{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-25-011047","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2025-08-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.419400+00:00","generated_at":"2026-05-17T15:10:34.713129+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Capricor Q2 net loss $25.9M; FDA accepts all PLI observations; StealthX vaccine enters clinic","bullets":["Net loss of $25.9M ($0.57 per share) for Q2 2025 vs $11.0M ($0.35) in Q2 2024; revenue $0 vs $4.0M.","Cash, equivalents and securities $122.8M at June 30, 2025; expected to fund operations into Q4 2026.","FDA accepted all 483 observations from Pre-License Inspection; Type A meeting scheduled for August 2025 to discuss Deramiocel BLA resubmission.","FDA cleared IND for StealthX exosome-based vaccine; NIAID-initiated Phase 1 trial initiated in August 2025; first dosing imminent.","HOPE-3 Phase 3 topline data expected Q4 2025; Orphan Drug Designation granted for Deramiocel in Becker muscular dystrophy."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-25-011047","json":"https://secwatch.observer/filing/0001558370-25-011047.json","markdown":"https://secwatch.observer/filing/0001558370-25-011047.md","text":"https://secwatch.observer/filing/0001558370-25-011047.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025011047/0001558370-25-011047-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000155837025011047/capr-20250811x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T15:10:34.713129+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"}