Relmada Therapeutics, Inc.

Greetings, and welcome to Ramada Therapeutics, Inc. Third Quarter 2021 Earnings Call. At this time, all participants are in 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, Tim McCarthy.

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 Accounting and Compliance Officer Chuck Entz. This afternoon, Ramada issued a news release providing a business update and announcing financial results for the three and nine months ended September 30th, 2021 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 provision of the Private Securities Litigation Reform Act. We caution listeners that During this call, Ramada'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 questionnaire statements contained in Ramada'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, 2020, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, November 11, 2021. 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'd like to turn the call over to Sergio. Sergio?

Thank you, Tim, and good afternoon to everyone. And we also have on the call today, Maggie Shenouda, that is our CFO on top of Jack Hance. And I'm pleased to welcome you to RealMada third quarter 2021 conference call. On today's call, I will provide an update on the comprehensive development program for our lead product candidate, REL 1017. for the Adjunctive and Monotherapy Treatment of Major Depression Disorder, or MDD, highlight the substantial market opportunity for this compelling product candidate, and review upcoming milestones. Following this, I will turn the call over to Margit Schnuder, Chief Financial Officer for Review of the Financials. I will then provide a brief overview of the data that we recently presented at the Neuroscience Education Institute Congress, Luskin. With that, I will begin by highlighting the point that we will have data readouts in each quarter of next year. I will elaborate further on this shortly, but in summary, in the first quarter of next year, 2022, we expect top-line results from our second human abuse potential or HAP study, this one assessing REL1017 versus intravenous ketamine. Following this, in the second quarter, we anticipate top-line data from Reliance 3, the ongoing monotherapy registration of Phase 3 trial. In the third and fourth quarter of 2022, we expect top-line results from Reliance 1 and Reliance 2, respectively, the two ongoing Phase 3 sister two-arm placebo-controlled Pivotal studies. With that, I would like now to reiterate the important development and regulatory update that we provided for REL 1017 last month. To begin with, the Reliance 3, which aims to randomize 364 patients, is expected to be completed in the second quarter of 2022, prior to the anticipated conclusion of Reliance 1 and Reliance 2, the adjunctive NDD studies, which I will discuss momentarily. This MBD monotherapy study is for individuals who are diagnosed with depression and are not currently taking standard antidepressant therapy. Importantly, conducting REL-3 as a phase 3 study may meaningfully reduce the time for a potential approval of REL-1017 as an MBD monotherapy. In addition, in order to support potential regulatory submission seeking approval for REL 1017 as a monotherapy as well as a junkie treatment, the FDA confirmed that based on what is known at this time, REL NADA will not be required to conduct a two-year carcinogenicity study of REL 1017 with an understanding that sufficient preclinical safety data has been generated to the The FDA also confirmed that RealMata does not need to conduct a TQT cardiac study in humans to support cardiac safety in a potential regulatory submission for REL 1017. The data provided to date, as well as the data to be generated from the Phase III program, will be adequate to evaluate and confirm the cardiac safety profile of REL 1017. Moving on. I will now provide an update of the ongoing Reliance 1 and Reliance 2 studies, each of which will include 364 participants per study across 55 sites as well per study. As a reminder, Reliance 1 and 2 are designed to evaluate REL1017 as an adjunctive treatment for MDD, and both include two arms, placebo and 25 milligrams of REL1017. both of which are in addition to a standard antidepressant treatment for participants who have had an inadequate response to a minimum of one and up to three standard antidepressant therapy. The clinical trial protocol remains unchanged, with the primary endpoints being change in Madras score at day 28, and key secondary endpoints include the change in Madras score at day seven and the change in clinical global impression severity score at day 28, the CGIS. Both Reliance 1 and Reliance 2 are progressing with top-line data expected in the second half of next year. The Reliance Development Program also includes Reliance OLS, a long-term open-label safety study that is enrolled in both rollover participants from all three PIVOTR studies, as well as the NOVA participants. Reliance OLS is ongoing and enrolling participants is planned. Data from this long-term open-label safety study will be part of the NDA filing package. As we look ahead to the key reliance clinical development program, the catalyst I outlined earlier, It is important to know that we are highly confident that we have more than sufficient power in our studies to demonstrate the desired effect and targeted decrease in MADRA score improvement. Of significance, while REL1017 demonstrated an eight-point improvement score to placebo in the Phase II trial. Moving on, our second PAP study evaluating REL1017 versus intravenous ketamine, which has an established as an effective positive control is ongoing. Based on the current rate of recruitment, we expect top-line results from this study in the first quarter of 2022. As a reminder, in the third quarter, we announced positive top-line results from our first HAP study, evaluating Weld 1017 versus oxycodone 40 milligrams as an active control. As we discussed this data at length on our last two investor calls, I won't go into too much detail here. However, I will reiterate that this study was designed in a manner that followed the FDA 2017 guidance on the assessment of the abuse potential of drugs. Topline results for the primary endpoint showed that all three doses of REL1017 evaluated in recreational opioid users demonstrated a highly statistically significant difference versus the active control drug oxycodone 40 mg. Notably, the highly statistically significant difference was confirmed between the active control and 150 mg of REL1017, which is the maximum tolerated dose and six times the proposed therapeutic dose. Other secondary endpoints, such as desire of taking the drug again, were consistent with those of the primary endpoint, demonstrated no evidence of any meaningful abuse potential. Importantly, these results are consistent with app study results that have been seen in other drugs that affect the CNS and which have been scheduled at classes four, five, or even unscheduled. I also wanted to take a moment to reaffirm the need for a new therapeutic option with the potential clinical profile than RAN1017 presents. Over 17 million individuals in the U.S. suffer from NPD, and the current options are limited in their ability to help these patients. Current antidepressant standards have significant side effects and can take up to four, six weeks to show efficacy. 65% of patients do not respond to their first antidepressant treatment, and 30% do not respond to any of the current available oral treatment. Furthermore, there are only three FDA-approved adjunctive treatments for major depression disorder, all of which are antipsychotic, which often can cause long-term serious side effects. It is evident that new treatment options are needed, and we believe the REL 1017 has the potential to make a difference for these patients and their caregivers. Is it a monotherapy or a junkie treatment? I will now pass the call over to Nagit for his review of financial, and we'll then touch on the recent poster presentation of the recently held Neuroscience Education Institute Conference. Please go ahead, Nagit.