NMRA
Neumora TherapeuticsADocument history
Earnings documents stored for NMRA.
Investor releaseQuarter not tagged2026-08-14Neumora Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
GlobeNewswire
Neumora Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
Favorable pre-clinical data reported for NMRA-215 with plan to submit IND in fourth quarter of 2026 and initiate Phase 1 study by end of 2026 Progressing NMRA-511 in Alzheimer’s disease (AD) agitation and NMRA-898 in schizophrenia with clinical data expected in fourth quarter of 2026 and second half of 2026, respectively Joshua Pinto, Ph.D., appointed chief executive officer and member of the Board of Directors Paul L. Berns appointed Executive Chair, continuing to serve as a key strategic leader to advance Company growth $116.8 million in cash and cash equivalents expected to support operations into the third quarter of 2027 WATERTOWN, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a business update. “We delivered another quarter of disciplined execution against our strategic priorities, advancing key programs across our pipeline and positioning Neumora for a series of meaningful clinical milestones,” said Paul L. Berns, co-founder and executive chair, Neumora. “More broadly, the last 18 months have been a period of meaningful evolution for Neumora, and I’m pleased to announce Josh’s appointment as chief executive officer. Josh has contributed significantly to the organization during his tenure and has already demonstrated his ability to take on greater responsibility with his elevation to President last year. I’m incredibly proud of what our team has accomplished and confident that Josh is the right leader to guide the company through its next phase of growth. I look forward to continuing to work closely with Josh and the broader Neumora team as we advance our mission to develop transformative treatments for brain and centrally mediated diseases.” “It has been a privilege to work alongside Paul and the exceptional team at Neumora, and I’m honored to step into the role of CEO,” said Joshua Pinto, Ph.D., president and chief executive officer, Neumora. “Our programs target some of the greatest medical challenges of our generation, and our commitment to developing innovative treatments for patients is deeply personal to me and at the core of everythi…Read full documentShow less
Favorable pre-clinical data reported for NMRA-215 with plan to submit IND in fourth quarter of 2026 and initiate Phase 1 study by end of 2026 Progressing NMRA-511 in Alzheimer’s disease (AD) agitation and NMRA-898 in schizophrenia with clinical data expected in fourth quarter of 2026 and second half of 2026, respectively Joshua Pinto, Ph.D., appointed chief executive officer and member of the Board of Directors Paul L. Berns appointed Executive Chair, continuing to serve as a key strategic leader to advance Company growth $116.8 million in cash and cash equivalents expected to support operations into the third quarter of 2027 WATERTOWN, Mass., Aug. 14, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the second quarter ended June 30, 2026, and provided a business update. “We delivered another quarter of disciplined execution against our strategic priorities, advancing key programs across our pipeline and positioning Neumora for a series of meaningful clinical milestones,” said Paul L. Berns, co-founder and executive chair, Neumora. “More broadly, the last 18 months have been a period of meaningful evolution for Neumora, and I’m pleased to announce Josh’s appointment as chief executive officer. Josh has contributed significantly to the organization during his tenure and has already demonstrated his ability to take on greater responsibility with his elevation to President last year. I’m incredibly proud of what our team has accomplished and confident that Josh is the right leader to guide the company through its next phase of growth. I look forward to continuing to work closely with Josh and the broader Neumora team as we advance our mission to develop transformative treatments for brain and centrally mediated diseases.” “It has been a privilege to work alongside Paul and the exceptional team at Neumora, and I’m honored to step into the role of CEO,” said Joshua Pinto, Ph.D., president and chief executive officer, Neumora. “Our programs target some of the greatest medical challenges of our generation, and our commitment to developing innovative treatments for patients is deeply personal to me and at the core of everything we do. I look forward to working alongside our talented team to advance towards the upcoming clinical milestones across our pipeline and, ultimately, to improve the lives of the patients we aim to serve.” LEADERSHIP UPDATE Neumora today announced the appointment of Joshua Pinto, Ph.D., as president and chief executive officer and a member of the Board of Directors. Co-founder Paul L. Berns, will serve as Executive Chair. Additionally, Neumora appointed Doron Sagman, M.D., FRCPC, as the Company’s chief medical officer. Dr. Sagman brings more than 20 years of executive leadership experience in clinical development, medical affairs, regulatory strategy, and psychiatry to Neumora. KEY PIPELINE HIGHLIGHTS NMRA-215 (NLRP3 Inhibitor): Phase 1 Study Expected to Initiate by End of 2026 Neumora is developing NMRA-215 for the treatment of obesity and cardiometabolic disease. The Company expects to submit an IND in the fourth quarter of 2026 and to initiate a Phase 1 study by the end of 2026. NMRA-511 (Vasopressin 1a Receptor Antagonist): On Track to Report Data from Multiple Ascending Dose (MAD) Expansion Cohort in Alzheimer’s Disease (AD) Agitation in Fourth Quarter of 2026Neumora plans to report data from a MAD expansion cohort evaluating higher doses of NMRA-511 in healthy elderly participants in the fourth quarter of 2026 and to initiate a Phase 2 study with NMRA-511 in Alzheimer's disease agitation by the end of 2026. NMRA-898 (M4 Positive Allosteric Modulator): Phase 1 Data Expected in Second Half of 2026Neumora is conducting a MAD study with NMRA-898 in healthy volunteers and patients with stable schizophrenia and expects to report data from the study in the second half of 2026. SECOND QUARTER 2026 FINANCIAL RESULTS Cash Position: As of June 30, 2026, Neumora had cash and cash equivalents of $116.8 million. Financial Guidance: The Company expects that its cash and cash equivalents as of June 30, 2026, will enable it to fund its operating plan into the third quarter of 2027. R&D Expense: Research and development expenses for the second quarter of 2026 were $29.3 million, as compared to $38.7 million for the same period in 2025. The decrease was primarily due to a reduction in clinical trial costs, and lower personnel-related costs. G&A Expense: General and administrative expenses for the second quarter of 2026 were $12.9 million, as compared to $15.3 million for the same period in 2025. The decrease was primarily attributable to lower personnel-related costs. Net Loss: The Company reported a net loss of $43.1 million for the second quarter of 2026, as compared to $52.7 million for the same period in 2025. About NeumoraNeumora 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 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 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; the timing, progress and plans for its therapeutic development programs, including the timing of clinical trial initiation and data readouts, including for the NMRA-215, NMRA-511 and NMRA-898 studies; support for continued development, and upcoming milestones and catalysts; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; 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 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, 2026 which 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, 2026 are not necessarily indicative of our operating results for any future periods. Financial Tables Neumora Contact:Helen [email protected]
Investor releaseQuarter not tagged2026-07-27Neumora Therapeutics Reports Favorable NMRA-215 Toxicology Results with Planned Clinical Advancement in 2026
GlobeNewswire
Neumora Therapeutics Reports Favorable NMRA-215 Toxicology Results with Planned Clinical Advancement in 2026
Company plans to submit an IND in the fourth quarter of 2026 and to initiate Phase 1 study by the end of 2026 WATERTOWN, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today reported favorable pre-clinical toxicology results from NMRA-215, a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor in development for the treatment of obesity and cardiometabolic disease. Neumora conducted a repeat 13-week toxicology study in rats following results from a prior study in which unexpected in-life adverse findings were observed in 5 of 142 animals. The Company opened a for-cause audit of that study which revealed various discrepancies resulting in a number of critical audit observations. In a repeat 13-week rat toxicology study in 162 animals, no instances of unexpected in-life adverse findings were observed. Based on the audit observations, the repeat study data and the results from the previously completed 28-day rat, 28-day dog and 13-week dog toxicology studies, Neumora continues to believe the prior adverse findings were not related to NMRA-215 and plans to submit an IND application for NMRA-215 in the fourth quarter of 2026. “The differentiated properties of NMRA-215 enable it to achieve sustained IC90 coverage in the brain which has resulted in compelling pre-clinical efficacy in the diet induced obesity mouse model. NMRA-215 demonstrated class-leading weight loss as a monotherapy, including incretin-like induction, additive weight loss in the combination setting with semaglutide and potential for use as a switch or maintenance treatment. NMRA-215 also improved peripheral biomarkers related to cardiometabolic risk, which has translated to robust decreases in CV risk factors in clinical studies with other NLRP3 inhibitors,” said Nick Brandon, Ph.D., chief scientific officer, Neumora. “These data and the toxicology package to date, support advancing NMRA-215 towards the clinic. We eagerly anticipate initiating a clinical study in 2026.” About NMRA-215NMRA-215 is a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor in development for the treatment of obesity and cardiometabolic disorders. The NLRP3 inflam…Read full documentShow less
Company plans to submit an IND in the fourth quarter of 2026 and to initiate Phase 1 study by the end of 2026 WATERTOWN, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today reported favorable pre-clinical toxicology results from NMRA-215, a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor in development for the treatment of obesity and cardiometabolic disease. Neumora conducted a repeat 13-week toxicology study in rats following results from a prior study in which unexpected in-life adverse findings were observed in 5 of 142 animals. The Company opened a for-cause audit of that study which revealed various discrepancies resulting in a number of critical audit observations. In a repeat 13-week rat toxicology study in 162 animals, no instances of unexpected in-life adverse findings were observed. Based on the audit observations, the repeat study data and the results from the previously completed 28-day rat, 28-day dog and 13-week dog toxicology studies, Neumora continues to believe the prior adverse findings were not related to NMRA-215 and plans to submit an IND application for NMRA-215 in the fourth quarter of 2026. “The differentiated properties of NMRA-215 enable it to achieve sustained IC90 coverage in the brain which has resulted in compelling pre-clinical efficacy in the diet induced obesity mouse model. NMRA-215 demonstrated class-leading weight loss as a monotherapy, including incretin-like induction, additive weight loss in the combination setting with semaglutide and potential for use as a switch or maintenance treatment. NMRA-215 also improved peripheral biomarkers related to cardiometabolic risk, which has translated to robust decreases in CV risk factors in clinical studies with other NLRP3 inhibitors,” said Nick Brandon, Ph.D., chief scientific officer, Neumora. “These data and the toxicology package to date, support advancing NMRA-215 towards the clinic. We eagerly anticipate initiating a clinical study in 2026.” About NMRA-215NMRA-215 is a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor in development for the treatment of obesity and cardiometabolic disorders. The NLRP3 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. NLRP3-mediated neuroinflammation in the hypothalamus is linked to obesity, and targeting NLRP3 in the hypothalamus is hypothesized to modulate dysfunctional neuronal circuitry related to appetite, leading to decreased food intake. About NeumoraNeumora 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 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 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 mission 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; advancement towards milestones for potential best-in-class programs including NMRA-215 in obesity; the timing, progress and plans for its therapeutic development programs, including the timing of IND submission and clinical trial initiation for NMRA-215; 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 Company’s receipt and review of the histopathology report for the three-month toxicity study; comparisons to efficacy results from other sponsors should be interpreted with caution due to differences in compounds, study designs, subject characteristics, and other factors that may limit direct comparability; 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 March 31, 2026 which was filed with the SEC on May 7, 2026. 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 [email protected]
Investor releaseQuarter not tagged2026-05-07Neumora Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
GlobeNewswire
Neumora Therapeutics Reports First Quarter 2026 Financial Results and Provides Business Update
KOASTAL-2 and -3 studies evaluating navacaprant in major depressive disorder on track for joint topline readout in the second quarter of 2026 Progressing NMRA-511 in Alzheimer’s disease agitation and NMRA-898 in schizophrenia with clinical data expected for each program in the second half of 2026 Strong financial position with $147.1 million in cash and cash equivalents expected to support operations into the third quarter of 2027 WATERTOWN, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. “We focused on steady execution during the first quarter, highlighted by the full enrollment of the navacaprant KOASTAL‑2 and ‑3 studies with more than 400 patients per study. We look forward to the topline readout of these studies this quarter,” said Paul L. Berns, chairman and chief executive officer, Neumora. “Additionally, we reported the Phase 1b study with NMRA-511 demonstrating an unsurpassed clinical effect in Alzheimer’s disease agitation and we remain on track to report data from the MAD expansion cohort in the second half of 2026, with a Phase 2 study anticipated to begin in the first quarter of 2027.” “The Phase 1 study for NMRA‑898 is ongoing, with data expected in the second half of 2026, and we are advancing NMRA‑215, which is expected to enter the clinic in the first quarter of 2027, reflecting the breadth and continued momentum of our pipeline. With a strong balance sheet, we believe we are well positioned to execute on these planned milestones and to continue progressing our portfolio in a disciplined manner,” continued Mr. Berns. KEY PIPELINE HIGHLIGHTS Navacaprant (Kappa Opioid Receptor Antagonist): Joint KOASTAL-2 and -3 Readout Expected in Second Quarter of 2026 The KOASTAL-2 and -3 studies were fully enrolled in the first quarter of 2026 with more than 400 patients in each study. The Company expects a joint topline data readout for KOASTAL-2 and -3 in the second quarter of 2026, including topline data for each study as well as pre-specified analyses with more than 450 patients enrolled after study optimizations in early 2025…Read full documentShow less
