Relmada Therapeutics, Inc.

Greetings. Welcome to the Realmata Therapeutics Incorporated fourth quarter and full year 2020 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. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the call over to your host, Tim McCarthy. Please go ahead.

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, Chief Financial Officer, Maggot Shenouda, 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 fourth quarter and full year ended December 31st, 2020. 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, RealMotto'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 RealMotto'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, March 23rd, 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. I'm very pleased to welcome you to Ramada's first ever earning conference call. We do believe that the company has reached a maturity time that is a good time, a right time to have a call. And since we expect a significant number of near-term catalysts moving forward, we intend to host update calls on a quarterly basis. The plan for today, because this is our first earning call, and some of the people connected may not be very familiar with the company. I will begin with a brief overview of RealMada, our promising lead product candidate for the adjunctive treatment of depression, REL 1017, and the large market opportunity that we are targeting. I will then turn the call over to Megan for his review of our financials, and after that, I will provide an update on our most recent accomplishment and review of upcoming milestones and do my best to leave as much time as possible for your questions. As a brief background on how we arrived at this critical point in our corporate evolution, Ramada is a late stage central nervous system CNS company. focus on the development of REL 1017, which has the potential to address the significant medical needs of major depression disorder, MDD. There are about 17 or more million people in the U.S. They are affected by MDD, and they have limited safe and effective therapeutic options. A standard antidepressant can take up to four to six weeks to show efficacy. And up to 65% of the patients do not respond or do not respond well to their first antidepressant treatment. And there are about 30% of the patients that don't respond up to four different antidepressant treatments. REL1017 is being developed as a new chemical entity. It's already administered as a once-daily pill. We have patent protection up to 2033 with additional patent files that could extend the exclusivity to 2038 and beyond. We have over 50 issued and filed patents for REL 1017 and fast track designation for the adjunctive treatment of MDD. So based on the novel mechanism of action and phase two data that showed statistically significant rapid and sustained antidepressant effect with a favorable safety and tolerability profile, we do believe that REL-1017 has the potential to be the first FDA-approved antidepressant for the adjunctive treatment of MDD. In the Phase II study, REL-1017 achieves statistically significant significance compared to placebo on all evaluated efficacy measures. Specifically, there was solid effects we observed on the Madras scale, that is a well-established measure of the severity of depression, with p-value below 0.03, and the large effect size, 0.7 up to 1, from day 4 to day 14. The extended efficacy up to 14 days was well beyond the seven days of dosing in the study, and it may suggest a potential neuroplastic and synaptogenic effect. Very importantly, there were no notable adverse events observed in the trial, with no evidence of treatment-induced dissociative psychotomimetic or opioid withdrawal symptoms. In December last year, we initiated Reliance I, that is the first trial in our Phase III program of REL 1017 for the adjunctive treatment of depression. I will review the ongoing phase three program and discuss the upcoming milestone shortly. But before I do that, I will turn the call over to Magid, who is the view of the financial. Magid is all yours.