Neumora Therapeutics(US:NMRA)2025-05-12 20:33PART I. FINANCIAL INFORMATION This section covers unaudited financial statements, management's discussion, market risk, and internal controls Item 1. Financial Statements (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 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 quarter18 Condensed Consolidated Statements of Operations and Comprehensive Loss 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 expenses20 Condensed Consolidated Statements of Cash Flows 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 202524 Notes to Unaudited Condensed Consolidated Financial Statements 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 months28 - 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 achieved586670 - 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 financials7980105 - 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 milestones106 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 2026114 - 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 2025114 | 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 executives133134 Item 3. Quantitative and Qualitative Disclosures About Market Risk 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 securities159 - The company does not hedge against foreign currency exchange rate fluctuations, as this exposure is considered immaterial161 Item 4. Controls and Procedures 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 effective164 - No changes occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting165 PART II. OTHER INFORMATION This section addresses legal proceedings, risk factors, equity sales, other information, and exhibits Item 1. Legal Proceedings 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 IPO168 - 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 merit168 Item 1A. Risk Factors 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 future174176 - Substantial contingent consideration obligations from acquisitions (e.g., BlackThorn, Amgen, Vanderbilt) could result in stockholder dilution or be a drain on cash resources174184 - 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 products174206 - 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 candidates180341342 - 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 compliance329337 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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, 2025452 - The company confirms no material change in the planned use of proceeds from its September 2023 IPO453 Item 5. Other Information 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 arrangement457 Item 6. Exhibits 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 2002458