KOASTAL-2 and -3 studies evaluating navacaprant in major depressive disorder on track for joint topline readout in the second quarter of 2026 Progressing NMRA-511 in Alzheimer’s disease agitation and NMRA-898 in schizophrenia with clinical data expected for each program in the second half of 2026 Strong financial position with $147.1 million in cash and cash equivalents expected to support operations into the third quarter of 2027 WATERTOWN, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the first quarter ended March 31, 2026, and provided a business update. “We focused on steady execution during the first quarter, highlighted by the full enrollment of the navacaprant KOASTAL‑2 and ‑3 studies with more than 400 patients per study. We look forward to the topline readout of these studies this quarter,” said Paul L. Berns, chairman and chief executive officer, Neumora. “Additionally, we reported the Phase 1b study with NMRA-511 demonstrating an unsurpassed clinical effect in Alzheimer’s disease agitation and we remain on track to report data from the MAD expansion cohort in the second half of 2026, with a Phase 2 study anticipated to begin in the first quarter of 2027.” “The Phase 1 study for NMRA‑898 is ongoing, with data expected in the second half of 2026, and we are advancing NMRA‑215, which is expected to enter the clinic in the first quarter of 2027, reflecting the breadth and continued momentum of our pipeline. With a strong balance sheet, we believe we are well positioned to execute on these planned milestones and to continue progressing our portfolio in a disciplined manner,” continued Mr. Berns. KEY PIPELINE HIGHLIGHTS Navacaprant (Kappa Opioid Receptor Antagonist): Joint KOASTAL-2 and -3 Readout Expected in Second Quarter of 2026 The KOASTAL-2 and -3 studies were fully enrolled in the first quarter of 2026 with more than 400 patients in each study. The Company expects a joint topline data readout for KOASTAL-2 and -3 in the second quarter of 2026, including topline data for each study as well as pre-specified analyses with more than 450 patients enrolled after study optimizations in early 2025. NMRA-511 (Vasopressin 1a Receptor Antagonist): On Track to Report Data from MAD Expansion Cohort in Alzheimer’s Disease (AD) Agitation in Second Half of 2026 In the first quarter of 2026, Neumora announced results from its Phase 1b signal-seeking study of NMRA-511 demonstrating an unsurpassed effect size and a favorable tolerability and safety profile with no reports of somnolence or sedation in people with AD agitation. Neumora plans to report data from a multiple ascending dose (MAD) expansion cohort evaluating higher doses of NMRA-511 in the second half of 2026 and to initiate a Phase 2 study with NMRA-511 in Alzheimer's disease agitation in the first quarter of 2027. NMRA-898 (M4 Positive Allosteric Modulator): Phase 1 Data Expected in Second Half of 2026 Neumora is conducting a MAD study with NMRA-898 in healthy volunteers and patients with stable schizophrenia. The goal of the study is to identify a maximum tolerated dose of NMRA-898 and confirm central nervous system penetration via cerebrospinal fluid exposure. The Company expects to report data from the study in the second half of 2026. NMRA-215 (NLRP3 Inhibitor): Preclinical Work Ongoing; Program Update Expected in the Second Half of 2026 Neumora is developing NMRA-215 for the treatment of obesity. The Company expects to provide a program update in the second half of 2026 and for the program to enter the clinic in the first quarter of 2027. FIRST QUARTER 2026 FINANCIAL RESULTS Cash Position: As of March 31, 2026, Neumora had cash and cash equivalents of $147.1 million. Financial Guidance: The Company expects that its cash and cash equivalents as of March 31, 2026, will enable it to fund its operating plan into the third quarter of 2027. R&D Expense: Research and development expenses for the first quarter of 2026 were $38.6 million, as compared to $52.2 million for the same period in 2025. The decrease was primarily due to a reduction in clinical trial costs, and lower personnel-related costs. G&A Expense: General and administrative expenses for the first quarter of 2026 were $14.3 million, as compared to $18.8 million for the same period in 2025. The decrease was primarily attributable to lower personnel-related costs. Net Loss: The Company reported a net loss of $53.5 million for the first quarter of 2026, as compared to $68.0 million for the same period in 2025. 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 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; the timing, progress and plans for its therapeutic development programs, including the timing of clinical trial initiation and data readouts, including for the KOASTAL-2 and KOASTAL-3, NMRA-215, NMRA-511 and NMRA-898 studies; support for continued development, and upcoming milestones and catalysts; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; 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: comparisons to efficacy results from other sponsors should be interpreted with caution due to differences in compounds, study designs, subject characteristics, and other factors that may limit direct comparability; 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 March 31, 2026 which 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 March 31, 2026 are also not necessarily indicative of our operating results for any future periods. Financial Tables Neumora Contact: Helen Rubinstein 617-402-5700 [email protected]
Investor releaseQuarter not tagged2026-03-31Neumora Therapeutics Inc (NMRA) Q4 2025 Earnings Call Highlights: Strong Financial Position ...
GuruFocus.com
Neumora Therapeutics Inc (NMRA) Q4 2025 Earnings Call Highlights: Strong Financial Position ...
This article first appeared on GuruFocus. Cash Position: $182.5 million in cash, cash equivalents, and marketable securities as of December 31, 2025. Cash Runway: Expected to support operations into the third quarter of 2027. Net Loss: Total net loss for 2025 was comparable to the same period in 2024. Release Date: March 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Neumora Therapeutics Inc (NASDAQ:NMRA) reported positive results from the Phase Ib study of NMRA-511, showing a clinically meaningful effect size in Alzheimer's disease agitation with a favorable safety profile. The company has fully enrolled the KOASTAL-2 and KOASTAL-3 studies for navacaprant, with data expected in the second quarter of 2026. Neumora announced promising data for NMRA-898, their lead program in the M4 PAM franchise, showing potential for development in schizophrenia. The company reported class-leading weight loss data for NMRA-215 in a 12-week diet-induced obesity study, supporting its potential in obesity treatment. Neumora has a strong financial position with $182.5 million in cash, expected to support operations into the third quarter of 2027. Unexpected adverse findings were observed in a 13-week rat toxicology study for NMRA-215, leading to a delay in clinical trials until the first quarter of 2027. The company has paused development of NMRA-861, another M4 PAM, although it remains a potential candidate for future development. There are risks and uncertainties associated with forward-looking statements, which could result in actual results differing materially. The company faces challenges in optimizing patient enrollment and ensuring data quality in ongoing clinical trials. Neumora's net loss for 2025 was comparable to 2024, indicating ongoing financial challenges despite progress in clinical development. Warning! GuruFocus has detected 2 Warning Sign with NMRA. Is NMRA fairly valued? Test your thesis with our free DCF calculator. Q: Could you clarify if one positive study and supportive evidence would be sufficient for the navacaprant filing in MDD? A: Yes, with one positive study, either KOASTAL-2 or KOASTAL-3, plus supportive data, we would be in a strong position to request a pre-NDA meeting. Supportive data could include improvements on anhedonia, a compelling safety profile, or other forms of evidence. (D…Read full documentShow less
This article first appeared on GuruFocus. Cash Position: $182.5 million in cash, cash equivalents, and marketable securities as of December 31, 2025. Cash Runway: Expected to support operations into the third quarter of 2027. Net Loss: Total net loss for 2025 was comparable to the same period in 2024. Release Date: March 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Neumora Therapeutics Inc (NASDAQ:NMRA) reported positive results from the Phase Ib study of NMRA-511, showing a clinically meaningful effect size in Alzheimer's disease agitation with a favorable safety profile. The company has fully enrolled the KOASTAL-2 and KOASTAL-3 studies for navacaprant, with data expected in the second quarter of 2026. Neumora announced promising data for NMRA-898, their lead program in the M4 PAM franchise, showing potential for development in schizophrenia. The company reported class-leading weight loss data for NMRA-215 in a 12-week diet-induced obesity study, supporting its potential in obesity treatment. Neumora has a strong financial position with $182.5 million in cash, expected to support operations into the third quarter of 2027. Unexpected adverse findings were observed in a 13-week rat toxicology study for NMRA-215, leading to a delay in clinical trials until the first quarter of 2027. The company has paused development of NMRA-861, another M4 PAM, although it remains a potential candidate for future development. There are risks and uncertainties associated with forward-looking statements, which could result in actual results differing materially. The company faces challenges in optimizing patient enrollment and ensuring data quality in ongoing clinical trials. Neumora's net loss for 2025 was comparable to 2024, indicating ongoing financial challenges despite progress in clinical development. Warning! GuruFocus has detected 2 Warning Sign with NMRA. Is NMRA fairly valued? Test your thesis with our free DCF calculator. Q: Could you clarify if one positive study and supportive evidence would be sufficient for the navacaprant filing in MDD? A: Yes, with one positive study, either KOASTAL-2 or KOASTAL-3, plus supportive data, we would be in a strong position to request a pre-NDA meeting. Supportive data could include improvements on anhedonia, a compelling safety profile, or other forms of evidence. (Daljit Aurora, Chief Operating and Development Officer) Q: Can you provide more details about the conduct issues in the NMRA-215 tox study and how they relate to the toxicity findings? A: We believe the findings are procedure-related, and we have started a repeat study with a different CRO. Such findings are common in the industry, and other sponsors have successfully repeated studies to move programs forward. (Nick Brandon, Chief Scientific Officer) Q: What led to NMRA-898 being prioritized in the M4 program, and is there still potential for NMRA-861? A: NMRA-898 was prioritized due to compelling data, including a favorable pharmacologic profile. NMRA-861 remains a viable compound for future indications, but 898 will lead in schizophrenia for now. (Joshua Pinto, Chief Financial Officer) Q: Could you elaborate on the prespecified analysis for the KOASTAL-2 and 3 readouts? A: We will provide top line data for each study and analyze the post-pause pooled population. Measures were implemented to enhance patient quality, resulting in higher screen failure rates, which gives us confidence in the data quality. (Daljit Aurora, Chief Operating and Development Officer) Q: How does the delay in the NMRA-215 program affect your capital allocation strategy? A: The delay reduces our spend on 215 this year, freeing up capital for other areas. The maintenance data from the DIO study validates our hypothesis and supports the potential for best-in-class weight loss. (Joshua Pinto, Chief Financial Officer) For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-03-31Neumora Therapeutics, Inc. Common Stock Q4 2025 Earnings Call Summary
Moby
Neumora Therapeutics, Inc. Common Stock Q4 2025 Earnings Call Summary
Management attributed 2025 progress to the implementation of clinical optimizations in the Phase III navacaprant program, specifically designed to address high placebo responses seen in earlier studies. The company prioritized NMRA-898 as the lead M4 PAM candidate for schizophrenia due to its 80-100 hour half-life, which supports a once-daily dosing profile comparable to established neuropsychiatry blockbusters. Strategic focus shifted for the NLRP3 inhibitor NMRA-215 to prioritize obesity, driven by preclinical data suggesting its potential as both a monotherapy and a maintenance 'switch' therapy from GLP-1s. Operational execution in the NMRA-511 program focused on identifying a specific patient subpopulation with elevated agitation scores to align with established regulatory precedents for Alzheimer's disease treatments. Management emphasized a 'best-in-class' pharmacology approach, targeting novel mechanisms with high brain penetrance to differentiate from existing standard-of-care therapies in CNS and metabolic diseases. The decision to pause NMRA-861 development was framed as a strategic choice to focus resources on the more compelling profile of NMRA-898 while retaining the former as a future lifecycle management option. Management expects a joint top-line data readout for the KOASTAL-2 and KOASTAL-3 Phase III MDD studies in the second quarter of 2026. The regulatory strategy for navacaprant assumes that one positive Phase III study plus supportive evidence may be sufficient for an FDA filing, pending a pre-NDA meeting. Clinical entry for the obesity candidate NMRA-215 is now delayed until the first quarter of 2027 to accommodate a repeat 13-week rat toxicology study following conduct issues at a previous site. Data from the NMRA-511 MAD extension cohort and the NMRA-898 MAD study in schizophrenia are both anticipated in the second half of 2026. Cash runway is projected to support operations into the third quarter of 2027, factoring in reduced near-term spending on the delayed NLRP3 program. A for-cause audit was initiated for a 13-week rat toxicology study of NMRA-215 due to 'unexpected adverse findings' linked to documented study conduct issues rather than drug-related toxicity. Management implemented a 'post-pause' analysis for navacaprant trials, excluding data from sites or patients that did not meet enhanced 'SAFER' screening criteria introduced…Read full documentShow less
