NMRA-511 demonstrated a clinically meaningful effect size in people with AD agitation.Alzheimer's Disease Agitation DataIn the Phase 1b study, NMRA-511 showed a favorable safety profile with no somnolence or sedation, and meaningful improvements in agitation. Patients saw placebo-adjusted CMAI total score changes of -2.6 and -2.1 at Weeks 6 and 8, while those with elevated anxiety improved by -7.6 and -5.6, respectively.William Blair projects peak U.S. sales of $1.8 billion for NMRA-511 and called the early ...

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.

Core Insights - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases through novel mechanisms of action [3] - The company will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11, 2026, at 4:00 p.m. ET [1] - A live webcast of the event will be available on the company's website, with a replay accessible for up to 30 days [2] Company Overview - Neumora's therapeutic pipeline includes seven neuroscience programs targeting underserved neuropsychiatric disorders and neurodegenerative diseases [3] - The company aims to redefine neuroscience drug development by utilizing an integrated suite of translational, clinical, and computational tools to enable precision medicine [3] - Neumora's mission is to improve treatment outcomes and quality of life for patients suffering from brain diseases [3]

Market Overview - U.S. stocks showed mixed performance, with the Dow Jones index declining approximately 0.2% on Wednesday [1] Company Highlights - Monte Rosa Therapeutics Inc (NASDAQ:GLUE) experienced a significant increase in share price, rising 45.2% to $23.25 after announcing interim data from a Phase 1 clinical study for MRT-8102 [1] - Ventyx Biosciences Inc (NASDAQ:VTYX) shares surged 37.5% to $13.82 following reports of advanced acquisition talks with Eli Lilly & Co. (NYSE:LLY) for over $1 billion [2] - Neumora Therapeutics Inc (NASDAQ:NMRA) saw a rise of 24.7% to $2.27 [2] - Regencell Bioscience Holdings Ltd (NASDAQ:RGC) increased by 21.1% to $40.00 [2] - Erasca Inc (NASDAQ:ERAS) rose 17.1% to $4.25, with Piper Sandler initiating coverage with an Overweight rating and a price target of $5 [2] - Anywhere Real Estate Inc (NYSE:HOUS) gained 15.6% to $16.71 [2] - AXT Inc (NASDAQ:AXTI) increased by 13.8% to $22.96 [2] - Immuneering Corp (NASDAQ:IMRX) rose 13.1% to $7.60 [2] - Compass Therapeutics Inc. (NASDAQ:CMPX) gained 13.1% to $5.56 [2] - MBX Biosciences Inc (NASDAQ:MBX) rose 11.2% to $31.90 [2] - Rezolve AI PLC (NASDAQ:RZLV) increased by 10.8% to $3.36 [2] - United Microelectronics Corp (NYSE:UMC) gained 10.4% to $8.96 after reporting sales growth for December and the full year [2] - PBF Energy Inc (NYSE:PBF) rose 9.2% to $29.73 [2] - Navan Inc (NASDAQ:NAVN) increased by 8.3% to $18.42 [2] - Ascentage Pharma Group International (NASDAQ:AAPG) gained 8.3% to $28.17 after announcing IND clearance for BTK Degrader APG-3288 by the U.S. FDA [2] - Intel Corp (NASDAQ:INTC) rose 6.4% to $42.60 as the company is enhancing its gaming strategy by developing a new chip for handheld gaming devices [2]

Core Viewpoint - Premarket trading is showing significant activity with notable price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - Ventyx Biosciences, Inc. (VTYX) increased by 57% to $15.79 [3] - Cardio Diagnostics Holdings, Inc. (CDIO) rose by 36% to $4.02 [3] - Monte Rosa Therapeutics, Inc. (GLUE) saw a 28% increase to $20.54 [3] - Momentus Inc. (MNTS) gained 27% reaching $12.50 [3] - BioAge Labs, Inc. (BIOA) went up by 13% to $17.50 [3] - Neumora Therapeutics, Inc. (NMRA) increased by 11% to $2.03 [3] - Mobileye Global Inc. (MBLY) rose by 10% to $13.45 [3] - Society Pass Incorporated (SOPA) increased by 10% to $3.47 [3] - SU Group Holdings Limited (SUGP) saw an 8% rise to $6.32 [3] - Critical Metals Corp. (CRML) gained 7% reaching $12.73 [3] Premarket Losers - Evolution Metals & Technologies Corp. (EMAT) decreased by 28% to $15.20 [4] - Ascent Solar Technologies, Inc. (ASTI) fell by 12% to $4.65 [4] - Apogee Enterprises, Inc. (APOG) saw a 10% decline to $33.30 [4] - Next Technology Holding Inc. (NXTT) dropped by 8% to $8.49 [4] - AST SpaceMobile, Inc. (ASTS) decreased by 7% to $90.45 [4] - Nomadar Corp. (NOMA) fell by 7% to $3.66 [4] - EZGO Technologies Ltd. (EZGO) decreased by 7% to $1.99 [4] - Cohen & Company Inc. (COHN) saw a 6% decline to $28.30 [4] - PMGC Holdings Inc. (ELAB) dropped by 4% to $5.34 [4] - Anghami Inc. (ANGH) decreased by 3% to $4.49 [4]

