NEW YORK, March 4, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Neumora Therapeutics, Inc. ("Neumora Therapeutics, Inc." or the "Company") (NASDAQ: NMRA) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Neumora Therapeutics, Inc. investors who were adversely affected by alleged securities fraud. This lawsuit is on behalf of a class of all persons or entities who purchased or otherwise acquired Neumora common stock pursuant and/or tra ...

NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of common stock of Neumora Therapeutics, Inc. (NASDAQ: NMRA) pursuant and/or traceable to the registration statement and related prospectus (collectively, the “Offering Documents”) issued in connection with Neumora’s September 2023 initial public offering (the “IPO”), of the important April 7, 2025 lead plaintiff deadline in the securities class action first filed by the firm. SO WHAT: If ...

Neumora Therapeutics, Inc. (NASDAQ:NMRA) Q4 2024 Results Conference Call March 3, 2025 8:00 AM ET Company Participants Helen Rubinstein - Vice President of Investor Relations & Communications Paul Berns - Chief Executive Officer Josh Pinto - President Bill Aurora - Chief Operating & Development Officer Michael Milligan - Chief Financial Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Douglas Tsao - H.C. Wainwright Delma Caiati - Guggenheim Paul Matteis - Stifel Sam Lee - Mizuho Tes ...

Financial Data and Key Metrics Changes - Total operating expenses for Q4 2024 were $58.8 million, a decrease from $108.7 million in Q4 2023 [32] - Total operating expenses for the full year 2024 were $243.8 million, compared to $235.9 million in 2023, indicating a slight increase [32] - As of December 31, 2024, the company had $307.6 million in cash, cash equivalents, and marketable securities, expected to support operations into mid-2026 [33] Business Line Data and Key Metrics Changes - Navacaprant is in Phase 3 development for MDD, with significant changes made to optimize ongoing studies based on KOASTAL-1 learnings [11][12] - NMRA-511 is being investigated in a Phase 1b study for Alzheimer's disease agitation, targeting a significant unmet need [15][16] - The M4 franchise is expected to progress into the clinic by mid-2025, with confidence in its PAM mechanism [17][28] Market Data and Key Metrics Changes - MDD affects over 280 million people globally, representing a substantial market opportunity for navacaprant [11] - Approximately 70% of the estimated 7 million people with Alzheimer's disease experience agitation, highlighting the need for effective treatments [16] Company Strategy and Development Direction - The company aims to deliver transformative medicines for brain diseases, focusing on novel mechanisms of action and best-in-class pharmacology [7][10] - A strong financial position allows the company to advance multiple clinical and preclinical programs [8][33] - The strategy includes rigorous prioritization of resources towards the KOASTAL program and other clinical initiatives [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of navacaprant despite challenges faced in the KOASTAL-1 study, viewing the results as potentially anomalous [12][45] - The company is committed to enhancing patient selection and monitoring in upcoming studies to improve outcomes [39][65] - 2025 is anticipated to be a pivotal year for the company, with ongoing efforts to address unmet needs in brain disease treatments [19] Other Important Information - The company has a pipeline of four preclinical programs targeting various brain disorders, including Alzheimer's agitation and schizophrenia [29] - The management team emphasizes the importance of a strong balance sheet and strategic financing options to support ongoing operations [66][70] Q&A Session Summary Question: Differences between vendors for KOASTAL-1 and SAFER - The company is enhancing medical monitoring to confirm independent diagnoses for MDD, utilizing the SAFER approach for verification [38][39] Question: Enrollment status of KOASTAL-2 and 3 - Enrollment numbers are not disclosed, but studies are expected to resume for another 12 to 15 months, with changes aimed at improving outcomes [51][52] Question: Placebo response in KOASTAL-1 - An outsized placebo response was noted, particularly in males, and site experience was identified as a key factor influencing performance [46][65] Question: Cash runway and financing strategies - The company maintains a strong financial position with cash runway extending into mid-2026, exploring various funding mechanisms [66][70] Question: Interim analysis for KOASTAL studies - No interim analysis is planned for KOASTAL-2 and 3 due to the short duration of the studies [87] Question: Update on NMRA-266 clinical hold - The company is working to determine the path forward for NMRA-266 while progressing follow-on compounds in the M4 franchise [92]