Management attributed 2025 progress to the implementation of clinical optimizations in the Phase III navacaprant program, specifically designed to address high placebo responses seen in earlier studies. The company prioritized NMRA-898 as the lead M4 PAM candidate for schizophrenia due to its 80-100 hour half-life, which supports a once-daily dosing profile comparable to established neuropsychiatry blockbusters. Strategic focus shifted for the NLRP3 inhibitor NMRA-215 to prioritize obesity, driven by preclinical data suggesting its potential as both a monotherapy and a maintenance 'switch' therapy from GLP-1s. Operational execution in the NMRA-511 program focused on identifying a specific patient subpopulation with elevated agitation scores to align with established regulatory precedents for Alzheimer's disease treatments. Management emphasized a 'best-in-class' pharmacology approach, targeting novel mechanisms with high brain penetrance to differentiate from existing standard-of-care therapies in CNS and metabolic diseases. The decision to pause NMRA-861 development was framed as a strategic choice to focus resources on the more compelling profile of NMRA-898 while retaining the former as a future lifecycle management option. Management expects a joint top-line data readout for the KOASTAL-2 and KOASTAL-3 Phase III MDD studies in the second quarter of 2026. The regulatory strategy for navacaprant assumes that one positive Phase III study plus supportive evidence may be sufficient for an FDA filing, pending a pre-NDA meeting. Clinical entry for the obesity candidate NMRA-215 is now delayed until the first quarter of 2027 to accommodate a repeat 13-week rat toxicology study following conduct issues at a previous site. Data from the NMRA-511 MAD extension cohort and the NMRA-898 MAD study in schizophrenia are both anticipated in the second half of 2026. Cash runway is projected to support operations into the third quarter of 2027, factoring in reduced near-term spending on the delayed NLRP3 program. A for-cause audit was initiated for a 13-week rat toxicology study of NMRA-215 due to 'unexpected adverse findings' linked to documented study conduct issues rather than drug-related toxicity. Management implemented a 'post-pause' analysis for navacaprant trials, excluding data from sites or patients that did not meet enhanced 'SAFER' screening criteria introduced in early 2025. The screen failure rate in current Phase III MDD trials is approximately 10% higher than in previous studies, which management views as a positive indicator of improved patient selection quality. NMRA-511 demonstrated a Cohen's d effect size of 0.32 to 0.34 in a prespecified subpopulation, which management noted is similar in magnitude to approved treatments like Rexulti. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management believes one positive study could suffice if supported by secondary data such as anhedonia improvements (SHAPS) or a compelling safety profile in an untreated population. A pre-NDA meeting would be requested immediately following a single positive Phase III result to confirm this path. The adverse findings were not dose-dependent and occurred alongside 'documented study conduct issues' at the CRO. Management is proactively repeating the study with a different CRO and believes precedent exists for the FDA to clear an IND if the repeat study is clean. The long half-life is a key differentiator, intended to maintain steady-state levels even if patients miss a dose, which is common in schizophrenia. Early data shows heart rate changes comparable to Cobenfy, which management interprets as a positive pharmacodynamic marker of target engagement. Preclinical DIO models showed that switching from a GLP-1/NLRP3 combination to NLRP3 monotherapy maintained weight loss levels similar to continuous GLP-1 use. This suggests a potential commercial role for the drug as a maintenance therapy that allows patients to transition off incretins. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.
Investor releaseQuarter not tagged2026-03-30Neumora Therapeutics Q4 Earnings Call Highlights
MarketBeat
Neumora Therapeutics Q4 Earnings Call Highlights
Neumora expects a "catalyst-rich" 2026 with both KOASTAL-2 and KOASTAL-3 (navacaprant) fully enrolled (>400 patients each) and a joint top-line readout slated for Q2 2026; management says one positive study plus supportive data could justify a pre-NDA meeting with the FDA. NMRA-511 (vasopressin 1A antagonist) produced a clinically meaningful signal in a phase 1b study (Cohen's d ~0.32–0.34 on CMAI in NPI‑AA ≥4 patients), supporting a MAD extension with data expected H2 2026 and a planned phase II start in Q1 2027. NMRA-215 (brain-penetrant NLRP3 inhibitor for obesity) showed promising mouse efficacy but unexpected adverse findings in a 13-week rat tox study prompted a repeat study and delayed the clinic entry to Q1 2027; Neumora ended 2025 with $182.5M in cash, funding operations into Q3 2027. Interested in Neumora Therapeutics, Inc.? Here are five stocks we like better. Neumora Therapeutics (NASDAQ:NMRA) outlined clinical and pipeline updates alongside its fourth-quarter and full-year 2025 financial results, highlighting multiple anticipated data catalysts in 2026 and providing additional detail on several preclinical and clinical programs. Chief Executive Officer Paul Berns said 2025 included “important clinical progress and execution,” pointing to progress across the company’s pipeline, including NMRA-511 in Alzheimer’s disease agitation, the phase III navacaprant program in major depressive disorder (MDD), expansion of the company’s M4 positive allosteric modulator (PAM) franchise, and updated preclinical work for NMRA-215 in obesity. → Down 25%, Chinese Giant PDD Could Be a Strong Long-Term Value President Joshua Pinto said the company is entering “a catalyst-rich period with multiple clinical data readouts expected this year,” with the phase III KOASTAL navacaprant readout expected in the second quarter of 2026 and additional clinical updates anticipated later in the year for other programs. Pinto said Neumora recently reported positive results from a phase 1b “signal-seeking” study of NMRA-511, an oral vasopressin 1A receptor antagonist being developed for Alzheimer’s disease (AD) agitation. He emphasized the study showed a “clinically meaningful effect size” and favorable safety and tolerability “with no reports of somnolence or sedation.” → The Often-Missed Corner of Healthcare That Wall Street Is Loving On the call, the company highlighted new data…Read full documentShow less
Neumora expects a "catalyst-rich" 2026 with both KOASTAL-2 and KOASTAL-3 (navacaprant) fully enrolled (>400 patients each) and a joint top-line readout slated for Q2 2026; management says one positive study plus supportive data could justify a pre-NDA meeting with the FDA. NMRA-511 (vasopressin 1A antagonist) produced a clinically meaningful signal in a phase 1b study (Cohen's d ~0.32–0.34 on CMAI in NPI‑AA ≥4 patients), supporting a MAD extension with data expected H2 2026 and a planned phase II start in Q1 2027. NMRA-215 (brain-penetrant NLRP3 inhibitor for obesity) showed promising mouse efficacy but unexpected adverse findings in a 13-week rat tox study prompted a repeat study and delayed the clinic entry to Q1 2027; Neumora ended 2025 with $182.5M in cash, funding operations into Q3 2027. Interested in Neumora Therapeutics, Inc.? Here are five stocks we like better. Neumora Therapeutics (NASDAQ:NMRA) outlined clinical and pipeline updates alongside its fourth-quarter and full-year 2025 financial results, highlighting multiple anticipated data catalysts in 2026 and providing additional detail on several preclinical and clinical programs. Chief Executive Officer Paul Berns said 2025 included “important clinical progress and execution,” pointing to progress across the company’s pipeline, including NMRA-511 in Alzheimer’s disease agitation, the phase III navacaprant program in major depressive disorder (MDD), expansion of the company’s M4 positive allosteric modulator (PAM) franchise, and updated preclinical work for NMRA-215 in obesity. → Down 25%, Chinese Giant PDD Could Be a Strong Long-Term Value President Joshua Pinto said the company is entering “a catalyst-rich period with multiple clinical data readouts expected this year,” with the phase III KOASTAL navacaprant readout expected in the second quarter of 2026 and additional clinical updates anticipated later in the year for other programs. Pinto said Neumora recently reported positive results from a phase 1b “signal-seeking” study of NMRA-511, an oral vasopressin 1A receptor antagonist being developed for Alzheimer’s disease (AD) agitation. He emphasized the study showed a “clinically meaningful effect size” and favorable safety and tolerability “with no reports of somnolence or sedation.” → The Often-Missed Corner of Healthcare That Wall Street Is Loving On the call, the company highlighted new data from a pre-specified analysis in patients with a Neuropsychiatric Inventory agitation/aggression (NPI-AA) score of 4 or greater, which Pinto said aligns with enrollment criteria used in pivotal studies of Rexulti and Auvelity. Chief Operating and Development Officer Bill Aurora said this analysis included 53 patients and that NMRA-511-treated patients showed clinical benefit with a Cohen’s d effect size of 0.32 to 0.34 on the Cohen-Mansfield Agitation Inventory (CMAI) total score, “a similar magnitude to Rexulti.” Aurora also said the company observed an “unsurpassed effect size” across the CMAI Aggressive Behaviors subfactor and CGI-S agitation score in that population. Aurora said the phase 1b was not powered for statistical significance and was designed to evaluate effect size across measures to inform future development. He added that the favorable tolerability in phase 1b provides an opportunity to test higher doses. Neumora plans a multiple ascending dose (MAD) extension, with data expected in the second half of 2026, and expects to initiate a phase II study in the first quarter of 2027. → Russell 2000 Stocks: Too Early or Finally Interesting? In response to a question on effect size over time, Aurora said the effect size was “quite consistent” across timepoints. Pinto added that the new NPI-AA analysis supports a “well-established regulatory pathway” while “preserving the ability for a broad label” in AD agitation. Neumora’s phase III program for navacaprant, a kappa-opioid receptor antagonist being studied as monotherapy for MDD, has reached full enrollment. Aurora said KOASTAL-2 and KOASTAL-3 each enrolled more than 400 patients and are now fully enrolled, with a “joint top-line data readout” expected in the second quarter of 2026. Aurora said the company incorporated “key learnings” from the prior KOASTAL-1 readout, including enhanced medical monitoring to verify appropriate patients, screening tools to rule out “professional patients,” and focusing on sites with MDD trial expertise. He added that screen fail rates were approximately 10% higher than KOASTAL-1, which management characterized as supportive of improved patient selection. Management said the upcoming joint readout is expected to include: Top-line results for KOASTAL-2 Top-line results for KOASTAL-3 Pre-specified analyses including a post-optimization population of more than 450 patients enrolled after changes were implemented in early 2025 During Q&A, Aurora said Neumora believes “one positive study, either KOASTAL-2 or KOASTAL-3 plus supportive data,” would support requesting a pre-NDA meeting with the FDA. He said supportive evidence could come in “a variety of forms,” including measures such as anhedonia as measured by SHAPS and safety/tolerability in a large population. Neumora announced it has selected NMRA-898 as its lead M4 PAM program for development in schizophrenia. Aurora said NMRA-898 showed an approximately 80- to 100-hour half-life in humans in an ongoing phase I study, supporting once-daily dosing, and that exposures were dose-proportional with low variability. He also said the company observed “on-target changes in heart rate” that it views as pharmacodynamic evidence of target engagement. Aurora said Neumora is conducting a MAD study of NMRA-898 in healthy volunteers and patients with stable schizophrenia, with objectives including identifying a maximum tolerated dose and confirming CNS penetration via CSF exposure. Data are expected in the second half of 2026. Management also said development of NMRA-861 has been paused, though Pinto said it remains a “viable compound for future indications.” In the metabolic franchise, Chief Scientific Officer Nicholas Brandon reviewed new 12-week diet-induced obesity (DIO) mouse data for NMRA-215, the company’s brain-penetrant oral NLRP3 inhibitor being prioritized for obesity. Brandon said the study supports potential use in “mechanism of action switch and maintenance treatment paradigms.” He described results in which mice switched at week 8 from NMRA-215 plus semaglutide to NMRA-215 monotherapy maintained weight loss similar to semaglutide monotherapy through the full study duration. He also said NMRA-215 showed “sustained semaglutide-like weight loss” after switching from semaglutide to NMRA-215 at week 8. However, management also disclosed “unexpected adverse findings” in a small number of animals in a separate 13-week rat toxicology study. Brandon said the observations were not dose-dependent, were not associated with a known molecule-related or on-target effect, and occurred alongside “documented study conduct issues.” He said the company opened a for-cause audit and has started dosing a repeat 13-week rat toxicology study at a different CRO. Brandon said Neumora has completed 28-day rat and dog and 13-week dog toxicology studies without similar findings and with margins management believes are sufficient to achieve IC90 brain concentrations. Neumora now expects to bring NMRA-215 into the clinic in the first quarter of 2027. Pinto said the delay reduces 2026 spending on NMRA-215 and “will free up capital” for other areas. Chief Financial Officer Michael Milligan said Neumora ended 2025 with $182.5 million in cash, cash equivalents, and marketable securities, and expects its current cash position to support operations into the third quarter of 2027. Milligan also said the company’s total net loss for 2025 was comparable to 2024, and directed investors to the company’s press release for additional financial detail. Neumora Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on developing precision therapies for disorders of the central nervous system. The company applies an integrated approach that combines advanced biological insights, single-cell genomics and machine learning to accelerate the discovery and development of novel treatments for neurological and psychiatric diseases. Neumora's product pipeline spans small molecules, biologics and gene-based modalities targeting areas of high unmet need such as neurodegenerative conditions, mood and anxiety disorders, neuropathic pain and movement disorders. The article "Neumora Therapeutics Q4 Earnings Call Highlights" was originally published by MarketBeat.
