Q3 2024 Neumora Therapeutics Inc Earnings Call
Yeah.
Operator: 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: 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'll be a question and answer session. Please be advised that today's conference is being recorded.
Helen Rubinstein: I would now like to turn the conference over to Helen Rubinstein, Vice President of Investor Relations. Please go ahead.
Speaker Change: Now I'd like to turn the conference over to Allen Rubinstein, Vice President of Investor Relations. Please go ahead.
Helen Rubinstein: Good morning, and thank you for joining Neumora Therapeutics' 3rd Quarter 2024 Financial Results Conference Call. Before we begin, I encourage everyone to go to the Investors & Media section of our website at NeumoraTX.com, where you can find the press release related to today's call. With me today are President and Chief Executive Officer, Henry Gosebruch, and Chief Financial Officer, Josh Pinto.
Speaker Change: Good morning, and thank you for joining me more therapeutics third quarter, two measly poor financial results conference call.
Speaker Change: Let me begin I encourage everyone to go to the investors and media section of our website at <unk> Dot.
Speaker Change: Com, where you can find the press release related to today's call.
Speaker Change: Today, our president and Chief Executive Officer, Henry that Scott and Chief Financial Officer, Josh.
Helen Rubinstein: Head of Research and Development, Rob Lenz, will join us for the Q&A portion of the call. 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 details.
Speaker Change: Head of research and development will.
Speaker Change: He will join us for the Q&A portion of the call.
Speaker Change: To point out that we'll be making forward looking statements, which are based on our current expectations and beliefs.
Speaker Change: 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.
Speaker Change: Filings for additional detail.
Henry Gosebruch: With that, I'll now turn the call over to Henry. Thanks, Alan.
Henry Scott: With that I'll now turn the call over to Henry.
Henry Gosebruch: Good morning, everyone, and thank you for joining us for our first ever quarterly.
Henry Scott: Thanks, Alan and good morning, everyone and thank you for joining us for our first ever quarterly conference call.
Henry Gosebruch: Brain diseases collectively represent one of the greatest medical challenges of our generation. affecting upwards of 1.5 billion people globally. They are the leading cause of disability with a significant impact on quality of life, not only for patients. Caregivers, Families, and Society.
Henry Scott: Brain diseases collectively represent one of the greatest medical challenges of our generation.
Henry Scott: Affecting upwards of one 5 billion people globally.
Henry Scott: They are the leading cause of disability with a significant impact on quality of life not only for patients, but for their caregivers families and society at large.
Henry Gosebruch: We all know somebody affected by brain disease, and at Neumora, our goal is to bring the next generation of medicines forward to alleviate the substantial unmet need. To achieve that goal, we have developed a robust portfolio of seven clinical and preclinical programs, all targeting novel mechanisms of action in their response to COVID-19. And importantly, we believe that each of our programs has the potential to reshape the treatment of its target indication, making a significant difference for the patients and families we aid.
We all know somebody affected by brain disease and at Nomura. Our goal is to bring the next generation of medicines forward to alleviate the substantial unmet need.
Henry Scott: To achieve that goal, we have developed a robust portfolio of seven clinical and preclinical programs all targeting novel mechanisms of action and their respective indications.
Henry Scott: Importantly, we believe that each of our programs has the potential to reshape the treatment of its target indication, making a significant difference for the patients and families. We aim to serve.
Henry Gosebruch: I'll start with our lead program, Novacopran, which we are investigating for the treatment of major depressive disorder, or MDD, and other neuropsychiatric. MDD is a leading cause of disability worldwide, affecting more than 280 million people. Yet, it has been more than 30 years since a drug with a novel mechanism of action has been approved to treat it. People living with MDD often experience inadequate treatment responses and or significant tolerability leading them to discontinue standard of care. In fact, up to 85% of patients either don't receive pharmacological treatment or don't achieve remission with SIRS-LIME. And approximately 70% of people with MDD experience anhedonia, or the lack of ability to experience pleasure from daily activities, which is not adequately treated.
Henry Scott: I'll start with our lead program know Docker brands, which we are investigating for the treatment of major depressive disorder, or <unk> and other neuropsychiatric conditions.
Henry Scott: <unk> is a leading cause of disability worldwide affecting more than 280 million people.
Henry Scott: Yes.
Has been more than 30 years since they drag with a novel mechanism of action has been approved to treat it.
Henry Scott: People living with MPD, often experience inadequate treatment responses and or significant tolerability challenges, leading them to discontinue standard of care treatments in fact up to 85% of patients either don't receive pharmacological treatment, where don't achieve remission with first line therapy.
