ProKidney Corp.

What they do

ProKidney isolates Selected Renal Cells from a patient's own kidney biopsy, expands and formulates them as rilparencel, and reinjects them into the damaged kidney through a minimally invasive outpatient procedure. Because the therapy is autologous, patients do not require the lifelong immunosuppressive therapy needed after an allogeneic kidney transplant. The company has no approved products and has not generated revenue from product sales; it is conducting the Phase 3 REGEN-006 (PROACT 1) study and has completed two Phase 2 studies.

Revenue drivers

• Rilparencel (lead product candidate) — The only cell therapy in Phase 3 study for advanced CKD and type 2 diabetes; not approved or commercialized, so it generates no product revenue.
• Reported revenue — Annual revenue was $0 in 2022 and 2023, $76,000 in 2024 and $893,000 in 2025; quarterly revenue was $217,000 (Q3 2025), $225,000 (Q4 2025), $226,000 (Q1 2026) and $150,000 (Q2 2026).

Recent performance

In Q2 2026, ProKidney reported revenue of $150,000, down from $226,000 in Q1 2026. R&D expenses rose to $36.1 million from $25.9 million a year earlier, driven by $8.7 million of higher clinical study and related manufacturing costs tied mainly to PROACT 1. G&A expenses fell to $12.4 million from $14.0 million, largely on lower compensation costs. Net loss before noncontrolling interest was $46.4 million versus $37.0 million in the prior-year quarter. Cash, cash equivalents and marketable securities totaled $181.6 million at June 30, 2026, down from $224.9 million at March 31, 2026.

Strategy

Management's priority is executing the Phase 3 PROACT 1 trial of rilparencel in advanced CKD and type 2 diabetes and preparing for regulatory and commercial milestones. The company completed enrollment of patients contributing to the accelerated approval efficacy analysis and remains on track to complete full enrollment of approximately 470 patients in the second half of 2026. It appointed Kenneth Locke as Chief Technical Officer in June 2026, adding manufacturing, CMC and supply chain experience. ProKidney completed a domestication to Delaware effective July 1, 2025 and a related restructuring of its operating subsidiaries. It has stated it expects to continue incurring significant losses and will need substantial additional capital.

Risks

• No product revenue; continuing losses — ProKidney has no approved products and has incurred net losses before noncontrolling interest of $151.6 million (2025), $163.3 million (2024) and $135.4 million (2023), with an accumulated deficit of $1,269.8 million at December 31, 2025.
• Clinical and regulatory uncertainty — Rilparencel remains in Phase 3 testing, and the accelerated approval pathway depends on the annualized eGFR slope surrogate endpoint in PROACT 1.
• Liquidity and additional capital needs — The company had $181.6 million in cash, cash equivalents and marketable securities at June 30, 2026 and states this supports operations into mid-2027, implying a need to raise more capital.
• Negative shareholder equity — Shareholder equity was negative $883.5 million at June 30, 2026, against total assets of $249.0 million and total liabilities of $26.2 million.

Outlook

Management anticipates topline data for the PROACT 1 accelerated approval efficacy analysis, based on annualized eGFR slope, in the second quarter of 2027. It expects to complete full enrollment of approximately 470 patients in the second half of 2026, with topline confirmatory composite time-to-event results in the second half of 2029. The company says its $181.6 million in cash, cash equivalents and marketable securities at June 30, 2026 supports operations into mid-2027.