Investor releaseQuarter not tagged2026-03-30Neumora Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
GlobeNewswire
Neumora Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
New data for NMRA-511 supports unsurpassed clinical effect in a pre-specified population comparable to Rexulti and Auvelity pivotal studies KOASTAL-2 and -3 fully enrolled in the first quarter of 2026; on track for topline readout in the second quarter of 2026 NMRA-898 selected as lead program in M4 franchise based on promising clinical results from ongoing Phase 1 study Strong financial position with $182.5 million in cash, cash equivalents and marketable securities expected to support operations into the third quarter of 2027 Company to host conference call today at 8:00 a.m. ET WATERTOWN, Mass., March 30, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “We saw significant progress in 2025, laying the foundation for a catalyst-rich year ahead as we advance our pipeline of next-generation therapies for people living with brain diseases,” said Paul L. Berns, co-founder, chairman and chief executive officer of Neumora. “In the first quarter of 2026, we confirmed next steps for navacaprant and our M4 franchise, as well as generated compelling results supporting the potential unsurpassed profile of NMRA-511 in Alzheimer’s disease agitation, which we built upon today with the announcement of additional data from a pre-specified analysis.” KEY PIPELINE HIGHLIGHTS NMRA-511: New Phase 1b data from pre-specified analysis further reinforce potential best-in-class profile in Alzheimer’s disease (AD) agitation Following the topline Phase 1b results announced in January 2026, Neumora today announced new data from a pre-specified analysis of the Phase 1b study in patients with a Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) score ≥4, which aligns with the enrollment criteria from other sponsors’ pivotal studies. Key findings from the pre-specified analysis include: 53 patients were included in the pre-specified analysis set of NPI-AA ≥4. In this population, patients treated with NMRA-511 demonstrated a Cohen’s d effect size of 0.34 on the Cohen-Mansfield Agitation Inventory (CMAI) total score and 0.51 on the CMAI aggression sub-fa…Read full documentShow less
New data for NMRA-511 supports unsurpassed clinical effect in a pre-specified population comparable to Rexulti and Auvelity pivotal studies KOASTAL-2 and -3 fully enrolled in the first quarter of 2026; on track for topline readout in the second quarter of 2026 NMRA-898 selected as lead program in M4 franchise based on promising clinical results from ongoing Phase 1 study Strong financial position with $182.5 million in cash, cash equivalents and marketable securities expected to support operations into the third quarter of 2027 Company to host conference call today at 8:00 a.m. ET WATERTOWN, Mass., March 30, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. “We saw significant progress in 2025, laying the foundation for a catalyst-rich year ahead as we advance our pipeline of next-generation therapies for people living with brain diseases,” said Paul L. Berns, co-founder, chairman and chief executive officer of Neumora. “In the first quarter of 2026, we confirmed next steps for navacaprant and our M4 franchise, as well as generated compelling results supporting the potential unsurpassed profile of NMRA-511 in Alzheimer’s disease agitation, which we built upon today with the announcement of additional data from a pre-specified analysis.” KEY PIPELINE HIGHLIGHTS NMRA-511: New Phase 1b data from pre-specified analysis further reinforce potential best-in-class profile in Alzheimer’s disease (AD) agitation Following the topline Phase 1b results announced in January 2026, Neumora today announced new data from a pre-specified analysis of the Phase 1b study in patients with a Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) score ≥4, which aligns with the enrollment criteria from other sponsors’ pivotal studies. Key findings from the pre-specified analysis include: 53 patients were included in the pre-specified analysis set of NPI-AA ≥4. In this population, patients treated with NMRA-511 demonstrated a Cohen’s d effect size of 0.34 on the Cohen-Mansfield Agitation Inventory (CMAI) total score and 0.51 on the CMAI aggression sub-factor score at Week 8. NMRA-511 demonstrated unsurpassed effect sizes across other endpoints in the pre-specified analysis, including Clinical Global Impression-Severity (CGI-S) agitation, and NPI-AA. NMRA-511 continued to demonstrate a favorable tolerability and safety profile consistent with what was seen in the topline analysis. Neumora plans to report data from a multiple ascending dose (MAD) expansion cohort evaluating higher doses of NMRA-511 in the second half of 2026 and to initiate a Phase 2 study with NMRA-511 in Alzheimer's disease agitation in the first quarter of 2027. Navacaprant: Joint readout of KOASTAL-2 and -3 expected in the second quarter of 2026 Neumora today announced that the KOASTAL-2 and -3 studies were fully enrolled in the first quarter of 2026, with more than 400 patients enrolled in each study. The Company expects a joint topline data readout for KOASTAL-2 and -3 in the second quarter of 2026 including topline data for each study as well as pre-specified analyses with more than 450 patients enrolled after study optimizations in early 2025. M4 Positive Allosteric Modulator (PAM) Franchise: Neumora plans to advance NMRA-898 for development in schizophrenia Neumora today announced that it has designated NMRA-898 as the lead program in its M4 franchise. The Company believes that NMRA-898 is well suited for continued development in schizophrenia based on promising clinical results from an ongoing Phase 1 study, including: NMRA-898 demonstrated an approximately 80-100-hour half-life in humans to date, confirming the potential for once-daily dosing and supporting development advantages. Exposures were dose proportional with low variability and predicted free exposures in the brain above in vitro M4 EC50 levels. Exposure-dependent increases in heart rate, of similar magnitude to those demonstrated by Cobenfy (KarXT), providing pharmacodynamic evidence of target engagement. NMRA-898 was safe and well-tolerated at all doses tested to date. Neumora is conducting a MAD study with NMRA-898 in healthy volunteers and patients with stable schizophrenia. The goal of the study is to identify a maximum tolerated dose of NMRA-898 and confirm CNS penetration via CSF exposure. The Company expects to report data from the study in the second half of 2026. NMRA-215: 12-week diet induced obesity (DIO) study provides support for potential use in switch and maintenance settings; clinical studies expected to initiate in the first quarter of 2027 Neumora today provided an update on its NMRA-215 development program in obesity, including new positive 12-week DIO data, as well as findings from a separate 13-week rat toxicology study. The new 12-week DIO study reinforces the potential of NMRA-215 for the treatment of obesity in both the mechanism of action switch and weight loss maintenance paradigms: NMRA-215 demonstrated sustained, semaglutide-like weight loss in DIO mice at 12 weeks following a mechanism-of-action switch from semaglutide monotherapy to NMRA-215 monotherapy at week 8. Following a switch from a combination of semaglutide and NMRA-215 to NMRA-215 monotherapy alone at week 8, DIO mice maintained weight loss similar to mice who received semaglutide monotherapy for the entire study duration by week 12. Neumora has successfully completed 28-day rat and dog and 13-week dog toxicology studies with NMRA-215. Each study identified a No Observed Adverse Effect Level (NOAEL) with high margins to predicted human exposures of NMRA-215 that Neumora believes will achieve sustained IC90 concentrations in the brain. Separately, in a 13-week rat toxicology study, unexpected adverse findings were observed in 5 of the 142 animals. The findings were not dose dependent and are not associated with a known on-target or molecule related effect. Neumora believes these findings may be related to a study conduct issue, and has opened a for-cause audit of the 13-week rat toxicology study. In parallel, Neumora is repeating the 13-week rat toxicology study with a different contract research organization and now expects to bring NMRA-215 into the clinic in the first quarter of 2027. The Company will provide guidance on expected data readouts from the clinical program when it is initiated. FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS Cash Position: As of December 31, 2025, Neumora had cash and cash equivalents of $182.5 million. Financial Guidance: The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2025, will enable it to fund its operating plan into the third quarter of 2027. R&D Expense: Research and development expenses for the fourth quarter of 2025 were $44.7 million, as compared to $45.9 million for the same period in 2024. Research and development expenses for the full year ended December 31, 2025 were $176.1 million, as compared to $200.9 million for the same period in 2024. This decrease was primarily due to a reduction in navacaprant program expenses following the completion of the KOASTAL-1 study, lower personnel related costs, and a reduction in expense incurred under research and collaboration agreements with Amgen, partially offset by an increase in preclinical research and manufacturing. G&A Expense: General and administrative expenses for the fourth quarter of 2025 were $13.8 million, as compared to $17.0 million for the same period in 2024. General and administrative expenses for the full year ended December 31, 2025, were $60.1 million, as compared to $62.5 million for the same period in 2024. The decrease was primarily attributable to reduced consulting and personnel-related costs. Net Loss: The Company reported a net loss of $59.4 million for the fourth quarter of 2025, as compared to $58.8 million for the same period in 2024. Neumora reported a net loss of $236.9 million for the full year ended December 31, 2025, as compared to $243.8 million for the same period in 2024. 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 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; the timing, progress and plans for its therapeutic development programs, including the timing of clinical trial initiation and data readouts, support for continued development, and upcoming milestones and catalysts; results from a pre-clinical toxicology study; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; 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: comparisons to efficacy results from other sponsors should be interpreted with caution due to differences in compounds, study designs, subject characteristics, and other factors that may limit direct comparability; 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 Annual Report on Form 10-K for the year ended, December 31, 2025 which was filed with the SEC on March 30, 2026. 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 December 31, 2025 are also not necessarily indicative of our operating results for any future periods. Financial Tables Neumora Contact: Helen Rubinstein 617-402-5700 [email protected]
TranscriptFY2025 Q42026-03-30FY2025 Q4 earnings call transcript
Earnings source - 78 paragraphs
FY2025 Q4 earnings call transcript
Ladies and gentlemen, thank you for standing by. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. Please be advised that today's conference is being recorded. I would now like to turn the call over to Helen Rubinstein, Vice President of Investor Relations and Corporate Strategy at Neumora. Please go ahead.
Good afternoon, and thank you for joining Neumora Therapeutics' Fourth Quarter and Full Year 2025 Financial Results conference call. Before we begin, I encourage everyone to visit the Investors and Media section of our website at neumoratx.com, where you can find the press release related to today's call. With me on the call today are Chief Executive Officer Paul Berns, President Josh Pinto, Chief Operating and Development Officer Bill Aurora, Chief Scientific Officer Nick Brandon, and Chief Financial Officer Mike Milligan. I'd like to point out that we will be making forward-looking statements during today's call, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. Please review the risk factors discussed in today's press release and in our SEC filings for additional detail. With that, I'll now turn the call over to Paul.