Financial Performance and Obligations - The company has incurred significant losses since its inception in November 2019, with an accumulated deficit of $947.2 million as of December 31, 2024[194]. - The company has no products approved for commercial sale and has not generated any revenue from product sales, expecting to incur significant losses for the foreseeable future[194]. - The company is obligated to pay up to $365 million in contingent consideration related to the acquisition of BlackThorn Therapeutics, with milestone payments due upon specific events[199]. - The company has additional obligations of up to $720 million in commercial milestone payments to Amgen based on sales thresholds and royalties[200]. - The company anticipates that its expenses will continue to increase substantially as it expands research and development efforts and seeks regulatory approval for product candidates[195]. - The company may need to raise additional capital to finance operations, which could lead to delays or reductions in product development programs if unable to secure funding[206]. - The company has invested significantly in acquiring technologies and companies, which may affect operating results if returns on these investments are lower than expected[193]. Competition and Market Challenges - The company operates in a highly competitive industry, facing risks of competitors developing or commercializing products more successfully[193]. - The biotechnology and biopharmaceutical industries are highly competitive, with significant resources concentrated among competitors, which may impact the company's ability to market new products successfully[235]. - The company anticipates facing intense competition as new drugs and therapies emerge, necessitating continuous technological advancement to remain competitive[236]. - Limited financial and managerial resources may lead the company to focus on specific product candidates, potentially missing out on more profitable opportunities[241]. - The company faces intense competition for skilled personnel, particularly in Massachusetts and California, which may hinder its ability to attract and retain qualified employees[229]. Regulatory and Compliance Issues - The company is subject to extensive regulatory processes, which are lengthy and unpredictable, potentially delaying the commercialization of product candidates[198]. - The company must conduct well-controlled clinical trials to demonstrate the safety and efficacy of its product candidates to obtain FDA approval, which is a time-consuming and costly process[250]. - Regulatory approval processes are lengthy and unpredictable, with no prior NDA submissions made by the company[288]. - Compliance with evolving regulatory requirements, such as the CTR, may impact the company's clinical development plans and timelines[261]. - The company must adhere to various federal and state healthcare laws, including the Anti-Kickback Statute and the False Claims Act, to avoid legal repercussions[305]. - The company faces substantial costs to ensure compliance with healthcare laws and regulations, which may involve significant penalties if violations occur[306]. Clinical Development and Trials - Clinical and preclinical drug development is lengthy and expensive, with uncertain outcomes that may delay regulatory approvals and commercialization[249]. - Delays in clinical trials may arise from various factors, including patient recruitment challenges and regulatory compliance issues, which could significantly impact the timeline and costs of product development[257]. - The Phase 1 trial of NMRA-266 was placed on clinical hold by the FDA in April 2024 due to nonclinical studies showing convulsions in rabbits[253]. - The company relies on patient enrollment and retention in clinical trials, with potential delays adversely affecting research and development efforts[274]. - The company may face significant delays or inability to develop and commercialize product candidates if it does not achieve timely regulatory approvals[215]. Intellectual Property and Licensing - The company has licensed intellectual property from third parties, and any breach or termination of these agreements could harm its business[347]. - Future royalty obligations from licensed technologies may be significant, impacting the company's profitability[350]. - The company faces risks related to the enforcement and maintenance of patents and intellectual property rights, which are critical for its business[354]. - The ability to enforce patent rights is crucial, but detecting infringement can be difficult, and litigation may divert management attention and resources[369]. - The company may need to license additional technology from third parties to avoid infringement, which could lead to increased costs and development delays[361]. Data Protection and Privacy - The company faces potential liability related to the privacy of health information utilized in product development and clinical trials, with compliance costs expected to increase in the future[324]. - The company may be subject to significant penalties if it violates HIPAA regulations, which impose obligations on healthcare providers and their associates regarding the safeguarding of individually identifiable health information[325]. - The California Consumer Privacy Act (CCPA) requires businesses processing personal information of California residents to provide disclosures and respond to access requests, potentially increasing compliance costs for the company[327]. - The company is subject to rapidly evolving data protection laws in foreign jurisdictions, which could affect its ability to operate and transfer personal data internationally[330]. Strategic Partnerships and Collaborations - The company may enter into collaborations and strategic partnerships to enhance its technology exploitation, but there are risks that could delay development and commercialization plans[355]. - Significant competition exists in securing strategic partners, and the negotiation process is complex and time-consuming, potentially hindering collaboration efforts[357]. - The company may need to curtail product candidate development or increase expenditures if unable to negotiate timely collaborations, which could adversely affect its financial condition[358]. Operational Risks - The company relies on third-party manufacturers for the production of its product candidates, which increases the risk of supply disruptions and compliance issues with regulatory requirements[337]. - The company does not have long-term supply agreements with manufacturers, which could lead to delays or terminations of clinical trials if supply issues arise[338]. - The company is currently dependent on third-party manufacturers for its product candidates, which may adversely affect future profit margins and commercialization timelines[339]. - Legislative developments, such as the BIOSECURE Act, could restrict U.S. biopharmaceutical companies from collaborating with certain Chinese vendors, potentially impacting supply chains[340].

