Q2 2024 Relmada Therapeutics Inc Earnings Call
Breaking news about bad weather. Mother Nature Angry Caught on Camera top 5 and top 10 and Top 10. Extreme weather 2021 recipient10PetersenSo?PeteHugo 1010PeteHugo 2021.10. 10-K imberly-Alexandria, TX Not summer No winter, no tomorrow
Unknown Executive: Welcome to the Ramada through your Putex Inc.
Good afternoon.
Unknown Executive: 2nd quarter, 2020 for Erning's conference call. At this time, online search and listen-only mode. Following the presentation, we welcome back a question-and-answer session. If at any time during this call you require immediate assistance, these presses store zero for the operator.
Speaker Change: Welcome to the Relmada Therapeutics, Inc. 2nd Quarter 2020 Earnings Conference Call.
Speaker Change: At this time, all lines are in a 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.
Unknown Executive: The call is being recorded on Wednesday, August 7, 2024.
Tima Cordy: I would now like to turn the conference over to Tima Cordy, Lifestyle Advisors. Please go ahead, sir. Thank you, operator, and thank you for joining us this afternoon. With me on today's call, our Dr. Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer.
Speaker Change: This call is being recorded on Wednesday, August 7, 2024. I would now like to turn the conference over to Tim McCarty, Lifesign Advisors. Please go ahead, sir.
Timothy McCarthy: Thank you, Operator, and thank you all for joining us this afternoon. With me on today's call are Dr. Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer. This afternoon, Relmada issued a press release providing a business update and announcing financial results for the quarter ended June 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, Relmada's management team will be making forward-looking statements.
Tim McCarty: Thank you operator and thank you all for joining us this afternoon. With me on today's call are Dr. Sergio Traversa, Chief Executive Officer, and Maged Shenouda, Chief Financial Officer.
Unknown Executive: Definite and Ramada issue, the press release providing a business update announcing financial results for the quarter-ended June 30th, 2024. Please note that certain information discussed on the call today is covered under the safe harbor's 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. As the 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 Ramada's press release issued today and the company's SEC filings, including the annual report on Form 10-K for the year ended December 31, 2023, and with subsequent filings, including the second quarter, 2024, 10-K filed after the close today.
Speaker Change: This afternoon, Relmada issued a press release providing a business update announcing financial results for the quarter ended June 30, 2024.
Speaker Change: Please note that certain information discussed on the call today is covered under the Safe Harbor's 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.
Speaker Change: 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.
Speaker Change: 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
Speaker Change: In the annual report on Form 10-K for the year ended December 31, 2023, and with subsequent filings including the second quarter 2024, 10-Q filed after the close today.
Unknown Executive: This conference call also contains time-sensitive information that is accurate only as of the date of this lab broadcast on August 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.
Speaker Change: This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast on August 7, 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.
Sergio Traversa: Now we'd like to turn on the call or the Sergio. Thank you, team, and thanks to everyone for taking time to join us this afternoon. Ramada is dedicated to the development of transformative medicine for people living with central nervous system disorder, and I'm pleased to report that Ramada's clinical program has made meaningful progress over the last five months. We believe that the portfolio led by the phase 3 program for REL1017 as a potential adjunctive treatment for major depressive disorder, or MDD, is poised to reach several important milestones when we are encouraged by the company's progress.
Speaker Change: Now I'd like to turn the call over to Sergio. Sergio?
Sergio Traversa: Thank you, Tim. And thanks to everyone for taking the time to join us this afternoon.
Sergio Traversa: Thank you, Tim, and thanks to everyone for taking time to join us this afternoon.
Sergio Traversa: Relmada is dedicated to the development of transformative medicine for people living with central nervous system disorder and I'm pleased to report that Relmada's clinical program has made meaningful progress over the last five months.
Sergio Traversa: We believe that the portfolio led by the Phase 3 program for REL 1017 as a potential adjunctive treatment for major depressive disorder, or MDD, is poised to reach several important milestones, and it will complete the study package required to file the SDA, the NDA. Discuss the planned interim analysis, planned by year-end 2024 for the Reliance II set, and review the timing to complete enrollment in the two phase three studies in the REL 1017 program.
Sergio Traversa: We believe that the portfolio led by the Phase III program for RELM 1017 as a potential adjunctive treatment for major depressive disorder, or MDD, is poised to reach several important milestones.
Sergio Traversa: As a quick reminder, REL1017 is a small molecule that preferentially blocks a hyperactive brain channel called NMDA receptor that is associated with MDT. REL1017 has been designed to rapidly improve symptoms and provide these patients with a new treatment option on top of their current regimen. Completing the phase 3 program for REL1017 is Ramada's number one objective, and it will complete a study package required to file the NDA. During today's call, we will discuss the plans in trim analysis, planned by your end, 2024 for the REL1017 study. Review the time into complete enrollment in the two Phase 3 studies in the REL1017 program.
Sergio Traversa: We are encouraged by the company's progress.
Speaker Change: As a quick reminder, REL1017 is a small molecule that preferentially blocks a hyperactive brain channel called NMNDA receptor that is associated with MDT.
Speaker Change: ResNet-17 has been designed to rapidly improve symptoms and provide these patients with new treatment options on top of their current regimen.
Speaker Change: Completing the Phase 3 program of RHEL 1017 is Relmada's number one objective.
Speaker Change: And it will complete the study package required to file the NDA.
Speaker Change: During today's call, we will discuss the planned interim analysis planned by year-end 2024 for the Reliance II study.
Speaker Change: Review the timing to complete enrolment in the two Phase III studies in the REL 1017 programme.
Sergio Traversa: Outlight timing to initiate a Phase I study for Bababa Prophecylocybin Program, RELP11, in development for metabolic diseases, and comments on our cash balance, which we expect to support our planet operation into 2025 and several key clinical milestones, especially for the RELTS-17 program.
Sergio Traversa: Outline the timing to initiate a phase one study for our proprietary psilocybin program, RELP11, in development for metabolic diseases, and comment on our cash balance, which we expect to support our planned operation into 2025 and several key clinical milestones, especially for RELP1017. After that, I will make a few closing remarks, and then we will open the call for you, starting with RAL 1070.
Speaker Change: outlining timing to initiate a phase one study for our proprietary psilocybin program, RELP-11, in development for metabolic diseases, and comments on our cash balance, which we expect to support.
