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Neumora Therapeutics(NMRA) - 2025 Q2 - Quarterly Report
2025-08-06 20:31
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)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(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](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the unaudited condensed consolidated financial statements. [1. Organization and Liquidity](index=9&type=section&id=1.%20Organization%20and%20Liquidity) 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](index=25&type=chunk) - 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](index=25&type=chunk) - 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](index=27&type=chunk) - 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](index=27&type=chunk)[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies and Basis of Presentation](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies%20and%20Basis%20of%20Presentation) 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](index=29&type=chunk)[30](index=30&type=chunk)[32](index=32&type=chunk) - 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](index=36&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - The company ceased to be an 'emerging growth company' as of December 31, 2024[49](index=49&type=chunk) - 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](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) [3. Cash Equivalents and Marketable Securities](index=13&type=section&id=3.%20Cash%20Equivalents%20and%20Marketable%20Securities) 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](index=55&type=chunk) [4. Fair Value Measurements](index=13&type=section&id=4.%20Fair%20Value%20Measurements) 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](index=57&type=chunk) [5. Debt](index=14&type=section&id=5.%20Debt) 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](index=58&type=chunk) - 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](index=60&type=chunk)[61](index=61&type=chunk)[65](index=65&type=chunk) - 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](index=61&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk) 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](index=16&type=section&id=6.%20Balance%20Sheet%20Components) 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](index=16&type=section&id=7.%20Acquisitions%20of%20Assets) 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](index=70&type=chunk)[71](index=71&type=chunk) - 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](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - 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](index=81&type=chunk)[84](index=84&type=chunk) [8. Commitments and Contingencies](index=18&type=section&id=8.%20Commitments%20and%20Contingencies) 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](index=86&type=chunk) - Various manufacturing, clinical, and research contracts are generally terminable with advanced written notice and payment for services received or non-cancelable obligations incurred[87](index=87&type=chunk) [9. Strategic License and Research and Collaboration Agreements](index=18&type=section&id=9.%20Strategic%20License%20and%20Research%20and%20Collaboration%20Agreements) 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](index=89&type=chunk)[90](index=90&type=chunk) - 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](index=91&type=chunk)[92](index=92&type=chunk)[121](index=121&type=chunk) - 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](index=94&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) - 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](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk) [10. Stockholders' Equity](index=20&type=section&id=10.%20Stockholders'%20Equity) 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](index=102&type=chunk) - 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](index=21&type=chunk)[103](index=103&type=chunk) 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](index=103&type=chunk) [11. Stock-Based Compensation](index=20&type=section&id=11.%20Stock-Based%20Compensation) 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](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - 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](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk) 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](index=115&type=chunk) [12. Segment Reporting](index=22&type=section&id=12.%20Segment%20Reporting) 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](index=116&type=chunk) - 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](index=117&type=chunk) 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](index=23&type=section&id=13.%20Net%20Loss%20Per%20Share) 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](index=120&type=chunk) [14. Related Party Transactions](index=24&type=section&id=14.