Financial Data and Key Metrics Changes - Total operating expenses for Q4 2024 were $58.8 million, down from $108.7 million in Q4 2023, while full-year operating expenses increased slightly to $243.8 million from $235.9 million in 2023 [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 - The company is advancing navacaprant, currently in Phase 3 development for MDD, and has made changes to optimize ongoing studies based on learnings from the KOASTAL-1 study [11][12] - NMRA-511 is being investigated in a Phase 1b study for Alzheimer's disease agitation, with top-line data expected by the end of 2025 [15][17] Market Data and Key Metrics Changes - Approximately 70% of the estimated 7 million people living with Alzheimer's disease experience agitation, indicating a significant unmet need in this market [16] Company Strategy and Development Direction - The company aims to deliver transformative medicines for brain diseases, focusing on a pipeline of seven programs targeting novel mechanisms of action [7] - The strategy for the KOASTAL program includes enhancing patient monitoring and site selection to improve study outcomes [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of navacaprant despite previous study results, citing a strong pipeline and a commitment to addressing unmet needs in brain disease treatment [19][31] - The company is focused on disciplined capital allocation to leverage its strong balance sheet for future catalysts across its programs [32] Other Important Information - The company has discontinued the Phase 2 trial for navacaprant in bipolar depression to prioritize resources for the KOASTAL program [14] - The company is advancing four preclinical programs targeting various brain disorders, including Alzheimer's agitation and schizophrenia [29] Q&A Session Summary Question: Differences between KOASTAL-1 vendor and SAFER - The company is enhancing medical monitoring to confirm patient diagnoses and is partnering with Mass General Hospital's SAFER for independent reviews [37][39] Question: Enrollment status of KOASTAL-2 and 3 - The company is not disclosing specific enrollment numbers but is optimistic about the changes made to improve outcomes in these studies [51] Question: Placebo response in KOASTAL-1 - The company identified that site experience significantly impacted performance, particularly in male patients, and is focusing on site selection for future studies [46][48] Question: Cash runway and financing strategies - The company maintains a strong financial position and is exploring various funding mechanisms to support operations [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].

Core Viewpoint - Neumora Therapeutics, Inc. is facing a securities class action lawsuit related to its September 2023 IPO, with a lead plaintiff deadline set for April 7, 2025 [1][3]. Group 1: Class Action Details - Investors who purchased Neumora common stock may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties can join by contacting the Rosen Law Firm [3][6]. - The lawsuit alleges that the Offering Documents contained false or misleading statements regarding the Phase Two Trials and their implications for the Phase Three Program [5]. Group 2: Legal Representation - The Rosen Law Firm emphasizes the importance of selecting qualified legal counsel with a proven track record in securities class actions [4]. - The firm has a history of significant recoveries for investors, including over $438 million in 2019 alone [4]. - Investors are advised that until a class is certified, they are not represented unless they retain counsel [7].

Core Viewpoint - Neumora Therapeutics, Inc. is facing a class action lawsuit due to allegations of issuing misleading statements regarding its clinical trials and the efficacy of its flagship therapeutic candidate, Navacaprant [2][3]. Group 1: Allegations - The lawsuit claims that Neumora amended the original Phase Two trial inclusion criteria to include patients with moderate to severe Major Depressive Disorder (MDD) to justify its Phase Three Program [2]. - It is alleged that the company added a prespecified analysis to the Phase Two statistical analysis plan, focusing on patients suffering from moderate to severe MDD [2]. - The complaint also states that the Phase Two Trials lacked adequate data, particularly concerning the patient population size and gender ratio, which could affect the predictability of the KOASTAL-1 study results [2]. Group 2: Class Action Details - The class period for the lawsuit commenced on or about September 15, 2023, and shareholders who purchased shares during this time are encouraged to register [1][3]. - The deadline for shareholders to seek lead plaintiff status is April 7, 2025, and there is no cost or obligation to participate in the case [3]. - Registered shareholders will be enrolled in a portfolio monitoring software to receive updates throughout the lifecycle of the case [3]. Group 3: Law Firm Information - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting the rights of investors affected by deceit and fraud [4]. - The firm aims to ensure that companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements or omissions [4].

Core Points - A class action has been filed against Neumora Therapeutics, Inc. on behalf of investors who purchased shares during the IPO on September 15, 2023 [1] - The allegations claim that Neumora misled investors regarding the prospects of its flagship candidate, Navacaprant, for treating major depressive disorder (MDD) [2][3] - Following the announcement of disappointing results from the KOASTAL-1 study on January 2, 2025, Neumora's stock price plummeted from $17 to $1.91, representing an 88.7% decline [3] Allegations - The Offering Documents allegedly failed to disclose critical information about Navacaprant's Phase Two Trial, including amendments to inclusion criteria and inadequate data regarding patient demographics [2] - The complaint highlights that the Phase Two Trials did not provide sufficient data to predict the outcomes of the subsequent KOASTAL-1 study [2] Stock Performance - Neumora's common stock has seen a significant decline since the IPO, dropping from an initial price of $17 per share to $1.91 per share by February 5, 2025 [3] Legal Proceedings - Shareholders interested in participating as lead plaintiffs in the class action must file by April 7, 2025 [4] - The representation in the class action is on a contingency fee basis, meaning shareholders incur no fees or expenses [5]