Neumora Therapeutics(NMRA) - 2025 Q2 - Quarterly Report

PART I. FINANCIAL INFORMATION This section presents Neumora Therapeutics' unaudited condensed consolidated financial statements and management's discussion and analysis. Item 1. Financial Statements (Unaudited) This section presents Neumora Therapeutics' unaudited condensed consolidated financial statements, including balance sheets, income statements, equity, and cash flows, with accompanying notes. Condensed Consolidated Balance Sheets (June 30, 2025 vs. December 31, 2024) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | | Total Current Assets | $222,909 | $314,055 | $(91,146) | | Total Assets | $223,825 | $316,972 | $(93,147) | | Total Current Liabilities | $21,156 | $29,886 | $(8,730) | | Total Liabilities | $40,946 | $29,908 | $11,038 | | Total Stockholders' Equity | $182,879 | $287,064 | $(104,185) | Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :------------------ | :------------------ | :-------------------- | | Research and development | $38,724 | $48,628 | $(9,904) | | General and administrative | $15,316 | $15,194 | $122 | | Total operating expenses | $54,040 | $63,822 | $(9,782) | | Net loss | $(52,731) | $(58,700) | $5,969 | | Net loss per share, basic and diluted | $(0.33) | $(0.37) | $0.04 | Condensed Consolidated Statements of Operations and Comprehensive Loss (Six Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :------------------ | :------------------ | :-------------------- | | Research and development | $90,875 | $94,385 | $(3,510) | | General and administrative | $34,101 | $29,511 | $4,590 | | Total operating expenses | $124,976 | $123,896 | $1,080 | | Net loss | $(120,723) | $(112,421) | $(8,302) | | Net loss per share, basic and diluted | $(0.75) | $(0.71) | $(0.04) | Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :------------------ | :------------------ | :-------------------- | | Net cash used in operating activities | $(111,852) | $(99,113) | $(12,739) | | Net cash provided by (used in) investing activities | $74,557 | $(128,746) | $203,303 | | Net cash provided by financing activities | $18,457 | $4,499 | $13,958 | | Net change in cash and cash equivalents and restricted cash | $(18,838) | $(223,360) | $204,522 | Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed explanations and additional information supporting the unaudited condensed consolidated financial statements. 1. Organization and Liquidity This note describes the company's business, therapeutic focus, key programs, and its assessment of liquidity and capital needs. - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for brain and centrally mediated diseases, with seven programs targeting novel mechanisms of action[25] - Key programs include a Phase 3 program for navacaprant (Major Depressive Disorder), a Phase 1b study for NMRA-511 (agitation in Alzheimer's disease), and a Phase 1 SAD/MAD study for NMRA-861 (schizophrenia)[25] - As of June 30, 2025, the company had an accumulated deficit of $1,067.9 million and has not generated revenue from product sales[27] - The company believes its existing cash, cash equivalents, and marketable securities of $217.6 million as of June 30, 2025, will be sufficient to support operations for at least the next 12 months, but additional capital will be needed for long-term development and commercialization[27][28] 2. Summary of Significant Accounting Policies and Basis of Presentation This note outlines the accounting principles, policies, and basis used in preparing the interim condensed consolidated financial statements. - The unaudited interim condensed consolidated financial statements are prepared in accordance with U.S. GAAP and SEC rules, reflecting all necessary normal recurring adjustments[29][30][32] - Key accounting policies include expensing research and development costs as incurred, classifying marketable securities as available-for-sale at fair value, and amortizing debt issuance costs to interest expense[36][43][44] - The company ceased to be an 'emerging growth company' as of December 31, 2024[49] - The company is evaluating the impact of new accounting standards (ASU 2024-04, ASU 2024-03, ASU 2023-09) and the recently enacted One Big Beautiful Bill Act, but preliminarily does not expect a material impact on the 2025 effective tax rate from the tax law changes[50][51][52][53] 3. Cash Equivalents and Marketable Securities This note details the composition and fair value of the company's cash equivalents and marketable securities. Cash Equivalents and Marketable Securities (Fair