%20Related%20Party%20Transactions) 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](index=121&type=chunk) - 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](index=121&type=chunk) [15. Subsequent Event](index=24&type=section&id=15.%20Subsequent%20Event) 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](index=122&type=chunk) - This milestone payment will be recognized as acquired in-process research and development expense in the third quarter of 2025[122](index=122&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=125&type=chunk) - Key programs include **navacaprant (Phase 3 for MDD)**, **NMRA-511 (Phase 1b for agitation in AD)**, and **NMRA-861 (Phase 1 for schizophrenia)**[125](index=125&type=chunk) 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](index=129&type=chunk) [Overview](index=25&type=section&id=Overview) This section provides a high-level summary of the company's business, pipeline, and financial outlook. [Acquisitions of Assets](index=26&type=section&id=Acquisitions%20of%20Assets) 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](index=130&type=chunk) - These acquisitions involve substantial contingent consideration payments tied to development, regulatory, and sales milestones, which may be settled in cash or stock[132](index=132&type=chunk)[133](index=133&type=chunk) [Strategic License and Research and Collaboration Agreements](index=26&type=section&id=Strategic%20License%20and%20Research%20and%20Collaboration%20Agreements) 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](index=131&type=chunk) [Contingent Consideration](index=26&type=section&id=Contingent%20Consideration) 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](index=132&type=chunk) - 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](index=133&type=chunk) [Components of Operating Results](index=26&type=section&id=Components%20of%20Operating%20Results) 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](index=134&type=chunk)[140](index=140&type=chunk) - R&D expenses are expensed as incurred and are expected to remain significant as product candidates advance through clinical development and regulatory approval[136](index=136&type=chunk)[137](index=137&type=chunk) - 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](index=141&type=chunk) - Interest income, net, includes interest earned on cash equivalents and marketable securities, offset by interest expense from the Loan Agreement[142](index=142&type=chunk) [Operating Expenses](index=26&type=section&id=Operating%20Expenses) This section details the company's research and development and general and administrative expenses. [Other Income (Expense)](index=28&type=section&id=Other%20Income%20(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)](index=28&type=section&id=Results%20of%20Operations%20(Three%20Months%20Ended%20June%2030,%202025%20and%202024)) 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](index=143&type=chunk) - 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](index=144&type=chunk) - Interest income, net, decreased by **$3.5 million (66%)** to **$1.8 million**, attributable to lower balances in cash equivalents and marketable securities[146](index=146&type=chunk) [Results of Operations (Six Months Ended June 30, 2025 and 2024)](index=30&type=section&id=Results%20of%20Operations%20(Six%20Months%20Ended%20June%2030,%202025%20and%202024)) 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](index=148&type=chunk) - 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](index=148&type=chunk) - 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](index=149&type=chunk) - Interest income, net, decreased by **$6.7 million (58%)** to **$4.9 million**, due to lower balances in cash equivalents and marketable securities[151](index=151&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=152&type=chunk) - 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](index=152&type=chunk) - 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](index=156&type=chunk)[157](index=157&type=chunk) 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](index=34&type=section&id=Critical%20Accounting%20Estimates) 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](index=33&type=chunk)[167](index=167&type=chunk) - No material changes to critical accounting estimates were reported since the 2024 Annual Report on Form 10-K[168](index=168&type=chunk) [Recent Accounting Pronouncements](index=34&type=section&id=Recent%20Accounting%20Pronouncements) 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](index=50&type=chunk)[169](index=169&type=chunk) - The company is evaluating the disclosure requirements of ASU 2024-03 (Disaggregation of Income Statement Expenses), effective after December 15, 2026[51](index=51&type=chunk)[169](index=169&type=chunk) - The company is evaluating the impact of ASU 2023-09 (Income Taxes), effective January 1, 2025[52](index=52&type=chunk)[169](index=169&type=chunk) [JOBS Act Accounting Smaller Reporting Company