Business
ProKidney Reports First Quarter 2025 Financial Results and Business Highlights
Full data from Group 1 in the Phase 2 REGEN-007 study expected in Q2 2025FDA previously confirmed in a Q4 2024 Type B meeting that the accelerated approval
About this update from Prokidney Corp.
[{"type":"text","content":"Full data from Group 1 in the Phase 2 REGEN-007 study expected in Q2 2025FDA previously confirmed in a Q4 2024 Type B meeting that the accelerated approval pathway is available for rilparencel; additional details on the accelerated pathway are expected in mid-2025 after our planned Type B meeting with the FDAEnded the first quarter with $328.5 million in cash and cash equivalents and marketable securities, supporting operations into mid-2027 WINSTON-SALEM, N.C., May 12, 2025 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney” or the “Company\"), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today reported financial results and business highlights for the first quarter ended March 31, 2025. “The next two quarters are important for ProKidney as we approach two key milestones: the release of full Group 1 data from the Phase 2 REGEN-007 study and a regulatory update on the accelerated approval pathway for rilparencel following a planned Type B meeting with the FDA,” said Bruce Culleton, M.D., CEO of ProKidney. “With cash runway into mid-2027, we are in a strong financial position to continue executing our Phase 3 PROACT 1 study. I appreciate the continued engagement from our investigators, patients, and the ProKidney team as we work to address a significant unmet therapeutic need in patients with advanced CKD and type 2 diabetes.” Business Highlights Full data from Group 1 of the Phase 2 REGEN-007 study are expected in Q2 2025 and will comprise approximately 20 patients who have received two rilparencel injections, with an average follow-up of approximately 18 months.In a Type B meeting held in Q4 2024, the U.S. Food and Drug Administration (FDA) confirmed that the accelerated approval pathway is available for rilparencel if an acceptable surrogate endpoint, which may include eGFR slope, is used. Additional details on the potential accelerated approval pathway are expected in mid-2025 after our planned Type B meeting with the FDA. First Quarter 2025 Financial Highlights Liquidity: Cash, cash equivalents and marketable securities as of March 31, 2025, totaled $328.5 million, compared to $358.3 million as of December 31, 2024. We expect that our existing cash, cash equivalents and marketable securities held at March 31, 2025 will enable us to fund our operating expense...