Value) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :----------------------------- | :------------------------------- | | Total Cash Equivalents | $58,770 | $125,292 | | Total Marketable Securities | $93,065 | $165,430 | | Total | $151,835 | $290,722 | - As of June 30, 2025, gross unrealized losses on marketable securities were de minimis ($15 thousand), and no allowance for expected credit loss was deemed necessary[55] 4. Fair Value Measurements This note provides information on the fair value hierarchy used for financial assets and liabilities. Fair Value Hierarchy (June 30, 2025) | Asset Category | Level 1 (in thousands) | Level 2 (in thousands) | Level 3 (in thousands) | Total (in thousands) | | :-------------------------- | :--------------------- | :--------------------- | :--------------------- | :------------------- | | Money market funds | $57,780 | — | — | $57,780 | | Commercial paper (CE) | — | $990 | — | $990 | | Commercial paper (MS) | — | $68,224 | — | $68,224 | | Certificates of deposit | — | $607 | — | $607 | | U.S. government securities | $11,953 | — | — | $11,953 | | Corporate debt securities | — | $12,281 | — | $12,281 | | Total | $69,733 | $82,102 | — | $151,835 | - Money market funds are valued at a stable $1.00 net asset value (Level 1). Other marketable securities (commercial paper, certificates of deposit, U.S. government, and corporate debt) are valued using third-party pricing services with observable inputs (Level 2)[57] 5. Debt This note describes the company's term loan agreement, its terms, and future principal payment obligations. - On May 9, 2025, the company entered into a Loan Agreement with K2 HealthVentures LLC (K2HV) for up to $125.0 million in term loans over four tranches, with $20.0 million funded on the closing date[58] - The Term Loan matures on May 1, 2029, bears a variable interest rate (effective 12.9% for Q2 2025), and is secured by substantially all company assets (excluding certain IP)[60][61][65] - The agreement includes customary covenants, a minimum liquidity covenant starting January 1, 2026, and K2HV has an option to convert up to $10.0 million of outstanding principal into common stock[61][62][63] Outstanding Debt and Future Principal Payments (June 30, 2025) | Metric | Amount (in thousands) | | :-------------------------------- | :-------------------- | | Gross proceeds | $20,000 | | Unamortized debt issuance costs | $(549) | | Total debt, long-term | $19,451 | | Future Principal Payments (including final fee of $1.4M): | | | Year ended December 31, 2026 | $— | | Year ended December 31, 2027 | $— | | Year ended December 31, 2028 | $11,394 | | Year ended December 31, 2029 | $9,996 | | Total principal payments | $21,390 | 6. Balance Sheet Components This note provides a breakdown of specific accrued liabilities on the balance sheet. Accrued Liabilities (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accrued clinical trial and preclinical costs | $11,845 | $11,606 | | Compensation and benefits | $6,645 | $9,975 | | Professional services | $1,313 | $2,686 | | Other | $450 | $326 | | Total accrued liabilities | $20,253 | $24,593 | 7. Acquisitions of Assets This note details the company's asset acquisitions, including related contingent consideration and milestone payments. - Acquired BlackThorn Therapeutics, Inc. in June 2020, gaining navacaprant (MDD) and NMRA-511 (agitation in AD) programs, and a computational psychiatry platform. Contingent consideration includes up to $365.0 million in development/regulatory milestones and $450.0 million in sales-based milestones for navacaprant, and $100.0 million each for NMRA-511. A Phase 3 navacaprant milestone ($60.8 million) was settled in December 2023 via stock and cash[70][71] - Entered into two license agreements with Amgen Inc. in September 2021 for CK1δ and GCase programs for neurodegenerative diseases. Upfront consideration of $157.0 million (Series A-2 preferred stock) was expensed in 2021. Amgen is eligible for up to $360.0 million per product in commercial milestone payments for each program[77][78][79] - Obtained an exclusive license from Vanderbilt University in February 2022 for M4 PAMs for schizophrenia. Paid a $13.0 million upfront cash payment, expensed as acquired in-process R&D. Vanderbilt is eligible for up to $42.4 million in development milestones and $380.0 million in commercial milestones. A $2.0 million milestone was achieved in October 2023 and a $5.0 million milestone in July 2025[81][84] 8. Commitments and Contingencies This note outlines the company's indemnification agreements and contractual obligations. - The company enters