Neumora Therapeutics Q2 2024 Financial Results and Business Update

Neumora Therapeutics, Inc., a clinical-stage biopharmaceutical company based in Watertown, Massachusetts, reported its financial results for the second quarter ending June 30, 2024, alongside significant updates on its ongoing clinical programs. The company, listed on Nasdaq under the ticker NMRA, focuses on developing treatments for brain diseases and boasts a pipeline featuring seven clinical and pre-clinical programs targeting neuropsychiatric and neurodegenerative disorders.

CEO and President Henry Gosebruch highlighted the substantial progress in their clinical development efforts during the first half of the year, emphasizing their commitment to pioneering new treatments for brain diseases. A key focus is the pivotal Phase 3 KOASTAL-1 study of navacaprant for major depressive disorder (MDD), with topline data expected in the fourth quarter of 2024. Gosebruch expressed optimism about quickly delivering navacaprant to millions suffering from MDD.

Neumora's clinical pipeline also includes a Phase 2 study of navacaprant for bipolar depression and a Phase 1b study of NMRA-511 targeting agitation related to Alzheimer’s disease (AD). The company aims to submit an Investigational New Drug application (IND) for an additional M4 compound in early 2025. These developments address significant unmet medical needs and are hoped to offer favorable benefit-risk profiles.

Key highlights from Neumora's therapeutic pipeline include:

1. Navacaprant (NMRA-140): This selective kappa opioid receptor (KOR) antagonist is being developed as a potential monotherapy for MDD. The registrational Phase 3 KOASTAL program, encompassing KOASTAL-1, KOASTAL-2, and KOASTAL-3, is ongoing. These are randomized, placebo-controlled, double-blind studies aimed at evaluating the efficacy and safety of navacaprant. Results from KOASTAL-1 are expected in Q4 2024, with KOASTAL-2 and KOASTAL-3 data anticipated in the first half of 2025. Additionally, a Phase 2 study for bipolar depression has begun, with results expected in the latter half of 2025.

2. NMRA-511: This compound is a vasopressin 1a receptor (V1aR) antagonist developed for treating agitation associated with dementia due to AD and other neuropsychiatric disorders. A Phase 1b study was initiated in June 2024, focusing first on healthy elderly participants and then on those with agitation related to AD. Data from this study is projected for the second half of 2025.

3. M4 Positive Allosteric Modulator (PAM) Franchise: This includes multiple novel compounds like NMRA-266. Work on NMRA-266 is currently paused due to a clinical hold by the FDA, but Neumora is in discussions to resolve this. Other compounds in the M4 PAM franchise have shown promising preclinical activity, with plans to submit an IND for another M4 PAM compound in the first half of 2025.

In terms of financial performance, Neumora reported $371.6 million in cash, cash equivalents, and marketable securities as of June 30, 2024, which is expected to fund operations into 2026. Research and development expenses rose to $48.6 million in Q2 2024 from $32.8 million in Q2 2023, driven by the advancement of clinical and preclinical programs. General and administrative expenses also increased to $15.2 million from $9.3 million year-over-year, primarily due to personnel costs and professional services expansion. The net loss for Q2 2024 was $58.7 million, compared to $38.5 million for the same period in 2023.

Neumora remains committed to addressing the global brain disease crisis by developing novel therapies aimed at improving treatment outcomes and quality of life for patients. Their integrated suite of translational, clinical, and computational tools supports this mission, promising to redefine neuroscience drug development.

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