Metagenomi(US:MGX)2025-08-12 20:09PART I. FINANCIAL INFORMATION Presents Metagenomi's unaudited condensed financial statements for Q2 and H1 2025, detailing financial position, operations, equity, and cash flows Financial Statements (Unaudited) Presents Metagenomi's unaudited condensed financial statements for Q2 and H1 2025, including balance sheets, statements of operations, equity, and cash flows Condensed Balance Sheets Provides a snapshot of Metagenomi's financial position, including assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024 Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $26,850 | $27,386 | | Available-for-sale marketable securities | $178,143 | $220,921 | | Total current assets | $211,681 | $257,960 | | Total assets | $272,284 | $324,599 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $33,265 | $37,309 | | Total liabilities | $76,453 | $89,742 | | Accumulated deficit | $(267,949) | $(223,002) | | Total stockholders' equity | $195,831 | $234,857 | Condensed Statements of Operations and Comprehensive Loss Details Metagenomi's financial performance, including revenue, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $8,513 | $20,008 | $12,640 | $31,167 | | Research and development | $22,507 | $28,320 | $47,649 | $59,759 | | General and administrative | $6,993 | $8,551 | $13,798 | $17,303 | | Loss from operations | $(20,987) | $(16,863) | $(48,807) | $(45,895) | | Net loss | $(19,908) | $(10,739) | $(44,947) | $(35,887) | | Net loss per share | $(0.54) | $(0.29) | $(1.21) | $(1.24) | Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders' Equity Outlines changes in Metagenomi's equity structure, including the accumulated deficit and the conversion of preferred stock post-IPO - The company's accumulated deficit increased from $223.0 million at the end of 2024 to $267.9 million as of June 30, 2025, primarily driven by the net loss incurred during the period28 - Following the company's IPO in February 2024, all outstanding redeemable convertible preferred stock was converted into 23,935,594 shares of common stock2885 Condensed Statements of Cash Flows Summarizes Metagenomi's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 and 2024 Cash Flow Summary for the Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(44,093) | $(56,159) | | Net cash provided by (used in) investing activities | $43,800 | $(107,768) | | Net cash provided by (used in) financing activities | $(243) | $84,505 | | Net (decrease) in cash, cash equivalents and restricted cash | $(536) | $(79,422) | - Financing activities in the first six months of 2024 were primarily driven by $84.5 million in net proceeds from the company's Initial Public Offering (IPO)30 Notes to Unaudited Condensed Financial Statements Provides detailed explanations of Metagenomi's accounting policies, significant agreements, and other financial disclosures supporting the condensed statements - The company had an accumulated deficit of $267.9 million as of June 30, 2025. Management believes its existing cash, cash equivalents, and marketable securities of $205.0 million are sufficient to fund operations for at least the next 12 months37 - The collaboration agreement with Moderna was mutually terminated on April 26, 2024, with the company regaining full rights to its base editing and RNA-mediated integration systems that were subject to the agreement59 - A securities class action lawsuit was filed against the company in September 2024, alleging misleading statements regarding the Moderna collaboration. The company has filed a motion to dismiss the claims82 - In March 2025, the company established an At-The-Market (ATM) offering program to sell up to $75.0 million of its common stock. As of June 30, 2025, no shares have been sold under this program8889 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses Metagenomi's financial condition, operational results, and strategic focus on genome editing therapies and collaborations Overview Introduces Metagenomi's core business as a precision gene editing company, highlighting its lead program MGX-001 and key collaborations - The company is a precision gene editing company developing curative therapeutics using a proprietary, metagenomics-derived genome editing toolbox99 - The lead wholly-owned program, MGX-001 for hemophilia A, is designed to insert a Factor VIII DNA cassette into a 'safe harbor location' of the albumin gene. Emerging data from NHP studies showed higher than expected FVIII activity, prompting additional studies. IND and CTA submissions are planned for 2026102106 - The collaboration with Ionis focuses on cardiometabolic diseases, with all four Wave 1 targets achieving in vivo rodent proof-of-concept in 2024. The company plans to nominate one to two development candidates in 2025108 - On April 14, 2025, collaboration partner Affini-T exercised an option for a non-exclusive license for one of its pre-specified targets, triggering a $0.3 million payment to Metagenomi109 Results of Operations Analyzes Metagenomi's financial performance, focusing on changes in collaboration revenue, operating expenses, and net loss for the first half of 2025 Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2025 | 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Collaboration revenue | $12,640 | $31,167 | $(18,527) | | Research and development | $47,649 | $59,759 | $(12,110) | | General and administrative | $13,798 | $17,303 | $(3,505) | | Net loss | $(44,947) | $(35,887) | $(9,060) | - The decrease in collaboration revenue for the first six months of 2025 was primarily due to an $18.7 million reduction in revenue from the Moderna agreement, which was terminated in April 2024134 - Research and development expenses decreased by $12.1 million in the first half of 2025 compared to the same period in 2024, driven by reductions in R&D supplies, stock-based compensation, and employee-related costs136 Liquidity and Capital Resources Assesses Metagenomi's financial resources, including cash position and management's outlook on funding future operations - As of June 30, 2025, the company had $205.0 million in cash, cash equivalents, and available-for-sale marketable securities145 - Management estimates that existing cash will be sufficient to fund projected operating expenses and capital expenditure requirements for at least the next 12 months145 - Net cash used in operating activities decreased to $44.1 million for the first six months of 2025 from $56.2 million in the same period of 2024147148150 Quantitative and Qualitative Disclosures About Market Risk The company, as a smaller reporting company, is not required to provide the information for this item - Metagenomi is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is therefore not required to provide the information under this item158 Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2025. No material changes were made to the company's internal control