Azitra (NYSE: AZTR) widens Q1 2026 loss but strengthens cash and pipeline
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Azitra, Inc. reported Q1 2026 results showing higher operating investment and a stronger cash position while advancing its dermatology pipeline. Research and development expenses were $1.6 million versus $1.3 million a year earlier, and general and administrative expenses were $2.4 million versus $1.9 million. Net loss was $3.9 million compared with $3.1 million in Q1 2025, reflecting increased spending to support programs.
As of March 31, 2026, Azitra held $10.1 million in cash and cash equivalents, up from $2.1 million at year-end 2025, and total assets were $12.1 million. The company highlighted clinical progress for ATR-12 in Netherton syndrome, ATR-04 for EGFR inhibitor–associated rash, ATR-01 in ichthyosis vulgaris, and a new ATR-COSF cosmeceutical initiative targeting cosmetic applications, supported by a previously priced private placement of up to approximately $10.5 million with additional potential warrant proceeds.
Positive
- Cash and cash equivalents increased to $10.1 million as of March 31, 2026, from $2.1 million at December 31, 2025, significantly strengthening liquidity.
- Azitra priced a private placement financing of up to approximately $10.5 million, with up to an additional approximately $20.9 million available upon warrant exercise, expanding potential funding sources.
- Total assets more than doubled to $12.1 million at March 31, 2026, from $5.0 million at December 31, 2025, reflecting increased capital resources.
- The company advanced multiple programs, including ATR-12 and ATR-04 clinical trials and a new ATR-COSF cosmeceutical initiative, creating several near-term data and business catalysts.
Negative
- Net loss widened to $3.9 million for Q1 2026 from $3.1 million in Q1 2025, reflecting higher operating expenses.
- General and administrative expenses rose to $2.4 million from $1.9 million year over year, increasing the company’s cost base.
- Research and development expenses increased to $1.6 million from $1.3 million, adding to near-term cash burn while programs remain in early-stage development.
Insights
Azitra increased R&D and G&A spending, expanded its pipeline, and strengthened liquidity.
Azitra posted a Q1 2026 net loss of $3.93M versus $3.07M in Q1 2025 as it boosted research and administrative spending to advance multiple dermatology programs. R&D reached $1.56M and G&A $2.37M, consistent with a company building clinical and commercial capabilities.
Cash and cash equivalents rose to $10.05M from $2.07M at December 31, 2025, helped by financing, while total assets more than doubled to $12.13M. The private placement of up to roughly $10.5M, plus potential warrant exercise proceeds of about $20.9M, provides additional potential funding capacity.
Pipeline milestones are concentrated in H2 2026, including topline data from the ATR-12 Phase 1b trial in Netherton syndrome and initial cohort data from the ATR-04 Phase 1/2 trial. Progress on the ATR-COSF cosmetic initiative and ATR-01 preclinical program adds diversification alongside the rare disease focus.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Q1 2026 net loss: $3,927,240
Q1 2025 net loss: $3,068,345
Q1 2026 R&D expenses: $1,560,565
+5 more
8 metrics
Q1 2026 net loss
$3,927,240
Net loss for quarter ended March 31, 2026
Q1 2025 net loss
$3,068,345
Net loss for quarter ended March 31, 2025
Q1 2026 R&D expenses
$1,560,565
Research and development for quarter ended March 31, 2026
Q1 2026 G&A expenses
$2,373,359
General and administrative for quarter ended March 31, 2026
Cash and cash equivalents
$10,051,003
As of March 31, 2026
Cash and cash equivalents prior period
$2,068,083
As of December 31, 2025
Private placement size
up to approximately $10.5 million
Priced private placement financing
Potential warrant proceeds
up to approximately $20.9 million
Additional proceeds upon exercise of warrants
Key Terms
Phase 1b clinical trial, Phase 1/2 trial, engineered live biotherapeutic, Fast Track designation, +2 more
6 terms
Phase 1b clinical trial financial
"The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients."