Thanks, Helen. Good morning, everyone, and thank you for joining us. 2025 marked a year of important clinical progress and execution for Neumora. We made meaningful strides in advancing our diverse pipeline of novel mechanism therapies, reported compelling data for NMRA-511, our oral, highly potent, brain-penetrant, and selective vasopressin 1A receptor antagonist, progressed our phase III program for Navacaprant with optimizations based on key learnings from prior studies, expanded our M4 PAM franchise with two new programs in clinical development, and prioritized obesity as the lead indication for our brain-penetrant NLRP3 inhibitor, NMRA-215, and reported Class-Leading DIO Data, all while continuing to strengthen our financial foundation. Our mission at Neumora remains clear, to advance the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients living with brain diseases.
We believe through our differentiated approach, centered on advancing programs with best-in-class pharmacology and brain-penetrant chemistry, targeting novel mechanisms of action, we have the potential to deliver transformative therapies to millions of patients in need of better options. Now, as we move into 2026, Neumora is well positioned to achieve multiple potentially value-creating milestones within the next 12 months. As we approach these near-term catalysts, I am confident in the strength of our science, the focus of our strategy, and the dedication of our distinguished Neumora team to deliver revolutionized therapies for patients living with brain diseases. I will now turn the call over to Josh to review our pipeline updates. Josh?
Thank you, Paul. We are poised to build on the strong momentum from 2025 as we enter a catalyst-rich period with multiple clinical data readouts expected this year. Leading with NMRA-511, our oral, highly potent, brain-penetrant, and selective antagonist of the vasopressin 1A receptor in Alzheimer's disease agitation. In January, we announced positive results from the phase I-B signal-seeking study of NMRA-511. NMRA-511 demonstrated a clinically meaningful effect size in people with Alzheimer's disease and a favorable safety and tolerability profile, with no reports of somnolence or sedation. Today, we built upon those positive findings with new data from a pre-specified analysis of the phase I-B study in patients with a neuropsychiatric inventory, agitation, aggression, or NPI-AA score of four or greater, which aligns with the enrollment criteria from the Rexulti and Auvelity pivotal studies.
These data further reinforce the potential for an unsurpassed profile of NMRA-511 in AD agitation, an area with significant unmet need for new treatments. As a next step, we are exploring higher doses of NMRA-511 in a MAD extension cohort from which we expect to report data in the second half of 2026. From there, we plan to initiate a phase II study with NMRA-511 in the first quarter of 2027. Turning to Navacaprant, our kappa-opioid receptor antagonist for the monotherapy treatment of major depressive disorder. The KOASTAL-2 and KOASTAL-3 studies are now fully enrolled with more than 400 patients enrolled in each study. We look forward to reporting data from these studies in the second quarter. Additionally, on our M4 PAM franchise, we announced today that we have selected NMRA-898 as our lead program.
We believe that NMRA-898 is well suited for continued development in schizophrenia based on promising clinical results from an ongoing phase I study. We are currently conducting a multiple ascending dose study of NMRA-898 in healthy volunteers and patients with stable schizophrenia, and we expect to report data in the second half of 2026. Turning to our metabolic franchise, we announced two key updates today regarding NMRA-215, our highly brain-penetrant oral NLRP3 inhibitor for the treatment of obesity. The first update, and a very exciting one for us, is new positive data from a 12-week diet-induced obesity or DIO mouse study that reinforces the potential of NMRA-215 for the treatment of obesity in both the mechanism of action switch and the weight loss maintenance paradigm. These encouraging results further validate what we reported previously.
Class-leading weight loss as a monotherapy, additive weight loss in combination settings, potential for an incretin-sparing and/or switch treatment paradigm, and weight loss maintenance that matches semaglutide. We are eager to advance next steps for NMRA-215. However, as we shared this morning, there were unexpected adverse findings from a separate 13-week rat tox study in a small number of animals. We have opened a for-cause audit of this study and expect to bring NMRA-215 into the clinic in the first quarter of 2027. Nick will go into more detail on both of these updates shortly. First, I will turn the call over to Bill to provide additional detail on our clinical programs. Bill?
Thank you, Josh. We are excited about the data from NMRA-511, which demonstrated a differentiated profile for the treatment of agitation in Alzheimer's disease. In January, we shared top-line results from our phase I-B signal-seeking study of NMRA-511. This was a two-part signal-seeking study that was not powered to detect statistical significance. Instead, we evaluated the effect size of NMRA-511 on a variety of clinical measures to inform additional development in AD agitation. In the phase I-B study, NMRA-511 demonstrated an unsurpassed clinical effect size on CMAI total score and a range of other endpoints in a pre-specified population with elevated anxiety at baseline. Today, we announced new data from a pre-specified analysis from the phase I-B in 53 patients with an NPI-AA score of greater than or equal to four at baseline.
This population is similar to the group studied in pivotal trials with Rexulti and Auvelity. 511 treated patients demonstrated a clinical benefit and had a Cohen's d effect size of 0.32-0.34 on CMAI total score, a similar magnitude to Rexulti. Additionally, in this population, 511 showed an unsurpassed effect size across the CMAI Aggressive Behaviors subfactor score and CGI-S agitation score. Notably, 511 demonstrated a favorable tolerability and safety profile in phase Ib, which we believe provides an opportunity for us to test higher doses. We are advancing a MAD extension study this year, with data expected in the second half of the year, before moving to a phase II study in the first quarter of 2027.
Transitioning to Navacaprant, we are pleased with the significant progress we have made with the Navacaprant KOASTAL program for the treatment of major depressive disorder. Today, we announced that KOASTAL-2 and KOASTAL-3 studies are fully enrolled with more than 400 patients enrolled in each study. We expect to report a joint top-line data readout for KOASTAL-2 and KOASTAL-3 in the second quarter of 2026. As a reminder, KOASTAL-2 and KOASTAL-3 are phase III studies being run both in the U.S. and in ex-U.S. territories. The design for these studies incorporated key learnings that we implemented in early 2025 following the KOASTAL-1 readout. This included enhanced medical monitoring to verify inclusion of appropriate patients, screening tools to rule out professional patients, and site selection that focused on sites with expertise in conducting MDD studies.
We believe that these optimizations facilitated appropriate patient enrollment in these trials. For example, we saw an approximately 10% higher screen fail rate in the KOASTAL-2 and KOASTAL-3 studies compared to KOASTAL-1. Overall, we are confident that these changes will result in a stronger dataset and look forward to the results. In the joint top-line readout, we expect to include top-line results for each individual study, as well as pre-specified analyses with more than 450 patients enrolled after study optimizations occurred in early 2025. We believe this approach will provide a comprehensive view of the data and help us better assess Navacaprant's clinical profile. We will assess next steps regarding regulatory submission once we have the data in hand, but we believe that with the FDA's recent commentary, one positive study plus supportive evidence may be sufficient for approval.
With one positive study, we would request a pre-NDA meeting with the FDA. Lastly, on our M4 positive allosteric modulator franchise, today we announced that we have designated NMRA-898 as the lead program in the franchise and plan to advance it for development in schizophrenia. This decision is supported by the encouraging data we have seen to date from our ongoing phase I study. In that study, NMRA-898 demonstrated an approximately 80-100-hour half-life in humans, which confirms the potential for once-daily dosing, and is within a similar range to the half-lives of highly successful neuropsychiatry medications like Vraylar, Abilify, and Rexulti. We also observed dose proportional exposures with low variability, as well as predicted free brain exposure significantly above the in Vitro M4 EC50 levels.
In addition, we saw on-target changes in heart rate that were similar to those demonstrated by Cobenfy, which we believe provide pharmacodynamic evidence of target engagement. Taken together, these findings strengthen our confidence in NMRA-898 and support our view that it has a potential best-in-class pharmacologic profile. We are conducting a multiple ascending dose study of 898 in healthy volunteers and patients with stable schizophrenia. The goals of this study are to identify a maximum tolerated dose and to confirm CNS penetration through CSF exposure. We expect to report data from this MAD study in the second half of 2026. While we have paused development of our other M4 PAM, NMRA-861, we believe it has a profile that could support development in the future. We are pleased to have this optionality in our portfolio.
As you can see, we are making significant progress across our clinical pipeline that I believe has the potential to translate to meaningful medicines for patients. With that, I'll now turn it over to Nick to walk through our NLRP3 update in more detail. Nick?
Thanks, Bill. I'll begin with our 12-week DIO data with our NLRP3 inhibitor, NMRA-215. As Josh noted, the results from this study further highlight our CNS penetrant pharmacology that translated to class-leading weight loss in these models. In earlier DIO studies, NMRA-215 drove dose-dependent class-leading weight loss as a monotherapy and in a combination setting with semaglutide. The 12-week DIO data we announced today provides supportive evidence for potential use of NMRA-215 in both the mechanism of action switch and maintenance treatment paradigms. DIO mice that were switched from a combination of NMRA-215 plus semaglutide to NMRA-215 monotherapy at week eight maintained weight loss similar to mice who received semaglutide monotherapy for the entire study duration.
NMRA-215 also demonstrated sustained semaglutide-like weight loss at 12 weeks following the switch from semaglutide monotherapy to NMRA-215 monotherapy at week eight. These findings, along with our previously reported data, are very encouraging and support our view that central NLRP3 inhibition may offer an important new mechanism for weight loss. Additionally, with data from multiple sponsors in the space showing reductions in hs-CRP, it's become clear that NLRP3 inhibitors offer potentially compelling cardioprotective benefits. We believe that this is a class effect, and we are likely to see hs-CRP reductions with NMRA-215 when it enters the clinic. Now, as Josh mentioned, we also shared that unexpected adverse findings were observed in a very small number of animals in a 13-week rat toxicology study. A few details to highlight.
The observations were not dose-dependent and not associated with a known molecule-related or on-target effect, but did occur in conjunction with documented study conduct issues. We have opened a for-cause audit into the study. We have also completed 28-day rat and dog and 13-week dog toxicology studies with no similar findings and sufficient margins to achieve IC90 concentrations in the brain, which we believe are needed for weight loss. We remain confident in the potential of NLRP3 inhibition for the treatment of obesity and have started dosing in a repeat 13-week rat toxicology study. We now expect to bring NMRA-215 into the clinic in the first quarter of 2027. From here, I will turn it over to Mike to review the financials. Mike?
Thanks, Nick, and good afternoon, everyone. As of December 31st, 2025, we ended the year with $182.5 million in cash equivalents, and marketable securities. We expect our current cash position to support operations into the third quarter of 2027. Additional financial results are available for review in the press release that we issued this morning, including detailed information on our fourth quarter and full year 2025 operating expenses. Our total net loss for 2025 was comparable to the same period in 2024. With that, I'll now hand the call over to Helen to manage the Q&A with the operator. Helen?
Thanks, Mike. Before I turn it over to the operator, I'll ask that you limit yourself to one question. If you have an additional question, please feel free to return to the queue. With that, I'll turn it over to the operator to handle Q&A. Operator?
Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to our first question. One moment, please. Our first question today comes from the line of Myles Minter from William Blair. Please go ahead.
Hey everyone. Congrats on the progress. I'll keep it to one. Just wanted to follow up on comments that potentially one study and supportive evidence would be sufficient for the Navacaprant filing in MDD. Did wanna confirm that just means that a positive KOASTAL-2 or KOASTAL-3 would be that one study, and then the source of supportive evidence, maybe that comes from the combined trial analysis of those more than 450 patients enrolled post-protocol amendment?
Is that coming from something like the phase II you've already got in hand or even external data like from the FAST-MAS that supports the kappa antagonist mechanism here? Thanks very much.
Good morning, Myles. This is Bill. Thank you for your question. Yes, we do believe that with one positive study, either KOASTAL-2 or KOASTAL-3 plus supportive data, we'd be in a strong position to proceed in requesting a pre-NDA meeting. Supportive data can take a variety of forms, whether that's an improvement on anhedonia as measured by SHAPS, whether it is tolerability safety profile that's quite compelling in an untreated large population. There are a variety of ways by which we believe supportive data could play an important role, but one of the two studies being positive puts us in that position to have a meeting.
Thank you. We will now go to the next question. The next question comes from the line of Brian Abrahams from RBC Capital Markets. Please go ahead.
