ProKidney Corp. (PROK), a clinical-stage cell therapy company focused on chronic kidney disease or CKD, reported financial results for the full year 2025 and provided business highlights about its lead investigational candidate, Rilparencel or REACT.
For the full year 2025, net loss attributable to noncontrolling interest narrowed to $82.63 million from $102.15 million in the year-ago period.
Net loss before noncontrolling interest shrank to $151.61 million from $163.34 million in the prior year.
As of December 31, cash and cash equivalents totalled $270 million, compared to $358.3 million in the prior year. The firm expects it to fund operating expenses and capital expenditure requirements into mid-2027.
ProKidney is developing Rilparencel, a proprietary autologous cell therapy, and is being evaluated in the ongoing Phase 3 REGEN-006 (PROACT 1) study for its potential to preserve kidney function in patients with advanced CKD and type 2 diabetes.
Looking ahead, the firm provided the following anticipated milestones for Rilparencel,
-Expects to complete enrolment of approximately 360 patients in the Phase 3 PROACT 1 accelerated approval efficacy analysis by mid-2026.
-Plans to complete full enrolments of approximately 470 patients for Phase 3 PROACT 1 confirmatory composite time-to-event analysis in the second half of 2026.
-Plans Phase 3 PROACT 1 readout of surrogate endpoint (eGFR slope) for accelerated approval in the second quarter of 2027.
-Plans BLA submission of Rilparencel in the fourth quarter of 2027.
-If everything goes well, the firm plans BLA approval and commercial launch of Rilparencel in the second half of 2028.
-Expects Phase 3 PROACT 1 topline readout of confirmatory endpoint for full approval in the second half of 2029.
CKD is a progressive condition characterised by the gradual decline of kidney function, which can ultimately lead to end-stage kidney disease (ESKD) requiring dialysis or transplantation.
ProKidney estimates that there are over 1 million people in the U.S. with Stage 3b/4 CKD and diabetes seeking better therapeutic options to prevent or delay the need for dialysis.
PROK has traded between $0.46 and $7.13 in the last year. The stock closed Wednesday's trade at $2.08, down 2.35%.
In the overnight market, PROK is down 1.92% at $2.04.
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