8-K
Neumora Therapeutics, Inc. (NMRA)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 5, 2026
NEUMORA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41802 | 84-4367680 |
|---|---|---|
| (State or other jurisdiction<br> <br>of incorporation) | (Commission<br> <br>File Number) | (IRS Employer<br> <br>Identification Number) |
| 260 Arsenal Way, Suite 1<br> <br>Watertown, Massachusetts | 02472 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
(857) 760-0900
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange<br>on which registered |
|---|---|---|
| Common Stock, $0.0001 par value per share | NMRA | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01 | Other Events. |
|---|
On January 5, 2026, Neumora Therapeutics, Inc. (the “Company”) issued press releases announcing positive results from its Phase 1b signal-seeking study of NMRA-511 in people with Alzheimer’s disease (AD) agitation and key pipeline updates and anticipated 2026 milestones. Copies of the press releases are filed as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated by reference herein.
| Item 9.01 | Financial Statements and Exhibits. |
|---|
(d) Exhibits
| Exhibit<br>No. | Description |
|---|---|
| 99.1 | Press release (NMRA-511 Phase 1b Study) dated January 5, 2026 |
| 99.2 | Press release (Pipeline Updates and Anticipated Milestones) dated January 5, 2026 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NEUMORA THERAPEUTICS, INC. | ||
|---|---|---|
| Date: January 5, 2026 | By: | /s/ Michael Milligan |
| Michael Milligan | ||
| Chief Financial Officer |
EX-99.1
Exhibit 99.1
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 clinicallymeaningful effect
NMRA-511 demonstrated unsurpassed clinical effect size on CMAI totalscore 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 doseexpansion cohort in 2026
Company to host conference call today at 8:00 am ET
WATERTOWN, Mass., January 5, 2026 – 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.”
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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 [MAS^i^]). |
|---|---|
| • | 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.<br> |
| --- | --- |
| • | 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.<br> |
| --- | --- |
| • | NMRA-511 demonstrate a favorable tolerability and safety profile.<br>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<br>tract infection, anemia, arthralgia, diarrhea, dizziness, headache, hyponatremia, myalgia, nausea, vomiting and abdominal pain. |
| --- | --- |
NEXTSTEPS
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<br>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.<br> |
| --- | --- |
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.
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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 improvedtreatment 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 ofbaseline 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 ofthe 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 areforward-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 bematerially 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 therapeuticcandidates; 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 thatcould 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 theSecurities 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
Helen.Rubinstein@neumoratx.com
| ^i^ | Modified Analysis Set: 2 placebo patients excluded based on rater change driving outlier data (>3 standard<br>deviations from the mean). |
|---|
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EX-99.2
Exhibit 99.2
Neumora Therapeutics Highlights 2026 Pipeline Strategy and
Anticipated Upcoming Milestones
Multiple clinical data readouts expected in 2026 present opportunity for substantial value creation
KOASTAL-2 and -3 on track for consolidated topline readoutin the second quarter of 2026
Plans to conduct NMRA-215 clinical program in 2026 followingclass-leading preclinical data from diet induced obesity model
Advancing NMRA-511 followingPhase 1b results demonstrating clinically meaningful effect on CMAI total score
Cash, cash equivalents and marketable securitiesexpected to support operations into the third quarter of 2027
WATERTOWN, Mass., January 5, 2026 – NeumoraTherapeutics, 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 key pipeline updates and anticipated 2026 milestones that support the Company’s mission to redefine neuroscience drug development with the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients living with brain diseases.
“2025 was a productive and strategically important year for Neumora, as we advanced our pipeline of novel mechanism therapies, prioritized obesity as the lead indication for our highly brain-penetrant NLRP3 inhibitor, NMRA-215, expanded our M4 PAM franchise with two new programs in clinical development, progressed the Phase 3 program for navacaprant, and produced compelling data for NMRA-511 – all while continuing to strengthen our financial foundation,” said Paul L. Berns, co-founder, chairman and chief executive officer of Neumora. “This progress set up important expected milestones across our programs. We are entering a catalyst-rich period that I believe will meaningfully shape the future of Neumora, as well as the future of treatment for several underserved disease areas. Supported by a strong team, we are well-positioned to execute on our goal to advance a next generation of therapies for people living with brain diseases.”
2026 PIPELINE STRATEGY
Navacaprant: Planned joint readout of KOASTAL-2 and -3 in second quarterof 2026
Neumora today announced that it plans to increase enrollment in each of the KOASTAL studies, targeting up to 25 percent enrollment beyond the original target of 332, as the study protocols permit. The Company expects a joint topline data readout for both KOASTAL-2 and KOASTAL-3 in the second quarter of 2026 and believes this approach optimizes assessment of navacaprant efficacy in major depressive disorder in the KOASTAL program.
NMRA-215: Plans to initiate Phase 1 clinical program following class-leading preclinical data
Neumora expects to initiate a clinical program evaluating NMRA-215 monotherapy and combination therapy for the treatment of obesity in the first half of 2026. The Company expects to report weight loss data following treatment with NMRA-215 around the end of 2026.
M4 Positive Allosteric Modulator (PAM) Franchise: Progressing Phase 1clinical studies for NMRA-898 and NMRA-861
Neumora expects to provide a comprehensive M4 franchise update in mid-2026, including potentially advancing development of one or both programs.
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NMRA-511: Reported positive results from Phase 1b study inAlzheimer’s disease (AD) agitation
In January 2026, 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.
KEY BUSINESS UPDATES
The Company is in a strong financial position and expects its cash, cash equivalents and marketable securities to support operations into the third quarter of 2027.
AboutNeumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.
Cautionary Note Regarding Forward-Looking 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 improvedtreatment outcomes and quality of life for patients suffering from brain diseases; the timing, progress and plans for its therapeutic development programs, including the NMRA-511, NMRA-215 and M4 programs, the KOASTAL-2 and KOASTAL-3 studies, 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 thanstatements 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 statementsare 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 inherentuncertainty 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 affectsufficiency 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 toNeumora’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, Neumoraundertakes no obligation to update or revise these forward-looking statements.
Neumora Contact
Helen Rubinstein
617-402-5700
Helen.Rubinstein@neumoratx.com
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