Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q1 - Quarterly Results

Business Highlights and Outlook Artiva advanced AlloNK® clinical programs with FDA IND clearance, strengthened leadership, and extended cash runway - Received Investigational New Drug (IND) clearance and initiated a global basket trial for AlloNK® plus rituximab in several autoimmune diseases, including refractory rheumatoid arthritis and Sjögren's disease[1] - Cash runway extended into Q2 2027, with cash, cash equivalents, and investments of $166.0 million as of March 31, 2025[2] CEO's Remarks CEO highlighted AlloNK®'s global autoimmune trial initiation and anticipated key data readouts by H1 2026 - Announced the initiation of a company-sponsored allogeneic cell therapy trial for rheumatoid arthritis and Sjögren's disease in the U.S., two indications that could benefit from AlloNK's potential ease of use and safety profile[3] - Plans to share initial safety and translational data by the end of 2025, announce a lead indication, and present clinical response data for that indication in the first half of 2026[3] - Longer-term data in aggressive B-NHL is maturing to a level comparable with approved auto-CAR-T therapies, providing proof of concept for AlloNK's ability to achieve deep and durable B-cell depletion[3] AlloNK® (AB-101) Program Updates AlloNK® advanced with a global Phase 2a autoimmune trial, strong B-NHL data, and demonstrated manufacturing scalability - Following FDA IND clearance, the company is initiating a global Phase 2a basket clinical trial of AlloNK + rituximab for refractory rheumatoid arthritis (RA), Sjögren's disease, myositis (IIM), and systemic sclerosis (SSc)[4] - Longer-term clinical data from the Phase 1/2 trial in B-NHL shows complete response rates and median duration of response in line with approved auto-CAR-T therapies[10] - Manufacturing process data demonstrates consistency across over 40 lots and high viability and cytotoxicity after 4 years of shelf life[10] Corporate Updates Artiva strengthened its leadership by appointing Dr. Subhashis Banerjee as Chief Medical Officer, enhancing development expertise - Appointed Subhashis Banerjee, M.D., as Chief Medical Officer on April 8, 2025, to build a seasoned development team with strong expertise in autoimmune disease and cell therapy[7] Upcoming Milestones Artiva outlined key AlloNK® autoimmune milestones: initial safety data by year-end 2025 and clinical response data in H1 2026 - By Year-End 2025: Release initial safety and translational data for AlloNK® + mAb across multiple autoimmune indications and disclose the lead autoimmune indication for further development[10] - 1H 2026: Present initial clinical response data in the lead autoimmune indication, with longer follow-up, to inform the company's registrational strategy[10] First Quarter 2025 Financial Results Artiva reported a net loss of $20.3 million in Q1 2025 due to increased expenses, maintaining a strong cash position of $166.0 million Q1 2025 Financial Highlights (vs. Q1 2024) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and Development Expenses | $17.1 million | $11.2 million | | General and Administrative Expenses | $5.1 million | $3.6 million | | Other Income, net | $1.9 million | $0.5 million | | Net Loss | $20.3 million | $14.0 million | - As of March 31, 2025, the company had cash, cash equivalents, and investments of $166.0 million, which is expected to fund operations into Q2 2027[14] Financial Statements Unaudited condensed financial statements for Q1 2025 detail the company's financial position and operational results, including a $20.3 million net loss Condensed Balance Sheets Artiva's total assets were $191.3 million as of March 31, 2025, with total liabilities at $22.5 million and stockholders' equity at $168.8 million Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and investments | $165,963 | $185,428 | | Total assets | $191,263 | $209,581 | | Total liabilities | $22,480 | $22,940 | | Stockholders' equity | $168,783 | $186,641 | Condensed Statements of Operation and Comprehensive Loss For Q1 2025, Artiva reported a net loss of $20.3 million, or ($0.83) per share, primarily due to increased R&D expenses Statement of Operations Data (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $17,052 | $11,156 | | General and administrative | $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) | | Weighted-average common shares outstanding | 24,341,978 | 809,758 |