Relmada Therapeutics, Inc.

Good afternoon. My name is Kathy and I'll be your conference operator for today. At this time, I would like to welcome everyone to the Ramada Therapeutics, Inc. third quarter 2022 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during that time, simply press the star followed by the one on your telephone keypad. If you'd like to withdraw your question, again, press star one. Thank you. And Brian, Richie, you may begin your conference.

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 Maga Chinada. This afternoon, RealMata issued a news release providing a business update announcing financial results for the three and nine months ended September 30th, 2022. and filed its quarterly report on Form 10Q with the SEC. 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 during this call that Romada's management team will be making forward-looking statements. Action 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 forwarded statements are qualified by the cautionary statements contained in Romada'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 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 November 10, 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 would like to turn the call over to Sergio. Sergio?

Thank you, Brian, as always, and good afternoon to everyone. I'm pleased to welcome you to the Realmada Third Quarter 2022 Conference Call. During today's call, I will provide an update on our ongoing late-stage reliance clinical development program for REL 1017, our lead product candidate that we are currently studying as a novel treatment for patients with major depressive disorder, or MDD. Following my comment, Megha Shenouda, our chief financial officer, will review our financial results and balance sheet, and we will then take your questions. 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 was the Phase III two-arm placebo-controlled registrational study evaluating REL 1017-25mg as a potential monotherapy treatment for MDD. We announced top-line results last month for Reliance III in which REL 1017 was administered for 28 days to 232 subjects. The study did not achieve the primary endpoint of a statistically significant improvement in depression symptoms compared to placebo as measured by the Montgomery-Asper Depression Rating Scale, or MADRIS, on day 28. In this study, the REL1017 treatment arm showed a moderate reduction of 14.8 points at day 28 versus 13.9 points for the placebo arm. This was in higher than expected placebo response. Paradoxical results were observed in certain study sites where placebo dramatically outperformed REL1017. To better understand the paradoxical results, a post-op exploratory analysis using the bandpass method, which excludes sites with implausibly high or low placebo response was conducted. In this study, an implausibly high or low placebo response was defined as a mean decrease from baseline in Madras 10 score greater than 14 and less than 3 points. The results of the bandpass analysis showed a meaningful difference between REL1017 and placebo greater than 4.9 points on the MRAS representing a p-value below 0.05. It's important to note that while we are pleased with this statistically significant difference seen using the bandpass method, we understand that this is not sufficient to be used as an FDA submission, and we may consider planning additional studies. I want to highlight that in Reliance III, REL 1017 demonstrated very favorable tolerability and safety, confirming the results of Phase I and Phase II studies, with no opioid-like effect, no withdrawal effect, and no cytokinetic effect. While we are currently further evaluating the data from Reliance III, we believe that the primary driver behind the study not being successful was the enrollment of subjects who are not truly suffering from MDD. and responded dramatically and rapidly to placebo. As an example of this, the top enrolling center had a mean change from baseline of 23 points in the placebo group. As we approach the top line readout for Reliance 1, expected before year end, it is important to note that the high enrolling center is in Reliance 3, also recruited significantly in Reliance 1. Mitigating that to some degree is the different patient population reliance one. That is patients that are enrolled and should already be diagnosed with depression and are not responding adequately to at least one and up to three courses of antidepressant therapy. We cannot predict how this factor will balance out. Looking further ahead, we intend to apply several protocol and operational changes in the current enrolling Reliance 2 study and make certain improvement to how the trial is being conducted. We now expect top-line results from this study next year. Once we have finalized and determined how to best execute on this enrollment, we will provide a firmer timeline for top-line results for Reliance 2. Moreover, In order to be proactive and increase the likelihood of clinical success for REL1017 as a potential therapy for MDD, an indication in which two successful studies are required to achieve FDA approval, we may consider initiating new clinical trials in 2023. As we apply key learnings from Reliance 3 to improve how Reliance 2 is being conducted going forward, we focused on the four key pillars that mainly impact the success of an MDD trial. the protocol, the site selection, the patient selection, and the rating process. We will integrate our key learnings in this area into the Reliance 2 study and any possible additional study we may consider. Now, let's move on to Reliance OLS, the long-term open-label safety study that is enrolled in both rollover participants for all three PIVAPA studies, as well as de novo participants. Reliance OLS is ongoing and continues to involve participant-as-planned. Data from this long-term open-label safety study, which we now expect in first half of 2023, will be part of the planned NDA filing package. Finally, I want to emphasize that Reliance 3 was a trial-execution failure, and we remind highly confident in the potential of Rel1017 to be a safe and effective new therapy for the sweet-net-to-MDD. It is important to note that we have the financial flexibility to continue advising Proud 1017 in the clinic due to our strong balance. Maggot will review our financial in detail shortly, but we ended the third quarter with cash, cash equivalent and short-term investment of approximately $124 million. With that, I will now turn the call over to Maggot for a review of the financial. Maggot, the stage is yours.