Neumora Therapeutics Q4 2024 Earnings Call Transcript

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Provided by Quartr
March 3, 2025
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Operator

Ladies and gentlemen, thank you for standing by. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.

Operator

I would now like to turn the conference over to Helen Rubinstein, Vice President of Investor Relations and Communications. Please go ahead.

Helen Rubinstein
Helen Rubinstein
VP-IR and Communications at Neumora Therapeutics

Good morning, and thank you for joining Neumora 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 numeratechx.com, where you can find the press release related to today's call. With me on the call are Nomura's Chief Executive Officer, Paul Burns President, Josh Pinto Chief Operating and Development Officer, Bill Arora and Chief Financial Officer, Mike Milligan. 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.

Helen Rubinstein
Helen Rubinstein
VP-IR and Communications at Neumora Therapeutics

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.

Paul L. Berns
Paul L. Berns
Co-Founder, Chairman and Chief Executive Officer at Neumora Therapeutics

Thanks, Helen. Good morning, everyone, and thank you for joining us to review our fourth quarter and full year twenty twenty four 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 medicines 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 L. Berns
Paul L. Berns
Co-Founder, Chairman and Chief Executive Officer at Neumora Therapeutics

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, 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 brain disease. I will now turn the call over to Josh Tinto, 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. Josh?

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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. I'm excited to take on this expanded role as President of Neumora as we make important updates to our pipeline and prepare for a productive year. Beginning with nivacoprant, which is a highly selective kappa opioid receptor antagonist, It's currently in Phase three development for the monotherapy treatment of MDD, which is the leading cause of disability worldwide affecting more than two eighty million people. 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 three studies with nivacoprant in MDD, which Bill will walk through shortly.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

We remain confident in the potential of navacoprant as a novel treatment for MDD in Anadonia. Multiple positive clinical studies from independent sponsors, including data from our own Phase two study with navacoprant in MDD, the NIH run FASTMAP study and the aticaprant Phase two study validate the clinical potential for kappa opioid receptor antagonism. This body of evidence suggests that our COSTAL one results may be an anomaly and there is an important role for this mechanism in the treatment of mood disorders. The strategy for the COSTAL program was to stagger the studies intentionally to allow the opportunity to fine tune the COASTAL-two and three studies based on learnings from COASTAL-one. We've now tested nivacoprant in nearly six hundred people with MDD to date, which has allowed us to follow data driven insights that inform the changes we've deployed across the program.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

We are passionate about our mission of bringing novel treatment options to people living with MDD. I look forward to reporting top line data from KOSTAL three in the first quarter of twenty twenty six and KOSTAL two in the second quarter of twenty twenty six. Additionally, this morning we announced that we discontinued the Phase two clinical trial investigating nivacopran for the treatment of bipolar depression. While we still believe that nivacopran 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. Therefore, we will evaluate opportunities to investigate nivacoprant in bipolar depression and other indications beyond MDD in the future.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

Beyond nivacoprant, we are advancing NMRA five eleven, 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 disease and is associated with increased morbidity and mortality, earlier placement in long term care facilities and greater caregiver stress. Approximately seventy percent of the estimated seven 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.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

So it is clear that there is a substantial unmet need to treat Alzheimer's disease agitation. We look forward to reporting top line data from the Phase 1b signal seeking study by the end of the year. We also expect to advance our M4 franchise by progressing our next compound into the clinic by mid-twenty twenty five. We are confident in the PAM mechanism for a number of reasons. First, we believe that agonists struggle for selectivity.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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 m4pam may offer.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

2025 is going

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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. I look forward to updating you on our progress throughout the year. I'll now turn the call over to Bill to provide additional details on our clinical programs. Bill?

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

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. I'll start with Novacoprant, our highly selective, novel, once daily kappa opioid receptor antagonist being developed as a potential monotherapy treatment for MDD in the Phase III coastal program. Earlier this year, we announced that nivacoprant did not demonstrate a statistically significant improvement on the primary or key secondary endpoint in the COSTAL-one study. COSTAL-one is the first of three randomized placebo controlled double blind Phase three studies that comprise the pivotal COASTAL program.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

Following the announcement of top line results from the COASTAL one study, we paused recruitment for COASTAL two and three and conducted extensive analyses to identify factors that might have contributed to the study outcome. With the benefit of data on nivacoprant in more than 600 patients across COASTOL1 and our Phase two study, we are in a strong position to make meaningful changes to improve COSTAL two and three. 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 studies. To do this, we are adding the clinician rated Massachusetts General Hospital clinical trials network and institute SAFR approach. SAFR is an independent review conducted by clinical psychiatrists to verify the diagnosis and appropriateness of the patient population.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

