{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-24-010206","form_type":"8-K","ticker":"ABEO","cik":"0000318306","company_name":"ABEONA THERAPEUTICS INC.","filed_at":"2024-03-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:26.553031+00:00","generated_at":"2026-06-04T16:05:49.421075+00:00","sec_items":["2.02","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Abeona Therapeutics reports FY2023 results; FDA completes pz-cel PLI with Form 483, PDUFA May 25, 2024","bullets":["FDA completed Pre-License Inspection of Cleveland manufacturing facility; Form 483 issued for process controls; company submitted response.","Clinical site inspections (Stanford, UMass) for Phase 3 VIITAL study completed with no Form 483 observations.","Net loss $54.2M ($2.53 per share) for FY2023; revenue $3.5M from Taysha license milestone.","Cash and investments $52.6M at Dec 31, 2023; received $20M tranche from $50M Avenue credit facility in Jan 2024.","Cash runway estimated into Q1 2025, excluding potential pz-cel commercial revenue or PRV sale."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-24-010206","json":"https://secwatch.observer/filing/0001493152-24-010206.json","markdown":"https://secwatch.observer/filing/0001493152-24-010206.md","text":"https://secwatch.observer/filing/0001493152-24-010206.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/318306/000149315224010206/0001493152-24-010206-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/318306/000149315224010206/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T16:05:49.421075+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":[{"claim_id":"03f32659d4947b22aefa8ce79b263cd559e9c0cd","claim":"ABEONA THERAPEUTICS INC. reported full year ended December 31, 2023 results: revenue 3.5 million, net income -54.2 million, EPS -2.53.","evidence_excerpt":"sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher, if awarded by the FDA. License and other revenues for the year ended December 31, 2023 were $3.5 million, as compared to $1.4 million for the same period of 2022. The revenues in both years primarily represent clinical milestone payments under a licensing agreement with Taysha Gene","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/318306/000149315224010206/0001493152-24-010206-index.htm","confidence":0.98,"family_label":"Earnings Releases","details":[{"label":"Period","value":"full year ended December 31, 2023"},{"label":"Revenue","value":"3.5 million"},{"label":"Net income","value":"-54.2 million"},{"label":"EPS","value":"-2.53"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}