---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-276140"
form_type: "8-K"
ticker: "ATOS"
cik: "0001488039"
company_name: "ATOSSA THERAPEUTICS, INC."
filed_at: "2025-11-12T23:59:59+00:00"
generated_at: "2026-05-16T21:05:05.471731+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Atossa advances (Z)-endoxifen regulatory path; Q3 op-ex $9.3M

## Summary
- FDA Type C meeting set Nov 17 to discuss accelerated NDA path for (Z)-endoxifen in breast cancer risk reduction; written comments received.
- Appointed Janet R. Rea as SVP R&D and Mark Daniel as CFO to lead commercialization readiness.
- Selected PSI as CRO for planned Phase 2 mBC dose-ranging study; IND filing targeted Q4 2025, topline data in 2026.
- Q3 operating expenses $9.3M (up from $6.4M); interest income $0.6M; net loss not separately disclosed.
- New Israel patent issued; two US patents under post-grant challenges; majority of IP portfolio unaffected.

## SEC filing metadata
- accession: 0001193125-25-276140
- form_type: 8-K
- ticker: ATOS
- cik: 0001488039
- company_name: ATOSSA THERAPEUTICS, INC.
- filed_at: 2025-11-12T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1488039/000119312525276140/0001193125-25-276140-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1488039/000119312525276140/atos-20251112.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-276140
- JSON: https://secwatch.observer/filing/0001193125-25-276140.json
- Plain text: https://secwatch.observer/filing/0001193125-25-276140.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.