Relmada Therapeutics, Inc.

Ladies and gentlemen, and thank you for standing by. Welcome to the Relmada Therapeutics Incorporated first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Should you require operator assistance during the conference, please press star zero to signal an operator. Please note, this conference is being recorded. I will now turn the conference over to your host, Tim McCarthy with Lifestyle Advisors.

Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Dr. Sergio Traversa and Chief Accounting and Compliance Officer Chuck Ence. This afternoon, RealMata issued a news release providing a business update and announcing financial results for the first quarter ended March 31st, 2021. Please note that certain information discussed on the call today is covered under the safe harbor 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 statements contained in RealMata's press release issued today and the company's SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that is accurate only As of the date of this live broadcast, May 12th, 2021, RealMata 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 good afternoon to everyone. I'd like to welcome you to RealMata's first quarter 2021 conference call. Today's call will provide ...on the comprehensive development program for the treatment of depression, the L1017, and the upcoming milestones. I will turn the call again to our chief officer, and we're standing today for our magazine for a review of the data. By the chief of recent data, that we presented at three recent scientific conferences. With that, I'll begin with an update on RELIANCE, that is the ongoing program that consists of a third one, placebo-controlled pivotal studies, RELIANCE I and RELIANCE II, which includes 64 participants per study of 45,000. Reliance OLS that stands for Long-Term Open Label Safety Study that is enrolled in both rollover participants from the PIVOT studies as well as the novo participants. These studies are designed to evaluate REL 1017 as an adjunctive treatment for major depressive disorder, MPD, and includes SMART. and 25 milligrams of REL-1017. I just got somebody told me that I'm breaking up, so I'll try to switch. Now it should be better. And I was saying placebo and 25 milligrams of REL-1017, and both are on top of standard antidepressant treatment for participants. We have already unsuccessfully tried a minimum of one up to three antidepressant therapy. The primary endpoint is change in Madras score at day 28. Key secondary endpoints include change in Madras score at day seven and change in CGIS, the stage four severity, at the score at day 28. The first phase three trial, Reliance One, continues to enroll as expected, and additional sites are coming online nicely. In addition, we recently began enrolling participants into the second Phase III trial, Reliance II, which is a mirror study of Reliance I. Top-line data from these two trials are expected in the first half of next year. The Reliance long-term open-label safety study is also underway, and the rolling participant has planned. Reliance OLS will include both participants from the PIVA studies as well as the novel participants. The data for this long-term open-label safety study will be part of the NDA filing package. We remain on track to initiate the study, evaluating the use of REL 1017 as a monotherapy for NDD during the current quarter. At a very high level, the most significant difference between this trial and the ongoing clinical studies is the patient population. The patient population plan for MDD monotherapy study will consist of people who are diagnosed with depression and they are not currently taking standard antidepressant therapy. We anticipate the completion of this study by year end 2021. Moving on, I would now like to provide an update on the human abuse potential or the HAP studies. And as we discussed previously, we discontinued the study 120. that was assessing REL1017 versus oral ketamine as an active control. As part of a pre-planned blinded analysis of the initial study completers, it showed that a significant material group of participants did not respond to the active control ketamine, and so most likely this lack of response was due to the poor bioavailability of oral ketamine. And this would have resulted in non-conclusive findings, so we decided to stop it. And we are now working toward initiating a new ketamine control study. We call it Study 126, which will use as an active comparator intravenous IV ketamine that has an established history as an effective positive control. We plan to complete this study by year-end of this year, so end of The second HAP study, the ABUSE study, study 124, is comparing REL 1017 to OxyContin. It's progressing as planned, and we continue to expect to complete the study by end of the current quarter. These HAP studies are a standard component of the NDA submission for many CNS drugs, and will inform the assessment of REL 1017 for the scheduling. The app studies also represent an important opportunity to add to the existing very strong body of literature that clearly differentiates REL1017 from the parent drug, racemic methadone, and any potential perceived association with opioid effect or dissociative symptoms. I'm also happy to share the RELMADA just completed presentation of a total of nine posters over three different scientific congresses. I will provide a brief overview of the data for REL 1017 that we presented. However, before I do that, I will turn the call over to Chuck for his review of the financial. Chuck?