Our internal medical team will partner with the SAFR 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 who are participating in multiple clinical trials and excluding them from enrolling in the COASTAL two and three studies. This is an additive approach to the clinical trial subject database we used in Coastal One and we believe it will help to ensure the appropriate patients are enrolled in our ongoing studies. 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 avacoprant to make a real difference for patients.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

Historically, there have been many approved blockbuster medicines in MDD and psychiatry broadly that have failed Phase III studies, but ultimately succeeded in multiple studies and became important treatments. 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. Beyond avacoprant, we are currently evaluating NMRA511, our 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 five eleven given its pharmacology, strong preclinical data and well tolerated safety profile to date.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

We look forward to sharing results from the lead study end of twenty twenty five. We also expect to advance our M4 franchise by progressing our next compound into the clinic by mid-twenty twenty five. Each of our M4 PAM compounds is chemically differentiated, strengthening our franchise of Muscareinix that have the potential to deliver antipsychotic efficacy in multiple indications. We believe that we are well positioned to become a leader in Muscarenex, an important new class of medicines, and we look forward to providing an update on our M4 PAM franchise by mid-twenty twenty five. Lastly, we are advancing an exciting pipeline of four preclinical programs, each of which has strong biologic rationale.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

These programs have a range of potential indications, including Alzheimer's agitation, schizophrenia, Parkinson's and ALS, 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. With that overview, I'll now turn the call over to Mike for a review of the financials. Mike?

Michael Milligan
Michael Milligan
CFO at Neumora Therapeutics

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 results. 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 programs. Total operating expenses for the fourth quarter were $58,800,000 compared to $108,700,000 for the same period in 2023.

Michael Milligan
Michael Milligan
CFO at Neumora Therapeutics

Total operating expenses for the full year ended 12/31/2024, were $243,800,000 compared to $235,900,000 for the same period in 2023. The increase was driven primarily by activities related to the Phase three program for Novacoprint, ongoing studies across the rest of our portfolio and investments to support the growth of our business. As of 12/31/2024, we ended the year with $307,600,000 in cash, cash equivalents and marketable securities, which we expect to support operations into mid-twenty twenty six. We believe this runway places us in a very strong financial position to execute on appropriate next steps for nivacaprant, NMRA511, our M4 franchise and the rest of our pipeline. With that, I'll now hand the call over to Helen to manage Q and A with the operator.

Michael Milligan
Michael Milligan
CFO at Neumora Therapeutics

Helen?

Helen Rubinstein
Helen Rubinstein
VP-IR and Communications at Neumora Therapeutics

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.

Operator

Our first question comes from Brian Abrahams with RBC Capital Markets. Your line is open.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Hey, good morning. Thanks for taking my question. Can you elaborate a little bit more on some of the differences between the vendor that you utilized for Coastal One and SAFR? And any changes in the site auditing and patient caps that you utilized in Coastal One that you'll apply for Coastal Two and Three? Thanks.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

Good morning, Brian. This is Phil Arora. Thanks for your question. When 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 to confirm the patients who are being enrolled have an independently verified diagnosis for MDD and we have an opportunity to take a look at their prior history coming into the study. That being said, we're relying on Mass General Hospital, their CTNI group to institute SAFR.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

So as you may be familiar, SAFR is an independent review conducted by clinical psychiatrists at MGH to verify the diagnosis and the appropriateness of the patient population. Our internal medical team will partner with the SAFER clinical team to confirm the patient records and the appropriateness of the patients before they're randomized.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

And Brian, this is Josh here. I would just add, this approach to ADSAFE 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 SAFR. We are continuing to do the full approach we had been doing up to this point and then adding SAFR on top of that to really help as Bill highlighted, ensure that we're randomizing the most appropriate patients based on the eligibility criteria.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Got it. Thanks, Josh. Thanks, Bill.

Operator

Thank you. Our next question comes from Douglas Tsao with H. C. Wainwright. Your line is open.

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Hi, good morning. Thanks for taking the questions. I guess a couple from 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 inter enrollment Coastal II and III are right now? And just broadly, how impactful do you think these changes could be?

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

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 one? Thank you.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

Great. Thanks, Doug. This is Josh. I'll answer the the second part of the question and 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.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

We've seen, you know, important positive studies from a multitude of independent sponsors, including our Phase two study with the VAC brand MDD, the NIMH run FASTMAP study as well as the aticoprant Phase two studies. And so, we feel like the body of evidence out there really suggests that the COASTAL one results might be an anomaly within this class. And as we've talked about before, we truly believe that nivacrine has best in class pharmacology here. As we've unpacked Coastal One a bit more, beyond the gender differences that we've 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.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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. 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. And so, this has 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, you know, the best sites with a critical level of experience, as well as the patient screening and medical monitoring in terms of adding SAFR in the BCT database so that we can ultimately optimize the patient population that's coming into the study.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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. And 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 two for a successful MDD study. And so, now I'll transition over to Bill to really highlight, you know, where we are with the K2, K3 studies at the current moment.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

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 our, you know, a diminished number of folks. It gives us some added confidence as we're looking at today. 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.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

But what I can say is that for K2 and K3, those studies were initiated at the end of or towards the end of twenty twenty three before being paused in January of twenty twenty five. We're now guiding to those studies resuming for another twelve to fifteen months. This gives us confidence that the changes we are making along with 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 trials. COSAL two and three are already different than K1 as an example, that both already enrolled a higher proportion of females relative to males that are more aligned to historical MDD studies.

