ProKidney Reports Second Quarter 2025 Financial Results and Provides Regulatory and Clinical Updates

Core Insights - ProKidney Corp. has made significant advancements in 2025, particularly with positive topline data from the Phase 2 REGEN-007 study and alignment with the FDA on the accelerated approval pathway for rilparencel [2][3][7] Regulatory and Clinical Updates - The FDA confirmed that the slope of estimated glomerular filtration rate (eGFR) can serve as a surrogate endpoint for the accelerated approval of rilparencel, requiring an effect size of at least 1.5 mL/min/1.73m² per year improvement [3][4][7] - ProKidney anticipates topline data readout to support the accelerated approval application in Q2 2027, with over half of the required 350 patients already enrolled in the Phase 3 PROACT 1 study [4][7] - The Phase 2 REGEN-007 study showed a 78% improvement in annual decline of eGFR slope, from -5.8 to -1.3 mL/min/1.73m², with 63% of patients meeting key Phase 3 inclusion criteria [5][6][7] Financial Highlights - As of June 30, 2025, ProKidney reported cash, cash equivalents, and marketable securities totaling $294.7 million, down from $328.5 million as of March 31, 2025, expected to fund operations into mid-2027 [10][11][12] - Research and development expenses decreased to $25.9 million for Q2 2025 from $29.4 million in Q2 2024, primarily due to reduced clinical study costs [11] - General and administrative expenses increased slightly to $14.0 million in Q2 2025 from $13.7 million in Q2 2024, driven by higher cash compensation and operational expenses [12] Company Overview - ProKidney is focused on developing rilparencel, a first-in-class autologous cellular therapy for chronic kidney disease (CKD) patients, particularly those with diabetes and advanced CKD [18][14] - CKD affects an estimated 37 million adults in the U.S., with diabetes being the leading cause, highlighting the significant unmet clinical need for effective treatments [14]