ATR-04

BRANFORD, Conn., May 13, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended March 31, 2025 , and provided a business update. Q1 2025 and Recent Business Highlights Announced acceptance of poster detailing the Phase 1/2 clinical trial of the ATR-04 program in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting Entered into Purchase Agreement for up to $20 Million in Partnership with institutional investor Alumni Capital LP , to fund clinical pipeline Announced closing of two public offerings raising a total of $2.2M "The start of 2025 has been a vital period for Azitra as we build towards key milestones expected by mid-year for our first-in-class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases," said Francisco Salva , CEO of Azitra . "For ATR-12, our lead program targeting the rare, chronic and devastating Netherton syndrome, we expect to provide initial safety data from our Phase 1b trial in the first half of 2025 with topline results expected by year-end 2025. There are no approved treatments for Netherton syndrome, and we believe this novel approach has potential to be life-changing for these patients." Salva continued: "Also by mid-2025, we look forward to dosing the first patient in our Phase 1/2 trial with our ATR-04 program, which contains a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFRi-associated rash. EGFRi-associated rash is a dermatologic toxicity that often accompanies EGFRi treatments for cancer, impacting approximately 150,000 patients in the United States annually. These severe skin conditions can interfere with cancer treatment efforts, often causing significant physical and psychological discomfort for patients. Given the importance of EGFRi therapies to the cancer industry, Azitra was invited to present an update of our ATR-04 Phase 1/2 trial at ASCO 2025, which is the most prestigious cancer research conference in the world." Salva concluded: "The remainder of 2025 is expected to be a milestone-rich period for Azitra during which we look forward to showcasing the potential of ATR-12 and ATR-04, as well as our unique, proprietary platform for delivering engineered proteins using topical live biotherapeutic products." Pipeline and Anticipated Milestones 1H 2025: Initial safety data from first set of Netherton syndrome patients in the ATR-12 Phase 1b trial 1H 2025: First patient dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04 YE 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients Financial Results for the Quarter Ended March 31, 2025 Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31, 2025 , were $1.3 million compared to $1.5 million for the comparable period in 2024. General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31, 2025 , were $1.9 million compared to $1.5 million for the comparable period in 2024. Net Loss was $3.1 million for the quarter ended March 31, 2025 , compared to $2.9 million for the comparable period in 2024. Cash and cash equivalents: As of March 31, 2025 , the Company had cash and cash equivalents of $3.2 million . 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 StatementsThis 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 (i) our provision of initial safety data and topline results for the phase 1b trial for our ATR-12, (ii) the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program and (iii), 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 experience delays in the provision of initial safety data and topline results for ATR-12 or, if we do, that such data may not be favorably received, 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 StaskeyChief Financial Officerstaskey@azitrainc.com Investor Relations Tiberend Strategic Advisors, Inc. Jon Nugent 205-566-3026jnugent@tiberend.com Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald 646-577-8520cmcdonald@tiberend.com Condensed Statement of Operations(Unaudited) Three months Ended March 31 , 2025 2024 Operating expenses: General and administrative $ 1,850,138 $ 1,488,527 Research and development 1,250,100 1,472,970 Total operating expenses 3,100,238 2,961,497 Loss from operations (3,100,238) (2,961,497) Other income (expense): Interest income 37,164 7,609 Interest expense (1,293) (915) Change in fair value of warrants 143 28,255 Other expense (4,121) (6,327) Total other income 31,893 28,622) Net loss before income taxes (3,068,345) (2,932,875) Income tax expense - - Net loss $ (3,068,345) $ (2,932,875) Net loss attributable to common shareholders $ (3,068,345) (2,932,875) Net loss per Share, basic and diluted $ (0.23) $ (4.32) Weighted average common stock outstanding, basic and diluted 13,171,516 678,885 Condensed Balance Sheets(Unaudited) March 31 , December 31 , 2025 2024 Assets Current Assets: Cash and cash equivalents $ 3,206,710 $ 4,554,719 Other receivables 103,046 101,896 Prepaid expenses and other current assets 561,798 571,675 Total current assets $ 3,871,554 $ 5,228,290 Property and equipment, net 621,012 653,957 Other assets 1,415,325 1,476,555 Total assets $ 5,907,891 $ 7,358,802 Liabilities, and stockholders' equity Current liabilities: Accounts payable $ 558,924 $ 490,255 Current financing lease liability 16,456 16,066 Current operating lease liability 237,647 255,177 Accrued expenses 467,394 614,359 Total current liabilities 1,280,421 1,375,857 Long-term financing lease liability 5,843 10,105 Long-term operating lease liability 213,765 274,161 Warrant liability 238 381 Total liabilities 1,500,267 1,660,504 Stockholders' equity Common stock 1,498 763 Additional paid-in capital 65,040,296 63,263,360 Accumulated deficit (60,634,170) (57,565,825) Total stockholders' equity 4,407,624 5,698,298 Total liabilities and stockholders' equity $ 5,907,891 $ 7,358,802 View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-announces-q1-2025-results-and-provides-business-updates-302454497.html SOURCE Azitra, Inc.

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.