Q4 2024 Neumora Therapeutics Inc Earnings Call and Business Update
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Operator: Ladies and gentlemen, thank you for standing by. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.
Speaker Change: Ladies and gentlemen, thank you for standing by at this time all participants are in listen only mode. After the speaker's presentation there'll be a question and answer session. Please be advised that today's conference is being recorded.
Helen Rubinstein: I would like to turn the conference over to Helen Rubinstein, Vice President of Investor Relations and Communications. Please go ahead.
Speaker Change: I would like to turn the conference over to Hal Rubenstein, Vice President of Investor Relations and Communications. Please go ahead.
Helen Rubinstein: Good morning, and thank you for joining Neumora Therapeutics fourth quarter and full year 2024 Financial Results Conference call. Before we begin, I encourage everyone to go to the investors and media section of our website at neumoratx.com where you can find the press release related to today's call.
Speaker Change: Good morning, and thank you for joining me more therapeutics fourth quarter and full year 'twenty 'twenty four financial results conference call before we begin I encourage everyone to go to the investors and media section of our website at Nomura, Yes, Dot Com, where you can find the press release related to today's call.
Helen Rubinstein: With me on the call are Neumora's Chief Executive Officer Paul Burns, President Josh Pinto, Chief Operating and Development Officer Bill Aurora, and Chief Financial Officer Mike Milligan.
Speaker Change: With me on the call Army Morris, Chief Executive Officer, Paul Byrne, President, Josh Pinto, Chief operating and development Officer, Illawarra and Chief Financial Officer, Mike Milligan.
Speaker: I would like to point out that we will be making forward-looking statements which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.
Speaker Change: I would like to point out that we will be making forward looking statements, which are based on our current expectations and beliefs. These.
Paul Byrne: These statements are subject to certain risks and uncertainties and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SEC filings for additional detail with that I'll now turn the call over to Paul.
Speaker: Please review the risk factors discussed in today's press release and in our SEC filings for additional details.
Speaker: With that, I'll now turn the call over. Thanks, Helen.
Paul Byrne: Thanks Alan.
Paul Burns: Good morning, everyone, and thank you for joining us to review our fourth quarter and full year 2024 financial results and business update. As you may know, I've recently taken over as CEO, and I'm pleased to be here with all of you today. I have been fortunate to have had multiple experiences leading teams to drive the successful development and approval of medicine. And I believe Neumora has the potential to achieve this outcome as well. The first two months of 2025 have been productive for the company. And we believe that we are poised to make a difference for the millions of people living with brain diseases as we strive to improve on the limitations associated with current treatment options.
Paul Byrne: Good morning, everyone and thank you for joining us to review, our fourth quarter and full year 2024 financial results and business update.
Speaker Change: As you May know I've recently taken over as CEO and I'm pleased to be here with all of you today.
Speaker Change: I have been fortunate to have had multiple experiences leading teams to drive the successful development and approval of <unk>.
Speaker Change: I believe you Maura has the potential to achieve this outcome as well.
Speaker Change: The first two months of 2025 have been productive for the company.
Speaker Change: And we believe that we are poised to make a difference for the millions of people living with brain diseases as we strive to improve on the limitations associated with current treatment options.
Paul Burns: We have built an industry-leading pipeline of seven programs, all targeting novel mechanisms of action with best-in-class pharmacology. We are in a strong financial position.
Speaker Change: We have built an industry leading pipeline of seven programs all targeting novel mechanisms of action with best in class Pharmacology.
Speaker Change: We are in a strong financial position, providing us the flexibility to advance several clinical and preclinical programs Adair.
Paul Burns: providing us the flexibility to advance several clinical and preclinical programs. adapt and follow the science, and ultimately deliver medicines to patients who urgently need new treatment options. We are also fortunate to have assembled a deep roster of neuroscience drug developers and business leaders that we believe can drive our mission to deliver medicines to patients suffering from.
Speaker Change: Adapting to follow the science and ultimately deliver medicines to patients who urgently need new treatment options.
Speaker Change: We are also fortunate to have assembled a deep roster of neuroscience drug developers and business leaders that we believe can drive our mission to deliver medicines to patients suffering from rare disease.
Josh Pinto: I will now turn the call over to Josh Pinto, who has been newly appointed president of Neumora after serving as our chief financial officer for the last four years. to review the pipeline updates.
Speaker Change: I will now turn the call over to Josh <unk>, who has been newly appointed President of Nomura After serving as our Chief Financial Officer for the last four years to review the pipeline updates.
Josh Pinto: Josh. Thank you, Paul. It is an honor to work with our team as we strive to deliver transformative medicines in a number of prevalent brain diseases.
Speaker Change: Josh.
Speaker Change: Thank you Paul.
Speaker Change: It is an honor to work with our team as we strive to deliver transformative medicines in a number of prevalent brain diseases.
Josh Pinto: I'm excited to take on this expanded role as president of Neumora as we make important updates to our pipeline.
Speaker Change: I am excited to take on this expanded role as president of Nomura as we make important updates to our pipeline and prepare for a productive year.
Josh Pinto: Care for a Productive Year. Beginning with nevacopran, which is a highly selective kappa opioid receptor antigen. It's currently in phase three development for the monotherapy treatment of MDD, which is the leading cause of disability worldwide, affecting more than 280 million. As we detailed in today's press release, we've made important changes based on the learnings from the COASTAL-1 study to optimize the ongoing Phase 3 studies with nevacopran in MDG.
Speaker Change: Beginning with <unk>, which is a highly selective kappa opioid receptor antagonist.
Speaker Change: It's currently in phase III development for the monotherapy treatment of MTBE, which is the leading cause of disability worldwide affecting more than 280 million people.
Speaker Change: As we detailed in today's press release, we've made important changes based on the learnings from the coastal one study to optimize the ongoing phase III studies within the Vaca <unk> and mbd.
Josh Pinto: which Bill will walk through shortly. We remain confident in the potential of nevacopran as a novel treatment for MDD and anedoma. multiple positive clinical studies from independent sponsors. including data from our own Phase 2 study with Nevaca Prant in MD. the NIH-run FASTMAP. and the Atikaprant Phase II Study validate the clinical potential for Kappa opioid receptor. This body of evidence suggests that our COSTL1 results may be an anomaly and there is an important role for this mechanism in the treatment of mood disorders.
Bill: Bill will walk through shortly.
Bill: We remain confident in the potential of <unk> as a novel treatment for <unk> in Indonesia.
Bill: Multiple positive clinical studies from independent sponsors, including data from our own phase II study with <unk> and MTGE.
Bill: The NIH run fast mass study and the ticket print phase III study validate the clinical potential for Kappa opioid receptor antagonism.
Bill: This body of evidence suggests that our coastal one results maybe an anomaly and there is an important role for this mechanism in the treatment of mood disorders.
