Q1 2024 Relmada Therapeutics Inc Earnings Call
Good afternoon, ladies and gentlemen, and welcome to the rail MADA Therapeutics, Inc. First quarter 2024 financial results 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.
Operator: Good afternoon, ladies and gentlemen, and welcome to the Relmada Therapeutics Inc. First Quarter 2024 Financial Results Conference Call. At this time, all lines are in listen-only mode.
Operator: Following the presentation, we'll conduct a question-and-answer session. If at any time during this call you require immediate assistance, please press star zero for the offer. This call is being recorded on Wednesday, May 8, 2024. I would now like to turn the conference over to Tim McCarthy, Lifesci Advisors. Please go ahead.
Timothy McCarthy: During this call you require immediate assistance. Please press star zero for the offering.
Operator: Those being recorded on Wednesday may eight 2024, I would now like turn the conference over to Tim Mccarthy lifestyle Advisors. Please go ahead.
Timothy McCarthy: Thank you, Colin, 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. This afternoon, Relmada issued a press release providing a business update and announcing financial results for the three months ended March 31st, 2024. Please note that certain information discussed on the call today is covered under the Safe Harbor provision of the Private Securities Li
Timothy McCarthy: Thank you Colin and thank you all for joining US. This afternoon with me on today's call are Chief Executive Officer, Sergio Teresa and Chief Financial Officer magazine to yet.
Timothy McCarthy: This afternoon Ramada issued a press release, providing a business update announcing financial results for the three months ended March 31 2024. Please.
Timothy McCarthy: Please note that certain information discussed on the call today is covered under the safe Harbor provision of the private Securities Litigation Reform Act.
Timothy McCarthy: We caution listeners that during this call, Relmada's management team will be making forward-looking statements. However, 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 31st, 2023, and subsequent filings.
Timothy McCarthy: We caution listeners that during this call for a modest management team will be making forward looking statements.
Timothy McCarthy: 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.
Timothy McCarthy: These forward looking statements are qualified by the cautionary statements contained in <unk> 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.
Timothy McCarthy: This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, May 8, 2024. 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 turn the call over to Sergio.
Timothy McCarthy: This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast may eight 2024.
Sergio: <unk> undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this conference call.
Timothy McCarthy: Now I would like to turn the call over to Sergio Sergio.
Sergio Traversa: Thank you, Tim, as always, and good afternoon to everyone and welcome to the Relmada First Quarter 2024 Conference. We continue to achieve meaningful progress in the advancement of our ongoing phase three program for REL 1017 in major depressive disorder, MDD, as well as in the promising preclinical novel psilocybin program, all of which I will briefly cover today. Following this, Maged will review our first quarter 2024 financial results, and then we will take your questions.
Sergio: Thank you, Tim and as always and good afternoon to everyone and welcome to the <unk> first quarter 2024 conference call.
Sergio Traversa: We continue to achieve meaningful progress in the advancement of our ongoing phase III program for well 10, 17 in major depressive disorder or <unk> as well as in the promising preclinical Novo silo saving program all of which I will briefly cover today.
Maged: Following these magnet will review our first quarter of 2024 financial results and then we will take your questions.
Sergio Traversa: Let's begin with an update on the late stage phase three program for REL 1070. As a reminder, Relmada is focused on developing REL1017 as an adjunctive treatment for MD. We previously executed important revisions to Reliance 2, the ongoing study 302, which is a phase three, two-arm placebo-controlled pivotal study evaluating REL1017, 25 milligrams for adjunctive MDT. These modifications were aimed at controlling placebo response and improving the profile of patients enrolled. The amended study 302 protocol has been implemented across all of our clinical trials.
Sergio Traversa: Let's begin with an update on the late stage phase III program for Ralph Pen 17.
Sergio Traversa: As a reminder.
Sergio Traversa: Roma East focus on developing <unk> as an adjunctive treatment for M D.
Sergio Traversa: We previously executed important revision to reliance to the ongoing study three zero too, which is a phase III two arm placebo controlled pivotal study evaluating <unk> pen 17, 25 milligrams for adjunctive M D D.
Sergio Traversa: These modification were aimed at controlling placebo response and improving the profile of patients enrolled.
Sergio Traversa: The amended study 302 protocol is being implemented across all of our clinical sites.
Sergio Traversa: Enrollment continues to advance, and our ability to leverage our close relationship with the study sites continues to play a critical role. Moreover, the ongoing initiative we put in place to drive trial awareness with prospective patients is also generating positive results. As we said on our last call, we are evaluating the quality and productivity of sites on a real-time basis and making tweaks.
Sergio Traversa: Enrollment continues to advance and our ability to leverage our close relationship with the study sites continue to play a critical role.
Sergio Traversa: Moreover, the ongoing initiative, we put in place to drive trail trials widen this awareness with prospective patients are also generating positive results.
Sergio Traversa: As we said on our last call, we are evaluating the quality and productivity of sites on a real time basis and making tweaks.
Sergio Traversa: Ed DePauw, As a reminder, we plan to enroll approximately 300 patients into Reliance. Based on our current projection, we continue to expect Reliance 2 to be completed with top-line data anticipated in the second half of the year. We are also continuing to enroll those patients in our second phase three trial for WELL-1017, Relight, or study 304, that also has a planned enrollment of approximately 300. Like Reliance 2, Relight is a randomized, double-blind, placebo-controlled, four-week trial evaluating the efficacy and safety of REL1017 as an adjunctive treatment of MDD in patients experiencing inadequate response to ongoing background antidepressants. The primary endpoint of both studies is the same.
