0001701478-26-000013
SEC filingAzitra, Inc. reported a net loss of $11.0 million for the fiscal year ended December 31, 2025, compared to a net loss of $9.0 million in the prior year, representing a 22% increase in losses. The company generated no revenue in FY 2025, consistent with its status as an early-stage clinical biopharmaceutical company that has not commenced commercial operations. Operating expenses totaled $11.0 million, primarily driven by general and administrative costs of $6.1 million and research and development expenses of $4.8 million. The company ended the period with $2.1 million in cash and cash equivalents, down from $4.6 million at the end of 2024, and reported an accumulated deficit of $68.5 million. Management's discussion indicates substantial doubt about the company's ability to continue as a going concern, with cash on hand expected to cover operations for only three months from the filing date.
Azitra, Inc. reported a net loss of $11.0 million for the fiscal year ended December 31, 2025, representing a 22% increase from the $9.0 million net loss reported in the prior year. The company generated no revenue in either period, consistent with its status as an early-stage clinical biopharmaceutical company that has not commenced commercial operations. Operating expenses remained relatively stable at $11.0 million compared to $11.0 million in the prior year, with general and administrative expenses of $6.1 million and research and development expenses of $4.8 million. The company's accumulated deficit grew to $68.5 million as of December 31, 2025, up from $57.6 million at the end of 2024. Management's discussion indicates substantial doubt about the company's ability to continue as a going concern, citing recurring losses, negative cash flows from operations, and an accumulated deficit.
The company reported $0 revenue for FY 2025, consistent with $0 revenue in the prior year. The document indicates the company has not commenced revenue-producing operations apart from limited grant and service revenue. In FY 2024, the company generated $7,500 in service revenue from a related party joint development agreement, but this decreased to $0 in FY 2025 due to a decrease in reimbursable development costs. The company's business model focuses on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products, with three lead product candidates in various stages of clinical development: ATR-12 for Netherton syndrome, ATR-04 for EGFRi-associated rash, and ATR-01 for ichthyosis vulgaris.
With $0 revenue, the company reported negative gross margin and operating margin. Operating expenses totaled $11.0 million, consisting of $6.1 million in general and administrative expenses and $4.8 million in research and development expenses. General and administrative expenses decreased by 2% from the prior year, primarily due to reductions in legal fees, salaries and benefits, and insurance expenses. Research and development expenses increased by 2% from the prior year, driven by increased clinical trial costs for the ATR-04 and ATR-01 programs, partially offset by decreased costs for the ATR-12 program and consultant expenditures. The net loss margin cannot be calculated due to zero revenue.
The company used $11.2 million in operating activities during FY 2025, primarily driven by the net loss of $11.0 million. Cash and cash equivalents decreased to $2.1 million at December 31, 2025, from $4.6 million at the end of 2024. Total assets were $5.0 million, down from $7.4 million in the prior year. The company had working capital of $2.0 million and total stockholders' equity of $3.8 million. Financing activities provided $8.9 million in cash during the year through public offerings, private placements, and draws on an equity line of credit. The balance sheet shows $2.1 million in cash and cash equivalents, $3.0 million in total current assets, and $1.2 million in total liabilities.
Management indicates that cash on hand as of the filing date will not be sufficient to cover proposed operations beyond three months. The company intends to seek additional funds through various financing sources, including equity sales, licensing fees, and joint ventures. The report states there is substantial doubt about the company's ability to continue as a going concern. The company faces significant risks including its early-stage status, history of operating losses, dependence on third-party manufacturers, need for regulatory approvals, and intense competition in the biopharmaceutical industry. Clinical development timelines suggest it will take four to six years from the filing date to obtain regulatory approval for first drug candidates, assuming approval is obtained at all.