Financial Performance - Neumora reported a net loss of $58.8 million for Q4 2024, compared to a net loss of $108.7 million for the same period in 2023, indicating a 46% improvement[13]. - Neumora's total operating expenses for the full year 2024 were $263.5 million, compared to $252.1 million for 2023, marking a 5% increase[15]. - General and administrative expenses for Q4 2024 were $17.0 million, up from $11.2 million in Q4 2023, representing a 52% increase[13]. Research and Development - Research and development expenses for Q4 2024 were $45.9 million, up from $38.9 million in Q4 2023, reflecting a 18% increase[13]. - The Phase 1b study for NMRA-511 in Alzheimer's disease agitation is on track to report data by the end of 2025[7]. - Neumora plans to report topline data from the KOASTAL-3 study in Q1 2026 and from KOASTAL-2 in Q2 2026[5]. - The M4 positive allosteric modulator program is expected to enter the clinic by mid-2025[8]. Cash Position - The company had cash, cash equivalents, and marketable securities of $307.6 million as of December 31, 2024, expected to support operations into mid-2026[13]. Clinical Trials and Studies - The company has paused the KOASTAL-2 and -3 studies to optimize site selection and medical monitoring, with plans to resume in March 2025[4]. - Neumora discontinued the Phase 2 trial for navacaprant in bipolar depression to focus resources on the KOASTAL program[6].

KOASTAL-2 and -3 studies optimized based on learnings from KOASTAL-1; topline data expected from KOASTAL-3 in the first quarter of 2026 and -2 in the second quarter of 2026 Topline data from NMRA-511 in Alzheimer’s disease agitation expected by the end of 2025 Expect to progress next M4 positive allosteric modulator (PAM) program into the clinic by mid-2025 Strong financial position with $307.6 million in cash, cash equivalents and marketable securities expected to support operations into mid-2026 WATERTOWN ...

NEW YORK, March 3, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Neumora Therapeutics, Inc. (NASDAQ: NMRA).Shareholders who purchased shares of NMRA during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/neumora-therapeutics-inc-loss-submission-form/?id=132968&from=4CLASS PERIOD: T ...

Core Points - A securities class action lawsuit has been filed against Neumora Therapeutics, Inc. on behalf of investors who purchased its common stock during its initial public offering around September 15, 2023 [1] - The lead plaintiff deadline for the lawsuit is set for April 7, 2025 [1] Allegations Against Defendants - The complaint alleges that Neumora made materially false and misleading statements in its Offering Documents, including the need to amend Phase Two Trial inclusion criteria to justify its Phase Three Program [2] - It is claimed that Neumora added a prespecified analysis to the Phase Two statistical analysis plan focusing on patients with moderate to severe major depressive disorder [2] - The Phase Two Trials reportedly lacked adequate data regarding patient population size and gender ratio, which could affect the predictability of the KOASTAL-1 study results [2] Lead Plaintiff Process - Investors in Neumora can seek to be appointed as a lead plaintiff representative of the class by April 7, 2025, or may choose to remain absent [3] - The lead plaintiff acts on behalf of all class members and selects counsel to represent the class [3] - Participation as a lead plaintiff does not affect the ability to share in any recovery from the lawsuit [3] Firm Information - Kessler Topaz Meltzer & Check, LLP is known for prosecuting class actions and has recovered billions for victims of corporate misconduct [4] - The firm encourages Neumora investors who have suffered losses to contact them for more information [4]

Core Viewpoint - Neumora Therapeutics, Inc. is facing a class action securities lawsuit due to alleged securities fraud affecting investors who purchased its common stock since September 15, 2023 [1][2]. Class Definition - The lawsuit aims to recover losses for all individuals or entities that acquired Neumora common stock based on the Offering Documents [2]. Case Details - The complaint alleges that Neumora made false statements and concealed critical information regarding its Phase Three Program and Phase Two Trials, including: 1. Amendments to the original Phase Two trial inclusion criteria to include patients with moderate to severe Major Depressive Disorder (MDD) to demonstrate the efficacy of Navacaprant [3]. 2. Addition of a prespecified analysis in the Phase Two statistical analysis plan focusing on moderate to severe MDD patients [3]. 3. Insufficient data in the Phase Two Trials, particularly regarding patient population size and gender ratio, which undermined the ability to predict outcomes of the KOASTAL-1 study [3]. Next Steps - Investors who suffered losses during the relevant timeframe have until April 7, 2025, to request appointment as lead plaintiff, although participation does not require this role [4]. No Cost to Participants - Class members may be entitled to compensation without any out-of-pocket costs or fees, and there is no obligation to participate [4]. Why Levi & Korsinsky - The firm has a strong track record in securities litigation, having secured hundreds of millions for shareholders and consistently ranking among the top securities litigation firms in the U.S. [5].