Part I Part I - Financial Information Financial Statements (Unaudited) Unaudited Q1 2025 financial statements reflect decreased assets to $191.3 million and an increased net loss of $20.3 million, driven by higher R&D expenses Condensed Balance Sheets As of March 31, 2025, total assets decreased to $191.3 million from $209.6 million, primarily due to reduced cash and investments, while stockholders' equity also declined Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $30,401 | $40,235 | | Short-term investments | $135,562 | $145,193 | | Total current assets | $170,004 | $188,631 | | Total assets | $191,263 | $209,581 | | Liabilities & Stockholders' Equity | | | | Total current liabilities | $12,204 | $12,253 | | Total liabilities | $22,480 | $22,940 | | Total stockholders' equity | $168,783 | $186,641 | | Total liabilities and stockholders' equity | $191,263 | $209,581 | Condensed Statements of Operations and Comprehensive Loss For Q1 2025, net loss increased to $20.3 million from $14.0 million in Q1 2024, mainly due to higher research and development expenses Condensed Statement of Operations Data (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | License and development support revenue | $0 | $251 | | Research and development expenses | $17,052 | $11,156 | | General and administrative expenses | $5,119 | $3,587 | | Loss from operations | $(22,171) | $(14,492) | | Net loss | $(20,311) | $(13,963) | | Net loss per share, basic and diluted | $(0.83) | $(17.24) | Condensed Statements of Cash Flows Net cash used in operating activities increased to $19.8 million in Q1 2025, leading to a $9.6 million decrease in total cash and equivalents Condensed Statement of Cash Flows Data (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,841) | $(15,086) | | Net cash provided by investing activities | $9,971 | $9,782 | | Net cash provided by financing activities | $239 | $0 | | Net decrease in cash, cash equivalents and restricted cash | $(9,631) | $(5,304) | | Cash, cash equivalents and restricted cash at end of period | $30,862 | $48,458 | Notes to Condensed Financial Statements The notes detail the company's accumulated deficit of $267.0 million, its IPO proceeds, and key collaboration agreements with GC Cell - The company has an accumulated deficit of $267.0 million as of March 31, 2025, and expects to continue incurring net losses. Existing cash, cash equivalents, and investments of $166.0 million are believed to be sufficient to fund planned operations for at least one year30 - In July 2024, the company completed its IPO, raising aggregate net proceeds of $162.3 million. Immediately upon the IPO, all outstanding convertible preferred stock converted into common stock2984 - The company has multiple license and service agreements with related party GC Cell for its core NK cell therapy platform, including for product candidates AB-101, AB-201, and AB-205. These agreements involve potential milestone payments up to $22.0 million for AB-101, $25.0 million for AB-201, and $29.5 million for AB-205, plus sales-based milestones and royalties646670 - Stock-based compensation expense was $2.1 million for Q1 2025, up from $1.4 million in Q1 2024, primarily recorded under R&D and G&A expenses101 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's focus on developing NK cell-based therapies, particularly AlloNK, with increased R&D expenses and sufficient liquidity into Q2 2027 Overview Artiva is a clinical-stage biotechnology company developing off-the-shelf, allogeneic NK cell therapies, with lead candidate AlloNK in trials for autoimmune diseases - The company's lead product candidate, AlloNK, is being evaluated in a Phase 1/1b trial for systemic lupus erythematosus (SLE) and a Phase 2a basket trial for rheumatoid arthritis (RA) and other autoimmune diseases119120 - Artiva expects to report initial safety and translational data for AlloNK in autoimmune indications by the end of 2025, and initial clinical response data in the first half of 2026120 Results of Operations Total operating expenses increased by $7.4 million in Q1 2025, driven by a $5.9 million rise in R&D expenses for the AlloNK program Research and Development Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | External R&D | | | | AB-101 | $7,545 | $3,289 | | Other programs | $14 | $47 | | Internal R&D | | | | Personnel-related | $6,243 | $4,740 | | Other | $3,250 | $3,080 | | Total R&D Expense | $17,052 | $11,156 | - The $5.9 million increase in R&D expenses was primarily due to a $4.2 million increase in AB-101 costs related to product development and clinical trials for B-NHL and the commencement of the AlloNK for SLE/LN program142 - General and administrative expenses increased by $1.5 million, mainly due to a $1.2 million rise in personnel-related costs, including a $0.5 million increase in non-cash stock-based compensation143 Liquidity and Capital Resources The company has an accumulated deficit of $267.0 million but holds $166.0 million in cash and investments, sufficient to fund operations into Q2 2027 - As of March 31, 2025, the company had cash, cash equivalents and investments of $166.0 million and an accumulated deficit of $267.0 million146 - Based on current operating plans, the company expects its existing cash, cash equivalents and investments will be sufficient to fund planned operating expenses and capital expenditure requirements into the second quarter of 2027146187 Summary of Net Cash Flow (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,841) | $(15,086) | | Net cash provided by investing activities | $9,971 | $9,782 | | Net cash provided by financing activities | $239 | $0 | Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Artiva is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Artiva is not required to provide quantitative and qualitative disclosures about market risk173 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level174 - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls175 Part II Part II - Other Information Legal Proceedings The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any litigation or legal proceedings that management believes are likely to have a material adverse effect on the business177 Risk Factors The company faces significant financial, clinical, manufacturing, intellectual property, regulatory, and commercialization risks inherent to its early-stage biopharmaceutical operations - Financial Risks: The company has a limited operating history, a significant accumulated deficit ($267.0 million as of March 31, 2025), and will need substantial additional funding to continue operations180182186 - Clinical & Development Risks: The company's NK cell-based approach is unproven, especially for autoimmune diseases where clinical data is limited. The business is substantially dependent on the success of its lead product candidate, AlloNK190202206 - Manufacturing & Supply Risks: Manufacturing cell therapies is complex and novel. The company relies on GC Cell for manufacturing certain candidates and on third-party suppliers for critical materials like cord blood and viral vectors, some of which are single-source268272278 - Intellectual Property Risks: The company depends substantially on intellectual property licensed from GC Cell. Loss of these licenses could halt the development of its product candidates365 - Regulatory Risks: The regulatory approval process for novel cell therapies is lengthy, complex, and uncertain. The regulatory landscape is still developing, which could result in delays or unexpected costs295304 - Commercialization Risks: The company faces significant competition from other biopharmaceutical companies, has no marketing or sales organization, and faces uncertainty regarding market acceptance and reimbursement for its potential products282286287 Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities occurred during the quarter, and the planned use of $162.3 million IPO proceeds remains unchanged - The company completed its IPO on July 22, 2024, receiving net proceeds of approximately $162.3 million after deducting underwriting discounts and offering expenses473474 - There has been no material change in the planned use of proceeds from the IPO as described in the final prospectus475 Defaults Upon Senior Securities This item is not applicable Mine Safety Disclosures This item is not applicable Other Information No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the first quarter of 2025479 Exhibits This section lists the exhibits filed with the Form 10-Q, including corporate documents and officer certifications Signatures
Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q1 - Quarterly Report