Q1 2025 Neumora Therapeutics Inc Earnings Call
Ladies and gentlemen, thank you for standing by. At this time, all participants are in 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.
Speaker Change: Give officer, Paul Burns, President, Josh Pinto, Chief operating and development Officer, Bella Terra and Chief Financial Officer, Mike Milligan.
Speaker Change: 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.
Speaker Change: Please review the risk factors discussed in today's press release and in our SEC filings for additional detail.
Paul: With that I'll now turn the call over to Paul.
Paul: Thanks, Alan and good afternoon, everyone and thank you for joining us.
Paul: At Nomura, we believe the greatest medical challenge of our generation is the global brain disease crisis.
Paul: This effects upwards of one 5 billion people and causes a severe impact on quality of life not only for patients, but also their families and society at large.
Paul: 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.
Nomura: When we founded Nomura It was with the intention to confront this challenge head on.
Nomura: And focus on bringing novel mechanisms forward to redefine neuroscience drug development.
Nomura: We have made important progress towards that goal.
Nomura: 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.
Nomura: As we are poised to achieve a number of upcoming clinical catalysts across our pipeline.
Nomura: I believe we have the right science people and strategy in place to realize our vision are revolutionizing the treatment of brain diseases.
Speaker Change: I will now turn the call over to Josh Pinto President of Nomura to review, our business and pipeline update.
Nomura: Josh.
Speaker Change: Thanks, Paul.
Paul: We are focused on clinical execution as we are advancing multiple programs towards key milestones over the next 12 months.
Paul: We are on track to deliver top line data for Anna Murray 511, our vasopressin receptor antagonist and Alzheimers disease agitation around the end of the year.
Paul: We are also progressing tobacco brand in the phase III coastal programming MTV, where.
Paul: Where we have implemented important changes for the ongoing studies and plan to report top line data from coastal III in the first quarter of 2026 and coast. So too in the second quarter of 2026.
Paul: In RM for franchise, we are working with urgency to bring our best in class <unk> Pam into the clinic in the middle of this year.
Paul: Additionally, we announced this morning that we entered into a $125 million debt facility with <unk> to help debentures with up to $40 million available for draw this year.
Paul: K to health ventures has deep expertise in life Sciences, and we are pleased with the opportunity to work with their team.
Paul: Financial discipline has always been a core tenet of how we operate our business and today it is more important than ever to maintain diligence stewardship of capital.
Paul: The non dilutive capital from this facility combined with the cash already on our balance sheet.
Paul: <unk> strengthens our financial position and will support our efforts to achieve value, creating milestones across our pipeline.
Paul: With this update we now expect our cash cash equivalents and marketable securities together with the $20 million funded at close under the key two facility to support our operations into 2027.
Paul: Well beyond anticipated clinical data milestones.
Paul: As you can see we are well positioned to generate value from a number of programs and were supported by a strong financial foundation.
Paul: Each one of our programs evaluate the novel mechanism of action in their respective indications with the potential to bring new treatment options to patients and capitalize on significant market opportunities.
Paul: Our pipeline is supported by very strong intellectual property portfolio with worldwide rights to all of our programs and composition of matter patents extending into the 2014.
Paul: As a multi product company with multiple shots on goal, we are prepared to execute against our vision of maximizing all pathway for success and generating long term company growth.
Paul: With that overview I will now turn the call over to bill to provide additional details on our clinical programs.
Paul: Bill.
Bill: Thanks, Josh we are excited about the industry, leading pipeline, we have constructed and the potential of this novel mechanisms to revolutionize the treatment of brain diseases.
Bill: Starting with tobacco brand, we are confident in the potential for <unk> to become a differentiated treatment option for patients with <unk> there.
Bill: There is a strong body of clinical evidence validating the potential of Kappa opioid receptor antagonist to show benefit in MDT and Indonesia.
Bill: Supporting studies include the National Institute of Health or NIH run fast mass study the J&J phase II study of <unk> and importantly, our own phase II study of <unk>, which was recently published in the journal clinical Psychopharmacology.
