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Initial AlloNK® (AB-101) clinical data demonstrated 71% ACR50 response in refractory rheumatoid arthritis (RA) patients with at least six months of follow-up in the company-sponsored Phase 2a basket trial, with no patients relapsing or requiring new immunomodulatory agents AlloNK treatment regimen demonstrated a consistent pattern of deep B-cell depletion and tolerability results supportive of outpatient administration in community rheumatology settings U.S. Food and Drug Administration (FDA) alignment on a single Phase 3 registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory RA patients, with ACR50 at six months as the primary endpoint; trial initiation planned for H2 2026 Multiple oral and poster presentations at EULAR 2026, including a late-breaking oral presentation on AlloNK clinical efficacy in refractory RA, Sjögren disease (SjD) and systemic sclerosis (SSc) SAN DIEGO, May 08, 2026 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with debilitating autoimmune diseases, today announced financial results for the first quarter ended March 31, 2026, and highlighted recent progress. “Artiva has reached an important inflection point, with positive initial clinical data across multiple autoimmune diseases and FDA alignment on a single Phase 3 registrational trial design in refractory RA,” said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. “The initial RA data demonstrated meaningful responses in highly refractory patients, alongside a tolerability profile supportive of outpatient administration in community rheumatology settings. Together, these data support AlloNK’s potential to become the first deep B-cell depleting therapy to advance into a Phase 3 trial in refractory RA, the autoimmune indication with the largest number of refractory patients.” Dr. Aslan continued, “By combining deep B-cell depletion, meaningful clinical responses and an outpatient profile suited to community rheumatology practices, AlloNK has the potential to redefine the treatment paradigm for patients with refractory autoimmune disease.” Recent Business Highlights Reported positive initial clinical data from ongoing clinical t...

Initial clinical response data for AlloNK® in refractory rheumatoid arthritis (RA) expected in first half of 2026 U.S. Food and Drug Administration (FDA) interaction to discuss potential pivotal trial design for AlloNK expected in first half of 2026 Strengthened board and executive leadership with deep immunology, commercial and financial expertise Robust balance sheet with cash, cash equivalents and investments of $108.0 million as of December 31, 2025, expected to fund operations into Q2 2027 SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the full year ended December 31, 2025, and highlighted recent progress. “2025 was a year of strong execution as we advanced our AlloNK program, successfully enrolling patients in community settings across autoimmune indications and prioritizing refractory RA as our lead indication,” said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. “AlloNK has the potential to redefine the treatment paradigm for refractory RA by combining the durable efficacy of deep B-cell depletion with an outpatient-ready profile suitable for community rheumatology practices.” Dr. Aslan continued, “In 2026, our focus is to advance AlloNK from an early clinical program in the deep B-cell depletion space to what could become the first therapy in this class to initiate a registrational trial in RA, the autoimmune disease with the largest refractory population. We look forward to sharing initial clinical response data and engaging with the FDA on a potential pivotal trial design in refractory RA in the first half of 2026.” Recent Business Highlights Prioritized refractory RA as lead indication: Received FDA Fast Track designation for AlloNK in refractory RA and prioritized RA as the program’s lead autoimmune indication. Despite multiple approved biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs), there are more than 150,000 RA patients in the U.S. who have failed at least two prior therapies. Real-world data suggest ACR50 response rates at six months are typically in the 10 – 20% range, underscoring the significant unmet nee...

Over 100 patients treated with AlloNK across autoimmune and oncology indications Refractory rheumatoid arthritis (RA) prioritized as lead indication following FDA Fast Track Designation for AlloNK®, the first known therapy within the emerging deep B-cell depletion category to receive this designation in RA Company to host webcast later this morning to discuss initial safety and translational data from clinical trials evaluating AlloNK in combination with anti-CD20 monoclonal antibodies across autoimmune diseases; presentation to also include outpatient feasibility and tolerability observations Initial clinical response data in refractory RA expected in the first half of 2026, with FDA discussions planned to align on potential pivotal trial design in refractory RA Cash runway into Q2 2027, with cash, cash equivalents, and investments of $123.0 million as of September 30, 2025 SAN DIEGO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the third quarter ended September 30, 2025, and provided recent business updates. “During the third quarter, we continued to execute on our mission to deliver accessible, scalable immunotherapies for autoimmune disease. We have now treated over a hundred patients with AlloNK across oncology and autoimmune disease, a significant milestone for the company,” said Fred Aslan, M.D., President and Chief Executive Officer of Artiva. “With refractory rheumatoid arthritis now established as our lead indication and Fast Track designation granted by the FDA, we have taken an important step forward in the development of AlloNK. We look forward to sharing the emerging translational and safety data later today, supporting AlloNK’s profile as an outpatient-ready therapy capable of achieving deep B-cell depletion, followed by clinical response data in the first half of 2026 from more than 15 refractory RA patients, several of whom will have six or more months of follow-up. In addition, we are planning FDA interactions in the first half of 2026 that could enable AlloNK to become the first deep B-cell depleting therapy to advance to a pivotal trial in patients with RA.” Recent Business Highlights...

