NASDAQ:NMRA Neumora Therapeutics Q1 2025 Earnings Results & Report $0.36 -0.01 (-1.67%) As of 09:57 AM Eastern This is a fair market value price provided by Massive. Learn more. Neumora Therapeutics missed analyst earnings expectations in its Q1 2025 results, released May 12, 2025. The company reported EPS of -$0.42 versus the -$0.40 consensus estimate. Research:ProfileEarnings HistoryForecast Earnings Announcement Details QuarterQ1 2025Report DateMay 12, 2025TimeAfter Market ClosesConference Call4:30 PM ET Neumora Therapeutics EPS ResultsActual EPS-$0.42Consensus EPS -$0.40Beat/MissMissed by -$0.02One Year Ago EPSN/AEPS Beat Rate4 of last 8 quartersNeumora Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AUpcoming EarningsNeumora Therapeutics' Q3 2026 earnings is estimated for Thursday, November 5, 2026, based on past reporting schedulesConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Neumora Therapeutics Q1 2025 Earnings Call TranscriptProvided by QuartrMay 12, 2025ShareShareShare This ReportLink copied to clipboard.Key Takeaways Nomura has resumed and refined its Phase III COASTal-two and COASTal-three trials for avacoprant in MDD, implementing enhanced screening and monitoring measures and expects topline data in Q1 and Q2 2026. The company plans to report results for NMRA-511, a vasopressin 1a receptor antagonist for Alzheimer’s disease agitation, from a Phase Ib signal-seeking study around year-end. A best-in-class M4 PAM candidate is on track for first-in-human dosing by mid-2025, aiming to offer improved safety, tolerability and once-daily dosing for antipsychotic therapy. Nomura secured a $125 million debt facility (with $20 million funded at close), extending its cash runway into 2027 to support multiple upcoming clinical catalysts. First-quarter net loss widened to $68 million from $53.7 million year-over-year, reflecting increased R&D and operational expenses. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallNeumora Therapeutics Q1 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Ladies and gentlemen, thank you for standing by. At this time, all participants are on a 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. I would now like to turn the conference over to Helen Rubinstein, Vice President of Investor Relations and Communications. Please go ahead. Helen RubinsteinVP of Investor Relations at Neumora Therapeutics00:00:21Good afternoon, and thank you for joining Neumora Therapeutics' first quarter 2025 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. With me from Neumora are Chief Executive Officer Paul Berns, President Josh Pinto, Chief Operating and Development Officer Bill Aurora, and Chief Financial Officer Mike Milligan. I'd 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. 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 BernsChairman and CEO at Neumora Therapeutics00:01:15Thanks, Helen. Good afternoon, everyone, and thank you for joining us. At Neumora, we believe the greatest medical challenge of our generation is the global brain disease crisis. This affects upwards of 1.5 billion people and causes a severe impact on quality of life not only for patients, but also their families and society at large. Despite a number of approved therapies, there is a significant outstanding unmet need for safe and effective treatment options to alleviate the burdens of these diseases. When we founded Neumora, it was with the intention to confront this challenge head-on and focus on bringing novel mechanisms forward to redefine neuroscience drug development. We have made important progress towards that goal. We are advancing an industry-leading pipeline of programs all targeting novel mechanisms of action, with the potential to address some of the most prevalent brain diseases and are supported by a strong financial foundation. Paul BernsChairman and CEO at Neumora Therapeutics00:02:21As we are poised to achieve a number of upcoming clinical catalysts across our pipeline, I believe we have the right science, people, and strategy in place to realize our vision of revolutionizing the treatment of brain diseases. I will now turn the call over to Josh Pinto, President of Neumora, to review our business and pipeline updates. Josh. Josh PintoPresident at Neumora Therapeutics00:02:44Thanks, Paul. We are focused on clinical execution as we are advancing multiple programs towards key milestones over the next 12 months. We are on track to deliver top-line data for NMRA-511, our vasopressin 1a receptor antagonist in Alzheimer's disease agitation, around the end of the year. We are also progressing navacaprant in the Phase III KOASTAL program in MDD, where we have implemented important changes for the ongoing studies and plan to report top-line data from KOASTAL III in the first quarter of 2026 and KOASTAL II in the second quarter of 2026. In our M4 franchise, we are working with urgency to bring a best-in-class M4 PAM into the clinic in the middle of this year. Additionally, we announced this morning that we entered into a $125 million debt facility with K2 HealthVentures, with up to $40 million available for draw this year. Josh PintoPresident at Neumora Therapeutics00:03:55K2 HealthVentures has deep expertise in life sciences, and we are pleased with the opportunity to work with their team. Financial discipline has always been a core tenet of how we operate our business, and today it is more important than ever to maintain diligent stewardship of capital. The non-dilutive capital from this facility, combined with the cash already on our balance sheet, further strengthens our financial position and will support our efforts to achieve value-creating milestones across our pipeline. With this update, we now expect our cash, cash equivalents, and marketable securities, together with the $20 million funded at close under the K2 facility, to support our operations into 2027, well beyond anticipated clinical data milestones. As you can see, we are well positioned to generate value from a number of programs, and we are supported by a strong financial foundation. Josh PintoPresident at Neumora Therapeutics00:05:03Each one of our programs evaluates a novel mechanism of action in their respective indications, with the potential to bring new treatment options to patients and capitalize on significant market opportunities. Our pipeline is supported by a very strong intellectual property portfolio with worldwide rights to all of our programs and composition of matter patents extending into the 2040s. As a multi-product company with multiple shots on goal, we are prepared to execute against our vision of maximizing all pathways for success and generating long-term company growth. With that overview, I will now turn the call over to Bill to provide additional details on our clinical programs. Bill. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:05:51Thanks, Josh. We are excited about the industry-leading pipeline we have constructed and the potential of these novel mechanisms to revolutionize the treatment of brain diseases. Starting with navacaprant, we are confident in the potential for navacaprant to become a differentiated treatment option for patients with MDD. There is a strong body of clinical evidence validating the potential of kappa opioid receptor antagonists to show benefit in MDD and anhedonia. Supporting studies include the National Institutes of Health, or NIH, run FAST/MAST study, the Johnson & Johnson Phase II study of aticaprant, and importantly, our own Phase II study of nevacaprant, which was recently published in the Journal of Clinical Psychopharmacology. This publication highlights that nevacaprant demonstrated statistically significant and clinically meaningful reductions in symptoms of depression and anhedonia in participants with moderate to severe MDD. