Artiva Biotherapeutics (ARTV) 25th Annual Needham Virtual Healthcare Conference summary

Strategic focus and clinical development

• Prioritizing rheumatoid arthritis (RA) as the lead indication due to the potential for deep B-cell depletion and scalable, community-based therapy.

• Upcoming clinical efficacy data in RA will cover at least 15 patients, most with six months or more of follow-up, and include updates on FDA interactions for a potential pivotal trial.

• Targeting late-line RA patients who have failed two distinct targeted mechanisms, aiming for an ACR50 response rate of 50%, which would be unprecedented in this population.

• At least 32 autoimmunity patients have been treated as of October, with ongoing enrollment and a focus on demonstrating durability of response.

• Median duration of response of at least 18 months is considered highly compelling for this refractory patient group.

Mechanism of action and efficacy rationale

• Therapy uses non-genetically modified NK cells combined with rituximab, offering safety advantages and deep B-cell depletion.

• Oncology experience showed complete response rates and durability comparable to auto CAR T, with some patients in remission for over two years.

• High-sensitivity assays show no detectable B cells post-treatment, supporting the hypothesis of a robust immune reset.

• Efficacy is expected to surpass what could be achieved by cyclophosphamide, fludarabine, or rituximab alone, especially at the low doses used.

Safety and tolerability profile

• No cases of CRS or ICANS observed in 32 autoimmunity patients; side effects are mainly known, transient cytopenias from Cy/Flu and manageable infections.

• Only one hospitalization reported due to an ear infection; most patients treated in community settings.

• Long-term risks such as secondary malignancy and fertility issues are minimal at the low doses used.

• Rheumatologists initially cautious about lymphodepletion, but feedback has been positive after experience with the regimen.