ProKidney Reports Third Quarter 2025 Financial Results and Provides Regulatory and Clinical Updates

Full results from the Phase 2 REGEN-007 study of rilparencel were recently presented as a late-breaking clinical trial at the American Society of Nephrology (ASN) Kidney Week 2025More than half of the patients required for the Phase 3 REGEN-006 (PROACT 1) accelerated approval analysis using estimated glomerular filtration rate (eGFR) slope have been enrolled; topline results anticipated in Q2 2027Ended the third quarter with $272 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027

WINSTON-SALEM, N.C., Nov. 10, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cell therapy company focused on chronic kidney disease (CKD), today reported financial results for the third quarter ended September 30, 2025, and provided regulatory and clinical updates.

“The Phase 2 REGEN-007 full results recently presented at ASN Kidney Week further strengthen the body of evidence supporting our ongoing Phase 3 PROACT 1 study and underscore the potential of rilparencel to become a novel treatment option for patients with advanced CKD and diabetes,” said Bruce Culleton, M.D., Chief Executive Officer of ProKidney. “In Group 1, which mirrored the dosing regimen being evaluated in the ongoing Phase 3 PROACT 1 study, treatment with rilparencel led to statistically significant and clinically meaningful stabilization of kidney function. Notably, 63% of Group 1 patients met the key PROACT 1 inclusion criteria, and similar efficacy was observed in this subgroup compared to the overall Group 1 results. We remain focused on the continued execution of PROACT 1 to bring a potential new treatment option to patients with advanced CKD and diabetes at high risk of kidney failure, an area of significant unmet need.”

Phase 2 REGEN-007 Full Results Recently Presented at ASN Kidney Week 2025
On November 6, 2025, ProKidney presented full results from the Phase 2 REGEN-007 study evaluating rilparencel in patients with advanced CKD and diabetes. The data, featured in a late-breaking clinical trials presentation, further demonstrate the potential of rilparencel to preserve kidney function in patients with advanced CKD and diabetes who are at high risk of kidney failure. Highlights include:

In Group 1 (n=24), bilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 improvement in the annual decline in eGFR slope; this 78% improvement was statistically significant and clinically meaningful (p