ProKidney Reports $163.3 Million Net Loss for 2024, Increases R&D Spending

ProKidney Corp. (formerly Social Capital Suvretta Holdings Corp. III) reported a net loss before noncontrolling interest of $163.3 million for the year ended December 31, 2024, compared to a net loss of $135.4 million in 2023 and $148.1 million in 2022. The company's accumulated deficit increased to $1,200.8 million as of December 31, 2024, from $1,139.7 million at the end of 2023. The increase in net loss was primarily due to higher research and development expenses, general and administrative expenses, and a decrease in interest income, partially offset by a decrease in equity-based compensation costs. The company generated $76,000 in revenue during 2024 from leasing activities, a new revenue stream not present in prior years.

Research and development expenses increased by approximately $21 million in 2024 compared to 2023, driven by increased compensation and recruitment costs, higher clinical study and product manufacturing costs, and increased operational costs related to quality management system remediation. General and administrative expenses rose by approximately $11.3 million, primarily due to increased compensation and recruitment costs, an impairment charge related to a Greensboro facility, and higher equity-based compensation costs. Interest income decreased by approximately $2.3 million due to lower average cash and investment balances.

As of December 31, 2024, ProKidney had 204 full-time employees. The company's lead product candidate, rilparencel, an autologous cell therapy for chronic kidney disease (CKD), is currently in Phase 3 clinical development, with an ongoing Phase 2 trial. Rilparencel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. A Phase 1 trial for rilparencel in subjects with CKD due to congenital anomalies was completed in January 2023. The company also discontinued a Phase 3 trial (REGEN-016/PROACT 2) in 2024, focusing instead on the ongoing Phase 3 REGEN-006 (PROACT 1) trial, which the FDA confirmed could support a Biologics License Application (BLA) submission.

ProKidney's cash, cash equivalents, and short-term investments totaled approximately $358.3 million as of December 31, 2024. The company anticipates that these resources will fund operations into mid-2027, but this projection is subject to various factors, including market conditions and potential changes in capital requirements. The company raised approximately $136.7 million in net proceeds from public offerings in June 2024 and an additional $7.7 million from sales under an open market sale agreement. The company expects to continue to incur significant losses for the foreseeable future and will require substantial additional capital to finance its operations. The company's outlook includes obtaining regulatory approval for and commercializing rilparencel, maintaining and refining its manufacturing expertise, and discovering and developing additional product candidates.