On May 8, 2026 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, reported financial results for the first quarter ended March 31, 2026, and highlighted recent progress.
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"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 trials evaluating AlloNK in combination with rituximab across multiple autoimmune diseases
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As of the April 3, 2026 data cutoff, the initial clinical dataset included 21 refractory RA patients with at least 12 weeks of follow-up, including 13 patients with at least six months of follow-up from Artiva’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial evaluating AlloNK in B-cell driven autoimmune disease. The broader autoimmune dataset also included 11 SjD patients and five SSc patients, including seven SjD patients and four SSc patients with at least six months of follow-up.
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In refractory RA, clinically meaningful improvements were observed across multiple measures of disease activity, including ACR responses, CDAI and DAS28-ESR. Five of seven patients (71%) with six months of follow-up in the company-sponsored Phase 2a basket trial achieved an ACR50 response. Nineteen of 21 RA patients demonstrated clinically meaningful reductions from baseline in both CDAI and DAS28-ESR.
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The AlloNK treatment regimen demonstrated tolerability results supportive of outpatient administration in community rheumatology settings, with no CRS, ICANS or treatment discontinuations related to AlloNK reported as of the data cutoff.
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Deep B-cell depletion was observed across evaluable patients, including complete B-cell depletion using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff, supporting AlloNK’s proposed mechanism of action.
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Clinical responses in SjD and SSc were consistent with the RA data and support the potential of AlloNK across B-cell-driven autoimmune diseases.
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More than 70 autoimmune patients have been treated with AlloNK across more than 40 active clinical sites, mostly in community rheumatology settings, providing a strong foundation for planned registrational trial initiation.
Achieved FDA alignment on Phase 3 registrational trial design in refractory RA
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Artiva announced alignment with the FDA on a single Phase 3 registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory RA patients, with ACR50 response at six months as the primary endpoint.
Upcoming Milestones
Present AlloNK clinical data at EULAR 2026
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Multiple abstracts accepted for presentation at EULAR 2026, expected to further characterize AlloNK’s mechanism of action, clinical activity and outpatient feasibility, including:
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Late Breaking Oral Abstract Presentation – LB0003: AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy Combined with Rituximab, Generates Robust Clinical Efficacy Responses Comparable with Autologous CAR T in 31 Patients with Rheumatologic Diseases
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Oral Abstract Presentation – OP0129: AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated
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Poster View Presentation – POS1177: Robust and Durable Clinical Responses Observed Following Treatment with AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab in Patients with Severe Rheumatoid Arthritis and Inadequate Response to Multiple Prior Targeted Therapies
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Poster Tour – POS0355: AB-101, an Allogeneic NK Cell Therapy, in Combination with Anti-CD20 Monoclonal Antibodies, Consistently Achieves Deep B-cell Depletion Comparable with CAR T Cell Therapies in Patients with Rheumatologic Diseases
Initiate Phase 3 registrational trial in refractory RA
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In the second half of 2026, Artiva plans to initiate a Phase 3 randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 RA patients who have had an inadequate response to two or more biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) of distinct classes, with ACR50 response at six months as the primary efficacy endpoint.
First Quarter 2026 Financial Results
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Cash, Cash Equivalents and Investments. As of March 31, 2026, Artiva had cash, cash equivalents and investments of $86.8 million, which is expected to fund operations into Q2 2027.
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Research and Development Expenses. Research and development expenses were $19.3 million for the three months ended March 31, 2026, compared to $17.1 million for the three months ended March 31, 2025.
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General and Administrative Expenses. General and administrative expenses were $5.1 million for each of the three months ended March 31, 2026 and 2025.
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Other Income, net. Other income, net, was $0.9 million for the three months ended March 31, 2026, compared to other income, net, of $1.9 million for the three months ended March 31, 2025.
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Net Loss. Net loss totaled $23.5 million for the three months ended March 31, 2026, as compared to net loss of $20.3 million for the three months ended March 31, 2025, with non-cash stock-based compensation expense of $1.6 million and $2.1 million for the three months ended March 31, 2026 and 2025, respectively.
(Press release, Artiva Biotherapeutics, MAY 8, 2026, View Source [SID1234665382])