Josh Pinto: The strategy for the COASTAL program was to stagger the studies intentionally to allow the opportunity to fine-tune the COASTAL 2 and 3 studies based on learnings from COASTAL 1. We've now tested Nevacaprant in nearly 600 people with MDD to date, which has allowed us to follow data-driven insights that inform the changes we've deployed across the program. We are passionate about our mission of bringing novel treatment options to people living with MDE.
Bill: The strategy for the coastal program with the staggered the study's intentionally to allow the opportunity to fine tune the coastal two and three studies based on learnings from coastal one.
Bill: We've now tested in the Vaca <unk> in nearly 600 people with mbd to date, which has allowed us to follow data driven insights that inform the changes we've deployed across the program.
Bill: Okay.
Bill: We are passionate about our mission of bringing novel treatment options to people living with mbd.
Josh Pinto: I look forward to reporting top line data from Coastal 3 in the first quarter of 2020. Coastal 2 in the second.
Bill: I look forward to reporting topline data from coastal III in the first quarter of 2026 and coastal too in the second quarter of 2026.
Josh Pinto: Additionally, this morning we announced that we discontinued the Phase 2 clinical trial investigating nevacopram for the treatment of bipolar depression. While we still believe that Nevacoprint may offer benefits for treating bipolar depression, we're focusing on rigorous prioritization to allocate our resources to the COASTAL program and other clinical programs. Therefore, we will evaluate opportunities to investigate nevacoprine and bipolar depression and other indications beyond MDD in the future.
Bill: Additionally, this morning, we announced that we discontinued the phase III clinical trial investigating the vaca <unk> for the treatment of bipolar depression.
Bill: While we still believe that <unk> may offer benefits for treating bipolar depression, we're focusing on rigorous prioritization to allocate our resources to the coastal program and other clinical programs for now.
Bill: Therefore, we will evaluate opportunities to investigate <unk> in bipolar depression, and other indications beyond mbd in the future.
Josh Pinto: Beyond Nevacopran, we are advancing NMRA 511, which we are currently investigating in a Phase 1b signal-seeking study in Alzheimer's disease agitation. Agitation is among the most disruptive symptoms of Alzheimer's. and is associated with increased morbidity and mortality.
Bill: Beyond the vacuum brand, we are advancing Annemarie 511, which we are currently investigating in a phase one b signal seeking study and all timers disease agitation.
Bill: Agitation is among the most disruptive symptoms of Alzheimers disease and is associated with increased morbidity and mortality.
Josh Pinto: Earlier Placement in Long-Term Care Facilities. and Greater Caregiver Strength. Approximately 70% of the estimated 7 million people currently living with Alzheimer's disease experience agitation. And as the number of people living with Alzheimer's increases, its devastating impact will only grow. The only approved product carries a black box warning for mortality in elderly people. So it is clear that there is a substantial unmet need to treat Alzheimer's disease.
Bill: Earlier placement in long term care facilities and greater caregiver stress.
Bill: Approximately 70% of the estimated 7 million people currently living with all farmers disease experience agitation.
Bill: And as the number of people living with all timers increases its devastating impact will only grow.
Bill: The only approved product carries a black box warning for mortality in elderly people. So it is clear that there is a substantial unmet need to treat all timers disease agitation.
Josh Pinto: We look forward to reporting top-line data from the Phase 1b Signal Seeking Study by the end of the year.
Bill: We look forward to reporting topline data from the phase one b signal seeking study by the end of the year.
Josh Pinto: We also expect to advance our M4 franchise by progressing our next compound into the clinic by mid-2025. We are confident in the PAM mechanism for a number of reasons. First, we believe that agonists struggle for selectivity.
Bill: We also expect to advance our <unk> franchise by progressing our next compound into the clinic by mid 2025.
Bill: We are confident in the Pam mechanism for a number of reasons.
Bill: First we believe that agonist struggle for selectivity.
Josh Pinto: It is clear that M4 is the driver of the antipsychotic activity seen with muscarinic drugs to date. We are also excited by the possibility of non-titrated once-daily dosing and the improved safety and tolerability profile that M4 PAMs may offer.
Bill: It is clear that <unk> is the driver of the antipsychotic activity seen with muscarinic drugs to date.
Bill: We are also excited by the possibility of non titrated once daily dosing and the improved safety and Tolerability profile that <unk> may offer.
Josh Pinto: 2025 is going to be an important year for Neumora. As we move forward, we will be relentless in pursuing our mission to deliver new medicines to people living with brain disease. because they represent one of the greatest areas of unmet need and patients deserve better.
Bill: 2025 is going to be an important year for new Maura.
Bill: We move forward, we will be relentless in pursuing our mission to deliver new medicines to people living with brain disease, because they represent one of the greatest areas of unmet need and patients deserve better.
Josh Pinto: I look forward to updating you on our progress throughout the year.
Bill: I look forward to updating you on our progress throughout the year.
Bill Aurora: I'll now turn the call over to Bill to provide additional details on our clinical programs. Bill. Thanks, Josh. We are advancing studies across two clinical stage programs in our pipeline, giving us the opportunity to deliver innovative medicines to people living with brain disease. Let's start with Nuvacapram, our highly selective, novel, once-daily kappa-opioid receptor antagonist being developed as a potential monotherapy treatment for MDD in the Phase 3 Coastal Program. Earlier this year, we announced that Nevacopran did not demonstrate a statistically significant improvement on the primary or key secondary endpoint in the COASTAL-1 study. COASTAL-1 is the first of three randomized placebo-controlled, double-blind Phase III studies that comprise the Pivotal Coastal Program.
Bill: Now I'll turn the call over to bill to provide additional detail on our clinical programs.
Bill: Bill.
Bill: Thanks, Josh we are advancing studies across two clinical stage programs in our pipeline, giving us the opportunity to deliver innovative medicines to people living with brain diseases.
Bill: I'll start with tobacco brands are highly selective novel once daily Kappa opioid receptor antagonist being developed as a potential monotherapy treatment.
Bill: Mbd in the phase III coastal program.
Bill: Earlier this year, we announced that <unk> did not demonstrate a statistically significant improvement on the primary or key secondary endpoint in the coastal one study coastal one is the first of three randomized placebo controlled double blind phase III studies that comprised the pivotal coastal program.
Bill Aurora: Following the announcement of top-line results from the COASTAL-1 study, we paused recruitment for COASTAL-2 and 3 and conducted extensive analyses to identify factors that might have contributed to the study outcome. With the benefit of data on nifacopram in more than 600 patients across Coastal 1 and our Phase 2 study, we are in a strong position to make meaningful changes to improve Coastal 2 and 3. First, we are enhancing engagement with sites around medical monitoring to confirm that the patients enrolled in the studies have an independently verified diagnosis of MDD that helps to ensure they are appropriately meeting the eligibility criteria for study.
Bill: Following the announcement of topline results from the coastal one study we pause recruitment for coastal two and three and conducted extensive analysis to identify factors that might have contributed to the study outcome.
