Good afternoon, ladies and gentlemen, and welcome to the Relmada Therapeutics Inc. third quarter 2023 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. This call is being recorded on Wednesday, November 8, 2023. I would now like to turn the conference over to Tim McCarthy of LifeSci Advisors. 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, Sergio Traversa, and Chief Financial Officer, Maged Shenouda, and Dr. Cedric O'Gorman, Chief Medical Officer. This afternoon, Relmada issued a press release providing a business update, announcing financial results for the three and nine months ended September 30, 2023. 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, Relmada'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 Relmada'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 31, 2022, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, November 8, 2023. Relmada 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 call, turn the call over to Sergio. Sergio? Thank you, Tim, as always, and good afternoon to everyone, and welcome to Relmada third quarter 2023 conference call. We have achieved some important clinical milestone recently in the ongoing phase III program for REL-1017 in major depressive disorder, MDD, as well as in our promising preclinical novel psilocybin program that I will briefly cover today. Following this, Maged will review the third quarter financial results, and then we will take your questions. Let's begin with an update on the phase III program for REL-1017, which continues to proceed as planned. As a reminder, Relmada is focused on developing REL-1017 as an adjunctive treatment for MDD. As previously communicated, we have made critical changes to RELIANCE II, the ongoing study 302, a phase III, two-arm, placebo-controlled pivotal study evaluating REL-1017 25 mg for adjunctive MDD. The amended Study 302 protocol has been implemented across all our clinical sites. Enrollment is progressing as we leverage our close relationship with the study sites and the number of ongoing initiatives to drive trial awareness with prospective patients. As a reminder, we are planning to enroll approximately 300 patients and continue to expect that RELIANCE II will be completed in the first half of 2024, most likely toward the end of the first half, so around mid-year. In the second phase III trial for REL-1017, named RELIGHT or Study 304, we begin dosing patients during the third quarter. RELIGHT also has a planned enrollment of approximately 300 patients. Completion of enrollment in this trial continues to be anticipated in the second half of 2024. To reiterate what we have said previously, like RELIANCE II, RELIGHT is a randomized, double-blind, placebo-controlled, four-week trial evaluating the efficacy and safety of REL-1017 as an adjunctive treatment for MDD in patients experiencing inadequate response to ongoing background antidepressant treatment. The primary endpoint of both studies is the same: the change in the MADRS total score from baseline to Day 28 for REL-1017 as compared to placebo. Also, during the third quarter, we announced efficacy and safety results from the open-label one-year safety study for REL-1017, the Study 310. These long-term safety exposure data are required for the purpose of the NDA filing. More specifically, in September, we shared efficacy result for the 204 de novo or new to treatment patients, and safety results for all 627 study subjects. Study REL-1017 310, 310, was a long-term, open-label, non-comparative open-label, registrational phase III trial designed to evaluate the efficacy and safety of REL-1017, administered once daily in patients with MDD for up to one year. I will now reiterate some of the previously communicated results in the de novo patients. Rapid and sustained improvement in MADRS score were observed with REL-1017 in the de novo patient and the entire study population. As the de novo patient reflect a more reliable picture of the real-world condition, I will highlight the de novo patient results. The mean MADRS score, total score was 33.8 at baseline. Treatment with REL-1017 in this patient resulted in mean improvement from baseline in the MADRS total score of 16.8 points at month one, 19.9 points at month three and six, and 22.5 points at month 12. High rates of clinical response, both rapid and sustained, were seen in de novo patients. When treated with REL-1017 in the MADRS total score at day seven, 26.6% of the de novo patients achieved clinical response. That is defined as the greater than or equal to a 50% improvement in the MADRS score, which increased to 51% by month one and 77.2% by month 12. Virtual absence of depressive symptoms or clinical remission was achieved by 12.1% of the de novo patients at day seven, which increased to 30.1% at month one, and then again, 54.4% at month 12. Clinical remission is defined as a MADRS total score of less than or equal to 10. In summary, patients treated daily with REL-1017 for up to one year experienced a rapid, clinically meaningful, and sustained improvement in depression symptoms and associated functional impairment. Importantly, the overall MADRS change and response and remission results in study REL-1017-310 for the de novo patient and the full analysis set were consistent in both groups. For all the REL-1017-310 subjects, REL-1017 was well tolerated with long-term dosing, showing low