Azitra, Inc. Announces Full Year 2025 Results and Provides Business Updates
MWN-AI** Summary
Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company, has provided its financial results and business updates for the full year ending December 31, 2025. Highlighting a year of significant progress, Azitra initiated its Phase 1/2 clinical trial for ATR-04, designed to address EGFRi-associated rash in oncology patients, alongside presenting trial results at the 2025 ASCO Annual Meeting. Additionally, positive preclinical data was reported for its ATR-01 program aimed at treating ichthyosis vulgaris, and promising safety data emerged from the Phase 1b trial of ATR-12, targeting Netherton Syndrome.
For 2025, Azitra saw research and development expenses totaling $4.8 million, slightly up from $4.7 million in the previous year, while general and administrative expenses decreased to $6.2 million from $6.3 million. The net loss for 2025 was recorded at $11 million, compared to $9 million in 2024. As of the end of the fiscal year, the company had cash and cash equivalents of $2.1 million.
CEO Francisco Salva emphasized the year’s achievements, particularly the progress towards revolutionizing dermatological treatments through innovative, engineered biotherapeutics. Fast Track designation from the FDA for ATR-04 underscores its potential in the marketplace, given the significant need for effective therapeutic solutions in treating side effects associated with cancer treatments.
Looking ahead, Azitra anticipates important milestones, including topline data from its clinical trials in Netherton syndrome and EGFRi-associated rash and plans to complete investigational new drug (IND)-enabling studies for ATR-01. The company remains committed to advancing transformative treatments for patients facing severe skin conditions and creating substantial value for shareholders.
MWN-AI** Analysis
Azitra, Inc. has released its full-year results for 2025, reflecting a period of significant development within the clinical stage biopharmaceutical sector, particularly in precision dermatology. The company reported a net loss of $11 million for the year, which, although larger than the prior year's loss of $9 million, is indicative of a growing investment in research and development essential for progress in this competitive landscape.
Key highlights from 2025 include the initiation of the Phase 1/2 trial for the ATR-04 program, targeting skin reactions linked to oncology treatments, as well as promising data from the ATR-12 trial focused on Netherton Syndrome. The Fast Track designation granted to ATR-04 by the FDA showcases its potential in addressing unmet needs for patients affected by EGFR inhibitors, underscoring the urgency and significance of its development.
Despite a decline in cash reserves, down to $2.1 million at year-end, the company successfully raised $8.5 million through various financial instruments, which should provide some operational runway as it progresses through clinical trials. With upcoming milestones in 2026—including topline results for both major clinical trials—investor focus should sharpen around the outcomes of these studies.
For potential investors, Azitra presents a high-risk, high-reward situation. The dermatology market's growth, alongside innovative product pipelines, positions Azitra with favorable prospects if clinical outcomes are positive. Nevertheless, risks persist, particularly concerning timely funding and potential delays in trial results. Given the biotech sector's inherent volatility, investors should approach with caution, ideally positioned to capitalize on share price fluctuations as news develops surrounding trial outcomes and regulatory progress. Therefore, monitoring Azitra’s clinical data releases and financial health will be crucial for informed investment decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
BRANFORD, Conn., Feb. 27, 2026 /PRNewswire/ -- Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2025, and provided a business update.
FY 2025 and Recent Business Highlights
- Initiated Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash; presented ATR-04 trial design and update at ASCO 2025
- Announced positive preclinical data for ATR-01 program, targeting the treatment of ichthyosis vulgaris
- Reported promising safety data from Phase 1b Trial of ATR12 in Netherton Syndrome
- Completed financings of $8.5 million through private placements, follow-on financings and utilization of an equity line of credit.
"2025 was an exciting year for Azitra as we continued our work to revolutionize the treatment of dermatological diseases with our pipeline of first-in-class, engineered products delivered using topical live biotherapeutics," said Francisco Salva, CEO of Azitra. "A key highlight in 2025 was the progress made in our Phase 1/2 trial for ATR-04 targeting oncology patients with EGFRi-associated rash and the dosing of the trial's first patient. We were thrilled to have the opportunity to present this technology and the trial design to leaders in the field at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, where we received positive feedback and encouraging interest."
