Azitra Q3 2026 loss widens to $2.95M from $2.76M
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Form Type
8-K
Rhea-AI Filing Summary
Azitra, Inc. reported a Q3 2026 net loss of $2.95 million, compared with $2.76 million in Q3 2025, and cash and cash equivalents of $3.75 million as of September 30, 2026. Research and development expense was $1.29 million, versus $1.18 million; general and administrative expense was $1.61 million, versus $1.59 million.
In ex vivo studies, a single ATR-COSF application reduced fine-line and wrinkle appearance by approximately 50% after 48 hours; an optimized formulation improved skin elasticity. Initial results from a first-in-human cosmetic study are expected by year-end 2026. ATR-04 completed Cohort 1, and its safety review committee recommended proceeding to Cohort 2. Eligibility expanded to include rashes associated with KRAS and MEK inhibitors, including among patients with neurofibromatosis type 1. Cohort 2 is expected to enroll approximately 24 patients for once-daily treatment for 28 days; Cohort 1 topline data are expected in Q4 2026. After ATR-COSF results are announced, institutional investors in Azitra’s March 2026 financing will have an opportunity to invest an additional $5.25 million to $10.5 million through instruments issued in that transaction.
0 points · 0 major1 major · 1 point
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- None.
Negative
- Major pointNet loss increased to $2.95 million from $2.76 million in Q3 2025.
Filing Explained
The Q3 filing reports
Sources and calculations
- Azitra Form 8-K and Exhibit 99.1 (2026-11-12)
- Azitra Q3 2026 fundamentals (2026Q3)
- Available liquidity against the last reported quarterly operating outflow, in days at that rate $3,750,710 / ($2,901,894 / 92) = 118.9 days
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, or exhibit attachments filed with this report.
Key Figures
Net loss: $2.95 million
Research and development expense: $1.29 million
General and administrative expense: $1.61 million
+4 more
7 metrics
Net loss
$2.95 million
Three months ended September 30, 2026; compared with $2.76 million in Q3 2025
Research and development expense
$1.29 million
Three months ended September 30, 2026; compared with $1.18 million in Q3 2025
General and administrative expense
$1.61 million
Three months ended September 30, 2026; compared with $1.59 million in Q3 2025
Cash and cash equivalents
$3.75 million
As of September 30, 2026
Fine-line and wrinkle appearance reduction
Approximately 50%
After 48 hours following a single application in laboratory studies
Cohort 2 expected enrollment
Approximately 24 patients
ATR-04 Phase 1/2 trial
Cohort 2 treatment duration
28 days
Expected once-daily treatment
Key Terms
ex vivo, live biotherapeutic, Phase 1/2 trial, Fast Track designation, +2 more
6 terms
ex vivo technical
"ex vivo human skin"
Ex vivo describes tests or treatments performed on living cells, tissues, or organs that have been removed from the body and studied in an external environment. For investors, ex vivo work sits between basic lab dish tests and whole‑animal or human studies, offering a more realistic preview of how a therapy or diagnostic might behave in real tissue — like running an engine on a test stand before putting it back into a car — which can reduce scientific risk and inform development milestones.
live biotherapeutic medical
"investigational live biotherapeutic for skin rashes"
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.
Phase 1/2 trial medical
"ongoing Phase 1/2 trial"
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.
Fast Track designation regulatory
"Fast Track designation from the FDA"
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.
recombinant filaggrin domains technical
"delivery and distribution of recombinant filaggrin domains"
topline data medical
"topline data from Cohort 1"
Topline data are the initial, high-level results from a clinical study that show whether the main goals of the trial were met, much like the headline of a news story that summarizes the most important point. Investors care because these early outcomes quickly indicate a drug’s commercial potential and regulatory path — positive topline results can boost a company’s value, while disappointing ones can sharply reduce expected future revenue.
Earnings Snapshot
Research and development expense: $1.29 million
Three months ended September 30, 2026
Research and development expense
$1.29 million
Compared with $1.18 million in Q3 2025
General and administrative expense
$1.61 million
Compared with $1.59 million in Q3 2025
Net loss
$2.95 million
Compared with $2.76 million in Q3 2025
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were AZTR’s Q3 2026 net loss and cash balance?
Azitra reported a net loss of $2.95 million for the quarter ended September 30, 2026, compared with $2.76 million in the year-earlier quarter. Cash and cash equivalents totaled $3.75 million as of September 30, 2026.
What is the status of AZTR’s ATR-04 trial?
Cohort 1 was complete, and the safety review committee recommended proceeding to Cohort 2. Trial eligibility expanded to include patients with rash associated with KRAS and MEK inhibitors, including patients with neurofibromatosis type 1 and MEK inhibitor-associated rash. Cohort 2 is expected to enroll approximately 24 patients for once-daily treatment for 28 days; Cohort 1 topline data are expected in Q4 2026.
