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Azitra is developing ATR04-484 for the treatment of EGFR inhibitor-associated rash with plans to dose first patient in Phase 1/2 trial in the first half of 2025 BRANFORD, Conn., April 25, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that an abstract detailing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30-June 3, 2025 in Chicago. "We look forward to presenting an update on the ATR-04 program at ASCO as we plan to dose the first patient in the first half of 2025," said Francisco Salva, CEO of Azitra. "ASCO is widely regarded as the most prestigious cancer research conference in the world, and we are eager to educate leaders in the oncology community on the potential of ATR04-484 to treat the unique dermatologic toxicities that often accompany EGFRi treatments, which can hamper treatment efforts and cause significant physical and psychological discomfort for patients." ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484. ATR04-484 is in development for EGFRi-associated skin rash, which is associated with the suppression of skin immunity by EGFR inhibitors and subsequent inflammation, often accompanied by elevated levels of IL-36γ and S. aureus. Azitra has received Fast Track designation from the FDA for EGFRi associated rash and has initiated a Phase 1/2 clinical study in patients with EGFRi rash with the first patient expected to be dosed in the first half of 2025. EGFR inhibitors are a class of cancer drugs that target and block the activity of the EGFR protein, which plays a crucial role in cell growth and survival. They are primarily used to treat certain types of cancer, including non-small cell lung cancer (NSCLC) and colorectal cancer. The full ASCO abstracts will be available on May 22, 2025, after 5 p.m. ET. Abstract titles are available at: https://www.asco.org/abstracts. About Azitra, Inc. Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. 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 abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies. 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 that we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman Staskey Chief Financial Officer staskey@azitrainc.com Investor Relations Tiberend Strategic Advisors, Inc. Jon Nugent 205-566-3026 jnugent@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald 646-577-8520 cmcdonald@tiberend.com View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-to-present-atr-04-program-update-at-asco-2025-302437932.html SOURCE Azitra, Inc.

ATR-04 is in development for epidermal growth factor receptor inhibitor (EGFRi)-induced dermal toxicity, which affects approximately 150,000 patients in the US Reduces methicillin-resistant S. aureus by 99% on ex vivo pig skin Reduces IL-36g, a pro-inflammatory cytokine that drives inflammation in EGFRi-induced toxicity, in human skin model by 75% compared to erlotinib-treated skin Increases human beta defensin 18-fold vs. vehicle on human skin model 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 are being presented on Friday, May 17, 2024, in two oral sessions entitled “Staphylococcus epidermidis for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity” and “Cutaneous delivery of LEKTI via an engineered strain of Staphylococcus epidermidis for the treatment of Netherton syndrome” at the Society of Investigative Dermatology (SID) 2024 Annual Meeting in Dallas, TX. “We are pleased to announce the first publication of preclinical data around ATR-04 in EGFR inhibitor (EGFRi)-associated dermal toxicity,” said Travis Whitfill, Azitra’s co-founder and COO. “These data show robust preclinical activity of ATR-04 in models of EGFRi-induced dermal toxicities that support an upcoming Investigational New Drug (IND) application to the FDA for a Phase 1b in patients undergoing EGFR inhibitors with dermal toxicity. We anticipate the expansion of our clinical-stage pipeline this year with ATR-04.” ATR-04 is a live biotherapeutic product candidate consisting of an S. epidermidis strain that was isolated from a healthy volunteer and engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFRi-associated skin toxicity, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi-induced skin toxicity in the United States. The data in the oral presentations today showcase the preclinical development of ATR-04. ATR-04 led to a decrease in S. aureus across multiple models. In in vitro skin models, ATR-04 treatment led to a 96% reduction in methicillin-resistant S. aureus (MRSA) compared to untreated skin (p<0.0001). In ex vivo pig skin treated with ATR-04, there was a ~99% reduction in MRSA compared to untreated skin (p=0.012). Additionally, in human skin models treated with erlotinib, an EGFRi, ATR-04 reduced IL-36γ by 75% (p=0.009) to levels comparable to untreated skin models. Finally, ATR-04 increased human beta defensin, a key protein involved in host defenses, by 18-fold compared to vehicle. Together, the data show that ATR-04 can address multiple drivers of EGFRi-induced skin toxicity. The presentations are now available on Azitra’s website at . 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 . 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 advancement of ATR-04 into a Phase 1b clinical trial; expectation that the initial pre-clinical data for ATR-04 will be consistent with the further pre-clinical data; and the benefits of the Company’s proprietary platform and microbial library. 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 pre-clinical trial for ATR-04 will not be favorably consistent with the initial pre-clinical data to date, (ii) the risk that the Company’s IND application for ATR-04 may not receive a safe to proceed letter from the FDA, (iii) success in early phases of pre-clinical trials do not ensure later clinical trials will be successful; we may fail to timely raise additional required funding; and those additional 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.