Elections](index=34&type=section&id=JOBS%20Act%20Accounting%20Smaller%20Reporting%20Company%20Elections) 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](index=170&type=chunk)[172](index=172&type=chunk) - 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](index=446&type=chunk)[447](index=447&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=173&type=chunk) - The term loan facility with K2HV bears a variable interest rate, meaning an increase in the prime rate could increase debt service obligations[174](index=174&type=chunk) - 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](index=176&type=chunk) - 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](index=179&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=180&type=chunk) - 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](index=181&type=chunk) 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](index=36&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=184&type=chunk) - 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](index=184&type=chunk) - The company does not believe these allegations have merit and intends to move to dismiss the lawsuit[184](index=184&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) 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](index=187&type=chunk)[190](index=190&type=chunk) - The company is a clinical-stage biopharmaceutical company with significant losses since inception and no products approved for commercial sale, making profitability uncertain[189](index=189&type=chunk)[190](index=190&type=chunk) - Substantial contingent consideration from acquisitions and license agreements may result in stockholder dilution, cash drain, or debt obligations[189](index=189&type=chunk)[197](index=197&type=chunk)[200](index=200&type=chunk) - 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](index=249&type=chunk)[250](index=250&type=chunk)[253](index=253&type=chunk) - 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](index=290&type=chunk)[293](index=293&type=chunk) - The company relies on third parties for manufacturing and clinical trials, increasing risks related to supply, quality control, and adherence to regulatory requirements[345](index=345&type=chunk)[347](index=347&type=chunk)[352](index=352&type=chunk) - Dependence on intellectual property licensed from third parties and challenges in obtaining, maintaining, and enforcing patent protection pose significant risks to the business[356](index=356&type=chunk)[379](index=379&type=chunk)[380](index=380&type=chunk) - 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](index=422&type=chunk)[424](index=424&type=chunk) [Summary Risk Factors](index=36&type=section&id=Summary%20Risk%20Factors) 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](index=37&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Condition%20and%20Need%20for%20Additional%20Capital) This section details risks stemming from the company's early stage, financial losses, and ongoing need for substantial funding. [Risks Related to Our Business](index=41&type=section&id=Risks%20Related%20to%20Our%20Business) 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](index=48&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Clinical%20Testing%20of%20Our%20Product%20Candidates) This section outlines risks inherent in the lengthy, complex, and uncertain process of drug development and clinical trials. [Risks Related to Our Regulatory Environment](index=55&type=section&id=Risks%20Related%20to%20Our%20Regulatory%20Environment) This section addresses risks associated with extensive and unpredictable regulatory approval processes for drug products. [Risks Related to Our Dependence on Third Parties](index=65&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) This section highlights risks arising from reliance on third parties for manufacturing, clinical trials, and other critical operations. [Risks Related to Intellectual Property](index=68&type=section&id=Risks%20Related%20to%20Intellectual%20Property) This section details risks concerning the company's intellectual property, including patents, licenses, and potential infringement. [Risks Related to Ownership of Our Common Stock](index=81&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) This section covers risks specific to holding the company's common stock, such as price volatility and dilution. [General Risk Factors](index=86&type=section&id=General%20Risk%20Factors) 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](index=91&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=466&type=chunk) - 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](index=467&type=chunk) [Item 3. Defaults Upon Senior Securities](index=91&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the current reporting period. [Item 4. Mine Safety Disclosures](index=91&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the current reporting period. [Item 5. Other Information](index=91&type=section&id=Item%205.%20Other%20Information) 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](index=471&type=chunk) [Item 6. Exhibits](index=92&type=section&id=Item%206.%20Exhibits) 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](index=473&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer (31.1, 31.2, 32.1, 32.2) are also included[473](index=473&type=chunk) [Signatures](index=93&type=section&id=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](index=479&type=chunk) - The signing date for the report is August 6, 2025[479](index=479&type=chunk)