Speaker Change: Our planned operation into 2025 and several key clinical milestones, especially for the REL 1017 program.
Sergio Traversa: I'll briefly review our program, and in a few minutes, Maged will provide you with a summary of our second-order financial. After that, I will make a few closing remarks, and then we will open the call for your questions. Starting with the RELTS-17, we are enrolling two people without Phase III studies for RELTS-17, Reliance through and relight. This study is built on positive Phase II data with RELTS-17 for the transitive treatment of depression. Our clinical data set also demonstrated a RELTS-17 is well tolerated, with no indication of abuse potential. Our ongoing Phase III studies are designed to assess the impact of RELTS-17 of the mattress core as an indicator of depression severity.
Speaker Change: I'll briefly review our program, and in a few minutes, Maged will provide you with a summary of our second quarter financial.
Maged Shenouda: After that, I will make a few closing remarks and then we will open the call for your questions.
Maged Shenouda: starting with RAL 1017.
Maged Shenouda: We are enrolling two Pivotal Phase III studies for Routes 1017.
Maged Shenouda: Reliance You and Relight
Maged Shenouda: This study is built on positive phase 2 data with REL1017 for the junctive treatment of depression.
Maged Shenouda: Our clinical data set also demonstrated that RAL1017 is well tolerated with no indication of abuse potential.
Maged Shenouda: Our ongoing phase 3 studies are designed to assess the impact of REL1017 of the Madras score as an indicator of depression severity.
Sergio Traversa: The studies are evaluating RELTS-17 in patients with documented clinical depression undergoing treatment with an approved antidepressant. Each of the ongoing studies, Reliance through and Relight, is enrolling up to 340 subjects. The studies are randomized once-in-one and designed and powered to detect two to and a half points delta in the Madras core at day 28. The protocols have been totally designed to incorporate several elements intended to de-risk each study with a thorough patient adjudication process. As a snapshot, the features that we have emphasized in the reliance to and relight studies are focused on optimizing the protocol, carefully selecting study sites and monitoring the number of patients per site, and most importantly, carefully verifying the diagnosis of depression and each patient's medical history to ensure enrollment of patients with clinical depression.
Unknown Executive: The studies are evaluating BREL-1017 in patients with documented clinical depression undergoing treatment with an approved antidepressant. Each of the ongoing studies, Reliance II and Relight, is enrolling up to 340 subjects. The protocols have been thoughtfully designed to incorporate several elements intended to de-risk each study with a thorough patient adjudication process and, most importantly, carefully verifying the diagnosis of depression and each patient's medical history to ensure enrollment of patients with clinical depression. We have been especially focused on defining the patient enrollment criteria with extra.
Maged Shenouda: The studies are evaluating BREL-1017 in patients with documented clinical depression undergoing treatment with an approved antidepressant.
Maged Shenouda: Each of the ongoing studies, Reliance II and Relight, is enrolling up to 340 subjects.
Maged Shenouda: The studies are randomized one-to-one and designed and powered to detect two 2.5 points delta in the Madras score at date 28.
Maged Shenouda: The protocols have been thoughtfully designed to incorporate several elements intended to de-risk each study with a thorough patient adjudication process.
Maged Shenouda: As a snapshot, the features that we have emphasized in the Reliance II and Reliance studies are focused on optimizing the protocol,
Maged Shenouda: Careful selecting study sites and monitoring the number of patients per site.
Maged Shenouda: And most importantly, carefully verifying the diagnosis of depression and each patient's medical history to ensure enrollment of patients with clinical depression.
Sergio Traversa: We have been especially focused on defining the patient enrollment criteria with extra care. The current protocols include a review of medical and pharmacy records. The studies also require that patients have been treated with an approved antidepressant for at least six weeks and have experienced an improvement of less than 50% since starting treatment. Adoption of these elements has increased our confidence that we are appropriately enrolled in the most suitable patients into Reliance to and Relight. As the results of these efforts, changing in the screen-fader rate can be considered one way to assess the stringency of the enhanced enrollment criteria.
Maged Shenouda: We have been especially focused on defining the patient enrollment criteria with extra care.
Unknown Executive: The current protocols include a review of medical and pharmacy records. Adoption of these elements has increased our confidence that we are appropriately enrolling the most suitable patients into RADIA II and RADIA III. As a result of these efforts, changing the screen fader rate can be considered one way to assess the stringency of the Enhanced Envolvement Criteria. And so today, we are observing an approximately 80% screen failure rate.
Maged Shenouda: The current protocols include a review of medical and pharmacy records.
Maged Shenouda: The studies also require that patients have been treated with an approved antidepressant for at least six weeks and have experienced an improvement of less than 50% since starting treatment.
Maged Shenouda: Adoption of these elements has increased our confidence that we are appropriately enrolling the most suitable patients into RADIA II and RELITE.
Speaker Change: As a result of these efforts, changing in the screen fader rate can be considered one way to assess the stringency of the Enhanced Envolvement Criteria.
Sergio Traversa: As of today, we are observing an approximately 80% screen-fader rate versus a 50% screen-fader in the Reliance One study. We intend to reach two important milestones by end of the year, reporting the output of a three planned in-tree analysis and completion of enrollment of reliance. and Sue. We expect completion of enrollment being realized to follow approximately six months after that. The pre-planned interim analysis of reliance to study is intended to be a de-reskin tool to increase the probability of a successful study outcome. The analysis will include a futility analysis and a sample size re-assessment, if necessary, with the potential to adjust the sample size to ensure proper statistical powering.
Maged Shenouda: And so today, we are observing an approximately 80% screen failure rate.
Maged Shenouda: versus a 50% screen failure in the Reliance One study.
Unknown Executive: We intend to reach two important milestones by the end of the year, reporting the output of a pre-planned interim analysis and completion of enrollment in Reliance. We expect completion of enrollment in real life to follow approximately six months later. The preplanned interim analysis of the Reliance II study is intended to be a de-risking tool to increase the probability of a successful study outcome, with the potential to adjust the sample size to ensure proper statistical analysis. There are three potential outcomes from the interim analysis. The study is futile. We will conduct the interim analysis and expect to report the outcome of this analysis before year-end 2020. Now, I would like to spend a few moments on Raoul P. Illes.
