News & Events zu Artiva Biotherapeutics Inc (ARTV)ARTVArtiva Biotherapeutics Inc

Artiva Discontinues AlloNK Development and Reduces Workforce by 94%

Artiva Biotherapeutics announced that it will discontinue further development of AlloNK, its non-genetically modified, allogeneic NK cell therapy candidate being evaluated in combination with rituximab in rheumatoid arthritis, or RA, and other B-cell-driven autoimmune diseases. The decision follows the company's review of the overall risk-benefit in the context of updated clinical data, including longer-term follow-up, and recent Grade 5 safety events. The company also announced that it is implementing a reduction in workforce and evaluating strategic alternatives to maximize stockholder value that may include a merger, business combination, sale or licensing of assets, or dissolution and liquidation. A participant in the company's Phase 2a basket trial experienced a fatal neurological event following study treatment, which included protocol-specified lymphodepletion with cyclophosphamide and fludarabine. The investigator and an independent safety review assessed the event as likely related to fludarabine-associated neurotoxicity. Artiva reported the event to the FDA, investigators and the Data Safety Monitoring Board. Following notification, the FDA asked Artiva to pause enrollment and dosing in the Phase 2a study. The company also paused the planned Phase 3 trial enrollment and dosing. Given the widespread use of fludarabine-containing lymphodepletion regimens in cell therapy development, Artiva intends to share additional details of this case in a scientific publication. A second participant in the trial experienced sudden death approximately two months after initiating study treatment. The investigator assessed this event as unrelated to AlloNK or any other component of the study treatment regimen, and the cause of death has not been determined. Artiva promptly reported this event to the FDA, investigators and the Data Safety Monitoring Board. Updated clinical response data from patients receiving AlloNK in combination with rituximab continued to demonstrate deep B cell depletion and clinical activity consistent with the company's previously reported findings. However, longer-term follow-up did not reflect the level of durability of clinical response the company believes is needed to support continued development. Following an assessment of the risk-benefit of the therapy, likely enrollment delays and the overall development and potential commercial outlook, Artiva has decided to halt further development of AlloNK. No additional patients will be dosed in any ongoing AlloNK clinical study and the planned Phase 3 pivotal trial will not be initiated. The Company will work closely with the FDA, investigators and institutional review boards to ensure an appropriate and orderly close-out of its clinical development program, including continued safety monitoring and reporting as required. In light of the decision to discontinue AlloNK development, Artiva no longer plans to present its previously announced clinical data at ACR Convergence 2026 and will cancel its investor webcast scheduled for November 9. Updated clinical data may be presented at future scientific meetings depending on the outcome of the strategic alternatives process. Artiva's board of directors is evaluating internal options and potential strategic alternatives intended to maximize stockholder value. Leerink Partners has been engaged as the company's financial advisor to assist in the strategic evaluation process. These alternatives may include a merger, business combination, sale or licensing of assets, dissolution and liquidation. There can be no assurance that the evaluation will result in any transaction or particular outcome. In connection with the discontinuation of AlloNK development and to preserve capital while evaluating strategic alternatives, Artiva is reducing its workforce by approximately 94%. As of September 30, Artiva had approximately $319.1M in cash, cash equivalents and investments. The preliminary cash, cash equivalents and investments as of September 30 are unaudited and subject to adjustment.

Artiva Shares Drop 26% to $4.54

Artiva shares are down $1.62, or 26%, to $4.54 in pre-market trading.

Artiva Biotherapeutics Updates AlloNK Clinical Data

Artiva Biotherapeutics highlighted updated clinical, safety and translational data for AlloNK in combination with rituximab, presented by Guillermo Valenzuela, M.D., F.A.C.R., medical director of Integral Rheumatology & Immunology Specialists, in an oral session at the 17th International Symposium on Sjogren's Disease in Paris. Updated Sjogren disease data show improvement across clinical and functional measures: Among eight patients with baseline hyposalivation and six-month stimulated salivary-flow measurements available at the July 2, 2026 data cutoff, mean flow increased from 0.4 to 1.1 mL/min, exceeding the threshold for normal salivation of greater than 1.0 mL/min shown in the presentation. Updated safety and translational data support outpatient treatment approach: No cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease or hypogammaglobulinemia was observed, and no patients discontinued treatment due to adverse events. Eight patients experienced serious adverse events, including two with serious infections reported as unrelated to AlloNK.