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:06:50When trying to understand how KOASTAL I results compared to other studies, we identified a few factors that were different from what you'd expect to see in a typical MDD population. For example, approximately two-thirds of the patients had never taken a prior antidepressant, despite experiencing an average of five prior episodes of MDD in their lifetimes. Prior trials and publications suggest that a substantially higher percentage of people with chronic MDD would have received prior antidepressant treatment. As we've looked at the data, we concluded that the total population in KOASTAL I was not necessarily representative of the MDD population, and that's why we've made modifications in site selection, patient screening, and medical monitoring in KOASTAL II and III to help ensure that appropriate patients are enrolled. The studies resumed enrolling in March with the following changes. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:07:46We enhanced engagement with sites around medical monitoring to confirm the patients enrolled in the studies have an independently verified diagnosis of MDD that helps to ensure they appropriately meet eligibility criteria for these studies. We added the Clinician-Rated Massachusetts General Hospital Clinical Trials Network and Institute SAFER approach, which is an independent review conducted by clinicians to verify the diagnosis and appropriateness of the patient population. Our internal medical team is partnering with the SAFER clinical team to confirm eligibility prior to randomization. We also added an additional tool called the Verified Clinical Trial Screening Database, aimed at better identifying patients who are participating in multiple clinical trials and excluding them from enrolling in the KOASTAL II and III studies. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:08:39This is an additive step to the clinical trial subject database we used in KOASTAL I, and we believe it will help to ensure the appropriate patients are enrolled in our ongoing studies. Finally, 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. We have already seen benefits from these added measures in the KOASTAL II and KOASTAL III studies. For example, the Verified Clinical Trial Screening Database has identified multiple potential participants who are not appropriate for inclusion, enabling us to exclude them from the studies. More broadly, it's important to remember that many approved medicines in MDD and psychiatry broadly have failed individual Phase III studies, but ultimately succeeded in multiple studies and become important treatments. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:09:34We designed the KOASTAL program with the historical challenges in mind, knowing that we would need two of the three trials to be successful in order to file an NDA. We anticipate data from KOASTAL III in the first quarter of 2026 and KOASTAL II in the second quarter of 2026. I also want to highlight our franchise of M4 PAMs that we are advancing, where we plan to move a candidate into the clinic in the middle of this year. Based on available data, it is clear that M4 is the driver of antipsychotic activity seen with muscarinic drugs to date. We believe we are well positioned to become a leader in M4 PAMs that can potentially offer improved safety and tolerability profile and once-a-day dosing. We look forward to sharing more on the pharmacology of our M4 programs when they enter the clinic in mid-2025. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:10:28In Phase Ib is our vasopressin 1a receptor antagonist, NMRA-511, which is a highly potent and highly selective antagonist being evaluated for Alzheimer's disease agitation. The V1A target is a proven pathway, as it is known to play a role in the regulation of aggression, affiliation, stress, and anxiety response. In preclinical data, NMRA-511 reduced measures of anxiety, agitation, aggression, and was very well tolerated in a Phase I SAD/MAD study, as well as in healthy elderly volunteers. We believe that based on these data combined with findings from other sponsors, there's a strong rationale for NMRA-511 in AD agitation, an area of significant unmet need with only one approved agent that carries a black box warning. We look forward to delivering top-line data from Phase Ib signal-seeking study around the end of this year. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:11:27In parallel, we continue to progress our four preclinical programs, which have opportunity to make impacts in serious and common diseases such as Parkinson's disease, Alzheimer's disease, and ALS. Those programs are advancing, and we look forward to sharing more information on those studies in the near future. In short, it has been a productive start to 2025 for Neumora, and we're well positioned to achieve our multiple upcoming clinical catalysts in the second half of this year and beyond. With that, I'll now turn it over to Mike for a review of the financials. Mike. Mike MilliganCFO at Neumora Therapeutics00:12:04Thanks, Bill, and good afternoon, everyone. Our financial results for the first quarter of 2025 are detailed in the press release that we issued this morning. I'd like to take a moment to provide some context and highlight a few key points. Net loss for the first quarter was $68 million, compared to $53.7 million for the same period in 2024, and we ended the quarter with $249.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025. As Josh noted, we are focused on disciplined capital allocation and expect our cash on hand and the $20 million drawn at the close of the K2 facility to support operations into 2027. We expect that this runway will allow us to realize multiple catalysts across our programs. With that, I'll now hand the call over to Helen to manage Q&A with the operator. Helen. Helen RubinsteinVP of Investor Relations at Neumora Therapeutics00:12:59Thanks, 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. Now I'll turn it over to the operator to handle Q&A. Operator. Operator00:13:14As a reminder, if you'd like to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Douglas Tsao with H.C. Wainwright. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:13:38Hi, good afternoon. Thanks for taking the questions. I guess two for me. First, starting with nevacaprant, I understand the operational changes that were put in place. I'm just curious, have you had any sort of sense of how it has affected sort of the pace of enrollment, early going, just sort of early experiences and sort of what gives you that confidence in terms of achieving the readouts next year? Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:14:14Thanks, Doug. This is Bill. Appreciate your question. We've already seen benefits from steps that we've taken with both SAFER and the Verified Clinical Trial Screening Database that we've implemented in the K2 and the K3 studies. Both have identified multiple potential participants who really aren't appropriate for inclusion in the study, enabling us to exclude these patients from being put in. We do have confidence that the steps we're taking are helping to get appropriate patients randomized into K2 and K3. