• Newly granted patent protects a filaggrin-secreting strain of Staphylococcus epidermidis for the treatment of ichthyosis vulgaris

• Ichthyosis vulgaris is a high unmet need with no FDA-approved treatment option and affects approximately 1.3 million people in the United States

• Broadens Azitra’s foundational intellectual property (IP) for its platform using metagenomics and engineered skin bacteria for precision dermatology

• Azitra now holds 3 granted U.S. patents and numerous pending patent applications

BRANFORD, Conn. / Jan 16, 2024 / Business Wire / Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent No. 11,850,267 covering future potential pipeline candidates for indications including ichthyosis vulgaris, titled “Methods and compositions for treating skin disease with recombinant microorganisms.”

Travis Whitfill, Azitra’s COO, co-founder, and inventor of the patent stated, "Securing this patent is crucial for expanding our pipeline. Importantly, the indication addressed by this patent, ichthyosis vulgaris (IV), a chronic, scaly skin disease with no FDA-approved treatment option and affects approximately 1.3 million people in the United States. This new patent issuance reinforces the value of our platform for precision dermatology and our commitment to patient populations with no FDA-approved treatment options."

Azitra is developing live biotherapeutic product candidates intended to treat ichthyosis vulgaris, a disease caused by missing or abnormal filaggrin levels. Azitra is developing a novel topical treatment modality for IV that directly addresses the disease pathophysiology by delivering filaggrin to the skin. The strain consists of a functional unit of the human filaggrin protein with an attached cell penetrating peptide. The goal is to supplement the skin with stable delivery of filaggrin via topical application and deeper skin penetration with a cell penetrating peptide.

This modality of a topical live biotherapeutic consisting of a protein-secreting of S. epidermidis to deliver missing proteins is similar to Azitra’s ATR-12 product candidate, which delivers Lympho-epithelial Kazal-type-related inhibitor (LEKTI) for Netherton syndrome, caused by missing LEKTI. Azitra has initiated a first-in-human study of ATR-12 for adult Netherton syndrome patients (NCT06137157).

Azitra’s growing patent portfolio now has three granted patents in the US with numerous additional applications pending globally to further expand its IP position.

About Azitra, Inc.

Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts and helps screen the Company's library of strains for drug like molecules. The Company's initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit https://azitrainc.com/.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected benefits of the recently issued patent covering ichthyosis vulgaris and Azitra’s development of live biotherapeutic product candidates intended to treat ichthyosis vulgaris.

Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, we are in the early preclinical stages of developing our live biotherapeutic product candidates intended to treat ichthyosis vulgaris and there can be no assurance that we will be able to advance any such product candidate to clinical trials or, if we do, that such clinical trials will be successful; we may fail to timely raise additional required funding as and when needed; and those other risks described in our prospectus dated June 15, 2023 filed with the SEC on June 21, 2023. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.