Azitra (NYSE American: AZTR) widens Q2 loss while advancing dermatology and protein pipeline
Rhea-AI Filing Summary
Azitra, Inc. reported Q2 2026 results and outlined pipeline priorities in precision dermatology, cosmetics and biotechnology applications. Preclinical data from ATR-COSF showed repeat-dose delivery and anti-wrinkle activity in ex vivo human skin, supporting a planned human cosmetic application study starting in Q3 2026. The company continued enrolling the first cohort in its Phase 1/2 trial of ATR-04 for EGFR inhibitor-associated rash, with topline data from the first cohort expected in Q4 2026, and advanced a recombinant protein portfolio including TEV Protease and T7 RNA Polymerase. Azitra plans to strategically pause further enrollment in the Phase 1b study of ATR-12 for Netherton syndrome to focus capital on programs with nearer-term opportunities. For Q2 2026, R&D expenses were $1.4 million, G&A expenses were $2.1 million, and net loss was $3.3 million versus $2.9 million a year earlier. As of June 30, 2026, cash and cash equivalents were $6.7 million and total stockholders’ equity was $7.3 million.
Positive
- Cash and cash equivalents increased to $6.7 million as of June 30, 2026 from $2.1 million at December 31, 2025, strengthening the balance sheet to support ongoing development programs.
- Total stockholders’ equity rose to $7.3 million at June 30, 2026 from $3.8 million at December 31, 2025, reflecting additional paid-in capital and a larger capital base.
- ATR-COSF delivered positive preclinical anti-wrinkle data in ex vivo human skin, with a human cosmetic application study planned to start in Q3 2026, adding a near-term consumer-facing catalyst.
Negative
- Net loss widened to $3.3 million for Q2 2026 from $2.9 million in Q2 2025, reflecting higher operating expenses.
- General and administrative expenses rose to $2.1 million from $1.5 million year over year in Q2, indicating a significant increase in overhead.
- ATR-12 Phase 1b enrollment will be strategically paused, slowing progress in Netherton syndrome to prioritize other programs and capital allocation.
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
Net loss Q2 2026: $3,347,660
Net loss Q2 2025: $2,888,993
R&D expenses Q2 2026: $1,351,529
+5 more
8 metrics
Net loss Q2 2026
$3,347,660
Net loss for the quarter ended June 30, 2026
Net loss Q2 2025
$2,888,993
Net loss for the quarter ended June 30, 2025
R&D expenses Q2 2026
$1,351,529
Research and development expenses for the quarter ended June 30, 2026
G&A expenses Q2 2026
$2,067,639
General and administrative expenses for the quarter ended June 30, 2026
Cash and cash equivalents
$6,727,810
Cash and cash equivalents as of June 30, 2026
Total assets
$8,916,046
Total assets as of June 30, 2026
Total stockholders’ equity
$7,334,339
Total stockholders’ equity as of June 30, 2026
Net loss per share Q2 2026
$0.17
Basic and diluted net loss per share for the quarter ended June 30, 2026
Key Terms
Phase 1/2 clinical trial, EGFR inhibitor-associated rash, recombinant protein portfolio, Fast Track designation, +2 more
6 terms
Phase 1/2 clinical trial medical
"Continued enrollment of the first cohort in the Phase 1/2 clinical trial evaluating ATR-04"
A phase 1/2 clinical trial is an early human study that combines first-in-people safety and dosing checks (phase 1) with an initial look at whether the treatment appears to work (phase 2). Think of it as a short test drive where researchers both confirm the product won’t cause serious harm and gather early signs it could be effective; for investors, successful results reduce risk and can unlock value-creating milestones like larger trials or regulatory discussions.
EGFR inhibitor-associated rash medical
"evaluating ATR-04 for EGFR inhibitor-associated rash"
recombinant protein portfolio technical
"advance development of its recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase"
Fast Track designation regulatory
"Azitra has received Fast Track designation from the FDA for EGFR inhibitor-associated rash"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
Netherton syndrome medical
"Phase 1b study evaluating ATR-12 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.
live biotherapeutic medical
"ATR-04, an investigational live biotherapeutic for EGFR inhibitor associated rash"
A live biotherapeutic is a medical product made from live microorganisms intended to prevent, treat, or cure disease—think of it as a medicine made from helpful microbes rather than chemical compounds. Its live, biological nature means tighter safety rules, specialized manufacturing and storage, and a formal drug-approval pathway rather than simple supplement rules, so development costs, approval timelines and market uptake can strongly affect an investor’s risk and return.
Earnings Snapshot
Net loss: $3,347,660
Quarter ended June 30, 2026
Net loss
$3,347,660
Increased from $2,888,993 in the comparable 2025 quarter
R&D expenses
$1,351,529
Comparable to $1,401,839 in the prior-year quarter
G&A expenses
$2,067,639
Increased from $1,469,513 in the prior-year quarter
Cash and cash equivalents
$6,727,810
Increased from $2,068,083 as of December 31, 2025
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What were Azitra (AZTR) Q2 2026 financial results?
Azitra reported a net loss of $3.35 million for Q2 2026, compared with $2.89 million in Q2 2025. R&D expenses were $1.35 million and G&A expenses were $2.07 million, leading to total operating expenses of $3.42 million.
How much cash did Azitra (AZTR) have as of June 30, 2026?
As of June 30, 2026, Azitra had cash and cash equivalents of $6.73 million. This compares with $2.07 million at December 31, 2025, indicating a larger cash position to fund ongoing clinical and preclinical programs.
What is the status of Azitra (AZTR) ATR-04 clinical program?
Azitra is enrolling the first cohort of a Phase 1/2 trial evaluating ATR-04 for EGFR inhibitor-associated rash. The company expects to report topline data from the first cohort in Q4 2026, with six active clinical sites participating.
What progress has Azitra (AZTR) made with ATR-COSF?
ATR-COSF generated positive preclinical data showing repeat-dose delivery and anti-wrinkle activity in ex vivo human skin. Azitra plans a human cosmetic application study for ATR-COSF, expected to start in Q3 2026 as a proof-of-concept cosmetic study.
Why is Azitra (AZTR) pausing enrollment in the ATR-12 trial?
Azitra plans to strategically pause further enrollment in the Phase 1b ATR-12 study for Netherton syndrome. The company states this reflects a disciplined capital allocation approach and a focus on programs with greater near-term clinical and commercial potential.
What are Azitra (AZTR) doing with their recombinant protein platform?
Azitra is advancing a recombinant protein portfolio that includes TEV Protease and T7 RNA Polymerase. The platform targets high-quality proteins for biotechnology research and manufacturing, aiming to leverage microbial genetic engineering expertise and broaden long-term commercial opportunities.
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): August 12, 2026
___________________________________
(Exact name of registrant as specified in its charter)
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(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 August 12, 2026 , Azitra, Inc. (the “Company”) issued a press release announcing its financial results as of and for the quarter ended June 30, 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 August 12, 2026 regarding the Registrant's financial results for the fiscal quarter ended June 30, 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 August 12, 2026 .
AZITRA, INC. | |||||
By: | /s/ Francisco D. Salva | ||||
Name: | Francisco D. Salva | ||||
Title: | Chief Executive Officer | ||||
Exhibit 99.1
Azitra, Inc. Announces Q2 2026 Results and Provides Business Updates
BRANFORD, Conn. – August 12, 2026 — Azitra, Inc. (“Azitra” or the “Company”) (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and high value cosmetic proteins and peptides, today reported financial results for the quarter ended June 30, 2026, and provided a business update.
Q2 2026 and Recent Business Highlights
•Reported the first preclinical data from ATR-COSF demonstrating breakthrough repeat-dose distribution, controlled delivery into targeted skin layers and anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept clinical study.
•Continued enrollment of the first cohort in the Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash.
•Continued advancement of recombinant protein initiatives, including Tobacco Etch Virus (TEV) Protease and T7 RNA Polymerase, expanding the Company's platform into biotechnology research and manufacturing applications.
•Issued CEO Letter to Shareholders detailing Azitra's expanded strategy to leverage its proprietary microbial genetic engineering platform across therapeutics, cosmetic ingredients and biotechnology products.
