Core Insights - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases, with a pipeline that includes seven programs, three of which are in clinical stages [1][3] - The company will host a conference call and live webcast on August 6, 2025, to report its second quarter 2025 financial results and provide a business update [1][2] Company Overview - Neumora's mission is to address the global brain disease crisis by innovating the development of treatments for neuropsychiatric disorders and neurodegenerative diseases [3] - The therapeutic pipeline targets novel mechanisms of action and is supported by a suite of translational, clinical, and computational tools aimed at enabling precision medicine [3]

Core Insights - Neumora Therapeutics has initiated a Phase 1 study for NMRA-861, a positive allosteric modulator of the M4 muscarinic receptor, targeting schizophrenia and other neuropsychiatric disorders [1][2] - NMRA-861 is expected to demonstrate a favorable therapeutic profile compared to current antipsychotics, with potential for once-daily dosing and reduced side effects [2][3] - Schizophrenia affects approximately 3 million adults in the U.S., with significant unmet medical needs due to limitations of current treatments [5] Company Overview - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for brain diseases, with a pipeline of seven neuroscience programs [6] - The company has licensed intellectual property related to NMRA-861 from Vanderbilt University, with patent protection extending to 2044 [4] - Neumora aims to redefine neuroscience drug development by utilizing innovative mechanisms of action to improve treatment outcomes for patients [6] Drug Development Insights - NMRA-861 has shown robust activity in preclinical efficacy models and has been well-tolerated in toxicology studies, with no convulsions observed in multiple species [1][2] - Targeting M4 receptors is considered a promising approach for treating schizophrenia, potentially leading to better tolerability and efficacy compared to traditional antipsychotics [3][4] - The Phase 1 SAD/MAD study is expected to provide safety, tolerability, and pharmacokinetic data in early 2026 [1][2]

Company Overview - Neumora Therapeutics aims to redefine neuroscience drug development with novel therapies for brain diseases[2, 3] - The company has raised $850 million since 2021, providing a cash runway into 2027 to support growth[6, 81] - Neumora's clinical-stage pipeline targets approximately 30 million patients, with IP extending into 2041+[10] Pipeline Programs - Navacaprant (NMRA-140) is in Phase 3 development for Major Depressive Disorder (MDD), targeting 21 million U S adults[11, 16] - Topline data for KOASTAL-3 is expected in Q1 2026, and KOASTAL-2 in Q2 2026[13, 35] - NMRA-511, a V1aR antagonist, is in Phase 1b for Agitation in Alzheimer's Disease, with data expected around year-end 2025[13, 38] - The company plans to advance an M4 PAM program for Schizophrenia into the clinic by mid-2025, addressing a market of 3 million patients in the U S [13, 68] Navacaprant (KOASTAL-1) Trial Data - KOASTAL-1 enrolled 383 adult patients with MDD[92] - In the Intent-to-Treat (ITT) population, the change from baseline to Week 6 in MADRS total score was -12 5 for both Navacaprant (n=191) and Placebo (n=192) groups (p=0 993)[33, 92] - The discontinuation rate due to Treatment-Emergent Adverse Events (TEAEs) was low for both navacaprant (2 1%) and placebo (3 1%)[34] Alzheimer's Disease Agitation - Approximately 7 million U S adults currently have Alzheimer's Disease, projected to increase to 13 million by 2050[42] - Over 70% of people with Alzheimer's Disease experience agitation at some point[45]

Core Viewpoint - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by officers and directors of Neumora Therapeutics, Inc. related to misrepresentation in clinical trial data [1][2]. Group 1: Legal Investigation - Kuehn Law is looking into whether Neumora Therapeutics' insiders misrepresented or failed to disclose critical information regarding the company's Phase Three Program [2]. - The investigation centers on amendments made to BlackThorn's original Phase Two Trial inclusion criteria, which were altered to include patients with moderate to severe Major Depressive Disorder (MDD) [2]. - The Phase Two Trials reportedly lacked sufficient data, particularly concerning patient population size and gender ratio, which raises concerns about the predictive accuracy for the KOASTAL-1 study results [2]. Group 2: Shareholder Actions - Shareholders who purchased NMRA shares before September 15, 2023, are encouraged to contact Kuehn Law to discuss their rights and potential involvement in the investigation [3]. - Kuehn Law offers to cover all case costs for investor clients, emphasizing the importance of timely action for shareholders [3].

