Azitra, Inc. Announces Full Year 2025 Results and Provides Business Updates
Rhea-AI Summary
Azitra (NYSE American: AZTR) reported full-year 2025 results and clinical progress. Key clinical advances include dosing the first patient in the Phase 1/2 ATR-04 trial (EGFRi-associated rash), Fast Track designation for ATR-04, promising Phase 1b safety data for ATR-12 in Netherton syndrome, and positive preclinical ATR-01 data.
Financials: R&D $4.8M, G&A $6.2M, net loss $11.0M, and cash & equivalents $2.1M; completed $8.5M financing activity in 2025.
Positive
- ATR-04 dosed first patient in Phase 1/2 trial
- ATR-04 holds FDA Fast Track designation
- Promising Phase 1b safety data for ATR-12 in Netherton syndrome
- Completed $8.5M financing activities in 2025
Negative
- Net loss increased to $11.0M for FY2025 (from $9.0M)
- Cash and cash equivalents of $2.1M at December 31, 2025
- Topline clinical data timing concentrated in mid‑2026 to H2 2026, near-term catalysts required
Key Figures
Market Reality Check
Peers on Argus
Pre-news, AZTR was down 3.85% while peers showed mixed moves: QNRX (-1.41%), XRTX (+7.89%), APVO (+2.95%), JAGX (+3.48%), XBIO (+7.20%). Momentum data flags 2 biotech peers moving up and 3 down, suggesting broader sector cross-currents rather than a purely idiosyncratic move.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 12 | Q3 2025 earnings | Negative | -14.6% | Reported higher net loss with modest cash and continued R&D spending. |
| Aug 11 | Q2 2025 earnings | Negative | -7.6% | Earnings update with ongoing losses despite trial progress and new credit line. |
| May 13 | Q1 2025 earnings | Negative | -0.7% | Quarterly loss and financing needs alongside trial and ASCO plans. |
| Feb 24 | FY 2024 results | Negative | -4.3% | Full-year loss and rising expenses despite pipeline progress and offerings. |
| Nov 12 | Q3 2024 earnings | Negative | -3.9% | Net loss and higher R&D with recent follow-on financing and trial start. |
Earnings and financial updates have consistently been followed by negative price reactions for AZTR.
Over the past five earnings-related announcements from Nov 2024 through Nov 2025, Azitra repeatedly reported operating losses alongside clinical and financing progress. These updates featured ongoing development of ATR-12, ATR-04, and ATR-01, equity raises (including a $10M follow-on and a $20M equity line), and Fast Track status for ATR-04. Despite operational milestones, shares fell after each earnings release, indicating a pattern of cautious market reception to financial results similar to today’s full-year 2025 update.
Historical Comparison
Past earnings releases for AZTR led to an average move of -6.23%, typically following updates that pair clinical progress with persistent losses and financing needs, similar in structure to this full-year 2025 report.
Across these earnings updates, Azitra advanced ATR-12 from initial dosing toward Phase 1b readouts, moved ATR-04 from FDA clearance to first patient dosing, and pushed ATR-01 through preclinical work and toward IND-enabling studies, while repeatedly raising capital to fund development.
Market Pulse Summary
This announcement details full-year 2025 financials and continued clinical progress for ATR-12, ATR-04, and ATR-01. Azitra reported a net loss of $11.0M, year-end cash of $2.1M, and $8.5M raised through financings, against a backdrop of prior earnings releases that often coincided with share price pressure. Investors may watch upcoming Phase 1b and Phase 1/2 topline data in 2026, cash runway developments, and additional financing steps as key drivers for future sentiment.
Key Terms
phase 1/2 medical
phase 1b medical
fast track designation regulatory
ind-enabling studies regulatory
netherton syndrome medical
AI-generated analysis. Not financial advice.
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
"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
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
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
- 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 $4.7 million - General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2025, were
$6.2 million $6.3 million - Net Loss was
$11.0 million $9.0 million - 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
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 | ||||
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SOURCE Azitra, Inc.
FAQ
What clinical progress did Azitra (AZTR) report for ATR-04 on February 27, 2026?
When does Azitra (AZTR) expect topline data for ATR-12 in Netherton syndrome?
How much cash did Azitra (AZTR) report at year-end 2025 and what financings occurred?
What were Azitra's reported FY2025 operating expenses and net loss for investors to note?
What is the status of Azitra's ATR-01 program targeting ichthyosis vulgaris as of February 27, 2026?
