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Current Report · Items 8.01, 9.01 · 8-K

Azitra Inc

AZTRNYSE_AMERICANEQUITYCurrent

Other Events

Item 8.01 Other Events. On October 1, 2026, the Company issued a press release. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

Filed Oct 1, 2026Accepted Oct 1, 2026, 8:10 AM EDTCIK 1701478Accession 0001493152-26-045260
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Company context

We are an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. We have 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 an artificial intelligence and machine learning technology that analyzes, predicts and helps screen our library of strains for drug-like molecules. The platform also utilizes a licensed genetic engineering technology, which can enable the transformation of previously genetically intractable strains. Our initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which we consider to be an optimal therapeutic candidate species for engineering of dermatologic therapies. The particular species demonstrates a number of well-described properties in the skin. As of the date of this prospectus, we have identified among our microbial library over 60 distinct bacterial species that we believe are capable of being engineered to create living organisms or engineered proteins with significant therapeutic effect.

Current securities

Recent company filings

  1. Entry into a Material Definitive AgreementSep 28, 2026
  2. 424B5 filingSep 28, 2026
  3. Regulation FD DisclosureSep 8, 2026
  4. Other EventsAug 21, 2026
  5. SCHEDULE 13G filingAug 14, 2026

Registered securities in this filing

AZITRA, INC. · 8-K · Filed 2026-10-01

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common stock, par value $0.0001

Symbol
AZTR
Exchange
NYSEAMER
Classification
COMMON
Status
Current
Filing context

Context: AsOf2026-10-01

Dimensions: Not supplied

Accession 000149315226045260 · 1 registered-security cover member

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Disclosure sections

Items 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events. On October 1, 2026, the Company issued a press release. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Filed exhibits (1)
EX-99.1 (by filename) ex99-1.htm

Exhibit 99.1 Azitra, Inc. Advances ATR-04 Phase 1/2 Clinical Trial to Cohort 2 Following Safety Review Committee Clearance BRANFORD, Conn. - October 1, 2026 - Azitra, Inc. (“Azitra” or the “Company”) (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the completion of Cohort 1 in its Phase 1/2 clinical trial evaluating ATR04-484 as a potential treatment for EGFR inhibitor (EGFRi)-associated skin rash. Following its review of available safety data from patients enrolled in Cohort 1, the study’s safety review committee recommended that the trial may proceed to Cohort 2, enabling Azitra to begin enrollment and dosing in the second cohort. The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical study ( NCT06830863 ) is designed to evaluate the safety and tolerability of topical ATR-04 for the treatment of EGFRi-associated dermal toxicity affecting adult patients. The safety, bioavailability, pharmacodynamics, and preliminary efficacy of ATR04-484 are being compared to its vehicle (3:1 randomization) in two patient cohorts. Seven patients in Cohort 1 received …

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