Strong Clinical Momentum and Multiple Near-Term Catalysts
Company highlighted a catalyst-rich 12 months with multiple expected readouts: KOASTAL-2/3 topline data in Q2 2026, NMRA-511 MAD extension data in H2 2026, NMRA-898 MAD data in H2 2026, and planned clinical entry for NMRA-215 in Q1 2027 (now delayed due to tox retest). Management emphasized differentiated mechanisms and brain-penetrant chemistry across the pipeline.
NMRA-511 (vasopressin 1a antagonist) — Positive Phase Ib Prespecified Analysis
Phase Ib prespecified analysis in 53 patients with NPI-AA ≥4 showed clinically meaningful benefit with a Cohen's d effect size of 0.32–0.34 on CMAI total score (similar magnitude to Rexulti). Safety/tolerability favorable with no reported somnolence or sedation. Company will run a MAD extension (data expected H2 2026) and plans Phase II initiation in Q1 2027.
Navacaprant (kappa opioid antagonist) — Phase III Programs Fully Enrolled
KOASTAL-2 and KOASTAL-3 are fully enrolled with >400 patients in each study. Joint topline readout expected in Q2 2026. Study design included optimizations after KOASTAL-1 (enhanced monitoring, screening tools, site selection), resulting in ~10% higher screen-fail rate versus KOASTAL-1, intended to improve dataset quality.
M4 PAM Franchise — NMRA-898 Selected as Lead with Compelling Early Human PK/PD
NMRA-898 chosen as lead for schizophrenia based on Phase I data: human half-life ~80–100 hours (supports once-daily dosing), dose-proportional exposures with low variability, predicted free brain exposure above in vitro M4 EC50, and on-target pharmacodynamic heart rate changes indicative of engagement. MAD data expected H2 2026.
NMRA-215 (CNS NLRP3 inhibitor) — Class-Leading DIO Mouse Data
12-week diet-induced obesity (DIO) mouse study showed supportive results: dose-dependent, class-leading weight loss as monotherapy and additive effects in combination with semaglutide; switching paradigms preserved weight loss (NMRA-215 maintained semaglutide-like loss when switched at week 8). Management referenced ~20–25% relative weight-loss effects in prior studies and ~23% combo reduction referenced in Q&A modeling.
Financial Position — Cash on Hand and Runway
As of Dec 31, 2025, cash, cash equivalents and marketable securities totaled $182.5 million. Management expects this cash position to support operations into Q3 2027. Total net loss for 2025 was comparable to 2024.