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:14:47I guess, Bill, as a follow-up, just is it having a negative impact in terms of the pace of enrollment or obviously you're sort of disqualifying some patients? I guess it sounds like, though, that the rate of that is occurring at a rate consistent with what you were expecting. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:15:04Yes, Doug. It is consistent. The rate of those patients being excluded is consistent with our expectation. It does not impact our timing guidance that we have provided with respect to the enrollment. Things are progressing as planned. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:15:16Okay, great. That's great to hear. Just on the K2 financing, I'm just curious if you can provide any details in terms of sort of limitations on prepayment or so just to the extent that as you hit other milestones, are you able to perhaps pay down that debt as sort of your cost of equity comes down? Thank you. Josh PintoPresident at Neumora Therapeutics00:15:43Hey, Doug. It's Josh here. I'll take that one. The details of the facility are disclosed in our 10Q, so I would point you towards that. Really, with this facility, what we were looking to achieve in this financing was extending our cash runway into 2027. With the $20 million that we're able to draw at close, plus our existing cash balance, we were able to achieve that goal, and we've extended our cash runway now into 2027. In terms of the milestones, you can think about progression of nevacaprant through some of the clinical stages as well as some regulatory stages as ways to ungate additional capital. As we noted in the press release, beyond the first $20 million that was funded at close, there will be another $20 million that we can bring in at our discretion before the end of this year. Josh PintoPresident at Neumora Therapeutics00:16:33There is flexibility in terms of bringing more capital onto our balance sheet this year through the facility. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:16:40Josh, just to confirm, though, that you only need the $20 million to get you into 2027? Josh PintoPresident at Neumora Therapeutics00:16:48Correct. Our existing cash balance sheet as of the end of March, plus the $20 million funded at close, gets our runway into 2027. Any additional drawdowns beyond that would provide funding for additional investments or extension of the cash runway beyond that. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:17:04Okay, great. Thank you so much. Operator00:17:09Our next question comes from Yatin Suneja with Guggenheim. Yatin SunejaSenior Managing Director, Biotechnology Analyst at Guggenheim Securities00:17:15Hey, guys. Thank you for taking my question. A couple of questions on the KOASTAL program. Could you talk about the patient population who might have received an antidepressant and how you are tracking it? Because as I recall, in KOASTAL I, there was a lot of patients that had never taken antidepressant therapy in the past. Just curious to know, is there a particular percentage of patients that you are targeting who would have taken a prior antidepressant in this study and how that might be tracking? The other question is also on the K2 and 3, are there any possibility of some form of an interim analysis in this study? Thank you. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:17:58Hi, Anthon. This is Bill. Thanks for your question. With respect to how we are ensuring we've got the proper patients being included in K2 and K3 after the pause, the steps that we've taken include having a SAFER clinical team involved in providing the assessment for patients, taking a look at their history, both of depression treatment. Our own clinical team is partnering closely with the MGH SAFER team to ensure that we are providing the degree of oversight that is consistent with our expectations to ensure we have patients with the proper history being enrolled. We are, in fact, strengthening that quite a bit and avoiding some of the things that we saw in K1 as part of that. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:18:40With respect to the interim analysis, we do not have plans for an interim analysis, and we are moving ahead with the enrollment and the timelines for K3 being in Q1 and K2 in Q2 of 2026. Operator00:19:00Our next question comes from Brian Abrahams with RBC Capital Markets. Nevin VargheseSenior Equity Research Associate at RBC Capital Markets00:19:07Hi, everyone. Thank you for taking my question. This is Nevin On for Brian. Just to kind of high level, I guess, what are kind of your latest views on how to reconcile the CORA mechanism based on the Phase II data that you've shown as well as J&J's? Also, with respect to the KOASTAL I study readout and J&J's decision to discontinue aticaprant or pivot that into different indications. I have a follow-up after as well. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:19:45Sure, Nevin. This is Bill. Let me start here. We were surprised by J&J's decision to terminate their program given their January of 2025 communication about submitting an NDA later this year. We're looking forward to the presentation of their pooled data later this month. That being said, there are several important differences between nevacaprant and aticaprant, as well as the development strategies that are employed with each of the agents. First off, from a pharmacology point of view, nevacaprant is significantly more selective for kappa opioid receptors over mu opioid receptors than aticaprant is. Secondly, the study design for each of the programs and molecules were different. We believe the KOASTAL program really reflects the most appropriate study design for this mechanism to be utilized in the monotherapy setting. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:20:33The steps that we've taken for enhancing K2, K3 really, in our view, improve the probability of success with the changes that we're making. I would simply say that it's difficult to think about the aticaprant program in read-throughs. There are limitations due to the pharmacology and study design that limit that read-through. We remain confident in nevacaprant. I still believe KOASTAL I results may have been an anomalous finding. We are excited about K2, K3 progressing and the timing for those reading out. Nevin VargheseSenior Equity Research Associate at RBC Capital Markets00:21:05Great. Thanks so much. I also saw in the 10Q that was released that you had triggered the second tranche of funding from PBT for selection of an NLRP3 candidate. I guess, what can you tell us about this early program? When we could see more from this and when you might be able to disclose more data regarding this program? Josh PintoPresident at Neumora Therapeutics00:21:29Yeah, Nevin, this is Josh here. Thanks for the question. I appreciate that. NLRP3 has been a program that we've been very excited about and progressing for a while now. It is really focused around targeting the NLRP3 inflammasome, which we believe is a critical part of the innate immune system and can have an impact on a range of CNS as well as other conditions. We tend not to talk a lot about our programs until we move them into the clinic. As you've noted, we have been making progress with our NLRP3 program. I am looking forward to having more specific updates on that program as we move through the next few quarters and into early 2026. Nevin VargheseSenior Equity Research Associate at RBC Capital Markets00:22:09Great. Thank you so much. Operator00:22:14Our next question comes from Greg Sivanovich with Mizuho Securities. Graig SuvannavejhBiotech & Biopharma Analyst at Mizuho Securities00:22:20Hey, good afternoon. Thanks for taking my questions. Appreciate the updates that you've provided. Two questions, each on pipeline candidates. Just with respect to 511 and the readout in Alzheimer's disease agitation, maybe could you put in perspective what you expect to see with that data set, especially relative to the data, the Phase III data sets that exist for a competitor product, AXS-05 from Axsome Therapeutics? Secondly, on the M4 PAM, maybe if you could revisit kind of your thoughts on differentiation between your candidate and perhaps the other program, Enracladine, in which, unfortunately, the Phase II, III data were not great. Any color as to the confidence that you have that you'll perhaps show a different set of outcomes? Thanks. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:23:31Hey, Greg. This is Bill. Thanks for your question. Let me start out here with the 511 question. Just as a reminder, this is a study that has not been powered to show statistical separation of active from placebo, but is rather a signal-seeking study. Two parts. Part A, the Phase Ib, surely the randomized, double-blind, placebo-controlled cohort designed to evaluate safety, efficacy, tolerability, PK in healthy elderly volunteers. That portion has been completed. Part B of the Phase Ib is a multi-center randomized, double-blind, placebo-controlled study where we are evaluating NMRA-511, 20 milligrams twice a day in about 88 patients relative to placebo in agitation associated with Alzheimer's. The primary endpoint for the signal-seeking study is the change from baseline to week eight on the CMAI or the Cohen-Mansfield Agitation Inventory. We are looking at the total score change there. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:24:31We will really look at these data to help better understand which domains on the CMAI improved and helped inform our thinking about the design for the next Phase of study that would follow looking at these results. With respect, Greg, to the M4. Josh PintoPresident at Neumora Therapeutics00:24:49Yeah, Greg. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:24:51Question? Josh PintoPresident at Neumora Therapeutics00:24:51Yeah, this is Josh. In terms of the M4 differentiation, one of the areas we've been very focused on engineering is ensuring that our compounds have high blood-brain barrier penetration. We think given the class and the cardiovascular-related AEs being one of the key limiters for the M4 muscarinics, that really ensuring optimal blood-brain barrier penetration is going to provide the biggest chance to show a great central effect. In terms of areas where we think we could differentiate, we do think CNS penetration is one of them. We look forward to providing more specific details on our M4 PAM programs when we bring the next set into the clinic by middle of 2025. Graig SuvannavejhBiotech & Biopharma Analyst at Mizuho Securities00:25:35Okay. Thank you very much. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:25:41Our next question comes from John Boyle with William Blair. John BoyleBiotechnology Equity Research Associate at William Blair00:25:45Hi, this is John. I'm from Myles Minter. Thanks so much for taking our question. I was just wondering if you could talk a little bit about maybe potential timing for when you might decide to increase enrollment in KOASTAL II or KOASTAL III, and also just what aspects of the blinded data are you looking at and considering when making that decision? Thanks. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:26:07Sure. Hi, John. This is Bill. I'll start here and basically communicate that with KOASTAL II and III, those studies were designed and scheduled to randomize up to 332 patients into the protocol. We've built in flexibility that allows us to go 25% higher than that 332. With respect to KOASTAL I, you'll recall that we were just north of 380 patients enrolled. So we did end up about 15% over-enrolling relative to the 332 base. K2 and K3 are progressing. We haven't made a decision on what that overall number will be, but we'll provide updates at the appropriate time point. Operator00:26:54Our next question comes from Ami Fadia with Needham & Company. Poorna KannanBiotech Equity Research Associate at Needham & Company00:26:59Hi, this is Purna, Ami for Ami. Thank you for taking our question. I'm just curious, in KOASTAL I, how does the MADRS baseline scores compare with the severity that was seen in the Phase II study where you saw the differentiation? Also, just wanted to understand how, what is the mix of females that you're seeing now in K2 and K3, and if you're managing the mix of patients? Thank you. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:27:24Sure. Looking at K1 relative to Phase II, in Phase II, we utilized the HAMD-17. In that study, there were about 100 patients that had moderate to severe MDD. In KOASTAL I, we were utilizing the MADRS, and we were using a cutoff of 25 or higher on the MADRS, consistent with a moderate to severe MDD population. Once you think about those populations as being similar with respect to disease severity in that manner. When we think about the mix of subjects in K2 and K3 relative to KOASTAL I, it was a bit anomalous to see the high percentage of males in K1 relative to historically conducted studies. In K2, K3, we are seeing a mix that's more representative of what's historically been seen, roughly two-thirds female, one-third male. We are pleased to see that being the demographic sex distribution for K2, K3. Poorna KannanBiotech Equity Research Associate at Needham & Company00:28:26Got it. Thank you. Operator00:28:31That concludes today's question and answer session. I'd like to turn the call back to Paul Berns for closing remarks. Paul BernsChairman and CEO at Neumora Therapeutics00:28:37All right. Thank you, operator, and thank you for all of your questions to the participants in today's call. We very much appreciated the opportunity to give you the quarterly update. I would also like to thank my fellow Neumora team members for their commitment to excellence as we advance their programs with the goal of bringing novel new therapeutics to treat patients with brain disease. With that, I bid you adieu and a good afternoon. Operator00:29:01This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesMike MilliganCFOBill AuroraChief Operating and Development OfficerJosh PintoPresidentPaul BernsChairman and CEOHelen RubinsteinVP of Investor RelationsAnalystsGraig SuvannavejhBiotech & Biopharma Analyst at Mizuho SecuritiesNevin VargheseSenior Equity Research Associate at RBC Capital MarketsPoorna KannanBiotech Equity Research Associate at Needham & CompanyJohn BoyleBiotechnology Equity Research Associate at William BlairYatin SunejaSenior Managing Director, Biotechnology Analyst at Guggenheim SecuritiesDouglas TsaoManaging Director of Equity Research at H.C. WainwrightPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Neumora Therapeutics Q1 2025 Earnings FAQ Did Neumora Therapeutics beat earnings estimates for Q1 2025? Neumora Therapeutics (NASDAQ:NMRA) reported earnings of -$0.42 per share for Q1 2025, missing the consensus estimate of -$0.40. The report was announced on Monday, May 12, 2025. Where can I read Neumora Therapeutics' Q1 2025 earnings call transcript? The full Neumora Therapeutics Q1 2025 earnings conference call transcript is published on this page, including prepared remarks and the analyst Q&A session, along with the participants who spoke on the call. When is Neumora Therapeutics' next earnings date? Neumora Therapeutics' next