ProKidney Streamlines Phase 3 Program to Expedite U.S. Approval of Rilparencel for Chronic Kidney Disease

Strategic Update:
ProKidney has refined its Phase 3 program to accelerate the path to potential U.S. approval and commercial launch of rilparencel, an investigational treatment for patients with type 2 diabetes and advanced CKD.

Trial Discontinuation:
The company has discontinued the ex-U.S.-based PROACT 2 trial to focus resources on PROACT 1, which is expected to expedite enrollment and accelerate estimated topline data readout to Q3 2027.

RMAT Designation:
Rilparencel has been granted RMAT designation by the FDA, which allows for an expedited approval pathway based on successful completion of the ongoing Phase 3 REGEN-006 (PROACT 1) trial.

Cost Savings:
The revised Phase 3 program is expected to reduce expenses by approximately $150 to $175 million and extend current cash to support operating plans into Q1 2027.

Clinical Focus:
The Phase 3 REGEN-006 (PROACT 1) trial focuses on patients with stage 4 CKD (eGFR 20-30ml/min/1.73m^2) and aims to evaluate the safety and efficacy of rilparencel in preserving kidney function.

Unmet Need:
ProKidney addresses a high unmet clinical and economic need in the treatment of CKD, with over 35 million U.S. adults having CKD and approximately 135,000 patients progressing to dialysis every year.