NMRA Neumora Therapeutics Inc

Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, today announced that the Company will host a roundtable discussion on the neuropsychiatric treatment landscape and role of kappa opioid receptor antagonists (KORAs) in neuropsychiatry. The discussion will feature leading experts in neuropsychiatry and will take place on Thursday, September 12 at 8:00 a.m. ET.

“We look forward to an engaging discussion with our panel of distinguished medical experts and to providing an overview of the potential for navacaprant to make a difference for patients,” said Henry Gosebruch, chief executive officer, Neumora. “It is clear that there is significant excitement among the scientific community regarding the potential of KORAs across many neuropsychiatric indications. We share their enthusiasm and are pleased to be executing the comprehensive Phase 3 KOASTAL program with navacaprant in MDD in the monotherapy setting and a Phase 2 study in bipolar depression. We believe navacaprant has the potential to reshape the treatment of these serious brain disorders. We look forward to reporting topline data from our first Phase 3 study, KOASTAL-1, in the fourth quarter.”

The program agenda will feature the following topics and speakers:

• Global Brain Disease: Neumora’s Mission and Pipeline
  • Josh Pinto, Ph.D., Chief Financial Officer

• The Role of Kappa Opioid Receptors in MDD and Overview of Navacaprant Phase 2 Data
  • Bill Aurora, Pharm.D., Chief Strategy Officer

• Indication Opportunities for Navacaprant: MDD, BPD, and Beyond
  • Rob Lenz, M.D., Ph.D., Head of Research and Development

• Fireside Chat: A Discussion on the Neuropsychiatric Treatment Landscape and Opportunity for Navacaprant
  • Roger McIntyre, M.D., University of Toronto
  • Sanjay Mathew, M.D., Baylor College of Medicine
  • John Krystal, M.D., Yale University School of Medicine

• Company Outlook: A Look Ahead
  • Henry Gosebruch, Chief Executive Officer

Webcast InformationThe event will begin at 8:00 a.m. ET on Thursday, September 12, 2024. 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 webcasts will be available following the completion of the event and will be archived for up to 30 days.

About Navacaprant Clinical Development ProgramNavacaprant (NMRA-140) is a highly selective, novel, once-daily kappa opioid receptor (KOR) antagonist being developed as a potential monotherapy treatment for major depressive disorder (MDD) and other neuropsychiatric disorders. The KOR antagonist approach has been clinically validated in three independent studies.

Neumora is currently enrolling the registrational Phase 3 KOASTAL program, which is designed to evaluate the efficacy and safety of navacaprant monotherapy for the treatment of MDD. KOASTAL-1, KOASTAL-2, and KOASTAL-3 are replicate Phase 3, randomized, placebo-controlled, double-blind studies in adult patients with MDD. Neumora is also evaluating the potential of navacaprant for the treatment of bipolar depression (BPD) in a Phase 2 study initiated in May 2024.

Neumora expect to report data from KOASTAL-1 study in the fourth quarter of 2024, topline data from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025 and topline data from the Phase 2 BPD study in the second half of 2025.

About NeumoraNeumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. 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 suffering from brain diseases.

Cautionary Note Regarding Forward-Looking StatementsThis 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; Neumora’s goal to make navacaprant available for MDD patients; the timing, progress and plans for its therapeutic development programs, including the timing of patient enrollment, initiation and data read outs for its programs and studies, as well as its clinical trial and development plans 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 or 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 CROs; 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, 2024 that was filed with the SEC on or about the date hereof. 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. Our results for the quarter ended June 30, 2024 are also not necessarily indicative of our operating results for any future periods.

Neumora Contact:Helen Rubinstein315-382-3979Helen.Rubinstein@neumoratx.com