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

ProKidney

FDA confirmed at a July 2025 Type B meeting and in the subsequent meeting minutes that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced CKD; FDA also confirmed that the ongoing Phase 3 PROACT 1 study may be used to support both accelerated and confirmatory approval of rilparencel More than half of the patients required for the accelerated approval analysis using eGFR slope have been enrolled in the Phase 3 PROACT 1 study; topline data anticipated in Q2 2027 On July 8, 2025, ProKidney reported positive topline results from the Phase 2 REGEN-007 study; eGFR slope in Group 1 (n=24) improved by 78% after treatment with rilparencel Full results from REGEN-007 will be submitted to the American Society of Nephrology 2025 Kidney Week as a late-breaking clinical trial Ended the second quarter with $295 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027

WINSTON-SALEM, N.C., Aug. 12, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company"), a leading late clinical-stage cell therapeutics company focused on chronic kidney disease (CKD), today reported financial results for the second quarter ended June 30, 2025, and provided regulatory and clinical updates.

“We’ve made tremendous progress in 2025, and July was a pivotal month for ProKidney with the release of positive topline data from our Phase 2 REGEN-007 study and alignment with the FDA on the accelerated approval pathway for rilparencel using eGFR slope as the surrogate endpoint,” said Bruce Culleton, M.D., CEO of ProKidney. “We are now focused on maintaining enrollment momentum in the Phase 3 PROACT 1 study and preparing for a late-breaking submission of Phase 2 REGEN-007 data at ASN Kidney Week in November. Each step brings us closer to our goal of delivering a novel treatment option to patients with diabetes and advanced CKD, a population where there remains high unmet clinical need.”

FDA Alignment Achieved for the Rilparencel Accelerated Approval Pathway In a July 2025 Type B meeting, the U.S. Food and Drug Administration (FDA) confirmed that the slope of estimated glomerular filtration rate (eGFR) in patients from the ongoing Phase 3 PROACT 1 study can serve as the surrogate endpoint and primary basis for a Biologics License Application (BLA) submission of rilparencel under the accelerated approval pathway. The FDA agreed that a rilparencel effect size (versus sham controls) of at least 1.5 mL/min/1.73m2 per year improvement would be an acceptable demonstration of efficacy in the setting of patients receiving appropriate standard of care therapies.

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ProKidney anticipates topline data readout of eGFR slope as the surrogate endpoint to support an application for accelerated approval in Q2 2027. To date, more than half of the approximately 350 patients required for the accelerated approval analysis have been enrolled in the ongoing Phase 3 PROACT 1 study. The FDA also confirmed that PROACT 1 may serve as the confirmatory study to support full approval of rilparencel based on the primary time-to-event composite endpoint specified in the protocol. Formal meeting minutes from the FDA following the Type B meeting held in July 2025 confirm alignment with ProKidney. ProKidney will continue to maintain its ongoing dialogue with the FDA under rilparencel’s regenerative medicine advanced therapy (RMAT) designation.

Phase 2 REGEN-007 Positive Topline Results
On July 8, 2025, ProKidney announced statistically and clinically significant topline results from the Phase 2 REGEN-007 study. Of note, in Group 1 (n=24), which replicated the rilparencel dosing schedule of the ongoing Phase 3 PROACT 1 study, kidney function stabilized. The annual decline in eGFR slope improved by 78%, from -5.8 in the pre-injection period to -1.3 mL/min/1.73m² in the period following the last rilparencel injection. This 4.6 mL/min/1.73m2 per year difference1 was statistically significant (p