NMRA

Paul Burns mentioned 2025 was a year of important clinical progress and execution for Pneumora, with strides in advancing diverse pipeline, including NMRA 511, Novacropran, M4PAM franchise, and NMRA215. Josh Pinto reviewed pipeline updates: NMRA 511 had positive Phase 1B study results, Nevacopran's COSTAL 2 and 3 studies are fully enrolled, NMRA 898 is the lead in M4 PAM franchise, and NMRA215 had positive DIO mouse study data but had unexpected adverse findings in a rat tox study. Bill Arora provided details on clinical programs: NMRA 511's Phase 1b study details, Nevacopran's study optimizations, and M4PAM franchise's NMRA 898 progress. Nick Brandon walked through NLRP3 update: NMRA215's DIO data and rat tox study issues. Mike Milligan reviewed financials with $182.5 million in cash, cash equivalents, and marketable securities.

Nemora is well positioned to achieve multiple potentially value-creating milestones within the next 12 months. NMRA 511 will have a MAD extension cohort data in second half of 2026 and Phase 2 study in first quarter of 2027. Nevacopran's COSTAL 2 and 3 studies expect data in second quarter of 2026. NMRA 898's multiple ascending dose study of NMRA 898 in healthy volunteers and patients with stable schizophrenia expects data in second half of 2026. NMRA215 expected to be brought into clinic in first quarter of 2027.

Unexpected adverse findings from a 13-week rat tox study in a small number of animals for NMRA215. Forward-looking statements are subject to certain risks and uncertainties, and actual results may differ materially. Need to consider risks discussed in press release and SEC filings.

Q: Follow up on Novacopran filing in MDD, confirming one positive study and supportive evidence.

A: Bill said with one positive study like Coastal 2 or 3 plus supportive data, would request pre-NDA meeting.

Q: Color on conduct issues and toxicity findings for NMRA215.

A: Nick said ongoing audit, findings procedure-related, repeating study to progress.

Q: More on M4 program, why 898 is lead and 861's future.

A: Josh said prioritizing 898 for schizophrenia, 861 for future indications.

Q: Details on pre-specified analysis for Coastal 2 and 3 readouts.

A: Josh and Bill said top line data for each study and post-pause pooled population analysis.

Q: Details on maintenance data for NMRA215 and capital allocation.

A: Josh said reduced spend for 215, maintenance data validating, hitting expected results.

Q: Clarification on 215 DOC study and IND clearance.

A: Nick said re-running study based on guidance, confident in clearance.

Q: Effect size and phase two design for NMRA 511.

A: Bill said effect size consistent, phase two plans including design, inclusion criteria.

Q: Differentiation of 898 vs other programs and BP changes.

A: Nick, Bill, Josh said 898's half-life, pharmacodynamic effects, BP changes consistent with class.

Q: Follow-up on 898 BP changes in single ascending dose study.

A: Bill said no BP changes seen yet, monitor as progresses.

Q: Combination and optimization for NMRA215 maintenance study.

A: Josh said next step is clinic, data validating best-in-class potential