Sergio Traversa: As appropriate.
Sergio Traversa: As a reminder, we plan to enroll approximately 300 patients into reliance to bear.
Sergio Traversa: Based on our current projects should we continue to expect relay is due to be completed with top line data anticipated in the second half of Bcf.
Sergio Traversa: We are also continuing to enroll and dose patients in our second phase III trial for routing 17 Relight. All studied 304. It also has a planned enrollment of approximately 300 patients.
Sergio Traversa: Like reliance to Relight is a randomized double blind placebo controlled four weeks trial evaluating the efficacy and safety of <unk> 10, 17, as an adjunctive treatment of MD deep in patients experiencing inadequate response to ongoing background antidepressant treatment.
Sergio Traversa: The primary end point of both studies is the same.
Sergio Traversa: The change in the Madras total score from baseline to day 28 for well 1017 as compared to placebo. I would like to emphasize again that we have made meaningful revisions to our screening and enrollment processes in order to ensure that we have patients that meet all of the qualifying criteria within our desired patient process. To this end, we are now implementing a comprehensive adjudication process through which we require medical and pharmacy records for all patients enrolled in Reliance II and Reliance.
Sergio Traversa: The change in the <unk> total score from baseline to day 28, Port 10, 17 as compared to placebo.
Sergio Traversa: <unk>.
Sergio Traversa: I would like to emphasize again that we have made meaningful revision to our screening and enrollment processes in order to ensure that we had patients that meet all of the qualifying criteria within our desired patient profile.
Sergio Traversa: Moody's and we're now executing on a comprehensive adjudication process through which we require medical and pharmacy rate goes to all patients enrolled in Williams, two and relight.
Sergio Traversa: Even so, the screen failure rate in this study has increased to approximately 80% versus approximately 50% in Reliance 1 and Reliance 3, our previously completed phase 3 trial, REL 1017. However, we are highly confident that these changes will substantially enhance the probability of success of the current study. I would also like to highlight that we have completed all of the necessary preclinical manufacturing and phase one studies required for a potential REL 1017 NDA filing, and our current focus is on executing the remaining two phase three studies, 302 and 304.
Sergio Traversa: Even this the screen failure rate in Saudi is increased to approximately 80% versus approximately 50% in reliance one Andrew Alliance III. Our previously completed phase III trial Route 10 17.
Sergio Traversa: However, we are highly confident that these changes will substantially enhance the probability of success of the current studies.
Sergio Traversa: I would also like to highlight that we have completed all of the necessary preclinical manufacturing and.
Sergio Traversa: And phase one studies required for a potential, whereas 10 17, NDA filing and our current focus is on executing the remaining two phase III studies tier two and three or four.
Sergio Traversa: Moving on now to the promising novel modified-release psilocybin program, we continue to anticipate the initiation of a single-ascending-dose phase I trial in obese patients in the first half of this year to define the pharmacokinetic safety and tolerability profile of our modified-release psilocybin formulation in this population, followed by a Phase 2A trial to establish clinical approval. Data from the PLANET 2A study is anticipated in the first half of 2020. These impressive studies will build on the compelling preclinical data that were presented in a poster presentation at last November's AASLD meeting, the liver conference.
Sergio Traversa: Moving on now to the promising novel modified release, Tyler Soybean program. We continue to anticipate the initiation of a single ascending dose phase one trial in obese patients in the first half of Bcf to define the pharmacokinetics safety and Tolerability profile.
Sergio Traversa: Of our modified release Talos IV formulation in this population followed by a phase II a trial to establish clinical proof of concept data from the planet II. A study is anticipating the FIS tours tackled 2025.
Sergio Traversa: These planned studies will build on the compelling preclinical data that were presented in a poster presentation of last november's, a a S. L D meeting the leader conference.
Sergio Traversa: These results show the beneficial effect of low-chronic-dose psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction-associated sciatotic liver disease, or MASLD. Based on this data, low-dose psilocybin could improve lipids and glucose with potential for fewer side effects over other investigative treatment approaches such as GLP-1, glucagon, and GI. So, to summarize our multiple upcoming key milestones over the next 12-18 months, we anticipate the ongoing Reliance II study to be completed with top-line data in the second half of December.
Sergio Traversa: The results showed the beneficial effect of low chronic does psilocybin on multiple metabolic parameters in a rodent model of metabolic dysfunction associated C. Adult leber disease or M. A S. L D.
Sergio Traversa: Based on these data load those psilocybin could improve lipids and glucose with potential for fewer side effects or other investigative treatment approaches says Gee LTE such as G. L. P. One glucagon engie IP.
Sergio Traversa: Yeah.
Sergio Traversa: In addition, we anticipate initiating a phase one clinical trial for our modified release formulation of psilocybin before the end of the current quarter. Lastly, while Maged will provide a detailed review of our financials, I would like to highlight that we continue to advance our pipeline for a position of significant financial strength with cash on hand to take us comfortably into 2020. I will now turn the call over to Maged to review our first quarter financial results.
Sergio Traversa: So to summarize our multiple upcoming key milestones over the next 12 to 18 months, we anticipate the ongoing reliance to study to be completed with topline data in the second half a bcf.
Maged: In addition, we anticipate initiating a phase one clinical trial for our modified release formulation of silo siding before the end of the current quarter.
