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spk03: Thank you. Hello, and welcome to the Realmata Therapeutics third quarter 2024 earnings conference call.
spk06: At this time, all participants are in a listen-only mode. After the prepared remarks, we will conduct a question and answer session. To ask a question, please press star 1. As a reminder, this conference call is being recorded and will be available for replay on the location website. I would now like to turn the call over to Tim McCarthy from LifeSci Advisors. Please go ahead, Mr. McCarthy.
spk07: Good day, everyone, and thank you for joining us today.
spk01: This afternoon, Ramada issued a press release providing a business update and outlining its financial results for the three months ended September 30th, 2024. 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 cautionary statements contained in RealMata'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, 2023, and subsequent filings, including the third quarter 2024 10-Q filed after the close today. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, November 7, 2024. Ramada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me on today's call are Ramada's CEO, Dr. Sergio Traversa, who will briefly provide a summary of recent business highlights, and Ramada's CFO, Megan Shenouda, who will provide a review of the company's Q3 financial results. After that, we will open the line for brief Q&A session. Now, I would like to hand the call over to Sergio Traversa. Sergio?
spk04: Thank you, Tim, and good afternoon, and welcome everyone to the REL MADA Third Quarter 2024 Conference Call. REL MADA number one priority is to advance the development of new treatments for CNS disorder, including major depressive disorder, or MDD. Our number one objective is to successfully complete the Phase III program and the NDA package for REL 1017, or HES methadone, with a laser focus on de-risking the study design and execution. We expect to report the outcome of the interim analysis for the Reliance II Phase III study by year-end 2024, and believe that this could potentially be an important de-risking event for the study and the REL 1017 program and the company. As a reminder, with REL 1017, we aim to provide patients with MDD a new adjunctive treatment option to be used in combination with their current regimen. Approximately 10 million people were treated for a major depressive episode in the last year, and 40% of these patients, that is about 4 million people, required combination therapy. This is U.S. only. Our Phase III registrational program has been designed to build on key learnings from our previously conducted Phase III and Phase II programs. In today's call, I will focus on REL 1017 and also provide a brief update on our psilocybin-based metabolic disease program. After that, Magid will review our financial results, and then we will take your questions. The clinical program for REL-1017 is comprised of two studies, RELIANCE-2 and RELIGHT. As a reminder, each study was designed as a double-blinded, placebo-controlled, randomized, Phase III registration or clinical trial to evaluate REL-1017 in patients with clinical depression. We are on track to provide the outcome of the planned sample size re-estimation interim analysis for the Reliance II study by your end 2024. There are three potential outcomes based on the DMC data management committee recommendations from the unblind and interim analysis. The first potential outcome is that the study can continue with a preplanned number of patients. This is, of course, our preferred outcome and at the basis of a top-line data readout in the first half of 2025. The second potential outcome would be a recommendation to continue the study with the addition of more patients. This would indicate that the promising efficacy signal was observed with the interim data and that an increased sample size is required to improve the power of the final analysis. We will view this as an encouraging signal from the study and worth the time and cost to extend enrollment. The third potential outcome is that the study is deemed to be futile. It is important to note that we set the futility level such that a clinically meaningful result in the final analysis would be highly unlikely. Specifically, it translates to a drug placebo delta below approximately 2.2 points. The outcome of these scenarios will provide a clear indication of how the study is going, and we do believe that this will be an important, very risky event for REL 1017. Before I ask Nagy to review the financial results, I will provide a brief update of the psilocybin program for metabolic disease. The phase one safety study from our investigation of candidate REL P11 is a screening subject, and we expect the first randomization very soon. The study will be conducted in Canada with obese individuals and will allow us to define the pharmacokinetic safety and tolerability profile for a single dose of RAPB11 and select the optimal dose or doses for evaluation in a Phase IIa proof-of-concept study. We do expect to begin the Phase 2A study in 2025. Now we turn the call to our CFO, Maggots Chinudit. Maggots?
spk00: Sure. Thank you, Sergio. As noted by Tim, this afternoon we issued a press release announcing our business and financial results for the third quarter ended September 30, 2024. During today's call, I'll provide a brief overview of the financials. Full details are available in our press release and the 1Q filing we completed today. These documents are available on our website in the News and SEC Filings tabs on the Investor Relations page. As of September 30, 2024, RealMata had cash, cash equivalents, and short-term investments of approximately $54.1 million, compared to $96.3 million as of December 31, 2023. Cash use and operations in the third quarter ended September 30, 2024, was $16.7 million compared to $11.6 million for the same period in 2023. Based on our current plan for clinical development, we expect our current cash physician to support operations through key near-term milestones into 2025. Moving through the rest of the financial results, total research and development expense was approximately $11.1 million as compared to $10.5 million for the comparable period of 2023, an increase of approximately $0.6 million. The increase was primarily associated with a ramp-up of expenses related to the 302 and 304 studies in 2024. The non-cash charge related to stock-based compensation for R&D totaled $1.7 million in the third quarter of 2024. Total general and administrative expense for the third quarter was approximately $11.9 million as compared to $12.2 million for the comparable period of 2023, a decrease of approximately $0.3 million. The decrease was primarily driven by a decrease in stock-based compensation expense. The non-cash charge related to stock-based compensation expense for GMA totaled $6.2 million in the third quarter of 2024. The net loss for the third quarter of 2024 was $21.7 million, or 72 cents per basic, and diluted share, compared with a net loss of $22 million for $0.73 for basic and diluted shares in the comparable period of 2023. Note that the company had 30.2 million common shares outstanding as of November 4, 2024. Before we open the call for questions, I'll turn back to Sergio for some closing comments. Sergio?
