Azitra, Inc. — Q3 2026 Earnings Summary

Financial Performance:

• Research and development expenses were $1.3 million for the quarter ended September 30, 2026, compared to $1.2 million in the same period in 2025.
• General and administrative expenses were $1.6 million for the quarter ended September 30, 2026, compared to $1.6 million in the comparable period in 2025.
• Net loss was $3.0 million for the quarter ended September 30, 2026, compared to $2.8 million in the comparable period in 2025.
• Cash and cash equivalents totaled $3.8 million as of September 30, 2026, up from $2.1 million as of December 31, 2025.
• Total operating expenses were $2.9 million for the quarter ended September 30, 2026, compared to $2.8 million in the comparable period in 2025.
• Net loss per share (basic and diluted) was $0.29 for the quarter ended September 30, 2026, compared to $6.71 in the comparable period in 2025.
• Total assets were $6.0 million as of September 30, 2026, compared to $5.0 million as of December 31, 2025.
• Total liabilities were $1.6 million as of September 30, 2026, compared to $1.2 million as of December 31, 2025.
• Stockholders' equity was $4.4 million as of September 30, 2026, compared to $3.8 million as of December 31, 2025.

Guidance and Future Outlook:

• Initial results from the first-in-human cosmetic study of ATR-COSF are anticipated by year-end 2026.
• Topline data from Cohort 1 of the ATR-04 Phase 1/2 trial is expected in the fourth quarter of 2026.
• Cohort 2 of the ATR-04 trial is expected to enroll approximately 24 patients receiving once-daily treatment for 28 days.
• Institutional investors who participated in the March 2026 financing may have the opportunity to invest an additional $5.25 million to $10.5 million through certain financial instruments once ATR-COSF results are announced.

Business Segments and Product Lines:

• ATR-COSF: Ex vivo studies demonstrated a single application reduced the appearance of fine lines and wrinkles by approximately 50% after 48 hours. An optimized formulation improved skin elasticity across every measure tested. Repeat-dose results showed increased delivery and distribution of recombinant filaggrin domains.
• ATR-04: Completed Cohort 1 of the Phase 1/2 trial with the safety review committee recommending progression to Cohort 2. Trial eligibility was expanded to include patients with KRAS and MEK inhibitor-associated rash, including those with neurofibromatosis type 1.
• The company received Fast Track designation from the FDA for cancer treatment-associated rash, which impacts up to 300,000 people in the U.S.

Market and Competitive Landscape:

• Azitra aims to develop the first live biotherapeutic for skin rashes associated with cancer and MEK inhibitor treatment for neurofibromatosis.
• The company notes that more efficient competitors or more effective competing treatments may emerge.

Risks and Challenges:

• Clinical trial results may not be predictive of future outcomes, and enrollment delays or protocol amendments may not facilitate recruitment as anticipated.
• Results from ex vivo and preclinical studies may not be predictive of results in humans.
• Holders of instruments issued in the private placement may not exercise them, potentially impacting funding.
• The company may fail to timely raise additional required funding or maintain the listing of its common stock on the NYSE American.
• The company is dependent on third parties for manufacturing, research, and clinical testing.

Management Commentary and Tone:

• CEO Francisco Salva stated the company made substantial progress with its two priority programs, generating encouraging results for ATR-COSF and advancing ATR-04.
• Management expressed confidence in ATR-COSF's potential as a differentiated cosmetic ingredient and believes ATR-04 has the potential to become the first live biotherapeutic for its specific indications.
• Salva described the remainder of 2026 as a "defining period" for Azitra.

Other Key Points:

• Azitra is a clinical-stage biopharmaceutical company focused on precision dermatology, high-value cosmetic proteins, and peptides.
• The company's technology platforms combine engineered proteins, topical live biotherapeutics, artificial intelligence, and a proprietary microbial library.
• The press release includes forward-looking statements regarding clinical trial timing, product potential, and funding sufficiency.