rates of adverse events and discontinuation due to adverse events. No new safety signals were detected. Moving now to our promising preclinical novel modified release psilocybin program. At next week or this weekend, AASLD meeting, the new data will be presented in a poster presentation. The data demonstrate the beneficial effect of non-psychedelic, low-dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated steatotic liver disease, or MASLD. As a reminder, there are not currently approved drugs for MASLD, and these initial preclinical results support the therapeutic potential of non-psychedelic, low-dose psilocybin. Based on this data, non-psychedelic, low-dose psilocybin could improve lipid and glucose levels, with potential for fewer side effects over other investigative treatment approaches, such as the GLP-1s. We intend to initiate a single-ascending dose phase I trial in obese patients with steatotic liver disease in early 2024 to define the pharmacokinetic safety and tolerability profile of our modified-release psilocybin formulation in this population, followed by a phase IIa trial in the same patient population to establish clinical proof of concept. Moving on, Maged will provide a detailed review of our financials. But I would like to emphasize that Relmada remains sufficiently funded to fully execute our plans to reach data readouts for both REL-1017 phase III trials, RELIANCE II and RELIANCE III. I will now turn the call over to Maged to review our second quarter financial results. Maged? Sure. Thank you, Sergio. Today, we issued a press release announcing our business and financial results for the three and nine months ended September 30, 2023, which I will now review. For the third quarter ended September 30, 2023, total research and development expense was approximately $10.5 million, as compared to $30.5 million for the comparable period of 2022, a decrease of approximately $20 million. The decrease was primarily associated with the completion of RELIANCE I, that's Study 301, and RELIANCE III, Study 303, in late 2022. The non-cash charge related stock-based compensation totaled $1.7 million in the most recently completed third quarter. Total general and administrative expense for the third quarter ended September 30, 2023, was approximately $12.2 million, as compared to $8.2 million for the comparable period of 2022, an increase of approximately $4 million. The increase was primarily driven by an increase in stock-based compensation. This non-cash charge totaled $9.6 million in the most recently completed third quarter. Net cash used in operating activities for the three months ended September 30, 2023, totaled $11.6 million, compared to $26.9 million for the three months ended September 30, 2022. For the third quarter ended September 30, 2023, the net loss was $22 million, or $0.73 per basic and diluted share, compared with a net loss of $39.4 million and $1.31 per basic and diluted share in the comparable period of 2022. Turning to the results for the nine months ended September 30, 2023. Total research and development expense was approximately $40.1 million, as compared to $86.5 million for the comparable period of 2022, a decrease of approximately $46.4 million. Again, the decrease was primarily associated with the completion of RELIANCE I, Study 301, and RELIANCE III, Study 303 in late 2022. The non-cash charge related to stock-based compensation totaled $5.5 million in the most recently completed nine-month period. For the nine months ended September 30, 2023, total general and administrative expense was approximately $36.8 million, as compared to $36.1 million for the comparable period of 2022, an increase of approximately $700,000. The increase was primarily driven by an increase in stock-based compensation. This non-cash charge totaled $28.5 million in the most recently completed nine-month period. Net cash used in operating activities for the nine months ended September 30, 2023, totaled $41.4 million, compared to $67.9 million for the nine months ended September 30, 2022. For the nine months ended September 30, 2023, net loss was approximately $73.6 million, or $2.45 per basic and diluted share, compared to a net loss of $119.1 million, or $4.04 per basic and diluted share in the comparable period of 2022. As of September 30, 2023, we had cash, cash equivalents, and short-term investments of approximately $106.3 million, compared to approximately $148.3 million as of December 31, 2022. Again, cash used in operations for the third quarter was $11.6 million. Based on our clinical development plan, our current cash position provides us with ample runway through the end of 2024. Of note, this time period, as Sergio mentioned, includes data readouts from both phase III trials, Reliance II, that's Study 302, and RELIGHT, that's Study 304, as well as the initiation of our planned phase I trial for our modified release psilocybin formulation. I'll turn the call over now to the operator. Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star, followed by one on your touch tone phone. You will hear a three-tone prompt acknowledging your request, and your questions will be polled in the order they are received. Should you wish to decline from the polling process, please press star followed by two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Marc Goodman, Leerink Partners. Marc, please go ahead. Hi, good afternoon. This is Basma for Mark. Congratulations on the quarter, and I have a question regarding the RELIANCE-OLS study. Was this study conducted at the same site as RELIANCE I and RELIANCE III? And I also have a question about the MDD, RELIANCE I and RELIANCE III, regarding the patient characteristics. Can you remind us again about the average age of the participants after you looked at the data, after you blinded the data? And have you noticed any correlation between the inaccurate diagnosis of MDD and the age of the participants? Thank you. Great. Well, thanks for the question. I do believe that Cedric, our Chief Medical Officer, is the most appropriate to address them. Cedric? Yes, thanks, Sergio, and thanks for the question. So yes, as is very common, when you have controlled trials, you also have an open label extension trial that's offered. So therefore, yes, the sites that were part of RELIANCE I and RELIANCE III also had the opportunity to be part of the open label study and contribute subjects to that long-term study. Remember, there was a question then about the average age, and, you know, these studies are run in adults 18 to 65 years of age. And of course, you know that major depressive disorder is represented at a two-one ratio in females than males. We haven't looked at, you know, age breakdown. There's lots of interesting analysis that we will do, but can't comment on a correlation or outcomes by age. But you know, the average age was probably in the area of the 40s or 50s. Got it. Thank you so much. Thank you. Thank you. Thank you. Your next question comes from Uy Ear, Mizuho. Uy, please go ahead. Hi, this is Charles. I'm for Uy. I guess I kind of had a follow-up question to that. If there was any other read-throughs from the open label, de novo patients, to the phase III studies, and then also if you saw a difference between the adjunctive and the mono, therapy patients from that open label. Thanks. Thanks, Charles. Sergio here. Let me try to give you a little bit more like top down, and then Cedric can go more in detail. And so learning the long-term safety study is 12 months, and we look at the MADRS improvement data, and the conclusion are, you know, simple but significant and material because this represent real world experience. So what we have seen is that there is a rapid effect, and there is a clear effect and, you know, the 70+% of the patient responded after three months, 12 months, and the sustain, so there is no loss of efficacy over time, and the safety has confirmed that the drug is extremely safely and well tolerated. So these are really the key learning in a real world experience. To the answer or the question, there is a difference in adjunctive and monotherapy. In the 12-month study is not really, like, very significant to make a difference. It was not the—it's a mix, so it's very, it would be unfair to separate monotherapy from adjunctive because we don't know, right, in 12 months what people do. There's somebody take medication, they stop, then somebody doesn't take them. So it would not be a reliable information. Though, I mean, we look at the de novo and the overall population that come from, from the two phase III studies, it's over 500-600 patients. There is really no difference that would be remarkable. There is no... Let's put it this way: there is no subset of patients that would spike either way, that, the drug didn't work well or they work extremely well. It's pretty consistent, and that make us comfortable because this is a real-world experience. Cedric, do you want to add anything to my remarks? I think you said it all. Just to confirm what you said, that there's this consistent improvement trajectory with rapid onset in the de novo or the... It's the ideal group to look at when you're looking at efficacy in the open label, because that study isn't as well controlled as our placebo-controlled trials, you know, on who gets in. So there's a lot of subjects and a lot of concomitant medications that they're on. So it's quite a mixed bag, but one thing is consistently observed is that whatever the treatment setting, patients got better quickly with really high response and remission rates in the open label, and consistent trajectory as we've also seen in the controlled trials. Thanks so much. Thanks for taking my question. Thanks, Charles. Thank you. Your next question comes from Andrew Tsai, Jefferies. Andrew, please go ahead. Hi. Thanks so much. This is Dina on for Andrew. We just had a couple of quick questions. What are each of your two phase III studies, you know, sort of powered to show in terms of major separation versus placebo? And a question for Cedric. You know, operationally speaking, how can you say with high confidence the study integrity for the two phase III studies in REL-1017 are similar to how Axsome's successful studies were run? Are you seeing a lot of similarities between those two programs? And if you could just elaborate on that. Thank you. Yeah, thanks, Dina. Maybe Cedric should answer that. Maybe I just would like to try to answer your last question, right, on the comparison with Axsome. And Cedric runs both the trials, running our trial and run Axsome trial, but these are very, very, very different drugs, so I don't know how much would be reliable to compare the two programs. And then, Cedric, do you want to, you know, try to