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Neumora Therapeutics(NMRA) - 2025 Q4 - Earnings Call Transcript
2026-03-30 13:02
Neumora Therapeutics (NasdaqGS:NMRA) Q4 2025 Earnings call March 30, 2026 08:00 AM ET Company ParticipantsAlyssa Larios - Company RepresentativeBill Aurora - Chief Operating and Development OfficerBrian Abrahams - Global Managing Director and Sector Head of Healthcare ResearchDouglas Tsao - Managing Director of Equity ResearchHelen Rubinstein - VP of Investor Relations and Corporate StrategyJosh Pinto - PresidentJulian Pino - Biotechnology Equity Research Senior AssociateMike Milligan - CFONick Brandon - Ch ...
Neumora Therapeutics(NMRA) - 2025 Q4 - Earnings Call Transcript
2026-03-30 13:00
Neumora Therapeutics (NasdaqGS:NMRA) Q4 2025 Earnings call March 30, 2026 08:00 AM ET Speaker9Ladies 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. I would now like to turn the call over to Helen Rubenstein, Vice President of Investor Relations and Corporate Strategy at Neumora. Please go ahead.Speaker4Good afternoon, a ...
Neumora Therapeutics Stock Jumps, Analyst Sees Upside In Alzheimer's Treatment
Benzinga· 2026-02-17 19:32
Alzheimer's Disease Agitation Data - NMRA-511 demonstrated a favorable safety profile with no somnolence or sedation and significant improvements in agitation, with placebo-adjusted CMAI total score changes of -2.6 and -2.1 at Weeks 6 and 8, respectively [2] - Patients with elevated anxiety showed improvements of -7.6 and -5.6 at the same weeks [2] - William Blair projects peak U.S. sales of NMRA-511 to reach $1.8 billion, indicating promising early data despite previous setbacks with the V1a receptor antagonist approach [2] Obesity Update - Positive Phase 2 data for NMRA-215 in obesity is anticipated by year-end 2026, which could be a significant inflection point for Neumora [3] - William Blair has incorporated value into the Neumora model for NMRA-215, estimating a 15% probability of success that could unlock a market opportunity exceeding $2 billion under conservative assumptions [3] Depression Assets - The KOASTAL-2/3 trials of monotherapy navacaprant in major depressive disorder are expected to report results in the second quarter of 2026 [4] - There is intrigue surrounding the update in the KOR antagonist space, although caution is advised regarding the de-risking value of navacaprant [4] - NMRA stock experienced a 7.50% increase, reaching $3.45 at the last check [4]
Neumora Therapeutics (NasdaqGS:NMRA) 2026 Conference Transcript
2026-02-11 22:02
Summary of Neumora Therapeutics Conference Call Company Overview - **Company**: Neumora Therapeutics (NasdaqGS: NMRA) - **Event**: Guggenheim Emerging Outlook Biotech Summit, 2026 - **Date**: February 11, 2026 Key Points Industry and Product Focus - Neumora is focused on developing NMRA-511, a treatment for agitation in Alzheimer's disease (AD) [2][3] - The company is also exploring NLRP3 inhibitors for obesity and other indications [24][26] Clinical Data and Efficacy - NMRA-511 showed a significant clinical effect in a phase 1B study for AD agitation, achieving a 20.1-point reduction on the CMAI total score at week 8, with a Cohen's D effect size of 0.51-0.64 [5] - The CMAI aggression subfactor score for elevated anxiety populations had a robust effect size of 0.82 [6] - The CGI-S agitation score indicated a clinical effect size of 0.78 at week 6 and 0.38 at week 8, supporting the drug's potential [7] - NMRA-511 demonstrated a favorable safety and tolerability profile, allowing for higher dose testing planned for 2026 [8] Future Development Plans - Neumora plans to initiate a MAD extension cohort for NMRA-511 in 2026, transitioning to a QD extended-release formulation [9] - A pivotal phase 2/3 program is expected to start in 2027 [9] Market Opportunity - Approximately 60%-70% of Alzheimer's patients experience agitation and anxiety, indicating a significant market opportunity for NMRA-511 [10][11] - The company aims to enrich patient populations in pivotal studies to enhance treatment efficacy [11] Competitive Landscape - Competitors include Newleos and Azevan, which are also exploring treatments for anxiety and agitation [19] - Neumora's NMRA-511 is positioned as having a differentiated efficacy and safety profile compared to existing treatments like REXULTI and AUVELITY [8] Safety and Tolerability - No significant safety concerns were reported, with only minor cases of headache and one SAE related to hyponatremia deemed confounded by other factors [21][22] Financial Position - Neumora's current cash position is expected to support operations into the third quarter of 2027, covering all discussed catalysts [48] Other Programs - Neumora is advancing two M4 PAM compounds (NMRA-861 and NMRA-898) in phase 1 studies, with updates expected mid-2026 [40][44] - The company is also working on the KOASTAL program for navacaprant, with data readouts expected in the second quarter of 2026 [45][47] Conclusion Neumora Therapeutics is making significant strides in developing NMRA-511 for Alzheimer's disease agitation, with promising clinical data and a clear path for future studies. The company is well-positioned in a growing market, with a solid financial foundation to support its ongoing and future programs.
Neumora Therapeutics (NasdaqGS:NMRA) Update / Briefing Transcript
2026-01-05 14:02
Neumora Therapeutics (NasdaqGS:NMRA) Conference Call Summary Company Overview - **Company**: Neumora Therapeutics - **Focus**: Development of NMRA-511 for Alzheimer's disease agitation Key Industry Insights - **Alzheimer's Disease Agitation**: Affects over 70% of individuals with Alzheimer's disease dementia, leading to increased caregiver stress and earlier placement in long-term care facilities [4][5] - **Unmet Need**: Significant unmet need for effective treatments in this area due to current products having tolerability issues and limited efficacy [5] Core Findings from Phase 1B Study - **Study Objective**: To evaluate the clinical effect of NMRA-511 in Alzheimer's disease agitation [3] - **Effect Size**: NMRA-511 demonstrated a compelling effect size, similar to Auvelity in the total population and more pronounced in patients with elevated anxiety [5][15] - **Safety Profile**: NMRA-511 showed a favorable safety and tolerability profile, with a low discontinuation rate due to adverse events at 2.5% [16] Detailed Study Results - **CMAI Total Score Reduction**: - Modified analysis set: 15.7 points reduction at week eight [13] - Elevated anxiety population: 20.1 points reduction at week eight, with a Cohen's D effect size of 0.51 to 0.64, considered unsurpassed in AD agitation [15] - **Aggression Subscore**: Notable reduction of 5.3 points in the aggression subscore, important for caregiver safety [14] Future Development Plans - **Next Steps**: - Initiate a MAD extension cohort in 2026 to explore higher doses [17] - Transition to a once-daily extended-release formulation, expected to enhance patient compliance and extend market exclusivity until 2046 [18] - Plan to initiate a phase two-three study for NMRA-511 in AD agitation following the MAD extension [18] Competitive Landscape - **Comparison with Other Treatments**: - NMRA-511 is positioned against Rexulti and Auvelity, with a focus on a better benefit-risk profile and improved tolerability [46][47] - Rexulti has faced challenges due to side effects and black box warnings, while NMRA-511 aims to avoid these issues [46] Market Opportunity - **Large Patient Population**: Nearly all Alzheimer's patients experience some form of agitation or anxiety, indicating a significant market opportunity for NMRA-511 [48] Additional Considerations - **Regulatory Strategy**: Potential for formal enrichment of patient populations based on baseline anxiety levels in future studies, following precedents set by other sponsors [27][28] - **Broader Indications**: Future exploration of NMRA-511 in other anxiety-related conditions, such as PTSD and autism, is considered [28] Conclusion - **Overall Sentiment**: The data from the phase 1B study provides confidence in the potential of NMRA-511 to address a high-impact medical need in Alzheimer's disease agitation, with plans for further development and exploration of broader indications [61]
Neumora Therapeutics Highlights 2026 Pipeline Strategy and Anticipated Upcoming Milestones
Globenewswire· 2026-01-05 11:35
Core Insights - Neumora Therapeutics is positioned for significant value creation with multiple clinical data readouts expected in 2026, including consolidated topline readouts for KOASTAL-2 and KOASTAL-3 in Q2 2026 [1][3] - The company plans to initiate the NMRA-215 clinical program in 2026, following promising preclinical data related to obesity treatment [1][4] - NMRA-511 has shown positive results in a Phase 1b study for Alzheimer's disease agitation, indicating a clinically meaningful effect [1][6] - Neumora's financial position is strong, with cash and equivalents expected to support operations into Q3 2027 [1][7] Pipeline Updates - The KOASTAL