Approximately 70% of people with MTBE experience anhedonia with a lack of ability to experience pleasure from daily activities, which is not adequately treated by existing agents.
Henry Gosebruch: We believe nevacopran has the potential to reshape the treatment of NDD. Nevacopran is a highly selective, novel, once-daily kappa-opioid receptor antagonist that we are developing as a potential monotherapy. The Kappa Opioid Receptor Antagonist approach has been clinically validated in three independent In our Phase II MDD study, Nevacopren demonstrated efficacy in treating depressive symptoms, including anhedonia, in patients with moderate to severe depression, as well as a favorable safety and tolerability profile with no weight gain, sexual dysfunction, or other adverse events commonly associated with. It is designed to be. Easy to use as an oral, once daily, 80 milligram dose without Nevacoprine has the potential to make a significant difference in the treatment of MDD and beyond.
Henry Scott: We believe in tobacco brand has the potential to reshape the treatment of MPD.
Henry Scott: And if I could Brian is a highly selective novel once daily Kappa opioid receptor antagonist that we are developing as a potential monotherapy treatment.
Henry Scott: The Kappa opioid receptor antagonist approach has been clinically validated and three independent studies.
Henry Scott: In our phase III <unk> study Nowak at Bryan.
Henry Scott: <unk> demonstrated efficacy in treating depressive symptoms, including <unk> in patients with moderate to severe depression as well as a favorable safety and tolerability profile with no weight gain sexual dysfunction or other adverse events, commonly associated with standard of care.
It is designed to be.
Easy to use as an oral once daily 80 milligram dose without titration.
Henry Scott: <unk> has the potential to make a significant difference in the treatment of <unk> and beyond.
Henry Scott: Development efforts are successful.
Henry Gosebruch: The COASTAL program includes three replicates, phase three, randomized placebo-controlled double-blind studies, COASTAL-1, COASTAL-2, and COASTAL-3. Designed to evaluate the efficacy and safety of nevacavir monotherapy in adult patients with moderate to severe. We are also advancing an open-label extension study, Coastal LT, designed to evaluate the long-term safety. To support the coastal studies, we are deploying a state-of-the-art approach designed to strengthen probability of survival. This slide includes significant enhancements to both study design and operational execution relative to Phase II, which are detailed in our course. We know that both study design and execution are crucial for successful MDD studies, and we are laser-focused on them.
Henry Scott: The coastal program includes three replicate phase III randomized placebo controlled double blind studies, Costa one coastal too and coastal III.
Designed to evaluate the efficacy and safety of <unk> monotherapy in adult patients with moderate to severe mbd.
Henry Scott: We are also advancing an open label extension study close to LTE designed to evaluate the long term safety of tobacco brand.
To support the coastal studies, we are deploying a state of the art approach designed to strengthen probability of success that include significant enhancements to both study design and operational execution relative to take too which are detailed in our corporate deck.
Henry Scott: We know that both study design and execution are crucial for successful <unk> studies and we are laser focused on the coastal program.
Henry Gosebruch: We look forward to top-line data readout from Coastal 1 around the end of this year and to data from Coastal 2 and Coastal 3 in the first half of the year.
Henry Scott: We look forward to topline data readout from coastal one around the end of this year and to data from coastal to in cohort three in the first half of next year.
Henry Gosebruch: We are also exploring the potential of nevacoprine as a treatment for bipolar disorder. and are pleased to be advancing a Phase 2 signal-seeking study. This study is designed to inform further development of nevacopran in bipolar 2 depression, potentially including development in broader bipolar disorder populations. as it is power to show an effect size, albeit not power to show.
Henry Scott: We are also exploring the potential of Navarro brand as a treatment for bipolar disorder and are pleased to be advancing a phase II signal seeking study.
Henry Scott: This study is designed to inform further development of Navarro brand in bipolar depression, potentially including development and broader bipolar disorder populations.
Henry Scott: It is powered to show an effect size, albeit not powered to show statistical significance.
Henry Gosebruch: We look forward to sharing results from this study in the second half of 2020.
We look forward to sharing results from this study in the second half of 2025.
Henry Gosebruch: Beyond Novacoprend, we are currently evaluating NMRA 5.1.1, our vasopressin 1A receptor antagonist. Phase 1b Signal Seeking Study in People with Alzheimer's.
Henry Scott: Beyond <unk>, we are currently evaluating <unk> 501, one our vasopressin <unk> receptor antagonist and a phase one b signal seeking study in people with Alzheimer's disease agitation.