answer? Yeah. Sure. Yeah, no, I think that anybody who's in the drug development space, particularly in major depressive disorder, very much tries to run as high quality a program as possible. And that really comes down to three things: the protocol, the site selection, and subject selection. And so, it doesn't matter which sponsor you work for. You want to have a very tight, efficient protocol that aims to reduce placebo response. And then you want to work with the best sites that are conducting MDD trials. And of course, those of us who work in clinical research for depression know that there are always the same sites, you know, known to the sponsor. So you would expect that there would be knowledge and familiarity because these sites are the best, you know, in major depressive disorder. And then it's you just have to very carefully have an eligibility process that makes sure that you're avoiding that you're getting the right patient with confirmed diagnosis of MDD, and you're avoiding professional patients. And you're doing everything from a subject selection process as well that might minimize recruiting or enrolling patients or subjects, I should say, who may be prone to having a high placebo response. So you do that across the program, and I have to say that I'm very pleased with how rigorous our eligibility process is in letting subjects in into the trial. The question on the statistical powering, we haven't actually revealed that yet. So, you know, I mean, it would be reasonable to. If you, if you take the phase II data, and if you were to consider 301 or 303, where placebo was controlled to about 10 or 11 points improvement on the MADRS, you could probably figure out, how we're powering it because we are, targeting approximately 300 subjects, as Sergio mentioned at the beginning. I hope that helps a little with an answer to your question. But if I can add just one quick point. According to the KOLs and the historical literature, a difference in MADRS score versus placebo of 2-2.5 points is considered clinically meaningful and enough for approval. So you may imagine that we will file the statistical plan in accordance to, you know, these parameters. So, you know, the statistic will be set up to detect a MADRS difference from placebo that is clinically meaningful and good enough for approval. Hope I answer appropriately your question. Okay, thank you. Ladies and gentlemen, as a reminder, should you have a question, please press star one on your touch-tone phone. Your next question comes from Yatin Suneja, Guggenheim. Yaten, please go ahead. Hi, this is Thelma for Yaten, and thanks for taking my question. I have a few questions on the psilocybin program. I just wanted to ask you if you have already filed the IND for the phase one trial, and how many doses are you planning to use there? Are there any of these doses expected to trigger a psychedelic experience? Thank you. Yeah, sorry. I'll answer the first, Sergio here. The first part of the question, then, if you don't mind, repeat the second one, because I couldn't hear you very, very, very well. So no, we haven't filed the IND. We are on the process to prepare the IND, and, I do believe will be filed relatively soon. But, yeah, we are planning to start the phase one single dose, ascending in Q1 next year. So, you know, let's say two, three months from now. And can you please repeat the second part? Yeah, sure. I was just asking if you have those, how many doses you are planning to test there, and if any of these doses is expected to trigger a psychedelic experience? How many doses? No, we haven't finalized it and the exact dose regimen we'll discuss in the IND. But what I can share with you is what will be the dose limiting toxicity. And it is not real toxicity because we know that psilocybin is well tolerated from the literature and the history and from other programs that are ongoing. They are using 25 mg in a single dose, and we will use one-tenth of that. So, it's a fair assumption that the dose we'll be using will not be toxic or not well tolerated in general terms, but the dose limiting toxicity we are trying to determine is when you start to have psycho, you know, psychomimetic, psychological, psych, psychiatric or psycho symptoms. I put it in this way, when you start to feel that the drug is affecting your psych. So we are developing a low dose extended release that is non-psychedelic. So the dose limiting toxicity will be the psychedelic effect. We don't know exactly what the dose is, but we assume that- Yes. Right, you know, it will be like below 3-4 milligrams daily. Okay. Thank you. Bye. Thank you. There are no further questions at this time. Please proceed. Well, thank you. Look, in summary, we remain confident that we do have an approvable drug in REL-1017, and we are excited about the potential of the novel psilocybin and derivative programs. We look forward to reporting the progress with our pipeline in the months ahead, and I do remain grateful to the Relmada team for their continued hard work and dedication to executing on our mission. I would like to extend my sincere thanks to the patients and clinical partners involved in the REL-1017 trials for their participation in the advancement of this promising investigational medicine to development. Thanks a lot to everyone, and we'll reconnect soon. Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.