Opiant Pharmaceuticals, Inc.

Greetings and welcome to Opium Pharmaceutical's second quarter 2022 earnings 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, Ben Atkins, Vice President, Communications and Investor Relations. Please go ahead, sir.

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, and Chief Financial Officer, David O'Toole. This afternoon, Opiant issued a press release announcing financial results and providing a business update for the three months and six months ended June 30th, 2022. Today's press release is available on our website at www.opiant.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 due 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 31st, 2021, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, August 11th, 2022. Opium 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 second quarter and first six months of 2022. We appreciate everyone's time and attention. The first half of 2022 was important for opiates as we continue to advance our pipeline of new medicines for addiction and drug overdose. We have a tremendous sense of mission to create meaningful therapeutics that we believe can help curb substance use harm and relieve the burden it places on our communities and health care. Opient made its first impact by developing Narcan nasal spray for the emergency treatment of known or suspected opioid overdose. It was a new formulation, easier to use and containing a higher dose of naloxone compared to earlier unapproved kits. We remain very proud of Narcan and the role it plays in our communities Yet, we also believe new reversal agents are needed as the potency of illicit synthetic opioids grow. So let me start with a review of our progress with OPNT003 for the treatment of opioid overdose, and then to offer some context as to how we are thinking about its place in the market. OPNT003 is a nasal formulation containing the high affinity opioid antagonist In May, we announced positive results from our pharmacodynamic study evaluating OPNT003 head-to-head with 4 mg nasal naloxone. As we reported, OPNT003 met the primary endpoint of non-inferiority to nasal naloxone, producing a reversal in remifentanyl-induced respiratory depression that was nearly twice that produced by nasal naloxone at five minutes. Further analysis of the data showed it took nasal naloxone 20 minutes to achieve the same level of effect it took nasal nalmothene at only five minutes. Our completion of the PD study concluded the clinical program supporting OPNT003. As we shared, our NDA incorporates extensive data from our PD study and two prior pharmacokinetic studies. Our PK data demonstrated rapid absorption and higher plasma concentrations versus intramuscular injection of nalmothene. On our last earnings call, our chief scientific officer, Dr. Phil Skolnick, explained the full set of PD and PK results and that OPNT003's apparent fast action, strength, and long duration is well matched to address overdoses from illicit synthetic opioids, in particular fentanyl. The value of OPNT003 has been further strengthened by the allowance of certain formulation and method of use patent claims covering OPNT003 and intravail in a nasal formulation. We have already received a notice of allowance and we expect the patent to be granted in the coming weeks and we will also include this in our NDA submission. With our data reported, we are focused on completing the NDA filing for OPNC003, which we announced the start of in May as a rolling submission. We are making good progress. The non-clinical section has been submitted. The CMC section is on the final review and publishing, and the clinical section is in progress. This puts us on track to complete our submission by year end. Our planned filing timeline, if we receive priority review, provides us with a possible PDUFA date in the second quarter of 2023. Work is well underway preparing for a commercial launch of OPMT-003. A record number of people in the United States over 80,000 died of an opioid overdose during the 12 months ending February 2022, according to provisional data from the CDC. For each opioid-induced fatality, according to our own research of existing data, there are about eight non-fatal overdoses which can lead to long-term physical and mental disability. Health experts warn, however, about very troubling trends particular to fentanyl and other illicit synthetic opioids that illustrate the growing need for easy-to-use and effective opioid overdose reversal agents. In April, a report published in JAMA noted that for the first time in a decade, overdose deaths among teens in the United States rose dramatically in 2020 and kept rising through 2021 as well. the study found that fentanyl-related deaths increased from 253 in 2019 to 680 the following year. And in 2021, 77% of all teen overdose deaths involved fentanyl. A major cause is a surge nationwide in so-called Fentapills. These counterfeit pills are laced with fentanyl and are produced to closely resemble legitimate prescription medicines such as Adderall and Xanax. Turning now to the pipeline, we made progress during the course in our Phase II study evaluating OPNC002 nasal naltrexone for alcohol use disorder. We have enrolled over 200 patients, keeping us on track to complete enrollment of our target 300 patients by year end. As you know, OPNT002 is being developed as a nasal spray that someone can take as needed to quell the pleasurable effects of alcohol. We believe this can help someone reduce regular heavy drinking. AUD is a significant cause of disease, and OPNT002 could have a dramatic impact on one's ability to control unhealthy drinking. We're excited to complete this study and further our understanding of its therapeutic potential and the novel approach. We expect to report data in the first half of 2023. In conclusion, I am excited by the progress we have made. We continue to advance our mission to develop new medicines to treat addiction and drug overdose. The coming months will be pivotal for us as we continue to execute on our OPMT-003 program. and we're excited for the journey ahead. I want to thank the entire Opioid Team and our collaborators for the hard work and dedication. With that, I'll turn the call over to David to discuss the financials.