{"url_path":"/sec/prok/8-k/2026-05-15/item-7-01","section_key":"item-7-01","section_title":"Item 7.01 Regulation FD Disclosure.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-05-15","source_url":"https://www.sec.gov/Archives/edgar/data/1850270/0001193125-26-225848-index.html","accession_number":"0001193125-26-225848","cik":"0001850270","ticker":"PROK","issuer_name":"PROKIDNEY CORP.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1850270/0001193125-26-225848-index.html","primary_entity_key":"0001850270","primary_entity_name":"PROKIDNEY CORP."},"word_count":318,"has_tables":true,"body_markdown":"Item 7.01 Regulation FD Disclosure.\n\nThe Company has updated its investor presentation (the “Presentation”), which its senior management intends to use from time to time when interacting with investors and analysts, among others. The Presentation is available on the Company’s website at https://investors.prokidney.com/news-events/events-and-presentations. The Presentation is also attached hereto as Exhibit 99.2.\n\nThe Company is on track to complete enrollment for the Phase 3 PROACT 1 accelerated approval analysis in mid-2026, with pivotal topline results anticipated in Q2 2027. The PROACT 1 study is expected to have 90% power to detect an effect size in annualized eGFR slope of 1.75 mL/min/1.73m2, and 80% power to detect an effect size in annualized eGFR slope of 1.5 mL/min/1.73m2. Under rilparencel’s regenerative medicine advanced therapy (RMAT) designation, the U.S. Food and Drug Administration (FDA) agreed that an effect size in annualized eGFR slope of 1.5 mL/min/1.73m2 would be an acceptable demonstration of efficacy in the setting of patients receiving appropriate standard of care therapies. For context, in Group 1 of the Phase 2 REGEN-007 study, bilateral kidney injections with rilparencel were associated with a 4.6 mL/min/1.73m2 improvement in the annual decline in eGFR slope.\n\nThe information in this Item 7.01, including Exhibit 99.2 attached hereto, is being furnished, not filed, pursuant to Regulation FD. Accordingly, the information in this Item 7.01 and Exhibit 99.2 of this report will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 and Exhibit 99.2 is not intended to, and does not, constitute a determination or admission by the Company that the information in this report is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company or any of its affiliates."}