Neumora Therapeutics, Inc. (NMRA) is a clinical-stage biopharmaceutical company on a mission to revolutionize the treatment of brain diseases. With a robust pipeline of seven clinical and preclinical programs, the company is leveraging its innovative precision neuroscience approach to develop the next generation of novel therapies that have the potential to significantly improve outcomes for patients suffering from a wide range of neuropsychiatric and neurodegenerative conditions.
Business Overview Neumora was founded in November 2019 with the goal of tackling the global brain disease crisis by taking a fundamentally different approach to developing treatments for brain diseases. The company has rapidly scaled its therapeutic pipeline through strategic acquisitions and licensing deals. In September 2020, Neumora acquired BlackThorn Therapeutics, Inc., gaining access to its in-process research and development programs, including navacaprant (NMRA-140) for major depressive disorders and NMRA-511 for agitation in Alzheimer's disease. This acquisition also provided Neumora with a cloud-based computational psychiatry and data platform to support drug target identification, patient stratification, and objective clinical trial endpoints.
In September 2021, Neumora entered into two license agreements with Amgen Inc., obtaining exclusive, worldwide licenses to develop, manufacture, use, commercialize, and distribute products containing compounds directed to CK1δ and glucocerebrosidase GCase for the treatment of neurodegenerative diseases. Concurrently, the company executed a research collaboration agreement and a stock purchase agreement with Amgen. Further expanding its portfolio, in February 2022, Neumora licensed small molecule positive allosteric modulators (PAMs) predominantly of the muscarinic acetylcholine receptor subtype 4 (M4) from Vanderbilt University, with the intention of developing these PAMs for the treatment of schizophrenia and other neuropsychiatric disorders.
Neumora's most advanced product candidate, navacaprant (NMRA-140), is a novel once-daily oral kappa opioid receptor (KOR) antagonist being developed for the treatment of major depressive disorder (MDD), bipolar depression, and other neuropsychiatric disorders.
In 2023, Neumora initiated its pivotal Phase 3 KOASTAL program evaluating navacaprant monotherapy in patients with moderate to severe MDD. The KOASTAL program includes three replicate Phase 3 studies, KOASTAL-1, KOASTAL-2, and KOASTAL-3, as well as an open-label extension study, KOASTAL-LT, designed to evaluate the long-term safety of navacaprant. The company anticipates releasing topline results from the KOASTAL-1 study around the end of 2024 and topline results from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025. Each of the KOASTAL studies is targeting approximately 332 patients, with the studies powered at approximately 90%. Neumora believes that two positive studies out of the three KOASTAL trials will be needed to file for regulatory approval of navacaprant. The company also has the ability to increase the enrollment of the KOASTAL studies by up to 25% in a seamless manner, without requiring a protocol amendment.
Additionally, in May 2024, Neumora initiated a Phase 2 study for navacaprant in bipolar depression, with results expected in the second half of 2025. Beyond navacaprant, the company is also advancing NMRA-511, a vasopressin 1a receptor antagonist, in a Phase 1b signal-seeking study in people with Alzheimer's disease agitation, with data expected in the second half of 2025. Neumora is also continuing to progress its M4 franchise, with an IND for a second M4 positive allosteric modulator (PAM) expected in the first half of 2025.
Neumora's precision neuroscience approach is a key differentiator, as the company leverages public, partnered, and proprietary datasets across neuropsychiatric and neurodegenerative diseases to identify and validate biomarker-target relationships. This approach is designed to enhance the probability of success in the company's clinical trials and product development efforts.
Financials As of September 30, 2024, Neumora had $341.3 million in cash, cash equivalents, and marketable securities, which the company expects will support operations into mid-2026. This strong financial position provides Neumora with the resources to execute on its robust pipeline and achieve several clinical milestones over the next 18 months, including three Phase 3 readouts for navacaprant in MDD, data for navacaprant in bipolar depression, and data for NMRA-511 in Alzheimer's disease agitation.
For the nine months ended September 30, 2024, Neumora reported total operating expenses of $200.5 million, compared to $138.1 million for the same period in 2023. The increase was primarily driven by activities related to the Phase 3 program for navacaprant, ongoing studies across the rest of the company's portfolio, and investments to support the growth of the business.
Neumora has not generated any revenue from product sales to date, as the company's product candidates are still in various stages of clinical development. The company's net loss for the nine months ended September 30, 2024, was $185.0 million, compared to a net loss of $127.2 million for the same period in 2023.
For the most recent fiscal year (2023), Neumora reported no revenue and a net loss of $235,925,000. The company's operating cash flow (OCF) for 2023 was -$163,278,000, and its free cash flow (FCF) was -$163,395,000.
In the most recent quarter (Q3 2024), Neumora again reported no revenue and a net loss of $72,547,000. The OCF for this quarter was -$33,483,000, and the FCF was -$32,708,000. As the company is still in the clinical stage and has not yet commercialized any products, year-over-year revenue growth is not applicable.
Liquidity The company's strong cash position of $341.3 million as of September 30, 2024, provides Neumora with sufficient liquidity to fund its operations and ongoing clinical programs into mid-2026. This runway allows the company to pursue its strategic objectives and advance its pipeline without the immediate need for additional financing.
Neumora's financial ratios further illustrate its strong liquidity position. The company has a debt-to-equity ratio of 0.009, indicating a very low level of debt relative to equity. Both the current ratio and quick ratio stand at 10.98, suggesting that Neumora has ample short-term assets to cover its short-term liabilities. These ratios reflect the company's solid financial footing as it continues to invest in its clinical programs.
Risks and Challenges As a clinical-stage biopharmaceutical company, Neumora faces several risks and challenges common to the industry, including the inherent uncertainty of drug development, the need for substantial additional funding to support its operations and pipeline, and intense competition in the neuroscience field. The company's success is heavily dependent on the continued development and potential regulatory approval of its product candidates, particularly navacaprant.
Additionally, Neumora's ability to successfully commercialize any approved products will depend on a variety of factors, including the company's capacity to establish effective sales and marketing capabilities, as well as the availability of adequate coverage and reimbursement from third-party payers.
Neumora also faces the risk of intellectual property challenges, as the company's success is closely tied to its ability to obtain, maintain, and defend its patent and other intellectual property rights. The company's precision neuroscience approach, while a key competitive advantage, also increases the complexity of its operations and may expose the company to additional regulatory scrutiny and risks.
Outlook and Conclusion Neumora's robust pipeline and innovative precision neuroscience approach position the company as a leader in the development of novel treatments for brain diseases. The upcoming data readouts for navacaprant in MDD and bipolar depression, as well as for NMRA-511 in Alzheimer's disease agitation, represent significant potential catalysts for the company over the next 12-18 months.
With a strong balance sheet and a focus on disciplined capital allocation, Neumora appears well-equipped to navigate the challenges of drug development and continue advancing its mission to redefine neuroscience drug development. The company's guidance for its KOASTAL program, including the expected timeline for data readouts and the potential to increase enrollment if needed, demonstrates a clear strategic focus on advancing its lead candidate, navacaprant.
As Neumora continues to execute on its strategic priorities, it will be crucial for investors to closely monitor the company's progress, particularly the outcomes of the KOASTAL studies and the advancement of its other pipeline candidates. The success of these clinical programs, especially the pivotal Phase 3 trials for navacaprant, will be critical in determining Neumora's future trajectory and potential for bringing innovative treatments to market for patients with neuropsychiatric and neurodegenerative disorders.