A phase 1b clinical trial is an early-stage human study that follows initial safety tests and checks how a new drug or treatment works at different doses in the target patient group. It matters to investors because it is one of the first steps showing whether a therapy is tolerable and shows any sign of benefit in real patients — like a small proof-of-concept test that can significantly raise or lower a drug’s commercial prospects.
Phase 1/2 trial financial
"Dosed first patient in Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in Q3 2025."
A phase 1/2 trial combines the earliest human safety testing with an initial look at whether a treatment works, typically starting by checking tolerability and side effects and then expanding to measure early signs of benefit and the best dose. For investors, results from these trials are an early indicator of a drug’s clinical promise and regulatory path: positive data can materially increase a company’s value and reduce development risk, while negative data can sharply lower expectations.
engineered live biotherapeutic technical
"the broader potential of Azitra’s engineered live biotherapeutic platform."
Fast Track designation regulatory
"Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S."
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
cosmeceutical technical
"Launched innovative protein and peptide programs for the cosmetic and cosmeceutical markets leveraging proprietary filaggrin technologies."
Netherton syndrome medical
"ATR-12, the Company’s lead product candidate being developed for Netherton syndrome."
A rare inherited skin and immune disorder that causes fragile, scaly, inflamed skin, frequent infections, and fragile or unusual hair, like a house with faulty waterproofing that lets problems in. For investors, it matters because the small patient population, severe unmet medical need, and predictable biological cause can make treatments eligible for special regulatory incentives, faster development paths, and premium pricing if a safe, effective therapy is approved.
Earnings Snapshot
Net loss: $3,927,240
Q1 2026
Net loss
$3,927,240
R&D expenses
$1,560,565
G&A expenses
$2,373,359
Cash and cash equivalents
$10,051,003
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
Date of Report (date of earliest event reported): May 13, 2026
___________________________________
(Exact name of registrant as specified in its charter)
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(Address of principal executive offices and zip code) | ||||||||
(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 | ||||||
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 May 13, 2026, Azitra, Inc. (the “Company”) issued a press release announcing its financial results as of and for the quarter ended March 31, 2026. 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 and 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 May 12, 2026 regarding the Registrant's financial results for the fiscal quarter ended March 31, 2026. | |||||||
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 May 13, 2026.
AZITRA, INC. | |||||
By: | /s/ Francisco D. Salva | ||||
Name: | Francisco D. Salva | ||||
Title: | Chief Executive Officer | ||||
Exhibit 99.1
Azitra, Inc. Announces Q1 2026 Results and Provides Business Updates
BRANFORD, Conn. – May 13, 2026 — Azitra, Inc. (“Azitra” or the “Company”) (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended March 31, 2026, and provided a business update.
Q1 2026 and Recent Business Highlights
•Announced the addition of MD Anderson Cancer Center as a clinical site for Phase 1/2 trial of ATR-04 targeting EGFRi-associated skin rash.
•Launched innovative protein and peptide programs for the cosmetic and cosmeceutical markets leveraging proprietary filaggrin technologies.
•Secured new U.S. patent covering ATR-12, the Company’s lead product candidate being developed for Netherton syndrome.
•Announced poster presentation at American Society of Gene and Cell Therapy Annual Meeting (ASGCT) 2026 highlighting ATR-01 preclinical data and the broader potential of Azitra’s engineered live biotherapeutic platform.
•Priced private placement financing of up to approximately $10.5 million, with up to an additional approximately $20.9 million upon exercise of warrants.
“The first quarter of 2026 marked a period of meaningful execution across our clinical and strategic priorities as we continue to advance Azitra’s leadership in precision dermatology,” said Francisco Salva, CEO of Azitra. “Notably, we significantly grew the clinical footprint for our Phase 1/2 Trial of ATR-04 targeting EGFRi-associated skin rash by adding the world-renowned MD Anderson Cancer Center, which is one of the world’s premier oncology institutions. We believe the addition of MD Anderson will serve to enhance patient access and support efficient trial execution in EGFR inhibitor-associated rash—a condition impacting the majority of patients receiving these therapies.”