into indemnification agreements, including with directors and officers, for which the maximum potential future payments are not determinable[86] - Various manufacturing, clinical, and research contracts are generally terminable with advanced written notice and payment for services received or non-cancelable obligations incurred[87] 9. Strategic License and Research and Collaboration Agreements This note describes the company's various licensing, research, and collaboration agreements and their financial implications. - The 2015 TSRI License Agreement, assumed via BlackThorn acquisition, grants exclusive rights to Kappa Opioid Receptor and V1aR Receptor Antagonist programs (navacaprant, NMRA-511), with obligations for annual license fees, development/regulatory milestones (up to $1.5 million per product), commercial milestones (up to $3.5 million per occurrence), tiered low-single digit royalties, and mid-single digit sublicensing revenues. A $0.3 million milestone was paid in October 2023[89][90] - The Amgen Collaboration Agreement terminated in September 2024, with a final payment of $6.3 million made to Amgen in May 2025 for research and development activities[91][92][121] - Two sponsored research agreements with Vanderbilt (February 2022 and May 2024) focused on M4 PAM back-up programs, with research payments totaling up to $1.7 million annually for the first agreement and $0.6 million for the second[94][95][96][97] - The Parkinson's Research Ventures Funding Agreement (March 2024) provides up to $2.6 million in funding for the NLPR3 program, with $1.1 million received in March 2024 and $1.5 million in January 2025. Funding is recognized as a contra-R&D expense, with potential future payments up to £8.4 million upon trigger events[99][100][101] 10. Stockholders' Equity This note provides details on the company's authorized and outstanding common and preferred stock and shares reserved for issuance. - The company has authorized 50,000,000 shares of preferred stock, with none issued and outstanding as of June 30, 2025[102] - As of June 30, 2025, 161,947 thousand shares of common stock were outstanding, including 116,475 shares of restricted stock subject to repurchase[21][103] Common Stock Reserved for Future Issuance (June 30, 2025, in thousands) | Category | Shares Reserved | | :-------------------------------- | :-------------- | | Shares reserved for options and restricted stock units issued under equity plans | 24,559 | | Shares reserved for future issuance under equity plans | 18,922 | | Shares reserved for future issuance under employee stock purchase plan | 4,584 | | Total | 48,065 | - In December 2023, 6,072,445 shares of common stock were issued related to the BlackThorn Merger Agreement upon achievement of the Phase 3 navacaprant dosing milestone[103] 11. Stock-Based Compensation This note details the company's equity incentive plans, option repricing, and stock-based compensation expense. - The company operates under the 2023 Equity Incentive Plan and the 2023 Employee Share Purchase Plan (ESPP). The 2023 Plan's available shares increased by 8,085,495 on January 1, 2025, and the ESPP's shares increased by 1,617,099 on the same date, with 97,005 shares issued under the ESPP in May 2025[104][106][107] - An option repricing on May 28, 2025, for certain outstanding stock options resulted in $4.2 million of incremental stock compensation expense, with $0.3 million recognized in the three months ended June 30, 2025[109][110][111] Total Stock-Based Compensation (in thousands) | Period | Research and development | General and administrative | Total | | :-------------------------- | :----------------------- | :------------------------- | :------ | | Three Months Ended June 30, 2025 | $1,672 | $5,493 | $7,165 | | Three Months Ended June 30, 2024 | $7,152 | $5,616 | $12,768 | | Six Months Ended June 30, 2025 | $5,420 | $11,069 | $16,489 | | Six Months Ended June 30, 2024 | $9,964 | $10,177 | $20,141 | - As of June 30, 2025, there was $57.7 million and $11.9 million of unrecognized stock-based compensation related to stock options and restricted stock, respectively, expected to be recognized over weighted-average remaining service periods of 2.4 and 2.5 years[115] 12. Segment Reporting This note explains the company's single operating segment and how resources are managed and allocated. - The company operates as a single operating segment focused on the development of clinical and preclinical neuroscience programs[116] - The CEO, as the chief operating decision maker, manages and allocates resources on a consolidated basis, using