Opiant Pharmaceuticals, Inc.

And welcome to Opiant Pharmaceuticals first quarter 2022 earnings conference call. At this time, all participants are in a listener-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, Ben Atkins, Vice President of Communications and Investor Relations. Thank you and over to you.

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 Scientific Officer, Dr. Phil Skolnick, and Chief Financial Officer, David O'Toole, Chief Commercial Officer, Matt Roof, or join the question section of the call. This afternoon, Opeant issued a press release announcing financial results and providing a business update for the three months ended March 31st, 2022. We will also be presenting slides today. Today's press release and the slides for this call are available on our website at www.opeant.com. Before we start, 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 to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in opiates news releases 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 out of the date of this live broadcast, May 10th, 2022. Opient 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 Opient's financial results and business highlights for the first quarter 2022. We appreciate everyone's time and attention. At Opium, we are focused on our mission to advance medicines that better treat addictions and drug overdose. Few companies have dedicated research and development in this area. Fewer still their entire mission. Yet the disease, death, and economic costs associated with substance abuse is overwhelming. We are proud to be a leader in this field with a strong pipeline and exciting catalysts in the near term and beyond. The first quarter of 2022 marked another strong quarter for us as we move OPMT-003, nasal nalmothene, closer to NDA submission. We are very excited with the recent results of the Pharmacodynamic Studies Top Line Readout, which builds off the impressive data we saw from our prior clinical pharmacokinetic studies. Dr. Phil Skolnick, our Chief Scientific Officer, will speak to the PD results shortly. At the end of March, we completed a pre-NDA meeting with the FDA. The purpose of the meeting was to discuss our planned NDA submission to ensure that all requirements for a complete application will be met. Based on that meeting, we believe our NDA submission for OPNT-003 is on track and we remain hard at work to ready the filing. Simultaneously, our commercial preparations continue to advance in support of a launch. Opium teams continue to execute on our other pipeline programs while we prepare our regulatory submission for OPMT-003. Specifically, we are exploring the potential for OPMT-002, nasal naltrexone, to reduce heavy drinking associated with alcohol use disorder. We are in an ongoing phase two clinical trial in Europe. This is a condition which affects millions in the United States and for which there continues to be a significant need for better medical treatment. Less than 10% of people classified with alcohol use disorder receive pharmacotherapy. To date, we have enrolled over 80 patients in our trial with a target of 300 patients. We expect a complete enrollment in early 2023. I would also like to highlight OPNC004, Drinabant for Acute Cannabinoid Overdose, for which we expect to complete IND enabling activities this year. Our work is supported by a strong balance sheet and the continued support from our government partners. As I noted at the beginning, we are making good progress with OPNC003. The opioid epidemic has continued to evolve with synthetic opioids like fentanyl now accounting for almost 90% of opioid overdose deaths, which equates to about 70,000 deaths from synthetics in 2021, up from less than 10,000 in 2015. Significantly, fentanyl and other synthetic opioids are now found across non-opioid illicit substances, including cocaine and counterfeit prescription medicines such as Adderall and Percocet. Anecdotal accounts children and young adults being targeted by dealers selling these counterfeit pills through the use of social media is particularly distressful. In our efforts to develop treatment better able to confront our current opioid overdose crisis, we are very encouraged with the top-line data from our pharmacodynamic study. Phil Skolnick, our Chief Scientific Officer, designed the study and working with the FDA, which requested efficacy data compared with naloxone. I have asked Phil to join us today to provide more detail on the PD study and the package of data it completes. Phil, over to you.