On August 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 June 30, 2026, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Q2 2026 and Recent Business Highlights

Reported the first preclinical data from ATR-COSF demonstrating breakthrough repeat-dose distribution, controlled delivery into targeted skin layers and anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept clinical study.
Continued enrollment of the first cohort in the Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash.
Continued advancement of recombinant protein initiatives, including Tobacco Etch Virus (TEV) Protease and T7 RNA Polymerase, expanding the Company’s platform into biotechnology research and manufacturing applications.
Issued CEO Letter to Shareholders detailing Azitra’s expanded strategy to leverage its proprietary microbial genetic engineering platform across therapeutics, cosmetic ingredients and biotechnology products.
"The second quarter has marked an exciting evolution for Azitra with the first data from our ATR-COSF program, which provided validation of our strategy to leverage our microbial genetic engineering platform beyond traditional therapeutics," said Francisco Salva, Chief Executive Officer of Azitra. "Combined with the continued advancement of ATR-04 and our recombinant protein initiatives, these accomplishments reflect the breadth of opportunities we are creating in multiple billion dollar markets, including therapeutics, cosmetic ingredients and biotechnology applications."

Salva continued: "Our ATR-COSF program continues to excite our team, as it represents one of the first to demonstrate the wrinkle reducing potential of recombinant filaggrin ingredient in ex vivo human skin. It shows Azitra’s ability to translate our cutting edge science into observable benefits for consumers. The ATR-COSF program represents our first step in unlocking meaningful value for shareholders while positioning Azitra at the intersection of synthetic biology, artificial intelligence and next-generation biological manufacturing.

"During the quarter, we also continued enrollment of the first cohort in our Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash. With six active clinical sites, including MD Anderson Cancer Center, we remain on track to report topline data from the first cohort around year end. Additionally, we are in the process to open eligibility criteria to other cancer treatment related rashes driven by inhibitors along the same EGFR/KRAS/MEK/ERK pathway. EGFR inhibitor-associated rash remains a significant unmet medical need, affecting an estimated 50% to 90% of patients receiving EGFR-targeted cancer therapies and frequently leading to dose reductions, treatment interruptions or discontinuation."

Salva concluded: "Looking ahead, we remain focused on implementing the strategy outlined in our recent shareholder letter. That includes advancing ATR-COSF toward a planned proof-of-concept clinical study, continuing development of our recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase, and progressing ATR-04 as our lead clinical therapeutic program. We believe these initiatives position Azitra to unlock the full potential of our platform while creating multiple avenues for long-term growth and shareholder value."

Pipeline Achievements and Upcoming Milestones

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

Results from synthesized filaggrin ingredients, repeat application study on explanted cosmetic surgery skin.
Announced positive preclinical data demonstrating breakthrough repeat-dose delivery and distribution together with anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept cosmetic study evaluating the safety and efficacy of ATR-COSF.
Human cosmetic application study planned to start in Q3 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Billion Dollar Market Opportunity

Continued enrollment of the first cohort of the ongoing Phase 1/2 clinical trial evaluating ATR-04 for the treatment of EGFRi-associated rash.
Topline data from first cohort of Phase 1/2 trial expected in Q4-2026.
Recombinant Protein Platform

Announced plans to advance development of its recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase.
Platform provides opportunity to develop high-quality recombinant proteins for biotechnology research and manufacturing applications, representing potential opportunities to leverage its microbial genetic engineering expertise while broadening its long-term commercial potential.
ATR-12 – Advancing Phase 1b Clinical Trial in Netherton Syndrome

Consistent with the priorities outlined in the Company’s recent shareholder letter, Azitra plans to strategically pause further enrollment in the ongoing Phase 1b study evaluating ATR-12 for Netherton syndrome.
This decision reflects the Company’s disciplined approach to capital allocation and its focus on advancing programs with the greatest near-term opportunities for clinical, commercial and shareholder value creation.
Financial Results for the Quarter Ended June 30, 2026

Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2026, were $1.4 million compared to $1.4 million for the comparable period in 2025.
General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2026, were $2.1 million compared to $1.5 million for the comparable period in 2025.
Net Loss was $3.3 million for the quarter ended June 30, 2026, compared to $2.9 million for the comparable period in 2025.
Cash and cash equivalents: As of June 30, 2026, Azitra had cash and cash equivalents of $6.7 million.

(Press release, Azitra, AUG 12, 2026, View Source [SID1234670024])