Here are the 10-K annual reports from ProKidney Corp. (PROK) in our archive since June 2025, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 10-K covers the audited annual report, with the full financial statements, so if you follow PROK and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full PROK filings page.
ProKidney Corp. is a late-clinical-stage biotech company developing rilparencel, an autologous cell therapy aimed at preserving kidney function in patients with advanced chronic kidney disease and diabetes. The company completed a corporate domestication from the Cayman Islands to Delaware and streamlined its holding structure in 2025.
Rilparencel is the only cell therapy in a Phase 3 study for advanced CKD and type 2 diabetes and has FDA regenerative medicine advanced therapy designation. Phase 2 trials (including REGEN-007 and RMCL-002) showed statistically significant slowing of eGFR decline in key groups and a safety profile similar to kidney biopsy procedures.
The ongoing Phase 3 PROACT 1 (REGEN-006) trial targets about 470 patients with Stage 3b–4 CKD in the United States, Mexico and Taiwan, using annualized eGFR slope as the surrogate endpoint for potential accelerated approval, with topline surrogate data expected in the second quarter of 2027 and confirmatory time-to-event data in the second half of 2029. ProKidney operates an in-house GMP-aligned manufacturing facility in North Carolina, recently remediated to meet U.S. and European standards, and holds a broad global patent estate protecting rilparencel, its formulations, quality controls and methods of use.