consolidated financial information to evaluate performance and set incentive targets[117] Summary of Segment Loss and Significant Expenses (Six Months Ended June 30, 2025, in thousands) | Program/Expense Category | Amount | | :-------------------------------- | :----- | | Navacaprant (NMRA-140) program | $(46,750) | | M4 PAM programs | $(5,252) | | NMRA-511 program | $(4,837) | | Preclinical programs | $(2,461) | | Research and development personnel-related costs | $(19,943) | | General and administrative expense | $(34,101) | | Interest income, net | $4,888 | | Other segment items | $(12,267) | | Net loss | $(120,723) | 13. Net Loss Per Share This note presents the basic and diluted net loss per share and the weighted-average shares outstanding. Net Loss Per Share (Basic and Diluted) | Period | 2025 | 2024 | | :-------------------------- | :----- | :----- | | Three Months Ended June 30, | $(0.33) | $(0.37) | | Six Months Ended June 30, | $(0.75) | $(0.71) | Weighted-Average Shares Outstanding (Basic and Diluted, in thousands) | Period | 2025 | 2024 | | :-------------------------- | :----- | :----- | | Three Months Ended June 30, | 161,691 | 158,984 | | Six Months Ended June 30, | 161,572 | 158,464 | - As of June 30, 2025, 36,130 thousand potentially dilutive common stock equivalents (including options, restricted stock units, and term loan conversion election) were excluded from the diluted net loss per share calculation as their inclusion would be antidilutive[120] 14. Related Party Transactions This note discloses transactions with related parties, specifically a final payment to Amgen. - On May 1, 2025, the company made a final payment of $6.3 million to Amgen under the Amgen Collaboration Agreement for research and development activities[121] - This $6.3 million was recorded as research and development expense during the six months ended June 30, 2025, compared to $0 in the prior year period[121] 15. Subsequent Event This note describes a significant event that occurred after the reporting period but before the financial statements were issued. - In July 2025, a $5.0 million development milestone under the Vanderbilt License Agreement was achieved and subsequently settled in cash[122] - This milestone payment will be recognized as acquired in-process research and development expense in the third quarter of 2025[122] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Neumora Therapeutics' financial condition, operating results, liquidity, and critical accounting estimates, highlighting its clinical-stage focus and future funding needs. - Neumora Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for brain and centrally mediated diseases, with seven programs in its therapeutic pipeline[125] - Key programs include navacaprant (Phase 3 for MDD), NMRA-511 (Phase 1b for agitation in AD), and NMRA-861 (Phase 1 for schizophrenia)[125] Key Program Status and Milestone Guidance | Program | Indication | Target/Mechanism | Phase | Milestone Guidance | | :---------------- | :-------------------------- | :---------------- | :------ | :-------------------------------- | | Navacaprant | Major Depressive Disorder | KOR Antagonist | Phase 3 | KOASTAL-3, -2 topline data 1Q26, 2Q26 | | NMRA-511 | Agitation in Alzheimer's Disease | V1aR Antagonist | Phase 1b | Phase 1b data around year-end 2025 | | NMRA-861 | Schizophrenia | M4 Modulator | Phase 1 | Phase 1 SAD/MAD data 1Q26 | | NMRA-898 | Schizophrenia | M4 Modulator | Preclinical | Progress next M4 compound into the clinic 2025 | | NMRA-215 | Obesity/Parkinson's Disease | NLRP3 Inhibitor | Preclinical | Report DIO data 2025, Initiate Phase 1 studies 1Q26 | | NMRA-GCASE | Parkinson's Disease | GCase Activator | Preclinical | N/A | | NMRA-CK1δ | ALS/Alzheimer's Disease | CK1δ Inhibitor | Preclinical | N/A | - The company has not generated any revenue from product sales and expects to incur significant net losses for the foreseeable future as it advances its product candidates through development[129] Overview This section provides a high-level summary of the company's business, pipeline, and financial outlook. Acquisitions of Assets This section details the company's asset acquisitions and their associated contingent consideration. - The company has completed various asset acquisitions, including BlackThorn Therapeutics, Amgen licenses, and Vanderbilt licenses, which have expanded its pipeline and intellectual property[130] - These acquisitions involve substantial contingent consideration payments tied to development, regulatory, and sales milestones, which may be settled in cash or