Maged: Lastly, while magnet will provide a detailed review of our financial I would like to highlight that we continue to advance our pipeline for a position of significant financial strength with cash on hand to take us comfortably into 2025.
Maged: I will now turn the call over to Maggie to review, our first quarter financial results.
Sergio Traversa: Maggie.
Maged: Thank you Sergio.
Maged S. Shenouda: Thank you, Sergio. Today we issued a press release announcing our business and financial results for the three months ended March 31, 2024, which I will now review. For the first quarter and for March 31, 2024, total research and development expense was approximately $13.3 million, compared to $15.9 million for the comparable period of 2023, a decrease of approximately $2.6 million. The decrease was primarily associated with the completion of the long-term Open Label Study, Study 310, in the third quarter of 2023, as well as Reliance 1 and 3.
Maged: We issued a press release announcing our business and financial results for the three months ended March 31, 2024, which I will now review.
Maged S. Shenouda: The non-cash charge related to stock-based compensation for R&D totaled $1.7 million in the most recently completed first quarter. Total general and administrative expense for the first quarter ended March 31, 2024, was approximately $9.7 million, compared to $12.3 million for the comparable period of 2022, a decrease of approximately $2.6 million. The decrease was primarily driven by a decrease in stock-based compensation.
Maged S. Shenouda: For the first quarter ended March 31, 2024, total research and development expense was approximately $13 3 million as compared to $15 9 million for the comparable period of 2023, a decrease of approximately $2 $6 million.
Maged S. Shenouda: Decrease was primarily associated with the completion of the long term open label study study three plan in the third quarter of 2023 as well as for alliance, one and Curry a noncash charge related to stock based compensation for R&D totaled $1 $7 million and our most recently completed first quarter.
Maged S. Shenouda: <unk>.
Maged S. Shenouda: Total general and administrative expense for the first quarter ended March 31, 2024 was approximately $9 7 million as compared to $12 $3 million for the comparable period of 2022.
Maged S. Shenouda: A decrease of approximately $2 6 million. The decrease was primarily driven by a decrease in stock based compensation expense the.
Maged S. Shenouda: The noncash charge related to stock based compensation for G&A totaled $6 6 million in the most recently completed first quarter.
Maged S. Shenouda: The non-cash charge related to stock-based compensation for G&A totaled $6.6 million in the most recently completed first quarter, which ended March 31, 2024. The net loss was $21.8 million, or $0.72 per basic and diluted share, compared with a net loss of $26.3 million, or $0.87 per basic and diluted share, in a comparable period of 2023. As of March 31, 2024, we have cash, cash equivalents, and short-term investments of approximately $83.6 million, compared to $96.3 million as of December 31, 2023.
Maged S. Shenouda: For the first quarter ended March 31, 2024, the net loss was $21 8 million or <unk> 72 per basic and diluted share compared with a net loss of $26 $3 million or <unk> 87 cents per basic and diluted share in the comparable period of 2023.
Maged S. Shenouda: Hey.
Maged S. Shenouda: As of March 31, 2024, we had cash cash equivalents and short term investments of approximately $83 6 million compared.
Maged S. Shenouda: Compared to $96 $3 million as of December 31, 2023.
Maged S. Shenouda: Cashews and Operations in the first quarter of 2023 was $13 million. Based on our clinical development plan, our current cash position provides us with comfortable runway into 2025. I will now ask the operator to please open up the call for questions.
Maged S. Shenouda: Cash used in operations in the first quarter of 2023 was $13 million based.
Maged S. Shenouda: Based on our clinical development plan.
Maged S. Shenouda: Current cash position provides us with comfortable runway into 2025.
Speaker Change: I will now ask the operator to please open up the call for questions operator.
Operator: Thank you. Ladies and gentlemen, we'll now begin the question and answer session. If you'd like to ask a question, please press star, fold by one. If you'd like to withdraw your question, please press star, fold by two. If you're using a telephone, please lift the handset before pressing any keys.
Maged S. Shenouda: Yes.
Speaker Change: Thank you ladies and gentlemen, we'll now begin the question and answer session. If you'd like to ask a question. Please press star followed by one if you'd like to withdraw. Your question. Please press star followed by two Youre using it handset. Please lift the handset before pressing any keys.
Operator: Your first question comes from Mark Goodman from Lear, Inc. Partners. Mark, please go ahead.
Operator: Your first question comes from Marc Goodman from <unk>.
Mark Goodman: Leerink partners Mark. Please go ahead.
Basma: Hi, this is Basma on behalf of Mark. I have a question about the Reliance and Relied Trials, the ongoing Reliance and Relied Trials. You actually mentioned something that you were monitoring the trials, looking at the blinded data before in the previous call, the fourth queue earning call. Can you provide some color about this kind of blinded data from what you see right now from Reliance and Relied if you compare it to the prior trial that had a larger placebo response? Do you see any similarities? Do you see any differences? Just to give us some color about the strategy that you implemented to reduce the placebo response. Thank you.
Mark Goodman: Hi, this is asthma.
Basma: Mike.
Basma: Have a question about <unk>.
Basma: Reliance and rely tiles, the Hong Kong Airlines and our lifestyles.
Basma: You actually mentioned.
Basma: Something Thats you are monitoring the trial monitoring.
Basma: Hmm.
Basma: Looking at the blinded data before in the previous call.
Basma: Fourth Q.
Basma: Earning call.
Basma: Provide some color about kind of blinded data.
Basma: What do you see right now from the reliance from the light if you compare to the prior trials.
