Artiva Biotherapeutics Highlights Updated AlloNK® Data in Sjögren Disease Presented at the 17th International Symposium on Sjögren’s Disease (ISSjD 2026)

Both mean disease-activity and patient-reported symptom changes exceeded the presented thresholds for minimal clinically important improvement.

Rhea-AI Summary

Artiva Biotherapeutics (ARTV) presented updated Phase 2a results for AlloNK plus rituximab in Sjögren disease, showing six-month improvements in 11 patients. The ongoing single-arm trial had a July 2, 2026 data cutoff. Mean systemic disease activity improved by 6.9 points from 14.6, and patient-reported symptoms improved by 3.5 points from 8.0.

Among eight patients with baseline low saliva production and available six-month measurements, mean stimulated salivary flow increased from 0.4 to 1.1 mL/min. Preliminary safety data across 73 patients with several autoimmune diseases showed no cytokine release syndrome, immune-cell-associated neurotoxicity or adverse-event discontinuations. Eight patients (11%) experienced serious adverse events.

Positive

• Minor pointMean systemic disease activity improved 6.9 points from baseline 14.6 at six months.
• Minor pointMean patient-reported symptom score improved 3.5 points from baseline 8.0 at six months.
• Minor pointBoth mean score improvements exceeded the presented thresholds for minimal clinically important improvement.
• Minor pointMean stimulated salivary flow increased from 0.4 to 1.1 mL/min in eight patients at six months.
• Minor pointWeek 24 symptom improvements of at least one point occurred in dryness (82%), fatigue (55%) and pain (73%).

6 minor points

• Minor pointMean FACIT-Fatigue score increased 13.0 points from baseline 18.1 at six months, indicating improvement.
• Minor pointMean patient global assessment improved 3.5 points from baseline 7.21 at six months.
• Minor pointPreliminary safety in 73 patients showed no cytokine release syndrome, immune-cell-associated neurotoxicity, graft-versus-host disease or hypogammaglobulinemia.
• Minor pointNo patients discontinued treatment due to adverse events in the preliminary 73-patient safety population.
• Minor pointUniform B-cell depletion was observed by Day 13 in 51 patients across several autoimmune studies.
• Minor pointB-cell reconstitution in 13 patients showed an increased proportion of naïve/transitional B cells.

Negative

• Minor pointSingle-arm Sjögren results covered only the first 11 patients with at least six months of follow-up.
• Minor pointSerious adverse events occurred in eight patients (11%), including two with serious infections reported as unrelated to AlloNK.
• Minor pointTreatment-emergent adverse events most commonly included nausea (40%), headache (27%) and lymphopenia (25%).
• Minor pointTwo of 73 patients were hospitalized for treatment-emergent adverse events within 28 days; neither hospitalization was AlloNK-related.

Key Figures

Sjögren disease cohort: 11 patients ClinESSDAI change: Improved by 6.9 points from a baseline mean of 14.6 ESSPRI change: Improved by 3.5 points from a baseline mean of 8.0 +5 more

Sjögren disease cohort

11 patients

Phase 2a trial; at least six months of follow-up

ClinESSDAI change

Improved by 6.9 points from a baseline mean of 14.6

At six months

ESSPRI change

Improved by 3.5 points from a baseline mean of 8.0

At six months

FACIT-Fatigue change

Increased by 13.0 points from a baseline mean of 18.1

At six months

Stimulated salivary flow

Increased from 0.4 to 1.1 mL/min

Eight patients with baseline hyposalivation and six-month measurements

Safety population

73 patients

Phase 2a basket study across four autoimmune diseases

Serious adverse events

8 patients (11%)

Phase 2a basket study safety population

CRS, ICANS, graft-versus-host disease, hypogammaglobulinemia

None observed

Updated safety data across 73 patients; no treatment discontinuations due to adverse events

Historical Context

1 past event · Latest: Aug 06

1 event

1. Aug 06

   Phase 2a safety data

   24h Move

   -2.7%

   Prior 55-patient safety analysis reported no CRS, ICANS, related serious events or discontinuations.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, graft-versus-host disease, hypogammaglobulinemia, +1 more

5 terms

cytokine release syndrome medical

"No cytokine release syndrome (CRS), ICANS or graft-versus-host disease"

An intense immune overreaction in which the body's defense system releases a large surge of signaling proteins, causing fever, low blood pressure, breathing trouble or organ stress; imagine the immune system's alarm going into overdrive and flooding the body with emergency responders. Investors care because this side effect can slow or block regulatory approval, increase clinical trial costs and liabilities, limit how widely a therapy can be used, and therefore affect a drug's market value and sales potential.

