secwatch.observer — SEC 8-K summary
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Issuer:     Azitra, Inc. (AZTR)
CIK:        0001701478
Form:       8-K
Filed at:   2026-10-01T12:10:36+00:00
Accession:  0001493152-26-045260
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1701478/000149315226045260/0001493152-26-045260-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1701478/000149315226045260/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-045260

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