{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-107357","form_type":"8-K","ticker":"PROK","cik":"0001850270","company_name":"PROKIDNEY CORP.","filed_at":"2025-08-12T23:59:59+00:00","discovered_at":"2026-05-14T18:02:45.355417+00:00","generated_at":"2026-05-17T14:51:52.415295+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"ProKidney Q2 net loss $37M; FDA agrees eGFR slope for accelerated approval; Phase 2 shows 78% eGFR improvement","bullets":["FDA confirmed eGFR slope as surrogate endpoint for accelerated approval of rilparencel; topline data from PROACT 1 expected Q2 2027.","Phase 2 REGEN-007: eGFR slope improved 78% (from -5.8 to -1.3 mL/min/1.73m²/yr) in Group 1 (n=24), p<0.001; no SAEs related.","Cash and equivalents $294.7M as of June 30, 2025, down from $328.5M; funds operations into mid-2027.","Q2 net loss $37.0M vs $38.5M in prior year; R&D expenses $25.9M down from $29.4M.","More than half of ~350 patients for accelerated approval analysis enrolled in Phase 3 PROACT 1."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-107357","json":"https://secwatch.observer/filing/0000950170-25-107357.json","markdown":"https://secwatch.observer/filing/0000950170-25-107357.md","text":"https://secwatch.observer/filing/0000950170-25-107357.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1850270/000095017025107357/0000950170-25-107357-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1850270/000095017025107357/prok-20250812.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T14:51:52.415295+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}