Bill: This publication highlights that <unk> demonstrated statistically significant and clinically meaningful reductions in symptoms of depression and ended Danya in participants with moderate to severe MDT.
Bill: So when trying to understand how coastal one results compare to other studies, we identified a few factors that were different from what you would expect to see in a typical IBD population. For example, approximately two thirds of patients had never taken a prior anti depressant. Despite experiencing an average of five prior episodes of MB.
Bill: BD in their lifetimes.
Bill: Prior trials and publications suggest that a substantially higher percentage of people with chronic mbd would have received prior anti depressant treatment.
Bill: As we've looked at the data we concluded that the total population coastal one was not necessarily representative of the MPD population and that's why we've made modifications and site selection patient screening and medical monitoring and coastal two and three to help ensure that appropriate patients are enrolled.
Bill: The study has resumed enrolling in March with the following changes.
Bill: We enhanced engagement with sites around medical monitoring to confirm the patients enrolled in the studies have an independently verified diagnosis of mbd 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 independent review conducted by clinicians to verify the diagnosis inappropriateness of the patient population our internal medical team is partnering with the safer clinical team to confirm eligibility.
Bill: Prior to randomization.
Bill: 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 coastal two and three studies.
Bill: This isn't additive step 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 and finally, we have reduced the number of clinical sites and selected those sites that we believe have the greatest level expertise and conducting mbd studies.
Bill: We have already seen benefits from these added measures and the coastal and coastal three 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.
Bill: More broadly it is important to remember that many approved medicines and MDT and psychiatry broadly had failed individual phase III studies, but ultimately succeeded in multiple studies and become important treatments with.
Bill: We designed the coastal program with the historical challenges in mind, knowing that we would need two to three trials to be successful in order to file an NDA, we anticipate data from coastal III in the first quarter of 2026 and coastal too in the second quarter of 2026.
Bill: I also want to highlight our franchise of <unk> that we are advancing where we plan to move a candidate into the clinic in the middle of this year.
Bill: Based on available data. It is clear that <unk> is the driver of anti psychotic activity seen with muscarinic drugs today.
Bill: We believe we are well positioned to become a leader in <unk>.
Potentially offer improved safety and Tolerability profile and once a day dosing.
Bill: We look forward to sharing more on the pharmacology of our import programs when they enter the clinic in mid 2025.
Bill: In phase one b is our vasopressin <unk> receptor antagonist, and MRA 511, which is a highly potent and highly selective antagonist being evaluated for all timers disease agitation.
Bill: The <unk> target is a proven pathway as it is known to play a role in the regulation of aggression affiliation stress and anxiety response and.
Bill: In preclinical data and MRI 511 reduced measures of anxiety education aggression and was very well tolerated in a phase one sad Mad study as well as in healthy elderly volunteers.
Bill: We believe that based on these data combined with findings from other sponsors there's a strong rationale for MRI 511, and agitation and area of significant unmet need with only one approved agent. It carries a black box warning, we look forward to delivering topline data from phase one b signal seeking.
Bill: Around the end of this year.
Bill: In parallel we continue to progress our preclinical programs, which have opportunity to make impacts in serious and common diseases, such as Parkinson's disease, Alzheimer's disease and AOS.
Bill: Those programs are advancing and we look forward to sharing more information on those studies in the near future.
Bill: In short it has been a productive start to 2025 for tomorrow, 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: Thanks, 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.
Mike: I'd like to take a moment to provide some context and highlight a few key points.
Mike: 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 equivalence and marketable securities as of March 31 2025.
Mike: 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 <unk> facility to support operations into 2027.
Mike: 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 the Q&A with the operator pellet.
Helen: Thanks, Mike before I turn it over to the operator I'll ask that you limit yourself to one question. If you have an additional question. Please feel free to return to the queue now I'll turn it over to the operator to handle the Q&A operator.
Speaker Change: As a reminder, if you'd like to ask a question at this time. Please press star one on your telephone and wait for your name to be announced.
Speaker Change: To withdraw your question. Please press star one again.
Speaker Change: Please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from Douglas Tsao with H C Wainwright.
Douglas Tsao: Hi, good afternoon, thanks for taking the questions.
