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Neumora Therapeutics, Inc. Common Stock

Neumora Therapeutics, Inc. Common Stock Q3 FY2024 earnings call

November 12, 2024 · fiscal period ended 2024-09

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Summary

Generated 2024-11-12

Management highlights

• Brain diseases affect a large global population and represent a significant unmet medical need. Neumora has a portfolio of seven clinical and preclinical programs targeting novel mechanisms for brain diseases. • Lead program navacaprant is being investigated for major depressive disorder (MDD) and other neuropsychiatric conditions, with Phase 3 KOASTAL studies ongoing, aiming for top line data from KOASTAL-1 end of 2024 and KOASTAL-2/-3 in first half 2025. Also exploring navacaprant for bipolar disorder and advancing NMRA-511 in Alzheimer’s disease agitation. • M4 franchise has an IND expected for a second positive allosteric modulator in first half of 2025. • Operating expenses for Q3 2024 were $76.6 million, ending Q3 with $341.3 million in cash, expecting to support operations into mid-2026 with five clinical catalysts on the horizon.

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Segment performance

No detailed financial performance by product segment is provided in the transcript. The company focuses on a portfolio of clinical and preclinical programs targeting brain diseases, but no revenue contribution percentages for specific segments are mentioned.

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Guidance

• Anticipate top line data readout from KOASTAL-1 around the end of 2024 and data from KOASTAL-2 and KOASTAL-3 in the first half of 2025. • Look forward to sharing results from navacaprant’s Phase 2 signal seeking study in bipolar II depression in the second half of 2025 and NMRA-511’s Phase 1b study in Alzheimer’s disease agitation in the second half of 2025. • Preclinical portfolio has programs with promising early evidence.

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Risks

• Forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from expectations. Risks are detailed in the press release and SEC filings, but no specific risks are elaborated on in the call.

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Q&A highlights

Q: Is there a final sample size that you guys have for KOASTAL-1 that you’d be able to share and any upside to original powering assumptions?

A: Three replicate Phase 3 studies are ongoing, powered at ~90% with ~332 patients each. Enrollment can be increased by up to 25% without protocol amendment. Look forward to sharing the final sample size at the top line results.

Q: Talk about confidence in conduct of KOASTAL studies and QC measures?

A: Implemented measures at the program and study level to increase success probability. Moved from HAMD-17 to MADRS as the primary outcome measure, implemented equal allocation, central raters, video apps for compliance, and placebo scripts.

Q: Is it fair to assume discontinuation rates in the 5% to 10% range?

A: Won't comment specifically on discontinuation rate, but is encouraged by the rates seen in the study and will share baseline characteristics at the top line results.

Q: Dose selection for 80 mg navacaprant and receptor occupancy?

A: The 80 mg dose achieves ~90% receptor occupancy in the brain through the dosing period, based on a human PET study. The drug has ~300-fold selectivity for the kappa opioid receptor, contributing to a favorable safety profile.

Q: Initial thoughts on navacaprant commercial strategy and labeling if two KOASTAL studies positive?

A: Believe two of the three KOASTAL studies need to be successful to file, and are well positioned to commercialize the program in the U.S. on their own.

Q: Catalyst for resizing KOASTAL programs and thoughts on competitor's M4 program?

A: Look forward to sharing details of the design characteristics at the top line results. Policy is not to comment on other companies' data, but is confident in their own M4 franchise with multiple programs from Vanderbilt expertise.

Q: Confirm if last patient was enrolled for KOASTAL-1?

A: Won't comment specifically on enrollment details, but is confident in delivering the top line results by the end of 2024.

Q: IP with Vanderbilt and flexibility in M4 selectivity?

A: The franchise is focused on M4 positive allosteric modulators to date, feels good about programs moving into the clinic in the first half of 2025, but no further comment on specific IP.

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Transcript

November 12, 2024

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