Artiva Biotherapeutics Highlights AlloNK® Data Presented at EULAR 2026, FDA RMAT Designation in Refractory Rheumatoid Arthritis and Webcast Today

• Multiple EULAR presentations reinforce potential of AlloNK to drive deep B-cell depletion and meaningful clinical responses across refractory rheumatoid arthritis, Sjögren disease and systemic sclerosis
  
• Late-breaking oral presentation highlighted robust clinical responses with AlloNK plus rituximab across 31 patients with rheumatologic diseases
  
• Rheumatoid arthritis data showed clinically meaningful responses in highly refractory patients, including 71% ACR50 response at six months in the company-sponsored Phase 2a basket trial
  
• Safety and translational data support AlloNK’s potential as an outpatient-administered, community-compatible deep B-cell depleting therapy
  
• U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to AlloNK plus rituximab for the treatment of refractory rheumatoid arthritis
  
• Artiva to host virtual webcast today at 8:15 am EDT, featuring Dr. Paul Emery, Arthritis UK professor of rheumatology at the University of Leeds
  
  

SAN DIEGO, June 08, 2026 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with debilitating autoimmune diseases, today highlighted clinical, safety and translational data for AlloNK (also known as AB-101), an allogeneic, off-the-shelf, non-genetically modified natural killer (NK) cell therapy candidate, presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London.

Across five accepted abstracts, Artiva presented data evaluating AlloNK in combination with rituximab across B-cell driven autoimmune diseases, including rheumatoid arthritis (RA), Sjögren disease (SjD) and systemic sclerosis (SSc). The presentations included a late-breaking oral presentation highlighting clinical efficacy responses in 31 patients with rheumatologic diseases, an oral presentation describing the first SjD patient treated with AlloNK, a poster presentation of clinical responses in refractory RA, a poster tour presentation of deep B-cell depletion data and an additional publication-only abstract describing the safety profile observed across patients treated with AlloNK plus anti-CD20 antibodies.

In addition, the FDA recently granted RMAT designation to AlloNK in combination with rituximab for the treatment of refractory RA, supporting Artiva’s planned registrational strategy. RMAT designation provides access to expedited development and review benefits, including early and frequent FDA interactions, and is intended to facilitate efficient development of regenerative medicine therapies for serious conditions.

“EULAR provided an important opportunity to share the breadth of our AlloNK autoimmune dataset with the rheumatology community,” said Fred Aslan, M.D., chief executive officer of Artiva. “We believe the data presented further support AlloNK’s potential to deliver deep B-cell depletion with an off-the-shelf, scalable and outpatient-administered treatment regimen that could be highly differentiated for patients with refractory RA and other B-cell driven autoimmune diseases. With FDA alignment on our registrational strategy in refractory RA, RMAT designation providing access to expedited development and review benefits and capital from our recent financing expected to extend runway into 2029, we believe Artiva is well positioned to execute our planned Phase 3 trial and advance toward our goal of becoming first-in-class in refractory RA.”

Late-breaking oral presentation highlighted clinical responses across 31 patients with rheumatologic diseases

As of the April 3, 2026, data cutoff, patients demonstrated clinically meaningful improvements in disease activity measures across RA, SjD and SSc. The presentation also highlighted translational evidence of deep B-cell depletion, supporting AlloNK’s potential as an outpatient-administered regimen designed to be scalable and compatible with community rheumatology settings.

Refractory RA data demonstrated durable responses in patients with long-standing, highly active disease

Artiva presented data in refractory RA from both the company-sponsored Phase 2a basket trial and an investigator-initiated basket trial. Patients enrolled in these studies had long-standing, highly active disease and had received multiple prior targeted therapies. In the company-sponsored Phase 2a basket trial, 71% of patients with six months of follow-up achieved an ACR50 response. Across the pooled RA dataset, which included 21 patients with at least 12 weeks of follow-up, clinical responses were observed as early as three months and deepened at six months. Among patients with six months of follow-up, five of six patients in the investigator-initiated trial achieved an ACR50 or modified ACR50 response, and five of seven patients in the company-sponsored Phase 2a basket trial achieved an ACR50 response. As of the April 3, 2026 data cutoff, no patient had loss of response, required high-dose steroids or started a new biologic or targeted synthetic disease-modifying anti-rheumatic drug (b/tsDMARD) following treatment with AlloNK plus rituximab.

Initial SjD and SSc data support broader potential across B-cell driven autoimmune diseases

In SjD, Artiva presented an oral presentation describing the first treated patient, who demonstrated substantial improvement across disease activity, patient-reported and functional measures, including ClinESSDAI, ESSPRI, FACIT-Fatigue and stimulated salivary flow. In the broader SjD dataset, patients had high baseline disease activity, with mean ClinESSDAI of 16.1 and mean ESSPRI of 8.0. Patients demonstrated improvements across clinical measures and function, including normalization of mean stimulated salivary flow at six months, with mean stimulated salivary flow increasing from 0.65 mL/min at baseline to 1.23 mL/min at six months.

In SSc, initial data demonstrated improvement in modified Rodnan skin score (mRSS) and composite clinical response measures. Among patients with six months of follow-up, mean mRSS improved by 9.5 points, all patients achieved rCRISS25 and 50% achieved rCRISS50.