Bill: With the benefit of data on tobacco and more than 600 patients across coastal one and our phase III study, we are in a strong position to make meaningful changes to improve coastal two and three.
Bill: First we are enhancing engagement with sites around medical monitoring to confirm that the patients enrolled in the studies have an independently verified diagnosis of MPD that helps to ensure they are appropriately meeting the eligibility criteria for studies.
Bill Aurora: To do this, we are adding the clinician rated Massachusetts General Hospital Clinical Trials Network and Institute SAFER approach. SAFER is an independent review conducted by clinical psychiatrists to verify the diagnosis and appropriateness of the patient population. Our internal medical team will partner with the SAFER clinical team to help ensure patients appropriately meet the eligibility criteria for the studies prior to randomization. Second, we're adding an additional tool called the Verified Clinical Trial Screening Database aimed at identifying patients who are participating in multiple clinical trials and excluding them from enrolling in the POSTAL 2 and 3 study.
Bill: To do this we are adding the clinician rated Massachusetts General Hospital clinical trials network and Institute safer approach safer is an independent review conducted by clinical psychiatrist to verify the diagnosis and appropriateness of the patient population.
Bill: Our internal medical team will partner with the safer clinical team to help ensure patients appropriately meet the eligibility criteria for the studies prior to randomization.
Bill: Second were adding an additional tool called the verified clinical trial screening database aimed at identifying patients who are participating in multiple clinical trials and excluding them from enrolling in the coastal two and three studies.
Bill Aurora: This is an additive approach to the clinical trial subject database we use in POSTAL 1, and we believe it will help to ensure The appropriate patients are enrolled in our ongoing study. Third, we've reduced the number of clinical sites and selected those sites that we believe have the greatest level of expertise in conducting MDD studies to include going forward. We are taking these steps to help optimize the coastal program because we believe in the potential of an evac print to make a real difference for patients. Historically, there have been many approved blockbuster medicines in MDD and psychiatry broadly that have failed phase three studies, but ultimately succeeded in multiple studies and became important treatments.
Bill: This is an additive.
Bill: Approach to the clinical trial subject database, we used in coastal one and we believe it will help to ensure.
Bill: The appropriate patients are enrolled in our ongoing studies.
Bill: Third we've reduced the number of clinical sites and selected those sites that we believe have the greatest level of expertise in conducting mbd studies to include going forward.
Bill: We are taking these steps to help optimize the coastal program because we believe in the potential of <unk> to make a real difference for patients.
Bill: Historically, there have been many approved blockbuster medicines and MDT.
Bill: And psychiatry broadly that it failed phase III studies, but ultimately succeeded in multiple studies became important treatments with.
Bill Aurora: We designed the Coastal Program with these historical challenges in mind. knowing that we would need two or three trials to be successful in order to file an NDA.
We designed the coastal program with these historical challenges in mind.
Bill: Knowing that we would need two to three trials to be successful in order to file an NDA.
Bill Aurora: Beyond nevacoprant, we are currently evaluating NMRA 511 or vasopressin 1A receptor antagonist in a phase 1B signal-seeking study in people with Alzheimer's disease agitation. which is a large market opportunity with significant unmet need. Based on converging lines of clinical and preclinical evidence, V1A receptor antagonists have the potential to reduce symptoms of agitation. We are excited about NMRA 511 given its pharmacology, strong preclinical data, and well-tolerated safety profile to date.
Bill: Beyond <unk> we.
Bill: We're currently evaluating <unk> hundred 11, our visual <unk> receptor antagonist and a phase one b signal seeking study.
Bill: And people with Alzheimer's disease agitation.
Bill: Which is a large market opportunity with significant unmet need.
Bill: Based on converging lines of clinical and preclinical evidence <unk> receptor antagonists have the potential to reduce symptoms of agitation.
Bill: We are excited about <unk> 511, given its pharmacology strong preclinical data and well tolerated safety profile to date, we look forward to sharing results from the study end of 2025.
Bill Aurora: We look forward to sharing results from the study end of 2025.
Bill Aurora: We also expect to advance our M4 franchise by progressing our next compound into the clinic by mid-2025. Each of our M4 PAM compounds is chemically differentiated. strengthening our franchise of muscarinics that have the potential to deliver anti-psychotic efficacy in multiple indications.
Bill: We also expect to advance our <unk> franchise by progressing our next compound into the clinic by mid 2025 each.
Bill: Each of our <unk> Pam compounds is chemically differentiated string.
Bill: Strengthening our franchise of muscarinic that have the potential to deliver anti psychotic efficacy in multiple indications.
Bill Aurora: We believe that we are well positioned to become a leader in muscarinx, an important new class of medicines, and we look forward to providing an update on our M4-PAM franchise by mid-2025.
Bill: We believe that we are well positioned to become a leader in muscarinic an important new class of medicines, and we look forward to providing an update on our <unk> franchise by mid 2025.
Bill Aurora: Lastly, we are advancing an exciting pipeline of four preclinical programs, each of which has strong biologic rationale. These programs have a range of potential indications, including Alzheimer's agitation, schizophrenia, Parkinson's, and ALS.
Bill: Lastly, we are advancing an exciting pipeline of preclinical programs each of which a strong biologic rationale.
Bill: These programs have a range of potential indications, including Alzheimer's agitation schizophrenia, Parkinson's and ALS.
Bill Aurora: giving us the opportunity to address unmet needs across several brain disorders. With these programs, I believe we are well on our way to achieve our mission of redefining the development of novel medicines for brain diseases.
Bill: Giving us the opportunity to address unmet needs across several brain disorders.
With these programs I believe we are well on our way to achieve our mission of redefining the development of novel medicines for brain diseases.
Mike Milligan: With that overview, we'll now turn the call over to Mike for a review of the financials. Thanks, Bill, and good morning, everyone. Our financial results for the fourth quarter and full year 2024 are detailed in the press release that we issued this morning, which I encourage you to read. I'll take a moment to review these. As we advance our pipeline, we are focused on disciplined capital allocation that we believe will enable us to leverage our strong balance sheet to realize multiple catalysts across. Total operating expenses for the fourth quarter were $58.8 million compared to $108.7 million for the same period in 2020.
Bill: With that overview I will now turn the call over to Mike for a review of the financials Mike.
Mike Milligan: Thanks, Bill and good morning, everyone.
Mike Milligan: Our financial results for the fourth quarter and full year 2024 are detailed in the press release that we issued this morning, which I encourage you to read.
Mike Milligan: I'll take a moment to review these results.
Mike Milligan: As we advance our pipeline we are focused on disciplined capital allocation that we believe will enable us to leverage our strong balance sheet to realize multiple catalysts across our program.
Mike Milligan: Total operating expenses for the fourth quarter were $58 8 million compared to $108 7 million for the same period in 2023.