spk07: Thank you, Maggots.
spk04: I would like to leave you with these key messages from today's call. Bermuda's number one objective is to complete the Phase III program and the NDA package for REL 1070. We expect to report the results, outcomes of the pre-planned interim analysis for the Reliance II Phase III study by year-end 2024. And we do believe that this could be an important, de-risking event for the study and the REL 1070 program. We plan to enroll the first subject in the phase one single-agency study, dosing study for P11 in development for metabolic disease very soon.
spk07: With that said, we can open to questions. Operator?
spk06: Thank you. As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. One moment, please, for your first question. Our first question comes from the line of Andrew Tsai from Jefferies. Please go ahead.
spk02: Hey, good afternoon, and thanks for taking my questions. Thanks for the updates. First question is, what exactly can we expect you to say in the interim release? Will it be just a few sentences, or could it be something more detailed than that?
spk04: Yeah, hi, Andrew. Thanks for the question. It's Sergio here. Well, yeah, it's difficult to do it, to decide in advance. Really, we'll see what the outcome will be. And if there is any need for, like, go more in detail, we may have a call. Or if it is a straightforward message, then we may not. But we will have to wait. So what we can share is that we will give as many details as we can on the outcomes. Got it. So you will know what the DMC will tell us.
spk02: Okay. And I heard 2.2 points somewhere earlier in your prepared remarks, but is that for statistical significance? Just to clarify.
spk04: Yes. Thanks, Andrew. No, it was 2.0. I read two twice. So it's about around two points delta. And we say approximately because it depends, of course, from the standard deviation. So it can be slightly higher, slightly lower than two.
spk02: Got it. And then what threshold are you setting for the futility? What kind of placebo-adjusted delta, below what placebo-adjusted delta will you hit futility? Okay.
spk04: Yeah, it's the same number. It's about two points. So two points is kind of the threshold between clinical and non-clinical significance. So we would like, if we have a product, we would like to be sure that it is also clinically meaningful. So it's about two points. So below two points, plus minus a little bit due to the standard deviation. If it is below two points, it's probably going to be fewer times.
spk02: Very clear. Okay. Thank you and good luck on everything.
spk07: Thank you, Andy. I'll proceed.
spk06: Our next question comes from the line of Mark Goodman at Lering Partners. Please go ahead.
spk08: Hi. Good afternoon. This is Basma on for Mark. Thank you for taking our question. Regarding the interim readouts, are you going to be able to have access to any other information, such as baseline characteristics of the patients or data of matters changes, for instance, or is it mainly going to be the information related to the facility or not? Thank you.
spk04: Yeah, thanks for the question. No, we will only know what the data management committee will share with us, but it's pretty much like the three outcomes, they won't provide any additional color or, you know, details. The DMC and we want to maintain the integrity of the data. So we will only know, like, if it is futile, if we can continue as planned, or if we need to add patients to increase the power.
spk07: That's it. Thank you. That's very clear. Thank you. Our next question comes from the line of Uyir from Mizuho.
spk06: Please go ahead.
spk05: Hi. Thanks for taking my question. It's Charles on for Uy. So I was curious if the DMC recommends no change, would you continue to enroll to 300 or would that be that 400 or 340 number mentioned? Yeah. Thank you.
spk04: Yeah. Hi, Charles. Well, that would be the best outcome. It's difficult to give a straight answer. Technically, usually you tend to enroll a little bit more than the plan number, like maybe a few percent more, just to be sure to account for the dropouts. But, you know, the plan number is north of 300 between 3 and 340. So it's going to be around that number.
spk07: Okay. Thanks for taking my question. Our next question comes from the line of Andrea Newark from Goldman Sachs.
spk06: Please go ahead.
spk09: Hi, team. This is Talani on for Andrea. Thanks for taking our questions. Two from us. First, from a statistical perspective, can you confirm you're not taking a hit to alpha by conducting the interim analysis? And then secondly, just wondering if you have any updates on the percent screen failure rates in Reliance 2 compared to those from the prior studies? Thanks.
spk04: Yeah, sure. I can confirm that there is no alpha uh penalty paid in the interim analysis and the reason being that there is no early stop so it's not an efficacy uh inefficacy interim analysis so there is no plan to stop the the trial early the best case scenario is to continue as planned and that's one and the second one was uh the the dropout rate uh it is it is low right it is in the single digit mid single digit And it is lower than in the previous trial, but, you know, I would be cautious of everyone to read anything into that. It just means that there is, like, compliance and the adherence of the patient in the trial is good. So I would not translate anything from that in terms of efficacy or something like that.
spk07: It's about, like, mid-single digit. That's helpful. Thank you. Thank you.
spk06: There are no further questions at this time. I'd now like to turn the call over to Sergio Traversa for final closing comments.
spk04: Thank you. And in closing, as we get ready to read out on a very important upcoming clinical milestone, so REL 1017, as a potential adjunct treatment for MDD, we want to thank you, everyone, for your support and for taking time to join the call today. Thank you, and have a wonderful rest of the day.
spk06: This concludes our question and answer session and call for today. Thank you, everyone. You may now disconnect.
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