Douglas Tsao
Managing Director at H.C. Wainwright & Co.

Okay, great. Thank you so much. That's helpful.

Operator

Thank you. Our next question comes from Yatin Sannouha with Guggenheim. Your line is open.

Maddalena Delma Caiati
Biotech Equity Research Analyst at Guggenheim Securities

Hi, this is Zama for Yatin. Thanks for taking our questions. So when you look retrospectively at patients with exaggerated placebo response in KOSAL-one, what was their MADRS 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 KOSAL two and three, can you provide any granularity on the number of sites that will be removed?

Maddalena Delma Caiati
Biotech Equity Research Analyst at Guggenheim Securities

And what was the average number of patients per site in KOSAL one? Thank you.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

Dilma, thanks for the question. At this time, we're not providing details in terms of the average baseline score for patients in sites that had a high placebo response. But what we can say is that we do believe that the changes that we're making to coastal two and three will help to improve on how we executed coastal one and ultimately support what we really want to as we've looked at the data. What's clear to us is that 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 to randomization phase is absolutely critical to confirm patients appropriately meet the inclusion exclusion criteria.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

So as Bill highlighted, beyond all of the measures we already had in Coastal One, we have added the SAFR approach from MGH as well as the VCT database.

Maddalena Delma Caiati
Biotech Equity Research Analyst at Guggenheim Securities

Got it. Thank you. And do you expect the number of patients per site to increase now with COSR2 and COSR3?

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

In terms of the number of patients per site, we don't necessarily know that they'll increase. As you can recall, coastal two and three are sized the same way that coastal one is where the target number of patients enrolled in each is about three thirty two. We do want to make sure that for the remainder of coastal two and three, we are focused on the highest quality sites. But ultimately, we can't comment in terms of final number of sites at this point.

Maddalena Delma Caiati
Biotech Equity Research Analyst at Guggenheim Securities

Got it. Thank you so much.

Operator

Thank you. Our next question comes from Paul Matteis with Stifel. Your line is open.

Paul Matteis
Paul Matteis
Managing Director at Stifel Financial

Hey, thanks for taking the question. I guess one thing I'm a little bit confused about is during Coastal One, 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 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 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 doesn't feel like it was?

Paul Matteis
Paul Matteis
Managing Director at Stifel Financial

And then just secondarily, on cash 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 twelve months? Thanks so much.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

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 aim close to a 14 placebo response.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

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, NPH and SAFR will help us do that to verify the baseline degree of severity, 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 enroll.

Michael Milligan
Michael Milligan
CFO at Neumora Therapeutics

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 enables us to

Michael Milligan
Michael Milligan
CFO at Neumora Therapeutics

achieve multiple catalysts, not just with the macro print, but across the pipeline.

Michael Milligan
Michael Milligan
CFO at Neumora Therapeutics

Our current balance sheet, as you noted and we noted, provides cash runway into mid-twenty six. 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.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

Yes. And Paul, this is Josh. I'll just summarize a few of the comments. We had obviously deployed a number of enhanced measures as we were thinking about executing Coastal One beyond what we had done in Phase two. And I think what we've seen through the Coastal One results is that we can do more beyond what we had done.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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 that we are getting the right patients randomized that fit the inclusion exclusion criteria. And then to Mike's point, we've always been very focused on maintaining a strong balance sheet. We've always been focused on 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 we move through this year into 2026.

Operator

Thank you.

Helen Rubinstein
Helen Rubinstein
VP-IR and Communications at Neumora Therapeutics

Great. Operator, I think we'll take our next question.

Operator

Our next question comes from Myles Mentor with William Blair. Your line is open.

John Boyle
Biotechnology Equity Research Associate at William Blair

Hi, team. This is John on for Myles. Thanks so much for taking our questions. Maybe two from us. So first, I was just wondering if you have any updates on the PK data from Coastal One, and if there was anything you could glean from there on how the various sites performed or if there was any sex based differences?

John Boyle
Biotechnology Equity Research Associate at William Blair

And second, do you still have the opportunity to increase enrollment by 25% for Coastal Two and Three? And if so, was that included in your timeline guidance?

