ProKidney Presents Full Results from the Phase 2 REGEN-007 Trial of Rilparencel at the American Society of Nephrology Kidney Week 2025

In patients with advanced chronic kidney disease (CKD) and diabetes, treatment with rilparencel resulted in statistically significant and clinically meaningful slowing of CKD progressionBilateral kidney injection with rilparencel resulted in a 4.6 mL/min/1.73m2 (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in Group 1 (n=24) patientsNo rilparencel-related serious adverse events were observed; the overall study safety profile was consistent with previously reported study results and comparable to a kidney biopsyFDA previously confirmed eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencelMore than half of the patients required for the Phase 3 REGEN-006 (PROACT 1) accelerated approval analysis using eGFR slope have been enrolled; topline results anticipated in Q2 2027Rilparencel is the only cell therapy in a Phase 3 clinical study for the treatment of CKD and type 2 diabetes

WINSTON-SALEM, N.C., Nov. 06, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK)(“ProKidney” or the “Company"), a leading late clinical-stage cell therapy company focused on CKD, today presented full results from the Phase 2 REGEN-007 trial evaluating rilparencel in patients with advanced CKD and diabetes. The data, featured in a late-breaking clinical trials presentation at the American Society of Nephrology (ASN) Kidney Week 2025, 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 and have limited therapeutic options.

The full Phase 2 trial results presented at ASN Kidney Week 2025 add to the body of clinical data for rilparencel that support the ongoing registrational Phase 3 PROACT 1 study. A first-of-its-kind, proprietary, autologous cell therapy, rilparencel has the potential to be a novel treatment for advanced CKD and diabetes, offering patients an alternative therapeutic option to delay or prevent the need for dialysis.

“Cell therapy represents an emerging therapeutic class that seeks to treat CKD by addressing the multiple, maladaptive processes responsible for kidney injury and progression,” said Dr. Arnold Silva, principal investigator of the REGEN-007 study, founding physician partner and director of clinical research at Boise Kidney & Hypertension Institute. “These latest study findings further confirm the potential of rilparencel to positively impact kidney function in patients with advanced CKD and diabetes. Evidence of kidney function stabilization through assessments of eGFR slope, a valuable and clinically meaningful outcome measure of CKD progression, along with confirmation of a well-tolerated safety profile, support continued evaluation of rilparencel as a novel therapeutic option.”

Phase 2 REGEN-007 Overview and Full Results Summary
REGEN-007 was a multi-center Phase 2 open-label 1:1 randomized two-arm trial in patients with advanced CKD and diabetes. Eligible participants were assigned to one of two treatment groups using different dosing regimens. Group 1 replicated the dosing schedule of the ongoing Phase 3 PROACT 1 study in which patients receive two scheduled rilparencel injections (one in each kidney), approximately three months apart. Group 2 tested an exploratory dosing regimen to investigate whether disease progression triggers, rather than a time-based trigger, could optimize multiple doses of rilparencel. Group 2 received one injection and a second only if a re-dosing trigger was met within 15 months after the first injection. Participants were followed up to 18 months after their last injection. Overall, 87 rilparencel injections in 49 participants were performed during the study. The primary efficacy endpoint was change in eGFR slope from the pre-injection period to the period after the last injection analyzed using a linear mixed model. The primary safety endpoint was the percentage of participants with procedure- and investigational product-related treatment-emergent adverse events (TEAEs).

Among the full results from the study, key efficacy and safety findings 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