BRANFORD, Conn., Feb. 27, 2026 /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 full year ended December 31, 2025, and provided a business update. Pipeline Achievements and Upcoming Milestones ATR-12 - Advancing Phase 1b Clinical Trial in Netherton Syndrome ATR-04 – Addressing an Unmet Need for Cancer Patients in a Multi-billion Dollar Market ...

Product Development and Clinical Trials - Azitra, Inc. has developed a proprietary platform with a microbial library of approximately 1,500 unique bacterial strains for precision dermatology[22]. - The company is advancing its lead programs, ATR-12 and ATR-04, into clinical trials, with ATR-12 targeting Netherton syndrome and ATR-04 targeting EGFRi-associated rash[32]. - ATR-12 received Pediatric Rare Disease Designation from the FDA in 2019, and the Phase 1b clinical trial commenced in December 2023, with the first patient dosed in August 2024[23]. - ATR-04 obtained IND clearance from the FDA in August 2024 and Fast Track designation in September 2024, with the first patient dosed in the third quarter of 2025[23]. - The estimated incidence of ichthyosis vulgaris, targeted by ATR-01, is 1 in 250, suggesting a total patient population of approximately 1.3 million in the United States[24]. - ATR-12, a proprietary drug candidate for treating Netherton syndrome, contains a genetically modified strain of S. epidermidis that secretes a fragment of the LEKTI protein, addressing the underlying cause of the disease[45]. - ATR-12 is projected to represent a potential global sales opportunity of $250 million by mid-2030 based on market analysis[46]. - Preclinical studies indicate that SE351, the strain used in ATR-12, can colonize human skin and requires D-alanine for growth, confirming its controlled application[56]. - A single therapeutic dose of ATR-12-351 demonstrated approximately 2-fold higher LEKTI activity after 24 hours compared to 8 hours, indicating sustained production of functional rhLEKTI-D6[60]. - The company filed an IND for a Phase 1b clinical trial of ATR-12 in December 2022, with the first patient dosed in August 2024 and initial safety results expected in the first half of 2025[65]. - The Phase 1/2 clinical trial for ATR-04-484 began in Q3 2025, focusing on safety and quality of life as secondary endpoints[86]. - ATR-01 utilizes a novel engineering segment of human filaggrin to enhance skin delivery, targeting the underlying cause of ichthyosis vulgaris[87]. - ATR-01-616 is a novel topical formulation for treating ichthyosis vulgaris (IV), utilizing a genetically modified S. epidermidis strain to deliver recombinant human filaggrin[92]. - In preclinical studies, ATR-01-616 significantly reduced transepidermal water loss (TEWL) in a damaged pig skin model, achieving p-values <0.001 across all tested doses[94]. - The in vitro model demonstrated that ATR-01-616 restored keratohyalin granules and increased filaggrin levels in reconstructed human epidermis compared to untreated controls[96]. Partnerships and Collaborations - Azitra has established partnerships with Carnegie Mellon University and Fred Hutchinson Cancer Center to enhance its research capabilities and product development[25]. - The company holds an exclusive, worldwide license from Fred Hutch for the use of patented SyMPL technologies in genetic engineering[25]. - The SyMPL technology platform acquired from Fred Hutch allows for the genetic modification of previously intractable bacterial species, expanding the potential for future product candidates[41]. - The exclusive license agreement with Fred Hutchinson Cancer Center allows the company to develop and commercialize products related to SyMPL technologies, with patent rights expiring in 2037 and 2040[121][122]. Financial Performance and Projections - For the fiscal years ended December 31, 2025 and 2024, the company incurred a net loss of $11.0 million and $9.0 million, respectively, with an accumulated deficit of $68.5 million as of December 31, 2025[217]. - The company expects to continue incurring substantial expenses without any meaningful revenues until regulatory approval and successful commercialization of at least one product candidate[218]. - As of December 31, 2025, the company had total assets of $5.0 million and working capital of $2.0 million[220]. - In January 2025, the company completed a public offering of 729,381 shares at an offering price of $2.00 per share, receiving net proceeds of approximately $1.2 million[220]. - In February 2025, the company completed a registered direct offering of 374,696 shares at an offering price of $1.85 per share, receiving net proceeds of approximately $695 thousand[220]. - The company anticipates significant research, regulatory, and development expenses as it advances product candidates towards commercialization[218]. - The report from the independent registered public accounting firm indicates substantial doubt about the company's ability to continue as a going concern due to accumulated deficit and negative cash flow from operations[219]. - The company has a limited operating history and has not commenced revenue-producing operations apart from limited grant and service revenue[215]. Regulatory Environment - The biopharmaceutical industry presents intense competition, with potential competitors having greater financial resources and expertise[102]. - No FDA-approved drug exists for treating EGFRi-associated rash, affecting up to 90% of patients on anti-EGFR therapies[107]. - Pharmaceutical companies face extensive regulations from agencies like the U.S. FDA, impacting research, development, and marketing processes[125]. - The FDA approval process for new biologics includes multiple phases, with significant costs and time requirements, often extending over many years[126][129]. - The company must comply with Good Manufacturing Practices (cGMP) and other regulatory requirements to avoid fines or refusal of marketing applications[125][128]. - The FDA requires compliance with cGMP regulations for the manufacturing of product candidates, which involves significant investment in personnel, facilities, and quality control[138]. - A BLA submission must include comprehensive data from clinical studies, and the FDA aims to complete its initial review within ten months, or six months for serious conditions[141]. - The FDA may approve a BLA with conditions such as post-marketing studies or risk mitigation strategies, which could include REMS plans[142]. - The FDA can designate products for expedited review under Fast Track, Breakthrough Therapy, or Priority Review if they address unmet medical needs[146][149]. - Orphan Drug Designation provides seven years of market exclusivity for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[158]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained, leading to potential fines or product recalls[157]. - Manufacturers must continue to comply with cGMPs post-approval, with periodic inspections by the FDA to ensure ongoing compliance[143]. - The FDA strictly regulates marketing and promotion, allowing products to be promoted only for approved indications[156]. Market and Competitive Landscape - The company aims to build a sustainable pipeline of product candidates while exploring strategic partnerships to accelerate development and expand into new treatment areas[32]. - The company plans to establish a commercial organization in the U.S. to promote live biotherapeutic products and recombinant proteins for skin diseases[100]. - The company expects additional state and federal healthcare reform measures that could limit government payments for healthcare products and services, potentially reducing demand for its product candidates[209]. - Heightened scrutiny over drug pricing practices may lead to increased transparency and potential regulatory changes affecting profitability[203].