Mike Milligan: Total operating expenses for the full year ended December 31st, 2024 were $243.8 million compared to $235.9 million for the same period. The increase was driven primarily by activities related to the Phase 3 program for the vacufant, ongoing studies across the rest of our portfolio, and investments to support the growth of our As of December 31st, 2024, we ended the year with $307.6 million in cash, cash equivalents, and marketable securities.
Mike Milligan: Total operating expenses for the full year ended December 31, 2024, or $243 8 million compared to $235 9 million for the same period in 2023.
Mike Milligan: The increase was driven primarily by activities related to the phase III program for Nevada.
Mike Milligan: Ongoing studies across the rest of our portfolio and investments to support the growth of our business.
Mike Milligan: As of December 31, 2024, we ended the year with $376 million in cash cash equivalents and marketable securities.
Mike Milligan: which we expect to support operations into mid-2021. We believe this runway places us in a very strong financial position to execute on appropriate next steps for Nevacapran, NMRA 511, our M4 franchise, and the rest of our pipeline.
Mike Milligan: Which we expect to support operations into mid 2026.
Mike Milligan: We believe this runway places us in a very strong financial position to execute on appropriate next steps for the backup printer.
Mike Milligan: <unk> hundred 11, our <unk> franchise and the rest of our pipeline.
Helen Rubinstein: With that, I'll now hand the call over to Helen to manage Q&A with the operator.
Mike Milligan: With that I'll now hand, the call over to Helen to manage Q&A with the operator Hello.
Helen Rubinstein: Helen. Thanks, Mike. Before I turn it over to the operator, I'll ask that you limit yourself to one question. If you have an additional question, please feel free to return to the queue.
Thanks, Mike before I turn it over to the operator RFP you limit yourself to one question. If you have any additional question. Please feel free to return to the queue now I'll turn it over to the operator to handle the Q&A.
Operator: Now I'll turn it over to the operator to handle Q&A. Operator? Thank you.
Mike Milligan: Later.
Speaker Change: Thank you to ask a question. Please press star one one.
Operator: To ask a question, please press star 1. If your question has been answered and you'd like to remove yourself from the queue, please press star 11 again.
Speaker Change: Your question has been answered and you'd like to remove yourself from the queue. Please press star one again.
Brian Abrahams: Our first question comes from Brian Abrahams with RBC Capital Markets. Your line has been Hey, good morning. Thanks for taking my question.
Speaker Change: Our first question comes from Brian Abrahams with RBC capital markets. Your line is open.
Brian Abrahams: Hey, good morning, Thanks for taking my question.
Bill Aurora: Can you elaborate a little bit more on some of the differences between the vendor that you utilized for Coastal 1 and SAFER, and any changes in the site auditing and patient caps that you utilized in Coastal 1 that you'll apply for Coastal 2 and 3?
Brian Abrahams: Can you elaborate a little bit more on some of the differences between the vendor that utilized for coastal one and safer and any changes in the site auditing and patient caps that you've utilized.
The one that you will apply for coastal two and three.
Brian Abrahams: Okay.
Bill Aurora: Good morning, Brian. This is Bill Aurora. Thanks for your question. We take a look at the approach we are taking for Coastal 2 and 3. What we are looking to do is enhance the medical monitoring to confirm the patients who are being enrolled have an independently verified diagnosis for MDE, and we have an opportunity to take a look at their prior history coming into the study. That being said, we are relying on Mass General Hospital, their CTNI group, to institute SAFER. So, as you may be familiar, SAFER is an independent review conducted by clinical psychiatrists at MGH to verify the diagnosis and the appropriateness of the patient population.
Bill: Good morning, Brian This is bill so Laura Thanks for your question.
Paul Byrne: We take a look at the approach we are taking for coastal two and three what we are looking to do is enhance the medical monitoring confirms the patients are being enrolled and independently verified diagnosis or NBD and we have an opportunity to take a look at our prior history coming into the study.
Paul Byrne: That being said, we're relying on mass general hospital or C&I group.
Paul Byrne: So as you may be familiar safeguards and independent review conducted by clinical psychiatrist at MGH to verify the diagnosis and the appropriateness of the patient population our internal medical team will partner with safer uncle team confirm the patient records and the appropriateness of the patients.
Bill Aurora: Our internal medical team will partner with the SAFER clinical team to confirm the patient records and the appropriateness of the patients before they are randomized.
Paul Byrne: Quarter randomized.
Josh Pinto: And Brian, this is Josh here. I would just add this approach to add SAFER is really above and beyond all of the measures that we had already instituted in the coastal program. And so we are not swapping anything out to replace it with SAFER. We are continuing to do the full approach we had been doing up to this point and then adding SAFER on top of that to really help, as Bill highlighted, ensure that we're randomizing, you know, the most appropriate patients based on the eligibility criteria. Got it. Thanks, Jeff. Thanks, Bill. Thank you.
Paul Byrne: And Bryan this is Josh here I would just add this approach to add safer is really above and beyond all of the measures that we had already instituted in the coastal program and so we're not swapping anything to replace it with safer we are continuing to do the pull approach we had been doing up to this point and then adding safer on top of that really help us build highly.
Paul Byrne: Ensure that were randomized and the most appropriate patients based on the our ability criteria.
Paul Byrne: Got it thanks, guys. Thanks Bill.
Speaker Change: Thank you. Our next question comes from Douglas Tsao with H C. Wainwright Your line is open.
Douglas Tsao: Our next question comes from Douglas Tsao with H.C. Wainwright. Your line is open. Hi, good morning. Thanks for taking the questions.
Douglas Tsao: Hi, good morning, Thanks for taking the questions.
Douglas Tsao: I guess a couple for me, maybe just as a starting point, I think it might be helpful if you could provide some perspectives in terms of how far along inter-enrollment Coastal 2 and 3 are right now and just broadly how impactful do you think these changes could be?
Douglas Tsao: I guess a couple for me, maybe just as a starting point I think it might be helpful. If you could provide some perspective in terms of how far along into enrollment coastal Q3 are right now and just broadly how impactful do you think these changes could be and then I guess I was just curious if in the.
Douglas Tsao: And then I guess I was just curious if in the work you did, you were able to identify anything that might have led to the very distinct effect or differences in effect that we saw between male and female patients in Coastal 1. Thank you.
Speaker Change: Work you gave you were able to identify anything that might have led to.
Douglas Tsao: The very.
Douglas Tsao: Distinct factors differences in effect that we saw between between male and female patients in coastal one thank you.
Josh Pinto: Great. Thanks, Doug. This is Josh.
Josh Pinto: Great. Thanks, Doug This is Josh.
Josh Pinto: I'll answer the second part of the question, then turn it over to Bill to really hit on the first part. And so as we think about nevacopran and just the prospects of moving it forward, I think first we have to look at the target here and really the clinical validation that the kappa opioid receptor antagonist class has produced to date. We've seen important positive studies from a multitude of independent sponsors, including our Phase II study with nevacopran and MDD, the NIMH-run FASTMAS study, as well as the Atikapran Phase II studies. And so we feel like the body of evidence out there really suggests that the COSTA-1 results might be an anomaly within this class.