immune effector cell-associated neurotoxicity syndrome medical

"immune effector cell-associated neurotoxicity syndrome (ICANS)"

immune effector cell-associated neurotoxicity syndrome (ICANS) is a brain-related side effect that can occur after treatments that activate powerful immune cells, such as engineered cell therapies. It can cause confusion, speech problems, seizures or coma when the immune response unintentionally harms brain function; think of an overenthusiastic security system that starts damaging the house it’s protecting. Investors care because ICANS affects clinical trial results, regulatory approvals, product labeling, treatment adoption, monitoring costs and potential liability, all of which influence a therapy’s commercial value.

graft-versus-host disease medical

"graft-versus-host disease or hypogammaglobulinemia was observed"

Graft-versus-host disease is a complication that can occur after a transplant using donor immune cells, where those transplanted cells attack the recipient’s organs and skin instead of protecting them; imagine a new security team mistaking the building’s occupants for intruders. It matters to investors because its likelihood, severity, and available treatments shape clinical trial results, drug approval chances, safety labels, patient outcomes, and the commercial potential of therapies aimed at preventing or managing the condition.

hypogammaglobulinemia medical

"graft-versus-host disease or hypogammaglobulinemia was observed"

A condition in which a person has abnormally low levels of antibodies in the blood, leaving the immune system less able to fight infections; think of it as having too few security guards on duty to spot and stop intruders. For investors, it matters because the condition affects demand for treatments, outcomes and safety in clinical trials, regulatory scrutiny, and healthcare costs—factors that influence revenue and risk for companies in diagnostics, therapeutics, and care services.

lymphopenia medical

"headache (27%) and lymphopenia (25%)"

Lymphopenia is a lower-than-normal level of lymphocytes, the white blood cells that act like the body's front-line defenders against infections. For investors, it matters because the condition can be a sign of disease or a side effect of a drug or treatment in clinical trials, potentially leading to safety warnings, trial delays, changed labeling or reduced market value; think of it as a red flag showing the immune system may be weakened.

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• Oral presentation includes safety and efficacy data as of the July 2, 2026 data cutoff, highlighting clinically meaningful improvements in disease activity and symptoms at six months in 11 patients with longstanding, highly active Sjögren disease
  
  
• Mean stimulated salivary flow increased from 0.4 to 1.1 mL/min among eight patients with baseline hyposalivation and available six-month data
  
  
• Updated safety data across 73 Phase 2a basket study patients support the potential for outpatient administration, with no cytokine release syndrome, ICANS or treatment discontinuations due to adverse events
  
  

SAN DIEGO, Oct. 01, 2026 (GLOBE NEWSWIRE) -- 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, today highlighted updated clinical, safety and translational data for AlloNK® (also known as AB-101) in combination with rituximab, presented by Guillermo J. Valenzuela, M.D., F.A.C.R., medical director of Integral Rheumatology & Immunology Specialists, in an oral session at the 17th International Symposium on Sjögren’s Disease (ISSjD 2026) in Paris.

The presentation featured data from the first 11 patients with Sjögren disease (SjD) in Artiva’s ongoing company-sponsored Phase 2a basket trial who had at least six months of follow-up as of July 2, 2026. The study is single-arm and evaluates AlloNK plus rituximab following low-dose cyclophosphamide and fludarabine conditioning, with treatment administered intravenously in an outpatient setting.

“These updated Sjögren disease data build on the initial findings we presented at EULAR and show improvements across systemic disease activity, patient-reported symptoms and salivary function,” said Fred Aslan, M.D., chief executive officer of Artiva. “We believe these results support continued evaluation of AlloNK plus rituximab as an outpatient-administered deep B-cell depleting regimen for patients with B-cell-driven autoimmune diseases. We look forward to following these patients to assess the durability of their responses.”

Updated Sjögren disease data show improvement across clinical and functional measures

The 11 patients with SjD had longstanding, highly active disease despite prior standard therapies. All were women, and the mean disease duration was 12.2 years. At six months, mean ClinESSDAI, a measure of systemic disease activity, improved by 6.9 points from a baseline mean of 14.6. Mean ESSPRI, a patient-reported measure of dryness, fatigue and pain, improved by 3.5 points from a baseline mean of 8.0. Both mean changes exceeded the thresholds for minimal clinically important improvement shown in the presentation.

On the individual ESSPRI domains, 82% of patients had at least a one-point improvement in dryness, 55% in fatigue and 73% in pain at Week 24. Mean FACIT-Fatigue score increased by 13.0 points from a baseline mean of 18.1, indicating improvement, while mean patient global assessment improved by 3.5 points from a baseline mean of 7.21.

