Artiva Biotherapeutics (ARTV) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Strategic positioning and platform overview

• Advanced an NK cell platform for autoimmune disease, focusing on deep B-cell depletion to achieve durable clinical benefits, with a pivotal trial underway in rheumatoid arthritis (RA).

• Chose RA as a lead indication due to a unique safety profile and the ability to treat patients in community settings, differentiating from crowded indications like lupus.

• Leveraged oncology experience to demonstrate deep B-cell depletion and durable responses, with a favorable safety profile compared to other modalities.

• Positioned to be the first deep B-cell depleting product in RA since 2019, with no other phase II or III competitors announced.

• Emphasized the importance of product-specific data and safety over general perceptions of NK cell platforms.

Clinical development and trial design

• Phase III RA trial is initiating, with updates on site initiation and enrollment expected before year-end and top-line results anticipated by end of 2028.

• Phase II data showed high ACR50 rates in refractory RA patients, including those who failed multiple prior therapies, supporting the unmet need in this population.

• Enrollment has been strong, especially in community practices, with over 70 patients enrolled as of April and expansion to Europe and Latin America.

• Phase III trial will randomize patients to the investigational product or rituximab, excluding rituximab failures for ethical reasons.

• Plans to optimize patient selection in phase III by enriching for those with active inflammation and less structural damage.

Product profile, safety, and competitive landscape

• Product regimen includes cyclophosphamide and fludarabine (Cy/Flu), considered acceptable due to efficacy and tolerability at lower doses than oncology.

• Ongoing efforts to determine the minimum necessary Cy/Flu dosing and explore alternatives, but current focus is on bringing the product to market with the established regimen.

• Competitive landscape in RA is favorable, with few active programs in deep B-cell depletion and most competitors lagging in development.

• Debate continues between the risks of Cy/Flu and cytokine release syndrome (CRS) from other modalities, with community practitioners favoring regimens with less monitoring burden.

• Durability of response is targeted at 12-24 months, with potential for retreatment and commercial attractiveness due to extended benefit periods.