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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 III trials.
Aims to delay dialysis and provide more time for organ transplant opportunities.
Employs about 250 staff across North Carolina and Boston, all aligned with the mission to keep patients out of dialysis units.
Clinical progress and trial design
Overcame early manufacturing challenges and achieved GMP compliance for phase III studies.
Positive FDA interactions led to a single phase III trial and alignment on accelerated approval using eGFR slope as an interim endpoint.
Phase III trial is double-blind, sham-controlled, and enrolling well, with over 50% enrollment completed.
Accelerated approval readout is planned for Q2 2027, with full enrollment expected in 2026.
Key clinical data and mechanism of action
Phase II study showed a 78% improvement in kidney function decline in the group mirroring the phase III protocol.
Group two showed a 50% benefit, suggesting a dose-response relationship, though not statistically significant.
Product manufacturing expands cell count from tens of thousands to billions, with cells exhibiting antifibrotic and anti-inflammatory markers.
Mechanism likely involves antifibrosis, anti-inflammation, and support of the kidney's innate repair mechanisms.
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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