over financial reporting during the quarter - The company's management, including the principal executive officer and principal financial officer, concluded that disclosure controls and procedures were effective as of June 30, 2025159 - There were no changes in internal control over financial reporting during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls160 PART II. OTHER INFORMATION Contains additional disclosures not included in the financial statements, covering legal, risk, equity, and other corporate matters Legal Proceedings The company is subject to a securities class action lawsuit filed in September 2024, as detailed in Note 8 of the financial statements. The company believes the final outcome of ordinary course legal matters will not have a material adverse effect on its business - The company refers to Note 8 of its financial statements for information regarding a securities class action lawsuit filed in September 202482162 Risk Factors Details significant risks to Metagenomi's business, including financial position, early-stage development, competition, regulatory challenges, and intellectual property Risks Related to Financial Position and Need for Capital Highlights Metagenomi's history of losses, accumulated deficit, and ongoing need for substantial additional funding to support operations - The company has incurred significant losses since inception, with a net loss of $44.9 million for the six months ended June 30, 2025, and an accumulated deficit of $267.9 million. Profitability is not expected in the foreseeable future167 - Substantial additional funding is required for operations. Failure to raise capital on acceptable terms could force the company to delay, reduce, or terminate research and development programs177 Risks Related to Business, Technology, and Industry Addresses risks associated with Metagenomi's early-stage development, novel genome editing technology, and intense competition in the biotech industry - The company is in a very early stage of development, with all programs in the research or lead optimization phase. It will be many years, if ever, before a product is commercialized188 - The novel nature of genome editing technology subjects the company to risks such as uncertain regulatory guidance, potential for unintended editing events, and immunological reactions192193 - The company faces significant competition from major pharmaceutical companies, specialty biotech firms, and academic institutions in the rapidly evolving genome editing field221 Risks Related to Regulatory, Legal, and Clinical Trials Covers challenges related to the lengthy and uncertain regulatory approval process, data privacy laws, and potential cybersecurity incidents - The regulatory approval process for novel genome editing product candidates is lengthy, expensive, and uncertain, with a high failure rate in clinical trials195 - The company is subject to stringent and evolving data privacy and security laws (e.g., GDPR, CCPA), and failure to comply could result in significant penalties and reputational harm305 - Cybersecurity incidents or data breaches could disrupt product development, compromise confidential information, and expose the company to liability296 Risks Related to Third Party Relationships Discusses risks arising from Metagenomi's reliance on collaborations and third-party contract manufacturing organizations for development and supply - The company relies on collaborations with third parties like Ionis and Affini-T and has limited control over the resources they dedicate, which could adversely affect development and commercialization320 - Reliance on third-party contract manufacturing organizations (CMOs) for materials and future products increases risks related to supply sufficiency, cost, quality, and regulatory compliance337 Risks Related to Personnel, Operations, and Growth Focuses on the critical importance of retaining key personnel and the challenges associated with managing future operational expansion - Future success is highly dependent on the ability to retain the CEO and other key executives and to attract and motivate qualified scientific and clinical personnel in a competitive market350 - The company expects to expand its operations and may encounter difficulties in managing growth, which could disrupt operations and strain resources352 Risks Related to Our Intellectual Property Addresses the complexities and uncertainties in obtaining, maintaining, and enforcing intellectual property rights in the competitive CRISPR field - Commercial success depends on the ability to obtain, maintain, and enforce intellectual property rights for its proprietary genome editing systems, which is uncertain and complex357358 - The company may be sued for infringing on the intellectual property rights of third parties, which could be costly and prevent or delay the development and commercialization of its products404 - The CRISPR technology field is subject to extensive patent filings and complex litigation, creating a risk of infringement claims and challenges to the company's own patents407408 Risks Related to our Common Stock, and Operating as a Public Company Examines risks concerning stock price volatility, ongoing litigation, and reduced disclosure requirements as an emerging growth company - The market price of the company's common stock has been and may continue to be volatile, which could result in substantial losses for investors428 - The company is currently subject to a securities class action lawsuit, which is expensive and could divert management's attention and result in substantial damages430431 - As an "emerging growth company" and "smaller reporting company," Metagenomi is subject to reduced disclosure requirements, which may make its common stock less attractive to some investors441442 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities during the reporting period - None reported462 Defaults Upon Senior Securities The company reported no defaults upon senior securities - None reported463 Mine Safety Disclosures This item is not applicable to the company - Not applicable464 Other Information Discloses the recent appointment of Laurence Reid, Ph.D., to Metagenomi's Board of Directors, including his role and compensation - On August 11, 2025, Laurence Reid, Ph.D., was appointed to the Board of Directors and will serve as a member of the Research and Development Committee465 - In connection with his appointment, Dr. Reid will be granted a non-statutory stock option to purchase 42,000 shares of common stock, vesting over a three-year period468 Exhibits Lists all documents filed as exhibits with the Form 10-Q, including corporate governance documents and officer certifications - The report includes key corporate documents and officer certifications as exhibits, such as the Amended and Restated Certificate of Incorporation and Bylaws, and Sarbanes-Oxley Act certifications471