Relmada Therapeutics, Inc.

Greetings and welcome to RealMada Therapeutics Inc.' 's second quarter 2023 EARNS conference 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 operations assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Tim McCarthy, LifeSite Advisors. Please, Mr. Ching, 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 Magid Shenouda and Dr. Cedric O'Gorman, Chief Medical Officer. This afternoon, Elmada issued a press release providing a business update announcing financial results for the three and six months ended June 30th, 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 31, 2022 and subsequent violence. This conference call also contains time sensitive information that is accurate only as of the day of this live broadcast, August 8, 2023. 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 would like to turn the call over to Sergio. Sergio.

Thank you, Tim, as always, and good afternoon to everyone, and welcome to the REL MADA second quarter 2023 conference call. I am pleased to report today that the ongoing phase three program for REL 1017 in major depressive disorder, or MDD, is proceeding as planned. I will first provide with you a brief update, followed by Maggie's review of our second quarter financial results, and then we will take your questions. As a reminder, REMADA is focused on developing REL1017 as an adjunctive treatment for MDD. As previously communicated, we have made critical changes to RELIASU, the ongoing 302, a phase 3, two-arm placebo-controlled pivotal study evaluating REL1017 at 25 milligrams for adjunctive MDD. The amended study 302 protocol continues to be implemented across all our clinical sites. The protocol amendment had significantly lessened the burden to both subject and site by reducing required time spent by subject at the site. This was achieved by removing duplicative assessment and evaluation that were of exploratory interest. The amended protocol leverages our learning from the completed control control trials from the Reliance Development Program and optimizes the potential for reduction in the high placebo response seen in these completed studies. As enrollment continues over the next several months, we will keep you updated on the trial progress. We are planning to enroll approximately 300 patients and currently expect that Reliance 2 Study 302 to be completed in the first half of 2024. Screening has commenced for the newly-initiated trial, study 304, which we named RE-LITE, that also has a planned enrollment of approximately 300 patients. Completion of this study is currently anticipated in the second half of 2024. Like Reliance 2, RE-LITE is a randomized, double-blind, placebo-controlled four-week trial evaluating the efficacy and safety of REL-1017 as an adjunctive treatment of MDD in patients 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 as compared to placebo. has been designed to reduce the time spent at the sites and emphasize the quality of patient enrollment. We recently had successful investigator meetings with participating sites for both Phase III studies. During the investigator meetings, our team focused on providing intensive training on topics including appropriate subject enrollment, data quality, and strategies for controlling placebo response, and rater training. The open-label one-year safety study for REL 1017, study 310, has concluded with the attainment of the necessary long-term safety exposure required for the purpose of the MDA filing, and we expect this data to be available during the current quarter. As we continue to execute on the Phase III clinical development plan for REL 1017, we also remain focused on further enhancing the plethora of published and presented data in support of our late-stage product candidate. To this end, we will have a significant presence at several important scientific congresses over the next few months, including the presentation of multiple posters. We expect to present two posters at the 36th Annual ECMP Congress in October in Barcelona, among other scientific conferences in the second half of 2023. In addition, REL 1017 human abuse potential data were recently published in the peer-reviewed journal Translational Psychiatrists. Moving on, Maggot will provide a detailed review of our financial, but I would like to emphasize that RealMada remains sufficiently funded to fully execute our plans to reach data readouts for both Phase 3 trials, Reliance 2 and Reliance. I will now turn the call over to Magid to review our second quarter financial results. Magid?