Relmada Therapeutics, Inc.

Greetings and welcome to the Romada Therapeutics fourth quarter and full year 2021 earnings 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, Tim McCarthy of LifeSci Advisors. Thank you, Tim. You may begin.

Thank you, Paul, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Sergio Traversa and Chief Financial Officer Megan Shenouda. This afternoon, Realmata issued a news release providing a business update announcing financial results 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 provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Relmada's management team 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 Relmada's press release issued today and the company's SEC filings, including in the annual report on Form 10-K for the year ended December 30, 2020, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, March 23rd, 2022. Realmata 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 Sergio. Sergio?

Thank you, team, as always, and good afternoon to everyone. I'm pleased to welcome to the RealMada fourth quarter and full year 2021 conference call. During today's call, I will review our recently achieved milestones and provide an update on anticipated clinical trial readouts timeline for REL 1017, our lead product candidate that we are currently studying as an adjunctive treatment and monotherapy for patients with major depression disorder or MTT. Following my comments, Maggie Chinuda, our chief financial officer, will review the financial results and recently strengthened the power sheet, and we will then take your questions. Looking ahead, we expect 2022 to be a catalyst-rich year for RealMada. We kicked off 2022 by reporting top-line results from the second Human Abuse Potential, or HAP, study, which I will recap shortly. we intend to generate REL 1017 clinical data readout beginning mid-year for the ongoing Reliance Phase 3 trial. We anticipate completing the enrollment of Reliance 3, the ongoing monotherapy registration of Phase 3 trial, followed by top-line data readout by mid-year 2022. In the third and fourth quarter of this year, we expect top-line results from Reliance 1 and Reliance 2, respectively. These are two ongoing phase 3 sister, two-arm placebo-controlled pivotal studies evaluating REL-1017 as a potential adjunctive treatment for MDD. The goal of this comprehensive development program is to address the significant need for a new therapeutic option to the 17 million individuals in the U.S. who suffer from MDD. The current antidepressant therapies have significant limitations, in terms of efficacy. They can take up to four to six weeks to show any effect. Up to 65% of patients do not respond to their frontline antidepressant treatment, and up to 40% of patients take combination therapy. Furthermore, there are only three FDA-approved adjunctive treatments for MDD, all of which are antipsychotic. which offer limited efficacy and can cause long-term side effects. It is evident that new treatment options are needed, and we believe REL1017 has the potential to be a safe and effective option for these patients and their caregivers as a monotherapy and adjunctive treatment. We made significant progress in advancing our development program. To this end, In February, we reported positive top-line data from our second HAP study, which compared REL1017 versus intravenous ketone. As a reminder, our first HAP study comparing REL1017 versus Oxycodone was completed in July 2021 and presented in a poster presentation late last year at the 60th Annual Meeting of the American College of Neuropsychopharmacology. Both studies were designed in accordance with the FDA 2017 abuse potential guidance and the 2022 clinical and regulatory standards by incorporating extensive input from FDA staff on the measures and the comparators on trial design. While we went into extensive detail during our February investor call on the ketamine study results, I would like to recap just the main findings. The primary endpoint, as is typical in these studies, was a drug-like score comparison of three doses of REL-1017 to ketamine. Ketamine dose at 0.5 milligrams per kilogram in Perinos administers over 40 minutes. The three doses of REL-1017 were the same as in the oxycodone study that we presented last year. and they were the 25 milligrams, the therapeutic dose, the 75 milligrams, which is three times the therapeutic dose, and 150 milligrams, which is six times the therapeutic dose, and this is the maximum tolerated dose. 51 subjects completed all arms of the study. The FDA guidance on abuse potential trials details that the statistical analysis should be based on data from participants who complete the study, the all-completed population. Data based on the all-completed population for both of the HAB studies showed a statistically significant difference from ketamine and oxycodone at all tested doses of REL1017, and they were