Opiant Pharmaceuticals, Inc.

Greetings and welcome to the Opiate Pharmaceuticals fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen-only mode. A brief 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. It is now my pleasure to introduce your host, Ben Atkins, Vice President of Investor Communications and Investor Relations of Opient Pharmaceuticals. Thank you, Ben. You may begin.

Thank you, Operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer, Dr. Roger Crystal, Chief Commercial Officer, Matt Roof, and Chief Financial Officer, David O'Toole. This afternoon, Opient issued a press release announcing financial results and providing a business update for the three and 12 months ended December 31st, 2021. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, opiate management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statement contained in Opium's news release and SEC filings, including in our annual report on Form 10-K for the year ended December 31, 2021, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, March 15, 2022. OPNs undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, I'd like to turn the call over to Roger.

Thanks, Ben, and a very warm welcome to you all. Thank you for joining our conference call to discuss opiates, financial results, and business highlights for the fourth quarter and full year 2021. We appreciate everyone's time and attention. In 2021, we have four overarching goals. One, advance OPMC 003 naval now machine towards MDA submission. Two, establish leadership to potentially self-commercialize OPMC 003 if approved. Three, advance our pipeline. Four, maintain a strong balance sheet in support of our development and commercial goals. I am pleased to say that we have made significant progress in all four areas of focus. Starting first with OPNC003, our investigative treatment for opioid overdose. In 2021, we reported multiple achievements around its advancements. This included the results of our confirmatory pharmacokinetic study and initiation of two further studies, a multidose study and a pharmacodynamic study, both requested by the FDA. Moreover, in November, the FDA granted OPNT003 fast-track designation. This momentum has continued in early 2022. In February, we reported positive topline results from our multidose study. in which OPMT003 demonstrated safety, tolerability, and pharmacokinetic equivalence across multiple nasal doses. Importantly, these data are fully consistent with the rapid delivery of high plasma concentrations of nalmophene observed in our earlier single-dose PK study, which we reported in July 2021. I am also pleased to announce that we have completed enrollment and reached our target of 46 subjects in the pharmacodynamic study. This study is comparing OPMT-003 with nasal naloxone in reversing the respiratory depression produced by the synthetic opioid remifentanil in healthy volunteers. As a reminder, we designed this novel PD study at the request of and in consultation with the FDA. This is the first study ever conducted directly comparing the PD effects of nasal nalmophene and nasal naloxone in an experimental model of opioid-induced respiratory depression. We are confident the data generated in this study will support the data generated in our pharmacokinetic studies and provide additional valuable information on the attributes of OPMT003 relative to the current standard of care. In this study, Healthy volunteers were administered high concentrations of carbon dioxide to elevate respiration, and once this occurred, were administered an infusion of the synthetic opioid remifentanil. Like other opioids, remifentanil suppresses carbon dioxide-stimulated increases in respiration. The subjects then received either nasal naloxone or nasal nalmophene. The rate and extent of reversal was measured over time. Using a crossover design, subjects were dosed with either nasal naloxone or nasal melmothene on days one and five of the study. So, each subject received one dose of each opioid antagonist. The study was managed to strict safety criteria agreed with the FDA and the Institutional Review Board. As a reminder, as agreed to with the FDA, the study is powered to demonstrate non-inferiority between nalmophene and naloxone, with a primary endpoint measuring the change in minute ventilation at five minutes. Additional secondary endpoints cover a range of different time points. As the study progressed, there was a high rate of dropouts related to study conditions, including the wearing of a tight-fitting mask for an extended period and the side effects produced by remifentanyl infusion, which includes nausea, emesis, and dizziness. Unfortunately, this meant that the study took longer to complete than anticipated. With enrollments now complete, however, we are now diligently preparing our study data for analysis. Although we had initially hoped to have top line data by the end of Q1, given the completion of the clinical portion earlier this month, we now anticipate these results coming which results in the coming quarter. We believe this significant milestone completes all clinical studies required by the FDA. Earlier this year, we requested a pre-NDA meeting with the FDA, which is scheduled for later this month. Pending the outcome of this meeting, we anticipate a mid-year NDA submission, which, if approved, could position OPNC003 for commercial launch in the US by early 2023. As we progress OP&T 003, we continue to attract strong and experienced talent to