Henry Gosebruch: We look forward to reporting data from that study in the second half.
Henry Scott: We look forward to reporting data from that study in the second half of 2025.
Henry Gosebruch: Additionally, we are continuing to progress our M4 franchise with an IND for a second M4 positive allosteric modulator, or PAM, expected in the first half of 2020. We believe that with our franchise of several M4 PAMs in development. We are well positioned to become a leader in muscarinx, an important new class.
Additionally, we are continuing to progress our <unk> franchise with an IND for a second and for positive allosteric modulator or Tam expected in the first half of 2025.
Henry Scott: We believe that with our franchise of several <unk> and development, we are well positioned to become a leader in muscular <unk>, an important new class of medicine.
Henry Gosebruch: Finally, we are advancing a deep pipeline of additional novel clinical and preclinical opportunities addressing such conditions as Alzheimer's, agitation, schizophrenia, Parkinson's, and ALS. With these programs, I believe we are well on our way to achieve our mission of redefining the development of novel medicines for patients.
Henry Scott: Finally, we are advancing a deep pipeline of additional novel clinical and preclinical opportunities addressing such conditions at Alzheimer's agitation schizophrenia, Parkinson's and ALS.
Henry Scott: With these program I believe we are well on our way to achieve our mission of redefining the development of novel medicines for brain diseases.
Joshua Pinto: With that overview, I'll turn the call over to Josh to review our financials. Thanks, Henry, and good morning, everyone. Our financial results for the third quarter of 2024 are detailed in the press release This morning, which I encourage you to I'll take a moment to provide some context and highlight a few key As we advance our industry-leading CMS 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 Total operating expenses for the third quarter were $76.6 million, compared to $56.9 million for the same period in 2022.
Josh: With that overview I will turn the call over to Josh to review.
Our financials.
Josh: Josh.
Josh: Thanks, Henry and good morning, everyone. Our financial results for the third quarter of 2024 are detailed in the press release that we issued this morning, which I encourage you to read.
Josh: I'll take a moment to provide some context and highlight a few key points.
Josh: As we advanced our industry, leading CNS 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 third quarter were $76 6 million compared to $56 9 million for the same periods in 2023.
Joshua Pinto: The increase was driven primarily by activities related to the Phase 3 program for Nevac. ongoing studies across the rest of our portfolio and investments to support the growth of our We ended the third quarter with $341.3 million in cash, cash equivalents, and marketable securities, which we expect to support operations into mid-2020. We believe this runway places us in a very strong financial position to execute on.
Josh: The increase was driven primarily by activities related to the phase III program for tobacco brand.
Josh: Ongoing studies across the rest of our portfolio and investments to support the growth of our business.
Josh: We ended the third quarter with $341 3 million in cash cash equivalents and marketable securities, which we expect to support operations into mid 2026.
Josh: We believe this runway places us in a very strong financial position to execute on our goals.
Joshua Pinto: In fact, over the next 18 months, we have five clinical catalysts on the horizon. including three phase three readouts for Nevacopran in MDT. Data for Nevacoprine in Bipolar Depression, and Data with MMRA 511 in Alzheimer's Disease. Additionally, our preclinical portfolio comprises programs targeting novel mechanisms of action that are supported by promising early evidence.
Josh: In fact over the next 18 months, we have five clinical catalysts on the horizon, including three phase III Readouts for tobacco and M D.
Josh: Data from the Vaca <unk> in bipolar depression, and data with MRA 511 in all timers disease agitation.
Josh: Additionally, our preclinical portfolio comprises programs targeting novel mechanisms of action that are supported by promising early evidence.
Joshua Pinto: I believe that this represents an industry-leading neuroscience pipeline and sets us up well to achieve long-term results.
Josh: I believe that this represents an industry, leading neuroscience pipeline and sets us up well to achieve long term growth.
Helen Rubinstein: With that, I'll now hand the call over to Helen to manage Q&A with the operator. Thanks, Josh. 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.
Speaker Change: With that I'll now hand, the call over to Helen to manage Q&A with the operator.
Speaker Change: Alan.
Thanks, Josh before I turn it over to the operator I'll ask that you limit yourself to one question. If you have any additional questions. Please feel free to return to the queue now I'll turn it over to the operator to handle the Q&A operator.
Operator: Now, I'll turn it over to the operator to handle Q&A.
Operator: Operator? Thank you.
Operator: As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. One moment for questions.
Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, one moment for questions.
Paul Mathews: Our first question comes from Paul Mathews with Spiegel. He may proceed.
