Expanded eligibility significantly broadens potential treatment opportunities for ATR-04 beyond EGFR inhibitor-associated skin rash Additional protocol modifications expected to facilitate patient recruitment and accelerate clinical trial enrollment BRANFORD, Conn. , Oct. 29, 2026 /PRNewswire/ -- Azitra, Inc. (" Azitra " or the "Company") (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced amendments to its ongoing Phase 1/2 clinical trial of ATR04-484 that significantly expand patient eligibility to include individuals with rash associated with KRAS and MEK inhibitors. The expanded eligibility also includes patients with neurofibromatosis type 1 (NF1) with rash associated with MEK inhibitors. The amendments also shorten the required washout periods for antibiotics and steroids. Together, these changes broaden the potential treatment opportunities for ATR-04 beyond its initial focus on epidermal growth factor receptor inhibitor (EGFRi)-associated skin rash, while expanding the pool of eligible patients to facilitate recruitment. The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study ( NCT06830863 ) is evaluating the safety, tolerability, bioavailability, pharmacodynamics, and preliminary efficacy of topical ATR04-484. The protocol amendments for the Phase 1/2 clinical trial follow Azitra's recent announcement that the study's safety review committee recommended proceeding to Cohort 2 following its review of available safety data from Cohort 1. Cohort 2 is expected to enroll approximately 24 patients who will receive once-daily treatment for 28 days. KRAS inhibitors and MEK inhibitors are precision therapeutics used to treat various cancers, including non-small cell lung cancer (NSCLC), melanoma, colorectal cancer, and ovarian cancer. Combined, approximately 85,000 patients undergo KRAS or MEK inhibitor treatment in the United States annually. While these therapies have expanded treatment options for patients with cancer, dermatologic adverse effects, including skin rash, can substantially impair quality of life and may require dose reductions, treatment interruptions or discontinuation. The addition of these patients further broadens the potential clinical applications being explored for ATR-04 on top of the approximately 220,000 patients undergoing EGFRi treatment in the United States annually. The expanded eligibility criteria include patients with NF1 with MEK inhibitor-associated rash. NF1 is a rare genetic disorder characterized by the development of tumors along nerves that affects approximately 100,000 patients in the United States . "These expansions to the Phase 1/2 trial protocol represent a significant step for our ATR-04 program, increasing the possibility for this innovative treatment to benefit cancer and certain neurofibromatosis patients experiencing debilitating rash due to several targeted therapies," said Francisco Salva , Chief Executive Officer of Azitra . "While these therapies have transformed treatment for many patients, associated skin toxicities can significantly impact quality of life and interfere with treatment. By expanding our study to include patients with rash due to KRAS and MEK inhibitors, we are broadening the potential opportunity for ATR-04. Equally important, we believe the additional protocol modifications will facilitate patient recruitment and help accelerate enrollment. Following our recent advancement to Cohort 2, we are encouraged by the continued progress of this program and its potential to provide a new treatment option for patients affected by debilitating skin conditions." About Azitra's ATR-04 Program ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain in development for skin rashes associated with various therapies for cancer treatment and neurofibromatosis. ATR04-484 was selected based on its preclinical profile of reducing the pro-inflammatory cytokine IL-36γ and Staphylococcus aureus levels, both of which are elevated in patients with cancer treatment-associated skin rash. The strain was then engineered with the aim of improving its safety profile by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04. The U.S. Food and Drug Administration (the "FDA") has granted Fast Track designation to ATR04-484 for cancer treatment-associated rash, recognizing the high unmet medical need for up to 300,000 patients affected annually in the United States . About Azitra, Inc. Azitra, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and novel products across therapeutics, cosmeceuticals and biotechnology applications. The Company's portfolio is highlighted by ATR-COSF, a recombinant protein technology designed for cosmetic and skincare applications, and ATR-04,