ProKidney (PROK) FY Conference Transcript

Summary of ProKidney (PROK) FY Conference Call - July 14, 2025 Company Overview - ProKidney is a precommercial autologous cell therapy company focused on treating advanced chronic kidney disease (CKD) and type 2 diabetes with a single asset, roperinsel [3][4] - The company went public in 2022 and has since grown to approximately 250 employees [4] Key Developments - Resolved quality audit findings after a manufacturing pause in late 2023 [5] - Restarted phase three clinical study after protocol amendments [5] - Released top-line efficacy and safety data from a phase two study (REGEN 007) [5] Current Therapeutic Landscape for CKD - CKD treatment options include ACE inhibitors, ARBs, SGLT2 inhibitors, nonsteroidal MRAs, and GLP-1 receptor agonists [8] - ProKidney's roperinsel targets patients with advanced CKD (stage 3b and stage 4), where existing therapies have less data [9][10] Mechanism of Action and Study Insights - Roperinsel is expected to preserve kidney function rather than improve it, with a focus on anti-fibrosis and anti-inflammation [15][31] - The REGEN 007 study showed a 78% improvement in the decline of kidney function post-treatment, with a significant reduction in annual decline from -5.8 mL/min to -1.3 mL/min [23][24] Ongoing Clinical Trials - The PROACT 1 trial is designed to enroll over 600 patients with type 2 diabetes and CKD, comparing roperinsel to a sham control [36][39] - The primary endpoint is a composite of significant reductions in eGFR or the need for dialysis or transplant [37] Regulatory and Financial Outlook - A successful FDA meeting is anticipated to confirm eGFR slope as a surrogate endpoint for accelerated approval [45] - ProKidney has a cash balance of $328 million, expected to fund operations into Q2 2027 [46] Manufacturing and Market Expansion - Manufacturing is based in Winston Salem, with current capacity to support phase three trials and initial commercial launch [47] - Future expansion into international markets is considered, but the primary focus remains on the U.S. market [48] Upcoming Catalysts - Updates on the type B FDA meeting and full results from the REGEN 007 study are expected soon, with significant presentations anticipated at the American Society of Nephrology meeting [50]