ProKidney — Q3 2026 Earnings Summary

ProKidney is developing rilparencel, a novel autologous cell therapy derived from a patient's own kidney cells, designed to preserve kidney function in patients with advanced chronic kidney disease and type 2 diabetes. The company's pivotal Phase 3 PROACT 1 trial is currently ongoing with over 500 enrolled patients, targeting a top-line readout for the eGFR slope surrogate endpoint in the second quarter of 2027 to support an accelerated approval pathway. Clinical data from completed Phase 2 studies, including REGEN-007, demonstrated that rilparencel significantly stabilized kidney function with a median follow-up of 18 months and showed a favorable safety profile comparable to standard kidney biopsies. The therapy is administered via minimally invasive outpatient injections without the need for preconditioning or immunosuppression, addressing a significant unmet need for patients who have exhausted current standard-of-care options.