Financial Data and Key Metrics Changes - The net loss for Q1 2025 was $68 million, compared to $53.7 million for the same period in 2024 [20] - The company ended the quarter with $249.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025 [20] Business Line Data and Key Metrics Changes - The company is advancing multiple programs towards key milestones, including NMRA511 for Alzheimer's disease agitation and Avacoprant in the phase three COASTal program for major depressive disorder (MDD) [9][10] - The company expects to deliver top-line data for NMRA511 by the end of 2025 and for the COASTal studies in early to mid-2026 [9][10] Market Data and Key Metrics Changes - The company has entered into a $125 million debt facility with K2 Health Ventures, with $40 million available for draw this year, which strengthens its financial position [10][11] - The company expects its cash and the K2 facility to support operations into 2027, well beyond anticipated clinical data milestones [11] Company Strategy and Development Direction - The company aims to address the global brain disease crisis, which affects over 1.5 billion people, by advancing an industry-leading pipeline targeting novel mechanisms of action [6][7] - The company is focused on clinical execution and maintaining financial discipline to support its pipeline and achieve value-creating milestones [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of their pipeline to revolutionize the treatment of brain diseases and emphasized the importance of addressing unmet medical needs [6][7] - The management highlighted the strong intellectual property portfolio supporting their programs, with patents extending into 2040 [11] Other Important Information - The company is implementing operational changes to improve patient enrollment in clinical trials, ensuring appropriate patient selection [12][14] - The company is focused on enhancing the safety and efficacy of its treatments, particularly in the M4 PAM franchise and NMRA511 for Alzheimer's disease agitation [12][18] Q&A Session Summary Question: Impact of operational changes on enrollment pace - Management noted that operational changes have already shown benefits in identifying appropriate participants for the studies, maintaining confidence in enrollment timelines [24][27] Question: Details on K2 financing and prepayment limitations - The company clarified that the K2 facility extends their cash runway into 2027, with flexibility for additional capital drawdowns as needed [29][31] Question: Patient population tracking in COASTal program - Management confirmed that they are ensuring proper patient history assessments and do not plan for interim analyses in the ongoing studies [38][39] Question: Differentiation of Avacoprant from competitors - Management expressed confidence in Avacoprant's pharmacology and study design, believing it reflects the most appropriate approach for the mechanism [41][43] Question: Timing for increasing enrollment in COASTal studies - Management indicated flexibility in enrollment numbers for COASTal studies and will provide updates as necessary [56] Question: Comparison of MADRS baseline scores in studies - Management confirmed that the patient demographics in K2 and K3 are more representative compared to K1, with a balanced gender distribution [61]

Financial Data and Key Metrics Changes - The net loss for the first quarter of 2025 was $68 million, compared to $53.7 million for the same period in 2024 [18] - The company ended the quarter with $249.4 million in cash, cash equivalents, and marketable securities as of March 31, 2025 [18] - The company expects its cash on hand and the $20 million drawn from the K2 facility to support operations into 2027 [19] Business Line Data and Key Metrics Changes - The company is advancing multiple programs towards key milestones, including top-line data for NMRA 511 in Alzheimer's disease agitation expected by the end of the year [7] - The Avacoprant program is progressing with top-line data from COSTAL-three anticipated in Q1 2026 and COSTAL-two in Q2 2026 [7][9] - The M4 PAM franchise is set to bring a best-in-class candidate into the clinic in mid-2025 [14] Market Data and Key Metrics Changes - The company is focused on addressing the global brain disease crisis, which affects over 1.5 billion people [4] - The pipeline includes programs targeting novel mechanisms of action with potential to address prevalent brain diseases [5] Company Strategy and Development Direction - The company aims to revolutionize neuroscience drug development by advancing an industry-leading pipeline of programs [5] - Financial discipline is emphasized as a core tenet of the company's operations, with a focus on maintaining diligent stewardship of capital [8] Management's Comments on Operating Environment and Future Outlook - Management believes they have the right science, people, and strategy to achieve their vision of revolutionizing brain disease treatment [5] - The company is well-positioned to generate value from multiple programs supported by a strong financial foundation [9] Other Important Information - The company has entered into a $125 million debt facility with K2 Health Ventures, with up to $40 million available for draw this year [8] - The intellectual property portfolio supports the pipeline with worldwide rights and patents extending into 2040 [9] Q&A Session Summary Question: Impact of operational changes on enrollment pace for Avacoprant - Management noted that the operational changes have already shown benefits in identifying inappropriate participants, which helps ensure appropriate patients are randomized [21][22] Question: K2 financing details regarding prepayment limitations - Management indicated that the facility allows for flexibility in bringing more capital onto the balance sheet, with the initial $20 million sufficient to extend the cash runway into 2027 [26][28] Question: Patient population tracking for COSTAL program - Management confirmed that they are ensuring proper patient history is assessed for enrollment in K2 and K3, avoiding issues seen in COSTAL-one [33][34] Question: Differentiation of Avacoprant from competitor products - Management expressed confidence in Avacoprant's pharmacology and study design, believing it reflects the most appropriate approach for the mechanism [37][39] Question: Timing for increasing enrollment in COSTAL studies - Management stated that there is flexibility in the enrollment numbers for K2 and K3, with updates to be provided at the appropriate time [53] Question: Comparison of MADRS baseline scores in studies - Management explained that the MADRS scores in K1 are consistent with moderate to severe MDD populations, and the demographic mix in K2 and K3 is more representative historically [57][58]