Neumora Therapeutics(NMRA) - 2025 Q2 - Quarterly Results
2025-08-06 20:07
[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) Neumora Therapeutics reported strong Q2 2025 financial results and significant pipeline advancements, including the initiation of a Phase 1 study for NMRA-861 and prioritization of obesity for NMRA-215, with multiple clinical data readouts anticipated [Second Quarter 2025 Highlights](index=1&type=section&id=Q2%202025%20Highlights) Neumora Therapeutics reported Q2 2025 financial results and provided a business update, highlighting the initiation of a Phase 1 study for NMRA-861, prioritization of obesity for NMRA-215, and an upcoming period with up to six clinical data readouts. The company maintains a strong financial position, expected to support operations into 2027 - Initiated Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study with M4 positive allosteric modulator (PAM) NMRA-861, with data expected in the **first quarter of 2026**[1](index=1&type=chunk) - Announced prioritization of obesity as lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with data from diet-induced obesity (DIO) mouse model expected in **2025**[1](index=1&type=chunk) - Entering a catalyst-rich period with up to **six clinical data readouts** in patients over the next **18 months**, including Phase 3 data for navacaprant in major depressive disorder (MDD) and Phase 1b data for NMRA-511 in Alzheimer's disease agitation[1](index=1&type=chunk) - Strong financial position with **$217.6 million** in cash, cash equivalents and marketable securities expected to support operations into **2027**[1](index=1&type=chunk) [CEO Commentary on Strategic Progress](index=1&type=section&id=CEO%20Commentary) CEO Paul L. Berns emphasized the company's R&D efforts leading to multiple upcoming clinical data readouts and advancements in the preclinical pipeline, particularly the prioritization of obesity for NMRA-215, citing the unmet need and potential for centrally acting drugs. He also highlighted the potential of NMRA-861 for schizophrenia - R&D efforts have fueled multiple upcoming catalysts, with up to **six clinical data readouts** in patients over the next **18 months**[3](index=3&type=chunk) - Prioritized obesity as the lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with clinical studies expected to initiate in the **first quarter of 2026**[3](index=3&type=chunk) - Anticipates data from the NMRA-861 Phase 1 study in **early 2026**, highlighting its potential as a therapeutic option for people with schizophrenia[3](index=3&type=chunk) [Key Pipeline Highlights](index=1&type=section&id=KEY%20PIPELINE%20HIGHLIGHTS) The company provided updates on its key pipeline assets, including the initiation of a Phase 1 study for NMRA-861, prioritization of NMRA-215 for obesity, ongoing Phase 3 enrollment for navacaprant, and upcoming data for NMRA-511 [M4 Positive Allosteric Modulator (PAM) Franchise](index=1&type=section&id=M4%20Positive%20Allosteric%20Modulator%20(PAM)%20Franchise) Neumora initiated a Phase 1 SAD/MAD study for NMRA-861, a highly potent and selective M4 PAM, for schizophrenia and other neuropsychiatric disorders, with data expected in Q1 2026. The company also plans to bring another M4 PAM, NMRA-898, into the clinic in 2025 - Initiated a Phase 1 single-ascending dose/multiple-ascending dose (SAD/MAD) study of NMRA-861 in healthy adult participants and adults with stable schizophrenia in **July 2025**[4](index=4&type=chunk) - NMRA-861 is a highly potent and selective M4 PAM with potential best-in-class pharmacology for the treatment of schizophrenia and other neuropsychiatric disorders[4](index=4&type=chunk) - Expects to report data from the Phase 1 SAD/MAD study for NMRA-861 in the **first quarter of 2026**, including safety, tolerability, and human pharmacokinetic data[5](index=5&type=chunk) - The Company expects to bring another M4 PAM, NMRA-898, into the clinic in **2025**[5](index=5&type=chunk) [NMRA-215: Obesity Prioritized as Lead Indication for NLRP3 Inhibitor Program](index=2&type=section&id=NMRA-215:%20Obesity%20Prioritized%20as%20Lead%20Indication%20for%20NLRP3%20Inhibitor%20Program) Neumora has prioritized obesity as the lead indication for NMRA-215, a potential best-in-class, highly potent, and brain-penetrant NLRP3 inhibitor. Preclinical data from DIO studies are expected in 2025, with clinical initiation planned for Q1 2026 - Obesity prioritized as the lead indication for NMRA-215, a potential best-in-class, highly