earnings date is estimated for Thursday, November 5, 2026. MarketBeat tracks confirmed and estimated earnings dates for Neumora Therapeutics on the company's earnings history page. Neumora Therapeutics Earnings HeadlinesNeumora Therapeutics (NASDAQ:NMRA) Stock Dropped to "Strong Sell" by Wall Street ZenOctober 10, 2026 | americanbankingnews.comNeumora Therapeutics, Inc. (NMRA)September 15, 2026 | finance.yahoo.comHow one AI fund pays investors every ThursdayOne small fund tied to artificial intelligence stocks delivered $1,051 in a single month, not through selling shares or trading options, but simply by holding the fund and letting it pay out cash every Thursday. That works out to a 34% annualized distribution rate, even though the underlying AI stocks pay no dividends themselves. Tim Plaehn, Chief Income Strategist at Investors Alley, breaks down exactly how the fund generates these weekly payouts.October 14 at 1:00 AM | Investors Alley (Ad)Top Neumora Executive Makes Notable Move With Insider Stock SaleAugust 21, 2026 | tipranks.comNeumora Therapeutics Announces CEO Transition and Q2 ResultsAugust 14, 2026 | tipranks.comNeumora Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business UpdateAugust 14, 2026 | globenewswire.comSee More Neumora Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Neumora Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Neumora Therapeutics and other key companies, straight to your email. Email Address About Neumora TherapeuticsNeumora Therapeutics (NASDAQ:NMRA) is a clinical-stage biopharmaceutical company focused on developing treatments for disorders of the brain. The company combines neuroscience research with data science, including its proprietary MAP platform, to identify patient subgroups, discover potential drug targets and support the development of therapies for neurological and neuropsychiatric conditions. Neumora’s lead investigational product is navacaprant, an oral, selective kappa opioid receptor antagonist being evaluated for major depressive disorder. The company is also advancing additional programs aimed at conditions such as schizophrenia and other brain disorders. These products remain investigational and have not been approved for commercial use unless authorized by applicable regulatory agencies. Neumora was founded in 2019 through a collaboration involving ARCH Venture Partners and Amgen and is headquartered in Watertown, Massachusetts. The company became publicly traded on the Nasdaq under the symbol NMRA in 2023. 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PresentationSkip to Participants Operator00:00:00Ladies and gentlemen, thank you for standing by. At this time, all participants are on a 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. I would now like to turn the conference over to Helen Rubinstein, Vice President of Investor Relations and Communications. Please go ahead. Helen RubinsteinVP of Investor Relations at Neumora Therapeutics00:00:21Good afternoon, and thank you for joining Neumora Therapeutics' first quarter 2025 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. With me from Neumora are Chief Executive Officer Paul Berns, President Josh Pinto, Chief Operating and Development Officer Bill Aurora, and Chief Financial Officer Mike Milligan. I'd 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. 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 BernsChairman and CEO at Neumora Therapeutics00:01:15Thanks, Helen. Good afternoon, everyone, and thank you for joining us. At Neumora, we believe the greatest medical challenge of our generation is the global brain disease crisis. This affects upwards of 1.5 billion people and causes a severe impact on quality of life not only for patients, but also their families and society at large. Despite a number of approved therapies, there is a significant outstanding unmet need for safe and effective treatment options to alleviate the burdens of these diseases. When we founded Neumora, it was with the intention to confront this challenge head-on and focus on bringing novel mechanisms forward to redefine neuroscience drug development. We have made important progress towards that goal. We are advancing an industry-leading pipeline of programs all targeting novel mechanisms of action, with the potential to address some of the most prevalent brain diseases and are supported by a strong financial foundation. Paul BernsChairman and CEO at Neumora Therapeutics00:02:21As we are poised to achieve a number of upcoming clinical catalysts across our pipeline, I believe we have the right science, people, and strategy in place to realize our vision of revolutionizing the treatment of brain diseases. I will now turn the call over to Josh Pinto, President of Neumora, to review our business and pipeline updates. Josh. Josh PintoPresident at Neumora Therapeutics00:02:44Thanks, Paul. We are focused on clinical execution as we are advancing multiple programs towards key milestones over the next 12 months. We are on track to deliver top-line data for NMRA-511, our vasopressin 1a receptor antagonist in Alzheimer's disease agitation, around the end of the year. We are also progressing navacaprant in the Phase III KOASTAL program in MDD, where we have implemented important changes for the ongoing studies and plan to report top-line data from KOASTAL III in the first quarter of 2026 and KOASTAL II in the second quarter of 2026. In our M4 franchise, we are working with urgency to bring a best-in-class M4 PAM into the clinic in the middle of this year. Additionally, we announced this morning that we entered into a $125 million debt facility with K2 HealthVentures, with up to $40 million available for draw this year. Josh PintoPresident at Neumora Therapeutics00:03:55K2 HealthVentures has deep expertise in life sciences, and we are pleased with the opportunity to work with their team. Financial discipline has always been a core tenet of how we operate our business, and today it is more important than ever to maintain diligent stewardship of capital. The non-dilutive capital from this facility, combined with the cash already on our balance sheet, further strengthens our financial position and will support our efforts to achieve value-creating milestones across our pipeline. With this update, we now expect our cash, cash equivalents, and marketable securities, together with the $20 million funded at close under the K2 facility, to support our operations into 2027, well beyond anticipated clinical data milestones. As you can see, we are well positioned to generate value from a number of programs, and we are supported by a strong financial foundation. Josh PintoPresident at Neumora Therapeutics00:05:03Each one of our programs evaluates a novel mechanism of action in their respective indications, with the potential to bring new treatment options to patients and capitalize on significant market opportunities. Our pipeline is supported by a very strong intellectual property portfolio with worldwide rights to all of our programs and composition of matter patents extending into the 2040s. As a multi-product company with multiple shots on goal, we are prepared to execute against our vision of maximizing all pathways for success and generating long-term company growth. With that overview, I will now turn the call over to Bill to provide additional details on our clinical programs. Bill. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:05:51Thanks, Josh. We are excited about the industry-leading pipeline we have constructed and the potential of these novel mechanisms to revolutionize the treatment of brain diseases. Starting with navacaprant, we are confident in the potential for navacaprant to become a differentiated treatment option for patients with MDD. There is a strong body of clinical evidence validating the potential of kappa opioid receptor antagonists to show benefit in MDD and anhedonia. Supporting studies include the National Institutes of Health, or NIH, run FAST/MAST study, the Johnson & Johnson Phase II study of aticaprant, and importantly, our own Phase II study of nevacaprant, which was recently published in the Journal of Clinical Psychopharmacology. This publication highlights that nevacaprant demonstrated statistically significant and clinically meaningful reductions in symptoms of depression and anhedonia in participants with moderate to severe MDD. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:06:50When trying to understand how KOASTAL I results compared to other studies, we identified a few factors that were different from what you'd expect to see in a typical MDD population. For example, approximately two-thirds of the patients had never taken a prior antidepressant, despite experiencing an average of five prior episodes of MDD in their lifetimes. Prior trials and publications suggest that a substantially higher percentage of people with chronic MDD would have received prior antidepressant treatment. As we've looked at the data, we concluded that the total population in KOASTAL I was not necessarily representative of the MDD population, and that's why we've made modifications in site selection, patient screening, and medical monitoring in KOASTAL II and III to help ensure that appropriate patients are enrolled. The studies resumed enrolling in March with the following changes. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:07:46We enhanced engagement with sites around medical monitoring to confirm the patients enrolled in the studies have an independently verified diagnosis of MDD that helps to ensure they appropriately meet eligibility criteria for these studies. We added the Clinician-Rated Massachusetts General Hospital Clinical Trials Network and Institute SAFER approach, which is an independent review conducted by clinicians to verify the diagnosis and appropriateness of the patient population. Our internal medical team is partnering with the SAFER clinical team to confirm eligibility prior to randomization. We also added an additional tool called the Verified Clinical Trial Screening Database, aimed at better identifying patients who are participating in multiple clinical trials and excluding them from enrolling in the KOASTAL II and III studies. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:08:39This is an additive step to the clinical trial subject database we used in KOASTAL I, and we believe it will help to ensure the appropriate patients are enrolled in our ongoing studies. Finally, 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. We have already seen benefits from these added measures in the KOASTAL II and KOASTAL III studies. For example, the Verified Clinical Trial Screening Database has identified multiple potential participants who are not appropriate for inclusion, enabling us to exclude them from the studies. More broadly, it's important to remember that many approved medicines in MDD and psychiatry broadly have failed individual Phase III studies, but ultimately succeeded in multiple studies and become important treatments. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:09:34We designed the KOASTAL program with the historical challenges in mind, knowing that we would need two of the three trials to be successful in order to file an NDA. We anticipate data from KOASTAL III in the first quarter of 2026 and KOASTAL II in the second quarter of 2026. I also want to highlight our franchise of M4 PAMs that we are advancing, where we plan to move a candidate into the clinic in the middle of this year. Based on available data, it is clear that M4 is the driver of antipsychotic activity seen with muscarinic drugs to date. We believe we are well positioned to become a leader in M4 PAMs that can potentially offer improved safety and tolerability profile and once-a-day dosing. We look forward to sharing more on the pharmacology of our M4 programs when they enter the clinic in mid-2025. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:10:28In Phase Ib is our vasopressin 1a receptor antagonist, NMRA-511, which is a highly potent and highly selective antagonist being evaluated for Alzheimer's disease agitation. The V1A target is a proven pathway, as it is known to play a role in the regulation of aggression, affiliation, stress, and anxiety response. In preclinical data, NMRA-511 reduced measures of anxiety, agitation, aggression, and was very well tolerated in a Phase I SAD/MAD study, as well as in healthy elderly volunteers. We believe that based on these data combined with findings from other sponsors, there's a strong rationale for NMRA-511 in AD agitation, an area of significant unmet need with only one approved agent that carries a black box warning. We look forward to delivering top-line data from Phase Ib signal-seeking study around the end of this year. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:11:27In parallel, we continue to progress our four preclinical programs, which have opportunity to make impacts in serious and common diseases such as Parkinson's disease, Alzheimer's disease, and ALS. Those programs are advancing, and we look forward to sharing more information on those studies in the near future. In short, it has been a productive start to 2025 for Neumora, and we're well positioned to achieve our multiple upcoming clinical catalysts in the second half of this year and beyond. With that, I'll now turn it over to Mike for a review of the financials. Mike. Mike MilliganCFO at Neumora Therapeutics00:12:04Thanks, Bill, and good afternoon, everyone. Our financial results for the first quarter of 2025 are detailed in the press release that we issued this morning. I'd like to take a moment to provide some context and highlight a few key points. Net loss for the first quarter was $68 million, compared to $53.7 million for the same period in 2024, and we ended the quarter with $249.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025. As Josh noted, we are focused on disciplined capital allocation and expect our cash on hand and the $20 million drawn at the close of the K2 facility to support operations into 2027. We expect that this runway will allow us to realize multiple catalysts across our programs. With that, I'll now hand the call over to Helen to manage Q&A with the operator. Helen. Helen RubinsteinVP of Investor Relations at Neumora Therapeutics00:12:59Thanks, 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. Now I'll turn it over to the operator to handle Q&A. Operator. Operator00:13:14As a reminder, if you'd like to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from Douglas Tsao with H.C. Wainwright. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:13:38Hi, good afternoon. Thanks for taking the questions. I guess two for me. First, starting with nevacaprant, I understand the operational changes that were put in place. I'm just curious, have you had any sort of sense of how it has affected sort of the pace of enrollment, early going, just sort of early experiences and sort of what gives you that confidence in terms of achieving the readouts next year? Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:14:14Thanks, Doug. This is Bill. Appreciate your question. We've already seen benefits from steps that we've taken with both SAFER and the Verified Clinical Trial Screening Database that we've implemented in the K2 and the K3 studies. Both have identified multiple potential participants who really aren't appropriate for inclusion in the study, enabling us to exclude these patients from being put in. We do have confidence that the steps we're taking are helping to get appropriate patients randomized into K2 and K3. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:14:47I guess, Bill, as a follow-up, just is it having a negative impact in terms of the pace of enrollment or obviously you're sort of disqualifying some patients? I guess it sounds like, though, that the rate of that is occurring at a rate consistent with what you were expecting. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:15:04Yes, Doug. It is consistent. The rate of those patients being excluded is consistent with our expectation. It does not impact our timing guidance that we have provided with respect to the enrollment. Things are progressing as planned. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:15:16Okay, great. That's great to hear. Just on the K2 financing, I'm just curious if you can provide any details in terms of sort of limitations on prepayment or so just to the extent that as you hit other milestones, are you able to perhaps pay down that debt as sort of your cost of equity comes down? Thank you. Josh PintoPresident at Neumora Therapeutics00:15:43Hey, Doug. It's Josh here. I'll take that one. The details of the facility are disclosed in our 10Q, so I would point you towards that. Really, with this facility, what we were looking to achieve in this financing was extending our cash runway into 2027. With the $20 million that we're able to draw at close, plus our existing cash balance, we were able to achieve that goal, and we've extended our cash runway now into 2027. In terms of the milestones, you can think about progression of nevacaprant through some of the clinical stages as well as some regulatory stages as ways to ungate additional capital. As we noted in the press release, beyond the first $20 million that was funded at close, there will be another $20 million that we can bring in at our discretion before the end of this year. Josh PintoPresident at Neumora Therapeutics00:16:33There is flexibility in terms of bringing more capital onto our balance sheet this year through the facility. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:16:40Josh, just to confirm, though, that you only need the $20 million to get you into 2027? Josh PintoPresident at Neumora Therapeutics00:16:48Correct. Our existing cash balance sheet as of the end of March, plus the $20 million funded at close, gets our runway into 2027. Any additional drawdowns beyond that would provide funding for additional investments or extension of the cash runway beyond that. Douglas TsaoManaging Director of Equity Research at H.C. Wainwright00:17:04Okay, great. Thank you so much. Operator00:17:09Our next question comes from Yatin Suneja with Guggenheim. Yatin SunejaSenior Managing Director, Biotechnology Analyst at Guggenheim Securities00:17:15Hey, guys. Thank you for taking my question. A couple of questions on the KOASTAL program. Could you talk about the patient population who might have received an antidepressant and how you are tracking it? Because as I recall, in KOASTAL I, there was a lot of patients that had never taken antidepressant therapy in the past. Just curious to know, is there a particular percentage of patients that you are targeting who would have taken a prior antidepressant in this study and how that might be tracking? The other question is also on the K2 and 3, are there any possibility of some form of an interim analysis in this study? Thank you. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:17:58Hi, Anthon. This is Bill. Thanks for your question. With respect to how we are ensuring we've got the proper patients being included in K2 and K3 after the pause, the steps that we've taken include having a SAFER clinical team involved in providing the assessment for patients, taking a look at their history, both of depression treatment. Our own clinical team is partnering closely with the MGH SAFER team to ensure that we are providing the degree of oversight that is consistent with our expectations to ensure we have patients with the proper history being enrolled. We are, in fact, strengthening that quite a bit and avoiding some of the things that we saw in K1 as part of that. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:18:40With respect to the interim analysis, we do not have plans for an interim analysis, and we are moving ahead with the enrollment and the timelines for K3 being in Q1 and K2 in Q2 of 2026. Operator00:19:00Our next question comes from Brian Abrahams with RBC Capital Markets. Nevin VargheseSenior Equity Research Associate at RBC Capital Markets00:19:07Hi, everyone. Thank you for taking my question. This is Nevin On for Brian. Just to kind of high level, I guess, what are kind of your latest views on how to reconcile the CORA mechanism based on the Phase II data that you've shown as well as J&J's? Also, with respect to the KOASTAL I study readout and J&J's decision to discontinue aticaprant or pivot that into different indications. I have a follow-up after as well. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:19:45Sure, Nevin. This is Bill. Let me start here. We were surprised by J&J's decision to terminate their program given their January of 2025 communication about submitting an NDA later this year. We're looking forward to the presentation of their pooled data later this month. That being said, there are several important differences between nevacaprant and aticaprant, as well as the development strategies that are employed with each of the agents. First off, from a pharmacology point of view, nevacaprant is significantly more selective for kappa opioid receptors over mu opioid receptors than aticaprant is. Secondly, the study design for each of the programs and molecules were different. We believe the KOASTAL program really reflects the most appropriate study design for this mechanism to be utilized in the monotherapy setting. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:20:33The steps that we've taken for enhancing K2, K3 really, in our view, improve the probability of success with the changes that we're making. I would simply say that it's difficult to think about the aticaprant program in read-throughs. There are limitations due to the pharmacology and study design that limit that read-through. We remain confident in nevacaprant. I still believe KOASTAL I results may have been an anomalous finding. We are excited about K2, K3 progressing and the timing for those reading out. Nevin VargheseSenior Equity Research Associate at RBC Capital Markets00:21:05Great. Thanks so much. I also saw in the 10Q that was released that you had triggered the second tranche of funding from PBT for selection of an NLRP3 candidate. I guess, what can you tell us about this early program? When we could see more from this and when you might be able to disclose more data regarding this program? Josh PintoPresident at Neumora Therapeutics00:21:29Yeah, Nevin, this is Josh here. Thanks for the question. I appreciate that. NLRP3 has been a program that we've been very excited about and progressing for a while now. It is really focused around targeting the NLRP3 inflammasome, which we believe is a critical part of the innate immune system and can have an