stock[132][133] Strategic License and Research and Collaboration Agreements This section outlines the company's various licensing and collaboration agreements with third parties. - The company has assumed license arrangements and entered into additional license, research, and collaboration agreements with various third parties[131] Contingent Consideration This section describes the contingent payment obligations arising from the company's acquisitions and license agreements. - BlackThorn Merger Agreement requires contingent consideration for navacaprant (up to $365.0 million development/regulatory, $450.0 million sales-based) and NMRA-511 (up to $100.0 million development/regulatory, $100.0 million sales-based). A Phase 3 navacaprant milestone was paid in Q4 2023[132] - Vanderbilt License Agreement requires contingent consideration up to $42.4 million (development) and $380.0 million (commercial) plus tiered royalties. Development milestones of $2.0 million (Q4 2023) and $5.0 million (July 2025) have been achieved and settled[133] Components of Operating Results This section breaks down the key elements contributing to the company's operating performance. - Operating expenses primarily consist of external and internal research and development (R&D) expenses, and general and administrative (G&A) expenses[134][140] - R&D expenses are expensed as incurred and are expected to remain significant as product candidates advance through clinical development and regulatory approval[136][137] - G&A expenses are expected to increase due to supporting R&D activities, business growth, and costs associated with operating as a public company[141] - Interest income, net, includes interest earned on cash equivalents and marketable securities, offset by interest expense from the Loan Agreement[142] Operating Expenses This section details the company's research and development and general and administrative expenses. Other Income (Expense) This section covers non-operating income and expenses, primarily interest income and expense. Results of Operations (Three Months Ended June 30, 2025 and 2024) This section analyzes the company's financial performance for the three-month periods ended June 30, 2025 and 2024. - Net loss for the three months ended June 30, 2025, was $52.7 million, an improvement from $58.7 million in the prior year[143] - Research and development expenses decreased by $9.9 million (20%) to $38.7 million, primarily due to reduced navacaprant program costs ($3.3 million) and lower internal/unallocated personnel-related costs ($7.8 million), including a $5.4 million reduction in stock-based compensation[144] - Interest income, net, decreased by $3.5 million (66%) to $1.8 million, attributable to lower balances in cash equivalents and marketable securities[146] Results of Operations (Six Months Ended June 30, 2025 and 2024) This section analyzes the company's financial performance for the six-month periods ended June 30, 2025 and 2024. - Net loss for the six months ended June 30, 2025, increased to $120.7 million from $112.4 million in the prior year[148] - Research and development expenses decreased by $3.5 million (4%) to $90.9 million, driven by reduced navacaprant and preclinical program costs, and lower personnel-related costs, partially offset by increased NMRA-511 program expenses and a $6.3 million final payment for the Amgen Collaboration Agreement[148] - General and administrative expenses increased by $4.6 million (16%) to $34.1 million, primarily due to higher personnel-related costs, including severance and one-time bonus payments for key executives ($2.0 million) and increased stock-based compensation ($1.0 million)[149] - Interest income, net, decreased by $6.7 million (58%) to $4.9 million, due to lower balances in cash equivalents and marketable securities[151] Liquidity and Capital Resources This section discusses the company's cash position, funding sources, and future capital requirements. - As of June 30, 2025, the company had $217.6 million in cash, cash equivalents, and marketable securities[152] - The company has historically funded operations through equity sales, including $226.5 million net proceeds from its September 2023 IPO, and recently secured a $125.0 million term loan facility with K2HV, with $20.0 million funded in May 2025[152] - The company expects its existing capital to fund operating expenses and capital expenditure requirements for at least the next 12 months, but anticipates needing substantial additional funding for long-term development and commercialization[156][157] Summary of Cash Flows (Six