form 10-Q as of the end of July 2021, the company sold assets relating to U.S. human compounding pharmacy business, has subsequently ceased the manufacturing both human and veterinary pharmaceutical products, and is engaged in the process of selling or otherwise disposing of the remaining assets of the business and the employment of all USC employees has ended. I would now like to introduce our long-time controller and recently named CFO, David Benedicto, to provide some highlights from our recently filed financials. David?