Opiant Pharmaceuticals, Inc.

Good day, ladies and gentlemen, and welcome to the Opium Pharmaceuticals Third Quarter 2021 Financial Results and Business 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, please press star zero on your telephone keypad. I would now like to turn the call over to your host, Ben Atkins. Vice President of Communications and Investor Relations of Opiate Pharmaceuticals. Please go ahead.

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 Financial Officer David O'Toole, and Chief Commercial Officer Matt Roof. This afternoon, Opiant issued a press release announcing financial results and providing a business update for the three and nine months ended September 30th, 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, Opiant 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 statements contained in Opium's news releases and SEC filings, including in our annual report on Form 10-K for the year ended December 31, 2020, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, November 11th, 2021. 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. Given our focus on OPNT-003, most of my remarks today will cover our development progress as we look ahead to NDA submission next year. Joining me today is our Chief Commercial Officer, Matt Ruth, who will elaborate on our commercial readiness activities. These activities reflect our transformation from a development stage company to a commercial business as we anticipate the launch of OPNT-003. Also on today's call is David O'Toole, our Chief Financial Officer, who will remark on our financial performance and strong cash position as we approach the end of the year. Turning to the quarter, our development of OPMT-003 continues to make good progress. Last week, we announced the FDA granted us fast track designation. This underscores the potential for OPMT-003 to represent a major advance in opioid overdose treatment, which we believe can help communities better respond to this escalating crisis. Fast-track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. Programs with fast-track designation may benefit from early and frequent communication with the FDA in addition to the potential for a rolling submission of the new drug application. This designation comes as regulators and communities across the United States grapple with a worsening opioid epidemic driven by synthetic opioids such as fentanyl. Opioid overdoses claimed an estimated 63,000 lives in the 12 months ended March 2021. Synthetic opioids were linked to over 80% of these deaths. This makes opioid overdose both the number one cause of death for individuals between 25 and 64 years old and a significant contributor to the decline in average lifespan. Beyond this, there are hundreds of thousands of non-fatal overdoses each year. In October, the peer-reviewed journal Pharmacology and Therapeutics published a review by our chief scientific officer, Dr. Phil Skolnick, titled Treatment of Overdose in the Synthetic Opioid Era. The paper highlights that for each opioid-induced fatality, there are between 6.4 and 8.4 non-fatal overdoses. Most people don't realize that even if revived from an opioid overdose, victims can experience long-term physical and mental disabilities depending on how long the brain is deprived of oxygen during the overdose. The synthetic opioids responsible for the great majority of overdoses are far more potent and have a longer duration of action than opioids such as heroin. they can quickly depress a person's breathing and continue to deprive the brain of oxygen even after administration of naloxone. Given the widening prevalence and greater potency of synthetic opioids such as fentanyl, leadership at NIH has called for the development of stronger and longer-acting opioid antagonists. To meet this challenge, we are developing OPNT003 using nalmothine. Nalmothene, while also an opioid antagonist, is different from naloxone in several important ways. It has a longer half-life and a five-fold higher affinity than naloxone that makes it more potent at the mu opioid receptors in the brain. The recent data from a confirmatory pharmacokinetic study demonstrated that OPNT003 surpassed intramuscular nalmophene injection across all key metrics, exhibiting fast absorption and long duration. We believe that this data supports OPNT003 being a potentially major advance in opioid overdose reversal. We are also on track this quarter to complete a study comparing the effect of one dose of nalmophene in each nostril to two sequential doses. We expect top line data by January. To further support our new drug application, on the FDA's request, we designed a novel pharmacodynamic study comparing OPNT003 with nasal naloxone in reversing the respiratory depression produced by the synthetic opioid remifentanyl in healthy volunteers. The study is powered to demonstrate non-inferiority between nalmothene and naloxone at a primary endpoint measuring the change in minute ventilation at five minutes. Additional secondary endpoints cover a range of different time points. This is a novel clinical study that seeks to address important clinical questions not previously answered by other studies. As a result, we anticipate that we would be eligible to receive three years of market exclusivity if OPNT003 is ultimately approved. The study consists of two sequential parts. Part one determined the study conditions, including the optimal dose of remifentanyl, to allow for a safe and meaningful comparison. Part two is a head-to-head comparison against nasal naloxone. I am pleased to update that we have completed part one and expect to complete recruitment and dosing in part two by year end. We anticipate having top line data to share in the first quarter of next year. We had originally anticipated having top-line data in the fourth quarter of this year. However, we made the decision during part one of the study to modify the dose of remifentanyl. This modification was reviewed by the FDA and was subsequently approved by the IRB. Completion of the PD study represents the last step to finalizing a robust set of clinical data that will form the basis of our NDA, which we anticipate completing in the first half of 2022. Turning to the rest of our pipeline, we are working on startup activities for our phase two study evaluating OPNT002 nasal naltrexone for the treatment of alcohol use disorder. You will recall that we did not initiate recruitment in 2020 as we had planned due to COVID. I am pleased to say we expect to recruit our first subjects this quarter with dosing to follow soon thereafter. This will be a randomized 300 participant double-blind placebo-controlled study to determine whether OPMT-002 reduces heavy drinking in patients as measured by a change in the World Health Organization drinking risk levels. The study is anticipated to take about a year. In a phase 1 PK study, OPNT002 showed potential to become an as-needed nasal spray treatment when a patient anticipates drinking or is craving alcohol. With alcohol use disorder so prevalent in our society, we believe OPNT002, if proven effective in this trial, could dramatically improve the treatment landscape. Turning to OPNT004, Drinabant, for the treatment of acute cannabinoid overdose. We continue to advance our development of a parental formulation of Drinabant in collaboration with NCATS, and we see the potential opportunity to initiate clinical trials next year. Overall, we're really pleased with our pipeline progress, and particularly OPNT003. As I mentioned at the start of my remarks, we're joined today by Matt Ruth, our Chief Commercial Officer. Matt joined the team in July. Prior to Opium, he led the launch of Narcan nasal spray at Adapt Pharma. I asked Matt to join us today to share some insight into the work he's leading as we look ahead to transitioning to a commercial company.