Artiva Biotherapeutics (ARTV) investor relations material

Platform and community delivery

• AlloNK uses non-genetically modified NK cells with rituximab; rituximab targets CD20 and engages NK-cell CD16 to kill B cells.

• NK cells do not expand like T cells; the approach is intended to avoid T-cell-associated CRS and ICANS and support community treatment.

• More than 100 autoimmune patients have been treated, mostly in community rheumatology practices; no CRS or ICANS was reported.

• Treatment uses two 1-g rituximab doses 14 days apart, with a 5–10-minute AlloNK infusion on each dosing day; the process involves five infusion-center visits including preconditioning.

Clinical evidence and target population

• Refractory RA was defined in FDA discussions as failure of two or more distinct biologics or a JAK; cited ACR50 benchmarks for refractory patients are 10%–20%.

• EULAR data covered ~35 autoimmune patients, including ~20 with RA; ACR50 was 71% in the presented population, against a 50% target.

• Three RA patients reached 12 months without needing another therapy; the target is at least 12 months of durability for most responders.

• Redosing after response loss is part of the target treatment approach; retreatment PK, PD, B-cell depletion and clinical benefit are being assessed.

Safety and treatment regimen

• Cyclophosphamide and fludarabine cause transient, shallow cytopenia, including neutropenia; in the first 55 patients, two hospitalizations within 28 days were judged unrelated to treatment.

• During cytopenia, patients receive prophylactic antivirals, antibacterials and antifungals; hospitalization has been low in the treated population.

• The randomized trial regimen uses cyclophosphamide 300 mg/day, fludarabine 30 mg/m² and 4 billion NK cells per dose, given twice for 8 billion cells total.