Artiva Biotherapeutics (ARTV) H.C. Wainwright 4th Annual Cell Therapy Virtual Conference summary

Program overview and differentiation

• AlloNK, an allogeneic NK cell therapy, has shown potent and deep B-cell depletion in both oncology and autoimmune disease, with refractory RA as the lead indication.

• The therapy combines non-genetically engineered NK cells with monoclonal antibodies for targeted, deep B-cell depletion, achieving more consistent results than rituximab alone.

• Safety advantages include no CRS or ICANS, enabling treatment in community settings and reducing the need for hospital monitoring.

• Scalable manufacturing allows treatment of over 500 patients per umbilical cord unit, with low cost of goods and projected therapy cost around $8,000 per patient.

• The process uses established conditioning agents (cyclophosphamide and fludarabine) with demonstrated tolerability.

Clinical data and efficacy

• In a cohort of 21 refractory RA patients, 71% achieved ACR50, far exceeding the 10-20% rate seen with standard therapies in this population.

• Responses were durable, with no loss of response at six months and evidence of deepening efficacy over time.

• Safety data from 55 patients showed low hospitalization and infection rates, with cytopenias being short-lived and mostly asymptomatic.

• Efficacy in Sjögren's and scleroderma matched or exceeded late-stage competitors, with consistent clinical and objective improvements.

• The therapy's safety profile supports use in community settings, leveraging decades of experience with the conditioning agents.

Durability, re-treatment, and future outlook

• The therapy is designed for infrequent dosing, with potential for re-treatment at 12, 18, or 24 months, aiming for long-term disease control.

• Unlike auto CAR T, which faces challenges with redosing, AlloNK can be administered as needed, reducing ongoing immunosuppression.

• Ongoing basket studies will provide further data on durability, re-treatment, and efficacy across multiple autoimmune indications over the next 2-3 years.