Relmada Therapeutics, Inc.

Good afternoon, ladies and gentlemen, and welcome to the RealMata Therapeutics, Inc. third quarter 2023 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, November 8th, 2023. I would now like to turn the conference over to Tim McCarthy of LifeSci Advisors. 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 Sergio Traversa and Chief Financial Officer Maga Chinuda and Dr. Cedric O'Gorman, Chief Medical Officer. This afternoon, RealMata issued a press release providing a business update announcing financial results for the three and nine months ended September 30th, 2023. Please note that certain information discussed on the call today is covered under the Safe Harbors Provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, RealMata'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 RealMata'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 31, 2022, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, November 8th, 2023. 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 would like to turn the call over to Sergio. Sergio?

Thank you, Tim. As always, and good afternoon to everyone, and welcome to RealMata Third Quarter 2023 Conference Call. We have achieved some important clinical milestones recently in the ongoing Phase III program for REL 1017 in a major depressive disorder, MDD, as well as in our promising preclinical novel psilocybin program that I will briefly cover today. Following this, Magid will review the third quarter financial results, and then we will take your questions. Let's begin with an update on the Phase III program for REL 1017, which continues to proceed as planned. As a reminder, RealMata is focused on developing REL 1017 as an adjunctive treatment for MDD. As previously communicated, we have made critical changes to Reliance II, the ongoing Study 302, a Phase III two-arm placebo-controlled pivotal study evaluating REL 1017, 25 mg for adjunctive MDD. The amended 2D302 protocol has been implemented across all our clinical sites. Enrollment is progressing as we leverage our close relationship with the study sites and the number of ongoing initiatives to drive trial awareness with prospective patients. As a reminder, we are planning to enroll approximately 300 patients and continue to expect that Reliance 2 will be completed in the first half of 2024, most likely toward the end of the first half, so around mid-year. In the second phase 3 trial for REL 1017, named Relight or Study 304, we begin dosing patients during the third quarter. Relight also has a planned enrollment of approximately 300 patients. Completion of enrollment in this trial continues to be anticipated in the second half of 2024. To reiterate what we have said previously, like RELIANT-2, RELIANT is a randomized, double-blind, placebo-controlled four-week trial evaluating the efficacy and safety of REL1017 as an adjunctive treatment for MDD inpatient experiencing inadequate response to ongoing background antidepressant treatment. The primary endpoint of both studies is the same. The change in the Madras total score from baseline to day 28 for REL 1017 is compared to placebo. Also, during the third quarter, we announced efficacy and safety results from the open-label one-year safety study for REL 1017, study 310 or 310. These long-term safety exposure data are required for the purpose of the NDA filing. More specifically, in September, we shared efficacy results for the 204 de novo or new-to-treatment patients and safety results for all 627 study subjects. Study REL 1017-310310 was a long-term open-label, non-comparative open-label, registration of phase three trial design to evaluate the efficacy and safety of REL 1017 administered one daily in patient with MDD for up to one year. I will now reiterate some of the previously communicated results in the de novo patients. Rapid and sustained improvement in MADBRA score were observed in with REL1017 in the de novo patient and the entire study population. As the de novo patient reflects the more reliable picture of the real-world condition, I will highlight the de novo patient results. The mean Madras total score was 33.8 at baseline. Treatment with REL1017 in this patient resulted in mean improvement from baseline in the Madras total score of 16.8 points at month one, 19.9 points at month three and six, and 22.5 points at month 12. High rates of clinical response, both rapid and sustained, were seen in de novo patients. When treated with REL 1017 in the Madras total score at day seven, 26.6% of the de novo patients achieved the clinical response. That is defined as the greater than or equal to a 50% improvement in the MADRA score, which increased to 51% by month one and 77.2% by month 12. Virtual absence of depressing symptoms or clinical remission was achieved by 12.1% of the de novo patients at day 7, which increased to 30.1% at month 1, and then again 54.4% at month 12. Clinical remission is defined as the Madras total score of less than or equal to 10. Patients treated daily with REL1017 for up to one year experienced a rapid, clinically meaningful, and sustained improvement in depressive symptoms and associated functional impairment. Importantly, the overall madras change and response and remission results in study REL1017-310 for the de novo patient and the full analysis that were consistent in both groups. For all the REL1017-310 subjects, REL1017 was well-tolerated with long-term dosing, showing low rates of adverse events and discontinuation due to adverse events. No new safety signals were detected. Moving now to our promising preclinical novel modified release psilocybin program. At next week or this weekend, AASLD meeting, the new data will be presented in a poster presentation. The data demonstrate the beneficial effect of non-psychedelic low-dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver disease, or MASLD. As a reminder, they are not currently approved drugs for MAL-SMD. And these initial preclinical results support the therapeutic potential of non-psychedelic low-dose psilocybin. Based on this data, non-psychedelic low-dose psilocybin could improve lipid and glucose levels with potential for fewer side effects over other investigative treatment approaches, such as the GLP-1. We intend to initiate a single ascending dose phase one trial in obese patients with steatotic liver disease in early 2024 to define the pharmacokinetic safety and tolerability profile of our modified release psilocybin formulation in this population, followed by a phase two A trial in the same patient population to establish clinical approval concept.