“The second quarter has marked an exciting evolution for Azitra with the first data from our ATR-COSF program, which provided validation of our strategy to leverage our microbial genetic engineering platform beyond traditional therapeutics,” said Francisco Salva, Chief Executive Officer of Azitra. “Combined with the continued advancement of ATR-04 and our recombinant protein initiatives, these accomplishments reflect the breadth of opportunities we are creating in multiple billion dollar markets, including therapeutics, cosmetic ingredients and biotechnology applications.”
Salva continued: “Our ATR-COSF program continues to excite our team, as it represents one of the first to demonstrate the wrinkle reducing potential of recombinant filaggrin ingredient in ex vivo human skin. It shows Azitra’s ability to translate our cutting edge science into observable benefits for consumers. The ATR-COSF program represents our first step in unlocking meaningful value for shareholders while positioning Azitra at the intersection of synthetic biology, artificial intelligence and next-generation biological manufacturing.
“During the quarter, we also continued enrollment of the first cohort in our Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash. With six active clinical sites, including MD Anderson Cancer Center, we remain on track to report topline data from the first cohort around year end. Additionally, we are in the process to open eligibility criteria to other cancer treatment related rashes driven by inhibitors along the same EGFR/KRAS/MEK/ERK pathway. EGFR inhibitor-associated rash remains a significant unmet medical need, affecting an estimated 50% to 90% of patients receiving EGFR-targeted cancer therapies and frequently leading to dose reductions, treatment interruptions or discontinuation.”
Salva concluded: “Looking ahead, we remain focused on implementing the strategy outlined in our recent shareholder letter. That includes advancing ATR-COSF toward a planned proof-of-concept clinical study, continuing development of our recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase, and progressing ATR-04 as our lead clinical therapeutic program. We believe these initiatives position Azitra to unlock the full potential of our platform while creating multiple avenues for long-term growth and shareholder value."
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.
•Announced positive preclinical data demonstrating breakthrough repeat-dose delivery and distribution together with anti-wrinkle activity in ex vivo human skin, supporting advancement toward a planned proof-of-concept cosmetic study evaluating the safety and efficacy of ATR-COSF.
•Human cosmetic application study planned to start in Q3 2026.
ATR-04 – Addressing an Unmet Need for Cancer Patients in a Billion Dollar Market Opportunity
•Continued enrollment of the first cohort of the ongoing Phase 1/2 clinical trial evaluating ATR-04 for the treatment of EGFRi-associated rash.
•Topline data from first cohort of Phase 1/2 trial expected in Q4-2026.
Recombinant Protein Platform
•Announced plans to advance development of its recombinant protein portfolio, including TEV Protease and T7 RNA Polymerase.
•Platform provides opportunity to develop high-quality recombinant proteins for biotechnology research and manufacturing applications, representing potential opportunities to leverage its microbial genetic engineering expertise while broadening its long-term commercial potential.
ATR-12 - Advancing Phase 1b Clinical Trial in Netherton Syndrome
•Consistent with the priorities outlined in the Company's recent shareholder letter, Azitra plans to strategically pause further enrollment in the ongoing Phase 1b study evaluating ATR-12 for Netherton syndrome.
•This decision reflects the Company's disciplined approach to capital allocation and its focus on advancing programs with the greatest near-term opportunities for clinical, commercial and shareholder value creation.
Financial Results for the Quarter Ended June 30, 2026
•Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2026, were $1.4 million compared to $1.4 million for the comparable period in 2025.
•General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2026, were $2.1 million compared to $1.5 million for the comparable period in 2025.
•Net Loss was $3.3 million for the quarter ended June 30, 2026, compared to $2.9 million for the comparable period in 2025.
•Cash and cash equivalents: As of June 30, 2026, Azitra had cash and cash equivalents of $6.7 million.
About Azitra, Inc.
Azitra, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and novel products across therapeutics, cosmeceuticals and biotechnology applications. The Company's portfolio is highlighted by ATR-COSF, a recombinant protein technology designed for cosmetic and skincare applications, and ATR-04, an investigational live biotherapeutic for EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFR inhibitor-associated rash, which impacts approximately 150,000 people in the U.S. Azitra is also advancing additional recombinant protein initiatives designed to support biotechnology research and manufacturing applications. Azitra's technology platforms combine engineered proteins, topical live biotherapeutics, artificial intelligence, and a proprietary microbial library to develop differentiated products for consumer, research and healthcare 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 potential resumption and expected timing 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, (iv) statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies, including our cosmeceutical strategy and our recombinant protein platform, (v) the expected timing of our planned human cosmetic application study for ATR-COSF, and (vi) statements regarding our strategy plans and priorities, including those outlined in our recent shareholder letter.
