secwatch.observer — SEC 8-K summary
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Issuer:     ATOSSA THERAPEUTICS, INC. (ATOS)
CIK:        0001488039
Form:       8-K
Filed at:   2024-11-04T23:59:59+00:00
Accession:  0000950170-24-120268
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Atossa reports positive Phase 2 data for (Z)-endoxifen reducing breast density by up to 26.5%
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- Relative MBD reduction of 19.3% (1 mg) and 26.5% (2 mg) vs placebo in KARISMA-Endoxifen trial.
- Mean plasma endoxifen: 5.18 ng/mL (1 mg) and 10.87 ng/mL (2 mg) after 1 month; stable at 3 and 6 months.
- Drug-related discontinuations: 4 placebo, 5 (1 mg), 12 (2 mg); vasomotor symptoms minimal on 10-point scale.
- Historical tamoxifen study: 10%+ density reduction associates with 62% lower 5-year breast cancer incidence.
- Detailed results to be presented at San Antonio Breast Cancer Symposium in December 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1488039/000095017024120268/0000950170-24-120268-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1488039/000095017024120268/atos-20241104.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-120268

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