ProKidney (PROK) Conference Summary Company Overview - ProKidney is an autologous cell therapy company focused on preserving kidney function in patients with type two diabetes and advanced chronic kidney disease (CKD) [6][5] - The company's headquarters are located in North Carolina, with manufacturing in Winston Salem and clinical offices in Raleigh [6] Key Clinical Data - ProKidney announced top-line results from its Phase II trial, REGEN-seven, in July 2025 [7][9] - The trial involved 49 subjects with advanced CKD and type two diabetes, comparing two injection regimens of the therapy, roperinsel [9][10] - Group one (two injections) showed a 78% improvement in the decline of kidney function, with a pre-injection slope of -5.8 mL/min/year changing to -1.3 mL/min/year post-treatment [10][12] - Group two (one injection) showed a 50% improvement in kidney function decline, although this was not statistically significant [12] Regulatory and Future Plans - ProKidney is preparing for a late-breaking trial presentation at the ASN Kidney Week in November 2025, with an abstract submission deadline of September 9, 2025 [19][20] - The Phase III study, PROACT one, has been narrowed to patients with an eGFR of 20 to 35, focusing on those with advanced CKD [34][39] - The primary endpoint for PROACT one is the difference in eGFR slope between treatment and control groups, with an expected enrollment of 600 to 700 patients [39][42] Market Potential and Strategy - The potential total addressable market (TAM) for ProKidney's therapy is estimated to be between 500,000 to 1 million patients [69] - The company is focused on the largest market segment within CKD, specifically targeting patients with diabetes and advanced CKD [70] - ProKidney aims to explore other indications in the future, including rare kidney diseases, but is currently focused on executing the Phase III study [71] Manufacturing and Cost Considerations - Roperinsel is an autologous cell product, requiring a kidney biopsy from the patient for cell extraction, which is then expanded and injected back into the patient [55][57] - ProKidney is expanding its manufacturing capabilities to meet potential demand, which may exceed supply if Phase III results are favorable [79] - The company is confident in its ability to price the product competitively while maintaining a profitable business model [80][82] Intellectual Property and Financials - ProKidney has a solid patent portfolio with multiple patent families [95] - As of June 2025, the company reported sufficient cash runway into mid-2027, covering the timeline for accelerated approval [92][93] Additional Studies - REGEN008 is a long-term safety follow-up study for patients from prior Phase II trials, focusing on safety data collection without further injections [84][85] Conclusion - ProKidney is positioned to make significant advancements in the treatment of advanced CKD with its innovative cell therapy, backed by promising clinical data and a clear regulatory pathway. The upcoming ASN presentation is anticipated to provide further insights into the efficacy and safety of roperinsel.

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]