NMRA 8-K
Neumora Therapeutics, Inc. (NMRA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On October 27, 2025, Neumora Therapeutics, Inc. (the “Company”) issued a press release announcing positive preclinical data for NMRA-215, a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor from three diet-induced obesity (DIO) mouse studies. In the studies, NMRA-215 demonstrated class-leading weight loss of up to 19% as a monotherapy with semaglutide-like induction and 26% in combination with high doses of semaglutide. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01 Financial Statements and Exhibits.
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99.1 |
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104 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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NEUMORA THERAPEUTICS, INC. |
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October 27, 2025 |
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/s/ Michael Milligan |
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Michael Milligan |
Exhibit 99.1
Neumora Therapeutics Announces Class-Leading Weight Loss Demonstrated with NMRA-215 in Preclinical Diet-Induced Obesity Model
NMRA-215 demonstrated class-leading weight loss of up to 19% as a monotherapy with semaglutide-like induction
NMRA-215 demonstrated best-in-class weight loss of up to 26% in combination with semaglutide
Class-leading weight loss driven by best-in-class pharmacology and brain penetration of NMRA-215
Neumora plans to initiate Phase 1 clinical study in the first quarter of 2026
WATERTOWN, Mass., October 27, 2025 – Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced positive preclinical data for NMRA-215, a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor from three diet-induced obesity (DIO) mouse studies. In the studies, NMRA-215 demonstrated class-leading weight loss of up to 19% as a monotherapy with semaglutide-like induction and 26% in combination with high doses of semaglutide.
“We are very encouraged by the results of the DIO studies with NMRA-215, which validate its potential as a class-leading, novel, brain-penetrant, oral NLRP3 inhibitor for obesity,” said Paul Berns, co-founder, chief executive officer and chairman, Neumora. “These data demonstrate NMRA-215 drives meaningful weight loss as a monotherapy in mice, including incretin-like induction, additive weight loss in the combination setting with a high dose of semaglutide, and the potential to enable incretin-sparing dosing regimens in combination with a low dose of semaglutide. These data reinforce our conviction that NMRA-215 may be an effective, next-generation, oral treatment for obesity, both as a monotherapy as well as in combination with a GLP-1 agonist. We are looking forward to moving this program into the clinic in the first quarter of 2026.”
Neumora will present additional data during its virtual R&D day on October 27, 2025 at 8:00am ET.
Webcast Information
Neumora will host a virtual R&D day at 8:00 a.m. ET on Monday, October 27, 2025. Participants can register for the live webcast here. In addition, the live webcast of the event will be available on the events and presentations section of the Company’s website at www.neumoratx.com. A replay of the webcast will be available following the completion of the event and will be archived for up to 30 days.
About NMRA-215
NMRA-215 is a potential best-in-class NLRP3 inflammasome inhibitor in development for the treatment of certain cardiometabolic and neurodegenerative conditions. The inflammasome is a critical part of the innate immune system that responds to pathogens and cellular damage and is implicated in both CNS and peripheral system disorders, including obesity. The NLRP3 inflammasome can be activated in brain microglia, a type of cell in the brain, and other cell types by a range of proteins linked to neurodegeneration, including alpha-synuclein, which suggests the inflammasome may have a mechanistic role in reducing neuroinflammation in the brain, protecting organ and vascular systems from inflammation-related damage and reducing the risk of co-morbid diseases. Neumora is also exploring the potential of a NMRA-215 inhibitor program for the treatment of Parkinson’s disease.
About Neumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the greatest medical challenges of our generation by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases.
Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s intention to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases; the timing, progress and plans for its therapeutic development programs, including the NMRA-215 studies, best-in-class pharmacology and the potential of NLRP3 inhibitors in obesity; the potential for Neumora to continue to advance NMRA-215; the potential benefits of NMRA-215; intellectual property protection and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results to be materially different from the information expressed or implied by these forward-looking statements, including, among others: the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including contract research organizations; risks related to serious or undesirable side effects of our therapeutic candidates; risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 which was filed with the SEC on August 6, 2025. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora undertakes no obligation to update or revise these forward-looking statements.
Neumora Contact:
Helen Rubinstein
617-402-5700