Welcome to our dedicated page for ProKidney SEC filings (Ticker: PROK), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The ProKidney Corp. (PROK) SEC filings page brings together the company’s regulatory disclosures as a Nasdaq-listed biotechnology issuer developing autologous cellular therapies for chronic kidney disease (CKD). Through documents such as Form 8-K, Form 10-K, and Form 10-Q, ProKidney reports information about its financial condition, clinical development programs, capital markets activity, and material corporate events.
ProKidney’s recent Form 8-K filings illustrate how the company uses SEC reports to communicate key developments. These include press releases furnishing quarterly financial results, updates on cash, cash equivalents, and marketable securities, and commentary on research and development and general and administrative expenses. Other 8-Ks describe material definitive agreements, such as at-the-market equity offering arrangements under an Open Market Sale Agreement, and real estate transactions involving company property in Greensboro, North Carolina.
Filings also reference ProKidney’s clinical and regulatory progress for its lead product candidate, rilparencel (REACT®). For example, the company has furnished press releases via Form 8-K that discuss topline and full results from the Phase 2 REGEN-007 trial, the design and objectives of the Phase 3 REGEN-006 (PROACT 1) trial, and FDA alignment on using estimated glomerular filtration rate (eGFR) slope as a surrogate endpoint for an accelerated approval pathway. These documents provide context on how ProKidney presents its RMAT-designated program to regulators and investors.
Investors can also use SEC filings to track corporate structure and listing details, including ProKidney’s domestication from the Cayman Islands to the State of Delaware and confirmation that its Class A common stock trades on The Nasdaq Stock Market under the symbol PROK. On Stock Titan, AI-powered tools can help summarize lengthy filings, highlight key sections on clinical trial disclosures, financing arrangements, and risk factors, and make it easier to understand how new information in 8-K, 10-Q, and 10-K reports may relate to ProKidney’s CKD-focused development strategy.
ProKidney Corp. is holding its 2026 annual stockholder meeting on May 28, 2026 at 10:00 a.m. Eastern Time, with both a Boston in-person venue and virtual webcast access. Stockholders of record as of April 8, 2026 may vote on director elections and auditor ratification.
Three Class I directors — William F. Doyle, Alan M. Lotvin, M.D., and Brian J.G. Pereira, M.D. — are nominated for new three-year terms. Stockholders are also asked to ratify Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026.
The proxy describes ProKidney’s staggered eight-member board, committee structure, corporate governance guidelines, and related-party arrangements. It details 2025 executive pay, including total compensation of $2,956,447 for CEO Bruce Culleton, M.D., and outlines severance and change-in-control protections for key executives.
ProKidney Corp. reported 2025 results showing steady clinical progress and a typical development-stage loss profile. Revenue was $893 thousand, while research and development expenses were $114.1 million and general and administrative expenses were $51.8 million, leading to a net loss before noncontrolling interest of $151.6 million, an improvement from $163.3 million in 2024.
The company ended 2025 with $270.0 million in cash, cash equivalents and marketable securities and expects this to fund operations into mid-2027. Clinically, ProKidney advanced rilparencel with positive Phase 2 REGEN-007 data, strong enrollment momentum in the Phase 3 PROACT 1 trial, and FDA alignment on using eGFR slope as a surrogate endpoint for an accelerated approval pathway.
Key upcoming milestones include completing PROACT 1 enrollment in 2026, a Phase 3 surrogate endpoint readout in Q2 2027, and a planned BLA submission in Q4 2027.
ProKidney Corp. is a late-clinical-stage biotech company developing rilparencel, an autologous cell therapy aimed at preserving kidney function in patients with advanced chronic kidney disease and diabetes. The company completed a corporate domestication from the Cayman Islands to Delaware and streamlined its holding structure in 2025.
Rilparencel is the only cell therapy in a Phase 3 study for advanced CKD and type 2 diabetes and has FDA regenerative medicine advanced therapy designation. Phase 2 trials (including REGEN-007 and RMCL-002) showed statistically significant slowing of eGFR decline in key groups and a safety profile similar to kidney biopsy procedures.
The ongoing Phase 3 PROACT 1 (REGEN-006) trial targets about 470 patients with Stage 3b–4 CKD in the United States, Mexico and Taiwan, using annualized eGFR slope as the surrogate endpoint for potential accelerated approval, with topline surrogate data expected in the second quarter of 2027 and confirmatory time-to-event data in the second half of 2029. ProKidney operates an in-house GMP-aligned manufacturing facility in North Carolina, recently remediated to meet U.S. and European standards, and holds a broad global patent estate protecting rilparencel, its formulations, quality controls and methods of use.
Coulston James reported acquisition or exercise transactions in this Form 4 filing.
PROKIDNEY CORP. reported that its Chief Financial Officer, James Coulston, received a grant of employee stock options covering 600,000 shares of the company’s stock. The options were awarded at no cost on the grant date and are scheduled to vest in substantially equal monthly installments over a four-year period beginning March 1, 2026, tying the CFO’s potential upside closely to the company’s long-term performance.
PROKIDNEY CORP. reported that Chief Regulatory Officer Darin J. Weber received a grant of 400,000 employee stock options with an exercise price of $0.00 per share. The options vest in substantially equal monthly installments over four years beginning on March 1, 2026.
Girolamo Todd C reported acquisition or exercise transactions in this Form 4 filing.
PROKIDNEY CORP. reported that Chief Legal Officer Todd C. Girolamo received a grant of employee stock options covering 600,000 shares on March 1, 2026. These options vest in substantially equal monthly installments over a four-year period beginning on March 1, 2026, meaning the award is earned gradually rather than all at once.
PROKIDNEY CORP. reported that Chief Executive Officer Bruce Culleton received a grant of employee stock options covering 3,000,000 shares of the company’s stock. These options were awarded as a derivative security with a reported price per share of $0.0000.
According to the filing, the option grant is scheduled to vest in substantially equal monthly installments over a four-year period beginning on March 1, 2026. This means the CEO’s right to exercise the options increases gradually each month over those four years.
Morgan Stanley and Morgan Stanley Investment Management Inc. filed a Schedule 13G reporting beneficial ownership of 8,519,982 shares of ProKidney Corp. Class A common stock, representing 6.0% of the class as of December 31, 2025.
The filing shows no sole voting or dispositive power, with all reported voting and dispositive authority shared between these reporting persons, and certifies that the holdings are maintained in the ordinary course of business without the purpose of changing or influencing control of ProKidney.
ProKidney Corp. filed a current report to share an updated investor presentation that management plans to use in meetings with investors and analysts. The presentation, furnished as Exhibit 99.1 and on the company website, updates the Phase 3 REGEN-006 (PROACT 1) trial plan.
The PROACT 1 study now targets enrollment of approximately 470 subjects. ProKidney continues to expect topline data for the surrogate endpoint (eGFR slope) in the second quarter of 2027 and now anticipates topline data for the confirmatory composite time-to-event endpoint in the second half of 2029, with statistical powering assumptions unchanged.