Artiva Wins RMAT for AlloNK in Refractory Rheumatoid Arthritis
Cash, cash equivalents and investments stood at $349.4 million as of June 30, 2026, after an approximately $300 million May offering the company said will fund operations into 2029.
Artiva Biotherapeutics (ARTV) received U.S. Food and Drug Administration Regenerative Medicine Advanced Therapy designation for AlloNK plus rituximab in refractory rheumatoid arthritis, a step beyond the prior quarter’s FDA alignment on a Phase 3 design and a marker that the allogeneic NK-cell program is moving into registrational territory.
The clinical-stage biotechnology company said the designation supports its planned registrational strategy and provides access to expedited development and review mechanisms, including increased opportunities for FDA interaction. Chief Executive Fred Aslan, M.D., said the second quarter was transformative, citing EULAR 2026 data on AlloNK’s potential to drive deep B-cell depletion and meaningful clinical activity, with a tolerability profile supportive of outpatient administration.
In the company-sponsored Phase 2a basket trial, five of seven patients with six months of follow-up achieved an ACR50 response as of the April 3, 2026, data cutoff. As of that cutoff, no patient had lost response, required high-dose steroids, or started a new biologic or targeted synthetic DMARD after AlloNK plus rituximab. The regimen can be redosed if needed.
Those results support the hypothesis in the planned randomized Phase 3 trial: that AlloNK plus rituximab can achieve an ACR50 response rate greater than 50% in patients with refractory RA who have had an inadequate response to two or more distinct classes of b/tsDMARDs, versus an expected response rate of approximately 20% with rituximab alone based on published literature and real-world evidence. Artiva is initiating that Phase 3 registrational randomized controlled trial in the second half of 2026, evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory RA patients, with ACR50 response at six months as the primary efficacy endpoint. That timing matched the H2 2026 start the company had already flagged after FDA alignment in the first quarter.
Among 55 safety-evaluable autoimmune patients treated with AlloNK plus rituximab, no cytokine release syndrome, ICANS, AlloNK-related serious adverse events, or treatment discontinuations due to adverse events were observed as of the April 3 cutoff. The rate of Grade 3 or higher infections was 2%, and no patients were hospitalized for infection during the initial 28-day post-treatment period. Two of 55 patients were hospitalized for treatment-emergent adverse events in that window, neither deemed related to AlloNK.
Patients with Sjögren disease (n=11) showed improvements across clinical, patient-reported, and functional measures, including normalization of mean stimulated salivary flow among those with six months of follow-up (n=7). Patients with systemic sclerosis (n=5) showed improvements in mean modified Rodnan skin score; among those with six months of follow-up (n=4), mRSS decreased by 9.5 points on average, and all achieved rCRISS25. Artiva also published a first peer-reviewed manuscript in Cytotherapy describing AlloNK’s high-affinity CD16 158V/V phenotype, scalable GMP manufacturing, and preclinical enhancement of antibody-dependent killing of B cells from patients with systemic lupus erythematosus and RA when combined with anti-CD20 or anti-CD19 antibodies.
In May 2026, Artiva completed an underwritten offering of common stock and pre-funded warrants, generating gross proceeds of approximately $300 million before discounts, commissions, and expenses. Cash, cash equivalents, and investments were $349.4 million as of June 30, 2026, versus $108.0 million at December 31, 2025. The cash is expected to fund operations into 2029, versus the prior expectation of into the second quarter of 2027.
Research and development expenses were $21.9 million for the three months ended June 30, 2026, compared with $17.9 million a year earlier. General and administrative expenses were $5.0 million, versus $4.9 million. Other income, net, was $1.9 million, compared with $1.6 million. Net loss was $25.0 million, or $0.63 a share, versus $21.3 million, or $0.87 a share, a year earlier, with weighted-average shares of 39.4 million versus 24.4 million. Noncash stock-based compensation was $1.9 million.
Artiva appointed Diego Miralles, M.D., as president and head of research and development. Dr. Miralles brings more than 20 years of leadership across research, clinical development, commercialization, and company building. AlloNK, also known as AB-101, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK-cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity of anti-CD20 antibodies and drive deep B-cell depletion. In addition to refractory RA, it is being evaluated in Sjögren disease, systemic sclerosis, and myositis.