Core Insights - BioAge Labs, Inc. is expanding its BGE-102 development program into ophthalmology, specifically targeting diabetic macular edema (DME) as the initial proof-of-concept indication for its orally administered NLRP3 inhibitor [1][11] - BGE-102 has shown favorable tolerability in ongoing Phase 1 trials, with significant reductions in inflammatory biomarkers such as hsCRP, IL-6, and IL-1β, indicating its potential for broader anti-inflammatory benefits [1][3][10] - The company plans to initiate a Phase 1b/2a proof-of-concept trial in DME patients in mid-2026, with results expected in mid-2027, aiming to demonstrate target engagement and pharmacodynamics [6][7][13] Development Program - BGE-102 is a potent, orally available small molecule NLRP3 inhibitor, which has shown promise in preclinical models for preserving retinal vascular integrity and reducing age-related inflammatory markers [4][10] - The drug's mechanism targets the NLRP3 inflammasome, which is implicated in various retinal diseases, including DME and geographic atrophy, suggesting potential for expansion into additional indications [2][10] - The upcoming DME trial will run in parallel with a Phase 2a cardiovascular risk trial, with results for the latter anticipated in the second half of 2026 [1][13] Clinical Evidence - Clinical data supports the targeting of inflammation in retinal diseases, with injectable IL-6 inhibitors showing sustained visual acuity gains in patients with macular edema [5] - The primary endpoint for the DME trial will be the percent change in intraocular IL-6, with additional exploratory endpoints including best-corrected visual acuity and central subfield thickness [7] Anticipated Milestones - Key milestones include the completion of the Phase 1 trial with full data readout in the first half of 2026, initiation of the DME trial in mid-2026, and data readouts for both trials expected in mid-2027 [13]

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]