Azitra, Inc. Announces Addition of MD Anderson Cancer Center as Clinical Site for Phase 1/2 Trial of ATR-04 Targeting EGFRi-Associated Skin Rash [Accessibility Statement] Skip NavigationMD Anderson Cancer Center expands ATR-04 clinical trial site footprint, offering potential to accelerate enrollment and patient treatment milestonesBRANFORD, Conn., Feb. 24, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for preci ...

Core Viewpoint - Azitra, Inc. has adjourned its Special Meeting originally scheduled for February 6, 2026, due to insufficient shareholder participation, with a new date set for March 6, 2026, to solicit additional votes on key proposals [1]. Group 1: Special Meeting Details - The Special Meeting was adjourned because only approximately 13% of the outstanding shares entitled to vote were represented, falling short of the required 33 1/3% quorum [1]. - The Reconvened Special Meeting will take place on March 6, 2026, at 11:00 a.m. Eastern Time, and will continue to be held in a virtual format [1]. - Stockholders are encouraged to vote their shares before the new deadline of March 6, 2026, at 10:59 a.m. Eastern Time [1]. Group 2: Proposals for Vote - Proposal One seeks approval for the issuance of more than 19.99% of the company's outstanding shares, which includes shares underlying warrants as per the Securities Purchase Agreement with Alumni Capital LP [1]. - Proposal Two allows for the adjournment of the Special Meeting if necessary to solicit additional proxies if there are insufficient votes [1]. Group 3: Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on innovative therapies for precision dermatology, with its lead program, ATR-12, targeting Netherton syndrome, a rare skin disease [1]. - The company also has an advanced program, ATR-04, aimed at treating EGFR inhibitor-associated rash, which affects approximately 150,000 people in the U.S. [1]. - Azitra's programs utilize a proprietary platform of engineered proteins and topical live biotherapeutic products, supported by artificial intelligence and machine learning technology [1].

Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [3] - The company's lead program, ATR-12, targets Netherton syndrome, a rare chronic skin disease with no approved treatment options [3] - Azitra's additional clinical program, ATR-04, addresses EGFR inhibitor associated skin toxicity, with a Phase 1/2 clinical trial initiated [3] Clinical Development - ATR-12 is currently in a Phase 1b clinical trial for adults with Netherton syndrome [3] - ATR-04 has received Fast Track designation from the FDA for treating EGFRi associated rash, which affects approximately 150,000 people in the U.S. [3] - Azitra's programs are developed from a proprietary platform of engineered proteins and topical live biotherapeutic products, utilizing a microbial library of around 1,500 bacterial strains [3] Upcoming Events - Azitra will present at the Biotech Showcase 2026 in San Francisco from January 12-14, 2026 [1] - The presentation will include one-on-one meetings with registered investors and potential partners to discuss the company's clinical development strategy and recent achievements [2] - The event is scheduled for January 13, 2026, at 2:30 PM PT, with Travis Whitfill, the Chief Operating Officer, as the presenter [2]

Core Viewpoint - Azitra, Inc. has received approval from NYSE American for its compliance plan to meet continued listing standards after previously being notified of non-compliance due to insufficient stockholders' equity [1][2]. Group 1: Compliance and Listing Status - Azitra must regain compliance with the NYSE American listing standards by April 1, 2027, or face potential delisting proceedings [2]. - The company will remain listed on NYSE American during the compliance plan period and will undergo periodic reviews, including quarterly monitoring [3]. - Receipt of the notice from the Exchange does not immediately affect the listing or trading of Azitra's common stock [4]. Group 2: Company Overview and Programs - Azitra is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [5]. - The ATR-12 program includes a Phase 1b clinical trial in adult patients, while the ATR-04 program addresses EGFR inhibitor-associated rash and has received Fast Track designation from the FDA [5]. - Azitra's proprietary platform includes a microbial library of approximately 1,500 bacterial strains, enhanced by AI and machine learning for drug development [5].

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].