Speaker Change: I guess two for me first.
Douglas Tsao: Starting with tobacco Pratt.
Douglas Tsao: I understand the operational changes that were put in place I'm just curious.
Speaker Change: Have you.
Douglas Tsao: Ed.
Douglas Tsao: Any sort of sense of holidays that did sort of the pace of enrollment.
Douglas Tsao: Early going just sort of early experience is it.
Sure.
Douglas Tsao: Sort of what gives you that confidence in terms of.
Douglas Tsao: Achieving the Readouts.
Douglas Tsao: Sure.
Douglas Tsao: Thanks, Doug. This is bill I. Appreciate your question, we've already seen benefits from steps that we've taken with both safer and verify a clinical trial screening database that we've implemented in the case given the case III studies both have identified multiple.
Douglas Tsao: Central participants, who really aren't appropriate for inclusion in the study, enabling us to exclude these patients from being put in so we do have confidence that the steps. We're taking are helping to get appropriate patients randomized into K two in Q3.
Speaker Change: And I guess bill as a follow up just is that is it having a negative impact.
Speaker Change: Impact in terms of the pace of enrollment or obviously, you are sort of calling for some patients and I guess it sounds like though that is.
Speaker Change: The rate of that is occurring at a rate consistent with what you were expecting.
Douglas Tsao: Yes, Doug it is consistent the rate those patients being excluded is consistent with our expectation it doesn't impact our timing guidance that we provided with respect to the enrollment so things are progressing as planned.
Speaker Change: Okay, Great that's great to hear and then just on the K too.
Speaker Change: Finance.
Speaker Change: I'm just curious if you can provide any details in terms of.
Speaker Change: Limitations on prepayment.
Speaker Change: Or.
Speaker Change: So just to the extent that as you hit other milestones are you able to perhaps pay down that debt.
Speaker Change: Sure.
Speaker Change: The equity comes down thank you.
Speaker Change: Hey, Doug it's Josh here I'll take that one and the details of the facility are disclosed in our 10-Q, so I would.
Speaker Change: Point, you towards that but really with this facility what we're looking to achieve in this financing was extending our cash runway into 2027, and so with the 20 million that we're able to drive close plus our existing cash balance we were able to achieve that goal and we've extended our cash runway into 2027 in terms of the milestones.
Speaker Change: You can think about progression of.
Speaker Change: No backup France through some of the clinical stages as well as some regulatory stages as ways to update additional capital, but as we noted in the press release beyond the first $20 million that we have.
Speaker Change: 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. So there is flexibility in terms of bringing more capital onto our balance sheet.
Speaker Change: Through the facility.
Speaker Change: And Jack just to confirm that.
Speaker Change: You only need the 20 million to get you into 2027.
Speaker Change: Correct, our existing cash balance sheet as of the end of March plus the $20 million funded at close gets our runway into 2017, so any additional drawdowns beyond that.
Speaker Change: To provide funding for additional investments or extension of the catch up again.
Speaker Change: Okay, great. Thank you so much.
Our next question comes from John <unk> with Guggenheim.
John: Hey, guys. Thank you for taking my question a couple of questions on the coastal program.
John: Could you talk about the patient population, who might have receive an anti depression. In this how you are tracking it because as I recall in the close to one there was a lot of patients that had never taken antidepressant therapy in the past. So just curious to know is that a particular push.
John: Churn page of patients that you're targeting.
John: Have taken the prior antidepressant in the study and how that might be tracking.
John: And then.
John: The other question is also on the <unk>.
John: Any possibility of some form of an interim analysis in the study. Thank you.
John: Tim This is bill thanks for your question with respect to how we are ensuring we've got the proper patients being included in Q2 and Q3 after the pause the steps that we've taken include having safer clinical team involved in providing the assessment for patients taking once their history both of those.
John: Depression treatment our own clinical team is partnering closely with the MGH safer team to ensure that we are providing that degree of oversight.
John: That is consistent with our expectations to ensure we have patients with proper history being enrolled so we are in fact strengthening that quite a bit and avoiding some of the things that we saw in Q1 as part of that with.