Basma: Placebos costs do you see any similarities differences too.
Speaker Change: Give us some color Adam.
Basma: But please strategy.
Basma: Momentum to reduce the placebo response, thank you.
Basma: Okay.
Sergio Traversa: Yeah, sure. And thanks for the question. I'll give you like the top down answer. And then we have Dr. Andy Andrew Cutler.
Speaker Change: Yeah sure and thanks for the question and I'll give you like the the top down answer and then we have a doctor Andy Andrew Cutler, our clinical advisors on the call, we'll provide a little bit more details about these aspects well first of all let let me, let me say something about the blinded data right.
Andrea R. Tan: He's our clinical advisor on the call. We'll provide a little bit more detail about these aspects. Well, first, let me say something about the blinded data, right? There is absolutely no way to guess from the blinded data the outcome of a clinical trial. And we did that.
Sergio Traversa: We experienced that in the last two trials that we had. So, the help that we can get, or everybody can get from monitoring the blinded data is only an exclusive, exclusive, to see if there is something that it's not like that doesn't work. And I can't find the right word, but that is not consistent, right?
Andrea R. Tan: There is no absolutely no way to get from the blinded data the outcome of a clinical trial and what we did there. We are seeing is that in the last in the last two trials that we had so the the Hal.
Sergio Traversa: That we can get so everybody can get from monitoring the blinded data is only and excludes the <unk> exclusive.
Sergio Traversa: To achieve the right there is something that it's not like.
Sergio Traversa: It doesn't make.
Sergio Traversa: And all I can find the right word but that is not consistent right for Ed gave you. An example, if there are any.
Sergio Traversa: For a given example, if there are individual patients with MADRA scores week over week that go up and down, or we call it zigzag, then you know that there is something that is not right. That could be the patient or it could be the site. But usually, a patient that responds is consistent over four weeks. And if it doesn't respond, it's still consistent over the four weeks. So if you see a zigzag, that's a signal that something is not consistent.
Sergio Traversa: Individual patients with.
Sergio Traversa: The Madras scores week over week that goes amp, it up and down or we call. It Zig Zag. Then you know that there is something that is not right. It can be the patient or it can be to site, but usually a patient that responds is consistent over four weeks and if it doesn't respond is pretty consistent over the the four weeks. So if you see a zigzag.
Sergio Traversa: That's a signal that something is not it's not like it's all consistent and so we take a look to that to the patients and mostly to the site. So that would be really the only help that you can get from the from the blinded data, but it is important to continue to monitor to see that not many of these patients with these zigzag pattern.
Sergio Traversa: And so we take a look at that with the patients and mostly with the site. So that's really the only help that you can get from the blinded data. But it is important to continue to monitor to see that not many of these patients with this zigzag pattern get into the trial. Once it's in, there is nothing we can do. But we can at least revise and advise the site that something is kind of like a red flag. And Andy, you are on the call. Would you mind providing some more details about it? Yes, like
Andy: Get into the trial when he is in there is nothing we can do but we can at least the revised and advise the decide that.
Sergio Traversa: Something is kind of like a red flag and Andy.
Andy: You out on the call would you mind to provide some more details about it.
Andrea R. Tan: Yes, I absolutely agree with what Sergio said. What you look for is consistency and quality indicators. And in addition to what he said about the primary, the madras zigzagging, you also look for consistency across different scales. The primary secondary, the key secondary outcome, of course, being a CGI, usually that moves in the same direction as the madras, which is measuring depression symptoms.
Andy: Yes, I absolutely agree with what Sergio said, what you look for is <unk>.
Andrea R. Tan: Consistency in quality indicators and in addition to what he said about the primary the Madras Zig Zag and you also look for consistency across different scales.
Andrea R. Tan: The primary secondary key secondary outcome of course being a CGI usually that moves in the same direction as the Madras, which is measuring depression symptoms. So you look for that I would say also that in the previous trial.
Andrea R. Tan: So you look for that. I would also say that in the previous trial, sites were allowed to enroll rather quickly without watching the quality as closely as we're doing now. And that can certainly be a problem. So we're now really being much more careful with the enrollment, not allowing a site to over-enroll patients until we've looked at the quality, and monitoring the quality of each site and the trial overall. And I would say things are looking fine from that point of view.
Andrea R. Tan: Sites were allowed to enroll rather quickly.
Andrea R. Tan: Without watching the quality as closely as we're doing now and that's because that can certainly be a problem. So we're now really been much more careful with the enrollment not allowing a site to over enroll patients until we've looked at the quality monitoring the quality of each site in the trial overall I would say things are are.
Andrea R. Tan: Looking fine from that point of view at this point.
Sergio Traversa: Thank you, Andy, and I hope that answers your question.
Speaker Change: Thank you, Andy and I hope that answered your question.
Speaker Change: Thank you.
Operator: Your next question comes from Andrea Tan from Goldman Sachs. Please go ahead.
Speaker Change: Your next question comes from Andrea <unk> from Goldman Sachs. Please go ahead.
Andrea R. Tan: Hi, Sergio. Thanks so much for taking the question. Maybe one follow-up to your remarks right there. As you are monitoring the sites, if you do see the inconsistencies that you've just spoken about, maybe walk us through what steps you would take to remediate those issues. And then I have one follow-up question. Thank you.
Andrea R. Tan: Hi, Thanks.
Andrea R. Tan: Thanks, so much for taking the question maybe one follow up to you.
