Relmada Therapeutics, Inc.

Good afternoon. Thank you for attending today's Ramada Therapeutics, Inc. First Quarter 2023 Earnings Call. My name is Forum, and I will be your moderator for today's call. All lines will remain muted during the presentation portion of the call, with an opportunity for questions and answers at the end. If you would like to ask a question, please press star 1 on your telephone keypad. It is now my pleasure to pass the conference over to our host, Tim McCarthy, from LifeSci Advisors. Mr. McCarthy, please proceed.

Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Sergio Traversa, Chief Medical Officer Dr. Cedric O'Gorman, and Chief Financial Officer Magid Shenouda. This afternoon, ROMADA issued a press release providing a business update announcing financial results for the three months ended March 31, 2023. Please note that certain information discussed in 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 filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, May 11, 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. I am pleased to welcome you to the REL MADA first quarter 2023 conference call. During today's call, we will provide an overview of our ongoing phase three program for REL 1017 in major depressive disorder. Cedric will provide a clinical review and update, and Magid will review our financial results and balance sheet. We will then take your questions. To begin, as we said on our last call, Based on the results from study 301, we intend to primarily focus on REL-1017 as an adjunctive treatment for major depressive disorder, or MDD. We have implemented clinical changes, critical changes to the ongoing study 302, a phase three two-arm placebo-controlled pivotal study, evaluating REL-1017 25 milligram, and we will initiate our new trial, study 304, for Adjunctive MDD. Our Study 302 protocol amendment was finalized and is now being implemented across all clinical sites. The new Study 304 protocol has been drafted and will be ready for study initiation by mid-2023. The full results for REL 1017 in Study 301 reinforce that the two most important drivers for study success are recruiting the appropriate patient with true MDD, and controlling for placebo response. REL1017, unlike the conventional monominergic antidepressant, acts by blocking the NMNDA receptor and correcting the consequences of dysregulated glutamatergic pathways believed to underlie the pathophysiology of MDD. It does not affect mood by altering neurotransmitter levels or independently of pathophysiologies. It is believed that REL1017 has no effect in the situation of depressed patients, so its efficacy signal is dependent on enrolling appropriate subjects with a true MDD pathophysiology and diagnosis into the trial. Since our last call, we have been focused on optimizing the design of our clinical trial for signal detection via the amendment of the study 302 protocol and via the drafting of a new streamlined study 304 protocol. Both resulting protocols have concentrated on recruiting appropriately diagnosed subjects, controlling placebo response, and enhancing signal detection. Additionally, we have been finalizing the selection of the preferred clinical sites and have been visiting these sites as we strengthen our relationship and collaboration with them on our clinical trials. I'm also pleased to report that the open-label one-year safety study for REL 1017, study 310, is concluding with all treatment visits completed and finally safely follow-up visits occurring in the next couple of weeks. Therefore, attaining the necessary long-term safety exposure required for the purpose of our NDA filing. We expect to release data from this study later this year. Before moving on to provide further detail on the clinical progress in our first quarter financial results, I would like to emphasize that RealMada is sufficiently funded to fully execute our plans to reach data readouts from both phase three trials. I will turn now the call over to Cedric, our chief medical officer, to go over the clinical progress in the quarter and provide an update on the plans moving forward. Cedric?