ProKidney (PROK) Q4 2025 earnings summary

Executive summary

• Achieved alignment with FDA on accelerated approval pathway for rilparencel using eGFR slope as a surrogate endpoint in July 2025.

• Positive Phase 2 REGEN-007 results presented at ASN Kidney Week 2025 and published in CJASN.

• Significant enrollment momentum in Phase 3 PROACT 1 study, with pivotal topline results expected in Q2 2027.

• Ended 2025 with $270.0 million in cash and marketable securities, supporting operations into mid-2027.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $270.0 million at year-end 2025, down from $358.3 million at year-end 2024.

• Research and development expenses were $114.1 million in 2025, down from $127.7 million in 2024, mainly due to lower clinical study costs.

• General and administrative expenses were $51.8 million in 2025, down from $56.1 million in 2024, primarily due to lower impairment charges and equity-based compensation.

• Net loss before noncontrolling interest was $151.6 million in 2025, compared to $163.3 million in 2024.

• Weighted average shares of Class A common stock outstanding were 133,942,736 in 2025; net loss per share was $(0.52).

Outlook and guidance

• Expect to complete enrollment for Phase 3 PROACT 1 accelerated approval analysis by mid-2026 and full enrollment by 2H 2026.

• Anticipate pivotal eGFR slope data in Q2 2027 and BLA submission in Q4 2027.

• Project cash runway to fund operations into mid-2027.

• Commercial launch of rilparencel targeted for 2H 2028, pending approval.