Andrea R. Tan: Our remarks right. There as you are monitoring the sites. If you do see the inconsistency that Ive just spoken about maybe walk us through what steps then you would take two to remediate those.
Andrea R. Tan: Those issues and then I have one follow up question. Thank you.
Sergio Traversa: Yes, and good afternoon, Andrea. Thanks for the thanks for the question. As before, I will give you like the short answer. And then Andy, if you would like to provide a little bit more detail, but in general, well, first, you contact the site, and you discuss any detail regarding patients or patients that have some inconsistency. And then you go through the whole process. And ultimately, if that becomes a pattern, you don't want to have a site that shows inconsistency enrolling like, you know, 10, 20 patients because that would affect the old trial. So the ultimate measure is to close the site. But Andy, I'm sure I can give you a little bit more color on this.
Sergio Traversa: Hi, Yes, and good afternoon, and thanks for the thanks for the question as before I will give you. The short answer and then Andy if you would like to provide a little bit more more.
Andy: More and more details about in general but first.
Andy: Do you contact the site and you discuss any detail regarding patients. So patients that there is some inconsistency and and then now the.
Andy: You go through the old process and ultimately if that becomes a pad on it you don't want to have like a side that shows inconsistency enrolling like 10, 20 patient because that would affect the old trial.
Andy: The ultimate measure is to to close the close the site, but in the end you and I'm sure I can give you a little bit more color on this.
Andrea R. Tan: Yeah, that is well said. The most important thing is to not allow a site to continue to enroll patients and have problems like that. And so, as you know, if one site has too many patients, one or two sites, that can kill a trial. But also, if you do see this, well, first of all, the site also knows having run sites, the site knows now that you're looking over my shoulder, and you're going to call me. It really does make them be on their best behavior, if you will, and not cut corners. So, but ultimately, we have closed down some sites that had quality issues. So ultimately, what you do is you just stop them from enrolling so that they don't have a chance to hurt the study.
Andy: Yes that is well said the.
Andrea R. Tan: The most important thing is to not allow a site to continue to enroll patients and has problems like that so as you noticed one site is too many patients one or two sites that can kill a trial.
Andrea R. Tan: But also if you do see this well first of all the site also knows having run sites. The sight nose now if youre looking over my shoulder and Youre going to call me. It really does make them be on their best behavior, If you will and not cut corners.
Andrea R. Tan: So, but ultimately we have closed down some sites that had quality issues.
Andrea R. Tan: So ultimately what you do is you to stop them from enrolling so that they don't have a chance to hurt the study.
Sergio Traversa: Okay, thank you. Can you just remind us quickly if you're planning on having an interim analysis or is there going to be any type of mechanism in place for the DSMV to recommend stopping the study early as they did in your prior trial?
Speaker Change: Okay. Thank you Andrea can.
Sergio Traversa: Can you just remind us quickly. If you are you planning on having an interim analysis or is there going to be any type of mechanism in place for the DSM beta rockman stopping the study early as they had.
Sergio Traversa: In your prior trial.
Sergio Traversa: So, we will have, not we, but the data monitoring committee will have a look at the data at some point, very close to the end, but this is not an interim analysis because there is no statistical penalty, it's a simple re-estimation. They will let us know if the sample that we have in the trial is enough to reach statistical significance, or if we have to expand the trial, so there is no early stop plan. The other major difference is that The other major difference is that
Sergio Traversa: And so the we will have not we but the data ammonia committee will have a look at the data at some point close very close to the end.
Sergio Traversa: But this is not an interim analysis because there is no.
Sergio Traversa: These decal penalty.
Sergio Traversa: It's a simple re estimation they will let us know if the sample that we have and the trial is a is enough to reach a statistically significant or if we have to expand the trial. So there is no.
Sergio Traversa: Early stock plan.
Andrea R. Tan: The other major function of the DSMB, of course, is to monitor safety. And the good news is that safety and tolerability have looked very good.
Sergio Traversa: The other major.
Sergio Traversa: The other major function of the D. S. M. B of course is to monitor safety and the good news is the safety and the Tolerability has looked very good.
Speaker Change: Great. Thanks, I mentioned it.
Speaker Change: Thank you Beth.
Operator: Your next question comes from Andrew Tsai from Jefferies. Andrew, please go ahead.
Andrea R. Tan: Your next question comes from Andrew Tsai from Jefferies. Andrew. Please go ahead.
Matt: Hey, congrats on the progress. This is Matt calling in for Andrew, and I guess I'll continue with the same theme.
Operator: Hey, guys. Congrats on the progress this is Matt calling in for Andrew and I guess, continuing with the same theme do you have any specific on the numbers of high Tech you've had to pause close or been able to either reopen.
Matt: Monitoring for real time analysis and.
Sergio Traversa: Do you have any specifics on the numbers of sites that you've had to pause, close, or been able to even reopen using [inaudible] and also...
Matt: And also you know.
Operator: Sorry, I can; maybe it's me, but I can barely hear you.
Matt: Sorry, I can yeah.
Operator: Maybe it's me if I can barely hear you.
Matt: Okay, can you hear me better now?
Operator: Okay.
Matt: Can you hear me better now.
Sergio Traversa: Oh, much better. Yeah. Thank you. Sorry for that.
Speaker Change: Much better yes, thank you sorry for that.