Hey, good morning, guys. Thanks for taking my question and, congrats on the continued progress. Maybe just on 215, can you give us any color around these conduct issues that you mentioned, like what these were, why you suspect them, and how these might relate to the toxicity findings? I guess I'm curious, would the onus be on you to prove that the findings here were spurious or historically has the FDA been fine with progressing a program if a redo of a 13-week tox study comes up clean? Thanks.
Hi, Brian. It's Nick here. Because we do have an ongoing audit into the initial 13-week tox study, we can't really provide too many more details. Clearly, we have stated today that, you know, we do believe they are procedure related. We've now started a second repeat study with a different CRO and that's, you know, in that second study, we have made some changes. I think importantly, these types of findings in tox studies are very common in the industry. They're well documented in the literature. We know that other sponsors have, you know, repeated studies and have been able to, you know, move their programs forward. We're obviously looking forward to completing this second study and `progressing 215.
Thanks, Nick. Really helpful.
Thank you. Your next question today comes from the line of Douglas Tsao from H.C. Wainwright. Please go ahead.
Hi. Good morning. Thanks for taking the questions. Just on the M4 program, I'm curious if you could provide a little bit more in terms of what sort of put NMRA-898 in the lead. Also, I think, you know, Bill mentioned that you continue to see opportunity potentially for NMRA-861. I'm just curious, do you see that largely as a backup molecule right now, or do you potentially envision development in alternative indications? Thank you.
Yeah. Hey, Doug, it's Josh here. As we mentioned, we're prioritizing NMRA-898 this morning as our lead in schizophrenia. Really, you know, it's not because of anything that we saw with 861. It's because 898 looks so compelling based on the data that we've put out today, and both compounds are structurally distinct. With our focus being on schizophrenia, we're gonna progress 898 as the lead in that indication. We do view 861 as a viable compound for future indications. As we think about indication expansion in LCM within this franchise, we could look to bring another compound like 861 forward in that. For the time being, Doug, 898 is-- will be the lead for schizophrenia.
Based on the data that we've you know published today, the compound's behaving you know exceedingly well in early clinical studies.
Okay, great. Thank you.
Thank you. Your next question today, one moment, please, comes from the line of Marc Goodman from Leerink. Please go ahead.
Good morning, everyone. Thanks for taking the question. This is Alyssa. I'm for Marc. I was just wondering if you could give a little bit more details on the pre-specified analysis for the KOASTAL-2 and KOASTAL-3 readouts. What exactly are we gonna see? And, how do you imagine interpreting those results compared to kind of the entire top line analysis? Thank you.
Yeah. Hey, Alyssa, it's Josh here. In terms of the KOASTAL studies for the pre-specified analysis, you know, what you can really expect is that we will be putting out top line data for the KOASTAL-2 study, top line data for the KOASTAL-3 study, and then we will be looking at those patients that were in a post-pause pooled population, so those that have gone through the SAFER process since the KOASTAL-1 study read out. Bill, maybe you want to just add a bit more in terms of what we'll see from the pre-specified top line and what we're really going to be looking for in the KOASTAL results in the second quarter.
Sure. Thanks for the question, Alyssa. With respect to the KOASTAL-2 and KOASTAL-3 study, just as a quick reminder, when we paused those studies, we did implement a series of measures that were designed to enhance the quality of the patients coming in, and those included things such as working with MGH and implementing the SAFER process. It included implementing BCT as a screening database and paring back the number of sites overall. We're pleased with the measures that we had taken, and we've seen higher rates of screen failure as a consequence, for example, approximately 10% higher than in KOASTAL-1.
These would have otherwise been patients that would have been randomized into the study. It gives us confidence that in fact, we've done a better job in making sure that we get the quality of patients consistent with what the protocol and our expectations were. With respect to the post-pause population, we'll have an opportunity in each of the individual studies to take a look at how those patients perform, as well as taking a look at the pooled population post-pause. Those will be added measures on top of looking, of course, at the individual study results for K2 and K3.
Excellent. Thank you very much.
Thank you. We will now go to the next question, and the next question comes from the line of Paul Matteis from Stifel. Please go ahead.
Hey, thanks for taking our question and congrats on the progress. This is Julian on for Paul. Do you mind just walking us through really quickly the update that you shared with respect to the maintenance data for NMRA-215? I guess was this your expectation and you know how did you get to sort of modeling that target dose where you're showing you know an estimated 23% reduction in weight loss in the DIO model? Then really quickly, if I may, just how does the delay on the sort of tox-related issue for the program factor into your capital allocation strategy? Thanks so much.
Yeah. Thanks, Julian. You know, this is Josh here. Maybe I'll answer the second part of your question first. Obviously, you know, our spend this year for 215 will be reduced as we're not gonna be moving the program into the clinic until the first quarter of 2027. It'll free up capital as we think about allocation to other areas. In terms of the maintenance data, I think the data is exactly what we would expect, and it built on what we think was the best-in-class monotherapy and combination DIO data that we presented in October at our R&D Day. In terms of what we showed in this DIO study, it was completely focused on longer-term combination paradigms.
We demonstrated that you could switch from being on a GLP-1 to NMRA-215 and maintain the same level of weight loss, which commercially could be very important. We also looked at a paradigm where if you were on a combination of the two products and you took one off, could you maintain weight loss? We absolutely validated there that yes, if you're on a combo and you take away semaglutide, you can maintain monotherapy level weight loss with 215. In terms of how we selected the target dose, it was really around achieving IC90 concentrations in the brain, as we've highlighted previously.
Julian, as you look at what we achieved in the 12-week DIO study, the combination of semaglutide and 215 alone, highly consistent with the 28-day data we previously put out, where you saw about a, you know, 20%-25% reduction in combination therapy over the study. Julian, I would say very validating, hits exactly what we'd expect to see out of the study and exceedingly consistent with what we have shown previously for 215 in DIO studies.
Great. Thanks for the color.
Thank you. Your next question today comes from the line of Yatin Suneja from Guggenheim. Please go ahead.
Good morning, everybody. This is Thelma for Yatin. Thanks for the update. A clarification on the 215 tox study. Have you received any specific guidance from the FDA on what would be required to clear the IND? Or are you proactively rerunning the studies based on your own assessment? Thank you.
Yeah. Hey, Nick here again. Yes. We haven't discussed the studies with the FDA, but we have consulted multiple consultants and KOLs around what was the appropriate path forward. Repeating the study was clearly the clear guidance we were given. I would say based on the experience of our internal team, including myself and our consultants, you know, we're confident that this repeat study will allow us to get the FDA to approve the IND. Yeah. There's a lot of precedent for it. You know, personally, I can look back on my own prior experiences, other companies where we've done similar things. Yeah, we're confident that this repeat study would allow us to get the IND cleared.
Got it. Thank you.
Thank you. Your next question today comes from the line of Ami Fadia from Needham & Company. Please go ahead.
Hi, this is Poorna on for Ami. Thank you for taking our question. On NMRA-511, could you help us understand how the effect size changed at the different time points, week four and six, in the subpopulation? How are you envisioning the phase II study design in terms of the patient population, trial duration? Thank you.
Sure. Good morning. With respect to the effect size that we have seen in the trial overall, we're really pleased with the consistency of the results in looking at the effect size. The effect size, whether it be at week four or eight, depending on the various measures, is quite consistent, and we're pleased with what we've been seeing here. With respect to the next steps with the program, we've communicated that we'll be moving forward with another MAD cohort where we believe we've got room to push the dose given the favorable tolerability seen. Then from there, we'll describe in further detail what our plans are for phase II, including the design, inclusion criteria and the like.
Suffice it to say, the data that we put out today showing the NPIAA of four or greater is consistent with what other sponsors have used as a part of their inclusion criteria and been able to maintain a broad label. That is one where one could expect To follow the path of other sponsors and where there's a regulatory path that's been well-defined.
Yeah. Yeah, Bill, I would just add, I think the data today that we put out is really quite compelling for NMRA-511. I think it shows that in the total population, our data is consistent and just as compelling as what we've seen in patients with elevated anxiety. Bill, to your point, this new data that we've highlighted today shows that we can develop NMRA-511 down a well-established regulatory pathway while still preserving the ability for a broad label in patients with AD agitation. We actually view this data as the most compelling data set we've put out thus far for 511 and are really excited about this being the launching point of the program going forward. Got it. Thank you.
Thank you. Your next question comes from the line of Graig Suvannavejh from Mizuho. Please go ahead.
Good morning. Thank you for taking my question. I wanted to ask about NMRA-898 and the M4 PAM space. Could you just remind us how you're thinking about its differentiation versus, say, the Neurocrine program? If you could provide what you think the latest is with the Emraclidine, just as we think about the M4 PAM class, and again, vis-a-vis the broader muscarinic space and any kind of thoughts you have on the Cobenfy launch and what that means about how doctors are thinking about muscarinic in the schizophrenia landscape. Thanks.
Hey, Graig, it's Nick here. Thanks for the question on the M4. You know, in terms of the differentiation of 898 in particular compared to some of the other competitors, even including emerging companies like Neurocrine, I think, you know, I'd point to a number of key bits of data which we've put out. You know, knowing that we don't know a lot about a Neurocrine compound. 898 and 861 have a very, very potent and equipotent across assays, which is critical. Those compounds were also optimized for CNS penetration. We've put out some data around that which, you know, which is in our R&D Day. The more data comes out there, you know, really holds up.
Now critically, you know, we've got early clinical data and particularly with 898, it's really sort of showed its hands in the initial cohort. Clearly the half-life allows us for once-a-day dosing, which is critical. I might hand over to Bill in a second to talk about some of the other elements that may drive. We see really nice dose-dependent exposures. Variability is really low, and that's important. Other compounds in this class haven't had that quality. We also see really nice pharmacodynamic effects, and this is by the surrogate heart rate increases we see. Overall now the profile of 898 just looks really good as we compare to what we know about other sponsors in the field. Maybe Bill to that.
Sure, Nick. I would just simply add, Graig, that the half-life for 898 is within a similar range of half-lives of highly successful neuropsych meds like Vraylar, Abilify, and Rexulti. We conducted market research with community prescribers that also has underscored some of the potential advantages of the profile that they've seen. As an example, we know we have the ability to maintain steady state in the situations where a patient may miss a dose of the medication, which we know is a common phenomenon in schizophrenia. The half-life also has the potential to reduce withdrawal symptoms if patients discontinue medication. We're really pleased with the profile, and the excitement is certainly one that's been underscored through some of the work we've done with physicians treating schizophrenia patients in the profile they've seen with 898.
Graig, this is Joshua. I would just add, we're really compelled by the data that's been put out this morning. I think as we look at it in the SAD study, we have not hit an MTD yet, so continue to move forward. We're already seeing, you know, across the pharmacodynamic measures activity, you know, elevated from what we've seen with Emraclidine and even at levels relative to Cobenfy. If you look at what we've seen at the 15-milligram level in terms of heart rate, elevation, and beats per minute, that's comparable to what we've seen from Cobenfy at its highest doses. We feel like we, you know, are absolutely getting into a really good pharmacodynamic range, while also, you know, having a compound that is behaving very well from a safety and tolerability perspective.
Thank you.
Thank you. Our next question today is from the line of Myles Minter from William Blair. Please go ahead.
Great. Thanks for the quick follow-up. Follow-up on Graig question as well. On 898, did you also see any sort of transient increases in blood pressure in that single ascending dose study? Thanks.
The changes that we've seen in blood pressure are consistent with what we have expected. Nothing that is different from what's been seen with the class. It underscores that in the phase I-B, we plan to move forward as other muscarinics have with routine monitoring. We do anticipate as the molecule progresses in development, like other muscarinics have done, we would look to do an ambulatory blood pressure monitoring study as others have in the space.
Yeah. Just to be clear, Myles, in the single ascending dose study, we have not seen blood pressure changes thus far. We are seeing the positive, you know, changes in heart rate, as we believe the pharmacodynamic measure is as it's related to, you know, a measure of target engagement for M4 in the class. In these doses, we have not seen the elevated blood pressure yet, so we'll continue to monitor as it moves forward. To Bill's point, our assumption is that blood pressure could be a class effect. You know, we bake into our plans having to run an ambulatory blood pressure monitoring study if needed.