ATR-12 has nanomolar inhibition of key protease in vitro that drives Netherton syndrome Topical application of ATR-12 to ex vivo human skin results in superior LEKTI delivery compared to topical LEKTI application ATR-12 reduces IL-36g, a pro-inflammatory cytokine that drives Netherton syndrome Safe and well tolerated in minipigs 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 are being 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” at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting in Baltimore, MD. The data in the two oral presentations today showcase the preclinical development of ATR-12 and the clinical study design of a Phase 1b study in Netherton syndrome patients. In vitro data show that LEKTI (lympho-epithelial Kazal-type-related inhibitor) protein secreted by ATR-12 has nanomolar inhibition of a key protease that drives Netherton syndrome, kallikrein (KLK) 5 (IC50=26 nM). Additionally, in human ex vivo Netherton syndrome models, ATR-12 supernatant reduces protease activity nearly 7-fold to levels comparable to healthy skin. Furthermore, in ex vivo human skin models, ATR-12 led to a higher amount of LEKTI delivery to the skin compared to topically applied LEKTI alone (6.1 µg/cm2 vs. 2.3 µg/cm2, p=0.008) after 24 hours and resulted in deeper biodistribution of LEKTI. Application of ATR-12 in human skin cell culture reduced IL-36γ by 92% compared to skin extracts induced to overexpress IL-36γ. Topical application of ATR-12 to in vitro human skin treated with erlotinib reduced IL-36γ by 69%. In studies conducted in minipigs with abraded skin, topical application of ATR-12 resulted in 11.9 ng/cm2 of LEKTI on the surface of the skin vs. 2.6 ng/cm2 in the vehicle group at day 14. ATR-12 application was safe and well-tolerated in GLP toxicology studies with minipigs. The oral presentation entitled “Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR-12) for Netherton Syndrome” also provides the study design for an active clinical trial of ATR-12 in Netherton syndrome patients. The Phase 1b study (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in adults (n=12) with Netherton syndrome. Patients will be treated twice daily with 109 CFU / g ATR-12 for 14 days. The primary objective is to assess the safety and tolerability of topical application of ATR-12, and the secondary objectives are to evaluate efficacy signals (e.g., investigator and patient global assessments) and to evaluate the skin pharmacokinetics of LEKTI. Exploratory objectives include the evaluation of pharmacodynamic parameters, including anti-LEKTI response, cytokine responses, biomarkers such as KLK5, KLK7, IL-36γ, trypsin-like activity, and chymotrypsin-like activity. “We are thrilled to announce full preclinical data around ATR-12 as well as our clinical plan in Netherton syndrome 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.” The presentations are now available on Azitra’s website at . About ATR-12 ATR-12 (also known as ATR12-351) 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). Azitra has secured clinical sites and identified Netherton syndrome patients for enrollment in its 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints. Azitra expects to announce initial safety data before year end. 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 . 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, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, the timing of having a signed license agreement with Bayer, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical strategies. 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 that we may fail to successfully complete our Phase 1b trial for ATR-12 and pre-clinical studies of other product candidates and obtain required approval before commercialization; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional 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. View source version on businesswire.com: Contacts Norman Staskey Chief Financial Officer staskey@azitrainc.com Hayden IR James Carbonara (646) 755-7412 james@haydenir.com Source: Azitra, Inc. View this news release online at: