ATR-12

BRANFORD, CT, USA I August 20, 2024 I Azitra, Inc. (NYSE American: AZTR), a precision dermatology company announced that it has successfully screened the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The patient is scheduled to initiate treatment by the end of the month. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary and exploratory endpoints assessing efficacy signals and biomarkers. Azitra expects to report interim safety data from the Phase 1b trial in early 2025 with full results anticipated in the second half of 2025. ATR-12 is Azitra’s lead candidate, a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of an active subunit of the LEKTI protein to treat Netherton syndrome, a chronic genetic skin disease that can be life threatening. “Enrolling the first patient in our Phase 1b trial of ATR-12 will mark a significant milestone for Azitra and, more importantly, for patients suffering from Netherton syndrome, who currently have limited treatment options,” said Travis Whitfill, founder and COO of Azitra. “Our recent preclinical data demonstrate ATR-12’s potential to effectively deliver an active LEKTI subunit into the skin and address the underlying mechanisms of Netherton syndrome.” Mary Spellman MD, Azitra’s acting CMO, added, “We are thrilled to begin this clinical trial of ATR-12 in Netherton syndrome patients. These patients suffer from poor quality of life and often debilitating disease, and this trial will inform future studies for the treatment of Netherton syndrome in pediatric patients and for longer treatment durations.” The Phase 1b trial (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in approximately 12 adult patients with Netherton syndrome. Patients will be treated with 10 9 CFU / g twice daily with ATR-12 or its vehicle control on the contralateral side of the body twice daily for 14 days. The primary objective is to assess the safety and tolerability of topical ATR-12 application. Secondary objectives include evaluating efficacy signals (e.g., investigator and patient global assessments) and skin pharmacokinetics of the LEKTI subunit. Additional exploratory objectives include evaluating pharmacodynamic parameters, biomarkers, anti-LEKTI response, and cytokine responses. The trial design is supported by compelling preclinical data recently presented at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting. Key findings included: About ATR-12 ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses an active subunit 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 https://azitrainc.com/ . SOURCE: Azitra

BRANFORD, Conn.--( BUSINESS WIRE )--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the three months ended June 30, 2024, and provided a business update. Q2 2024 and Recent Business Highlights Completed a follow-on offering of $10 million in gross proceeds expected to provide cash runway into 2025. With the recent financing, the company anticipates announcing multiple clinical milestones Strengthened global intellectual property portfolio with newly granted and allowed patents Exhibited positive preclinical data from ATR-04 at the Society of Investigative Dermatology Annual Meeting Presented positive preclinical data of ATR-12 and clinical design in Netherton Syndrome at the ASGCT Annual Meeting Opened a Phase 1b clinical trial for ATR-12 for recruitment Francisco Salva, CEO of Azitra commented: “Azitra is poised to achieve significant milestones in the second half of 2024 and beyond, propelling our pipeline forward. In Q3 2024, we expect to dose the first Netherton syndrome patient with ATR-12. Additionally, we anticipate filing and clearing an Investigational New Drug (IND) application for ATR-04, targeting epidermal growth factor receptor inhibitor (EGFRi) rash, a condition with high unmet need. This milestone will expand our clinical pipeline to two clinical-stage programs. Approximately year-end 2024, we anticipate reporting initial safety data from the ATR-12 Phase 1b trial in Netherton syndrome patients and providing an update on our Bayer license agreement. We expect to initiate a first-in-human clinical trial with ATR-04 for EGFRi rash this fall. Looking ahead to mid-2025, we eagerly anticipate reporting topline data from the ATR-12 Phase 1b trial, a defining moment as we aim to demonstrate biological proof of concept of our innovative approach in addressing this severe, rare skin disorder. With a clear roadmap, strong financial position, and dedicated team, Azitra is well-positioned to execute these milestones, deliver transformative therapies to patients in need, and ultimately