studies for navacaprant will see increased enrollment, targeting up to 25% beyond the original 332 participants, with a joint topline data readout expected in Q2 2026 [3] - NMRA-215 is set to enter Phase 1 clinical trials for obesity treatment in the first half of 2026, with weight loss data anticipated by the end of 2026 [4] - The M4 Positive Allosteric Modulator (PAM) franchise is progressing with Phase 1 studies for NMRA-898 and NMRA-861, with a comprehensive update expected in mid-2026 [5] Business Strategy - Neumora aims to redefine neuroscience drug development by focusing on novel therapies for underserved brain diseases, supported by a robust pipeline of seven programs targeting various neuropsychiatric and neurodegenerative disorders [8]
Neumora Therapeutics (NasdaqGS:NMRA) 2025 Conference Transcript
2025-11-12 20:00
Neumora Therapeutics Conference Call Summary Company Overview - **Company**: Neumora Therapeutics (NasdaqGS: NMRA) - **Event**: 2025 Conference on November 12, 2025 - **Key Speakers**: Josh Pinto (President), Helen Rubinstein (Head of IR) Key Points Clinical Programs and Pipeline - Neumora has six clinical readouts planned across four main clinical stage assets over the next 12 months [2][5] - **NMRA-215**: An NLRP3 inhibitor showing class-leading weight loss data in diet-induced obesity models, with plans to move into human clinical trials in Q1 2026 and deliver proof-of-concept data by the end of 2026 [2][3] - **NMRA-511**: A phase 1b study for Alzheimer's disease agitation is ongoing, with readout expected by the end of 2025. The study is randomized, double-blind, and placebo-controlled, focusing on agitation levels [3][18] - **M4 PAM Franchise**: Two molecules, NMRA-898 and NMRA-861, are in clinical trials, with updates expected by mid-2026 [4][33] - **Navacaprant**: A selective kappa opioid receptor antagonist, with COASTAL 2 and 3 studies on track for readouts in Q1 and Q2 2026 [5] Financial Position - Neumora ended Q3 with over $170 million on the balance sheet, providing a cash runway into 2027 to fund operational plans and clinical catalysts [5] NLRP3 Inhibitor Insights - High correlation (up to 0.9) between diet-induced obesity models and clinical weight loss supports confidence in NMRA-215's potential [6][14] - NMRA-215 achieved IC90 concentrations in the CNS, which is critical for unlocking weight loss potential, unlike other NLRP3 inhibitors [8][11] V1aR Program - The vasopressin system is linked to stress response and agitation, with NMRA-511 showing promise in reducing agitation in Alzheimer's patients [16][17] - The ongoing study includes multiple endpoints to assess the impact on patient agitation and caregiver experience [20] M4 PAM Differentiation - Neumora believes that targeting the M4 receptor through a PAM approach can reduce adverse effects compared to selective agonists [32] - NMRA-898 and NMRA-861 are designed for high CNS penetration, addressing limitations seen in first-generation M4 PAMs [33][36] Strategic Outlook - Neumora aims to position itself as a significant neuroscience company by the end of 2026, with a focus on delivering high-quality data from its clinical programs [46] Additional Considerations - The company is open to various strategic paths for its programs, including collaborations or out-licensing, depending on the data outcomes [29] - Emphasis on the importance of CNS penetration and pharmacology in the development of its compounds [36][41] Conclusion Neumora Therapeutics is at a pivotal stage with multiple clinical programs advancing, a strong financial position, and a clear strategy to leverage its innovative pipeline in neuroscience. The upcoming clinical readouts will be critical in determining the future direction of the company and its assets.
