Azitra (AZTR) Corporate presentation summary

Foundational technology platforms

• Utilizes a proprietary bacterial cell library with ~1,500 strains, mainly Staphylococcus epidermidis, for dermatology applications.

• Employs AI/ML algorithms to discover novel microbial-derived proteins, peptides, and small molecules.

• Features a microbial genetic engineering platform with exclusive licenses from leading research institutions.

• SyMPL (SyngenicDNA minicircle plasmid) technology enables stealth genetic engineering by removing recognition motifs, improving protein yields and overcoming bacterial defenses.

• SyMPL applications target bio-identical filaggrin, mRNA kits, and recombinant Protein A, each addressing major biomanufacturing challenges.

Pipeline and product candidates

• ATR-COSF is a topical cosmeceutical ingredient delivering recombinant filaggrin protein for skin hydration, barrier function, and anti-aging benefits.

• ATR-01 is an engineered S. epidermidis strain delivering filaggrin for ichthyosis vulgaris, showing dose-dependent delivery and reduced transepidermal water loss in preclinical models.

• ATR-04 is a topical therapy for EGFR inhibitor-associated rash, inhibiting IL-36y and S. aureus, with Fast Track FDA designation and a potential >$1B peak sales opportunity.

• ATR-04 demonstrated reduction of IL-36y and S. aureus in vitro and is Phase 1/2 ready.

• Upcoming milestones include first-in-human studies for ATR-COSF and ATR-04, and IND submission for ATR-01 in early 2027.

Clinical and preclinical data

• ATR-COSF delivers filaggrin below the stratum corneum after a single dose, supporting its mechanism for skin barrier repair.

• ATR-04 reduces erlotinib-induced IL-36y and S. aureus in reconstructed human epidermis and ex vivo pig skin, with dose-dependent effects.

• ATR-01 delivers functional filaggrin in a dose-dependent manner and reduces transepidermal water loss in heat-damaged pig skin.

• Phase 1/2 clinical trial for ATR-04 is multicenter, randomized, double-blind, and vehicle-controlled, focusing on safety, tolerability, and efficacy signals.

• ATR-01 IND-enabling studies are ongoing, with submission targeted for 2027.