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ProKidney (PROK) investor relations material
ProKidney Morgan Stanley 23rd Annual Global Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Program and clinical development updates
Phase III ProAct One study is a large, randomized, sham-controlled trial targeting over 600 advanced CKD patients, with sites in the US, Mexico, and Taiwan.
Alignment with FDA on accelerated approval using eGFR slope as a primary endpoint, with top-line readout expected in Q2 2027.
Effect size for efficacy agreed with FDA is a 1.5 ml/min/year difference in eGFR slope, which is more robust than benchmarks from SGLT2 trials.
Enrollment is over 50% complete for the accelerated approval cohort, targeting around 350 subjects with 90% statistical power.
Study design was amended to focus on highest-risk CKD patients, aligning with clinical and payer priorities.
Regulatory and strategic milestones
RMAT designation since 2021 provides regulatory flexibility and facilitated productive FDA discussions.
Accelerated approval pathway and protocol amendments have advanced timelines, moving the expected readout earlier to Q2 2027.
Stopping a second Phase III study (ProAct Two) and focusing on RMAT capabilities saved significant capital.
Favorable Type C response received for manufacturing expansion facility.
Financial and operational highlights
Cash position at end of June was $295 million, providing runway through mid-2027 and covering Phase III data readout.
Recent $140 million capital raise and cost-saving measures, including halting unnecessary studies, have extended cash runway.
Opportunistic approach to additional capital raising, with an ATM facility available.
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