Speaker Change: Our first question comes from Paul <unk> with Stifel. You May proceed.
Julian Pino: Hi there, this is Julian on for Paul. Thanks so much for taking our question this morning. We're just wondering, is there a final sample size that you guys have for Coastal 1 that you'd be able to share? And we're curious if there's any upside to original powering assumptions there. Thank you.
Speaker Change: Hi, there this is Julian on for Paul. Thanks, So much for taking our question. This morning.
Speaker Change: Just wondering is there a final sample size that you guys have for coastal one that you'd be able to share.
Speaker Change: And we were curious if there is any upside to your original powering assumptions there. Thank you.
Robert Lenz: Hi, this is Rob. I can take that question. So, we have three replicates, phase three studies ongoing, all of which are powered at approximately 90%. They're targeting approximately 332 patients in each.
Rob: Hi, This is Rob I can take that question. So we.
Rob: We have three replicate phase III studies ongoing all of which were powered all.
Rob: Power to approximately 90%.
Rob: They are targeting approximately 332 patients in each.
Robert Lenz: When we did design the coastal studies, we actually did build in the ability to increase the enrollment by up to 25% in a seamless way, meaning without requiring us to conduct a protocol amendment. So, look forward to sharing the details on the enrolled population, including the final sample size, at the top line results. Thank you.
Rob: When we did design the coastal studies, we actually did build and the ability to increase the enrollment by up to 25% in a seamless way, meaning without requiring us to conduct a protocol amendment. So.
Rob: Look forward to sharing the details on the enrolled population, including the final sample size at the topline results.
Speaker Change: Thank you.
Brian Abrahams: Our next question comes from Brian Abrahams with RBC Capital Markets. Hey, good morning. Thanks for taking my question, and congrats on all the progress. Recent studies have shown that placebo rates can sometimes be pretty tough to keep down in neuropsych studies.
Speaker Change: Our next question comes from Brian Abrahams with RBC capital markets. You May proceed.
Brian Abrahams: Hey, good morning, Thanks for taking my question and congrats on all the progress.
Brian Abrahams: Recent studies have shown that placebo rates can sometimes be pretty tough to keep down and in neuroscience studies. So I was wondering if you could talk a little bit about your confidence in the conduct of the coastal studies and maybe some of the QC measures that you're employing how you believe they're working.
Robert Lenz: So I was wondering if you could talk a little bit about your confidence in the conduct of the COASTAL studies and maybe some of the QC measures that you're employing, how you believe they're working in terms of how you're balancing patients across the sites and diverting towards the most reliable, validated centers. Thanks.
Brian Abrahams: In terms of how youre balancing patients across the sites and diverting towards the most.
Brian Abrahams: Reliable validated the centers thanks.
Robert Lenz: Hi, this is Rob again. I can take that question. So, we've implemented a number of measures in the Coastal Program at a program level as well as at a study level to really focus on increasing the overall probability of success. So, at the program level, as mentioned, we're conducting three trials with the expectation that we would need two of those to be positive. And then at the study level, there's a number of things that we implemented from both a design perspective as well as an execution and oversight perspective that we think increases that overall probability of success.
Brian Abrahams: Hi, This is Rob again, I can I can take that question. So we've implemented a number of measures in the coastal program at a program level as well as the study level to really focus on increasing the overall probability of success at the program level mentioned, we're conducting three trials with the expectation that we would need.
Brian Abrahams: Two of those to be positive and then at the steady level. There is a number of things that we implemented from both a design perspective as well as in execution and oversight perspective that we think increases that overall probability of success I'll just mention a few.
Robert Lenz: I'll just mention a few. So, from a design perspective, we did move from the HAMD-17 to the MODRIS as the primary outcome measure. This is really driven by the fact that the MODRIS better captures the clinical concepts of anhedonia, which is something that we showed benefit with with nevacopran in our Phase 2 study. So, we feel that the MODRIS better captures the holistic benefit that we would expect to see than the HAMD-17 does. We did implement equal allocation in Phase 3 between those patients coming into active and those going to placebo. We know historically that reduces expectation bias, which in turn reduces placebo rates in trials.
Brian Abrahams: From a design perspective, we did move from the <unk> 17 to <unk> as the primary outcome measure of this is really driven by the fact that the module better captures the clinical concepts of anhedonia, which is something that we should benefit with tobacco brand in our phase III study. So we feel that the law address better capture.
Brian Abrahams: The holistic benefit that we would expect to see.
Brian Abrahams: Then the AMD 17 does.
Brian Abrahams: We did implement full allocation in phase III between those patients coming into active and those going to placebo. We know historically that reduced its expectation bias, which in turn reduces placebo rates in trials and.
Robert Lenz: And then on the execution side, we really implemented what we feel is sort of state-of-the-art. I'll mention just a few. One is we're utilizing central raters for the administration of our primary outcome measure to help ensure that patients coming into the trial have the appropriate degree of depressive symptoms as assessed by the MODRIS. We are also having every patient conduct video apps to confirm compliance with study drug administration and drive compliance in the study. And then in terms specifically of placebo, you know, we spent a fair amount of time training the sites, but also implementing a placebo script.
Brian Abrahams: And then on the execution side, we really implemented what we feel are sort of state of the art mentioned just a few.
One is we're utilizing central raters for the administration of a primary outcome measure to help ensure that patients coming into the trial have the appropriate degree.
Brian Abrahams: Depressive symptoms as assessed by the law address.
Brian Abrahams: We are also.
Brian Abrahams: Having every patients conduct video apps to confirm compliance with study drug administration and drive compliance in the study and then in terms of specifically of placebo.
Brian Abrahams: We spent a fair amount of time training the sites, but also implementing a placebo script and this is something that the states administer to the patients on each administration of the Madras and the literature again support but thats a technique that can can help mitigate placebo responses.
Robert Lenz: And this is something that the sites administer to the patients on each administration of the MODRIS. And the literature, again, supports that that's a technique that can help mitigate placebo responses. So, you know, in aggregate, you know, we really feel we've been laser-focused on doing those things to increase the overall probability of success of the program in each study.
Brian Abrahams: Aggregate really feel we've been laser focused on doing those things to increase the overall probability of success of the program in each study.
Robert Lenz: Thanks so much.
Speaker Change: Thanks, so much.
Operator: Thank you.
Speaker Change: Thank you.
Iris: Our next question comes from Yaten Sineo with Guggenheim. You may proceed. Good morning, this is Iris on for Yateng. Congratulations on your first quarterly conference call. So you previously guided for discontinuation. lower than in phase two.
Speaker Change: Our next.
Speaker Change: <unk> goes from Yadkin today with Guggenheim You May proceed.
Speaker Change: Good morning. This is always also yacht Heng congratulations on your first quarterly conference call.
Speaker Change: So you previously guided for discontinuation rates lower than Q now that we're getting close to the readout.
Robert Lenz: Now that we're getting close to the readout, is it fair to assume discontinuation rates in the five to 10% range? Thank you.
Eric This is Jim discontinuation rates in the 5% to 10% range. Thank you.
Robert Lenz: Yeah, this is Rob. I won't comment specifically on the details, the discontinuation rate. I'll say that we overall were encouraged by the discontinuation rates that we're seeing in the study, and look forward to sharing the details on the baseline characteristics when we show the top-line results.
Rob: Yes. This is rob.
I won't comment specifically on the details of the discontinuation rate I will say that we overall, we are encouraged by the discontinuation rates that we're seeing in the study and look forward to sharing the details on the baseline characteristics.
Rob: When we show the topline results.
Operator: Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you.
Myles Minter: Our next question comes from Myles Minter with William Blair. Hey, thanks for taking the question.
Speaker Change: Our next question comes from Myles Minter with William Blair You May proceed.
Speaker Change: Hi, Thanks for taking the question.
Robert Lenz: We've been receiving some inbounds just on the pretty benign safety profile here for Nevacopran and whether that's inherent to the drug itself or whether that might be a sign of maybe patients being underexposed for a CNS drug. I think specifically for this mechanism, people are pointing to the lack of itch seen at the 80 mg dose, you know, somnolence levels that might be lower than we expect for a CNS drug. So, can you kind of just level set for us? where the dose selection for the ADMIG came from, how you're ensuring correct exposures in your ongoing coastal program.
Speaker Change: <unk> savings from Inbounds, just on the pretty benign safety profile here for <unk> and whether that's inherent to the jargon Sao Paulo, whether that might be a sign of maybe patients being under expires CNS John look I think.
Speaker Change: Typically for this mechanism.
Speaker Change: Clients are the lack of it saying that the IV make darice.
Speaker Change: Once levels that might be lower than we expect for our CNS jobs. So.
Speaker Change: Can you kind of just level set for us.
Speaker Change: The dose selection for the idea came from how you're ensuring correct experiences in your ongoing Carsten prior Graham and I guess.
Robert Lenz: And I guess, you know, are you achieving that target receptor occupancy at CAPA? Thanks very much.