Months Ended June 30) | Metric | 2025 (in thousands) | 2024 (in thousands) | | :-------------------------------- | :------------------ | :------------------ | | Net cash used in operating activities | $(111,852) | $(99,113) | | Net cash provided by (used in) investing activities | $74,557 | $(128,746) | | Net cash provided by financing activities | $18,457 | $4,499 | | Net change in cash and cash equivalents and restricted cash | $(18,838) | $(223,360) | Critical Accounting Estimates This section highlights the significant accounting estimates and judgments made by management in preparing financial statements. - The preparation of financial statements requires management to make estimates and assumptions, particularly for accrued research and development expenses, accounting for acquisitions of assets, fair value measurements, stock-based compensation, and operating lease liabilities[33][167] - No material changes to critical accounting estimates were reported since the 2024 Annual Report on Form 10-K[168] Recent Accounting Pronouncements This section outlines new accounting standards and their potential impact on the company's financial reporting. - The company is evaluating the impact of ASU 2024-04 (Induced Conversions of Convertible Debt Instruments), effective after December 15, 2025[50][169] - The company is evaluating the disclosure requirements of ASU 2024-03 (Disaggregation of Income Statement Expenses), effective after December 15, 2026[51][169] - The company is evaluating the impact of ASU 2023-09 (Income Taxes), effective January 1, 2025[52][169] JOBS Act Accounting Smaller Reporting Company Elections This section discusses the company's change in status regarding the JOBS Act and its implications for reporting requirements. - The company ceased to qualify as an 'emerging growth company' and a 'smaller reporting company' as of December 31, 2024[170][172] - As a result, the company is now subject to increased reporting and disclosure requirements, which are expected to increase legal and financial compliance costs and divert management attention[446][447] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company's market risk primarily stems from interest rate fluctuations impacting its cash, marketable securities, and variable-rate debt, with immaterial foreign currency exposure. - As of June 30, 2025, the company had $217.6 million in cash, cash equivalents, and marketable securities, with primary market risk exposure to interest rate fluctuations[173] - The term loan facility with K2HV bears a variable interest rate, meaning an increase in the prime rate could increase debt service obligations[174] - The company has immaterial exposure to adverse changes in foreign currency exchange rates from contracting with foreign vendors and does not hedge this exposure[176] - Inflation is not believed to have had a material effect on the company's results of operations during the six months ended June 30, 2025[179] Item 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting. - As of June 30, 2025, management, with the participation of the CEO and CFO, concluded that the company's disclosure controls and procedures were effective[180] - No changes in internal control over financial reporting occurred during the six months ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[181] PART II. OTHER INFORMATION This section provides additional information beyond the financial statements, including legal proceedings, risk factors, and other disclosures. Item 1. Legal Proceedings A class action lawsuit was filed on February 6, 2025, alleging Securities Act violations related to the company's 2023 IPO, which the company intends to dismiss. - A putative class action lawsuit was filed on February 6, 2025, against the company, certain executive officers, and underwriters in the U.S. District Court for the Southern District of New York[184] - The complaint alleges violations of the Securities Act of 1933 related to the company's initial public offering on September 15, 2023, claiming false and misleading statements and omitted material facts about navacaprant's prospects[184] - The company does not believe these allegations have merit and intends to move to dismiss the lawsuit[184] Item 1A. Risk Factors Investing in the company's common stock carries high risk due to its clinical-stage status, ongoing losses, funding needs, and challenges in drug development. - Investing in the company's common stock involves a high degree of risk, including those related to its limited operating history, financial condition, and need for additional