Core Viewpoint - Neumora is discussing top line data from the Phase Ib signal-seeking study of NMRA-511, aimed at addressing agitation in Alzheimer's disease [2]. Group 1: Company Overview - The presentation is led by Helen Rubinstein, Vice President of Investor Relations and Communications at Neumora, who introduces the management team [2]. - Key members of Neumora's management team include Co-Founder and CEO Paul Berns, President Josh Pinto, Chief Scientific Officer Nick Brandon, and Chief Operating and Development Officer Bill Aurora [2]. Group 2: Study Focus - The focus of the discussion is on the Phase Ib study of NMRA-511, which targets agitation in patients with Alzheimer's disease [2].

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]

NMRA-511 Phase 1b Study Results - NMRA-511 Phase 1b study is for Alzheimer's Disease (AD) Agitation [2] - The company is focused on redefining neuroscience drug development [4] - Alzheimer's disease affects approximately 7 million U S adults in 2024, and this number is expected to increase to 13 million by 2050 [12] - Over 70% of people with Alzheimer's Disease experience agitation at some point [12] - NMRA-511 demonstrated a 15 7-point reduction in CMAI total score at Week 8 [47] NMRA-511 Clinical Trial and Safety - In the NMRA-511 Phase 1b study, 40 participants were in the NMRA-511 group and 40 in the placebo group [45] - 45% of the NMRA-511 group were male, compared to 37 5% in the placebo group [45] - 67 5% of the NMRA-511 group were White, compared to 75% in the placebo group [45] - Protocol-defined medication non-adherence was observed in 17 5% of the NMRA-511 group [45] - The company plans to initiate a multiple ascending dose extension in 2026 to enable higher dosing [61]

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]

Core Insights - Neumora Therapeutics announced positive results from its Phase 1b study of NMRA-511, demonstrating a clinically meaningful reduction in agitation symptoms in Alzheimer's disease patients, particularly those with elevated anxiety [2][3][10] - NMRA-511 showed a 15.7% reduction in mean CMAI total score, indicating a significant clinical effect size [1][10] - The drug exhibited a favorable safety and tolerability profile, with low rates of treatment discontinuation due to adverse events [1][10] Study Design and Results - The Phase 1b study included two parts: Part A focused on healthy elderly adults, while Part B involved 80 patients with Alzheimer's disease agitation [4] - In Part B, NMRA-511 demonstrated a placebo-adjusted change of -2.6 and -2.1 in CMAI total score at Weeks 6 and 8, respectively, with a Cohen's d effect size range of 0.20 – 0.23 [10] - Among patients with elevated anxiety, NMRA-511 showed a more pronounced effect with a -7.6 and -5.6 placebo-adjusted change at Weeks 6 and 8, respectively, resulting in a Cohen's d effect size range of 0.51 – 0.64 [10] Future Plans - Neumora plans to initiate a multiple ascending dose expansion cohort for NMRA-511 in 2026 to evaluate higher doses [1][6] - The company aims to develop an extended-release formulation for once-daily dosing and to start a Phase 2/3 dose-ranging study [10] - A conference call is scheduled for January 5, 2026, to discuss these developments [6] About NMRA-511 - NMRA-511 is a highly potent and selective antagonist of the vasopressin 1a receptor (V1aR), showing over 3,000-fold selectivity compared to V1b and V2 receptors [7] - The drug is positioned to address agitation symptoms in Alzheimer's disease and has potential applications in various neuropsychiatric disorders [7] About Neumora - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for brain diseases [8] - The company's pipeline includes seven programs targeting a range of prevalent diseases with unmet medical needs [8]