Neumora Therapeutics Q1 2025: Unraveling Contradictions in KOASTAL Trials and Patient Selection Strategies

Study design and patient selection for KOASTAL trials, interim analysis in KOASTAL trials, enrollment strategy and patient selection for Navacaprant and KOASTAL programs, planning for interim analysis in the KOASTAL program are the key contradictions discussed in Neumora Therapeutics' latest 2025Q1 earnings call.



Clinical Program Advancement:
- Neumora Therapeutics is advancing multiple programs towards key milestones, with plans to deliver top-line data for NMRA-511 in Alzheimer's disease agitation around the end of the year, and for navacaprant in the Phase 3 KOASTAL program in MDD in Q1 and Q2 of 2026.
- The progress is driven by the company's focus on clinical execution and its strong financial foundation.

Navacaprant Program Modifications:
- Neumora implemented changes in KOASTAL-2 and KOASTAL-3 to ensure appropriate patient enrollment, including enhanced medical monitoring, independent clinician review, and exclusion of patients participating in multiple clinical trials.
- These modifications aim to address the previous KOASTAL-1 results, which were not representative of the typical MDD population, and to improve the probability of success in the ongoing studies.

Financial Strength and Runway Extension:
- Neumora Therapeutics' cash, cash equivalents, and marketable securities totaled $249.4 million as of March 31, 2025.
- The company secured a $125 million debt facility with K2 HealthVentures, extending its cash runway into 2027, which will support its efforts to achieve multiple clinical catalysts across its pipeline.

M4 PAM Program and Clinical Readiness:
- Neumora plans to move a candidate into the clinic in the middle of the year for its franchise of M4 PAMs, aiming for improved safety and tolerability profile and once-a-day dosing.
- The focus on M4 PAMs is driven by the desire to become a leader in this area, as M4 is identified as the driver of antipsychotic activity in muscarinic drugs.