Azitra Announces Adjournment of Special Meeting and Information for Reconvened Special Meeting [Accessibility Statement] Skip NavigationBRANFORD, Conn., Feb. 6, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced its Special Meeting scheduled for and convened on February 6, 2026, (the "Special Meeting") has been adjourned until March 6, 2026, at 11:00 a.m. Eastern Time (the " ...

During the event, members of Azitra's management team will conduct one-on-one meetings with registered investors and potential partners, showcasing the company's clinical development strategy, recent corporate achievements, and anticipated milestones. Details are as follows: | Event: | Biotech Showcase 2026 | | --- | --- | | Date & Time | Tuesday, January 13, 2026, 2:30 PM, PT | | Location: | Hilton San Francisco Union Square, Yosemite C (Ballroom Level) | | Presenter | Travis Whitfill, Chief Operating Offi ...

BRANFORD, Conn., Dec. 17, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced it received a notice from the staff of NYSE American LLC (the "Exchange") approving Azitra's plan (the "Plan") to come into compliance with the Exchange's continued listing standards under Section 1003(a)(ii) of the NYSE American Company Guide. As previously reported, on October 1, 2025, Azitra rec ...

As filed with the Securities and Exchange Commission on December 10, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AZITRA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 46-4478536 (I.R.S. Employer Identification Number) 21 Business Park Drive Br ...

Core Insights - Azitra, Inc. reported significant progress in its clinical programs during Q3 2025, including the initiation of a Phase 1/2 trial for ATR-04 targeting EGFRi-associated rash in oncology patients [3][6] - The company presented positive preclinical data for ATR-01, aimed at treating ichthyosis vulgaris, a genetic disorder affecting approximately 1.3 million people in the U.S. [3][6] - Azitra's lead program, ATR-12, targets Netherton syndrome, a rare skin disease with no approved treatments, and is in a Phase 1b clinical trial [3][5] Business Highlights - The first patient was dosed in the Phase 1/2 trial for ATR-04 in August 2025, which has received Fast Track designation from the FDA [3][6][8] - Positive preclinical data for ATR-01 was presented at BIO-Europe, showcasing the potential for active filaggrin delivery [3][6] - The company raised $2.8 million in gross proceeds through an equity line of credit with Alumni Capital LP [6] Financial Results - R&D expenses for Q3 2025 were $1.2 million, up from $1.0 million in Q3 2024 [7] - G&A expenses decreased to $1.6 million in Q3 2025 from $1.9 million in Q3 2024 [7] - The net loss for Q3 2025 was $2.8 million, compared to a net loss of $1.0 million in the same period of 2024 [7][12] Cash Position - As of September 30, 2025, Azitra had cash and cash equivalents of $1.4 million, down from $4.6 million at the end of 2024 [7][12]

Financial Performance - The company reported a net loss of $2,764,528 for the three months ended September 30, 2025, representing a 174% increase compared to a net loss of $1,009,491 for the same period in 2024 [186]. - Total operating loss of $8,740,074 for the nine months ended September 30, 2025, compared to a loss of $8,550,984 in the prior year, reflecting a 2% increase [195]. - The company has not commenced revenue-producing operations and reported total revenue of $0 for the three months ended September 30, 2025, consistent with the prior year [186]. - The company generated no service revenue during the first nine months of fiscal 2025, a decrease of $7,500 compared to $7,500 in the same period of fiscal 2024 [196]. - Other income decreased by $1,958,417, or 99%, during the first nine months of fiscal 2025 compared to the same period in fiscal 2024 [201]. - Net cash used in operating activities was $8,331,514 for the first nine months of fiscal 2025, compared to $7,597,539 in the prior year [207]. - Financing activities provided $5,277,724 in cash during the first nine months of fiscal 2025, a decrease from $13,325,498 in the prior year [210]. - Management has expressed substantial doubt about the company's ability to continue as a going concern due to significant losses and the need for additional capital [206]. Research and Development - The company has a proprietary microbial library of approximately 1,500 unique bacterial strains, focusing on genetically engineered strains of Staphylococcus epidermidis for dermatologic therapies [168]. - ATR-12, a genetically modified strain for treating Netherton syndrome, received FDA clearance for a Phase 1b clinical trial, with the first patient dosed in August 2024 [175]. - ATR-04, targeting papulopustular rash in cancer patients, received IND clearance in August 2024 and Fast Track designation, with the first patient dosed in Q3 2025 [175]. - The company plans to conduct lead optimization and IND-enabling studies for ATR-01 in 2025, targeting ichthyosis vulgaris, with an estimated patient population of 1.3 million in the U.S. [175]. - Research and development expenses increased by 16% to $1,180,078 for the three months ended September 30, 2025, primarily due to increased clinical trial costs for the ATR-04 program [190]. - Research and development expenses for preclinical and clinical activities were $2,238,518 for the first nine months of fiscal 2025, up from $1,379,317 in the prior year [199]. - The company expects a significant increase in research and development expenses in the future due to planned clinical trial activities and continued development of product candidates [191]. - Research and development expenses increased by $224,688, or 6%, to $3,832,017 for the first nine months of fiscal 2025, driven by clinical trial costs related to the ATR-12 and ATR-04 programs [199]. - The company received IND clearance from the FDA for the ATR-04 program and initiated dosing the first patient in the ATR-04 Phase 1/2 clinical trial in the third quarter of 2025 [184]. - The company is focused on advancing its lead programs, ATR-12 and ATR-04, through clinical trials and exploring strategic partnerships to enhance its precision dermatology platform [184]. Capital and Financing - The company completed its IPO on June 21, 2023, issuing 7,508 shares at a price of $999 per share, converting all outstanding convertible preferred stock and promissory notes into 44,802 shares of common stock [162]. - A follow-on public offering in February 2024 raised $5 million by selling 83,404 shares at $59.94 per share, and another offering on July 25, 2024, raised approximately $10 million by selling 1,000,750 shares at $9.99 per share [162]. - As of November 12, 2025, the company has sold 7,955,823 shares and issued 795,579 warrants to Alumni Capital LP, generating estimated gross proceeds of $6.0 million, with $2.4 million received after September 30, 2025 [166]. - Total assets as of September 30, 2025, were approximately $4.3 million, with working capital of approximately $0.4 million [203]. - Cash and cash equivalents as of September 30, 2025, included approximately $1.4 million, which is insufficient to cover the proposed plan of operations for the next twelve months [203]. Compliance and Regulatory - The company received a deficiency letter from NYSE American on October 1, 2025, indicating non-compliance with continued listing standards due to stockholders' equity being below $4.0 million [177]. - General and administrative expenses decreased by 1% to $4,908,057 for the nine months ended September 30, 2025, from $4,951,155 in the prior year [195]. - General and administrative costs decreased by $43,098, or 1%, to $4,908,057 for the first nine months of fiscal 2025 compared to the prior year [197]. - The company expects a modest increase in general and administrative expenses due to personnel and facility operating costs [198].

