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ProKidney
ProKidney (PROK) investor relations material
ProKidney 44th Annual J.P. Morgan Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.44th Annual J.P. Morgan Healthcare Conference summary14 Jan, 2026
Strategic vision and clinical focus
Aims to transform treatment for advanced chronic kidney disease (CKD) with rilparencel, an autologous cell therapy targeting high-risk patients facing kidney failure.
FDA alignment on accelerated approval pathway using eGFR slope as a surrogate endpoint; pivotal Phase III topline results expected in Q2 2027.
Over 150 patients treated in phase II trials, showing kidney function stabilization and favorable safety profile; phase III pivotal readout expected in Q2 2027.
Focused on a single product, with robust clinical data, experienced leadership, and a cash runway extending past mid-2027.
Manufacturing expansion underway in North Carolina, with two new buildings totaling 180,000 sq ft to support commercial launch and BLA submission.
Clinical development and study design
Phase III PROACT 1 study targets advanced CKD and type 2 diabetes patients, using a randomized, sham-controlled, blinded design.
Enrollment for accelerated approval efficacy analysis expected to complete by mid-2026, with top-line readout in Q2 2027.
Power calculations for phase III are conservative, assuming a 1.5 ml/min difference in eGFR slope, despite phase II showing >4 ml/min difference.
Subgroup analyses and safety are key components of the upcoming top-line readout.
Target population for phase III narrowed to eGFR 20–35 to focus on highest-risk patients.
Rilparencel manufacturing and mechanism of action
Manufactured from patient’s own kidney cells, with no gene editing, preconditioning, or immunosuppression required.
Process involves kidney biopsy, cell expansion to over a billion cells, and bilateral kidney injections three months apart.
Final product primarily contains tubular and epithelial cells with reduced inflammatory and fibrotic markers.
Working hypothesis: injected cells exert anti-inflammatory effects and leverage innate kidney repair mechanisms, but do not form new nephrons.
Ongoing R&D and mechanism of action studies, with data expected throughout 2026 and presentations at major conferences.
Assess confidence in 1.5 eGFR slope target
Detail manufacturing scalability for commercial launch
How does rilparencel differentiate in advanced CKD?
PROACT 1 derisking: What's underappreciated
Rilparencel MOA: What to learn in 2026
2026 commercial prep: Key activities
Partial view of Summaries dataset, powered by Quartr API
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Next ProKidney earnings date
Q4 202518 Mar, 2026
ProKidney
Next ProKidney earnings date
Q4 202518 Mar, 2026
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Frequently asked questions
ProKidney Corp is a clinical-stage biotechnology company focused on the development of cell therapy products for chronic kidney disease. Its lead candidate is based on autologous cell therapy aimed at preserving kidney function. The company is headquartered in Winston-Salem, North Carolina, and its shares are listed on the NASDAQ.
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