AI-generated analysis. How Rhea-AI works. Not financial advice.
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): November 12, 2026
___________________________________
(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 CT06405 | ||||||||
(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 | ||||||
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 November 12, 2026 , Azitra, Inc. issued a press release announcing its financial results as of and for the quarter ended September 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 November 12, 2026 regarding the Registrant's financial results for the fiscal quarter ended September 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 November 12, 2026 .
AZITRA, INC. | |||||
By: | /s/ Francisco D. Salva | ||||
Name: | Francisco D. Salva | ||||
Title: | Chief Executive Officer | ||||
Exhibit 99.1
Azitra, Inc. Announces Q3 2026 Results and Provides Business Updates
BRANFORD, Conn. – November 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 September 30, 2026, and provided a business update.
Q3 2026 and Recent Business Highlights
•Announced revitalizing results from ex vivo study of ATR-COSF demonstrating ability to reduce fine lines and improve elasticity in human skin
•Reported breakthrough repeat dose and anti-wrinkle ex vivo results for ATR-COSF program, demonstrating increased distribution and elasticity
•Announced completion of Cohort 1 of the ATR-04 Phase 1/2 trial and the safety review committee’s recommendation to proceed to Cohort 2
•Expanded ATR-04 trial eligibility to include patients with KRAS and MEK inhibitor-associated rash, including patients with neurofibromatosis type 1 with rash associated with receiving MEK inhibitors
“During the third quarter and recent weeks, we made substantial progress with our two priority programs, generating encouraging results for ATR-COSF and advancing ATR-04 forward in the clinic while broadening its potential to benefit more patients,” said Francisco Salva, Chief Executive Officer of Azitra. “We were very pleased to report research involving ATR-COSF demonstrating a single application of the product was able to reduce the appearance of fine lines and wrinkles by approximately 50% after 48 hours in laboratory studies, while our optimized formulation improved skin elasticity across every measure tested in a separate study. These results strengthen our confidence in ATR-COSF’s potential as a differentiated cosmetic ingredient and set the stage for a first-in-human cosmetic study, with initial results anticipated by year-end.”
Salva continued: “The recommendation to advance ATR-04 to Cohort 2 brings us closer to our goal of providing a new treatment option for patients whose debilitating skin rash can disrupt essential therapy. Additionally, by expanding the trial to address rash associated with KRAS and MEK inhibitors, including in patients with neurofibromatosis type 1 with MEK inhibitor-associated rash, we are broadening ATR-04’s potential reach and expanding the eligible patient pool to support enrollment. We believe ATR-04 has the potential to become the first live biotherapeutic developed for skin rashes associated with cancer and MEK inhibitor treatment for neurofibromatosis treatments. We are encouraged by the potential to reach additional patient populations and look forward to reporting topline data from Cohort 1, which we anticipate in the fourth quarter of 2026.”
Salva concluded: “The remainder of 2026 has the potential to be a defining period for Azitra as we expect to report initial results from our first in-human cosmetic study of ATR-COSF and topline data from Cohort 1 of our ATR-04 Phase 1/2 trial. Importantly, once we announce the ATR-COSF results, institutional investors who participated in our financing earlier this year will have the opportunity to invest an additional $5.25 million to $10.5 million through certain financial instruments issued in that transaction.”
Pipeline, Platform and Corporate Updates
ATR-COSF - Consumer Initiative to Improve the Appearance of Fine Lines and Wrinkles
•Announced positive repeat-dose results demonstrating increased delivery and distribution of recombinant filaggrin domains and improved elasticity in ex vivo human skin.
•Reported additional ex vivo results showing reduced appearance of fine lines and wrinkles following a single application, with continued improvement through 48 hours, and improved elasticity with an optimized formulation.
•First-in-human cosmetic study planned with initial results expected by year-end 2026.
ATR-04 – Advancing a Potential Treatment for Targeted Therapy-Associated Rash
•Completed Cohort 1 of the ongoing Phase 1/2 trial and received safety review committee’s recommendation to proceed to Cohort 2.
•Expanded trial eligibility to include patients with KRAS and MEK inhibitor-associated rash, including patients with neurofibromatosis type 1 with rash associated with MEK inhibitors.
•Modified trial requirements to facilitate recruitment, with Cohort 2 expected to enroll approximately 24 patients receiving once-daily treatment for 28 days.
•Topline data from first cohort of Phase 1/2 trial expected in Q4 - 2026.
Financial Results for the Quarter Ended September 30, 2026
•Research and Development (R&D) expenses: R&D expenses for the quarter ended September 30, 2026, were $1.3 million compared to $1.2 million for the comparable period in 2025.
•General and Administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2026, were $1.6 million compared to $1.6 million for the comparable period in 2025.
•Net Loss was $3.0 million for the quarter ended September 30, 2026, compared to $2.8 million for the comparable period in 2025.