PART I. FINANCIAL INFORMATION This section covers unaudited financial statements, management's discussion, market risk, and internal controls [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2025 financials report a **$68.0 million** net loss, decreased cash, and a new **$125.0 million** loan agreement [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a decrease in total assets and stockholders' equity from December 2024 to March 2025 due to net loss | Financial Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $126,860 | $142,148 | | Total current assets | $254,866 | $314,055 | | Total assets | $256,748 | $316,972 | | Total liabilities | $28,384 | $29,908 | | Total stockholders' equity | $228,364 | $287,064 | - The company's total assets and stockholders' equity decreased from December 31, 2024, to March 31, 2025, primarily driven by the net loss incurred during the quarter[18](index=18&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements of operations show a **26.6%** increase in net loss for Q1 2025, driven by higher operating expenses | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Research and development | $52,151 | $45,757 | | General and administrative | $18,785 | $14,317 | | Total operating expenses | $70,936 | $60,074 | | Loss from operations | $(70,936) | $(60,074) | | Net loss | $(67,992) | $(53,721) | | Net loss per share, basic and diluted | $(0.42) | $(0.34) | - The net loss increased by **26.6%** year-over-year, driven by higher research and development and general and administrative expenses[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements indicate increased cash usage in operations and a shift in investing activities for Q1 2025 | Cash Flow Activity | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(59,448) | $(42,955) | | Net cash provided by (used in) investing activities | $44,160 | $(150,001) | | Net cash provided by financing activities | $0 | $1,845 | | Net change in cash and cash equivalents | $(15,288) | $(191,111) | - Cash used in operating activities increased in Q1 2025 compared to Q1 2024. The significant change in investing activities reflects a shift from purchasing marketable securities in 2024 to net proceeds from maturities in 2025[24](index=24&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail liquidity, significant contingent obligations, the Amgen collaboration termination, and a new **$125.0 million** loan agreement - The company believes its existing cash, cash equivalents, and marketable securities of **$249.4 million** as of March 31, 2025, are sufficient to support operations for at least the next 12 months[28](index=28&type=chunk) - The company has significant contingent consideration obligations from its acquisitions of BlackThorn, Amgen, and Vanderbilt, which include development, regulatory, and sales-based milestones that could total over **$1.8 billion** if all are achieved[58](index=58&type=chunk)[66](index=66&type=chunk)[70](index=70&type=chunk) - The research collaboration with Amgen terminated in September 2024. A final payment of **$6.3 million** was made on May 1, 2025, and was accrued in the Q1 2025 financials[79](index=79&type=chunk)[80](index=80&type=chunk)[105](index=105&type=chunk) - Subsequent to the quarter end, on May 9, 2025, the company entered into a loan and security agreement with K2 HealthVentures for up to **$125.0 million** in term loans, available in four tranches subject to certain milestones[106](index=106&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical pipeline progress, Q1 2025 financial results, and future funding needs, with key data readouts expected in 2025-2026 - The company's lead product candidate, navacaprant, is in a pivotal Phase 3 program (KOASTAL) for Major Depressive Disorder (MDD), with topline data from KOASTAL-3 expected in **Q1 2026** and KOASTAL-2 in **Q2 2026**[114](index=114&type=chunk) - The second most advanced candidate, NMRA-511 for agitation in Alzheimer's Disease, is in a Phase 1b study, with data expected around the end of **2025**[114](index=114&type=chunk) | Metric | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $52,151 | $45,757 | $6,394 | | General and administrative | $18,785 | $14,317 | $4,468 | | Total operating expenses | $70,936 | $60,074 | $10,862 | | Net loss | $(67,992) | $(53,721) | $(14,271) | - The increase in R&D expenses was primarily due to the final **$6.3 million** of costs incurred under the Amgen Collaboration Agreement. The increase in G&A expenses was mainly attributable to higher personnel-related costs, including severance and bonus payments for key executives[133](index=133&type=chunk)[134](index=134&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk is interest rate fluctuations on its **$249.4 million** cash and marketable securities, with other risks deemed immaterial - The company's main market risk is related to interest rate changes affecting its **$249.4 million** in cash, cash equivalents, and marketable securities[159](index=159&type=chunk) - The company does not hedge against foreign currency exchange rate fluctuations, as this exposure is considered immaterial[161](index=161&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of March 31, 2025, with no material changes to internal control over financial reporting - As of March 31, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[164](index=164&type=chunk) - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[165](index=165&type=chunk) PART II. OTHER INFORMATION This section addresses legal proceedings, risk factors, equity sales, other information, and exhibits [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company faces a class action lawsuit alleging misleading IPO statements regarding navacaprant, which it intends to dismiss - On February 6, 2025, a stockholder filed a class action lawsuit against the company, certain officers, and underwriters related to the September 15, 2023 IPO[168](index=168&type=chunk) - The complaint alleges that offering documents contained false and misleading statements regarding the prospects of navacaprant. The company intends to defend itself, believing the allegations are without merit[168](index=168&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company highlights risks including its clinical-stage status, significant losses, funding needs, contingent obligations, and challenges in neuroscience drug development - The company is a clinical-stage biopharmaceutical firm with a history of significant losses (**$1,015.2 million** accumulated deficit as of March 31, 2025) and expects to incur losses for the foreseeable future[174](index=174&type=chunk)[176](index=176&type=chunk) - Substantial contingent consideration obligations from acquisitions (e.g., BlackThorn, Amgen, Vanderbilt) could result in stockholder dilution or be a drain on cash resources[174](index=174&type=chunk)[184](index=184&type=chunk) - Neuroscience drug development is an extremely difficult field with a history of limited success, and the company's approach may not lead to effective and safe products[174](index=174&type=chunk)[206](index=206&type=chunk) - The company depends on intellectual property licensed from third parties (e.g., Amgen, TSRI, Vanderbilt), and a breach or termination of these agreements could cause the loss of rights to key product candidates[180](index=180&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk) - The company relies on third-party contract manufacturing organizations (CMOs) and contract research organizations (CROs), which increases risks related to supply, quality control, and regulatory compliance[329](index=329&type=chunk)[337](index=337&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales occurred in Q1 2025, and the planned use of IPO proceeds remains materially unchanged - There were no unregistered sales of equity securities during the three months ended March 31, 2025[452](index=452&type=chunk) - The company confirms no material change in the planned use of proceeds from its September 2023 IPO[453](index=453&type=chunk) [Item 5. Other Information](index=88&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - During the quarterly period, no director or officer adopted or terminated a Rule 10b5-1 trading plan or other non-Rule 10b5-1 trading arrangement[457](index=457&type=chunk) [Item 6. Exhibits](index=89&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including required certifications and XBRL data files - The report includes required certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[458](index=458&type=chunk)

