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WATERTOWN, Mass. - Neumora Therapeutics , Inc. (NASDAQ:NMRA) shares dropped 6.4% after the clinical-stage biopharmaceutical company announced changes to its ongoing depression drug trials and reported fourth-quarter financial results.
The company beat earnings expectations for the fourth quarter, reporting an adjusted loss per share of -$0.37, compared to analyst estimates of -$0.62. However, investors focused on Neumora’s plans to pause and optimize its KOASTAL-2 and KOASTAL-3 clinical trials for navacaprant in major depressive disorder (MDD).
Neumora said it would make several changes to the trials based on learnings from the failed KOASTAL-1 study, including reducing the number of clinical sites, enhancing medical monitoring, and adding screening tools to exclude participants enrolled in multiple studies. The company now expects topline data from KOASTAL-3 in the first quarter of 2026 and KOASTAL-2 in the second quarter of 2026.
"We have analyzed the data set provided by KOASTAL-1 and made important amendments to help optimize the ongoing KOASTAL-2 and -3 studies based on the learnings," said Paul L. Berns, CEO of Neumora. "We believe these changes strengthen the studies and look forward to delivering topline data in 2026."
The company also discontinued a Phase 2 trial of navacaprant for bipolar depression to focus resources on the KOASTAL program.
Neumora reported $307.6 million in cash, cash equivalents, and marketable securities as of December 31, 2024, which it expects will fund operations into mid-2026. Research and development expenses for the full year 2024 increased to $200.9 million from $142.7 million in 2023, primarily due to the advancement of navacaprant clinical trials.
Stifel analyst Paul Matteis maintained a Buy rating on the stock, but lowered its price target from $26.00 to $6.00.
The analyst stated, "We remain Buy rated on NMRA, as we think the risk/reward on the KOSTAL-2/3 trials is attractive--even if the risk profile here after KOSTAL-1 is of course much higher, reflected in our updated target price of $6. This morning Neumora announced various modifications to the KOSTAL2/3 studies, seeking to improve trial conduct and increase probability-of-success. While all of these changes are logical, it remains near impossible to deduce whether KOSTAL-1 failed due to issues with the study, or simple lack-of-efficacy from the drug (navacaprant)."
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