Azitra, Inc.

About Azitra’s ATR-04 Program

ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derivedStaphylococcus epidermidis strain in development for EGFRi-associated skin rash. The candidate was selected based on its preclinical profile of reducing IL-36γ andStaphylococcus aureus levels, both of which are elevated in patients with EGFRi-associated skin rash. The strain was then engineered with the aim of improving its safety profile by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04. Preclinical data have shown that ATR04-484 can reduce levels of IL-36γ, a key pro-inflammatory cytokine elevated in these rashes. ATR04-484 has also been shown to inhibit the growth ofS. aureus in preclinical studies, which often colonizes the skin of affected patients. The U.S. Food and Drug Administration (the “FDA”) has granted Fast Track designation to ATR04-484 for the treatment of EGFRi-associated rash, recognizing the high unmet medical need for the approximately 150,000 patients affected annually in the United States.