Sergio Traversa: Okay, no problem. So, yeah, I was just asking, continuing with the real-time site analysis, if you've had any specifics on the number of sites that you've had to pause, close, or maybe even reopen. And then also, over the past year, we've seen quite a few companies that have announced delays, for instance, in the schizophrenia and epilepsy spaces. And are you seeing any increased level of competition in terms of finding the right MDT depression patients?
Speaker Change: Okay no problem.
Sergio Traversa: Yeah, I was just asking continuing with like the real time.
Sergio Traversa: Analysis, if you'd had any specifics on the number of sites that you've had to pause close or maybe even reopen.
Sergio Traversa: And then also over the past year, we had.
Sergio Traversa: We've seen quite a few companies that have announced delays for instance, like schizophrenia and epilepsy spaces.
Sergio Traversa: Are you seeing an increased level of competition in terms of finding the right entity depression patients.
Sergio Traversa: Well, thanks for the question. Thank you very much for the question. So in terms of sites, the site selection is not like it's fixed, like you decide on 50, 60 sites at the beginning, and you finish with the same site. It is an ongoing process. So constantly, there is a revision of sites, and some sites are closed not only for quality issues but also for competing studies or the exhausted patient population that they can enroll into the site.
Speaker Change: And then thanks for the questions.
Speaker Change: Yes. Thank you very much for the question so in term of sites right.
Sergio Traversa:
Sergio Traversa: The site selection is not like it fix and like the you decided 50 60 sites at the beginning and you finished with the same sites at these and ongoing brown process. So it constantly there is the revision of sites and some site is closed not only for quality issue also for like in the <unk>.
Sergio Traversa: <unk> studies or or or the dead exhausted the patient population that they can do.
Sergio Traversa: They can enroll into the site. So it is an ongoing.
Sergio Traversa: So it is ongoing. I don't have on the top of my mind a really specific number, but it's not like at some point you do a review. It's an ongoing process. So maybe Andy, when I finish, the other answer can give you a little bit more details because he runs clinical sites. So he is more into the details of the process. And the second question, would you mind repeating it?
Sergio Traversa: I don't have on the top of my mind like a really specific number but it is not like that at some point you do a review it it's an ongoing process. So the maybe Andy.
Sergio Traversa: When he's finished the other answer Ken gave you a little bit more details because he run.
Andy: The clinical sites. So he is more and more into the detail of the process.
Andy: And and the second question would you mind to repeat it.
Sergio Traversa: Yeah, just... The complete... The complete... The complete...
Speaker Change: Yeah, just competing.
Andy: Yes exactly.
Sergio Traversa: Yeah, well, there is clearly some competition out there, and by mostly, I mean, usually, a site does not take on three, four studies that enroll the same kind of patients. In our case, it's a little bit particular because the studies are for adjunctive treatment of depression. So the competition is much less because there are not many other programs, especially in phase three, that enroll patients in adjunctive therapy. We do believe there was one other company that finished one sizable, big study a few weeks ago, but I do believe that the majority of their studies were outside the U.S., so there was relative competition.
Andy: Yeah, well there is clearly.
Sergio Traversa: Do you have some competition out there and the by the mostly.
Sergio Traversa: Usually decide does not.
Sergio Traversa: You cannot have does not take on day three four.
Sergio Traversa: Studies that enrolled the same kind of patients are in.
Sergio Traversa: In our case, it's a little bit, particularly out of because we are doing the studies out for adjunctive treatment of depression. So the desk. The competition is it's much less so as the and then on many other program, especially in phase III that.
Sergio Traversa: That enrolled patients in that is adjunctive, we do believe there was one.
Sergio Traversa: One other company that finished the one sizable now big study.
Sergio Traversa: A few weeks ago, and but I do believe that the majority of their sides of our outside the U S. So there was relative competition there was not an antidepressant anyway.
Sergio Traversa: It was not an antidepressant anyway. We keep on hearing that the psychedelic, psilocybin, there are a lot of trials ongoing with psilocybin in depression. It is not really a direct competitor, but still, it keeps the sites busy. And it's high-dose psilocybin for PTSD and MDD.
Sergio Traversa: We keep on hearing that the you know the psychedelic the silo side being.
Sergio Traversa: Then I had a lot of trial and ongoing with silo side being in depression that is not really a direct competitor, but it's still it's a it gives the site decides BZ and has high high those silos IBM for a PTSD and.
Sergio Traversa: And and M D D.
Sergio Traversa: So to summarize, yes, there is competition, but we are in a specific indication where the competition is much lower.
Sergio Traversa: So to summarize yes, there is competition, but we are in that unit specific.
Sergio Traversa: Pick indication, where the competition is much is much lower and Andy would you mind to provide little bit more color.
Andrea R. Tan: Yes. I'll answer the second one first, and that is that Sergio is exactly right. At the site level, you don't want to take too many competing studies. Usually, though, the study criteria are different enough that you can do, say, two or three depression studies without significantly impairing because a patient will more clearly fit into one protocol than another. So as far as the first question is concerned, I don't have the exact number of sites that we've closed down offhand. However, sites do close for various reasons.
Sergio Traversa: The second I'll answer the second one first and that is that.
Andrea R. Tan: So Joe is exactly right at the site level, you don't want to take too many competing studies.
Andrea R. Tan: Usually though the study criteria are different enough that you can do say two or three depression studies without significantly impairing does a patient will more clearly fit into one protocol than another.
Andrea R. Tan: So as far as the first question I don't have the exact number of sites that we've.
Andrea R. Tan: Closed down off hand, but sites to close for various reasons. So that's certainly true.