Maged Shenouda: We intend to reach two important milestones by end of the year, reporting the output of a pre-planned interim analysis and completion of enrollment over the next two years.
Maged Shenouda: We expect completion of enrollment in real life to follow approximately six months after that.
Maged Shenouda: The pre-planned interim analysis of Reliance II study is intended to be a de-risking tool to increase the probability of a successful study outcome.
Speaker Change: the analysis will include a futility analysis and the semple size reestimation if necessary
Maged Shenouda: with the potential to adjust the sample size to ensure proper statistical powering.
Sergio Traversa: There are three potential outcomes from the interim analysis. The study is futile; the study can continue with the addition of a certain number of patients, and the study can continue with the pre-planned number of patients that, of course, is what would be our preferred outcome. We will conduct the interim analysis and expect to report the outcome of these analysis before ear end of 2024.
Maged Shenouda: There are three potential outcomes from the interim analysis. The study's futile.
Speaker Change: The study can continue with the addition of a certain number of patients, and the study can continue with the pre-planned number of patients. That of course is what would be our preferred outcome.
Speaker Change: We will conduct the interim analysis and expect to report the outcome of this analysis before year-end 2024.
Sergio Traversa: Now we would like to spend a few moments on RALP 11. We identified the metabolic activity of RALP 11 as sort of a pre-clinical evaluation on its potential effect on neurodegenerative disease. As a pre-crinder, RALP 11 is a low dose, modified, reduced formulation of silocybin. Compaling data from a recognized pre-clinical rodent model of metabolic dysfunction associated with the Atotic liver disease, or M-A-S-L-D. Published last year, as November at the American Association for the Study of Liver Disease, is the cornerstone of our problems. These data show that RALP 11 is a benefit on multiple metabolic parameters, including triglyceride levels and glucose metabolites.
Speaker Change: Now I would like to spend a few moments on RALP-11.
Speaker Change: we identified the metabolic activity of well p leit a sort of a pretyclinic ivaluation on its potentional effect on neuro the general cdisease
Unknown Executive: As a quick reminder, RALP11 is a low-dose, modified-release formulation of silos. Compiling data from a recognized preclinical rodent model of metabolic dysfunction associated with athertic liver disease, or MASLD. This data led to our evaluation of P11 as a candidate for the treatment of metabolic disorders such as obesity. We expect to complete the Phase I SAD-TED study and initiate the Phase II-A study in H1 first half of 2020.
Speaker Change: As a quick reminder, RALP11 is a low-dose, modified-release formulation of psilocybin.
Speaker Change: Compiling data from a recognized preclinical rolling model of metabolic dysfunction-associated steatotic liver disease, or MASLD.
Speaker Change: Published last year in November at the American Association for the Study of Liver Disease is the cornerstone of our program.
Speaker Change: This data shows that RELP-11 has a benefit on multiple metabolic parameters, including triglyceride levels and glucose metabolism.
Sergio Traversa: Beside reducing stethosis of the liver, RALP 11 reduced blood glucose and body weight without producing any side effect on the CNNs. These data led to our valuation of P-11 as a candidate for the treatment of metabolic disorder such as obesity.
Speaker Change: Besides reducing steatosis of the liver.
Speaker Change: Relm P-11 reduced blood, glucose, and body weight without producing any side effects on the CNS.
Speaker Change: These data led to our evaluation of P11 as a candidate for the treatment of metabolic disorders such as obesity.
Sergio Traversa: We plan to initiate the Phase I single ashen is dosing, or as a study in this subject, for RALP 11 shortly. The Phase I study was defined as the pharmacokinetic, safety, and dollar-ability profile for RALP 11, and allow us to select a dose for evaluation in the Phase II-A approval concept study. We expect to complete the Phase I-S-A-D sad study and initiate the Phase II-A study in H1 first half of 2025.
Speaker Change: We plan to initiate the Phase I Single-Agenda Dosing or SAD study in this subject for RELP-11 shortly.
Speaker Change: The Phase I study will define the pharmacokinetic safety and tolerability profile for RELP-11 and allow us to select a dose for evaluation in the Phase IIa Approval Concept Study.
Speaker Change: We expect to complete the Phase 1 SAD-TAD study and initiate the Phase 2A study in H1 first half of 2025.
Maged Shenouda: Now, I would like to turn the call over to our Chief Financial Officer, Maggie Shnewden, to review our recent financial results. Maggie? Thank you, Sergio.
maggh newa: Now, I would like to turn the call over to our Chief Financial Officer, Maged Shenouda, to review our recent financial results.
Maged Shenouda: This afternoon, we issued a press release announcing our business and financial results for the three and six months ended June 30, 2024. During today's call, I will provide a brief overview of the three-month financial results. Full details are available in our press release and 10-Q filing on our website, located in the news and SEC filing tabs of the investor release. Research and Development Expense for the three months ended June 30, 2024, was approximately $10.7 million, compared to $13.7 million for the same period in 2023, a decrease of $3 million. The decrease was primarily driven by decrease in study costs associated with the completion of two phase three trials, and the long-term open label safety reliance three trials for study through ten.
maggh newa: Magid.
Magid: Thank you, Sergio. This afternoon, we issued a press release announcing our business and financial results for the three and six months ended June 30, 2024. During today's call, I will provide a brief overview of the three-month financial results.
Maged Shenouda: During today's call, I will provide a brief overview of the three-month financial results. Full details are available in our press release and 10-Q filing on our website, located in the News and SEC Filings tabs of Investor Relations. Before we go to your questions, I'll turn back to Sergio to make a few closing comments.
Speaker Change: Full details are available in our press release and 10-Q filing on our website located in the news and SEC filings tabs of the investor relations page.
Speaker Change: Research and development expense for the three months ended June 30, 2024 were approximately $10.7 million, compared to $13.7 million for the same period in 2023, a decrease of $3 million.
Speaker Change: The decrease was primarily driven by a decrease in study costs associated with the completion of two phase 3 trials and the long-term open label safety Reliance 3 trial or study 310.