statistically equivalent to placebo at all tested doses of REL1017. In summary, the finding of these two HAB studies are consistent with the 2019 DA statement on S-methadone that states that the D-isomer lacks significant respiratory depressant action and addiction liability. The results of the oxycodone and ketamine HAP study also confirm and support the previous data published regarding the potential for abuse of REL1017. We believe that the oxycodone comparative data significantly derisks the Schedule 2 potential for REL1017, and that the ketamine comparison data significantly derisks the drug Schedule 3 potential. Collectively, the data generated today from our REL1017 program indicates that REL1017 could be proposed as a Schedule 5 drug, and eventually non-scheduled following one or two years of marketing. In order to support the regulatory, potential regulatory submission seeking approval for REN1017 as a monotherapy, as well as adjunctive treatment, the FDA confirmed that based on what is known at this time, RealMada will not be required to conduct a two-year carcinogenicity carcinogenesis initiative study of REN1017 with an understanding that sufficient preclinical safety data have been generated today. The FDA also confirmed that Realmada does not need to conduct a TQT cardiac study in humans to support cardiac safety in a potential regulatory submission for REL 1070. The data provided to date, as well as the data to be generated from the ongoing Phase III program, would be adequate to evaluate and confirm the cardiac safety of REL 1070. Moving on to the Phase III program, we anticipate the completion of enrollment of Reliance III, the ongoing monotherapy registration of Phase III trial, followed by a top-line data readout by media. Reliance III aims to randomize up to 364 patients, and is targeted for individuals who are diagnosed with depression and unrecorded taking standard antidepressant therapy. Importantly, This is prior to the anticipated conclusion of Reliance I and Reliance II, the adjunctive MDD studies, which I will discuss momentarily. As a reminder, conducting Reliance III as a Phase III study could meaningfully reduce the time for a potential approval of REL 1017 as an MDD monotherapy. Let me now provide an update on the ongoing Reliance I and Reliance II studies, each of which is designed to include up to 364 participants per study across 55 sites per study. As a reminder, Reliance I and Reliance II are designed to evaluate REL1017 as an adjunctive treatment for MDD, and both include two arms, placebo and 25 milligrams of REL1017. Both arms are studying the use of Relatin-17 in addition to a standard antidepressant for participants who have had inadequate response to at least one and up to three standard antidepressant therapies. The primary endpoint is the change in Madras score at day 28. Key secondary endpoints include the change in Madras score at day seven and change in clinical global impression severity scale, the CGIS score at day 28. Day 28 was chosen as the primary endpoint in agreement with the FDA with an understanding that depression is a chronic disease and that day 28 would support REL 1017 as a chronic treatment. Both Reliance 1 and Reliance 2 are progressing with top-line data expected in the second half of this year. The Reliance Development Programs also includes the Reliance OLS, the Long-Term Open Label Safety Study, that is enrolling both rollover participants for all three pivotal studies, as well as the NOVA participants. Reliance OLS is ongoing and enrolling participants as planned. Data from this Long-Term Open Label Safety Study will be part of the planned NDA filing package. I would also like to add that the recent pre-planned interim safety analysis conducted on a periodic base by an independent data monitoring committee, the IDMC, confirmed the lack of safety signals and concluded with the recommendation for the studies to proceed as planned. This analysis reviewed data from all of the ongoing reliance trials, including the open-label safety studies. I would like to highlight that the Phase II data were published in the peer-reviewed American Journal of Psychiatry. It's the most widely read psychiatry journal in the world, late in 2021. The manuscript for the details, finding that from the Phase II study assessing REL1017 as a junkie treatment for NDD. The primary endpoint demonstrated B, RAPID. significant and sustained efficacy versus placebo REL 1017. As our robust REL 1017 development program continues to advance expeditiously, we continue to be supported by a strong balance sheet, which was further enhanced by the successful oversubscribed follow-on offering that closed in the fourth quarter of last year and generated gross proceeds of $172.5 million. With that, I will turn now the call to Maggot for review of the financial, including further details on the completed public offer. Maggot, the stage is yours.