First patient treated in company-sponsored global basket trial exploring AlloNK® + rituximab in refractory rheumatoid arthritis, Sjögren’s disease, idiopathic inflammatory myopathies, and systemic sclerosis Continued execution and enrollment progress with over a dozen patients treated with AlloNK + mAb across over a dozen sites in company-sponsored and investigator-initiated clinical trials in autoimmune diseases Initial safety, translational data, and lead indication selection for AlloNK in autoimmune diseases to be presented by year-end 2025; initial clinical response data in the lead indication to be presented in 1H2026 Cash runway into Q2 2027, with cash, cash equivalents, and investments of $142.4 million as of June 30, 2025 SAN DIEGO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the second quarter ended June 30, 2025, and highlighted recent progress. “We are making meaningful progress across our ongoing clinical trials exploring AlloNK® in autoimmune disease. We now have over a dozen sites enrolling across our trials in the US and have already treated over a dozen patients with AlloNK in combination with monoclonal antibodies across rheumatoid arthritis, SLE, lupus nephritis, Sjögren’s disease, and systemic sclerosis,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “By the end of 2025, we look forward to sharing initial translational data, supporting AlloNK’s mechanism of action, and safety data, supporting the potential of our therapy, which includes the use of cyclophosphamide and fludarabine, to be administered and managed in an outpatient setting across multiple autoimmune indications. We also look forward to announcing our lead indication by the end of 2025, setting the stage to share initial clinical response data in that indication in the first half of next year.” Recent Business Highlights AlloNK® (also known as AB-101) Updates Over a dozen clinical sites active and enrolling across two company-sponsored trials in autoimmune diseases: the Phase 2a basket clinical trial and the Phase 1/1b clinical trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN) Firs...

IND clearance and initiation of global basket trial exploring AlloNK® + rituximab in refractory rheumatoid arthritis, Sjögren’s disease, idiopathic inflammatory myopathies and systemic sclerosis First trial to explore an allogeneic cell therapy in refractory rheumatoid arthritis and Sjögren’s disease in the U.S. Initial safety, translational data, and lead indication selection to be presented by year-end 2025; initial clinical response data in the lead indication to be presented in 1H2026 Longer-term clinical data from Phase 1/2 trial exploring AlloNK + rituximab in B-NHL in heavily pretreated CAR-T naïve patients to be presented at ASGCT, demonstrating complete response rates and median duration of responses in line with approved auto-CAR-T therapies, support deep B-cell depletion Cash runway extension into Q2 2027, with cash, cash equivalents and investments of $166.0 million as of March 31, 2025 SAN DIEGO, May 08, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the first quarter ended March 31, 2025, and highlighted recent progress. “We are encouraged by our early experience with AlloNK® in autoimmune disease. We have initiated regulatory submissions globally for our company-sponsored basket trial in refractory rheumatoid arthritis, Sjögren’s disease, myositis and scleroderma. Notably, we are first to announce a company-sponsored allogeneic cell therapy trial in rheumatoid arthritis and Sjögren’s disease in the U.S.; two sizeable indications that could benefit from AlloNK’s potential ease of use and well-tolerated safety profile in the community setting,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “Since the IPO last July, we have transformed our development team and now have a deep bench of autoimmune expertise to expand and refine the clinical trial infrastructure and development strategy for AlloNK in autoimmune disease. By the end of 2025, we plan on sharing initial safety and translational data supporting AlloNK’s mechanism of action and tolerability profile across multiple autoimmune diseases, as well as announcing our lead indication. In the first half of 2026, we expect to share clinical res...

Initial data for AlloNK® from autoimmune program expected H1 2025 Updated clinical data from Phase 1/2 trial exploring AlloNK + rituximab in NHL showing continued durability of response to be presented at a medical conference in 2025 Strengthened key leadership with cell therapy and autoimmune expertise across organization Robust balance sheet with cash, cash equivalents and investments of $185.4 million as of December 31, 2024, is expected to fund operations at least through end of 2026 SAN DIEGO, March 24, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced financial results for the full year ended December 31, 2024, and highlighted recent progress. “2024 was a transformational year for Artiva including initiating dosing of AlloNK® in patients with autoimmune disease across our trials, a successful initial public offering strengthening our balance sheet, and expanding key leadership across the organization with expertise in cell therapy and autoimmune disease,” said Fred Aslan, M.D., CEO of Artiva. “We look forward to sharing initial data from our AlloNK® program in autoimmune disease this year. We also look forward to sharing updated clinical data from our non-Hodgkin’s lymphoma (NHL) trial with AlloNK® which continues to mature as one of the strongest data sets for the allogeneic field, demonstrating deep B-cell depletion, continued durability of response, and the compatibility of our treatment regimen with outpatient administration.” Recent Business Highlights Corporate and Financial Updates Expanded Board of Directors: In January 2025, Artiva appointed Dan Baker, M.D., as an independent member of its Board of Directors. Dr. Baker brings over two decades of drug development experience in the pharmaceutical industry. He is currently the interim Chief Development Officer of Cue Biopharma, Inc., and previously held a 19-year tenure at Johnson & Johnson (Janssen/Centocor) most recently as the Vice President of Immunology R&D. Bolstered Key Development Leadership: Artiva appointed key leadership with cell therapy and autoimmune expertise across the development organization, including Benjamin Dewees as Senior Vice President (SVP), Regulatory...