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

Hi, John. This is Bill. Let me take the first question here with respect to the PK data. The exposures from COSTRA1 were consistent with the results from the Phase two study. And so in that context, the exposures were as we expected consistent with Phase two where we did see the robust efficacy to severe population.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

We believe that the eighty milligram dose is a potentially efficacious dose with a favorable tolerability and safety profile. 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.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

Yes. And then John, on the guidance and timing piece, I think we've built in the flexibility in all three of the COSAL studies, COSAL I, II and III to increase the sample size by up to twenty five percent. And so, we have that flexibility in coastal two and three 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.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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 done

John Boyle
Biotechnology Equity Research Associate at William Blair

Thank you.

Operator

Thank you. Our next question comes from Gregg Sivanova with Mizuho. Your line is open.

Analyst

Hi, this is Sam on for Greg. Thank you for taking our question. You may have alluded to

Analyst

this a bit earlier, but as a result

Analyst

of the post trial modifications, have there been any changes to the powering assumptions? Thank you.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

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 prized of how we're thinking about that, but nothing has changed.

Analyst

Got it. Thank you.

Operator

Thank you. Our next question comes from Ami Fadia with Needham and Company. Your line is open.

Poorna Kannan
Biotech Equity Research Associate at Needham & Company

Hi, this is Boona on for Ami. Thank you for taking my question. I'm sorry if you've already asked before, but have you spoken any interim analysis for the other two courses?

Helen Rubinstein
Helen Rubinstein
VP-IR and Communications at Neumora Therapeutics

Sorry, Vorna. We can't hear you. Are you able to speak out a little bit?

Poorna Kannan
Biotech Equity Research Associate at Needham & Company

Can you hear me now?

Helen Rubinstein
Helen Rubinstein
VP-IR and Communications at Neumora Therapeutics

It's a little bit, but you're pretty muffled.

Poorna Kannan
Biotech Equity Research Associate at Needham & Company

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 coastal studies?

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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 six weeks. And as we have looked at it, putting an interim analysis into or a futility analysis, ultimately, we didn't feel it would yield any benefits or the coastal two and three studies that is not planned for these. And then 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.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

Sure. We don't typically comment on our interactions with the FDA. Clearly, the results in K1 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 K2 and K3. So we've been thinking a bit more about if those findings are replicated, how we might be able to take those forward.

Bill Aurora
Bill Aurora
Chief Operating & Development Officer at Neumora Therapeutics

We'll comment on those at a later time point if appropriate.

Poorna Kannan
Biotech Equity Research Associate at Needham & Company

Got it. Thank you.

Operator

Thank you. Our next question comes from Tess Romero with JPMorgan. Your line is open.

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Hi. Good morning team. Thanks so much for taking our question. So NMRA two sixty six has been on clinical hold for almost a year. Why has there not been an update?

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

And can you provide a little bit of color on your latest thinking on if the convulsions that were observed pre clinically with the product are specific to the candidate itself? Thanks.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

Hey, thanks Seth. This is Josh. I'll address that question. And so we've been working through February 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.

Joshua Pinto
Joshua Pinto
President at Neumora Therapeutics

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 twenty twenty five. 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 M4 franchise before we progress them into the clinic. And so we'll be coming forward with a fulsome update on the M4 franchise when we move our next program into the clinic over the next couple of months.

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

Thank

Tessa Romero
Tessa Romero
Equity Analyst at J.P. Morgan

you.

Operator

Thank you, everyone. That will conclude the Q and A portion of today's call. With that, I'll turn it back over to Mr. Burns for closing remarks.

Paul L. Berns
Paul L. Berns
Co-Founder, Chairman and Chief Executive Officer at Neumora Therapeutics

Great. Thank you, operator. And thanks to all of you for joining us this morning. I think it's pretty clear we believe Nemours poised to create significant value for patients and shareholders. By bringing forward the next generation of novel therapies, we aim to offer improved treatment outcomes and quality of life for people suffering from brain disease.

Paul L. Berns
Paul L. Berns
Co-Founder, Chairman and Chief Executive Officer at Neumora Therapeutics

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. Before I conclude, I actually wanted to just emphasize a great amount of thanks to the talented and dedicated Novart team members for their steadfast dedication and commitment to patients that we serve. Thanks again. Great questions today.

Paul L. Berns
Paul L. Berns
Co-Founder, Chairman and Chief Executive Officer at Neumora Therapeutics

Have a wonderful day, everybody.

Operator

Thank you for your participation. This does conclude the program. You may now disconnect. Good

Executives
    • Helen Rubinstein
      Helen Rubinstein
      VP-IR and Communications
    • Paul L. Berns
      Paul L. Berns
      Co-Founder, Chairman and Chief Executive Officer
    • Joshua Pinto
      Joshua Pinto
      President
    • Bill Aurora
      Bill Aurora
      Chief Operating & Development Officer
    • Michael Milligan
      Michael Milligan
      CFO
Analysts
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Earnings Conference Call
Neumora Therapeutics Q4 2024
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