key roles. In November, we welcomed Tanya Thomas as our VP of Regulatory and Medical Affairs. Tanya joined us after 15 years at Pfizer and GSK, having held senior positions leading regulatory affairs teams both in the US and globally. She has a demonstrated track record in supporting successful US and ex-US regulatory approvals. We look forward to Tanya leading our efforts with the FDA to obtain approval for OPMC-003. Now, turning to commercial, pipeline, and our balance sheet. Commercially, as we get closer to NDA submission, our preparations for the potential launch of OPMT-003 are progressing well. Matt Ruth, our chief commercial officer, will speak to that in a moment. In R&D, we continue to advance our pipeline and have several exciting milestones expected over the next 12 to 18 months. We reported in January that the initiated enrollment in our 300 patients phase two randomized double-blind placebo-controlled study evaluating OPNT002 nasal naltrexone for the treatment of alcohol use disorder, or AUD. The study, which we are conducting in Europe, has already reached 10% of our recruitment goals. We anticipate data from this trial in the first half of 2023. OPNT002 potentially represents a major breakthrough for treating AUD as its rapid onset of action and short half-life are ideally suited for administration on an as-needed basis without the need for prior abstinence. As we also previously reported, we are progressing OPNC004, Drinabant, a treatment for acute cannabinoid overdose, or ACO, towards IMD-enabling studies, working in partnership with the National Center for Advancing Translational Sciences. As more and more states legalize both the medical and recreational use of cannabis, and particularly edibles, which contain very large amounts of THC, there is an increased need for an effective treatment of ACO in the emergency room setting. For example, a study recently published in JAMA reports Ontario saw nine times more emergency department visits per month for cannabis poisoning in young children under the age of 10 after Canada legalized recreational cannabis in 2019. We hope to have a pre-IMD meeting by the end of this year and have OPMC-004 in clinical studies next year. Lastly, we managed our balance sheet in 2021 beyond the high end of our, which David will go into in more detail a little later. Let me end my remarks by reminding you of what we do at Opium and why. Our mission is to develop medicines with the potential to treat addictions and drug overdose. America is facing a deadlier opioid epidemic. From September 2020 to September 2021, opioids accounted for roughly three-quarters of the more than 104,000 deaths in the U.S. from drug overdoses. Since the mid-2010s, the opioid epidemic has transitioned to very potent and illicit synthetic opioids, in particular fentanyl. As we've discussed on previous calls, fentanyl and other emerging synthetic opioids are distinct from heroin and prescription opioids. Synthetics are highly lipophilic and enter the brain more quickly than other opioids. They act with far greater potency, and many of these compounds have long half-lives relative to heroin and prescription opioids. These longer half-lives increase the risk of re-narcotization if a victim is rescued with a short-acting agent like naloxone. In the few years since illicit synthetic opioids began to proliferate in the U.S., yearly drug overdose deaths have more than doubled, making this one of the most rapidly spreading epidemics in history. The increase in deaths due to opioid overdose has given rise to concerns about the longer-term effectiveness of current overdose reversal treatment and led to calls for innovation in this space. In a 2016 report, an FDA advisory committee indicated that higher or multiple doses of naloxone often were needed in the community setting to revive individuals when stronger opioids like fentanyl were involved. Since then, the CDC, the NIH, and other public health agencies have issued similar warnings. Opioid overdose is the leading cause of death amongst Americans aged 18 to 45. This is robbing us of lives and our future. In February, a new government report concluded that overdose deaths cost the economy a trillion dollars a year in health expenses, reduced productivity and other losses, equivalent to nearly half of America's economic growth last year. And this trajectory is getting worse. Recent estimates in the medical journal The Lancet suggest that opioid overdose could kill up to an additional 1.2 million Americans by 2029. Since opiates original development of the Narcan nasal spray and its FDA approval in 2015, Narcan nasal spray has helped lead the fight against opioid overdose. It has made a clear and extremely positive difference in communities across America. It has fundamentally changed how we respond to overdose by engaging bystanders within our homes and communities. Yet, the crisis today is different than it was when we developed Narcan nasal spray. The limitations when matched against far stronger and more lethal opioids are becoming more and more evident. To serve public health and to save lives, we must make progress on prevention and treatment of opioid overdose. New medicines are needed as the potency of illicit drugs flooding America grows. As the overdose crisis heightens, our colleagues across opiates are more determined than ever to be part of the next potentially game-changing breakthrough. And with that, I'll turn it over to Matt, our Chief Commercial Officer.