"ATR-04 has previously been granted Fast Track designation from the FDA, signaling the potential for this candidate to help the approximately 150,000 people in the United States annually who are impacted by major dermatologic toxicities associated with EGFR inhibitor treatments. Though an impactful treatment for various serious cancers, EGFR inhibition can result in adverse skin reactions that can make it difficult for patients to stay on these effective therapies."
Mr. Salva added: "For our lead program, ATR-12, we continue to be encouraged by the promising safety data generated thus far in our Phase 1b trial and are optimistic that this candidate has the potential to be a life-changing innovation for people with Netherton syndrome, a rare, autosomal recessive disease, a chronic condition characterized by severe inflammation, pruritus, scaling, red, and dehydrated skin with no known cure and limited treatment options."
Mr. Salva continued: "Also in 2025, we presented positive preclinical data for our ATR-01 program targeting ichthyosis vulgaris. Impacting approximately 1.3 million in the United States with no treatment options beyond symptom management, ichthyosis vulgaris, is an autosomal semidominant genetic disorder caused by missing or abnormal filaggrin levels. The condition is characterized by generalized xerosis and fine, white to gray scales that are prominent on the abdomen, chest, and extensor surfaces of the extremities."
Mr. Salva concluded: "2026 promises to be an important year for Azitra with several anticipated milestones including topline data for both our Phase 1b study in Netherton Syndrome and the Phase 1/2 study in EGFRi-associated rash. We also look forward to completing IND-enabling studies for ATR-01. We remain excited and optimistic as we work towards these key events, which we believe can help build significant value for our shareholders in 2026, while we progress innovative and potentially transformative treatments for patients with severe and life-altering dermatological conditions."
Pipeline Achievements and Upcoming Milestones
ATR-12 - Advancing Phase 1b Clinical Trial in Netherton Syndrome
- In June 2025, Azitra reported promising safety data with 50% of patients enrolled.
- ATR12-351, a live precision dermatology therapeutic candidate has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site to date.
- Topline data from the Phase 1b trial is anticipated H2 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Multi-billion Dollar Market Opportunity
- Dosed first patient in Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in Q3 2025.
- Topline data from first cohort of Phase 1/2 trial expected around mid-2026.
ATR-01 – Targeting Ichthyosis Vulgaris Which Impacts 1.3 million in the United States
- Announced positive preclinical data for ATR-01 program in Q3 2025, demonstrating delivery of active, functional filaggrin through human stratum corneum and repair of damaged model skin
- IND-enabling studies continue in 2026.
Financial Results for the Year Ended December 31, 2025
- Research and Development (R&D) expenses: R&D expenses for the year ended December 31, 2025, were $4.8 million compared to $4.7 million for the fiscal year 2024.
- General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2025, were $6.2 million compared to $6.3 million for the fiscal year 2024.
- Net Loss was $11.0 million for the year ended December 31, 2025, compared to $9.0 million for the fiscal year 2024.
- Cash and cash equivalents: As of December 31, 2025, Azitra had cash and cash equivalents of $2.1 million.
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. Azitra's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adults with Netherton syndrome. ATR-04, Azitra's additional clinical program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated skin toxicity; a Phase 1/2 clinical trial has been initiated for this program. Azitra has received Fast Track designation from the United States Food and Drug Administration for this program to treat EGFRi associated rash, which impacts approximately 150,000 people in the United States. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit https://azitrainc.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of (i) our provision of initial safety data and topline results for the Phase 1b trial for our ATR-12, (ii) the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, (iii) the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and (iv) statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies.
Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the timing of clinical trials and their results; we may experience delays in the provision of initial safety data and topline results for ATR-12 and, if we do, such data and results may not be favorably received; the safety and efficacy of our product candidates; possible delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the United States Securities and Exchange Commission on February 27, 2026. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact
Norman Staskey
Chief Financial Officer
staskey@azitrainc.com
Investor Relations
Tiberend Strategic Advisors, Inc.
