**ProKidney Corp. Reports Fiscal Year 2025 Results, Focuses on Rilparencel Development**

ProKidney Corp., a biotechnology company specializing in kidney disease treatment, announced its financial results for the fiscal year ending December 31, 2025. The company reported revenue of $0.89 million, a notable increase from the $0.08 million reported in the previous fiscal year, primarily due to a full year of leasing activities from acquired properties. However, the company also reported a net loss before noncontrolling interest of $151.6 million, compared to a net loss of $163.3 million in 2024. This loss reflects ongoing investments in research and development, particularly for its lead product candidate, rilparencel.

A significant portion of ProKidney's expenses was allocated to research and development, totaling $114.1 million in 2025, a decrease from $127.7 million in 2024. This decrease was attributed to the completion or termination of certain clinical trials, reduced professional fees related to manufacturing compliance, and lower equity-based compensation. These decreases were partially offset by increased cash-based compensation due to new hires and increased clinical study costs for the ongoing Phase 3 PROACT 1 trial. General and administrative expenses also decreased to $51.8 million from $56.1 million in the prior year, mainly due to lower impairment charges and equity-based compensation, offset by increased professional fees and operating expenses related to the company's domestication process.

Operationally, ProKidney is focused on the Phase 3 PROACT 1 trial, a randomized, blinded study assessing the efficacy and safety of rilparencel in subjects with advanced chronic kidney disease and type 2 diabetes. The company anticipates topline data readout of the surrogate endpoint (eGFR slope) in the second quarter of 2027 and topline data readout of the confirmatory endpoint (composite time-to-event) in the second half of 2029. ProKidney also completed its REGEN-007 trial, a Phase 2 study of rilparencel, with results presented at the American Society of Nephrology Kidney Week 2025. The company's manufacturing facility in Winston-Salem, North Carolina, is designed to comply with FDA and EMA quality standards and has the potential capacity to supply the Phase 3 study and a potential commercial launch.

Looking ahead, ProKidney anticipates that its existing cash, cash equivalents, and short-term investments, totaling approximately $270 million as of December 31, 2025, will be sufficient to fund operations into mid-2027. The company expects research and development expenses to increase as it continues to advance rilparencel through clinical development and prepares for potential commercialization. ProKidney's strategy includes obtaining regulatory approval for rilparencel, maintaining internal manufacturing expertise, and discovering additional product candidates for kidney disease treatment.

About PROKIDNEY CORP.

ProKidney Corp. is a clinical-stage biotechnology company developing autologous cell therapies to treat chronic kidney disease (CKD). Its lead product, rilparencel, uses patient-derived kidney cells to preserve kidney function and delay progression to end-stage renal disease. The company focuses on regenerative medicine, clinical trials, and manufacturing personalized therapies, targeting markets with high unmet needs in CKD management and aiming for regulatory approval and commercialization.

This description was generated via AI from an annual report. Updated 8 months ago.

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