Azitra, Inc. Announces New Preclinical Data to be Presented at the American Society of Gene and Cell Therapy Meeting

• Azitra will present two oral presentations at ASGCT (American Society of Gene and Cell Therapy) Baltimore, MD, May 7-11, 2024 related to ATR-12, Azitra’s candidate for Netherton syndrome
• Topical application of ATR-12 to ex vivo human skin demonstrates the potential for superior LEKTI delivery compared to topical LEKTI application
• Preclinical data suggests ATR-12 can significantly reduce IL-36g, a pro-inflammatory cytokine that drives Netherton syndrome

BRANFORD, Conn.--(BUSINESS WIRE)--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced preclinical data from the Company’s platform and pipeline. The data will be presented on Friday, May 10, 2024, in two oral sessions entitled “Engineered Staphylococcus Epidermidis as a Protein Delivery System for Treating Skin Diseases” and “Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR12-351) for Netherton Syndrome.”

“We are thrilled to announce new preclinical data for our precision dermatology platform that demonstrate proof-of-concept data supporting the use of genetically engineered skin commensals to deliver proteins to the skin,” said Travis Whitfill, Azitra’s co-founder and COO. “These data show the robust preclinical activity of ATR-12 in Netherton syndrome models and further supports the rationale behind our Phase 1b clinical trial in Netherton syndrome patients.”

ATR-12 is an engineered strain of S. epidermidis that expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately one to nine in every 100,000. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open IND for a Phase 1b clinical trial in adult patients (NCT06137157).

The data in the abstracts released online today show that topical application of ATR-12 in preclinical models reduced produced reduced IL-36γ by 93% compared to skin extracts induced to overexpress IL-36γ. Additionally, topical application of ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01). Finally, ATR-12 produced higher amounts of LEKTI compared to topical application of LEKTI protein alone (6.0 µg vs. 2.3 µg, respectively, p<0.01) after 24 hours and resulted in deeper skin penetration of LEKTI.

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 timing of the presentation of data from the Phase 1b study of ATR-12 and the expected benefits of our ATR-12.

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, but are not limited to, (i) the risk that the further data from the ongoing Phase 1b clinical trial for ATR-12 will not be favorably consistent with the initial data initial data readouts, (ii) the risk that we may not be able to advance to registration-enabling studies for our ATR-12 candidate, (iii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iv) we may fail to timely raise additional required funding; and (v) those risks concerning Azitra's programs and operations are described in its annual report on Form 10-K filed with the SEC on March 15, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.