maximize shareholder value.” Pipeline and Upcoming Milestones Q3 2024: First Netherton syndrome patient dosed with ATR-12 Q3 2024: New investigational new drug (IND) application filed and cleared with the FDA for a Phase 1/2 clinical study of ATR-04 in patients with dermal toxicity undergoing treatment with EGFR inhibitors (“EGFRi rash”) YE 2024: Initial safety data from first set of Netherton syndrome patients in the Phase 1b trial YE 2024: First patient dosed with ATR-04 for EGFRi rash by year end 2024 YE 2024: Bayer collaboration continues with update on license agreement expected by year end Mid 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients expected Financial Results for the Three Months Ended June 30, 2024 Service Revenue – Related Party : The Company generated $7,500 service revenue during the quarter ended June 30, 2024, compared to $172,000 for the comparable period in 2023. Research and Development (R&D) expenses : R&D expenses for the quarter ended June 30, 2024, were $1.1 million compared to $0.8 million for the comparable period in 2023. General and Administrative (G&A) expenses : G&A expenses for the quarter ended June 30, 2024, were $1.5 million compared to $0.8 million for the comparable period in 2023. Net Loss was $2.6 million for the quarter ended June 30, 2024, compared to $5.1 million for the comparable period in 2023. Cash and cash equivalents : As of June 30, 2024, the Company had cash and cash equivalents of $0.8 million. 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 20,000 patients globally. 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 that is actively recruiting adult Netherton syndrome patients (NCT06137157). Azitra has identified Netherton syndrome patients for enrollment in its 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints. About ATR-04 ATR-04 is a live biotherapeutic product candidate including an isolated, naturally derived S. epidermidis strain that was 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 EGFR inhibitor (“EGFRi”) associated rash, 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 rash in the United States. Azitra plans to initiate a Phase 1/2 clinical study in patients undergoing EGFRi rash by year end 2024. 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, 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 registration statement on Form S-1, which is on file with the SEC, and in its most recent quarterly report on Form 10-Q to be filed with the SEC. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Condensed Statement of Operations (Unaudited) Three months Ended June 30, 2024 2023 Service revenue – related party $ 7,500 $ 172,000 Total revenue 7,500 172,000 Operating expenses: General and administrative 1,549,228 844,639 Research and development 1,118,552 754,951 Total operating expenses 2,667,780 1,599,590 Loss from operations (2,660,280 ) (1,427,590 ) Other income (expense): Interest income 16,268 264 Interest expense (1,782 ) (76,187 ) Change in fair value of convertible note - (2,830,100 ) Change in fair value of warrants 4,272 (94,232 ) Other income (expense) 9,529 (1,683 ) Total other income (expense) 28,287 (3,001,938 ) Net loss before income taxes (2,631,993 ) (4,429,528 ) Income tax expense - - Net loss $ (2,631,993 ) (4,429,528 ) Dividends on preferred stock - (643,267 ) Net loss attributable to common shareholders $ (2,631,993 ) (5,072,795 ) Net loss per Share, basic and diluted $ (2.74 ) $ (70.83 ) Weighted average common stock outstanding, basic and diluted 960,146 71,622 Condensed Balance Sheets (Unaudited) June 30, December 31, 2024 2023 Assets Current Assets: Cash and cash equivalents $ 803,082 $ 1,795,989 Other receivables 111,895 223,474 Prepaid expenses and other current assets 420,828 516,116 Total current assets $ 1,335,805 $ 2,535,579 Property and equipment, net 658,731 710,075 Other assets 1,888,018 1,869,832 Total assets $ 3,882,554 $ 5,115,486 Liabilities, and stockholders’ equity Current liabilities: Accounts payable $ 996,700 $ 897,272 Current financing lease liability 15,317 14,600 Current operating lease liability 293,026 307,655 Accrued expenses 434,103 383,668 Total current liabilities 1,739,146 1,603,195 Long-term financing lease liability 18,329 26,169 Long-term operating lease liability 395,987 537,523 Warrant liability 2,926 35,453 Total liabilities 2,156,388 2,202,340 Stockholders’ equity Common stock 96 40 Additional paid-in capital 55,889,271 51,510,269 Accumulated deficit (54,163,201 ) (48,597,163 ) Total stockholders’ equity 1,726,166 2,913,146 Total liabilities and stockholders’ equity $ 3,882,554 $ 5,115,486