Azitra (AZTR) H.C. Wainwright 28th Annual Global Investment Conference summary

Platform overview and technology

• Utilizes a library of 1,500 unique skin bacterial strains, primarily Staph epidermidis, for precision dermatology applications.

• Employs AI/machine learning for drug discovery, predicting novel microbial proteins and molecules.

• Licensed genetic engineering platform (SIMPLE) from Fred Hutchinson Cancer Center to expand transformable bacterial species and improve manufacturing efficiency.

Pipeline and clinical programs

• ATR-04 targets EGFR inhibitor-associated rash, using an engineered Staph epidermidis strain; currently in phase I/II clinical trial with initial safety data expected later this year.

• ATR-01 is a preclinical filaggrin-secreting strain for ichthyosis vulgaris, with IND-enabling studies ongoing and IND submission planned for 2027.

• ATR-COSF, a cosmetic ingredient containing filaggrin, is moving into a first-in-human study focused on wrinkle reduction later this year.

Preclinical and clinical data highlights

• ATR-COSF demonstrated increased filaggrin delivery and binding to keratin in skin models, reducing transepidermal water loss.

• ATR-04 showed 75% reduction in IL-36 gamma and 99% reduction in Staph aureus in preclinical models.

• Clinical trial for ATR-04 is a multicenter, randomized, double-blind, vehicle-controlled study in 32 adults, with primary endpoints of safety and tolerability.