Maged Shenouda: General and administrative expense for the three months ended June 30, 2024, were approximately $8.1 million, compared to $12.3 million for the same period in 2023, a decrease of approximately $4.2 million. The decrease was primarily driven by a decrease in stock-based compensation expense. The net loss for the three months ended June 30, 2024, was $17.8 million, or $59 per basic and diluted share, compared with a net loss of $25.3 million, or $84 per basic and diluted share for the same period in 2023. I will also note that the company had $30.17 million common shares outstanding as of August 2, 2024.
Speaker Change: General and administrative expense for the three months ended June 30, 2024, were approximately $8.1 million, compared to $12.3 million for the same period in 2023, a decrease of approximately $4.2 million.
Speaker Change: The decrease was primarily driven by a decrease in stock-based compensation expense.
Speaker Change: The net loss for the three months ended June 30, 2024, was $17.8 million.
Speaker Change: or 59 cents per basic and diluted share, compared with a net loss of $25.3 million or 84 cents per basic and diluted share for the same period in 2023.
Speaker Change: I will also note that the company had 30.17 million common shares outstanding as of August 2nd, 2024.
Maged Shenouda: As of June 30, 2024, Rahul Mata had cash, cash equivalents, and short-term investments of approximately $70.4 million, compared to $96.3 million as of December 31, 2023. Cash use and operations for the second quarter was $13.3 million. Based on our current clinical development plans, we believe our current cash position is adequate to support operations into 2025 through key milestones, including the top-line data from the Reliance 2 study.
Speaker Change: As of June 30, 2024, Relmada had cash, cash equivalents, and short-term investments of approximately $70.4 million, compared to $96.3 million as of December 31, 2023.
Speaker Change: Cash used in operations for the second quarter was $13.3 million.
Speaker Change: Based on our current clinical development plans, we believe our current cash position is adequate to support operations into 2025 through key milestones including the top-line data from the Reliance II study.
Sergio Traversa: Before we go to your questions, I'll turn back to Sergio to make a few closing comments. Sergio. Thank you, Maggie.
Speaker Change: Before we go to your questions, I'll turn back to Sergio to make a few closing comments. Sergio?
Sergio Traversa: As we conclude the prepared remarks on this afternoon's call, I would like to leave you with a few key messages. Our two Phase 3 studies for our lead program, REL1017 for MDD, have been totally designed and are being carried out with appropriately adjudicated patients. We potentially there is the studies. We expect two important milestones from the Reliance 2 study. Before the end of the year, with the output of a pre-planned interim analysis, which includes both the futility analysis and the simple size of the estimation, if necessary, and the completion of enrollment of the Reliance 2 study.
Sergio Traversa: Thank you, Maged.
Sergio Traversa: As we conclude the prepared remarks on this afternoon's call, I would like to leave you with a few key messages.
Sergio Traversa: Our two phase three studies for our lead program, RALS 1017 for MDD, have been thoughtfully designed and are being carried out with appropriately adjudicated patients. We potentially have the study.
Sergio Traversa: Our two phase three studies for our lead program, RALS 1017 for MDD, has been thoughtfully designed and are being carried out with appropriately adjudicated patients. We potentially, there is the studies.
Sergio Traversa: We expect two important milestones from the Reliance II study before the end of the year, with the output of a pre-planned interim analysis, which includes both a futility analysis and a simple size re-estimation, if necessary. We expect completion of enrollment in RELI to follow approximately six months later. Preparation of the truck to begin the clinical program for RALP-11, our proprietary and silo-sided formulation for metabolic disorders, later this quarter or early next year. We believe our financial resources will support our planned operations into 2020 through key milestones, including top-line data from the Reliance study. Hello, operator, are you there?
Sergio Traversa: We expect two important milestones from the Reliance II study before the end of the year, with the output of a pre-planned interim analysis, which includes both a futility analysis and a simple size re-estimation, if necessary.
Sergio Traversa: We expect completion of enrollment of Reliance to follow approximately six months after that.
Sergio Traversa: and the completion of enrollment of the Reliance II study.
Sergio Traversa: We expect completion of enrollment of Reliance to follow approximately six months after that.
Sergio Traversa: Preparation of the truck to begin the clinical program for RELP 11, our proprietary and silo-sided formulation for metabolic disorders, later this quarter or early next quarter. We believe our financial resources will support our planet operations into 2025 through key milestones, including top-light data from the Reliance 2 study.
Speaker Change: Preparation of the truck.
Speaker Change: to begin the clinical program for RALP-11, our proprietary cytoside formulation for metabolic disorders, later this quarter or early next quarter.
Speaker Change: We believe our financial resources will support our planned operations into 2025.
Sergio Traversa: through key milestones, including top-line data from the Reliance study.
Unknown Executive: At this point, operator, we can open the call for... questions.
Speaker Change: At this point, Operator, we can open the call for questions.
Unknown Executive: Hello, operator, you're there? Apologies.
Speaker Change: Hello, operator, are you there?
Operator: Apologies. And ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press a star followed by the number one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press a star followed by the number two. One moment, please, for your first question.
Unknown Executive: And ladies and gentlemen, we will not begin the question in that answer session. To ask a question, you may press a star followed by the number one on your telephone keypad. If you're using a speaker phone, please speak up for your handset before pressing any keys. Then we do all your questions. These press a star followed by the number two. One moment, please, for your first question.
Speaker Change: Apologies. And ladies and gentlemen, we will now begin the question and answer session. To ask a question, you may press the star followed by the number one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing any keys.
Speaker Change: To withdraw your question, please press star followed by the number two. One moment please for your first question.
Mark Goodman: Your first question comes from the line of Mark Goodman with Living Partners. Please go ahead. Thanks for taking my question.
Speaker Change: Your first question comes from the line of Mark Goodman with Living Partners. Please go ahead.
Rudy: Thanks for taking my question. This is Rudy on the line for Mark. Can you remind us the baseline measures for the ongoing Reliance 2 study and how that compares with the Phase 2 Identity MDT trial and the Phase 3 Reliance 1 study? Thanks.
Sergio Traversa: This is Rudy on the line for Mark. Okay, can you remind us the base nine measures for an ongoing Relies Two study and how that compares with the Phase Two attend the MDD trial and the Phase Three Lines One study. Thanks. But thank you for the question. And so the baseline madras average when the patient's population starts, they're very similar. It's right in the mid 30s, like 33-34 range for all the studies. That's pretty typical for the depression studies. Got it.