Thanks.
Thank you. We will now take our final question for today, and our final question comes from the line of Douglas Tsao from H.C. Wainwright. Please go ahead. Douglas, are you on mute?
Hi. Thank you. Sorry about that. I was just curious, in terms of the combination, or for NMRA-215, sorry. For the combination to NMRA-215 maintenance study. I'm just curious about the dosing that was utilized and are things that you think you might be able to do to sort of further optimize the maintaining of the weight loss that was seen when it was used in combination with semaglutide.
Yeah. Hey, Doug, this is Josh here. As I mentioned before, I think in the 12-week DIO study, it validated the hypothesis that we absolutely wanted. The combo data, I think is consistent, where we saw over 12 weeks about a 23% reduction in weight loss on the combo. That's consistent with the roughly 25%-ish we've seen in the earlier studies. As we know in these DIO studies, as you continue to feed mice high-fat diets over time, the weight does tend to rebound, whereas that's not necessarily the case in the clinic. I think as we're looking at ways to optimize the molecule, Doug, moving forward, really the next step is to get it into the clinic, start to understand how it's behaving in humans from a PK perspective, and then we can look to move it forward there.
What I would say is the data we put out today continues to validate that NMRA-215 does have a best-in-class weight loss potential, at least as it relates to the DIO data we've put out between the R&D Day and today.
If I can, Josh, just as a follow-up. I mean, obviously you've sort of outlined in these DIO models a number of different use cases. How many do you anticipate ultimately bringing forward? Or do you think that this is more of a situation where you'll just sort of validate the you know, 215's ability to drive weight loss and maintain weight loss, and then kind of leave it up to clinicians to figure out their own particular dosing regimens and sort of ways of using the molecule. Thank you.
Yeah, Doug. Our view is there's gonna be a lot of different things and paradigms that can be tested out with this molecule in combination potential. I think in terms of what you can expect from us moving forward, what you can expect from us is consistent with what we've highlighted before, which is we're going to now be moving the program into the clinic in the first quarter of 2027. Initially at weight loss, you can expect data to come out from us in a standard monotherapy as well as combination approach. We'll talk about future paradigms downstream, you know, after we validated the hypothesis of weight loss clinically.
Great. Thank you very much.
Thank you, everyone. That will conclude the Q&A portion of today's call. I will now hand the call back to Paul Berns, CEO, for closing remarks.
Okay, thank you, operator, and thanks to all who joined us for this morning's call. We appreciate your interest and support. Have a lovely day.
Thank you.
Goodbye.
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Investor releaseQuarter not tagged2026-03-16Neumora Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on Monday, March 30, 2026
GlobeNewswire
Neumora Therapeutics to Report Fourth Quarter and Full Year 2025 Financial Results on Monday, March 30, 2026
WATERTOWN, Mass., March 16, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced that it will host a conference call and live webcast at 8:00 a.m. ET on Monday, March 30, 2026, to report its fourth quarter and full year 2025 financial results and provide a business update. A 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. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. 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 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. Neumora Contact: Helen Rubinstein 617-402-5700 [email protected]
Investor releaseQuarter not tagged2026-01-05Neumora Therapeutics Announces Positive Results from NMRA-511 Phase 1b Signal-Seeking Study in Alzheimer’s Disease Agitation
GlobeNewswire
Neumora Therapeutics Announces Positive Results from NMRA-511 Phase 1b Signal-Seeking Study in Alzheimer’s Disease Agitation
NMRA-511 demonstrated a 15.7 reduction on mean CMAI total score, representing a clinically meaningful effect NMRA-511 demonstrated unsurpassed clinical effect size on CMAI total score in a pre-specified population with elevated anxiety NMRA-511 demonstrated a favorable tolerability and safety profile Neumora plans to evaluate higher doses of NMRA-511 via initiation of a multiple ascending dose expansion cohort in 2026 Company to host conference call today at 8:00 am ET WATERTOWN, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced positive results from its Phase 1b signal-seeking study of NMRA-511 in people with Alzheimer’s disease (AD) agitation. NMRA-511, an oral, highly potent, brain-penetrant and selective antagonist of the vasopressin 1a receptor (V1aR) met the goal of the Phase 1b study, demonstrating a clinically meaningful effect size in people with AD agitation. In the study, NMRA-511 demonstrated a favorable tolerability and safety profile with no reports of somnolence or sedation. “The goal of this signal-seeking study was to investigate the clinical potential of NMRA-511 in AD agitation and to identify a clinical effect size to inform further development. It has achieved that goal, demonstrating a clinically meaningful and robust effect in a broad patient population. We are encouraged by these data, which demonstrate a clear clinical effect that NMRA-511 meaningfully improves agitation symptoms among people with AD agitation, and has an unsurpassed effect size among patients with higher levels of baseline anxiety, with a favorable safety and tolerability profile” said Bill Aurora, Pharm.D., chief operating and development officer, Neumora. “Anxiety is often an underlying symptom that is present early in the AD agitation disease course, and there is an unmet need for tolerable therapies that can reduce agitation and anxiety symptoms. We look forward to advancing the program and exploring higher doses of NMRA-511. Our deepest thanks go to the patients who participated in this study, their families, the dedicated investigators and others who contributed to the important work of developing better treatments for this de…Read full documentShow less
NMRA-511 demonstrated a 15.7 reduction on mean CMAI total score, representing a clinically meaningful effect NMRA-511 demonstrated unsurpassed clinical effect size on CMAI total score in a pre-specified population with elevated anxiety NMRA-511 demonstrated a favorable tolerability and safety profile Neumora plans to evaluate higher doses of NMRA-511 via initiation of a multiple ascending dose expansion cohort in 2026 Company to host conference call today at 8:00 am ET WATERTOWN, Mass., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced positive results from its Phase 1b signal-seeking study of NMRA-511 in people with Alzheimer’s disease (AD) agitation. NMRA-511, an oral, highly potent, brain-penetrant and selective antagonist of the vasopressin 1a receptor (V1aR) met the goal of the Phase 1b study, demonstrating a clinically meaningful effect size in people with AD agitation. In the study, NMRA-511 demonstrated a favorable tolerability and safety profile with no reports of somnolence or sedation. “The goal of this signal-seeking study was to investigate the clinical potential of NMRA-511 in AD agitation and to identify a clinical effect size to inform further development. It has achieved that goal, demonstrating a clinically meaningful and robust effect in a broad patient population. We are encouraged by these data, which demonstrate a clear clinical effect that NMRA-511 meaningfully improves agitation symptoms among people with AD agitation, and has an unsurpassed effect size among patients with higher levels of baseline anxiety, with a favorable safety and tolerability profile” said Bill Aurora, Pharm.D., chief operating and development officer, Neumora. “Anxiety is often an underlying symptom that is present early in the AD agitation disease course, and there is an unmet need for tolerable therapies that can reduce agitation and anxiety symptoms. We look forward to advancing the program and exploring higher doses of NMRA-511. Our deepest thanks go to the patients who participated in this study, their families, the dedicated investigators and others who contributed to the important work of developing better treatments for this devastating condition.” “AD agitation is a common and distressing symptom in Alzheimer's dementia that can significantly impact the quality of life for both patients and caregivers. It is associated with increased morbidity and mortality and earlier placement in long-term care facilities. Existing treatment options are often limited by modest efficacy, tolerability and safety concerns, leaving vast unmet need for therapies that reduce agitation, and improve outcomes without significant adverse effects,” said Anton P. Porsteinsson, M.D., William B. and Sheila Konar Professor of Psychiatry, Neurology, Neuroscience, and Medicine; Director, Alzheimer's Disease Care, Research and Education Program (AD-CARE), University of Rochester School of Medicine and Dentistry. “The results of treatment with NMRA-511 are particularly encouraging, as they demonstrated clinically meaningful effects in agitation symptoms among people with AD agitation, and even more profound results among those with elevated anxiety – representing a significant number of treated patients. These results are particularly compelling given the favorable tolerability profile, and as they are clearly supported by the understood link between the vasopressin system and regulation of anxiety.” PHASE 1b RESULTS SUMMARY The Phase 1b study investigated NMRA-511 in healthy elderly adult participants (Part A) as well as people with agitation associated with dementia due to AD (Part B). Part A was a randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability and pharmacokinetics of NMRA-511 in eight healthy elderly participants. Part B was a multicenter, randomized, double-blind, placebo-controlled, parallel-group cohort designed to evaluate the safety, tolerability, and efficacy of NMRA-511 20 mg twice-daily (BID) in 80 people with AD agitation. The Phase 1b study was designed as a signal-seeking study to demonstrate a clinical effect and was not powered for statistical significance. Key findings from Part B of the Phase 1b study include: 71 patients were included in the efficacy analysis (the modified analysis set [MASi]). 36 patients were included in the pre-specified sub-population of patients with elevated anxiety at baseline (Rating Anxiety in Dementia score ≥12). In the MAS, patients treated with NMRA-511 demonstrated a -2.6 and -2.1 placebo-adjusted change from baseline on CMAI total score at Weeks 6 and 8 respectively, representing a Cohen’s d effect size range of 0.20 – 0.23. In the elevated anxiety population, NMRA-511 demonstrated a -7.6 and -5.6 placebo-adjusted change from baseline on CMAI total score at Weeks 6 and 8 respectively, representing a Cohen’s d effect size range of 0.51 – 0.64. NMRA-511 demonstrate a favorable tolerability and safety profile. Treatment emergent adverse events (TEAEs) were typically mild to moderate in severity, and there were low treatment discontinuations due to TEAEs (2.5%). The most common adverse effects (>5% in either treatment group) in the study were nasopharyngitis, urinary tract infection, anemia, arthralgia, diarrhea, dizziness, headache, hyponatremia, myalgia, nausea, vomiting and abdominal pain. NEXT STEPS Neumora intends to advance the development of NMRA-511. The following next steps are planned for the program: Initiate a multiple ascending dose extension study investigating higher doses of NMRA-511 in 2026. Formulation development to enable once-daily dosing via an extended-release formulation of NMRA-511 in 2026. Initiate a Phase 2/3 dose ranging study with NMRA-511. Webcast Information Neumora will host a conference call at 8:00 a.m. ET on January 5, 2026. Participants can register for the live webcast here. In addition, a replay of the conference call 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-511 NMRA-511 is a highly potent and selective, best-in-class investigational antagonist of the vasopressin 1a receptor (V1aR) that exhibited greater than 3,000-fold selectivity over the V1b and V2 receptors and approximately 300-fold selectivity over the oxytocin receptor in preclinical studies. The V1aR is known to play a role in regulation of aggression, affiliation, stress and anxiety response and several lines of evidence, and the Phase 1b data reported today, indicate that V1aR antagonists have therapeutic potential for reducing symptoms of agitation. Based on data available to date, Neumora believes NMRA-511 has the potential to be a promising novel medication for multiple neuropsychiatric disorders and neurodegenerative diseases across the spectrum of anxiety, aggression and stress. 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; NMRA-511’s potential to meaningfully improve agitation symptoms among people with AD agitation and efficacy among patients with higher levels of baseline anxiety and potential differentiation from standard of care; the therapeutic potential of V1aR antagonists for reducing symptoms of agitation; the timing, progress and plans for its therapeutic development programs, including advancement of the development of NMRA-511 ; 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: comparisons to efficacy results from other sponsors should be interpreted with caution due to differences in compounds, study designs, subject characteristics and other factors that may limit direct comparability; 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 September 30, 2025, which was filed with the SEC on November 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 [email protected] iModified Analysis Set: 2 placebo patients excluded based on rater change driving outlier data (>3 standard deviations from the mean).