Speaker Change: You are shaping that target receptor occupancy at Qatar, thanks very much.
Robert Lenz: Hi, this is Rob. Yeah, I can take that. So, overall, we've been quite encouraged by the safety profile, and that's based on the totality of data from both the Phase I and the Phase II studies to date. I think, importantly, we haven't seen some of the troublesome side effects that are seen with existing therapies like weight gain or sexual dysfunction. In terms of specifically around our confidence in the dose selection, that's really predicated on a couple observations. One is we conducted a human PET receptor occupancy study with the intent to assess which doses and exposures are resulting in significant receptor occupancy through the entire dosing period.
Speaker Change: Hi, This is Rob I can take that so overall, we've been quite encouraged by the safety profile and that's based on the totality of data from both the phase one in the phase III studies to date.
Speaker Change: Importantly, we haven't seen.
Speaker Change: Some of the trouble some side effects that are seen with existing therapies.
Weight gain or sexual dysfunction in terms of specifically around our confidence in the dose selection and Thats really predicated on a couple of observations. One is we conducted a human pet receptor occupancy study.
Speaker Change: With the intent to assess which doses and exposures are resulting in.
Speaker Change: Significant receptor occupancy through the entire dosing period and what we found is that the 80 milligram dose achieved exposures in the brain.
Robert Lenz: And what we found is that the 80-milligram dose achieves exposures in the brain that resulted in approximately 90 percent receptor occupancy. throughout the dosing. So, you know, we looked across G-protein-coupled receptor pharmacology. The objective is to get sort of north or above 75 to 80 percent, and we certainly have achieved that with a high degree of confidence with Nevaca, France.
Speaker Change: Also within approximately 90%.
Speaker Change: Throughout the dosing.
Speaker Change: So.
Speaker Change: It looks across.
Speaker Change: Protein coupled receptor pharmacology, the objective is to get north or about 75% to 80% and we certainly have achieved that.
Speaker Change: Of your confidence with the backup brands.
Robert Lenz: And then in terms of, you know, specifics around pruritus, you know, let's say pruritus is certainly a complex biology. There's a number of receptor systems that have been implicated in pruritus. Histamine, the mu-opioid receptor, as well as the kappa-opioid receptor. There's central mechanisms, as well as peripheral mechanisms. And so I'd say, you know, it's premature to sort of extrapolate any observations of pruritus. We did not see pruritus in the Phase II, but we did see pruritus in the Phase I study at a low level. And so, you know, we've conducted, you know, we've designed Nevaca, France, specifically to be a highly selective molecule.
Speaker Change: And then in terms of specifics around pruritus.
Speaker Change: This is certainly a complex biology theres a number of receptor systems that have been implicated in pruritus histamine the mu.
Speaker Change: <unk> receptor as well as the cap opioid receptor they're central.
Speaker Change: Mechanisms as well as peripheral mechanism.
Speaker Change: So I would say.
Speaker Change: It's premature to sort of extrapolate any observations of pruritus, we did not see pruritus in phase two but we did see.
Speaker Change: <unk>.
Speaker Change: Phase one.
Speaker Change: Study at a low level. So we conduct we've designed the backup France, specifically to be a highly selective molecule. We've got about 300 fold selectivity of Kappa overview that was the objective of the program that we've achieved that.
Robert Lenz: We've got about 300-fold selectivity of kappa over mu. That was the objective of the program, and we've achieved that. And so, you know, we think that in part could be driving, you know, the favorable tolerability profile that we've seen to date.
Speaker Change: So we think that in part will be driving the favorable tolerability profile that we've seen to date.
Speaker Change: Thanks.
Operator: Thank you.
Speaker Change: Thank you.
Greg Suvinovich: Our next question comes from Greg Suvinovich with Mizuho, you may press start. Morning, everyone.
Our next question comes from Greg <unk> with Mizuho you May proceed.
Josh Heer: This is Charles Awkward Greg. Congrats to the team for the continued progress. So, assuming two positive... Can you share your initial thoughts regarding... Social Strategy, and Labeling Strategy.
Speaker Change: Good morning, everyone. This is Charles on for Greg Congrats routine for continued progress so assuming two positive <unk> study in.
Speaker Change: Can you share your initial thoughts regarding tobacco brands potential commercial strategy and Nathan strategy. Thanks.
Josh Heer: Josh Heer. You know, as we believe that we need two of the three studies in the coastal program to be successful to file the IND, you know, and at this point, you know, believe that we are well set up both with our balance sheet as well as our team to look to commercialize the program, you know, on our own within the U.S.
