On November 12, 2026 Azitra, Inc. ("Azitra" or the "Company") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, reported financial results for the quarter ended September 30, 2026, and provided a business update.

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Q3 2026 and Recent Business Highlights

Announced revitalizing results from ex vivo study of ATR-COSF demonstrating ability to reduce fine lines and improve elasticity in human skin
Reported breakthrough repeat dose and anti-wrinkle ex vivo results for ATR-COSF program, demonstrating increased distribution and elasticity
Announced completion of Cohort 1 of the ATR-04 Phase 1/2 trial and the safety review committee’s recommendation to proceed to Cohort 2
Expanded ATR-04 trial eligibility to include patients with KRAS and MEK inhibitor-associated rash, including patients with neurofibromatosis type 1 with rash associated with receiving MEK inhibitors
"During the third quarter and recent weeks, we made substantial progress with our two priority programs, generating encouraging results for ATR-COSF and advancing ATR-04 forward in the clinic while broadening its potential to benefit more patients," said Francisco Salva, Chief Executive Officer of Azitra. "We were very pleased to report research involving ATR-COSF demonstrating a single application of the product was able to reduce the appearance of fine lines and wrinkles by approximately 50% after 48 hours in laboratory studies, while our optimized formulation improved skin elasticity across every measure tested in a separate study. These results strengthen our confidence in ATR-COSF’s potential as a differentiated cosmetic ingredient and set the stage for a first-in-human cosmetic study, with initial results anticipated by year-end."

Salva continued: "The recommendation to advance ATR-04 to Cohort 2 brings us closer to our goal of providing a new treatment option for patients whose debilitating skin rash can disrupt essential therapy. Additionally, by expanding the trial to address rash associated with KRAS and MEK inhibitors, including in patients with neurofibromatosis type 1 with MEK inhibitor-associated rash, we are broadening ATR-04’s potential reach and expanding the eligible patient pool to support enrollment. We believe ATR-04 has the potential to become the first live biotherapeutic developed for skin rashes associated with cancer and MEK inhibitor treatment for neurofibromatosis treatments. We are encouraged by the potential to reach additional patient populations and look forward to reporting topline data from Cohort 1, which we anticipate in the fourth quarter of 2026."

Salva concluded: "The remainder of 2026 has the potential to be a defining period for Azitra as we expect to report initial results from our first in-human cosmetic study of ATR-COSF and topline data from Cohort 1 of our ATR-04 Phase 1/2 trial. Importantly, once we announce the ATR-COSF results, institutional investors who participated in our financing earlier this year will have the opportunity to invest an additional $5.25 million to $10.5 million through certain financial instruments issued in that transaction."

Pipeline, Platform and Corporate Updates

ATR-COSF – Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles

Announced positive repeat-dose results demonstrating increased delivery and distribution of recombinant filaggrin domains and improved elasticity in ex vivo human skin.
Reported additional ex vivo results showing reduced appearance of fine lines and wrinkles following a single application, with continued improvement through 48 hours, and improved elasticity with an optimized formulation.
First-in-human cosmetic study planned with initial results expected by year-end 2026.
ATR-04 – Advancing a Potential Treatment for Targeted Therapy-Associated Rash

Completed Cohort 1 of the ongoing Phase 1/2 trial and received safety review committee’s recommendation to proceed to Cohort 2.
Expanded trial eligibility to include patients with KRAS and MEK inhibitor-associated rash, including patients with neurofibromatosis type 1 with rash associated with MEK inhibitors.
Modified trial requirements to facilitate recruitment, with Cohort 2 expected to enroll approximately 24 patients receiving once-daily treatment for 28 days.
Topline data from first cohort of Phase 1/2 trial expected in Q4 2026.
Financial Results for the Quarter Ended September 30, 2026

Research and Development (R&D) expenses: R&D expenses for the quarter ended September 30, 2026, were $1.3 million compared to $1.2 million for the comparable period in 2025.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2026, were $1.6 million compared to $1.6 million for the comparable period in 2025.
Net Loss was $3.0 million for the quarter ended September 30, 2026, compared to $2.8 million for the comparable period in 2025.
Cash and cash equivalents: As of September 30, 2026, Azitra had cash and cash equivalents of $3.8 million.

(Press release, Azitra, NOV 12, 2026, View Source [SID1234674699])