Artiva Biotherapeutics (ARTV) H.C. Wainwright 28th Annual Global Investment Conference summary

Pipeline and clinical development

• Lead program targets refractory rheumatoid arthritis (RA) using allogeneic NK cell therapy, aiming to be first deep B-cell depleting product approved for RA since 2019.

• Phase II basket study includes RA, Sjögren's, scleroderma, and myositis; phase III trial design aligned with FDA.

• $300 million raised to fund operations through phase III completion into 2029.

• Updated data to be presented at ACR, including at least 20 RA, 10 Sjögren's, and 5 scleroderma patients with over six months follow-up.

• Over 70 autoimmune and 60 oncology patients treated, demonstrating robust efficacy across indications.

Differentiation and mechanism of action

• NK cell therapy combined with rituximab achieves deeper B-cell depletion than rituximab alone, as shown by highly sensitive assays.

• Phase III is a randomized controlled trial against rituximab to demonstrate superiority.

• NK cells avoid cytokine release syndrome and ICANS, enabling community-based administration and improved safety profile.

• Manufacturing process is scalable and cost-effective, resembling biologics more than traditional cell therapies.

• Simple bedside administration without need for specialized pharmacy or complex monitoring.

Efficacy, safety, and durability

• Phase II data: 71% ACR50 response at six months in evaluable RA patients, targeting at least 50% ACR50 in phase III versus 20% for rituximab.

• B cells recover with a naive phenotype post-treatment, potentially reducing infection risk compared to chronic therapies.

• Durability expected to last 12 months or more per treatment, with potential for redosing as needed.

• Redosing protocol in phase III monitors response duration and efficacy of subsequent treatments.

• Oncology data supports consistent pharmacokinetics and no evidence of cell rejection upon retreatment.