{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-23-013408","form_type":"8-K","ticker":"PVLA","cik":"0001583648","company_name":"PALVELLA THERAPEUTICS, INC.","filed_at":"2023-05-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.513691+00:00","generated_at":"2026-06-15T06:22:49.393427+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"earnings","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Pieris Q1 net loss widens to $13.2M; elarekibep Phase 2a data expected mid-2024","bullets":["Q1 2023 net loss of $13.2M ($0.45/share) vs. $5.1M ($0.07) in Q1 2022; cash $48.4M.","Elarekibep Phase 2a enrollment ongoing; topline data by mid-2024; AstraZeneca adding sites and geographies.","PRS-220 Phase 1 results expected H2 2023; PRS-400 toward candidate nomination H2 2023.","Cinrebafusp alfa in 2L+ HER2+ gastric cancer: 100% ORR in 5 patients; enrollment stopped for strategic reasons.","Seagen initiated Phase 1 for SGN-BB228 (CD228/4-1BB); $5M milestone paid."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-23-013408","json":"https://secwatch.observer/filing/0001437749-23-013408.json","markdown":"https://secwatch.observer/filing/0001437749-23-013408.md","text":"https://secwatch.observer/filing/0001437749-23-013408.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/0001437749-23-013408-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/pirs20230126b_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-15T06:22:49.393427+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":"da1347b66f4c45e49efa10588c6270be73b63c86","claim":"PALVELLA THERAPEUTICS, INC. reported financial results for the quarter ended March 31, 2023.","evidence_excerpt":"Pieris Pharmaceuticals, Inc. (Nasdaq: PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin® technology platform for respiratory diseases, cancer, and other indications, reported financial results for the quarter ended March 31, 2023, and provided a business update.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1583648/000143774923013408/0001437749-23-013408-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the quarter ended March 31, 2023"},{"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"}