Speaker Change: Thanks for taking my question. This is Rudy on the line from Merck. Okay, can you remind us the baseline measures for an ongoing Reliance 2 study and how that compares with the Phase 2 Identity MDT trial and the Phase 3 Reliance 1 study? Thanks.
Unknown Executive: But thank you for the question. And so the baseline Madras average, when the patient population starts, they're very similar. It's right in the mid thirties, like, thirty three, thirty four range for all the studies. That's pretty typical for
Speaker Change: Thank you for the question and so the baseline Madras average when the patient's population starts they are very similar it's right in the
Speaker Change: Meet 30s like 33 34 range for all the studies. That's pretty typical for Depression studies
Unknown Executive: Yes, just a quick follow-up. We'll give you the confidence that Reliance will finish enrollment six months after Reliance 2 and with a potential simple size re-estimation impact.
Sergio Traversa: Yes, just a quick follow up. We'll give you the confidence that we're relying on finishing enrollment six months after reliance two and with a potential sample size re-assimation impacted timeline for that trial. Yeah, well, the confidence we when reliance two will be over, and if successful, as we hope, then all the resources will be put on reliance. So we have, like, close to 100 sites that will be available; of course, if we may not involve all of them. So the full resource is dedicated to the studies. And so we do our confidence that, based on the enrollment rates that we are seeing now, we can finish in about six months.
Speaker Change: areent of their su
Speaker Change: yes just a quick fulll up will give through the confidence that reigned we re finish a rom six months after to reign two and with a potential simple size reestimation impacted time life for d djob
Speaker Change: Well, the confidence that when Reliance 2 will be over...
Speaker Change: And if successful, as we hope, then all the resources will be put on Relight. So we have like close to a hundred sites that will be available. Of course, we may not enroll all of them. So like the full resource is dedicated to the studies.
Speaker Change: And so we do our confidence that based on the enrollment rates that we are seeing now, we can finish in about six months.
Sergio Traversa: And sorry, the second question was how we're confident about the timeline for the sample size re-assessment. Now, I was asking whether the sample size re-assimation will impact the timeline for the second trial. That's a good question as well. We will address it when we know how many patients we'll have to enroll, but it could, but it's probably not going to be very material. When we're talking about sample size re-assimation, we are not talking about adding like 200 patients to the study; that would be like, would be probably a problem in general. And so sample size re-assimation will evaluate how many patients we'll have to enroll.
Speaker Change: and sorry the second question was how we're confident about the time lines for the sample size reestimation
Unknown Executive: Now I was asking whether the sample size re-estimation will impact the timeline for the second trial.
Speaker Change: I was asking whether the sample size re-estimation will impact the timeline for the second trial.
Speaker Change: That's a good question.
Speaker Change: We will address it when we know how many patients we have to enroll but it could but it's probably not going to be very material. When we are talking about sample size re-estimation we are not talking about adding like 200 patients to the study.
Speaker Change: that would be like, would be probably a problem in general. And so, like, sample status re-estimation will evaluate how many, if, and how many patients we'll have to enroll.
Sergio Traversa: Got it. So the answer to your question is that it may, but it's not going to be a material timeline. It's very helpful.
Speaker Change: So the answer to your question is that it may, but it's not going to be a material timeline.
Speaker Change: Very helpful.
Andrew Chai: And your next question comes from the line of Andrew Chai with Jeffrey Skiske. Go ahead.
Andrew Tsai: And your next question comes from the line of Andrew Tsai with Jeffries. Please go ahead. Andrew, you might be on mute.
Speaker Change: And your next question comes from the line of Andrew Tsai with Jeffries, please go ahead.
Sergio Traversa: Andrew, you might be on mute. Andrew Chai? Hi, can you hear me? Yes, no, yes. Yes. Oh, hi. Thanks for taking my question. So on clinical trials, we noticed there are some changes to the estimate patient enrollment estimated patient number to 340. I think you mentioned it in the preparatory mark. So can you talk about why that number changed from 300 to 340?
Speaker Change: Andrew, you might be on mute.
Speaker Change: Andrew Chai
Andrew Chai: Hi, can you hear me?
Andrew: Yes, now, yes.
Unknown Executive: On clinical trials, we noticed there were some changes to the estimated patient enrollment number to 340. I think you mentioned it in the prepared remarks. So can you talk about why that number changed?
Andrew Chai: yes hi thanks for taking my quest so on clinical trials we noticed there are some changes to the asate pati enrollment estimated patient in one a number of twothree hundredand forty i think you mentioned it in the prepared remarks so can you talk about why that number change from three hundred three forty
Sergio Traversa: Yes, sure. Good afternoon, Andrew. Well, a clinical trial that golf is more a general like indication that it's made mostly for the FDA. And it's an indication, right? The patient population would be up to 340. It doesn't mean that we'll go to 340. You don't want to change like the update clinical trial that golf too frequently. And so you put some guidelines that you expect to be meeting, and also you have to like depends if you include dropouts and non dropouts. But the number of patients is up to 340. That doesn't mean that we have to go to 340.
Speaker Change: Yeah, sure. Good afternoon, Andrew. Well, clinicalthreat.gov is more a general indication that is made mostly for the FDA, and it's an indication, right? The patient population would be up to 340. That doesn't mean that we'll go to 340.
Speaker Change: You don't want to change the update clinicalfiles.gov too frequently, and so you put some guidelines that you expect.
Speaker Change: to be meeting and also you have to like depends if you include dropouts and non-dropout but the number of patients is up to 340 that doesn't mean that we have to go to 340.
Sergio Traversa: Assuming no sample reestimation. So I will not take that as the final number.
Speaker Change: Assuming no sample re-estimation.
Sergio Traversa: The final number would be determined by the statistical plan that we have not finalized. Usually, sent to the FDA, the statistical plan as close to the end as possible because there is no upside and defining numbers before. It depends on the enrollment rates and values parameter. So I hope I answered your question. I don't take the 340 as the final absolute number. It's up to 340. Got it. Yep, very helpful.
Speaker Change: I will not take that as the final number. The final number will be determined by the statistical plan that we have not finalized. It's usually sent to the FDA, the statistical plan.
Speaker Change: As close to the end as possible, because there is no upside in defining numbers before, depends on the enrollment rate and values parameter. So I hope I answered your question. I don't take the three four years, but the final absolute number is up to three forty.