Josh: This is Josh here.
Speaker Change: As we believe that we need to observe three studies in the coastal program to be successful to file the final the IMD.
Speaker Change: And at this point believe that we are well set up both with our balance sheet as well as our team to look to commercialize the program on our own within the U S.
Operator: Thank you.
Speaker Change: Thank you.
Douglas Tsao: Our next question comes from Douglas Tsao, with H.G. Wainwright, and you may press start. Hi, good morning, thanks for taking the questions. Just one, I think you mentioned the opportunity for resizing the coastal programs without taking an interim look. And I'm just curious, what would potentially be the catalyst for that? And then just a second question, if I may, we obviously got a negative readout from a competitor with their M4 program. So just curious if you have any thoughts on how that might influence your own. and Core Program.
Speaker Change: Our next question comes from Douglas Tsao with H C. Wainwright you May proceed.
Douglas Tsao: Hi, good morning, Thanks for taking the questions.
Douglas Tsao: One I think you mentioned the opportunity for Aten sizing in the close to a program without taking an interim look I'm just curious what could potentially be a catalyst for that and then just a second question. If I may when we obviously got negative readout from our competitor, but Theyre EMCORE program. So just curious if any.
Douglas Tsao: And how that might influence your arm.
Robert Lenz: Thank you. Yeah, I can.
Douglas Tsao: EMCORE program. Thank you.
Robert Lenz: This is Rob. I can start with the first question. So, I'd say we look forward to sharing the details of the design characteristics when we have the top-line results. I'll just reiterate that this is, as they say, not a typical way to implement increases in sample size from an ongoing study without having to conduct a formal protocol amendment. And this was, you know, part of the design that was submitted up through the FDA. In terms of the M4 program, you know, it's our policy to not comment on other companies' data. What I will say is we do remain confident in our M4 franchise.
Rob: Yes, I can this is Rob I can start with the first question. So I'd say, we look forward to sharing the details of.
Rob: The design characteristics, where we have the top line results I'll just reiterate that this is a.
Rob: It's not atypical way.
Rob: Implement increases in sample size from an ongoing study without having to conduct a formal.
Rob: The protocol Amendment.
Rob: Part of the design that was submitted up through the FDA.
Rob: In terms of the <unk> program.
Rob: It's our policy to not comment on other companies' data what I will say is we do remain confident in our <unk> franchise.
Robert Lenz: Just by way of reminder, we do have multiple programs, each of which has unique chemistry and unique attributes in pharmacology. Just by way of recall, these programs were licensed from Vanderbilt, and that's a group there that has tremendous expertise in medicinal chemistry and really industry or sort of academic-leading experience in the muscarinic space.
Rob: As a reminder, we.
Rob: We do have multiple programs.
Rob: Each of which has unique chemistry and unique attributes and pharmacology.
Rob: Just by way of recall these programs licensed from Vanderbilt.
Rob: And that's a group there that has tremendous expertise in medicinal chemistry and really <unk>.
Rob: Industry or sort of academic leading experience in the muscarinic space. So we're very much looking forward to bringing our nexsan for Pam.
Robert Lenz: So, you know, we're very much looking forward to bringing our next M4 PAM into the clinic in the first half of next year.
Rob: The clinic in the first half of next year.
Operator: Okay, great.
Operator: Thank you so much.
Speaker Change: Okay, great. Thank you so much.
Operator: Thank you.
Speaker Change: Thank you.
Charlie Yang: Our next question comes from Charlie Yang with Bank of America. Hi, thanks for taking my questions. Can you just confirm whether the last patient was enrolled for the cost of one? And if so, when was it enrolled? Thank you.
Speaker Change: Our next question comes from Charlie Yang with Bank of America, You May proceed.
Hi, Thanks for taking my questions.
Speaker Change: Can you just confirm whether the last patient count was enrolled for the cost of one.
Speaker Change: And if so.
Speaker Change: When will always.
Speaker Change: Thank you.
Robert Lenz: Hi, this is Rob again. I can address that. So we won't comment specifically on details of enrollment.
Rob: Hi, This is Rob again, I can I can address that so we won't comment specifically on details of enrollment I will just reiterate our confidence in.
Robert Lenz: I will just reiterate our confidence in delivering the top line results around the end of the year and the things that we've put in place and the resources to help ensure that that happens. And we can share, you know, we'll look forward to sharing those details as we show the top line results.
Speaker Change: <unk>.
Speaker Change: Delivering the top line results around the end of the year and the things that we've put in place and the resources to help ensure that that happens.