Exhibit 99.1 Company to host conference call today at 4:30 p.m. ET WATERTOWN, Mass., May 12, 2025 – Neumora Therapeutics, Inc. (Nasdaq: NMRA) a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including two clinical-stage programs, today announced financial results for the first quarter ended March 31, 2025, and provided a business update. "Our vision in building Neumora is to make a difference for people living with brain diseases. With our di ...

Core Insights - Neumora Therapeutics is advancing its clinical pipeline with multiple upcoming data readouts and has secured a $125 million venture debt facility to support its operations into 2027 [2][9][10] Pipeline Highlights - The company is on track to report topline data from NMRA-511 in Alzheimer's disease agitation by the end of 2025 [7] - Enrollment for KOASTAL-2 and KOASTAL-3 studies resumed in March 2025, with topline data expected in Q1 2026 and Q2 2026 respectively [5][6] - The M4 positive allosteric modulator (PAM) program is expected to enter clinical trials in mid-2025 [8] Financial Overview - As of March 31, 2025, Neumora had cash, cash equivalents, and marketable securities totaling $249.4 million [16] - Research and development expenses for Q1 2025 were $52.2 million, an increase from $45.8 million in Q1 2024 [16] - The company reported a net loss of $68.0 million for Q1 2025, compared to a net loss of $53.7 million for the same period in 2024 [16][18]

WATERTOWN, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven brain disease programs including two clinical-stage programs, today announced that it will host a conference call and live webcast at 4:30 p.m. ET on Monday, May 12, 2025 to report its first quarter 2025 financial results and provide a business update. A live webcast of the event will be available on the events and present ...