ProKidney Announces Strategic Updates to its Phase 3 Program to Accelerate Rilparencel's Registration Process to Potential Approval in the U.S. Page 1

• The focus of the Phase 3 program has been refined to accelerate the path to potential U.S. approval and launch in the company's most important market.
• The PROACT 2 study conducted outside the United States has been discontinued and company resources have been focused on PROACT 1 to accelerate enrollment and shorten the expected release of topline data to the third quarter of 2027.

WINSTON-SALEM, N.C., Sept. 3, 2024 (GLOBE NEWSWIRE) — (Nasdaq: PROK) (“ProKidney” or the “Company”), a late-stage biotechnology company focused on developing a first-in-class cell therapy candidate for chronic kidney disease (CKD), today announced strategic updates to its Phase 3 program for rilparencel, an investigational drug for the potential preservation of kidney function in patients with type 2 diabetes and advanced CKD.

ProKidney recently completed a comprehensive internal and external review, including involvement from former FDA officials and experienced regulatory experts, to determine the optimal path to make rilparencel available to patients in the U.S. with type 2 diabetes and advanced CKD, a market where there is high unmet clinical and economic need. A key outcome of this review is that, under the terms of the Regenerative Medicine Advanced Therapy (RMAT) designation, the Company believes rilparencel will be eligible for initial FDA approval under an accelerated approval process if the ongoing Phase 3 REGEN-006 (PROACT 1) trial is successfully completed. ProKidney believes that the Phase 3 REGEN-016 (PROACT 2) trial is not required for initial U.S. approval. As a result, the Company will discontinue PROACT 2, which was focused on enrolling patients outside of the U.S. With the discontinuation of PROACT 2, ProKidney now expects current cash resources to support operating plans through the first quarter of 2027. The Company expects the revised Phase 3 program to deliver peak results by the third quarter of 2027 and reduce costs by approximately $150 million to $175 million.

“We have chosen to prioritize PROACT 1 to accelerate potential U.S. registration and launch. We are confident that this strategic shift in our Phase 3 program is the fastest and most resource-efficient approach to bring rilparencel to market in the U.S., our highest priority market,” said Bruce Culleton, MD, Chief Executive Officer. “The recent positive interim data update on REGEN-007 in June underscores the urgency of bringing our innovation to patients with advanced CKD. We look forward to continuing our collaboration with the FDA under the RMAT designation to bring rilparencel to market.”