Sergio Traversa: And it sounds like there's a futility analysis in the interim now. So did you have to change the protocol or the stats plan? Are you taking any statistical penalty with the futility option?
Speaker Change: Got it. Yep, very helpful. And it sounds like there's a futility analysis in the interim now. So did you have to change the protocol or the stats plan? And are you taking any statistical penalty with the futility option?
Sergio Traversa: Well, thanks, Andrew, for asking the question because it's very important. And then we did spend the last, I would say, a couple of months to work on the statistical plan. And I'll tell you why, because when we had in the 3301, the we had an interim review. And what we we get from the data monitoring committee was like stop the trial as early as possible. But we had absolutely no indication of what the reason for that could have been: futility or could have been efficacy. And that one was actually didn't really help from other because we stop it as indicated at the earliest. There was like 220 was 2027 patients.
Speaker Change: Thanks, Andrew, for asking the question, because it's very important. And we did spend the last, I would say, a couple of months to to work on the statistical plan. And I'll tell you why, because when we had in the study three or one.
Speaker Change: We had an interim.
Speaker Change: Review, and what we we get from the data monitoring committee.
Speaker Change: was like stop the trial as early as possible, but we had absolutely no indication of what was
Speaker Change: The reason for that could have been futility or could have been efficacy and that one was actually didn't really help.
Speaker Change: because we stopped it as indicated at the earliest, there was like 220, it was 2027 patients.
Sergio Traversa: And there was the results are not the one we were expecting. If we would have gone to the 300 plus, there was the plan. And maybe the study based on the numbers could have been statistically significant, especially because the second part of the trial was conducted when the COVID restrictions were lifted. And you may remember that the results of the last 63 patients enrolled in 301 were actually very, very good compared to the previous 165 patients. So that internal analysis was not only not very helpful, is actually create a little bit of a problem. So this time we don't want to end up in the same situation.
Speaker Change: And the results were not the one we were expecting.
Speaker Change: If we would have gone to the 300 plus that was the plan, maybe the study based on the numbers could have been statistically significant, especially because the second part of the trial was conducted when the COVID-19
Speaker Change: Restrictions were lifted and you may remember that the results of the last 63 patients enrolled in 301 were actually very, very good compared to the previous 165 patients.
Speaker Change: So that internal analysis was not only not very helpful, it actually created a little bit of a problem.
Speaker Change: So this time we don't want to end up in the same situation, so we have been very carefully planning.
Sergio Traversa: So we have been very careful carefully planning the interim analysis that we want within the boundary of what can be done. Of course, we want to get some information that can help to the risk the problem. And so we inserted the QDT analysis, so at least we want to know; we hope not, but we want to know if the satisfaction is out. Then we may decide if it is not the case to continue to preserve the cash that we already have. It is significant, the cash that we are already in our hands. And then there is a second scenario that is temporary estimation; the DMC will give us an indication, how many patients we should add to get to a likely p-value.
Speaker Change: the interim analysis. And we want within the boundary of what can be done, of course, we want to get some information that can help to de-risk the program. And so we inserted the
Speaker Change: Utility analysis. So at least we want to know, we hope not, but we want to know if the site is futile, then we may decide if it is not the case to continue to preserve you know the cash that we already have. It is significant, the cash that we are already in our hands.
Speaker Change: And then there is a second scenario that is.
Speaker Change: Temporary estimation, the DMC will give us an indication.
Speaker Change: How many patients we should add?
Speaker Change: to get to a likely p-value. Then there is the third scenario that is the one that everybody likes the most. They will tell us...
Sergio Traversa: Then there is the third scenario that is the one that most, everybody likes the most. They will tell us that we can stop the trial at the planned number of patients; it would be around the 300, 300 and 10 or whatever. The final number would be defined in the statistical analysis and statistical plan. And we will know if that would be what the DMC will tell us; we will know that the study is not futile because if it is futile, we will be informed and that we don't have to add any patients to get to a potential p-value.
Speaker Change: that we can stop the trial at the planned number of patients that would be around the 300, 310 or whatever is the final number will be defined in the statistical analysis.
Speaker Change: post information. That's the difficult plan.
Speaker Change: And we will know if that would be what the DMC will tell us. We will know that the study is not futile, because if it is futile, we will be informed.
Speaker Change: and that we don't have to add any patients to get to a potential.
Sergio Traversa: There's no guarantee that the study will succeed because we may have some more patients to add that they are not incorporated in the statistical analysis at the interim, but clearly would give some good sense that we are on the right direction. And the last of your question was the statistical penalty; there is no alpha penalty in the futility analysis because there is no analysis on the efficacy and there is no early stock, so you don't pay any alpha penalty.
Speaker Change: There's no guarantee then the study was successful because we may have some more patient to add that they are not incorporated in the.
Unknown Executive: Statistical analogy at the interim, but clearly would give some good sense that we are on the right, on the right track. Yep, thank you. And the very last one is what would be the threshold for futility if the placebo adjusted delta is below a certain level. Thank you, Andrew.
Speaker Change: the statistical analysis at the interim, but clearly would give some good sense that we are on the right direction.
Speaker Change: And the last of your questions was the statistical penalty. No, there is no alpha penalty in the futility analysis because there is no analysis on the efficacy and there is no early start. So you don't pay any alpha penalty.
Sergio Traversa: I hope it was a long answer, but I wanted to be very clear and specific of this. Yep, thank you.
Speaker Change: I hope it was a long answer, but I wanted to be very clear and specific on this.
Sergio Traversa: And very last one is what would be the threshold for futility if the placebo-adjusted delta is below a certain point on the address or DME calendar? Yeah, that's a more difficult answer, not because we don't want to, but we haven't finished or finalized the analysis. And then we get into the like a heavy, complicated statistics, but in general, we would say, we will set the futility close to what can be a non-clinically meaningful threshold, right? If the study would not have a chance to reach a very clinically meaningful result, then probably it would not be worth to continue, but we haven't finalized what the numbers will be.
Speaker Change: Yep, thank you. And very last one is what would be the threshold for futility if the placebo-adjusted Delta is below a certain...
Speaker Change: point on the address, or do you have any color on that? Yeah, that's a more difficult to answer, not because we don't want to, but we haven't finished or finalized the analysis.