Speaker Change: The second part of the question and then turn it over to Bill to really head on.
Speaker Change: The first part and so as we think about in the Vaca <unk> in just the prospects of moving it forward I think first we have to look at the target here and really the clinical validation of the Kappa opioid receptor antagonist class has produced to date, we've seen important positive studies from a multitude of independent sponsors.
Speaker Change: Including our phase II study with a background in mbd NIMH run fast Nash study as well as the <unk> phase two studies and so we feel like the body of evidence out there really suggest that the coastal one results.
Speaker Change: <unk> be an anomaly within this class and as we've talked about before we truly believe that Nevada has best in class pharmacology here as we've unpacked coastal one a bit more beyond the gender differences that we had previously highlighted we also looked at site to see were there any factors that particular impac.
Josh Pinto: And as we've talked about before, we truly believe that nevacopran has best-in-class pharmacology here. As we've unpacked Coastal One a bit more, beyond the gender differences that we had previously highlighted, we also looked at sites to see were there any factors that particularly impacted how sites performed. And one thing that we're about to pull out is we saw that site experience in relation to their performance in other recent positive MDD monotherapy phase three studies was another key driver of ultimately how performance was measured. And so sites that have participated in other recent positive MDD phase three studies tended to perform much better, not only in females, but the males in those sites actually performed quite well.
Speaker Change: Did <unk> performed and one of the thing that we're about to pull out as we started site experience.
Speaker Change: <unk> to their performance in other recent positive NBD monotherapy phase III studies was another key driver of ultimately how to.
Speaker Change: The outperformance was measured and so sites that have participated in other recent positive MPV phase III studies tended to perform much better not only in females, but the males in that those sites actually performed quite well.
Josh Pinto: And in the population that was not at sites that had recent experiences we've defined, you can see that the females still perform well, but the males in that particular subgroup had a large placebo effect, upwards of 15 points. And so we really feel like site experience is important as well.
Speaker Change: And in the population that.
Speaker Change: Not at sites that had recent experience as we've defined you can see that the female still performed well, but the males. In that particular subgroup had a large placebo effect upwards of 15 points and so we really feel like site experience is important as well and so this has all led to the modifications that were making for.
Josh Pinto: And so this is all led to the modifications that we're making for K2 and K3 to focus on site selection. We want to make sure we've got the best sites with a critical level of experience, as well as the patient screening and medical monitoring in terms of adding SAFER in the VCT database so that we can ultimately optimize the patient population that's coming into the study. And I think finally, we do have to remember that many of the approved medicines in MDD and psychiatry more broadly have failed a phase three study, but ultimately succeeded to become blockbuster medicines.
Speaker Change: <unk> three to focus on site selection, we want to make sure. We've got the best sites with a critical level of experience as well as the patient screening and medical monitoring in terms of adding safer and the BCP database. So that we can ultimately optimize the patient population thats coming into the study.
Speaker Change: And I think finally, we do have to remember that many of the approved medicines and mbd in psychiatry more broadly have failed a phase III study, but ultimately succeeded to become blockbuster.
Bill: Medicine, So that was part of the reason why we designed the coastal study the way we did where we are running three studies in parallel knowing that we only need to for a successful mbd study and so now I'll transition that over to bill to really highlight where we are with the <unk> study is that correct.
Josh Pinto: And so that was part of the reason why we designed the coastal study the way we did, where we're running three studies in parallel, knowing that we only need two for a successful MDD study.
Bill Aurora: And so now I'll transition over to Bill to really highlight where we are with the K2, K3 studies at the current moment. Thanks, Josh. And Doug, I would just comment that the population that Josh referred to, with respect to those sites that participated in recent positive MDD studies in the analysis, that constituted about a quarter of the population in K1. So we're not talking about a diminished number of folks. It gives us some added confidence as we're looking at the data. With respect to how many patients have been enrolled, it's just really been our perspective not to comment on patient numbers for ongoing clinical trial enrollment.
Speaker Change: Ellen.
Ellen: Thanks, Josh.
Speaker Change: And Doug I would just comment that the population of trash referred to with respect to those.
Speaker Change: Sites that participated in recent positive MPD studies and the analysis that constitute about a quarter of the population in Taiwan.
Speaker Change: We're not talking about ours.
Speaker Change: And the number of folks that gives us some confidence as we're looking at the data with respect to how many patients that enrolled it's just really been our perspective not to comment on patient numbers for ongoing clinical trial enrollment, but what I can say is that for Acacia and K three boats.
Bill Aurora: But what I can say is that for K2 and K3, Those studies were initiated at the end of, or towards the end of 2023 before being paused in January of 25. We're now guiding to those studies resuming for another 12 to 15 months. This gives us confidence that the changes we are making, along with the timelines and the patients yet to be enrolled in the study, have the potential to make a meaningful difference on the outcome of the overall trial.
Speaker Change: Those studies were initiated.
And towards the end of 2023 before being paused in January of 'twenty five we're now guiding to those studies resuming for another 12 to 15 months.
Speaker Change: This gives us confidence that the changes we are making along with the timelines and the patients to be enrolled in the study have the potential to make a meaningful difference on the outcome of the overall trials.
Bill Aurora: Coastal 2 and 3 are already different than K-1, as an example, if both already enrolled. a higher proportion of females relative to males that are more aligned to historical NDD studies. Okay, great. Thank you so much. That's helpful. Thank you.
Speaker Change: Coastal two and three are already different and Taiwan as an example, that's both already enrolled.
Speaker Change: A higher proportion of female relative to mail center more aligns historical on Dd's studies.
Speaker Change: Okay, great. Thank you so much that's helpful.
Speaker Change: Thank you. Our next question comes from Tim <unk> with Guggenheim. Your line is open.
Yaten Senuha: Our next question comes from Yaten Senuha with Guggenheim. Your line is open.
Yaten Senuha: Hi, this is Elma Foriati. Thanks for taking our questions. So, when you look retrospectively at patients with exaggerated placebo response in COSTAL-1, what was their Madras score at baseline, if you can give any cue on that? Was it lower than average? And in terms of adjustment of clinical sites now for COSTAL-2 and 3, can you provide any granularity on the number of sites that will be removed? And what was the average number of patients per site in COSTAL-1? Thank you.
Speaker Change: Hi, This is Dan Knauff with Watson, thanks for taking our questions.
Speaker Change: When you look today prospectively patients Ebix updated placebo response in question one.
Speaker Change: That market has scored at baseline if you can given Q on that.
Speaker Change: No wisdom.
Speaker Change: And in terms of the adjustment of getting sites now I'll focus on two and three.
Speaker Change: Can you provide that you get on reliability on the Monday of tightness will be removed.
Speaker Change: And what was the average number of patients per site in question.
Speaker Change: <unk>.
