ProKidney (PROK) investor relations material

Strategic overview and milestones

• Developing rilparencel, an autologous cell therapy for advanced chronic kidney disease (CKD), currently in phase III trials targeting patients at high risk of kidney failure and dialysis.

• Aims to delay or prevent dialysis, improve quality of life, and provide more time for transplantation opportunities.

• Phase III enrollment completion expected in late 2026, with phase III data for accelerated approval (eGFR slope) anticipated in Q2 2027; confirmatory data expected in the second half of 2029.

• BLA submission planned for early 2028, with funding secured through the phase III data readout.

Market landscape and opportunity

• Targeting over 1 million U.S. patients with stage 3B/4 CKD and diabetes, representing a significant market for cell therapy.

• Current standard of care includes ACE/ARB, SGLT2, finerenone, and GLP-1 therapies, but these are mainly studied in moderate CKD and have practical limitations in advanced stages.

• Rilparencel is positioned as an add-on therapy for advanced patients, aiming to fill a gap where existing treatments are less effective.

• Delaying dialysis offers substantial value, as dialysis costs exceed $100,000 per year for Medicare and are higher for private insurers.

Mechanism of action and clinical data

• Rilparencel involves two administrations of autologous kidney-derived cells, processed and expanded before injection into each kidney cortex three months apart.

• Preclinical and clinical data show rilparencel reduces oxidative stress, inflammation, and improves mitochondrial function in injured kidney cells.

• New mechanistic data to be presented at upcoming nephrology conferences.