Azitra (AZTR) Corporate presentation summary

Foundational technology platforms

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

• Employs AI/ML algorithms to discover novel microbial-derived proteins, peptides, and small molecules, with exclusive agreements for specific strains.

• Features a microbial genetic engineering platform capable of novel transformations, overcoming bacterial defense barriers, and licensed from Fred Hutchinson Cancer Center.

• SyMPL (SyngenicDNA minicircle plasmid) technology enables stealth genetic engineering by removing recognition motifs, improving protein yields and enabling production in previously intractable bacteria.

• SyMPL applications target large markets, including bio-identical filaggrin, mRNA kits, and recombinant Protein A, addressing manufacturing challenges.

Pipeline and product candidates

• ATR-COSF is a topical cosmeceutical ingredient delivering recombinant filaggrin protein via engineered S. epidermidis, enhancing skin hydration and barrier function.

• ATR-01 is an engineered S. epidermidis strain for topical filaggrin delivery, targeting ichthyosis vulgaris, a disease with no FDA-approved treatments.

• ATR-04 is a topical auxotrophic S. epidermidis candidate for EGFR inhibitor-associated rash, inhibiting IL-36y and S. aureus, with Fast Track FDA designation.

• ATR-01 and ATR-04 have demonstrated dose-dependent delivery and efficacy in ex vivo and preclinical models, with ATR-01 reducing transepidermal water loss and ATR-04 reducing IL-36y and S. aureus.

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

Clinical and preclinical data

• ATR-COSF delivers filaggrin below the stratum corneum after a single application, restoring skin elasticity in ex vivo models.

• ATR-04 reduces erlotinib-induced IL-36y and S. aureus in vitro and ex vivo, with a dose-dependent effect.

• ATR-01 delivers human filaggrin in a dose-dependent manner and reduces transepidermal water loss in damaged skin models.

• Phase 1/2 clinical trial for ATR-04 is designed as a multicenter, randomized, double-blind, vehicle-controlled study to assess safety, tolerability, and efficacy signals in EGFR inhibitor-associated rash.

• ATR-04 addresses a market of ~150,000 US patients with potential peak sales over $1B.