Relmada Therapeutics, Inc.

Greetings and welcome to Ramada Therapeutics' fourth quarter and full year 2022 earnings conference call. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Excuse me, Mr. Tim McCarthy. Thank you. You may begin.

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, RealMata issued a news release providing a business update announcing financial results for the three and 12 months ended December 31st, 2022. Please note that certain information discussed on the call today is covered under the Safe Harbors provision of the Private Security 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 in the company's SEC filings, including the annual report on Form 10-K for the year ended December 31st, 2021, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, March 23rd, 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'm pleased to welcome you to the Ramada Fourth Quarter and Fulia 2022 Conference Call. We are coming off from a challenge in 2022, but we have learned a great deal from our completed studies and believe that these learnings better enable us to realize the potential of REL 1017 for the treatment of MDD. Following the availability of top-line results for REL 1017 in Reliance 1 or Study 301 in December 2022, we have spent the last three months analyzing these data and considering the appropriate next steps. As a reminder, Reliance 1 or Study 301 and Reliance 2 or Study 302 are two Phase III sister two-arm placebo-controlled pivotal studies evaluating REL 1017 at 25% milligrams is an adjunctive treatment for MDD. Study 302 is ongoing. We are confident that we have identified the key issues that led to the Phase III data in Study 301 differing from the positive results seen in Phase II. As such, we intend to focus on REL 1017 as an adjunctive treatment based on the data generated to date and market potential, and will initiate one new trial, Study 304, and implement clinical critical changes to the ongoing study 302. Our study 302 protocol amendment has been finalized and is ready to be implemented immediately. And our new study 304 protocol has been drafted and will be ready to initiate by mid-2023. I would like to emphasize that broadly, we have learned that the two most important drivers for a successful depression trial are recruiting the appropriate patients with MDD, and controlling the placebo response. It is proposed that REL1017, unlike conventional oral antidepressants, accepts its antidepressant effect by inhibiting and correcting the consequences of hyperactive glutaminergic pathways. It does not affect mood by altering neurotransmitter levels, and it is thought not to have therapeutic effect in the absence of underlying MDD pathophysiology, namely glutaminergic dysfunction. This suggests that the drug would therefore have no effect in the situationally depressed or in those without a true diagnosis of major depressive disorder. The efficacy signal of REL1017 in a clinical trial would therefore be expected to be reduced directly proportional to the percentage of inappropriate subjects enrolled in the trial. You will see from the data we are going to share with you today the impact that clinical trial subject quality had on drug outcomes. During today's call, Cedric, our new chief medical officer, will provide the key details for our analysis of Study 301 that generated many valuable insights which influenced our future planned REL 1017 clinical programs. He will then review the changes we are making to study 302, and we'll also be implementing in our new study 304. Following Cedric's comment, Nagar Shenouda, our chief financial officer, will review our financial results and balance sheet. But I will say that we are sufficiently funded to fully execute our plan to reach data readouts for both phase three trials. We will then take your questions. And I will now turn the call over to Cedric. Cedric? The stage is all yours.