Investor releaseQuarter not tagged2025-11-06Neumora Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
Neumora Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update
Announced class-leading data from diet-induced obesity (DIO) mouse model with NMRA-215, a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor, and expect to initiate Phase 1 study in first quarter of 2026 Advancing Phase 1 studies with two potentially best-in-class positive allosteric modulators (PAMs), NMRA-861 and NMRA-898, with comprehensive franchise update expected by mid-2026 On-track to report data from Phase 1b study of NMRA-511 in Alzheimer’s disease agitation around the end of the year $40 million in non-dilutive capital drawn from Neumora’s existing facility with K2 HealthVentures Strong financial position with $171.5 million in cash, cash equivalents and marketable securities expected to support operations into 2027 WATERTOWN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a business update. “Our recent progress reflects the strength of our pipeline and the differentiated approach we’re taking to address some of the most pressing medical challenges of our time,” said Paul L. Berns, chairman and chief executive officer of Neumora. “We are particularly encouraged by the compelling data we reported last week for NMRA-215, our highly brain-penetrant NLRP3 inhibitor, which demonstrated class-leading weight loss in multiple DIO mouse models. These findings support our plans to move this program into the clinic in early 2026, with human proof of concept data later that year. Additionally, the expansion of our M4 muscarinic receptor PAM franchise with the initiation of a second Phase 1 study underscores our commitment to addressing the unmet needs in schizophrenia and other neuropsychiatric disorders. With continued progress in our KOASTAL Phase 3 program for navacaprant in MDD and the upcoming data readout for NMRA-511 in Alzheimer’s disease agitation, we remain focused on executing our strategy and delivering meaningful innovation for patients.” KEY BUSINESS UPDATES Neumora today announced that it has drawn an additional $40 million from its existing venture debt facility with K2 HealthVentures. The additional $40 milli…Read full documentShow less
Announced class-leading data from diet-induced obesity (DIO) mouse model with NMRA-215, a potentially best-in-class, highly brain-penetrant, oral NLRP3 inhibitor, and expect to initiate Phase 1 study in first quarter of 2026 Advancing Phase 1 studies with two potentially best-in-class positive allosteric modulators (PAMs), NMRA-861 and NMRA-898, with comprehensive franchise update expected by mid-2026 On-track to report data from Phase 1b study of NMRA-511 in Alzheimer’s disease agitation around the end of the year $40 million in non-dilutive capital drawn from Neumora’s existing facility with K2 HealthVentures Strong financial position with $171.5 million in cash, cash equivalents and marketable securities expected to support operations into 2027 WATERTOWN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the third quarter ended September 30, 2025, and provided a business update. “Our recent progress reflects the strength of our pipeline and the differentiated approach we’re taking to address some of the most pressing medical challenges of our time,” said Paul L. Berns, chairman and chief executive officer of Neumora. “We are particularly encouraged by the compelling data we reported last week for NMRA-215, our highly brain-penetrant NLRP3 inhibitor, which demonstrated class-leading weight loss in multiple DIO mouse models. These findings support our plans to move this program into the clinic in early 2026, with human proof of concept data later that year. Additionally, the expansion of our M4 muscarinic receptor PAM franchise with the initiation of a second Phase 1 study underscores our commitment to addressing the unmet needs in schizophrenia and other neuropsychiatric disorders. With continued progress in our KOASTAL Phase 3 program for navacaprant in MDD and the upcoming data readout for NMRA-511 in Alzheimer’s disease agitation, we remain focused on executing our strategy and delivering meaningful innovation for patients.” KEY BUSINESS UPDATES Neumora today announced that it has drawn an additional $40 million from its existing venture debt facility with K2 HealthVentures. The additional $40 million in non-dilutive capital from this facility drawn, combined with the cash already on the Company’s balance sheet, further strengthens its financial position. KEY PIPELINE HIGHLIGHTS NMRA-215: Announced Class-Leading DIO Data from NLRP3 Inhibitor Program In October 2025, Neumora 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. Neumora expects to initiate a clinical program with NMRA-215 in the first quarter of 2026, with 12-week human proof of concept data expected in 2026. M4 Positive Allosteric Modulator (PAM) Franchise: Initiated Second M4 Clinical Study The company is advancing Phase 1 clinical studies for NMRA-861 and NMRA-898, its potentially best-in-class M4 muscarinic receptor positive allosteric modulators (PAMs). The Company expects to provide a comprehensive franchise update in mid-2026. NMRA-511: On Track to Report Data from Phase 1b Signal-seeking Study in Alzheimer’s Disease (AD) Agitation Around Year-End Neumora is on track to report data from a Phase 1b signal-seeking study evaluating NMRA-511 as a treatment for AD agitation around the end of 2025. Navacaprant: Enrollment Ongoing in Phase 3 KOASTAL Program; Topline Data Expected in 1H 2026 The Company is on track to report topline data with navacaprant in MDD from KOASTAL-3 in the first quarter of 2026 and KOASTAL-2 in the second quarter of 2026. THIRD QUARTER 2025 FINANCIAL RESULTS Cash Position: As of September 30, 2025, Neumora had cash, cash equivalents and marketable securities of $171.5 million. Financial Guidance: The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2025, will enable it to fund its operating plan into 2027. R&D Expense: Research and development expenses for the third quarter of 2025 were $40.5 million, as compared to $60.6 million for the same period in 2024. This decrease was primarily due to no activity under our expired research and collaboration agreements with Amgen in the current period, compared to $12.5 million in the prior period, and a reduction in clinical trial costs. G&A Expense: General and administrative expenses for the third quarter of 2025 were $12.2 million, as compared to $16.0 million for the same period in 2024. The decrease was primarily due to lower consulting and personnel related costs. Net Loss: The Company reported a net loss of $56.8 million for the third quarter of 2025, as compared to $72.5 million for the same period in 2024. 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; the timing, progress and plans for its therapeutic development programs, including the timing of clinical trial initiation and data readouts and upcoming milestones and catalysts; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; 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 September 30, 2025 which 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 September 30, 2025 are also not necessarily indicative of our operating results for any future periods. Financial Tables Neumora Contact Helen Rubinstein 617-402-5700 [email protected]
Investor releaseQuarter not tagged2025-08-07Neumora Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
Neumora Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
Initiated Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study with M4 positive allosteric modulator (PAM) NMRA-861, with data expected in the first quarter of 2026 Announces prioritization of obesity as lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with data from diet-induced obesity (DIO) mouse model expected in 2025 Entering catalyst-rich period with up to six clinical data readouts in patients over the next 18 months, including Phase 3 data for navacaprant in major depressive disorder (MDD) and Phase 1b data for NMRA-511 in Alzheimer’s disease agitation Strong financial position with $217.6 million in cash, cash equivalents and marketable securities expected to support operations into 2027 Company to host conference call today at 4:30 p.m. ET WATERTOWN, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. “Our R&D efforts have fueled multiple upcoming catalysts, with up to six clinical data readouts in patients over the next 18 months. Additionally, we have productively advanced our pre-clinical pipeline, including prioritizing obesity as the lead indication for NMRA-215, our highly brain-penetrant NLRP3 inhibitor. An increasing body of evidence supports the need for the role of centrally acting drugs to drive weight loss in obesity, and we believe our expertise in developing highly brain-penetrant chemistry will support our advancement into the field. Obesity is associated with significant negative outcomes and lower quality of life, and unmet needs remain high despite the current generation of incretin therapies. In fact, up to a third of patients are non-responders to current therapies, and do not experience clinically meaningful weight loss. Additionally, patients experience significant on-target GI adverse effects, and weight regain is common after patients stop taking these drugs. We expect to initiate clinical studies with NMRA-215 in the first quarter of 2026,” said Paul L. Berns, chairman and chief executive officer, Neumora. “We are also looking forward to the upcoming clini…Read full documentShow less
Initiated Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study with M4 positive allosteric modulator (PAM) NMRA-861, with data expected in the first quarter of 2026 Announces prioritization of obesity as lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with data from diet-induced obesity (DIO) mouse model expected in 2025 Entering catalyst-rich period with up to six clinical data readouts in patients over the next 18 months, including Phase 3 data for navacaprant in major depressive disorder (MDD) and Phase 1b data for NMRA-511 in Alzheimer’s disease agitation Strong financial position with $217.6 million in cash, cash equivalents and marketable securities expected to support operations into 2027 Company to host conference call today at 4:30 p.m. ET WATERTOWN, Mass., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. “Our R&D efforts have fueled multiple upcoming catalysts, with up to six clinical data readouts in patients over the next 18 months. Additionally, we have productively advanced our pre-clinical pipeline, including prioritizing obesity as the lead indication for NMRA-215, our highly brain-penetrant NLRP3 inhibitor. An increasing body of evidence supports the need for the role of centrally acting drugs to drive weight loss in obesity, and we believe our expertise in developing highly brain-penetrant chemistry will support our advancement into the field. Obesity is associated with significant negative outcomes and lower quality of life, and unmet needs remain high despite the current generation of incretin therapies. In fact, up to a third of patients are non-responders to current therapies, and do not experience clinically meaningful weight loss. Additionally, patients experience significant on-target GI adverse effects, and weight regain is common after patients stop taking these drugs. We expect to initiate clinical studies with NMRA-215 in the first quarter of 2026,” said Paul L. Berns, chairman and chief executive officer, Neumora. “We are also looking forward to the upcoming clinical data readouts for navacaprant and NMRA-511, and we recently initiated a Phase 1 study with NMRA-861, our M4 PAM with potential best-in-class pharmacology. We anticipate data from the NMRA-861 study in early 2026 and are excited about its potential as a therapeutic option for people with schizophrenia that addresses the need for more effective and better tolerated therapies beyond current antipsychotics and non-selective muscarinic agents.” KEY PIPELINE HIGHLIGHTS M4 Positive Allosteric Modulator (PAM) Franchise: Initiated Phase 1 Clinical Study of NMRA-861 In July 2025, Neumora announced the initiation of a Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study of NMRA-861 in healthy adult participants and adults with stable schizophrenia. NMRA-861 is a highly potent and selective M4 PAM with potential best-in-class pharmacology that Neumora plans to develop for the treatment of schizophrenia and other neuropsychiatric disorders. Neumora expects to report data from the Phase 1 SAD/MAD study in the first quarter of 2026, including safety and tolerability, and human pharmacokinetic data confirming the potential for once-daily dosing and central nervous system penetration. Additionally, the Company expects to bring another M4 PAM, NMRA-898, into the clinic in 2025. NMRA-215: Obesity Prioritized as Lead Indication for NLRP3 Inhibitor Program Neumora today announced that the Company prioritized obesity as the lead indication for NMRA-215, its potential best-in-class, highly potent and brain-penetrant NLRP3 inhibitor. NMRA-215 has demonstrated potential best-in-class brain penetration, target engagement and pharmacodynamic activity in relevant animal models. Neumora is currently conducting preclinical DIO studies to characterize the potential of NMRA-215 in obesity and expects to report data in 2025. Additionally, Neumora expects to progress NMRA-215 into the clinic in the first quarter of 2026. Navacaprant: Enrollment Ongoing in Phase 3 KOASTAL Program; Topline Data Expected in 1H 2026 The Company is on track to report topline data with navacaprant in MDD from KOASTAL-3 in the first quarter of 2026 and KOASTAL-2 in the second quarter of 2026. NMRA-511: On Track to Report Data from Phase 1b Signal-seeking Study in Alzheimer’s Disease (AD) Agitation Around the End of 2025 Neumora is on track to report data from a Phase 1b signal-seeking study evaluating NMRA-511 as a treatment for AD agitation around the end of 2025. SECOND QUARTER 2025 FINANCIAL RESULTS Cash Position: As of June 30, 2025, Neumora had cash, cash equivalents and marketable securities of $217.6 million. Financial Guidance: The Company expects that its cash, cash equivalents and marketable securities as of June 30, 2025, will enable it to fund its operating plan into 2027. R&D Expense: Research and development expenses for the second quarter of 2025 were $38.7 million, as compared to $48.6 million for the same period in 2025. This decrease was primarily due to a reduction in stock-based compensation and personnel related expense, and a reduction in clinical trial costs. G&A Expense: General and administrative expenses for the second quarter of 2025 were $15.3 million, as compared to $15.2 million for the same period in 2024. Net Loss: The Company reported a net loss of $52.7 million for the second quarter of 2025, as compared to $58.7 million for the same period in 2024. Conference Call Information Neumora will host a live conference call and webcast at 4:30 p.m. ET today to review these updates. A 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. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. 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; the timing, progress and plans for its therapeutic development programs, including the timing of clinical trial initiation and data readouts and upcoming milestones and catalysts; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash resources and expectation of the timing of its cash runway; 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 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, 2025 are also not necessarily indicative of our operating results for any future periods. Financial Tables Neumora Contact Helen Rubinstein 617-402-5700 [email protected]

