ProKidney (PROK) investor relations material

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.