Azitra, Inc. Announces Q2 2025 Results and Provides Business Updates

, /PRNewswire/ -- Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended June 30, 2025, and provided a business update. Q2 2025 and Recent Business Highlights Announced initial safety results and 50% enrollment of the Phase 1b clinical trial of the ATR-12 program in Netherton syndrome, demonstrating a promising safety profile 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 a purchase agreement for up to $20 million to establish an equitly line of credit in partnership with institutional investor Alumni Capital LP, to fund clinical pipeline "The first half of 2025 was a vital period for Azitra as we hit a key milestone in 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 announced promising safety data in the first five patients dosed with ATR12-351, and we believe this novel approach has potential to be life-changing for these patients. Netherton syndrome has a high unmet need with no approved treatment options." Mr. Salva continued: "We also announced the design of our Phase 1/2 trial with our ATR-04 program at ASCO, which is investigating 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. We expect to dose the first patient in our Phase 1/2 trial in the third quarter of this year." Mr. Salva concluded: "The remainder of 2025 is anticipated 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 Q3 2025: First patient to be dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04 Q1 2026: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients Financial Results for the Quarter Ended June 30, 2025 Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2025, were $1.4 million compared to $1.1 million for the comparable period in 2024. General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2025, were $1.5 million compared to $1.5 million for the comparable period in 2024. Net Loss was $2.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the comparable period in 2024. Cash and cash equivalents: As of June 30, 2025, Azitra had cash and cash equivalents of $1.0 million. About Azitra, Inc. Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. Azitra'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 adults with Netherton syndrome. ATR-04, Azitra's additional clinical program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated skin toxicity; a Phase 1/2 clinical trial has been initiated for this program. Azitra has received Fast Track designation from the United States Food and Drug Administration for this program to treat EGFRi associated rash, which impacts approximately 150,000 people in the United States. 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 (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, (iii) the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and (iv) 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 United States Securities and Exchange Commission 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 Officer[email protected] Investor RelationsTiberend Strategic Advisors, Inc.Jon Nugent205-566-3026[email protected] Media RelationsTiberend Strategic Advisors, Inc.Casey McDonald646-577-8520[email protected] Condensed Statement of Operations (Unaudited) Three months Ended June 30, 2025 2024 Service revenue – related party $ - $ 7,500 Total revenue - 7,500 Operating expenses: General and administrative 1,469,513 1,549,228 Research and development 1,401,839 1,118,552 Total operating expenses 2,871,352 2,667,780 Loss from operations (2,871,352) (2,660,280) Other income (expense): Interest income 15,461 16,268 Interest expense (468) (1,782) Change in fair value of warrants 54 4,272 Other expense (32,688) 9,529 Total other income (expense) (17,641) 28,287 Net loss before income taxes (2,888,993) (2,631,993) Income tax expense - - Net loss $ (2,888,993) $ (2,631,993) Net loss attributable to common shareholders $ (2,888,993) (2,631,993) Net loss per Share, basic and diluted $ (0.18) $ (2.74) Weighted average common stock outstanding, basic and diluted 16,279,574 960,146 Condensed Balance Sheets (Unaudited) June 30, December 31, 2025 2024 Assets Current Assets: Cash and cash equivalents $ 1,045,730 $ 4,554,719 Other receivables 78,407 101,896 Prepaid expenses and other current assets 675,553 571,675 Total current assets $ 1,799,690 $ 5,228,290 Property and equipment, net 601,504 653,957 Other assets 1,554,828 1,476,555 Total assets $ 3,956,022 $ 7,358,802 Liabilities, and stockholders' equity Current liabilities: Accounts payable $ 635,842 $ 490,255 Current financing lease liability 16,854 16,066 Current operating lease liability 286,499 255,177 Accrued expenses 513,166 614,359 Total current liabilities 1,452,361 1,375,857 Long-term financing lease liability 1,479 10,105 Long-term operating lease liability 273,027 274,161 Warrant liability 184 381 Total liabilities 1,727,051 1,660,504 Stockholders' equity Common stock 1,798 763 Additional paid-in capital 65,750,337 63,263,360 Accumulated deficit (63,523,164) (57,565,825) Total stockholders' equity 2,228,971 5,698,298 Total liabilities and stockholders' equity $ 3,956,022 $ 7,358,802 SOURCE Azitra, Inc. 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Azitra, Inc. Announces Q2 2025 Results and Provides Business Updates

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