potent and brain-penetrant NLRP3 inhibitor[6](index=6&type=chunk) - NMRA-215 has demonstrated potential best-in-class brain penetration, target engagement and pharmacodynamic activity in relevant animal models[6](index=6&type=chunk) - Currently conducting preclinical DIO studies with data expected in **2025**, and expects to progress NMRA-215 into the clinic in the **first quarter of 2026**[7](index=7&type=chunk) [Navacaprant: Phase 3 KOASTAL Program](index=2&type=section&id=Navacaprant:%20Enrollment%20Ongoing%20in%20Phase%203%20KOASTAL%20Program) Enrollment is ongoing in the Phase 3 KOASTAL program for navacaprant in Major Depressive Disorder (MDD), with topline data from KOASTAL-3 expected in Q1 2026 and KOASTAL-2 in Q2 2026 - Topline data with navacaprant in MDD from KOASTAL-3 expected in the **first quarter of 2026**[8](index=8&type=chunk) - Topline data with navacaprant in MDD from KOASTAL-2 expected in the **second quarter of 2026**[8](index=8&type=chunk) [NMRA-511: Phase 1b Study in AD Agitation](index=2&type=section&id=NMRA-511:%20On%20Track%20to%20Report%20Data%20from%20Phase%201b%20Signal-seeking%20Study%20in%20Alzheimer's%20Disease%20(AD)%20Agitation) Neumora is on track to report data from its Phase 1b signal-seeking study evaluating NMRA-511 for Alzheimer's Disease (AD) agitation around the end of 2025 - Data from a Phase 1b signal-seeking study evaluating NMRA-511 as a treatment for AD agitation expected around the **end of 2025**[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=SECOND%20QUARTER%202025%20FINANCIAL%20RESULTS) Neumora reported its second quarter 2025 financial results, detailing a strong cash position, decreased R&D expenses, and an improved net loss compared to the prior year [Q2 2025 Financial Summary](index=2&type=section&id=Q2%202025%20Financial%20Summary) Neumora reported a cash position of $217.6 million as of June 30, 2025, providing runway into 2027. R&D expenses decreased to $38.7 million, while G&A expenses remained stable at $15.3 million. The net loss for the quarter improved to $52.7 million compared to the prior year Q2 2025 Key Financials | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :----- | :----------------- | :----------------- | :----------- | | Cash, Cash Equivalents & Marketable Securities | $217.6 | N/A | N/A | | R&D Expense | $38.7 | $48.6 | -$9.9 (-20.4%) | | G&A Expense | $15.3 | $15.2 | +$0.1 (+0.7%) | | Net Loss | $52.7 | $58.7 | -$6.0 (-10.2%) | - Cash, cash equivalents and marketable securities of **$217.6 million** as of June 30, 2025, expected to fund its operating plan into **2027**[10](index=10&type=chunk) [Unaudited Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, Neumora reported a net loss of $52.7 million, an improvement from $58.7 million in Q2 2024, primarily driven by a decrease in R&D expenses. For the six months ended June 30, 2025, the net loss was $120.7 million, compared to $112.4 million in the prior year Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 (Thousands) | Three Months Ended June 30, 2024 (Thousands) | Six Months Ended June 30, 2025 (Thousands) | Six Months Ended June 30, 2024 (Thousands) | | :-------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Research and development | $38,724 | $48,628 | $90,875 | $94,385 | | General and administrative | $15,316 | $15,194 | $34,101 | $29,511 | | Total operating expenses | $54,040 | $63,822 | $124,976 | $123,896 | | Loss from operations | $(54,040) | $(63,822) | $(124,976) | $(123,896) | | Interest income, net | $1,814 | $5,271 | $4,888 | $11,636 | | Net loss | $(52,731) | $(58,700) | $(120,723) | $(112,421) | | Net loss per share, basic and diluted | $(0.33) | $(0.37) | $(0.75) | $(0.71) | [Unaudited Condensed Consolidated Balance Sheets](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Neumora reported total assets of $223.8 million, a decrease from $317.0 million at December 31, 2024. Cash, cash equivalents, and marketable securities stood at $217.6 million. Total stockholders' equity decreased to $182.9 million from $287.1 million over the same period Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (Thousands) | December 31, 2024 (Thousands) | | :-------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and marketable securities | $217,588 | $307,578 | | Total assets | $223,825 | $316,972 | | Total liabilities | $40,946 | $29,908 | | Total stockholders' equity | $182,879 | $287,064 | [Additional Company Information](index=3&type=section&id=Additional%20Company%20Information) This section provides supplementary company information, including conference call details, an overview of Neumora Therapeutics, a cautionary note on forward-looking statements, and contact information [Conference Call Information](index=3&type=section&id=Conference%20Call%20Information) Neumora hosted a live conference call and webcast on August 6, 2025, at 4:30 p.m. ET to discuss the updates, with a replay available on their website - Neumora hosted a live conference call and