Artiva Biotherapeutics, which had been evaluating cell therapy AlloNK for the treatment of rheumatoid arthritis and other autoimmune diseases, is exploring strategic options that could include dissolution and liquidation.
Following two patient deaths and questions about the clinical response durability of its lead candidate, Artiva Biotherapeutics is ending development of the asset, wiping out 94% of its workforce and exploring strategic options. Those options could include a merger, business combination, sale or licensing of assets, or dissolution and liquidation, the San Diego–based biotech announced Tuesday.
Artiva had 115 employees as of June 30, according to an SEC filing, meaning the layoffs could affect around 108 employees and leave the business with fewer than 10 people. The company expects to complete the workforce reduction in the first quarter of 2027, according to a Tuesday SEC filing.
The biotech’s actions, which include canning a planned Phase 3 pivotal trial, followed a risk-benefit review of AlloNK. Artiva was evaluating the allogeneic, off-the-shelf natural killer cell therapy in combination with rituximab in rheumatoid arthritis and other B-cell-driven conditions.
The two patient deaths were tied to a Phase 2a basket autoimmune disease trial, according to the announcement. One participant experienced a fatal neurological event following study treatment, which included protocol-specified lymphodepletion chemotherapy. Artiva did not disclose how long after dosing the fatality occurred. The investigator and an independent safety review determined the death was likely related to a chemotherapy-associated neurotoxicity. After Artiva reported the death to the FDA, the agency, investigators and a data safety monitoring board asked the company to pause enrollment and dosing in the study. The biotech also paused plans for Phase 3 trial enrollment and dosing.
The second patient death occurred two months after initiating the Phase 2a basket trial treatment. The investigator determined the fatality was unrelated to AlloNK or any other component of the treatment regimen, and a cause of death has not yet been determined. Artiva reported the death to the FDA, investigators and the data safety monitoring board.
In the biotech’s Tuesday announcement, Artiva also noted that updated clinical response data from patients receiving AlloNK in combination with rituximab continued to demonstrate deep B cell depletion and clinical activity consistent with previously reported findings. However, longer-term follow-up failed to show the level of clinical response durability the company required to support continued development.
Founded in 2019, Artiva raised $179 million in a 2024 upsized initial public offering. More recently, in August, the company announced it had raised $300 million with an underwritten offering in May and noted it was well capitalized to initiate and execute the planned Phase 3 trial. The biotech had cash, cash equivalents and investments of approximately $319.1 million as of Sept. 30. That was down from $349.1 million as of June 30.
