AZTR

Azitra, Inc. (AZTR) 2025 Annual Report Summary

Business Context and Reporting Period

This Form 10-K covers the fiscal year ended December 31, 2025. Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on precision dermatology. The company utilizes a proprietary platform comprising a microbial library of approximately 1,500 unique bacterial strains, augmented by AI/ML and genetic engineering technologies, to develop live biotherapeutic products and engineered proteins. Azitra has not commenced commercial operations and has no sales or marketing organization.

Key Financial Metrics

Note: The filing text does not provide specific margin percentages as the company has no product revenue. The company reported a net loss per share of $(2.25) for 2025.

Material Changes vs. Prior Period

• Revenue: Service revenue from a related party (Bayer JDA) decreased from $7,500 in 2024 to $0 in 2025.
• Net Loss: Increased by approximately 22% (from $8.97 million to $10.96 million), primarily driven by a $4.0 million decrease in "Other Income" related to the change in fair value of warrants and a $2.1 million decrease in loss on issuance of common stock.
• Operating Expenses: Remained relatively flat. General and Administrative (G&A) expenses decreased slightly by 2%, while Research and Development (R&D) expenses increased by 2% due to clinical trial progression for ATR-04 and ATR-01, offset by decreases in ATR-12 costs.
• Liquidity: Cash and cash equivalents decreased by approximately $2.5 million year-over-year. The company raised approximately $8.9 million through financing activities in 2025, including follow-on offerings and draws on an Equity Line of Credit (ELOC).

Guidance, Outlook, and Risks

Clinical Progress:

• ATR-12 (Netherton Syndrome): First patient dosed in August 2024; initial safety results reported in H1 2025.
• ATR-04 (EGFRi-associated rash): Received Fast Track designation in September 2024; first patient dosed in Q3 2025.
• ATR-01 (Ichthyosis Vulgaris): Lead optimization completed in 2025; IND-enabling studies ongoing for a potential 2026 filing.

The independent auditor has expressed substantial doubt about the company's ability to continue as a going concern. Management estimates cash on hand is insufficient to cover operations beyond three months from the filing date. The company anticipates needing additional financing to execute its business plan.

Azitra received a deficiency letter from NYSE American in October 2025 regarding stockholders' equity requirements. A compliance plan was accepted, granting a deadline of April 1, 2027, to regain compliance. Failure to do so may result in delisting.

Management identified a material weakness in internal control over financial reporting related to a lack of adequate segregation of accounting functions.

• Dependence on third-party manufacturers for clinical and commercial supply.
• Uncertainty of clinical trial outcomes and regulatory approval.
• Need for significant additional capital; risk of dilution from future equity raises.
• Intellectual property protection and potential infringement claims.

Investor Verification Checklist

• Cash Runway: Verify the sufficiency of the $2.07 million cash balance against the stated burn rate and the timeline for the next financing round.
• NYSE Compliance: Monitor progress toward the April 1, 2027, deadline to meet stockholders' equity requirements to avoid delisting.
• Internal Controls: Review remediation efforts for the material weakness regarding segregation of accounting duties.
• Clinical Milestones: Track upcoming safety and efficacy data releases for ATR-12 and ATR-04, which are critical for valuation and future funding.
• Dilution Risk: Assess the impact of outstanding warrants (over 12 million) and the ELOC facility on future share count and ownership dilution.