Speaker Change: And then we get into the, like, heavy, complicated statistics, but...
Speaker Change: in general.
Speaker Change: We will set the futility.
Speaker Change: Close to what can be a non clinically meaningful
Speaker Change: threshold right if if the study
Speaker Change: Would not have a chance to reach it like many clinically meaningful Results then probably would not be worth to continue, but we haven't finalized what the numbers will be
Unknown Executive: Thank you, again. Thank you, Andrew.
Speaker Change: Thank you again.
Speaker Change: Thank you, Andrew.
Andrea Tan: And your next question comes from the line of Andrea Tan with Goldman Sachs. Please go ahead. Good afternoon. Thanks for taking the question.
Andrea Tan: And your next question comes from the line of Andrea Tan with Goldman Sachs. Please go ahead. Good afternoon.
Speaker Change: [inaudible]
Andrea Tan: And your next question comes from the line of Andrea Tan with Goldman Sachs. Please go ahead. Good afternoon. Thanks for taking the question. Sergio, just really quickly, can you remind us the extent of the trial that you expect to be completed ahead of the interim analysis? And following that, how soon after that could we expect to see the top line data?
Sergio Traversa: Sergio, just really quickly, could you remind us the extent of the trial that you expect to be completed ahead of the interim analysis? And following that, how soon after that could we expect to see the top-line data? Let me make sure I understand the high-end draft.
Unknown Executive: Let me be sure I understand. Hi, Andrea. Good afternoon. Let me be sure I understand your question. Do we have another trial before the interim analysis? No.
Sergio Traversa: Good afternoon. Let me be sure I understand your question. Do we have another trial before the interim analysis? No, the only two trials they are ongoing for relative and 17 are Reliance 2 and Relight. Everything else has been completed. Long-term safety. They're all done. Oh, I'm sorry. I'm so sorry.
Speaker Change: Let me be sure I understand. Hi, Andrea. Good afternoon. Let me be sure I understand your question. Do we do have another trial?
Speaker Change: Before the interim analysis, no, the only two trials that are ongoing for REL1017 is Reliance 2 and Relight. Everything else has been completed, long-term safety, they're all done.
Sergio Traversa: I was just asking in terms of the interim analysis that's being conducted or planned for Reliance 2. I guess maybe what proportion of that study is it? I think you may have mentioned in the past that it's around 80% to 90% of the trial at which point the interim analysis will take place. I got it again, sorry, I misunderstood. Theoretically, the latest you do it the better. Now there is the incremental benefit that you get it going like, let's say at 70 or 75 or 80 percent become smaller and smaller. So we'll try to do it as late as possible, but like we also want to know, and so it is going to be like before your end.
Speaker Change: Oh, no, I'm so sorry. I'm so sorry. I was just asking in terms of the interim analysis that's being conducted or planned for Reliance 2, I guess maybe what proportion of that study is it? I think you may have mentioned in the past that it's around 80 to 90 percent.
Speaker Change: of the trial, at which point the interim analysis will take place.
Speaker Change: I got it again. Sorry, I misunderstood. Theoretically, the later you do it, the better. Now, there is the incremental benefit that you get it going like...
Speaker Change: let's say a 70 or 75 80 percent become smaller and smaller so we'll try to do it as late as possible but like we also want to know and so it is going to be like before your end right over the next let's all go so the next I will say three four months
Sergio Traversa: Right, over the next three or four months, it takes a couple of months to prepare it, and so we are pretty close, yeah pretty close.
Speaker Change: It takes a couple of months to prepare it, and so we are pretty close, pretty close.
Unknown Executive: Okay, and if the DMC advises that you can continue without additional patients being enrolled, maybe what is the expected time frame over which we could then expect the top line data?
Sergio Traversa: Okay, and if the DMC advises that you could continue without additional patients being enrolled, maybe what is the expected time frame over which we could then expect the top line data? Well, it depends on how many patients we'll have to roll, but it's not going to be that far away. I don't have the exact number, but we are planning to finish and roll by your end, so you can imagine that I can be nearby your end or sometime early 2025, but not too long after. If they tell us that we don't need to roll any more patients, as we hope, it's going to be pretty short after that.
Speaker Change: Okay, and if the DMC advises that you could continue without additional patients being enrolled, maybe what is the expected time frame over which we could then expect the top-line data?
Speaker Change: Well, it depends on how many patients we have to enroll, but it's not going to be that far away. I don't have the exact number, but we are planning to finish and enroll by your end, so you can imagine that. It can be by your end or sometime early.
Unknown Executive: And I don't have the exact number, but we are planning to finish and roll by your end. So you can imagine that it could be by your end or sometime early.
Speaker Change: 2025, but not too long after. If they tell us that we don't need to enroll any more patients, as we hope, it's going to be pretty short after that.
Unknown Executive: Okay, and then one quick question on the psilocybin study. Just curious, or if you could speak to the decision to run that study in Canada and if that reflects any regulatory hurdles in the U.S., or it may be even a variation in how the different agencies view psilocybin.
Sergio Traversa: Okay, and then one quick question on the psilocybin study, just curious or if you could speak to the decision to run that study in Canada and if that reflects any regulatory hurdles in the US or maybe even a variation how the different agencies view psilocybin? Yeah, we do it in Canada for two main reasons, right? One is that Canada, for some reason, they have very good structure for phase one. Just to give you an example, red 1017, phase one was done in Toronto in Canada because they are very good facilities. And the second one is that the Canadian agency, it is very used to psychedelic and it's used to more than the FDA.
Speaker Change: Okay and then one quick question on the psilocybin study just curious or if you could speak to the decision to run that study in Canada and if that reflects any regulatory hurdles in the U.S. or it may be even a variation how the different agencies view psilocybin?
Unknown Executive: We do it in Canada for two main reasons. One is that Canada, for some reason, they have a very good structure for phase one. Just to give you an example, REL 1017, REL 1017.
Speaker Change: We do it in Canada for two main reasons. One is that Canada, for some reason, they have very good structure for phase one. Just to give you an example, Red 1017, Red 1017. Phase one was done in Toronto, in Canada, because they have very good facilities.
