ProKidney (PROK) Corporate presentation summary

Transforming chronic kidney disease (CKD) care

• Rilparencel is a first-in-class autologous cell therapy with RMAT designation, targeting patients with stage 3b/4 CKD and type 2 diabetes, aiming to preserve kidney function and delay dialysis or transplantation.

• Over 1 million people in the U.S. have stage 3b/4 CKD and diabetes, representing a significant market opportunity.

• Standard of care therapies do not prevent progression to kidney failure in a large proportion of patients, highlighting unmet needs.

• Rilparencel is made from a patient’s own kidney cells, requires no genetic modification, preconditioning, or lifelong immunosuppression, and has shown a favorable safety profile.

Clinical development and results

• Phase 2 studies demonstrated statistically significant stabilization of kidney function, with an 85% improvement in annual eGFR slope in patients meeting phase 3 criteria.

• No rilparencel-related serious adverse events were observed; safety profile was comparable to kidney biopsy.

• Phase 3 PROACT 1 trial is ongoing, with pivotal topline results for the eGFR slope surrogate endpoint expected in Q2 2027.

• FDA has agreed to use annualized eGFR slope as a surrogate endpoint for accelerated approval.

• Enrollment for the accelerated approval efficacy analysis is expected to complete by mid-2026.

Manufacturing and operational execution

• Two adjacent, company-owned manufacturing facilities totaling 180,000 square feet in Winston-Salem, NC, support clinical and future commercial supply.

• Ongoing capital investment is focused on process readiness for BLA submission and commercial launch.

• Expansion of in-house manufacturing capacity is aligned with clinical and commercial milestones.