capital[187][190] - The company is a clinical-stage biopharmaceutical company with significant losses since inception and no products approved for commercial sale, making profitability uncertain[189][190] - Substantial contingent consideration from acquisitions and license agreements may result in stockholder dilution, cash drain, or debt obligations[189][197][200] - Clinical and preclinical drug development is a lengthy, expensive, and uncertain process, with potential for delays due to various factors including patient enrollment, regulatory approvals, and manufacturing issues[249][250][253] - The development and commercialization of drug products are subject to extensive, lengthy, and unpredictable regulatory approval processes by the FDA and comparable foreign authorities[290][293] - The company relies on third parties for manufacturing and clinical trials, increasing risks related to supply, quality control, and adherence to regulatory requirements[345][347][352] - Dependence on intellectual property licensed from third parties and challenges in obtaining, maintaining, and enforcing patent protection pose significant risks to the business[356][379][380] - The company's stock price has experienced and may continue to experience volatility, influenced by clinical trial results, regulatory developments, economic conditions, and other factors[422][424] Summary Risk Factors This section provides a concise overview of the principal risks associated with investing in the company. Risks Related to Our Limited Operating History, Financial Condition and Need for Additional Capital This section details risks stemming from the company's early stage, financial losses, and ongoing need for substantial funding. Risks Related to Our Business This section covers general business risks, including competition, market acceptance, and operational challenges. Risks Related to the Development and Clinical Testing of Our Product Candidates This section outlines risks inherent in the lengthy, complex, and uncertain process of drug development and clinical trials. Risks Related to Our Regulatory Environment This section addresses risks associated with extensive and unpredictable regulatory approval processes for drug products. Risks Related to Our Dependence on Third Parties This section highlights risks arising from reliance on third parties for manufacturing, clinical trials, and other critical operations. Risks Related to Intellectual Property This section details risks concerning the company's intellectual property, including patents, licenses, and potential infringement. Risks Related to Ownership of Our Common Stock This section covers risks specific to holding the company's common stock, such as price volatility and dilution. General Risk Factors This section includes broader risks that could impact the company's operations and financial performance. Item 2. Unregistered Sales of Equity Securities and Use of Proceeds No unregistered equity sales occurred this quarter, and IPO proceeds use remains consistent with the prospectus. - No unregistered sales of equity securities occurred during the quarterly period[466] - The planned use of proceeds from the initial public offering (IPO) on September 19, 2023, has not materially changed from what was described in the prospectus[467] Item 3. Defaults Upon Senior Securities This item is not applicable to the company for the current reporting period. Item 4. Mine Safety Disclosures This item is not applicable to the company for the current reporting period. Item 5. Other Information No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements this quarter. - None of the company's directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarterly period covered by this report[471] Item 6. Exhibits This section lists exhibits filed with the Form 10-Q, including corporate documents, agreements, and officer certifications. - Key exhibits filed include the Amended and Restated Certificate of Incorporation (3.1), Bylaws (3.2), Loan and Security Agreement (10.1), and Amended and Restated Non-Employee Director Compensation Program (10.2)[473] - Certifications of the Principal Executive Officer and Principal Financial Officer (31.1, 31.2, 32.1, 32.2) are also included[473] Signatures The report is signed by the Chief Executive Officer and Chief Financial Officer of Neumora Therapeutics, Inc. on August 6, 2025. - The report is signed by Paul L. Berns, Chief Executive Officer, and Michael Milligan, Chief Financial Officer and Principal Accounting Officer[479] - The signing date for the report is August 6, 2025[479]