John: With respect to the interim analysis, we do not have plans for an interim analysis and we are moving ahead with enrollment and timelines for case III being in Q1 and Q2 in Q2 of 2026.
Speaker Change: Our next question comes from Brian Abrahams with.
Brian Abrahams: With RBC capital markets.
Brian Abrahams: Hi, everyone. Thank you for taking my question.
Sure Brian.
Brian Abrahams: Just.
Douglas Tsao: Kind of high level I guess, what are your kind of your latest views on how to reconcile the corner on mechanism.
Brian Abrahams: Based on.
Brian Abrahams: Phase two data that you've shown as well as J&J.
Brian Abrahams: But then also with respect to coastal one study readout.
Brian Abrahams: That decision.
Brian Abrahams: Continue take a plant or pivot to.
Brian Abrahams: Different indications.
Brian Abrahams: And then I.
Brian Abrahams: A follow up after that.
Bill: Fair enough and this is bill let me start here, we were surprised by <unk> decision to terminate their program given their January 2025 communication about submitting an NDA later this year, we're looking forward to the presentation of their full data later this month that being said there are several important differences between tobacco brand and the <unk>.
Brian Abrahams: <unk>.
Brian Abrahams: As well as the development strategies that are employed with each of the agents first off from a pharmacology point of view the baccarat is significantly more selective.
Brian Abrahams: Our caf opioid receptors over new opioid receptors, then took a practice secondly, the study design for each of the programs and molecules for different we believe the coastal program really reflects the most appropriate study design for this mechanism to be utilized in the monotherapy setting.
Brian Abrahams: The steps that we've taken.
Brian Abrahams: For enhancing K two K three really in our view improve the probability of success with the changes that we're making.
Brian Abrahams: If we say that it's difficult to think about the Utica program.
Brian Abrahams: And read throughs that are limitations due to the pharmacology study design that limit that breakthrough we remain confident in tobacco still believe boastful. One results may have been an anomalous finding so we're excited about the <unk> phase III progressing and the timing for those reading out.
Brian Abrahams: Great. Thanks, so much and then I.
I also saw in the 10-Q that was released that triggered the second tranche of funding from Pvp for selection of.
Brian Abrahams: And MLR three candidates so.
Brian Abrahams: I guess, what can you tell us about this early program when when we could see more from that.
Brian Abrahams: When you might be able to disclose more data.
Brian Abrahams: Morning.
Yes, David This is Josh here. Thanks for the question I appreciate that.
Brian Abrahams: <unk> has been a program that we've been very excited about progressing for a while now and really it's focused around targeting the MLR piece III inflame itself, which we believe is a critical part of the innate immune system and can have an impact on a range of <unk>.
Brian Abrahams: As well as other conditions, we tend not to talk a lot about our programs until we move them into the clinic and as you've noted we have been making progress with our <unk> III programming. So looking forward to having more specific updates on that program as we move through the next next few quarters and into early 2026.
Brian Abrahams: Alright, thanks, so much.
Speaker Change: Our next question comes from Greg <unk> with Mizuho Securities.
Greg: Hey, good afternoon, Thanks for taking my questions I appreciate.
Speaker Change: The update that you provided.
Speaker Change: Two questions each.
Speaker Change: On pipeline candidates, just with respect to 511 and the readout in <unk>.
Speaker Change: Alzheimer's disease agitation, maybe could you put in perspective, what you expect to see.
Speaker Change: With that dataset.
Speaker Change: Especially relative to the.
Speaker Change: The data the phase III datasets that exist.
Speaker Change: For a competitor product.
Speaker Change: So far from <unk> therapeutics.
Speaker Change: And then.
Speaker Change: Secondly on for.
Speaker Change: For Pam, maybe if you could revisit kind of your thoughts on differentiation between your candidate and perhaps.
Speaker Change: The.
Other program.
Speaker Change: And <unk> in which Fortunately the phase three data weren't great.
Speaker Change: Any color as to the confidence that you have that youll, perhaps show a different.
Speaker Change: Net of outcomes.
Bill: Hey, Greg This is bill. Thanks for your question, let me start out here with 511 question.
