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]