Opiant Pharmaceuticals, Inc.

Greetings. Welcome to the Opiate Pharmaceuticals First Quarter 2021 Financial Results 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 call over to your host, Ben Atkins. 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 and Chief Financial Officer David O'Toole. This afternoon, Opiant issued a press release announcing financial results and providing a business update for the first three months ended March 31, 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, opiates 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 31st, 2020, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11th, 2021. Oakland undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now, with that, I'd like to turn the call over to Roger.

Thanks, Ben, and a very warm welcome to you all. I'll begin by offering a brief corporate update and then hand off to David O'Toole, our Chief Financial Officer, to provide an overview of the financial highlights. Our mission is to transform the therapeutic treatment of addictions and drug overdose, and in so doing, help more patients and drive the future growth of our company. Our priority is OPMT-003, nasal now the theme for opioid overdose. About 180 people are dying every day from an opioid overdose in the United States, higher than ever before. 80% of these deaths are due to illicit synthetic opioids, mainly fentanyl. New therapeutic ideas are needed to save more lives, and we believe nalmophene has the potential to be particularly well-suited to treat synthetic opioid overdose. I will discuss the growing opioid epidemic and what differentiates OPMT003. First, I'd like to provide an update on the status of OPMT003 development program. In 2021, our focus is on execution and expanding on the robust body of data in support of OPMT003. I'm pleased to report that we are making important progress. We are fully enrolled and are close to completing our confirmatory pharmacokinetic study. We look forward to reporting top-line data from this study in the next few months. In addition, we have dosed the first subjects in our head-to-head clinical pharmacodynamics study, comparing the effectiveness of opium T003, nasal nalmophene, with nasal naloxone. In this study, we modeled respiratory depression using the synthetic FDA-approved opioid remifentanil in healthy volunteers. We expect to report top line data in the fourth quarter. Other drug development activities are also on track for an NDA filing using the 505 regulatory pathway by year end or early first quarter 2022. Further reflecting our progress, in March, we were awarded the third and final tranche of $1.8 million and the total grant of approximately $7.4 million from NIDA to support the advancement of OPMT-003. As a reminder, the development of OPMT-003 is also supported by BARDA. With that, I'd like to provide some further context on how we arrived both at this point in the evolving opioid crisis and in our development of OPMT-003. About eight years ago, we saw an opportunity to help save lives from opioid overdose. We developed Narcan nasal spray so any bystander could administer a potentially life-saving medicine to a victim. In 2018, the US Surgeon General Jerome Adams encouraged people to carry Narcan with them. adding that in some communities, when finding someone unconscious, you would more likely need to administer Narcan than carry out CPR. When we developed the Narcan nasal spray containing naloxone, overdoses were commonly linked to prescription opioids and heroin. Today, we face an entirely different class of opioid, illicitly made synthetic opioids, particularly fentanyl. In new data released by the CDC, deaths linked to illicit synthetic opioids, and in particular fentanyl, were up 55% to 53,877 during the 12 months ended September 2020. That figure compares to approximately 10,000 deaths in 2015, an illustration of how firmly fentanyl has become entrenched in America's illicit drug supply. Fentanyl and synthetic opioids differ from opiates. First, they are more lipophilic. Fentanyl, for example, is more easily taken by fatty tissues, including the brain. This enables it to cross into the brain more quickly and in greater quantity. This combination gives the user a fast and intense high. However, too much fentanyl entering the brain will also rapidly suppress breathing, leading to overdose. Depending on the circumstances surrounding the overdose, this can take seconds to a few minutes. The second differentiation are the sustained effects of synthetic opioids like fentanyl. Naloxone lasts between 30 to 90 minutes, while fentanyl has a plasma half-life of about seven hours. It is possible that as naloxone levels fall, while fentanyl levels fall far more slowly, the victim can sink back into an overdose known as re-narcotization. Both the potency and long plasma half-life of certain synthetic opioids is challenging naloxone. As we have discussed on previous calls, scientific literature reports from ENS teams, and in December, Public Health Advisory by the CDC collectively confirmed that multiple doses of naloxone are likely necessary to revive an overdose victim and that further doses could be needed to avoid a recurrence. It is this medical insight that has driven us at Opium to explore alternative molecules to naloxone. Based on its pharmacological characteristics and the compelling data from our pilot PK study, OPNT003, nasal nalmophene, could prove uniquely suited to treat synthetic opioids in three important ways. First, nalmophene has a higher affinity at the opioid receptors than naloxone, which makes OPNT003 more potent. Second, nalmophene has a longer half-life, which, as I explained before, reduces the potential for re-narcotization. Third, we formulated OPNT003 for rapid absorption by incorporating Intravail into our formulation and using a simple nasal spray device. This is important due to the shorter window to save a life from a synthetic opioid, including fentanyl. We believe OPNT003 has significant potential to treat synthetic opioid overdoses and look forward to the availability of the confirmatory PK and PD data in months ahead. With that, I'll now move to the rest of our pipeline. We continue to progress our IND-enabling work with the National Center for Advancing Translational Sciences to formulate OPNT004, Grinobant, for human studies for acute cannabinoid overdose. We expect to complete this work in 2021. Regarding OPNT002, nasal naltrexone for alcohol use disorder, we paused the start of our planned phase two study due to the COVID-19 pandemic in Europe. The start of the study remains on pause, and we are assessing the optimal time to proceed. In March, we were pleased to welcome Season's Clinical Development Executive, Dr. Lorianne Masuoka, to our Board of Directors. Her extensive experience successfully expanding the depth and value of the development pipelines of several biotech companies will be incredibly valuable to Opium as we further advance our mission to develop new medicines for the potential treatment of addictions and drug overdose. With that, I will now turn the call over to David to discuss the finances. David.