secwatch.observer — SEC 8-K summary
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Issuer:     ATOSSA THERAPEUTICS, INC. (ATOS)
CIK:        0001488039
Form:       8-K
Filed at:   2024-12-10T23:59:59+00:00
Accession:  0000950170-24-134779
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Atossa presents positive PK/tolerability data from Phase 2 EVANGELINE trial of (Z)-endoxifen
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- 50% of patients on 80 mg (Z)-endoxifen + goserelin met target plasma Css of 500-1,000 ng/mL.
- Tissue Css levels >2x plasma; >90% of patients achieved target tissue levels >500 ng/g.
- Ki-67 ≤10% response rate >85% across doses after 4 weeks, indicating antitumor activity.
- (Z)-endoxifen well tolerated with no Grade 3-4 toxicities; four gynecologic events in 80 mg groups.
- Randomized trial to compare 40 mg + OFS vs exemestane + OFS; recruitment expected to start 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1488039/000095017024134779/0000950170-24-134779-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1488039/000095017024134779/atos-20241210.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-134779

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer