Nkarta (NKTX) investor relations material

Key data and clinical insights

• NK cell therapies show consistent, rapid, and deep B cell depletion across multiple datasets, with minimal cytokine release syndrome or neurotoxicity observed so far.

• RuYi's CD19-directed CAR NK data in SLE shows over 70% improvement at nine months, with safety and efficacy comparable to autologous CAR T, but with better accessibility.

• Dose escalation in trials is ongoing, with current dosing at 2 billion cells per dose, and plans to escalate further if needed, following observed responses at lower doses.

• Fludarabine plus cyclophosphamide is now the preferred lymphodepletion regimen, leading to deeper B cell depletion and improved enrollment.

• U.S. trials aim for drug-free remissions, with ongoing evaluation of steroid use and background therapies to optimize patient outcomes.

Study design and operational updates

• Protocol amendments have streamlined patient enrollment, reducing stagger requirements and enabling more flexible dosing schedules.

• Trials are expanding to community-based centers, with support services for patients to improve access and convenience.

• Both lupus nephritis and other autoimmune indications are being studied under a combined protocol, with data expected from multiple disease areas.

• Expansion of cohorts will depend on observing durable complete responses at optimal dose levels.

• FDA collaboration has enabled protocol flexibility, with potential for dose expansion cohorts to serve as pivotal studies if data are robust.

Forward-looking statements and expectations

• Robust clinical data, including B cell depletion and clinical outcomes, are expected by next year, with presentations planned at major medical meetings.

• Durability benchmarks are still emerging, but six- and twelve-month data are considered important for regulatory and clinical assessment.

• The company is well-capitalized through 2029, supporting continued development and proof-of-concept milestones.

• Increased investigator and patient interest is driving enrollment, with rheumatologists becoming more comfortable managing cell therapies.

• The competitive landscape remains open, with no clear long-term leader among cell therapies, T cell engagers, or bispecifics.