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

Preliminary safety data as of July 2, 2026 included 73 patients in the Phase 2a basket study across SjD, rheumatoid arthritis, systemic sclerosis and inflammatory myositis, an expanded population from the 55 patients in the EULAR safety analysis. No cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), graft-versus-host disease or hypogammaglobulinemia was observed, and no patients discontinued treatment due to adverse events. Eight patients (11%) experienced serious adverse events, including two with serious infections reported as unrelated to AlloNK. The most common treatment-emergent adverse events were nausea (40%), headache (27%) and lymphopenia (25%). Two of 73 patients were hospitalized for treatment-emergent adverse events during the first 28 days; neither hospitalization was related to AlloNK.

The presentation also revisited translational findings previously reported at EULAR. Across several autoimmune studies, uniform B-cell depletion was observed by Day 13 in 51 patients, and B-cell reconstitution in 13 patients showed an increased proportion of naïve/transitional B cells. These findings are drawn from multiple autoimmune diseases and studies, beyond the 11-patient SjD cohort.

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 is initiating a Phase 3 registrational trial of its lead program, AlloNK® (also known as AB-101), for refractory rheumatoid arthritis (RA) during the second half of 2026. AlloNK is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved natural killer (NK) cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity in combination with a range of therapeutic antibodies. Initial clinical data evaluating AlloNK in combination with anti-CD20 antibodies have demonstrated encouraging activity across multiple B-cell-driven autoimmune diseases and a tolerability profile supportive of outpatient administration. Artiva is developing AlloNK plus rituximab as a scalable, outpatient-administered, deep B-cell depletion treatment regimen for use in community rheumatology settings. In addition to refractory RA, AlloNK is being evaluated in Sjögren disease, systemic sclerosis and myositis.

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 may include, without limitation, statements regarding: the potential benefits, accessibility, practicality, effectiveness, safety and tolerability of AlloNK, including based on interim pooled data across clinical trials, and the potential for administration in an outpatient community setting; the registrational Phase 3 trial for AlloNK, including trial design, expectations for response rates, and timing of initiation, future updates on site activation and enrollment, and topline data readout; and Artiva’s ability to generate sufficient data to support a BLA submission; clinical data expected to be presented from patients with refractory RA, SjD and SSc, and the timing of such data disclosures; the number of patients with data from the basket study who would be expected to meet the key eligibility criteria for the planned Phase 3 trial; Artiva’s ability to realize the potential benefits associated with FDA RMAT designation for AlloNK; Artiva’s beliefs regarding its competitive position, including its belief that AlloNK may be the first deep B-cell depleting therapy of any modality to reach patients with, and be approved and commercialized in, refractory RA; and Artiva’s future results of operations and financial position, including cash runway. 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 and delays relating to initiation of the Phase 3 registrational trial, activation of clinical trial sites, patient enrollment and the availability and timing of disclosure of data; 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, or with Artiva’s expectations; the risk that the number of patients, or the duration of follow-up for such patients, available for presentation differs from current expectations; the risk that differences exist between trial designs, patient characteristics and other factors for the Phase 3 trial, Artiva-sponsored Phase 2a basket trial and investigator-initiated basket trial, and caution should be exercised in drawing any conclusions from such data across separate trials as such pooling and comparative data is inherently limited and such data may not be directly comparable; the risk that other deep B-cell depleting therapies may advance more rapidly than Artiva currently anticipates, that Artiva’s assessment of publicly disclosed competitor development timelines may be incomplete or inaccurate, and that Artiva may not achieve or be the first to achieve regulatory approval or commercialization of a therapy in this category; the risk that Artiva’s registrational strategy is based in part on recent interactions with the FDA and later feedback from the FDA may be inconsistent with past interactions; Artiva’s ability to obtain adequate financing to fund its planned clinical trials and other expenses; 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 June 30, 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 & Media
Noopur Batsha Liffick, MPH
NBL LifeSci Advisory LLC
ir@artivabio.com

Source: Artiva Biotherapeutics, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Artiva’s AlloNK trial show in Sjögren disease at six months?

In 11 patients, mean systemic disease activity improved by 6.9 points from a baseline of 14.6, while mean patient-reported symptoms improved by 3.5 points from 8.0. Both mean changes exceeded the presented thresholds for minimal clinically important improvement. The results came from a single-arm study of AlloNK plus rituximab.

How was AlloNK administered in Artiva’s Phase 2a Sjögren disease study?

AlloNK plus rituximab was administered intravenously in an outpatient setting after low-dose cyclophosphamide and fludarabine conditioning. Artiva plans to continue following the patients to assess how long their responses last.

Who was included in Artiva’s updated AlloNK Sjögren disease cohort?

The cohort included 11 women with longstanding, highly active Sjögren disease despite prior standard therapies. Mean disease duration was 12.2 years. These were the first Sjögren patients in the ongoing company-sponsored Phase 2a basket trial with at least six months of follow-up as of July 2, 2026.