Josh Pinto: Thanks for the question. You know, at this time, we're not providing details in terms of the average baseline, you know, score, you know, for patients and sites that had a high placebo response. But, you know, what we can say is that, you know, we do believe that the changes that we're making to Coastal 2 and 3 will help to, you know, improve on how we executed Coastal 1 and ultimately support what we really want to. We've looked at the data. What's clear to us is that, you know, site selection is absolutely critical. And, you know, we have removed some of the sites from Coastal 2 and 3, and we'll be looking to potentially add some more.
Speaker Change: Yes, thanks for the question.
Speaker Change: At this time, we're not providing details in terms of the average.
Speaker Change: Baseline score or <unk>.
Speaker Change: Patients and sites that had a high placebo placebo response, but what we can say is that we do believe that the changes that we're making to coastal <unk> three will help to improve on how we executed postal one and ultimately support what we really want to its we've looked at the data what's clear to us.
Speaker Change: Is that.
Speaker Change: Site selection is absolutely critical and we have removed some of the sites from coastal two and three and we'll be looking to potentially add some more and then patient screening as well as medical monitoring during that screening randomization phase is absolutely critical to confirm patients appropriately meet the inclusion exclusion criteria. So bill hi.
Josh Pinto: And then patient screening, as well as medical monitoring during that screening to randomization phase is absolutely critical to confirm patients appropriately meet the inclusion exclusion criteria. So, as Bill highlighted, beyond all the measures we already had in Coastal 1, we have added the SAFER, you know, approach from MGH, as well as the VCT database. Got it. Thank you.
Speaker Change: Lighted beyond all of the measures we already had in postal one we've added the safer.
Speaker Change: Approach.
Speaker Change: <unk> as well as the <unk> database.
Speaker Change: Got it. Thank you and do you think that the number of patients per site.
Josh Pinto: And do you expect the number of patients per site to increase now with COSR 2 and 3? In terms of the number of patients per site, we don't necessarily know that they'll increase. As you can recall, Coastal 2 and 3 are sized the same way that Coastal 1 is, where the target number of patients enrolled in each is about 332. We do want to make sure that, you know, for the remainder of Coastal 2 and 3, we are focused on the highest quality sites. But ultimately, we can't comment, you know, in terms of the final number of sites at this point.
Anthony: Thank you Anthony.
Anthony: In terms of the number of patients per site, we don't necessarily know little increase as you can recall coastal two and three our size in the same way that coastal one is where the target number of patients enrolled in each of about 332, we do want to make sure that for the remainder of <unk>.
Anthony: <unk> two and three we are focused on the highest quality sites.
Anthony: But ultimately we can't comment.
Anthony: The final number of sites at this point.
Paul Matisse: Thank you so much. Thank you.
Speaker Change: Okay. Thank you so much.
Anthony: Yes.
Speaker Change: Thank you. Our next question comes from Paul Matisse with Stifel. Your line is open.
Paul Matisse: Our next question comes from Paul Matisse with Stiefel. Your line is open. Hey, thanks for taking the question. I guess one thing I'm a little bit confused about is during Coastal 1, the team was really confident that the study was going well, that it was well conducted. I remember talking to Henry about leveraging sites that were high-performing sites from the Phase 2 study and using central radars.
Paul Matisse: Hey, Thanks for taking my question I guess I, just one thing I'm a little bit confused about is during coastal one.
Speaker Change: The team was really confident that the study was going well, but it was well conducted I remember talking to Henry about leveraging sites that were high performing sites from the phase two study and using central raters and so I guess as you look back or you look back to kind of your thought process six to nine months ago, what do you think.
Paul Matisse: And so I guess as you look back or you look back to kind of your thought process six to nine months ago, what do you think you missed while the study was going on? What do you think led you to think the study was well conducted when ultimately now in hindsight it doesn't feel like it was?
Speaker Change: Missed while the study was going on what do you think led you to think the study was well conducted when ultimately now in hindsight it doesn't feel like.
Speaker Change: It doesn't feel like it was and then just secondarily on cash runway certainly pretty tight with these studies I understand that youre extending that guidance, which is great to see but whats your thought process there.
Paul Matisse: And then just secondarily, on Cache Runway, certainly pretty tight with these studies. I understand that you're extending that guidance, which is great to see, but what's your thought process there? And I guess how comfortable are you to go into these readouts with materially less than 12 months? Thanks so much.
Speaker Change: And I guess, how comfortable are you to go into these readouts with materially less than 12 months. Thanks, so much.
Bill Aurora: Good morning, Paul. This is Bill. Let me start out by talking about the placebo response and some of the things that we're doing to augment K2 and K3. You're absolutely right. We did see an outsized placebo response in K1, particularly in males where we had close to a 14-point placebo response. And we realized we could do more with K2 and K3 moving ahead. And one of those important steps is really to further enhance what we believe we had in place was the medical monitoring, strengthened medical monitoring that was already in place. And quite frankly, MPH and SAFER will help us do that to verify the baseline degree of severity, the diagnosis, which we know is critically important.
Speaker Change: Good morning, Paul This is bill I'll, let me start out by talking about.
Speaker Change: Placebo response in some of the things that we're doing to augment and take rate you're absolutely right. We just see an outsized placebo response and K one.
Speaker Change: Particularly in <unk>, where we had.
Speaker Change: And close to a 14 point placebo response.
Speaker Change: Realize we could do more with coach pay two and phase three moving ahead and one of those important steps as really to further enhance what we believe we have in place.
Speaker Change: The medical monitoring strengthen monitoring that was already in place and quite frankly, <unk> safer will help us do that to verify the baseline degree of severity of the diagnosis, which we know is critically important so those steps should put us in a stronger position with both of the studies that still have substantial number of patients to it at all.
Bill Aurora: So those steps should put us in a stronger position with both of the studies that still have a substantial number of patients to involve.
Speaker Change: Okay.
Mike Milligan: Hey, Paul. This is Mike. For the cash flow side, we always aim to be strategic and disciplined with our approach to financing the company. We believe we're in a strong financial position that are able to achieve multiple catalysts, not just with the back-up plan, but across the pipeline. Our current balance sheet, as you noted and we noted, provides cash runway in the mid-26. As a company, we're always opportunistic at looking at ways to fund the business, and that won't change in the upcoming year. There are a variety of funding mechanisms, including debt, business development, our current ATM facility, and equity that we can consider.
Speaker Change: Hey, Paul this is Mike.
Speaker Change: For the for the cash flow side.
Speaker Change: It's going to be strategic and disciplined with our approach to financing. The company. We believe we're in a strong financial position that will able to achieve multiple catalysts not just win tobacco plays out across the pipeline.
Speaker Change: Our current balance sheet as you noted and we noted provides cash runway into mid 26 as.
Speaker Change: As a company, we're always opportunistic looking at ways to fund the business and that will change in the upcoming year. There are variety of funding mechanisms of letting that business development. Our current ATM facility and equity that we can consider yen. Paul This is Josh I'll just summarize a few of the comments we.
