Relmada Therapeutics, Inc.

Thanks for having me.

Thank you, Operator, and thank you all for joining us this afternoon. With me on today's call are Dr. Sergio Traversa, Chief Executive Officer, and Megan Shenouda, Chief Financial Officer. This afternoon, Ramada issued a press release providing a business update announcing financial results for the quarter ended June 30, 2024. Please note that certain information discussed on the call today is covered under the Safe Harbor's provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, Ramada'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 Ramada'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, 2023, and with subsequent filings, including the second quarter 2024 10-Q filed after the close today. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on August 7, 2024. Ramada 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, and thanks to everyone for taking time to join us this afternoon. Bermuda is dedicated to the development of transformative medicine for people living with central nervous system disorder. And I'm pleased to report that Bermuda's clinical program has made meaningful progress over the last five months. We believe that the portfolio led by the Phase III program for REL 1017 as a potential adjunctive treatment for major depressive disorder, or MDD, is poised to reach several important milestones. And we are encouraged by the company's progress. As a quick reminder, REL1017 is a small molecule that preferentially blocks a hyperactive brain channel called NMNDA receptor that is associated with MDT. REL1017 has been designed to rapidly improve symptoms and provide these patients with new treatment options on top of their current regimen. Completing the Phase III program for REL 1017 is RealMata's number one objective, and it will complete the study package required to file the NDA. During today's call, we will discuss the planned interim analysis, planned by year-end 2024, for the Reliance II study, review the timing to complete enrollment in the two Phase III studies in the REL 1017 program, outline timing to initiate a Phase I study for VAPA proprietary psilocybin program, RELP11, in development for metabolic diseases, and comment on our cash balance, which we expect to support our planned operation into 2025 and several key clinical milestones, especially for the RELP1017 program. I'll briefly review our program. And in a few minutes, Margaret will provide you with a summary of our second quarter financial. After that, I will make a few closing remarks, and then we will open the call for your questions. Starting with REL 1017. We are enrolling two pivotal phase three studies for REL 1017, Reliance 2 and Relight. These studies built on positive phase two data with REL 1017 for the adjunctive treatment of depression. Our clinical data set also demonstrated that REL1017 is well tolerated with no indication of abuse potential. Our ongoing Phase III studies are designed to assess the impact of REL1017 of the MADRA score as an indicator of depression severity. The studies are evaluating REL1017 in patients with documented clinical depression undergoing treatment with an approved antidepressant. Each of the ongoing studies, Reliance 2 and Relight, is enrolling up to 340 subjects. The studies are randomized one-to-one and designed and powered to detect two 2.5-point delta in the Madras score at day 28. The protocols have been thoughtfully designed to incorporate several elements intended to de-risk each study with a thorough patient adjudication process. As a snapshot, the features that we have emphasized in the Reliance 2 and Relight studies are focused on optimizing the protocol, carefully selecting study sites and monitoring the number of patients per site, and most importantly, carefully verifying the diagnosis of depression and each patient's medical history to ensure enrollment of patients with clinical depression. We have been especially focused on defining the patient enrollment criteria with extra care. The current protocols include a review of medical and pharmacy records. The studies also require that patients have been treated with an approved antidepressant for at least six weeks and have experienced an improvement of less than 50% since starting treatment. Adoption of these elements has increased our confidence that we are appropriately enrolling the most suitable patients into Reliance 2 and Reliant. As a result of these efforts, changing in the screen failure rate can be considered one way to assess the stringency of the enhanced enrollment criteria. As of today, we are observing an approximately 80% screen failure rate versus a 50% screen failure in the Reliance 1 studies. We intend to reach two important milestones by end of the year, reporting the output of a pre-planned interim analysis and completion of enrollment of Reliance 2. We expect completion of enrollment in real life to follow approximately six months after that. The pre-planned interim analysis of Reliance 2 study is intended to be a de-risking tool to increase the probability of a successful study outcome. The analysis will include a futility analysis and a sample size re-estimation, if necessary, with the potential to adjust the sample size to ensure proper statistical powering. There are three potential outcomes from the interim analysis. The study is futile, the study can continue with the addition of a certain number of patients, and the study can continue with the pre-planned number of patients. That, of course, is what would be our preferred outcome. We will conduct the interim analysis and expect to report the outcome of this analysis before year-end 2024. Now, I would like to spend a few moments on RELP11. We identified the metabolic activity of RELP11 as part of a preclinical evaluation on its potential effect on neurodegenerative disease. As a quick reminder, RAUP11 is a low-dose, modified-release formulation of psilocybin. Compelling data from a recognized preclinical rodent model of metabolic dysfunction-associated steatotic liver disease, or MASLD, published last year in November at the American Association for the Study of Liver Disease, is the cornerstone of our program. This data showed that RELP11 has a benefit on multiple metabolic parameters, including triglyceride levels and glucose metabolism. Besides reducing steatosis of the liver, RELP11 reduced blood, glucose, and body weight without producing any side effects on the CNS. This data led to our evaluation of P11 as a candidate for the treatment of metabolic disorders such as obesity. We plan to initiate a Phase I single-accent dosing, or SAD, study in this subject for RELP11 shortly. The Phase I study will define the pharmacokinetic safety and tolerability profile for RELP11 and allow us to select a dose for evaluation in the Phase IIa proof-of-concept study. We expect to complete the Phase I SAD study and initiated Phase 2A study in H1, first half of 2025. Now, I would like to turn the call over to our Chief Financial Officer, Maga Shenouda, to review our recent financial results.