Neumora Therapeutics (NasdaqGS:NMRA) FY Conference Transcript
2025-11-10 20:30
Neumora Therapeutics Conference Call Summary Company Overview - **Company**: Neumora Therapeutics (NasdaqGS: NMRA) - **Event**: FY Conference on November 10, 2025 Key Updates and Core Points NMRA-215 Development - Neumora has completed DIO studies for NMRA-215, an NLRP3 inhibitor targeting obesity, showing class-leading weight loss of 15%-19% in monotherapy settings, comparable to semaglutide [2][7] - NMRA-215 demonstrated up to 26% weight loss when combined with semaglutide, indicating potential for enhanced efficacy through combination therapy [8] - The company plans to initiate first-in-human studies in Q1 2026, with 12-week proof-of-concept data expected by the end of 2026 [3][5] Other Clinical Programs - NMRA-511, a V1A receptor antagonist for Alzheimer's disease agitation, is currently in a phase 1B study, with data expected by year-end [3][21] - Two M4 PAM programs, NMRA-898 and NMRA-861, have entered clinical trials, with updates anticipated by mid-2026 [4][30] Financial Position - As of Q3 2025, Neumora has approximately $170 million in cash, providing a runway into 2027 to fund ongoing clinical trials [5] Pharmacological Insights - Neumora emphasizes the translatability of DIO model data to clinical outcomes, citing a correlation coefficient above 0.9 for weight loss predictions [6] - The company believes its CNS-penetrant pharmacology for NLRP3 inhibitors is superior to competitors, achieving necessary IC90 concentrations in the brain for effective weight loss [12][13] Safety and Patient Quality Improvements - Neumora has partnered with Massachusetts General Hospital to enhance patient selection for clinical trials, aiming to improve the quality of participants in COASTAL studies [35] - The COASTAL II and III studies will have a base size of 332 patients, with potential for a 25% increase based on protocol flexibility [37] Regulatory Considerations - Neumora aims to have two positive studies to support an NDA filing, although one positive study with supportive evidence could also be sufficient [39] Additional Insights - The company is focused on the obesity market as a primary therapeutic area, with plans to explore additional indications based on clinical data outcomes [16][17] - Neumora is preparing to capture biomarker data during its first-in-human studies to inform future development [17] Conclusion - Neumora Therapeutics is positioned for significant clinical milestones in the coming year, with multiple programs advancing through clinical trials and a strong financial foundation to support its initiatives [41]
Neumora Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-06 12:00
Core Insights - Neumora Therapeutics announced promising data for NMRA-215, a highly brain-penetrant oral NLRP3 inhibitor, showing class-leading weight loss in diet-induced obesity mouse models, with plans to initiate a Phase 1 study in Q1 2026 [1][4] - The company is advancing Phase 1 studies for two positive allosteric modulators, NMRA-861 and NMRA-898, with a comprehensive update expected by mid-2026 [1][5] - Neumora is on track to report data from a Phase 1b study of NMRA-511 for Alzheimer's disease agitation by the end of 2025 [1][6] - The company has drawn $40 million in non-dilutive capital from K2 HealthVentures, strengthening its financial position [1][3] - As of September 30, 2025, Neumora has $171.5 million in cash, cash equivalents, and marketable securities, expected to support operations into 2027 [1][10] Business Updates - Neumora's CEO highlighted the strength of the pipeline and the differentiated approach to address significant medical challenges, particularly emphasizing the data for NMRA-215 [2] - The company is committed to addressing unmet needs in schizophrenia and neuropsychiatric disorders through the expansion of its M4 muscarinic receptor PAM franchise [2] Financial Performance - For Q3 2025, Neumora reported a net loss of $56.8 million, a decrease from $72.5 million in Q3 2024, attributed to reduced R&D expenses and lower general and administrative costs [10][11] - Research and development expenses for Q3 2025 were $40.5 million, down from $60.6 million in the same period of 2024 [10][11] - General and administrative expenses decreased to $12.2 million in Q3 2025 from $16.0 million in Q3 2024 [10][11]
Neumora Therapeutics to Host Virtual R&D Day on October 27
Globenewswire· 2025-10-01 11:00
Core Insights - Neumora Therapeutics, Inc. is hosting a virtual R&D Day on October 27, 2025, to showcase its innovative therapeutic pipeline targeting various diseases [1][4] Group 1: R&D Day Highlights - The R&D Day will feature NMRA-215, a potent NLRP3 inhibitor, with preclinical results from diet-induced obesity mouse models [2] - Upcoming Phase 1b topline data for NMRA-511, a vasopressin 1a receptor antagonist for Alzheimer's agitation, will also be discussed [2] - Additional focus will be on Neumora's M4 franchise, including NMRA-861 and NMRA-898, and navacaprant, a kappa opioid receptor antagonist in Phase 3 studies [2] Group 2: Company Overview - Neumora Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing significant medical challenges through innovative treatment approaches for brain diseases [4] - The company has a pipeline of seven programs targeting novel mechanisms of action for a range of prevalent diseases [4] - Neumora aims to redefine neuroscience drug development by introducing next-generation therapies that enhance treatment outcomes and patient quality of life [4]