Josh Pinto: Yeah, and Paul, this is Josh. I'll just summarize a few of the comments. You know, we had obviously, you know, deployed a number of, you know, enhanced measures as we were thinking about executing Coastal 1 beyond what we had done in Phase 2. And I think what we've seen through the Coastal 1 results is that we can do more beyond what we had done. And I think in addition to the measures that we're deploying, I think what you'll hear from the team around the table today is that we are very diligent in terms of the oversight and the detail-oriented focus that we have to have in terms of not only engaging with the sites, but engaging with them to ensure, you know, that we are getting the right patients, you know, randomized that fit the inclusion-exclusion criteria.
Speaker Change: And obviously deployed a number of.
Speaker Change: <unk> measures, you're thinking about executing coastal one beyond what we had done in phase two and I think what we've seen through the coastal one result is that we can do more.
Speaker Change: Beyond what we had done and I think in addition to the measures that were deployed I think what you'll hear from the team around the table. Today is that we are very diligent in terms of the oversight and the detail oriented focus that we have to add in terms of not only engaging with the site, but engaging with them to ensure that we are getting.
Speaker Change: Patients randomized that fit the inclusion exclusion criteria and then to Mike's point, we've obviously always been very focused on maintaining a strong balance sheet, we've always been focused on.
Josh Pinto: And then to Mike's point, you know, we've obviously, you know, always been, you know, very focused on maintaining a strong balance sheet. You know, we've always been focused on, you know, our ability to opportunistically finance the company. And so we're going to continue that path as we move through 2025, you know, and look forward to, you know, continuing to progress the business, you know, as we move through this year into 2026.
Speaker Change: Our ability to Opportunistically finance the company and so we're going to continue that path as we move through 2025 and look forward to continuing to progress the business as it goes.
Speaker Change: Through this year and into 2026.
Speaker Change: Okay.
Myles Minter: Thank you. Our next question comes from Myles Minter with William Blair. Your line is open. Hi, team.
Speaker Change: Thank you great operator, I think we will take our.
Speaker Change: Our next question comes from Myles Minter with William Blair. Your line is open.
Speaker Change: Hi team. This is John on for Myles. Thanks, So much for taking my questions maybe two from US. So first I was just wondering if you have any updates on the PK data from coastal one and.
John: This is John on for Myles. Thanks so much for taking our questions. Maybe two from us.
John: So first, I was just wondering if you have any updates on the PK data from Coastal 1 and if there was anything you could glean from there on how the various sites performed or if there was any sex-based differences. And second, do you still have the opportunity to increase enrollment by 25% for Coastal 2 and 3? And if so, is that included in your timeline guidance?
Speaker Change: And if there was anything you could glean from there on how the various sites performed or if there was any tax basis differences.
Speaker Change: And second do you still have the opportunity to increase enrollment by 25% for coastal two and three.
Speaker Change: And if so is that included in your timeline guidance.
Bill Aurora: Hi, John. This is Bill. Let me take the first question here with respect to the PK data. The exposures from Coastal 1 were consistent with the results from the Phase 2 study. And so in that context, the exposures were, as we expected, consistent with Phase 2, where we did see the robust efficacy in the moderate to severe population. We believe that the 80 milligram dose is a potentially efficacious dose with a favorable tolerability and safety profile.
Bill: Hi, John This is bill again take the first question here with respect to the PK data the exposures from coastal one were consistent with the results from the phase II study.
Bill: And so in that context, the exposures were as we had expected consistent with phase II, where we did see the robust efficacy in the moderate to severe population, we believe that the 80 milligram dose.
Bill: Efficacious dose.
Bill: Favorable tolerability and safety profile.
Josh Pinto: We could have the potential to consider a higher dose in the future, given the clean safety and tolerability profile that we've been seeing. Yeah, and then, John, on the guidance and timing piece, you know, I think we've built in the flexibility in all three of the coastal studies, Coastal 1, 2, and 3, to increase the sample size by up to 25%, and so we have that flexibility in Coastal 2 and 3 as well. In terms of our timelines, you know, we have looked at a range of potential outcomes in terms of the number of patients that could come into the study, and that has been factored into our timing guidance.
Bill: We could have the potential to consider a higher dose in the future given the clean safety and Tolerability profile that we've been seeing.
Speaker Change: Yes, and then John on the on the guidance and timing piece I think we built in the flexibility in all three of the coastal studies coastal one two and three to increase the sample size by up to 25% and so we have that flexibility and coastal two and three as well in terms of our timelines.
Speaker Change: We have looked at a range of potential outcomes in terms of the number of patients that could come into the study and that has been factored into our timing guidance, we're not going to comment. This time in terms of the final number of patients that we expect to enroll in each of Q2 and Q3, but we have factored that into ultimately the guidance.
Josh Pinto: We're not going to comment this time in terms of the final number of patients that we expect to enroll in each of K2 and K3, but we have factored that into, ultimately, the guidance that we've come out with.
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Thank you. Our next question comes from Greg.
Sam: Our next question comes from Greg Savanova with Mizzou Health. Your line is open.
Greg: Greg Savannah.
Speaker Change: Your line is open.
Sam: Hi, this is Sam on for Greg. Thank you for taking our question. You may have alluded to this a bit earlier, but as a result of the coastal trial modifications, have there been any changes to the powering assumptions? Thank you.
Sam: Hi, This is Sam on for Greg. Thank you for taking my question.
Sam: I have alluded to this a bit earlier, but as a result of the postal trial modifications have there been any changes to the powering assumptions. Thank you.
Bill Aurora: Hi Sam, this is Bill. With respect to the powering assumptions, we have not modified assumptions with respect to the overall design, the powering, and of course, we will continue to keep you and the rest of the team apprised of how we're thinking about that, but nothing has changed. Got it, thank you. Thank you.
Speaker Change: I assume this is bill with respect to the powering assumptions, we have not modified assumptions with respect to the overall design powering and of course, we will continue to keep you and the rest of the team comprised of our <unk>.
Sam: About that but nothing has changed.
Got it thank you.
Speaker Change: Thank you. Our next question comes from Amit <unk> with Needham <unk> Company. Your line is open.
Poonam: Our next question comes from Ami Fadja with Needham and Company. Your line is open. Hi, this is Poonam for AMI.
Sam: Oh.
Speaker Change: Second question.
Sam: Hum.
Poonam: I'm sorry, she's already asked us to move forward, but I'll be speaking in... Sorry, we can't hear you. Are you able to speak up a little bit? Can you hear me now? It's a little better, but you're pretty muffled.
Sam: So not a lot.
Sam: Thank you and turn the molecule.
Sam: Alright.
Sam: Yes, Sir.
Sam: Love It.
Sam: Can you help me model.
Sam: It's a little bit about your pretty muscle.
