Nkarta (NKTX) Stifel 2026 Virtual Immunology and Inflammation Forum summary

Program overview and clinical strategy

• Developing an allogeneic, off-the-shelf CD19 CAR NK cell therapy for autoimmune diseases, administered outpatient across two INDs: Ntrust-1 (lupus nephritis) and Ntrust-2 (basket study: scleroderma, myositis, vasculitis, rheumatoid arthritis).

• First data to be presented at the American College of Rheumatology (ACR) Convergence 2026, focusing on myositis and scleroderma with oral and poster presentations, plus a dedicated safety session.

• Protocol amendments, in agreement with FDA, have removed many restrictions, enabling outpatient dosing, compressed schedules, and improved patient convenience, which has accelerated enrollment.

• Community-based centers have been added to broaden trial access and further boost enrollment, shifting focus from academic-only sites.

• The company will narrow its focus to key indications with the strongest data for pivotal trials, while revisiting other indications over time.

Dosing, safety, and efficacy approach

• Dose escalation has reached 4 billion cells per dose, with ongoing evaluation of higher doses and compressed regimens to optimize efficacy and safety.

• Dose decisions are guided by PK/PD, B-cell depletion (including lymph node biopsies), and clinical response data, with a focus on patient-reported outcomes.

• Safety profile allows for redosing and outpatient administration, with no hospitalization required; ability to retreat patients is demonstrated.

• Only steroids are allowed as background therapy; all other immunomodulators are discontinued prior to dosing.

• Efficacy endpoints include disease-specific indices (TIS for myositis, CRISS for scleroderma), durability of response, and patient-reported outcomes.

Regulatory and development outlook

• FDA has been supportive, allowing protocol flexibility and encouraging single-arm trials for registrational efforts.

• Plans to initiate registrational trials before the end of 2027, with high confidence in meeting this timeline.

• Focus will be on indications with robust data and durable responses, aiming for efficient enrollment and clear efficacy benchmarks versus CAR T therapies.

• Durability and safety will be key differentiators, with ongoing data collection to support long-term outcomes.

• Additional updates and expanded data sets are expected in 2027, with continued emphasis on safety and durability.