webcast at **4:30 p.m. ET on August 6, 2025**, to review updates[11](index=11&type=chunk) - A live webcast of the event is available on the events and presentations section of the Company's website at www.neumoratx.com, with a replay archived for up to **30 days**[11](index=11&type=chunk) [About Neumora](index=3&type=section&id=About%20Neumora) Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapies for brain diseases, with a pipeline of seven programs targeting underserved, prevalent diseases. Its mission is to redefine neuroscience drug development for improved patient outcomes - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront medical challenges by developing treatments for brain diseases[12](index=12&type=chunk) - The therapeutic pipeline currently consists of **seven programs** that target novel mechanisms of action for a broad range of underserved, prevalent diseases[12](index=12&type=chunk) - Neumora's mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients[12](index=12&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, highlighting inherent risks and uncertainties in clinical drug development, regulatory approvals, reliance on third parties, and intellectual property. It advises readers to refer to SEC filings for detailed risk factors - This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to be materially different[13](index=13&type=chunk) - Risks include inherent uncertainty of clinical drug development, unpredictability of regulatory approvals, reliance on third parties, and potential for serious or undesirable side effects of therapeutic candidates[13](index=13&type=chunk) - Readers should refer to the risk factors identified in the Company's filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended **June 30, 2025**[13](index=13&type=chunk) [Neumora Contact](index=4&type=section&id=Neumora%20Contact) Provides contact information for Neumora Therapeutics - Contact: Helen Rubinstein, **617-402-5700**, Helen.Rubinstein@neumoratx.com[18](index=18&type=chunk)
Neumora Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-06 20:05
Core Insights - Neumora Therapeutics has initiated a Phase 1 single-ascending dose/multiple-ascending dose study for NMRA-861, with data expected in Q1 2026 [1][4] - The company has prioritized obesity as the lead indication for NMRA-215, a highly brain-penetrant NLRP3 inhibitor, with data from preclinical studies expected in 2025 [1][6][7] - Neumora is entering a catalyst-rich period with up to six clinical data readouts anticipated over the next 18 months, including Phase 3 data for navacaprant in major depressive disorder and Phase 1b data for NMRA-511 in Alzheimer's disease agitation [1][3][8][9] - The company reported a strong financial position with $217.6 million in cash, cash equivalents, and marketable securities, expected to support operations into 2027 [1][14] Pipeline Highlights - NMRA-861, an M4 positive allosteric modulator, has entered Phase 1 clinical studies targeting schizophrenia and other neuropsychiatric disorders [4][5] - NMRA-215 has shown potential for best-in-class brain penetration and is being developed for obesity, with clinical studies expected to start in Q1 2026 [6][7] - Navacaprant is currently in Phase 3 trials for major depressive disorder, with topline data expected in the first half of 2026 [8] - NMRA-511 is on track to report data from a Phase 1b study for Alzheimer's disease agitation by the end of 2025 [9] Financial Overview - For Q2 2025, Neumora reported research and development expenses of $38.7 million, down from $48.6 million in the same period of 2024, primarily due to reduced stock-based compensation and clinical trial costs [14][16] - General and administrative expenses for Q2 2025 were $15.3 million, slightly up from $15.2 million in Q2 2024 [14][16] - The net loss for Q2 2025 was $52.7 million, compared to a net loss of $58.7 million in Q2 2024 [14][16]
Neumora Therapeutics to Report Second Quarter 2025 Financial Results on Wednesday, August 6, 2025
Globenewswire· 2025-07-23 11:00
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]
Neumora Therapeutics Announces Initiation of Phase 1 Clinical Study of M4 Positive Allosteric Modulator NMRA-861
Globenewswire· 2025-07-09 11:00
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]
Neumora Therapeutics (NMRA) Earnings Call Presentation
2025-06-19 08:57
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]
Kuehn Law Encourages Investors of Neumora Therapeutics, Inc. to Contact Law Firm
Prnewswire· 2025-05-14 19:50
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].
Neumora Therapeutics(NMRA) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:32
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]
Neumora Therapeutics(NMRA) - 2025 Q1 - Earnings Call Transcript
2025-05-12 21:30
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]
Neumora Therapeutics(NMRA) - 2025 Q1 - Quarterly Report
2025-05-12 20:33
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)