Speaker Change: We can share we'll look forward to sharing those details.
Speaker Change: As we show the top line results.
Speaker Change: Okay.
Myles Minter: Thank you. Our next question comes from Myles Minter with William Blair. Hey, thanks for taking the follow-up. Just on the IP with Vanderbilt and your muscarinic franchise, do you have any IP around M4 agonists or other cholinergic drugs that are maybe, you know, changed in selectivity for M1, M4? It just sounds like you've got to focus on the PAMs, which is understandable, but wondering whether you have flexibility to pivot outside of that selectivity. Thanks.
Speaker Change: Thank you.
Speaker Change: Our next question comes from Myles Minter with William Blair You May proceed.
Speaker Change: Hi, Thanks for taking the follow up.
Speaker Change: Just on the IP and the building.
Oscar: Oscar any franchise.
You have any IP around four agonists.
Speaker Change: All of that.
Cullen ASIC jobs that it may be changing selectivity for am one four it just sounds like you have got to focus on the Pam switches understandable, but I'm wondering whether you have flexibility to pay for it outside of that sort of activity. Thanks.
Josh Heer: This is Josh here. So, Myles, in terms of the franchise that we've been able to pull together with our partners at Vanderbilt, you know, it has been focused on M4-PAMs up to this point. You know, we believe that that, you know, pharmacology has potential, and, you know, we feel, as Rob has mentioned, very good, you know, about moving our programs into the clinic in the first half of next year. And so, you know, I'm not going to be able to comment any further just around the specific IP with the franchise that we have, but, you know, feel good about what we've built and put together with Vanderbilt.
Speaker Change: <unk>.
Speaker Change: This is Josh here.
Speaker Change: In terms of the franchise that we've been able to pull together with our partners at Vanderbilt. It has been focused on <unk> up to this point, we believe that that pharmacology has potential and we feel as Rob has mentioned very good about moving our programs into the clinic in the first half of next.
Speaker Change: Year.
Speaker Change: And so I'm not going to be able to comment any further just around the specific IP with the franchise that we have but feel good about what we've got built and put together with Vanderbilt.
Operator: Cool, thanks.
Speaker Change: Thanks.
Operator: Thank you, everyone.
Operator: That will conclude the Q&A portion of today's call.
Speaker Change: Thank you everyone that will conclude the Q&A portion of today's call with that I'll turn it back to Mr. Goldberg for closing remarks.
Henry Gosebruch: With that, I'll turn it back to Mr. Gosebruch for a closing remark. Thanks, Josh, and thanks again to everyone for joining us this morning. As you've heard, it's an exciting time to be at Neumora. And as we move forward, our goal remains steadfast to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for people suffering from brain diseases. We're looking forward to the first of our three Phase III data readouts for nevacoprend around the end of this year, with two more Phase III studies reading out in the first half of next year.
Mr. Goldberg: Thanks, Josh and thanks again to everyone for joining us this morning.
Mr. Goldberg: As you've heard it's an exciting time to be at Nomura and as we move forward. Our goal remains steadfast to redefine neuroscience drug development by bringing forward. The next generation of novel therapies that offer improved treatment outcomes and quality of life for people suffering from brain diseases.
Mr. Goldberg: We are looking forward to the first of our three phase III data readouts for <unk> around the end of this year with two more phase III studies reading out in the first half of next year.
Henry Gosebruch: As discussed beyond Nevacoprend, we are also advancing a deep pipeline of additional novel, clinical, and preclinical opportunities to address such conditions as Alzheimer's agitation, schizophrenia, Parkinson's, and ALS, creating a catalyst-rich upcoming year for Neumora. I'd like to take this opportunity to thank our talented and dedicated Neumora team. All of the progress we have made to date is the culmination of their hard work and their commitment to the patients we serve.
Mr. Goldberg: As discussed beyond tobacco brand. We are also advancing a deep pipeline of additional novel clinical and preclinical opportunities to address such such conditions as Alzheimers agitation schizophrenia, Parkinson's and ALS trading a catalyst rich upcoming year for Nomura.
Mr. Goldberg: I'd like to take this opportunity to thank our talented and dedicated Nomura team all of the progress. We have made today just a combination of their hard work and their commitment to the patients. We serve thanks again, everyone and have a wonderful day.
Henry Gosebruch: Thanks again, everyone, and have a wonderful day.
Operator: Thank you.
Operator: This concludes the conference. Thank you for your participation. You may now disconnect.
Chris: Thank you Chris.
Speaker Change: Concludes the conference. Thank you for your participation you may now disconnect.
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