Andrea R. Tan: That's certainly true, but we have stopped enrollment at a couple of sites. I can say that, but it's not a lot, fortunately. And I think some of it is simply the process of overseeing the sites. Now, the sites know that they're being watched. They know that we're monitoring quality, and that often changes the behavior enough so that significant corrective action isn't necessary.
Andrea R. Tan: But we have we have stopped enrollment at a couple of sites I can say that but it's not a lot Fortunately and I think some of it is simply the process of overseeing the sites now the sites know that they're being watched.
Andrea R. Tan: I know that we're monitoring quality and that often changes the behavior enough. So that you know significant corrective action isn't isn't necessary.
Sergio Traversa: Got it. Yeah, that makes sense. And then, regarding the phase one thylacidin program that you're going to be kicking off soon, can you describe the study design and what positive data would entail?
Andrea R. Tan: Yeah.
Speaker Change: Got it yeah that makes sense.
Sergio Traversa: And then I guess regarding the Facebook Tyler Seidman program that youre going to be kicking out soon can you describe the study design and with positive data would entail.
Sergio Traversa: And yes, it's very simple. We'll start with phase one, a single dose of psilocybin modified release. So the interesting part is the patient population or the technically phase one, you do it in a healthy volunteer, but it's well known that psilocybin is a relatively safe product at high doses, and we are using a dose very, very much, much lower, like 120th or 130th of the dose that is used as a psychedelic for the treatment of psychiatric diseases.
Sergio Traversa:
Sergio Traversa: Yes, it's very simple will start.
Sergio Traversa: With the phase one single dose the sending dose of psilocybin modified release, so the interesting part.
Sergio Traversa: Part is the patient population already technically phase one you do it in the healthy volunteer and but is well known that silo side being as a relatively safer.
Sergio Traversa: Save product at high dose and we're using a dose very much much lower at 120 of the 130th of the of the dose that is used as a as a psychedelic for the treatment of psychotic.
Sergio Traversa: So on the safety side, we feel extremely comfortable, but the indication that we'll pursue for psilocybin is into the metabolic space, so obesity, glucose, and fatty liver. So the data that we are looking for is mostly PK data in obese patients. So the particular patient population that will be obese, healthy volunteers. And we should start it in the next month or two. We said it would be within the first half. So we are getting, it is a short study. So the whole study will last for three, four months maximum.
Sergio Traversa: Diseases. So on the safety side, we feel extremely comfortable and but the indication they will pursue per silo side being is there is in the metabolic space, so obesity and glucose and fatty liver. So the data that are we are looking for is the mostly PK.
Sergio Traversa: And date that in obese patients. So the particular is the is the the patient population that would be obese healthy volunteer.
Sergio Traversa: And we should start over the next month or two.
Sergio Traversa: Okay, We said within the first half so we're getting there.
Sergio Traversa: Here's a short study so the old study, we lost like three or four months maximum.
Speaker Change: Excellent. Thank you.
Speaker Change: Thank you.
Operator: Ladies and gentlemen, as a reminder, if you'd like to ask a question, please press the star, followed by one. Your next question comes from Luier, from Brazil. Please go ahead.
Sergio Traversa: Ladies and gentlemen, as a reminder, if you'd like to ask a question. Please press star followed by one. Your next question comes from Luis <unk> from Mizuho.
Luier: Please go ahead.
Charles Hunter-Oy: Hi, this is Charles Hunter-Oy. I had a question about the screening failure rate and if you think that's going to kind of stay at 80 throughout the study enrollment. And then also, if you could clarify if the Reliance 2 screening failure rate was also 50% before the new protocol. Thank you.
Operator: Hi, This is Charles on her Oi.
Charles Hunter-Oy: I had a question about kind of the screening failure rate and if you think that's going to kind of stay at 80 throughout this study enrollment and then also if you could clarify if reliance to screening failure rate was also 50% before the new protocol.
Speaker Change: Thank you.
Sergio Traversa: Hey, Charlie, thanks for the question. And so the, yeah, the screening failure rate is high, but, you know, we look at the reasons for the screening failure, and they are, they are legitimate reasons, right? It's usually a drug drug interaction or concomitant medication. So, yeah, these are legitimate reasons not to enroll in the study. And most of the screening failures actually come from the site.
Speaker Change: Hey, Charlie Thanks for the question.
Sergio Traversa: So.
Sergio Traversa: So D. The screening failure is at its high but we look at the the reason for the screening failure and they are they are legitimate.
Sergio Traversa: Uh huh.
Sergio Traversa: Reasons, why it's usually a drug drug interaction or concomitant, mostly it's concomitant medication. So yeah. These are these are legitimate reason not to not to enroll in the in the study and most of it is still the screening failure, they actually come from the site.
Sergio Traversa: And with that said, we are constantly reviewing, and we listen very carefully to the feedback from the site. And if there is anything that we can do to increase the enrollment rate or decrease the screening failure, but without decreasing the quality or increasing the risk of the trial, we have been doing that.
Sergio Traversa: And with that said are we adding constantly review and we listen very carefully to the feedback from the sites and there is anything that we can do to incur.
Sergio Traversa: Increase the enrollment rate or decrease the screening failure, but without decreasing the quality and an increase in the risk of the trial. We have been doing that so the you know there are certain things that have been especially beyond the drug drug interaction that they or concomitant medications.