impact on a range of CNS as well as other conditions. We tend not to talk a lot about our programs until we move them into the clinic. As you've noted, we have been making progress with our NLRP3 program. I am looking forward to having more specific updates on that program as we move through the next few quarters and into early 2026. Nevin VargheseSenior Equity Research Associate at RBC Capital Markets00:22:09Great. Thank you so much. Operator00:22:14Our next question comes from Greg Sivanovich with Mizuho Securities. Graig SuvannavejhBiotech & Biopharma Analyst at Mizuho Securities00:22:20Hey, good afternoon. Thanks for taking my questions. Appreciate the updates that you've provided. Two questions, each on pipeline candidates. Just with respect to 511 and the readout in Alzheimer's disease agitation, maybe could you put in perspective what you expect to see with that data set, especially relative to the data, the Phase III data sets that exist for a competitor product, AXS-05 from Axsome Therapeutics? Secondly, on the M4 PAM, maybe if you could revisit kind of your thoughts on differentiation between your candidate and perhaps the other program, Enracladine, in which, unfortunately, the Phase II, III data were not great. Any color as to the confidence that you have that you'll perhaps show a different set of outcomes? Thanks. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:23:31Hey, Greg. This is Bill. Thanks for your question. Let me start out here with the 511 question. Just as a reminder, this is a study that has not been powered to show statistical separation of active from placebo, but is rather a signal-seeking study. Two parts. Part A, the Phase Ib, surely the randomized, double-blind, placebo-controlled cohort designed to evaluate safety, efficacy, tolerability, PK in healthy elderly volunteers. That portion has been completed. Part B of the Phase Ib is a multi-center randomized, double-blind, placebo-controlled study where we are evaluating NMRA-511, 20 milligrams twice a day in about 88 patients relative to placebo in agitation associated with Alzheimer's. The primary endpoint for the signal-seeking study is the change from baseline to week eight on the CMAI or the Cohen-Mansfield Agitation Inventory. We are looking at the total score change there. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:24:31We will really look at these data to help better understand which domains on the CMAI improved and helped inform our thinking about the design for the next Phase of study that would follow looking at these results. With respect, Greg, to the M4. Josh PintoPresident at Neumora Therapeutics00:24:49Yeah, Greg. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:24:51Question? Josh PintoPresident at Neumora Therapeutics00:24:51Yeah, this is Josh. In terms of the M4 differentiation, one of the areas we've been very focused on engineering is ensuring that our compounds have high blood-brain barrier penetration. We think given the class and the cardiovascular-related AEs being one of the key limiters for the M4 muscarinics, that really ensuring optimal blood-brain barrier penetration is going to provide the biggest chance to show a great central effect. In terms of areas where we think we could differentiate, we do think CNS penetration is one of them. We look forward to providing more specific details on our M4 PAM programs when we bring the next set into the clinic by middle of 2025. Graig SuvannavejhBiotech & Biopharma Analyst at Mizuho Securities00:25:35Okay. Thank you very much. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:25:41Our next question comes from John Boyle with William Blair. John BoyleBiotechnology Equity Research Associate at William Blair00:25:45Hi, this is John. I'm from Myles Minter. Thanks so much for taking our question. I was just wondering if you could talk a little bit about maybe potential timing for when you might decide to increase enrollment in KOASTAL II or KOASTAL III, and also just what aspects of the blinded data are you looking at and considering when making that decision? Thanks. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:26:07Sure. Hi, John. This is Bill. I'll start here and basically communicate that with KOASTAL II and III, those studies were designed and scheduled to randomize up to 332 patients into the protocol. We've built in flexibility that allows us to go 25% higher than that 332. With respect to KOASTAL I, you'll recall that we were just north of 380 patients enrolled. So we did end up about 15% over-enrolling relative to the 332 base. K2 and K3 are progressing. We haven't made a decision on what that overall number will be, but we'll provide updates at the appropriate time point. Operator00:26:54Our next question comes from Ami Fadia with Needham & Company. Poorna KannanBiotech Equity Research Associate at Needham & Company00:26:59Hi, this is Purna, Ami for Ami. Thank you for taking our question. I'm just curious, in KOASTAL I, how does the MADRS baseline scores compare with the severity that was seen in the Phase II study where you saw the differentiation? Also, just wanted to understand how, what is the mix of females that you're seeing now in K2 and K3, and if you're managing the mix of patients? Thank you. Bill AuroraChief Operating and Development Officer at Neumora Therapeutics00:27:24Sure. Looking at K1 relative to Phase II, in Phase II, we utilized the HAMD-17. In that study, there were about 100 patients that had moderate to severe MDD. In KOASTAL I, we were utilizing the MADRS, and we were using a cutoff of 25 or higher on the MADRS, consistent with a moderate to severe MDD population. Once you think about those populations as being similar with respect to disease severity in that manner. When we think about the mix of subjects in K2 and K3 relative to KOASTAL I, it was a bit anomalous to see the high percentage of males in K1 relative to historically conducted studies. In K2, K3, we are seeing a mix that's more representative of what's historically been seen, roughly two-thirds female, one-third male. We are pleased to see that being the demographic sex distribution for K2, K3. Poorna KannanBiotech Equity Research Associate at Needham & Company00:28:26Got it. Thank you. Operator00:28:31That concludes today's question and answer session. I'd like to turn the call back to Paul Berns for closing remarks. Paul BernsChairman and CEO at Neumora Therapeutics00:28:37All right. Thank you, operator, and thank you for all of your questions to the participants in today's call. We very much appreciated the opportunity to give you the quarterly update. I would also like to thank my fellow Neumora team members for their commitment to excellence as we advance their programs with the goal of bringing novel new therapeutics to treat patients with brain disease. With that, I bid you adieu and a good afternoon. Operator00:29:01This concludes today's conference call. Thank you for participating. You may now disconnect.Read moreParticipantsExecutivesMike MilliganCFOBill AuroraChief Operating and Development OfficerJosh PintoPresidentPaul BernsChairman and CEOHelen RubinsteinVP of Investor RelationsAnalystsGraig SuvannavejhBiotech & Biopharma Analyst at Mizuho SecuritiesNevin VargheseSenior Equity Research Associate at RBC Capital MarketsPoorna KannanBiotech Equity Research Associate at Needham & CompanyJohn BoyleBiotechnology Equity Research Associate at William BlairYatin SunejaSenior Managing Director, Biotechnology Analyst at Guggenheim SecuritiesDouglas TsaoManaging Director of Equity Research at H.C. WainwrightPowered by