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ProKidney (PROK) investor relations material
ProKidney Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities 2nd Annual Healthcare Innovation Conference summary12 Nov, 2025
Company overview and mission
Focused on preserving kidney function in advanced chronic kidney disease patients using an autologous cell therapy currently in phase 3 trials.
Aims to keep patients off dialysis and provide more time for organ replacement options.
Employs about 250 staff across North Carolina and Boston, all aligned with the mission.
Clinical progress and trial design
Overcame early manufacturing challenges and achieved GMP compliance for phase 3.
Phase 3 trial is double-blind, sham-controlled, and enrolling at over 60 sites in the US, Taiwan, and Mexico.
Over 50% enrolled for phase 3; top-line data expected in Q2 2027 using eGFR slope for accelerated approval.
Phase 3 is powered to detect a 1.5 mL/min/year difference in eGFR decline, with 90% power.
Key clinical data and mechanism of action
Phase 2 study (007) showed a 78% reduction in kidney function decline in the group mirroring the phase 3 protocol.
Group 2 showed a 50% benefit, suggesting a dose-response relationship, though not statistically significant.
Product is manufactured from 50,000-100,000 cells to billions, with unique antifibrotic and anti-inflammatory markers.
Mechanism involves antifibrosis, anti-inflammation, and supporting innate kidney repair.
Mitigate demand outpacing manufacturing capacity
Rilparencel differentiation from GLP-1s
Post-accelerated approval commercialization plan
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Q4 202517 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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