Sergio Traversa: So, the, you know, there are certain things that have been, especially drug-drug interaction that or concomitant medication more than interactions that have been changing over time. So, the, that should facilitate communication and these are the back and forth from the company and the site. So, they give us feedback, and we see patients with that characteristic that it's a, it could fit into the trial, but we cannot put it in.
Sergio Traversa: Jordan interaction that that have been have been changing over time, so the that should facilitate and data or is it back and forth from the company and and the site. So they gave us feedback and we see patient with that characteristic that it's a it could fit into the trial, but we cannot put it in.
Sergio Traversa: Because of the inclusion exclusion, so we revised and, in dialogue with the FDA, of course, we have made a few detailed revisions of the product all over time. So we don't know what we'll do about the screening failure, but definitely there is a chance that we could get a little better. And the second question was at the beginning.
Sergio Traversa: Because of the inclusion exclusion so we'd revise ending a dialogue with the FDA of course, we have made in the if you like details the Arab.
Sergio Traversa: We even have the protocol over time, so we don't know what we'll do to the screening failure, but definitely.
Sergio Traversa: Definitely there is a chance that we could get a little better and the second question was at the beginning.
Sergio Traversa: That's a great question, but I don't have the answer on the top of my head and the screening failure on the, at the beginning of three or two. Probably there are not like a lot of patients enroll, so I don't know how much that number is. It's meaningful, but maybe Andy or maggot if they have some more calls on that. It is screening failure on the study CO2 before we amend
Andy: Yeah, that's a great question, but I don't have the answer on the top of my head and and.
Sergio Traversa: And it did the screening failure on the at the beginning of three or two probably they are not like a lot of patients enrolled so I don't know how much that number is.
Sergio Traversa: It is meaningful, but maybe andy or maggot, if they have some more color on that.
Sergio Traversa: I mean, there's screening failure on the study's hereto before we amended the protocol.
Andrea R. Tan: I don't believe it was quite the, you know, go ahead, Maged, sorry. Go ahead, Andy. Yeah, I don't, it was certainly not quite as high. I don't want to, you know, put a number out there without confirming with our internal team, so we'll have to get back to you.
Speaker Change: I don't believe it.
Maged: Yeah go ahead, Mike Sorry go ahead, Andy Yeah. It was certainly not quite as high I don't want to put a number out there without confirming with our internal team.
Andy: So we'll have to get back to you.
unknown: Goodman, Yatin Suneja, Guofang Li, Sergio Traversa, Timothy McCarthy, Relmada, Yatin
unknown: !!musiC!!]!!musiC!!!!musiC!!
Maged: Yes, exactly but I would not be put off by the squeeze we're trying to find the right patients.
Speaker Change: Critically important patient selection is absolutely the source of failures and studies.
Sergio Traversa: Okay, right. And Yeah, as we mentioned in some of our calls, the big one of the biggest changes we made to the protocol is that there is now a requirement for medical and pharmacy records. And that by itself increases the screening failure, but also, at the same time, you are relatively comfortable that that patient comes from, like from a doctor that has diagnosed and prescribed medication, and that the patient actually purchased the medication from the pharmacy. So the two things go together, like high screening failure, but there is clearly an improvement in the risk profile of the patients enrolled. I hope that answers your question. Yeah, thank you.
unknown: Okay.
Sergio Traversa: Yes, we mentioned that.
Sergio Traversa: In some of our calls by the Big one of the biggest change. It amendment, we made to the protocol is that there is now a requirement for medical and pharmacy records and that's by itself.
Sergio Traversa: Increase the screening failure, but also at the same time.
Sergio Traversa: The you are relatively comfortable that that patient comes from like from a doctor that is diagnosed and prescribed medication and that the patient that actually.
Sergio Traversa: Purchase the medication from the pharmacy, so the two things they go together by high screening.
Sergio Traversa: Failure, but there is clearly an improvement in the risk profile of the patients enrolled.
Sergio Traversa: That answer your question.
Speaker Change: Yeah. Thank you.
Sergio Traversa: Okay.
Sergio Traversa: There are no further questions at this time. I'll turn it back to Sergio for closing remarks.
Sergio Traversa: There are no further questions at this time I'll turn it back to Sergio for closing remarks.
Sergio Traversa: Thank you. And, in summary, we continue to firmly believe that we have an approvable drug in REL1017. And we are excited by the potential of our novel psilocybin derivative program. We look forward to reporting on further progress with our pipeline throughout the remainder of 2024. I do remain grateful to the Relmada team for their continued hard work and dedication to executing on our mission. Also, as always, 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 through development. Thanks a lot to everyone for their attention and interest, and I'm looking forward to the next one.
Sergio Traversa: Thank you and then in summary, we continue to firmly believe that we have an approvable drug in <unk>.
Sergio Traversa: And we are excited by the potential of our novel Psilocybin the rehab program.
Sergio Traversa: We look forward to reporting on further progress with our pipeline throughout the remainder of 2024.
Sergio Traversa: I do remain grateful to the <unk> team for their continued hard work and dedication to executing on our mission.
Sergio Traversa: Also as always I would like to extend my sincere thanks to the patients and clinical partners involved in the route 10 17 trials for their participation in the advancement of these promising investigational medicine through development tankers. Thanks, a lot to everyone for the attention and the interest and looking.
Sergio Traversa: Forward to the next.
Sergio Traversa: Scott.
Sergio Traversa: Okay.
Operator: Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.
Speaker Change: Ladies and gentlemen, this concludes your conference call for today, we thank you for participating and ask that you. Please disconnect your lines.