Relmada Therapeutics, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Ramada Therapeutics Inc. 4th Quarter and Full Year 2022 Results Call. At this time, all lines are in a lesson-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 0 for the operator. This call is being recorded on Tuesday, March 19, 2024. I would now like to turn the conference over to Mr. Tim McCarty. Thank you. 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 Maggie Shenouda. This afternoon, Realmada issued a press release providing a business update announcing financial results for the three and 12 months ended December 31, 2023. 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, 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 31st, 2023, and subsequent violence. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, March 19th, 2024. Realmada 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, Tim, as always. Good afternoon to everyone, and welcome to the RealMata fourth quarter and full year 2023 conference call. We are continuing to make solid progress in advancing the ongoing phase three program for REL 10-17 in major depressive disorder, or MDD, as well as in the promising preclinical novel psilocybin program, all of which I will briefly cover today. Following this, Magid will review of our four-quarter and full-year 2023 financial results, and then we will take your questions. Let's begin with an update on the Phase 3 program for REL 1017. As you know, Realmada is focused on developing REL 1017 as an adjunctive treatment for MDD. As previously communicated, we have made critical changes to Reliance 2, the ongoing study 302, a phase 3 two-arm placebo-controlled pivotal study evaluating REL1017 25 milligrams for adjunctive NDD aimed at controlling placebo response and improving the enrollment quality. The amendment study 302 protocol has been implemented across all our clinical sites. Enrollment continues to steadily progress, and our ability to leverage our close relationship with the study site is paying dividends. Moreover, the ongoing initiative we put in place to drive trial awareness with prospective patients are also bearing fruit. Importantly, we are evaluating the productivity of sites on a real-time basis and making changes where needed. As a reminder, we plan to enroll approximately 300 patients into Reliance II. Based on our current projection, we expect the enrollment into Reliance II to be completed in mid-2024. In our second Phase III trial for REL 1017, named Relight or Study 304, we begin those inpatients during the third quarter of last year. Relight also has a planned enrollment of approximately 300 patients, that is planned to be completed by the end of 2024. To reiterate what we have said previously, like Relias II, Relias is a randomized, double-blind, placebo-controlled, four-week trial evaluating the efficacy and safety of REL1017 as an adjunctive treatment for MDD in patients experiencing inadequate response to ongoing background antidepressant treatment. The primary endpoint of both studies is the same, is the change in the Madras total score from baseline to day 28 as compared to placebo. I should highlight that we made significant changes to our screening and enrollment processes in order to ensure that we have patients that meet all the quality criteria. More specifically, we have instituted a comprehensive adjudication process through which we now require medical records for all patients enrolled in Reliance 2 and Reliance. Given this, our screen failure rate in these studies is now approximately 80% versus 50% previously in Reliance 1 and Reliance 3, our previously completed Phase 3 trial for REL 1017. We strongly believe that these changes will significantly enhance the probability of success of our current studies. Of note, We have completed all the necessary preclinical manufacturing and phase one studies required for a potential REL 1017-NDA filing, and are now focused on execution of various precommercial readiness activities. Moving now to our promising preclinical novel, modified release silo-typing program. You may recall that at last November, AASLD meeting, the liver conference, compelling preclinical data were presented in a poster presentation. These data demonstrated the beneficial effect of low chronic dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction associated steatotic liver disease, or MASLD. These initial promising preclinical results support the therapeutic potential of low chronic dose of psilocybin. As we said previously, based on this data, low dose psilocybin could improve lipids and glucose with potential fewer side effects over other investigative treatment approaches such as GLP-1, glucosol, and GIP. We intend... to initiate a single ascending dose phase one trial in obese patients in the first half of 2024 to define the pharmacokinetic safety and tolerability profiles for our modified release psilocybin formulation in this population. This will be followed by a phase two A trial to establish critical proof of concept. Data from the Plan 2A study is anticipated in the first half of next year. Just to summarize our multiple upcoming key milestones over the next 12 to 18 months, we anticipate completing enrollment in the ongoing Reliance 2 study mid-2024, with top line in the second half. In addition, we plan to complete enrollment in the Reliance study by the end of this year. We intend to initiate a Phase I clinical trial for the modified release formulation of psilocybin in the first half of this year. Moving on, while MAGA will provide a detailed review of our financial, I would like to emphasize that with current cash on hand to take us into 2025. RealMada remains sufficiently funded to fully execute our plans to reach data reach-outs from both REL 1017 Phase 3 trials, Reliant 2 and Reliant, as well as conduct the planned Phase 1 for our modified-release psilocybin formulation. I will now turn the call over to Magid to review our fourth quarter and full-year financial results. Magid.