ProKidney Q2: Rilparencel eGFR slope improves by 78%, topline PROACT 1 data in Q2 2027.

• FDA confirms eGFR slope as acceptable surrogate endpoint for rilparencel approval • FDA accepts ongoing Phase 3 PROACT 1 study for accelerated and confirmatory approval • Over half of patients required for accelerated approval enrolled in PROACT 1 study • Topline data from PROACT 1 expected in Q2 2027 • Phase 2 REGEN-007 study results show 78% improvement in eGFR slope with rilparencel treatment • Full REGEN-007 results to be submitted to FDA for review

ProKidney Corp. (Nasdaq: PROK) reported its second quarter 2025 financial results and provided significant regulatory and clinical updates on July 12, 2025. The company, which focuses on developing cellular therapies for chronic kidney disease (CKD), achieved notable progress in its pipeline, particularly with the Phase 2 REGEN-007 study and alignment with the FDA on the accelerated approval pathway for rilparencel.

Regulatory and Clinical Updates

# FDA Confirmation of eGFR Slope as Surrogate Endpoint
The FDA confirmed at a July 2025 Type B meeting that the slope of estimated glomerular filtration rate (eGFR) is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with type 2 diabetes and advanced CKD. This alignment paves the way for ProKidney to use data from the ongoing Phase 3 PROACT 1 study to support both accelerated and confirmatory approvals [1].

# Phase 3 PROACT 1 Study Progress
More than half of the approximately 350 patients required for the accelerated approval analysis have been enrolled in the Phase 3 PROACT 1 study. The FDA has confirmed that this study may be used to support both accelerated and confirmatory approvals of rilparencel. Topline data from PROACT 1 is anticipated in Q2 2027 [1].

Clinical Trial Results

# Phase 2 REGEN-007 Study
On July 8, 2025, ProKidney reported positive topline results from the Phase 2 REGEN-007 study. In Group 1 (n=24), the eGFR slope improved by 78% after treatment with rilparencel. This significant improvement was statistically and clinically meaningful, with no rilparencel-related serious adverse events observed [1].

Financial Highlights

# Cash Position and Expenses
ProKidney ended the second quarter with $295 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027. Research and development expenses were $25.9 million for the three months ended June 30, 2025, compared to $29.4 million for the same period in 2024. General and administrative expenses were $14.0 million for the three months ended June 30, 2025, compared to $13.7 million for the same period in 2024 [1].

Conclusion

ProKidney’s achievements in the second quarter 2025 underscore the company's progress in developing innovative treatments for CKD. The alignment with the FDA on the accelerated approval pathway for rilparencel, combined with the promising results from the Phase 2 REGEN-007 study, positions ProKidney to potentially deliver a novel therapy for patients with diabetes and advanced CKD, a population with high unmet clinical need.

References

[1] https://www.globenewswire.com/news-release/2025/08/12/3132100/0/en/ProKidney-Reports-Second-Quarter-2025-Financial-Results-and-Provides-Regulatory-and-Clinical-Updates.html