Poonam: So just wondering if you've built in any interim analysis for the other two coastal studies that could provide some insights this year and has there been any further discussions with the FDA or internally in order to understand what approach can you take if you continue to see a gender-based efficacy in the other coastal studies? So, in terms of the, this is Josh, in terms of the interim analysis, we have not built an interim analysis into the protocols. As you're aware, these are fairly short duration studies, only 6 weeks. And so, as we have looked at it, putting an interim analysis into or a futility analysis, ultimately, we didn't feel would yield any benefits for the coastal 2 and 3 studies.
Sam: So just one thank you.
Sam: Jim.
Sam: But the other two questions study that could provide some insight.
Sam: Has there been any discuss any further discussions with the FDA on internally and also understand what approach can you take if you continue to see agenda.
Sam: Cassini and the other question the studies.
Sam: So.
Josh Pinto: In terms of the this is Josh in terms of the interim analysis, we have not built in interim analysis into the protocol. As you are aware. These are fairly short duration study is only six weeks in so.
Josh Pinto: As we have looked at putting an interim analysis into our if utility analysis ultimately we didn't feel would yield any benefit.
Speaker Change: Or the coastal two or three studies does not plan for these and then I'll pass it over to Bill to just may be talk about.
Josh Pinto: That is not planned for these.
Bill Aurora: And I'll pass it over to Bill to just maybe talk about where we are in terms of discussions with the regulators around gender differences. Sure, we don't typically comment on our interactions with the FDA. Clearly, the results in day 1 were interesting and have us thinking a bit about some of the differences seen in females relative to males. We'll, of course, look to evaluate those findings and see if they're replicated in day 2 and day 3, but we've been thinking a bit more about if those findings are replicated, how we might be able to take those forward.
Josh Pinto: Where we are in terms of.
Bill: Our discussions with the regulators around gender differently.
Bill: We don't typically comment on our interactions with the FDA clearly the results since may one were interesting and have us thinking a bit about some of the differences seen in females relative to males.
Bill: Look to evaluate those find agency for replicated in phase II phase III.
Bill: A bit more about if those findings are replicated our might be able to take those forward will comment on those at a later time point if appropriate.
Poonam: We'll comment on those at a later time point, if appropriate. Got it, thank you. Thank you.
Bill: Got it thank you.
Bill: Thank you.
Tess Romero: Our next question comes from Tess Romero with J.P. Morgan. Your line is open. Hi. Good morning, Dean. Thanks so much for taking our question.
Speaker Change: Our next question comes from Tess Romero with J P. Morgan Your line is open.
Tess Romero: Hi, good morning, Thanks, so much for taking our question.
Josh Pinto: So, NMRA 266 has been on clinical hold for almost a year. Why has there not been an update? And can you provide a little bit of color on your latest thinking on if the convulsions that were observed preclinically with the product are specific to the candidate itself? Thanks.
Speaker Change: No.
Speaker Change: 260, Saks Hasnt been on clinical hold for almost a year.
Speaker Change: Why has there not been an update can you provide a little bit of color on your a little squinting on zircon volumes that were observed pre clinically with the product are specific to the Kennedy itself.
Speaker Change: Thanks.
Josh Pinto: Hey, thanks, Seth. This is Josh. I'll address that question. And so, you know, we've been working through 266, ultimately, to determine if we can move it off of clinical hold, and in parallel, we've been progressing the follow-on franchise to molecules for M4, and so we are excited to note today that we do plan to get one of the follow-on compounds into the clinic by the middle of 2025. We do have a lot of confidence in the follow-on franchise, and in terms of the rabbit convulsions, you know, we would agree it would be logical for us to look to de-risk the follow-on compounds within our M4 franchise before we progress them into the clinic, and so, you know, we'll be coming forward with a fulsome update on the M4 franchise when we move our next program into the clinic, you know, over the next, over the coming months.
Josh Pinto: Hey, Thanks, guys. This is Josh I'll address that question and so we've been working through.
Josh Pinto: 266, ultimately to determine if we can move it off of clinical hold and in parallel we did.
Speaker Change: Wrapping the follow on that franchise to molecules RM forward. So we are excited too.
Speaker Change: Note today that we do plan to get one of the follow on compounds into the clinic by the Middle of 2025, we do have a lot of confidence in the follow on franchise and in terms of the rabbit convulsion, we would agree it would be logical for us to look to derisk. The follow on compounds within our <unk> franchise before we progressed them into the clinic and so.
Speaker Change: So we will be coming forward with a fulsome update on the <unk> franchise, when we move our next program into the product.
Speaker Change: Over the coming months.
Speaker Change: Hello.
Speaker Change: Yeah.
Speaker: Thank you.
Speaker Change: Thank you.
Speaker Change: Okay.
Paul Burns: Thank you, everyone. Okay, great. Well, thank you.
Speaker Change: Thank you everyone, Okay very well thanks.
Paul Burns: That will conclude the Q&A portion of today's call.
Speaker Change: That will conclude the Q&A portion of today's call with that I'll turn it back over to Mr. Burns for closing remarks.
Paul Burns: With that, I'll turn it back over to Mr. Burns for closing remarks. Very great. Thank you, operator. And thanks to all of you for joining us this morning. I think it's pretty clear we believe Neumora is poised to create significant value for patients and shareholders. By bringing forward the next generation of novel therapy, we aim to offer improved treatment outcomes and quality of life for people suffering from brain disease. We have a diverse set of programs, and I would say most importantly, we are supported by a great team with a strong financial position that allows us to drive the programs forward with what we believe to be important value creation for patients and shareholders.
Okay, great. Thank you, operator, and thanks quality and for joining us this morning.
Mr. Burns: I think it's pretty clear, we believe the Morris poised to create significant value for patients and shareholders by bringing forward. The next generation of novel therapies. We aim to offer an improved treatment outcomes and quality of life for people suffering from rare disease.
Mr. Burns: We have a diverse set of programs and I would say most importantly.
Mr. Burns: We are supported by a great team and a strong financial position that allows us to drive our programs forward, what we believe to be important value creation for patients and shareholders.
Operator: Before I conclude, I actually wanted to just emphasize a great amount of thanks to the talented and dedicated Neumora team members for their steadfast dedication and commitment to the patients that we serve. Thanks again. Great questions today. Have a wonderful day, everybody. Thank you for your participation. This does conclude the program. You may now disconnect. Good day.
Mr. Burns: Before I conclude I ask.
Mr. Burns: Wanted to just emphasize great.
Mr. Burns: A great amount of thanks to the talented and dedicated <unk> team members for their steadfast dedication and commitment to patients that we serve thanks again, great questions today have a wonderful day everybody.
Mr. Burns: Thank you for Bart station. This does conclude the program you may now disconnect good day.
Mr. Burns: [music].
Mr. Burns: Okay.
Mr. Burns: Yes.
Mr. Burns: [music].
Mr. Burns: Okay.
Mr. Burns: [music].
Mr. Burns: Sure.
Mr. Burns: [music].