Bill: And just as a reminder, this is a study that hasnt been powered to show statistical separation of active from placebo, but rather a signal seeking study two parts part a of the phase one b surely the randomized double blind placebo controlled cohort designed to evaluate safety efficacy tolerability PK in healthy.
Bill: Elderly volunteers that portion has been completed part b of the phase <unk> multi center randomized double blind placebo controlled study, where we're evaluating MRI 511, 20 milligrams twice a day.
Bill: 88 patients relative to placebo and agitation associated with Alzheimer's the primary endpoint for the signal seeking study is the change from baseline to week eight on the CMA The Cohen Mansfield agitation inventory and so we're looking at the total score.
Bill: Change there.
Bill: And so when we look at these data to help better understand which domains on the CNI improve.
Bill: Helped inform our thinking about the design for the next phase of study that would follow looking at these results.
Bill: With respect Greg to the <unk>, yes.
Bill: Yes, Greg.
This is Josh in terms of the <unk> differentiation one of the areas we've been very focused on.
Bill: Engineering is ensuring that our compounds have high blood brain barrier penetration, we think given the class.
Bill: Sure.
Bill: Cardiovascular related Aes being one of the key limiters for the EB <unk> muscarinic, but really ensuring optimal blood brain barrier penetration is going to provide the biggest chance to show a great central effect and so in terms of areas, where we think we could differentiate we do think CN.
Bill: CNS penetration is one of them, we look forward to providing more specific details on our <unk> patent programs. When we bring the next set into the clinic by middle of 2025.
Bill: Okay. Thank you very much.
Speaker Change: Our next question comes from John Boyle with William Blair.
Speaker Change: Hi, This is John on for Myles Minter. Thanks, so much for taking my question.
Speaker Change: I was just wondering if you could talk a little bit about maybe potential timing for when you might decide to increase enrollment and coastal to our coastal three and also just what aspects of the blinded data are you looking at and considering when making that decision.
Speaker Change: Sure Hi, John This is bill I'll start here and basically communicate that with postal two and three those studies were designed to and schedules are randomized to 332 patients into the protocol. We've built in flexibility that allows us to grow 25% higher than that.
Speaker Change: $3 32.
Speaker Change: With respect to coastal one youll recall that we were just north of 380 patients enrolled so we did end up 15% over enrolling relative to the $3 32 base.
Speaker Change: Hey, two in phase three are progressing we haven't made a decision on what that overall number will be but we will provide updates at the appropriate time point.
Speaker Change: Our next question comes from Amit <unk> with Needham <unk> company.
Speaker Change: Hi, this is calling on for Amit. Thank you for taking our question.
Speaker Change: Curious and quicker one how does the mattress baseline score.
Speaker Change: Compared with the synthetic <unk> efficacy in the phase two study that you thought the conclusion.
Speaker Change: And also just wanted to understand how.
Speaker Change: What is the mix of females that youre, seeing now and Caitlin <unk> and if you're managing the mix of patients. Thank you.
Speaker Change: Sure So looking at K, one relative to phase two and.
Speaker Change: Phase two we utilize the AMD 17 and in that study there were about 100 patients that have moderate to severe MDT.
Speaker Change: In coastal one we're utilizing the mattress and we're using a cutoff of 25 or higher on the mattress consistent with our moderate to severe mbd population. So once you think about those populations as being similar with respect to disease severity.
Speaker Change: In that manner, when we think about the mix.
Speaker Change: Subjects in K, two K III relative to coastal one it was a bit anomalous to see this high percentage of males.
Speaker Change: One relative to historically conducted studies in <unk>, we are seeing a mix thats more representative of what's historically been seeing roughly two thirds female one third now and we're pleased to see that.
Speaker Change: The demographic Scotts ex distribution <unk>.
Speaker Change: Got it thank you.
Speaker Change: That concludes today's question and answer session I would like to turn the call back to Paul Burns for closing remarks.
Speaker Change: Alright, 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.
Speaker Change: And I would also like to thank my fellow new more team members for their commitment to excellence as we advance the programs with the goal of bringing novel, New therapeutics to treat patients with brain disease with that that you would do in a good afternoon.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
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