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-COSF, our recombinant protein platform, 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 and August 12, 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.
David Irish
231-632-0002
dirish@tiberend.com
Media Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com
Condensed Statement of Operations
(Unaudited)
| Three Months Ended June 30, | ||||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||
| General and administrative | $ | 2,067,639 | $ | 1,469,513 | ||||||||||||||||||||||
| Research and development | 1,351,529 | 1,401,839 | ||||||||||||||||||||||||
| Total operating expenses | 3,419,168 | 2,871,352 | ||||||||||||||||||||||||
| Loss from operations | 3,419,168 | 2,871,352 | ||||||||||||||||||||||||
| Other income (expense): | ||||||||||||||||||||||||||
| Interest income | 74,661 | 15,461 | ||||||||||||||||||||||||
| Interest expense | (1,365) | (468) | ||||||||||||||||||||||||
| Change in fair value of warrants | — | 54 | ||||||||||||||||||||||||
| Other income | (1,788) | (32,688) | ||||||||||||||||||||||||
| Total other income (expense) | 71,508 | (17,641) | ||||||||||||||||||||||||
| Loss before income taxes | 3,347,660 | 2,888,993 | ||||||||||||||||||||||||
| Income tax expense | — | — | ||||||||||||||||||||||||
| Net loss | $ | 3,347,660 | $ | 2,888,993 | ||||||||||||||||||||||
| Net loss per Share, basic and diluted | $ | (0.17) | $ | (1.18) | ||||||||||||||||||||||
| Weighted average common stock outstanding, basic and diluted | 19,300,704 | 2,444,340 | ||||||||||||||||||||||||
Condensed Balance Sheets
Unaudited
| June 30, | December 31, | |||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||
| Assets | ||||||||||||||||||||||||||
| Current Assets: | ||||||||||||||||||||||||||
| Cash and cash equivalents | $ | 6,727,810 | $ | 2,068,083 | ||||||||||||||||||||||
| Other receivables | 144,730 | 141,295 | ||||||||||||||||||||||||
| Prepaid expenses and other current assets | 571,282 | 809,949 | ||||||||||||||||||||||||
| Total current assets | 7,443,822 | 3,019,327 | ||||||||||||||||||||||||
| Property and equipment, net | 536,422 | 548,591 | ||||||||||||||||||||||||
| Other assets | 935,802 | 1,457,468 | ||||||||||||||||||||||||
| Total assets | $ | 8,916,046 | $ | 5,025,386 | ||||||||||||||||||||||
| Liabilities and stockholders’ equity | ||||||||||||||||||||||||||
| Current liabilities: | ||||||||||||||||||||||||||
| Accounts payable | $ | 497,985 | $ | 399,356 | ||||||||||||||||||||||
| Current financing lease liability | 1,486 | 10,111 | ||||||||||||||||||||||||
| Current operating lease liability | 357,569 | 255,776 | ||||||||||||||||||||||||
| Insurance premium financing liability | — | 198,983 | ||||||||||||||||||||||||
| Accrued expenses | 673,669 | 203,740 | ||||||||||||||||||||||||
| Total current liabilities | 1,530,709 | 1,067,966 | ||||||||||||||||||||||||
| Long-term operating lease liability | 50,998 | 156,190 | ||||||||||||||||||||||||
| Total liabilities | 1,581,707 | 1,224,156 | ||||||||||||||||||||||||
| Stockholders’ equity | ||||||||||||||||||||||||||
| Common stock | 6,060 | 1,074 | ||||||||||||||||||||||||
| Additional paid-in capital | 83,124,375 | 72,321,352 | ||||||||||||||||||||||||
| Accumulated deficit | (75,796,096) | (68,521,196) | ||||||||||||||||||||||||
| Total stockholders’ equity | 7,334,339 | 3,801,230 | ||||||||||||||||||||||||
| Total liabilities and stockholders’ equity | $ | 8,916,046 | $ | 5,025,386 | ||||||||||||||||||||||