Mr. Salva continued: “In parallel, we expanded our strategic footprint with the launch of our cosmeceutical initiative, leveraging our proprietary filaggrin protein and peptide technologies to potentially address large and growing consumer markets. Based on our preliminary research, we are confident that our technologies and expertise can offer an exciting new way to address the appearance of fine lines and wrinkles as well as dry sensitive skin and eczema-like rashes. As such, this program represents a compelling opportunity to extend our platform beyond therapeutics and create additional avenues for value creation.”
Mr. Salva added: “We are also highlighting our platform this week at ASGCT 2026, where we are presenting ATR-01 preclinical data that underscores the potential of our engineered live biotherapeutics. With this scientific visibility occurring alongside our quarterly update, we believe it reinforces the continued progress and relevance of our platform within the broader gene and cell therapy landscape.”
Mr. Salva concluded: “We are also excited to report the recent issuance of a new U.S. patent providing broad protection for our lead product, ATR-12, which we are advancing in a Phase 1b clinical trial for Netherton syndrome. With a strengthened balance sheet, expanding clinical execution, and multiple near-term catalysts, we believe Azitra is well positioned to drive continued progress across both our therapeutic pipeline and emerging cosmeceutical platform.”
Pipeline Achievements and Upcoming Milestones
ATR-COSF - New Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles
•Results from synthesized filaggrin ingredients, repeat application study on explanted cosmetic surgery skin, expected mid-2026.
•Human cosmetic application study planned for Q3 2026.
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 biotherapeutic product 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 in H2-2026.
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 Quarter Ended March 31, 2026
•Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31, 2026, were $1.6 million compared to $1.3 million for the comparable period in 2025.
•General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31, 2026, were $2.4 million compared to $1.9 million for the comparable period in 2025.
•Net Loss was $3.9 million for the quarter ended March 31, 2026, compared to $3.1 million for the comparable period in 2025.
•Cash and cash equivalents: As of March 31, 2026, Azitra had cash and cash equivalents of $10.1 million.
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company'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 adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. 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. Azitra is also developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market. The new initiative is the first amongst
others, which aims to leverage Azitra's microbial genetic engineering platform to manufacture innovative proteins and peptides for the cosmetic and research markets. 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) our provision of initial safety data and topline results for 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, including our cosmeceutical strategy.
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 ATR-04 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 (the “SEC”) on February 27, 2026 and our quarterly report on Form 10-Q filed on May 13, 2026 with the SEC. 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
(Unaudited)
| Three Months Ended March 31, | ||||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||
| General and administrative | $ | 2,373,359 | $ | 1,850,138 | ||||||||||||||||||||||
| Research and development | 1,560,565 | 1,250,100 | ||||||||||||||||||||||||
| Total operating expenses | 3,933,924 | 3,100,238 | ||||||||||||||||||||||||
| Loss from operations | (3,933,924) | (3,100,238) | ||||||||||||||||||||||||
| Other income (expense): | ||||||||||||||||||||||||||
| Interest income | 14,719 | 37,164 | ||||||||||||||||||||||||
| Interest expense | (3,411) | (1,293) | ||||||||||||||||||||||||
| Change in fair value of warrants | — | 143 | ||||||||||||||||||||||||
| Other income | (4,624) | (4,121) | ||||||||||||||||||||||||
| Total other income | 6,684 | 31,893 | ||||||||||||||||||||||||
