Every 8-K that ProKidney Corp. (PROK) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow PROK and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full PROK filings page.
ProKidney Corp. reported second quarter 2026 results and progress on its lead cell therapy program rilparencel for advanced chronic kidney disease with type 2 diabetes. Enrollment was completed for the Phase 3 PROACT 1 accelerated approval efficacy analysis, expected to include about 320 patients using annualized eGFR slope as a surrogate endpoint, with topline results anticipated in Q2 2027. Full enrollment of approximately 470 patients for the confirmatory time-to-event analysis is targeted for the second half of 2026, with topline results anticipated in the second half of 2029.
ProKidney ended Q2 2026 with $181.6 million in cash, cash equivalents and marketable securities, which the company expects will fund operations into mid-2027. For the quarter, research and development expenses were $36.1 million and general and administrative expenses were $12.4 million. Net loss before noncontrolling interest was $46.4 million, and net loss available to Class A common stockholders was $28.4 million, or $0.15 per basic and diluted share. Net cash used in operating activities for the first six months of 2026 was $82.1 million.
The company strengthened its leadership by appointing Kenneth Locke as Chief Technical Officer, bringing more than 25 years of R&D, CMC and supply chain experience as ProKidney advances toward potential regulatory and commercial milestones for rilparencel.
ProKidney Corp. reported the results of its 2026 Annual Meeting of Stockholders. Shareholders elected William F. Doyle, Alan M. Lotvin, M.D., and Brian J.G. Pereira to the Board of Directors, each for a three-year term ending at the 2029 annual meeting. Doyle received 196,164,585 votes for and 1,459,235 withheld; Lotvin received 193,179,768 for and 4,444,052 withheld; Pereira received 197,002,580 for and 621,240 withheld. Shareholders also ratified the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 239,091,167 votes for, 729,165 against, and 382,882 abstentions.
ProKidney Corp. reported a first-quarter 2026 net loss before noncontrolling interest of $42.6 million, compared with $38.0 million a year earlier, as it increased investment in its lead cell therapy, rilparencel. Revenue was minimal at $226 thousand.
Cash, cash equivalents and marketable securities totaled $224.9 million as of March 31, 2026, down from $270.0 million at year-end 2025, and are expected to fund operations into mid‑2027. Research and development expenses rose to $33.8 million, while general and administrative expenses declined to $11.3 million.
Clinically, the Phase 3 REGEN‑006 (PROACT 1) trial in advanced chronic kidney disease remains on track to complete enrollment for the accelerated-approval eGFR slope analysis in mid‑2026, with pivotal topline results anticipated in Q2 2027. Prior Phase 2 REGEN‑007 data showed a 4.6 mL/min/1.73m² improvement in annual eGFR slope in Group 1 after bilateral rilparencel injections.
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. 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.
ProKidney Corp. filed a current report to notify investors that it has updated its investor presentation. Senior management plans to use this updated presentation in meetings with investors and analysts, and it is available on the company’s website as well as attached as Exhibit 99.1. The company states that this material is being furnished under Regulation FD rather than filed, meaning it is not automatically part of other securities law filings unless specifically incorporated by reference. ProKidney also notes that providing this presentation does not represent a determination that the information is material or complete for investment decisions.
ProKidney Corp. furnished a press release announcing its financial results for the quarter ended September 30, 2025. The release is included as Exhibit 99.1 to this report.
The information provided, including Exhibit 99.1, is being furnished and is not deemed “filed” under Section 18 of the Exchange Act, nor incorporated by reference into other filings except as expressly stated.
ProKidney Corp. entered into a material definitive agreement to sell its Greensboro, North Carolina real property to Northpoint Development, LLC for approximately $19.1 million in cash.
The new agreement, signed on October 17, 2025, follows the termination of a prior sale agreement with Williams Development Group. The Northpoint agreement includes customary representations and closing conditions. The company plans to file the full agreement as an exhibit to its Form 10-K for the year ended December 31, 2025.
ProKidney Corp. (Nasdaq: PROK) furnished a Current Report on Form 8-K stating that it issued a press release announcing its financial results for the quarter ended June 30, 2025. The press release is furnished as Exhibit 99.1, and the filing also references an Inline XBRL cover page file for the report.
The report notes that the furnished press release and related information are not being "filed" for purposes of certain Exchange Act liabilities and will not be incorporated by reference into other registration statements unless expressly stated. The filing identifies ProKidney as an emerging growth company and is signed on behalf of the registrant by Chief Financial Officer James Coulston.
Form 8-K filing highlights ProKidney Corp. (Nasdaq: PROK) furnished an 8-K dated 15 July 2025 to disclose two items under Regulation FD and Other Events.
Investor presentation (Item 7.01) Management placed an updated slide deck covering business, clinical studies, development plans and financial position on the company’s investor website and attached it as Exhibit 99.2. The company emphasizes that the material should be viewed in the context of prior SEC filings and does not undertake to update it unless required by law.
Press release on FDA alignment (Items 7.01 & 8.01) Exhibit 99.1 contains a same-day press release announcing “confirmation of alignment with the U.S. Food and Drug Administration on the accelerated approval pathway for rilparencel,” the company’s lead asset. The first two paragraphs of that release are incorporated by reference into Item 8.01, signifying potential material relevance.
No financial data The filing does not include earnings figures, balance-sheet information or guidance. It is being furnished rather than filed, so it is not subject to Section 18 liability.
Key takeaway for investors The disclosed FDA alignment represents a regulatory milestone that may reduce development risk for rilparencel. However, without accompanying clinical data, timelines or financial metrics, the magnitude of impact cannot be fully assessed from this filing alone.