Safety and translational presentations support proposed deep B-cell depletion and immune reset hypothesis

Artiva’s safety presentation included data from 55 autoimmune patients treated with AlloNK plus rituximab and demonstrated a tolerability profile supportive of outpatient administration. As previously announced, no cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), AlloNK-related serious adverse events or treatment discontinuations due to adverse events were observed as of the April 3, 2026, data 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 during the initial 28-day period, neither of which was deemed related to AlloNK.

In a poster tour presentation, Artiva highlighted translational data demonstrating uniform and consistent B-cell depletion by Day 13 in all 51 evaluable autoimmune patients following treatment with cyclophosphamide/fludarabine, AlloNK and rituximab. Complete B-cell depletion was observed using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff. B-cell reconstitution was characterized by a predominance of naïve/transitional B cells, consistent with the proposed B-cell “reset” mechanism.

“The data presented at EULAR highlight consistent clinical activity across RA, SjD and SSc, alongside biologic evidence of deep B-cell depletion and reconstitution with a naïve/transitional B-cell phenotype that is consistent with the proposed immune reset hypothesis,” said Diego Miralles, M.D., president and head of research and development at Artiva. “Importantly, the responses observed in refractory RA were seen in patients with long-standing, highly active disease who had failed multiple prior targeted therapies. These data continue to inform our registrational strategy and support our planned Phase 3 trial in refractory RA.”

Artiva’s presentations at EULAR 2026 included:

• Late-Breaking Oral Presentation: 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
  
• Oral Presentation: AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated
  
• Poster View Presentation: 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
  
• Poster Tour: 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
  
• Publication-Only Abstract: Treatment with an Allogeneic NK Cell Therapy, AB-101, in Combination with Anti-CD20 Antibodies in Immune-mediated Diseases Demonstrates a Favorable Safety Profile and Comparable B-cell Depletion to CD19 CAR T Therapies
  
  

Virtual Webcast Details

Artiva will host a live webcast today, June 8, 2026, at 8:15 am EDT to review the data presented at EULAR. Members of the Artiva executive team will be joined by Paul Emery CBE, FLSW, MA, MD, FRCP, FMedSci, Arthritis UK professor of rheumatology at the University of Leeds and director of the Leeds NIHR Biomedical Research Centre. A live question and answer session will follow the formal presentation.

Investors and the general public are invited to listen to the webcast. To register, please click here.

To access the audio webcast and subsequent archived recording of this and other company presentations, please visit the Investors section of Artiva’s website. The archived audio webcast will remain available for replay on Artiva’s website for 90 days.

About AlloNK®
AlloNK® (also known as AB-101) is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved natural killer (NK) cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. In rheumatoid arthritis (RA) and other autoimmune diseases, AlloNK is being evaluated in combination with anti-CD20 monoclonal antibodies following a standard conditioning regimen of low-dose cyclophosphamide and fludarabine. AlloNK is currently being evaluated across multiple ongoing clinical trials in B-cell driven autoimmune diseases, including refractory RA, Sjögren disease, systemic sclerosis and myositis.

About Artiva Biotherapeutics

Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with debilitating autoimmune diseases. Artiva’s lead program, AlloNK® (also known as AB-101), is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved natural killer (NK) cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. Artiva is developing AlloNK in combination with anti-CD20 antibodies in autoimmune disease, with the goal of delivering auto-CAR-T-like activity through a scalable, outpatient-administered treatment regimen compatible with community rheumatology settings. AlloNK is currently being evaluated across B-dell driven autoimmune diseases, including refractory rheumatoid arthritis (RA), Sjögren disease, systemic sclerosis and myositis. Initial clinical data have demonstrated encouraging activity across multiple autoimmune indications, along with a tolerability profile supportive of outpatient administration. Artiva plans to initiate a Phase 3 registrational trial evaluating AlloNK in refractory RA in 2026.

Artiva is headquartered in San Diego, California. For more information, please visit www.artivabio.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements.  Such forward-looking statements include, without limitation, statements regarding: expectations of Artiva regarding the potential benefits, accessibility, effectiveness, safety and design of AlloNK®, including based on interim pooled data across clinical trials and including in comparison to CD19 CAR T-cell or other therapies; Artiva’s goal to delivering auto-CAR-T-like activity through a scalable, outpatient-administered treatment regimen compatible with community rheumatology settings; Artiva's plan to initiate a registrational Phase 3 trial for AlloNK in 2026; the potential benefits associated with RMAT designation for AlloNK; and Artiva's planned webcast.  These forward-looking statements are based on the beliefs of the management of Artiva as well as assumptions made by and information currently available to Artiva. Such statements reflect the current views of Artiva with respect to future events and are subject to known and unknown risks and uncertainties, including, without limitation, risks that future clinical trial results may not be consistent with interim, initial, preliminary, or topline results or results from prior preclinical studies or clinical trials; the risk that differences exist between trial designs, patient characteristics and other factors for Artiva’s Phase 2a basket trial, investigator-initiated trial and other studies, and caution should be exercised in drawing any conclusions from such data across separate trials as such pooling and/or comparative data is inherently limited and such data may not be directly comparable; risks inherent in developing product candidates; and risks related to the legal and regulatory framework for the industry. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause Artiva's actual results to differ from current expectations are discussed in Artiva's filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in Artiva's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, Artiva undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts

Investors
Noopur Batsha Liffick, MPH
NBL LifeSci Advisory LLC
ir@artivabio.com

Media
Jessica Yingling, Ph.D.
Little Dog Communications Inc.
jessica@litldog.com

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