Nkarta (NKTX) Evercore ISI 8th Annual HealthCONx Conference summary

Program updates and trial design

• Data readouts for the I&I program have been delayed to next year to ensure robust data from patients treated with the updated Flu/Cy lymphodepletion regimen rather than Cy alone.

• The switch to Flu/Cy was driven by physician feedback and has resulted in improved enrollment and investigator engagement.

• Enrollment has accelerated, with dose escalation progressing to the second cohort and plans to reach the highest dose cohort in January.

• The trial now uses a basket design with five indications, integrating safety oversight and enabling faster, indication-agnostic dose escalation.

• FDA guidance allows for potential pivotal expansion after dose escalation, providing flexibility for future development.

Clinical and operational strategy

• The Flu/Cy regimen is now standard, with compressed dosing and higher cell doses, aligning with best practices in the field.

• The new protocol eliminates previous 30-day patient dosing staggers, allowing for parallel dosing and faster enrollment.

• The program covers lupus nephritis, primary membranous nephropathy, scleroderma, ANCA-associated vasculitis, and myositis, with additional ISTs under consideration.

• Patient focus will be refined based on enrollment and data, with the FDA open to exploring further indications.

• Deep B-cell depletion is targeted across all indications, with the goal of achieving durable clinical responses.

Competitive landscape and differentiation

• Cell therapy is expected to outperform small molecules and bispecifics in response rates and durability, especially in severe or refractory disease.

• The ability to redose allogeneic NK cell therapy is a key differentiator, with prior oncology experience showing durable remissions after retreatment.

• Safety profile remains strong, with minimal neurotoxicity and cytokine release syndrome observed.

• The program aims for accessibility and community-based administration, positioning it favorably against CAR-T and other modalities.

• The FDA has provided consistent guidance, and the company is positioned to present competitive data next year.