Core Viewpoint - Azitra, Inc. has refuted claims regarding a false report of a $44 million registered direct offering, urging stakeholders to rely on official communications from the company [1][2]. Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease with no approved treatments [3]. - The ATR-12 program is currently in a Phase 1b clinical trial for adult patients with Netherton syndrome [3]. - Azitra's ATR-04 program addresses EGFR inhibitor-associated rash and has received Fast Track designation from the FDA, impacting approximately 150,000 individuals in the U.S. [3]. - The company is also advancing ATR-01, a preclinical program for ichthyosis vulgaris, with plans for an IND submission in 2026 [3]. - Azitra's proprietary platform includes a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning technologies for drug discovery [3].

Core Insights - Azitra, Inc. announced positive preclinical progress for its ATR-01 program targeting ichthyosis vulgaris, a genetic disorder affecting approximately 1.3 million people in the U.S. [1][2] - The ATR-01 program utilizes an engineered strain of S. epidermidis, ATR01-616, which secretes functional filaggrin, showing promising results in preclinical models [2][3] - The company plans to present detailed data at the BIO-Europe conference in November 2025 and aims to submit an IND for ATR-01 in 2026 [1][3] Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [3] - The company also has an advanced program, ATR-04, for treating EGFR inhibitor-associated rash, which has received Fast Track designation from the FDA [3] - Azitra's programs are developed from a proprietary platform of engineered proteins and topical live biotherapeutic products, supported by artificial intelligence and machine learning [3]

Core Viewpoint - Azitra, Inc. has received a notice from NYSE American regarding non-compliance with continued listing standards due to insufficient stockholders' equity, requiring a plan for compliance by October 31, 2025 [1][2]. Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 aimed at treating Netherton syndrome, a rare skin disease [4]. - The company also has an advanced program ATR-04 for treating EGFR inhibitor-associated rash, which has received Fast Track designation from the FDA [4]. Compliance and Future Plans - Azitra plans to submit a compliance plan to the Exchange and is exploring multiple funding avenues to meet the listing requirements [2]. - If the plan is accepted, Azitra will undergo periodic reviews to ensure compliance [2]. Current Status - The notice from the Exchange does not immediately affect the listing or trading of Azitra's common stock and does not impact its business operations or reporting requirements [3].

Core Insights - Azitra, Inc. is a clinical stage biopharmaceutical company focused on innovative therapies for precision dermatology [4] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [3] - Recent updates include promising safety results from the Phase 1b clinical trial of the ATR-12 program for Netherton syndrome and the initiation of the Phase 1/2 trial for the ATR-04 program targeting EGFR inhibitor-associated dermal toxicity [2][4] Company Overview - Azitra's lead program, ATR-12, targets Netherton syndrome, a rare skin disease with no approved treatments, and is currently in a Phase 1b clinical trial [4] - The ATR-04 program addresses EGFR inhibitor-associated rash, which affects approximately 150,000 people in the U.S., and has received Fast Track designation from the FDA [4] - The company utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning for drug discovery [4] Presentation Details - The virtual presentation by Travis Whitfill, Cofounder and COO, is scheduled for 7:00 AM ET on September 8, 2025 [3] - During the conference, one-on-one meetings will be held with registered investors and potential partners to discuss the company's business and clinical development strategy [3]