Azitra is developing genetically engineered bacteria for therapeutic use in dermatology. The company possesses a microbial library of 1,500 unique bacterial strains that are candidates for a variety of indications. Azitra's lead candidate is ATR-12 for the rare disease Netherton Syndrome (NS). A second candidate is ATR-04 targeting EGFRi-associated rash and a third, ATR-01, ichthyosis vulgaris. Each one is topically formulated. Preclinical work has shown effective and safe use of ATR-12 as a potentially disease-modifying therapy able to colonize the skin and replace the missing LEKTI protein. An IND has been cleared and Azitra has started a Ph1 for NS. An IND is expected for ATR-04 by year end 2024. ATR-12 provides the missing active protein segment for NS and if successful will be a disease modifying therapy. The therapy is not a cure and patients will require ongoing treatment. We expect clinical trials for NS will follow an expedited pathway as NS is a rare disease that affects children. Our forecasts call for Ph2 and pivotal trials producing a BLA submission in 2028 and approval the following year. ATR-12 may also qualify for a rare pediatric disease priority review voucher.
