---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-045260"
form_type: "8-K"
ticker: "AZTR"
cik: "0001701478"
company_name: "Azitra, Inc."
filed_at: "2026-10-01T12:10:36+00:00"
generated_at: "2026-10-12T14:16:11.732755+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Azitra clears ATR-04 safety review, advances Phase 1/2 trial to Cohort 2 enrollment

## Summary
- Safety review committee cleared ATR-04 after reviewing Cohort 1 data; seven patients received a single 4g topical application to face, chest and back, then 28 days of once-daily dosing.
- Cohort 2 will enroll approximately 24 patients receiving 4g once daily for 28 days at six clinical sites, including MD Anderson Cancer Center and Yale University.
- The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study (NCT06830863) uses 3:1 randomization comparing ATR04-484 to vehicle.
- ATR04-484 holds FDA Fast Track designation for EGFRi-associated rash, which affects roughly 50-80% of EGFR inhibitor patients and ~150,000 people annually in the U.S.
- CEO Francisco Salva said ATR-04 could become the first live biotherapeutic specifically developed for cancer treatment-associated rash.

## SEC filing metadata
- accession: 0001493152-26-045260
- form_type: 8-K
- ticker: AZTR
- cik: 0001701478
- company_name: Azitra, Inc.
- filed_at: 2026-10-01T12:10:36+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1701478/000149315226045260/0001493152-26-045260-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1701478/000149315226045260/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-045260
- JSON: https://secwatch.observer/filing/0001493152-26-045260.json
- Plain text: https://secwatch.observer/filing/0001493152-26-045260.txt

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