Relmada Therapeutics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Roamata Therapeutics Inc. first quarter 2022 earnings call. During the presentation, all participants will be in a listening mode. Afterwards, we will conduct a question and answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. If at any time during the conference you need to reach an operator, please press star 0. As a reminder, this conference is being recorded Thursday, May 5th, 2022. I would now like to turn the conference over to Tim McCarthy, LifeSite Advisors. Please go ahead.

Thank you, Ingrid, 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, Realmata issued a news release providing a business update announcing financial results for the three months ended March 31st, 2022, and filed its quarterly report on Form 10-Q with the SEC. Please note that certain information discussed on the call today is covered under the Safe Harbors Provision 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 30, 2021, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, May 5th, 2022. 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 I'm pleased to welcome you to the Realmada First Quarter 2022 Conference Call. During today's call, I will review our recently achieved milestones and the anticipated timelines associated with the multiple expected clinical trial readouts for REL 1017. That is our lead product candidate that we're currently developing as an adjunctive and monotherapy treatment for patients with major depressive disorder, or MTD. Following my comments, Maggot Shenoud, our Chief Financial Officer, will review our financial results and balance sheet, and we will take then your questions. As many of you know, we expect 2022 to be a catalyst switch year for Remark. We intend to generate REL 1017 clinical data readouts beginning mid-year for the ongoing Reliance Phase III trial. Specifically, we anticipated completing the enrollment of Reliance III the ongoing monotherapy registration of phase three trial, followed by top-line data readout by mid-year 2022, and followed by top-line results from Reliance 1 and Reliance 2 receptors. These anticipated timelines remain unchanged from prior guidance. As a reminder, Reliance I and Reliance II are two ongoing Phase III sister two-arm placebo-controlled pivotal studies evaluating REL 1017-25mg as a potential adjunctive treatment for MDD. Reliance III is the ongoing Phase III two-arm placebo-controlled registrational study evaluating REL 1017-25mg as a potential monotherapy treatment for MDD. All participants in the reliance trials take a loading dose on day one of 75 milligrams, that is three tablets of REL-1017. We made significant progress in advancing our development program. To this end, in February 2022, we reported top-line data from our second CAP, or Human Abuse Potential Study, which compared REL-1017 versus intravenous catalysis. Our first HAP study comparing REL1017 versus oxycodone was successfully completed in July 2021. Most importantly, the findings from these two HAP studies were consistent and confirmed the 2019 DEA statement on esmetadone that states that the D-isomer lacks significant respiratory depression action and addiction liability.