| Loss before income taxes | (3,927,240) | (3,068,345) | ||||||||||||||||||||||||
| Income tax expense | — | — | ||||||||||||||||||||||||
| Net loss | $ | (3,927,240) | $ | (3,068,345) | ||||||||||||||||||||||
| Net loss per Share, basic and diluted | $ | (0.25) | $ | (1.55) | ||||||||||||||||||||||
| Weighted average common stock outstanding, basic and diluted | 15,517,992 | 1,977,670 | ||||||||||||||||||||||||
Condensed Balance Sheets
Unaudited
| March 31, | December 31, | |||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||
| Assets | ||||||||||||||||||||||||||
| Current Assets: | ||||||||||||||||||||||||||
| Cash and cash equivalents | $ | 10,051,003 | $ | 2,068,083 | ||||||||||||||||||||||
| Other receivables | 154,492 | 141,295 | ||||||||||||||||||||||||
| Prepaid expenses and other current assets | 554,646 | 809,949 | ||||||||||||||||||||||||
| Total current assets | 10,760,141 | 3,019,327 | ||||||||||||||||||||||||
| Property and equipment, net | 530,438 | 548,591 | ||||||||||||||||||||||||
| Other assets | 836,225 | 1,457,468 | ||||||||||||||||||||||||
| Total assets | $ | 12,126,804 | $ | 5,025,386 | ||||||||||||||||||||||
| Liabilities and stockholders’ equity | ||||||||||||||||||||||||||
| Current liabilities: | ||||||||||||||||||||||||||
| Accounts payable | $ | 932,217 | $ | 399,356 | ||||||||||||||||||||||
| Current financing lease liability | 5,850 | 10,111 | ||||||||||||||||||||||||
| Current operating lease liability | 240,740 | 255,776 | ||||||||||||||||||||||||
| Insurance premium financing liability | 100,463 | 198,983 | ||||||||||||||||||||||||
| Accrued expenses | 270,511 | 203,740 | ||||||||||||||||||||||||
| Total current liabilities | 1,549,781 | 1,067,966 | ||||||||||||||||||||||||
| Long-term financing lease liability | — | — | ||||||||||||||||||||||||
| Long-term operating lease liability | 96,740 | 156,190 | ||||||||||||||||||||||||
| Warrant liability | — | — | ||||||||||||||||||||||||
| Total liabilities | 1,646,521 | 1,224,156 | ||||||||||||||||||||||||
| Stockholders’ equity | ||||||||||||||||||||||||||
| Common stock | 1,619 | 1,074 | ||||||||||||||||||||||||
| Additional paid-in capital | 82,927,100 | 72,321,352 | ||||||||||||||||||||||||
| Accumulated deficit | (72,448,436) | (68,521,196) | ||||||||||||||||||||||||
| Total stockholders’ equity | 10,480,283 | 3,801,230 | ||||||||||||||||||||||||
| Total liabilities and stockholders’ equity | $ | 12,126,804 | $ | 5,025,386 | ||||||||||||||||||||||
FAQ
How did Azitra (AZTR) perform financially in Q1 2026?
Azitra reported a Q1 2026 net loss of $3.9 million, compared with $3.1 million in Q1 2025. Higher R&D and G&A expenses drove the wider loss as the company invested in its precision dermatology pipeline and corporate infrastructure.
What was Azitra’s cash position as of March 31, 2026?
As of March 31, 2026, Azitra held $10.1 million in cash and cash equivalents. This compares with $2.1 million at December 31, 2025, indicating a significantly stronger liquidity position to support ongoing clinical and strategic initiatives.
How did Azitra’s operating expenses change year over year in Q1 2026?
Total operating expenses were $3.9 million in Q1 2026 versus $3.1 million in Q1 2025. Research and development rose to $1.6 million, and general and administrative increased to $2.4 million, reflecting expanded development and corporate activities.
What key clinical programs is Azitra (AZTR) advancing?
Azitra is advancing ATR-12 in a Phase 1b trial for Netherton syndrome and ATR-04 in a Phase 1/2 trial for EGFR inhibitor–associated rash. It is also progressing ATR-01 for ichthyosis vulgaris and a new ATR-COSF cosmeceutical initiative.
What upcoming milestones did Azitra highlight for 2026?
Azitra expects topline Phase 1b data for ATR-12 and initial cohort data from the Phase 1/2 trial of ATR-04 in H2 2026. The company also plans ATR-COSF cosmetic application studies and ongoing IND-enabling work for ATR-01 during 2026.
What financing activity did Azitra announce alongside Q1 2026 results?
Azitra priced a private placement financing of up to approximately $10.5 million, with potential additional proceeds of about $20.9 million upon warrant exercise. This financing is intended to bolster resources for its therapeutic and cosmeceutical programs.