Unknown Executive: Phase one was done in Toronto, in Canada, because they have very good facilities. And the second one is that the Canadian agency is very used to psychedelics and is used to them more than the FDA. So the regulatory hard rules are easier in Canada than in the US. So the combination of these two reasons made us do it in Canada. Nothing else.
Speaker Change: And the second one is that the Canadian agency...
Speaker Change: It is very used to psychedelic and what it's used to more than the FDA. So it's the regulatory hodles are the.
Sergio Traversa: So the regulatory hurdles are the easier in Canada than in the US. So the combination of these two reasons made us do it in Canada, nothing else, right? Got it.
Speaker Change: easier in Canada than in the U.S. So the combination of these two reasons made us do it in Canada, nothing else.
Unknown Executive: Got it. Okay. Thank you so much.
Unknown Executive: Okay, thank you so much. Thanks.
Charles: Go ahead. And your next question comes from the lineup. Wait here with Bizou Financial Group. Please go ahead. Hi, thanks for taking my question. This is Charles on her oil. I guess I had a question on the reestimation analysis. Just I guess kind of dig into how many more patients you might add potentially in this analysis. Is that kind of a preset number, or will they give you that number? And then also on the runway guidance. Is the runway still expected to read out to for rewrite as well? Thank you. Thank you, Charles.
Joberon: it okay thank you so much thanks joberon
Speaker Change: And your next question comes from the line of Uy Ear with Bizot Financial Group. Please go ahead.
Charles: Hi, thanks for taking my question. This is Charles from OY.
Speaker Change: Hi, thanks for taking my question. This is Charles on for Oi.
Charles: I guess I had a question on the re-estimation analysis. Just, I guess, kind of dig into how many more patients you might add potentially in this analysis. Is that kind of a preset number, or will they give you that number? And then also on the runway guidance. Is the runway still expected to read out for relight as well?
Charles: I guess I had a question on the re-estimation analysis.
Charles: I guess kind of dig into how many more patients you might add potentially in this analysis. Is that kind of a preset number or will they give you that number? And then also on the runway guidance, is the runway still expected to read out for relight as well?
Unknown Executive: Thank you, Charles. I will make it answer the second question, but the first one is that the number will be recommended by the DMC, and so on. It can be anywhere, right? Clearly, if the target number is somewhere north of 300, and we don't expect to double that number of patients or to add like 200 patients.
Sergio Traversa: I will mag it as a second question, but the first one is the number will be recommended by the DMC. And, and so bye. It can be anywhere, right? Clearly, if the target number is somewhere north of 300, and we don't expect to double that number of patients or to add like 200 patients, then there would be an indication that the signal may not be that strong. So, it would be a reasonable amount of, yeah, amount of patient it is also feasible in a reasonable amount of time. Charles, thank you for the question.
Speaker Change: Thank you.
Maged Shenouda: Thank you, Charles. I will, Maged, answer the second question, but the first one is the number will be recommended by the DMC.
Speaker Change: And so, bye.
Speaker Change: It can be anywhere, right? Clearly, if the target number is somewhere north of 300, and we don't expect to double that number of patients or to add like 200 patients.
Speaker Change: there would there would be an indication that the signal may not be that strong
Speaker Change: So it would be a reasonable amount of patient that is also feasible in a reasonable amount of time.
Maged Shenouda: Charles, thank you for the question. I'll take the financial, the finances question.
Unknown Executive: I'll take the financial, the finances question. You know, I don't think we want to get that specific with regard to, you know, the readout from the re-light study. What we have said is it will take us into 2025, certainly with data from the reliance to study, and then a lot depends on enrollment patterns, and that's, you know, developing day by day. So, you know, I can't be that specific at this point. Okay. Thank you. I take my question. All right. So, there is any more questions? Does it seem there are more? Any more questions? Well, I assume there are no more questions pending, and so we are not showing any more questions.
Charles: And Charles, thank you for the question. I'll take the, you know,
Maged Shenouda: You know, I don't think we want to get that specific with regard to, you know, the readout from the Relight study. What we have said is it will take us into 2025, certainly with data from the Reliance 2 study. And then a lot depends on enrollment patterns, and that's, you know, developing day by day. So, you know, I can't be that specific at this point. Thank you for taking my question.
Speaker Change: Financial the finances question, you know, I don't think we want to get that specific with regard to you know the readout from the relay study what we have said is it will take us into
Speaker Change: 2025, certainly with data from the Reliance 2 study. And then a lot depends on enrollment patterns. And that's, you know, developing day by day. So, you know, I can't be that specific.
Speaker Change: at this point.
Speaker Change: Thank you for taking my question.
Speaker Change: Operator, are there any more questions?
Speaker Change: It doesn't seem there are any more questions.
Operator: Well, then I assume there are no more questions pending. So we are not showing any more questions.
Speaker Change: Well, the...
Speaker Change: I assume there are no more questions pending.
Speaker Change: and
Sergio Traversa: Charles, I can go to the closing remarks. Well, thank you. Yes, we are; we are. We don't have any questions at this moment. You can now proceed with the closing remarks. Okay. Well, thanks a lot. And so, thank you everyone for joining us for the Ramada second quarter 2024 conference call today. We believe we are poised to achieve several important milestones that could represent an inflection point for all of us. We look forward to updating you on our progress, and thank you for joining us for this second quarter business update call. Have a great night.
Speaker Change: So, we are not showing any more questions, so I can go to the closing remarks.
Speaker Change: Yes. Yes. Yes.
Speaker Change: Apologies, we don't have any questions at this moment. You can now proceed with your closing remarks.
Unknown Executive: Yes. Yes. Okay. Well, thanks a lot. And so, thank you everyone for joining us for the Relmada second quarter 2024 conference call today.
Speaker Change: Okay, well, thanks a lot. And so thank you everyone for joining us for the Relmada second quarter 2024 conference call today.
Speaker Change: We believe we are poised to achieve several important milestones that could represent an inflection point for Relmada.
Speaker Change: We look forward to updating you on our progress and thank you for joining us for this second quarter business update call.
Unknown Executive: Thank you, presenters, and ladies and gentlemen. This concludes today's conference call. Thank you all for participating.
Speaker Change: Have a great night.
Speaker Change: Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. Signing out.
Unknown Executive: And now, let's go now. So, thank you all for joining us for the closing remarks.