Jon Nugent
205-566-3026
jnugent@tiberend.com
Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com
Condensed Statement of Operations | ||||||||
Audited | ||||||||
December 31, | ||||||||
2025 | 2024 | |||||||
Service revenue – related party | $ | — | $ | 7,500 | ||||
Total revenue | — | — | ||||||
Operating expenses: | ||||||||
General and administrative | 6,130,657 | 6,269,262 | ||||||
Research and development | 4,836,008 | 4,723,378 | ||||||
Total operating expenses | 10,966,665 | 10,992,640 | ||||||
Loss from operations | (10,966,665) | (10,985,140) | ||||||
Other income (expense): | ||||||||
Interest income | 70,209 | 122,553 | ||||||
Interest expense | (7,587) | (12,160) | ||||||
Change in fair value of warrants | 381 | 4,034,072 | ||||||
Loss on issuance of common stock | — | (2,132,800) | ||||||
Other income | (43,389) | 15,014 | ||||||
Total other income | 19,614 | 2,026,679 | ||||||
Loss before income taxes | (10,947,051) | (8,958,461) | ||||||
Income tax expense | (8,319) | (9,031) | ||||||
Net loss | $ | (10,955,370) | $ | (8,967,492) | ||||
Net loss attributable to common shareholders | $ | (10,955,370) | $ | (8,967,492) | ||||
Net loss per Share, basic and diluted | $ | (2.25) | $ | (15.70) | ||||
Weighted average common stock outstanding, basic and diluted | 4,873,552 | 571,162 |
Condensed Balance Sheets | ||||||||
Audited | ||||||||
December 31, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 2,068,083 | $ | 4,554,719 | ||||
Other receivables | 141,295 | 101,896 | ||||||
Prepaid expenses and other current assets | 809,949 | 571,675 | ||||||
Total current assets | $ | 3,019,327 | $ | 5,228,290 | ||||
Property and equipment, net | 548,591 | 653,957 | ||||||
Other assets | 1,457,468 | 1,476,555 | ||||||
Total assets | $ | 5,025,386 | $ | 7,358,802 | ||||
Liabilities, and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 399,356 | $ | 490,255 | ||||
Current financing lease liability | 10,111 | 16,066 | ||||||
Current operating lease liability | 255,776 | 255,177 | ||||||
Insurance premium financing liability | 198,983 | — | ||||||
Accrued expenses | 203,740 | 614,359 | ||||||
Total current liabilities | 1,067,966 | 1,375,857 | ||||||
Long-term financing lease liability | — | 10,105 | ||||||
Long-term operating lease liability | 156,190 | 274,161 | ||||||
Warrant liability | — | 381 | ||||||
Total liabilities | 1,224,156 | 1,660,504 | ||||||
Stockholders' equity | ||||||||
Common stock | 1,074 | 114 | ||||||
Additional paid-in capital | 72,321,352 | 63264009 | ||||||
Accumulated deficit | (68,521,196) | (57,565,825) | ||||||
Total stockholders' equity | 3,801,230 | 5,698,298 | ||||||
Total liabilities and stockholders' equity | $ | 5,025,386 | $ | 7,358,802 |
SOURCE Azitra, Inc.
FAQ**
What are the key outcomes expected from the upcoming topline data for Azitra Inc AZTR’s Phase trial in Netherton Syndrome, and how might they impact the future development of ATR-12?
How does Azitra Inc AZTR plan to utilize the $2.1 million in cash and cash equivalents at the end of 20to support ongoing clinical trials and research initiatives?
With the initiation of the Phase 1/2 trial for ATR-04, what specific milestones will Azitra Inc AZTR target in 2026, and how will these contribute to addressing EGFRi-associated rash?
Can you elaborate on the promising safety data reported for Azitra Inc AZTR’s ATR-12 program, and how does this data strengthen the case for its potential commercialization?
**MWN-AI FAQ is based on asking OpenAI questions about Azitra Inc (NYSE: AZTR).
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