Azitra (NYSE American: AZTR) widens 2025 loss while pushing key skin programs

Rhea-AI Filing Summary

Azitra, Inc. reported full-year 2025 results and highlighted progress across its dermatology pipeline. For the year ended December 31, 2025, the company generated no revenue versus $7,500 in 2024 and recorded a net loss of $10.96M, wider than $8.97M a year earlier.

Research and development expenses were $4.8M and general and administrative expenses were $6.1M, both roughly flat year over year. Cash and cash equivalents were $2.07M at December 31, 2025, down from $4.55M at the prior year-end, after completing $8.5M of financings during 2025.

Clinically, Azitra advanced ATR-12, its lead program for Netherton syndrome, reporting promising Phase 1b safety data and guiding to topline results in the second half of 2026. ATR-04 for EGFR inhibitor–associated rash dosed its first Phase 1/2 patient, with initial cohort data expected around mid-2026, while ATR-01 for ichthyosis vulgaris reported positive preclinical data and continues IND-enabling work into 2026.

Insights

Biotech equity analyst

Azitra advanced its pipeline but ended 2025 with modest cash and continued losses.

Azitra reported a full-year 2025 net loss of $10.96M versus $8.97M in 2024, reflecting largely stable R&D and G&A spending while still operating pre-revenue. Cash declined to $2.07M despite completing $8.5M of equity-related financings during the year.

On the development side, ATR-12 for Netherton syndrome produced promising Phase 1b safety data, with topline results targeted for H2 2026. ATR-04 for EGFR inhibitor–associated rash dosed its first Phase 1/2 patient, with initial cohort data expected around mid-2026, and ATR-01 delivered positive preclinical data with IND-enabling studies ongoing into 2026.

Future disclosures linked to these 2026 milestones will clarify whether early safety data translate into meaningful efficacy signals for ATR-12 and ATR-04 and whether ATR-01 progresses on the outlined IND-enabling timeline, all of which are central to Azitra’s precision dermatology strategy.

FALSE000170147800017014782026-02-272026-02-27

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

___________________________________

FORM 8-K

___________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

February 27, 2026

Date of Report (date of earliest event reported)

___________________________________

AZITRA, INC.

(Exact name of registrant as specified in its charter)

___________________________________

Delaware (State or other jurisdiction of incorporation or organization)			001-41705 (Commission File Number)			46-4478536 (I.R.S. Employer Identification Number)
21 Business Park Drive Branford, CT 06405
(Address of principal executive offices and zip code)
(203) 646-6446
(Registrant's telephone number, including area code)
(Former name or former address, if changed since last report.)

___________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class			Trading Symbol			Name of each exchange on which registered
Common Stock, par value $0.0001			AZTR			NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (Section 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (Section 240.12b-2 of this chapter).

Emerging growth company    ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 - Results of Operations and Financial Condition.

On February 27, 2026, Azitra, Inc. (the “Company”) issued a press release announcing its financial results as of and for the year ended December 31, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

The information in this Item 2.02, including the press release attached as Exhibit 99.1 hereto, is furnished pursuant to Item 2.02 but shall not be deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 - Financial Statements and Exhibits

(d): The following exhibits are being filed electronically herewith:

Exhibit No.						Description
99.1						Press release dated February 27, 2026 regarding the Registrant's financial year ended December 31, 2025.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized on February 27, 2026.

AZITRA, INC.
By:			/s/ Francisco D. Salva
Name:			Francisco D. Salva
Title:			Chief Executive Officer

Exhibit 99.1

Azitra, Inc. Announces Full Year 2025 Results and Provides Business Updates

BRANFORD, Conn. – February 27, 2026 — 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

FAQ

What were Azitra (AZTR) financial results for the year ended December 31, 2025?

Azitra reported no revenue and a net loss of $10.96M for 2025, compared with a $8.97M net loss in 2024. Operating expenses were $10.97M, driven by $4.84M in R&D and $6.13M in G&A costs.

How much cash did Azitra (AZTR) have at the end of 2025?

Azitra had cash and cash equivalents of $2.07M as of December 31, 2025. This compares with $4.55M a year earlier, reflecting ongoing operating losses despite raising $8.5M through private placements, follow-on financings and an equity line in 2025.

What progress did Azitra report for its ATR-12 Netherton syndrome program in 2025?

Azitra reported promising Phase 1b safety data for ATR-12 in Netherton syndrome, noting the candidate was generally safe and well tolerated. Topline data from this Phase 1b trial are anticipated in the second half of 2026, positioning ATR-12 as the company’s lead precision dermatology program.

What are the key milestones for Azitra’s ATR-04 oncology rash program?

Azitra dosed the first patient in its Phase 1/2 ATR-04 trial for EGFR inhibitor–associated rash in Q3 2025. The company expects topline data from the first cohort around mid-2026. ATR-04 has FDA Fast Track designation for EGFRi-associated rash in the United States.

What did Azitra disclose about its ATR-01 ichthyosis vulgaris program?

Azitra announced positive preclinical data for ATR-01 in Q3 2025, showing delivery of functional filaggrin and repair of damaged model skin. The program targets ichthyosis vulgaris, which affects about 1.3 million people in the U.S., with IND-enabling studies continuing through 2026.

How did Azitra’s operating expenses change between 2024 and 2025?

Total operating expenses were $10.97M in 2025, essentially flat versus $10.99M in 2024. R&D expenses increased slightly to $4.84M, while G&A expenses edged down to $6.13M, indicating stable spending while programs advanced clinically.

Filing Exhibits & Attachments

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Press Releases

• EX-99.9 EX-99.9 94.0 KB

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• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 12.7 KB