Neumora Therapeutics Q1 2024 Financial Results and Business Update

Neumora Therapeutics, Inc., a clinical-stage biopharmaceutical company with a robust pipeline focusing on brain diseases, has released its financial results for the first quarter ending March 31, 2024, and provided a detailed business update. The company is methodically advancing its seven clinical and pre-clinical programs aimed at addressing neuropsychiatric and neurodegenerative disorders through novel mechanisms.

Neumora is on track to report topline Phase 3 data from its KOASTAL-1 study involving navacaprant (NMRA-140) for the treatment of Major Depressive Disorder (MDD) by the fourth quarter of 2024. Navacaprant, a selective kappa opioid receptor (KOR) antagonist, is being developed as a potential monotherapy for MDD and other neuropsychiatric conditions. The KOASTAL program includes three Phase 3 studies, KOASTAL-1, KOASTAL-2, and KOASTAL-3, designed to evaluate the efficacy and safety of navacaprant. Following the KOASTAL-1 data release in late 2024, data from KOASTAL-2 and KOASTAL-3 are expected in the first half of 2025. Further, a Phase 2 clinical trial for navacaprant in bipolar depression (BPD) is anticipated to begin in the second quarter of 2024.

Neumora is also progressing with NMRA-511, an antagonist of the vasopressin 1a receptor (V1aR), for the treatment of agitation in Alzheimer's disease. A Phase 1 study in healthy adults indicated that NMRA-511 was well-tolerated, and the company plans to initiate a Phase 1b study in Alzheimer's disease agitation during the second quarter of 2024, with data expected in 2025.

In their M4 Positive Allosteric Modulator (PAM) franchise, Neumora is advancing preclinical work across multiple compounds, including NMRA-266. Although the Phase 1 study for NMRA-266 has been paused due to a clinical hold by the FDA, Neumora is collaborating with the FDA to resolve the issue. The company expects to submit an Investigational New Drug (IND) application in 2025 for other compounds in its M4 PAM portfolio, which have shown promising preclinical efficacy and selectivity profiles.

Neumora’s financial position remains strong, with $423.0 million in cash, cash equivalents, and marketable securities as of March 31, 2024. This financial cushion is expected to support the company’s operations into 2026. The first quarter of 2024 saw research and development expenses rise to $45.8 million from $29.5 million in the same period in 2023, primarily due to the advancement of clinical and preclinical programs. General and administrative expenses also increased to $14.3 million from $9.7 million, driven by personnel-related costs and professional services.

In a strategic funding move, Neumora entered into an agreement with Parkinson’s UK, securing £2.1 million to advance NMRA-NLRP3, an NLRP3 inhibitor aimed at reducing inflammation and protecting brain cells in Parkinson’s disease. This program is currently in the preclinical stage.

Neumora reported a net loss of $53.7 million for the first quarter of 2024, compared to a net loss of $35.6 million in the same period of the previous year. Despite this, the company's financial guidance remains optimistic, underpinned by its substantial cash reserves and a focused strategy to advance its therapeutic pipeline.

Neumora Therapeutics continues to pursue its mission of addressing the global brain disease crisis by developing innovative therapies that could significantly improve treatment outcomes and quality of life for patients. With multiple clinical trials and preclinical programs underway, the company is poised to achieve several potential value-creating milestones in the coming years.