•Cash and cash equivalents: As of September 30, 2026, Azitra had cash and cash equivalents of $3.8 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 skin rashes associated with cancer and neurofibromatosis treatments. Azitra has received Fast Track designation from the FDA for cancer treatment-associated rash, which impacts up to 300,000 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 (i) the expected timing of topline data from Cohort 1, and enrollment of Cohort 2, of the Phase 1/2 clinical trial of ATR-04, (ii) the potential of ATR-04 in expanded patient populations, (iii) the expected timing of initiation and initial results of the first in human cosmetic study of ATR-COSF, (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 potential exercise of financial instruments issued in our March 2026 private placement and any resulting proceeds, and (vi) the sufficiency of our cash resources.
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 enrollment delays; the protocol amendments may not facilitate recruitment or accelerate enrollment as anticipated; we may experience delays in the provision of initial or additional safety data, as applicable, and topline results for ATR-04 and, if we do, such data and results may not be favorably received; the expanded patient populations may present different safety or efficacy profiles; the results from Cohort 1 may not be predictive of results in Cohort 2 or later-stage trials; results from ex vivo and other preclinical studies may not be predictive of results in humans; the first-in-human study of ATR-COSF may be delayed or may not produce favorable results; the safety and efficacy of our product candidates; holders of instruments issued in our private placement may not exercise them, in whole or in part; we may fail to timely raise additional required funding; our ability to maintain the listing of our common stock on the NYSE American; 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 subsequent filings with the SEC, including our quarterly reports on Form 10-Q filed on May 13, 2026; August 12, 2026 and November 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 September 30, | ||||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||
| General and administrative | $ | 1,614,814 | $ | 1,588,406 | ||||||||||||||||||||||
| Research and development | 1,290,644 | 1,180,078 | ||||||||||||||||||||||||
| Total operating expenses | 2,905,458 | 2,768,484 | ||||||||||||||||||||||||
| Loss from operations | (2,905,458) | (2,768,484) | ||||||||||||||||||||||||
| Other income (expense): | ||||||||||||||||||||||||||
| Interest income | 48,531 | 4,823 | ||||||||||||||||||||||||
| Interest expense | — | (372) | ||||||||||||||||||||||||
| Change in fair value of warrants | — | 133 | ||||||||||||||||||||||||
| Other income | (92,852) | (628) | ||||||||||||||||||||||||
| Total other income (expense) | (44,321) | 3,956 | ||||||||||||||||||||||||
| Loss before income taxes | (2,949,779) | (2,764,528) | ||||||||||||||||||||||||
| Income tax expense | — | — | ||||||||||||||||||||||||
| Net loss | $ | (2,949,779) | $ | (2,764,528) | ||||||||||||||||||||||
| Net loss per Share, basic and diluted | $ | (0.29) | $ | (6.71) | ||||||||||||||||||||||
| Weighted average common stock outstanding, basic and diluted | 10,301,517 | 411,769 | ||||||||||||||||||||||||
Condensed Balance Sheets
(Unaudited)
| September 30, | December 31, | |||||||||||||||||||||||||
| 2026 | 2025 | |||||||||||||||||||||||||
| Assets | ||||||||||||||||||||||||||
| Current Assets: | ||||||||||||||||||||||||||
| Cash and cash equivalents | $ | 3,750,710 | $ | 2,068,083 | ||||||||||||||||||||||
| Other receivables | 124,580 | 141,295 | ||||||||||||||||||||||||
| Prepaid expenses and other current assets | 915,936 | 809,949 | ||||||||||||||||||||||||
| Total current assets | 4,791,226 | 3,019,327 | ||||||||||||||||||||||||
| Property and equipment, net | 520,304 | 548,591 | ||||||||||||||||||||||||
| Other assets | 662,063 | 1,457,468 | ||||||||||||||||||||||||
| Total assets | $ | 5,973,593 | $ | 5,025,386 | ||||||||||||||||||||||
| Liabilities and stockholders’ equity | ||||||||||||||||||||||||||
| Current liabilities: | ||||||||||||||||||||||||||
| Accounts payable | $ | 596,800 | $ | 399,356 | ||||||||||||||||||||||
| Current financing lease liability | — | 10,111 | ||||||||||||||||||||||||
| Current operating lease liability | 274,197 | 255,776 | ||||||||||||||||||||||||
| Insurance premium financing liability | — | 198,983 | ||||||||||||||||||||||||
| Accrued expenses | 669,137 | 203,740 | ||||||||||||||||||||||||
| Total current liabilities | 1,540,134 | 1,067,966 | ||||||||||||||||||||||||
| Long-term operating lease liability | 35,962 | 156,190 | ||||||||||||||||||||||||
| Total liabilities | 1,576,096 | 1,224,156 | ||||||||||||||||||||||||
| Stockholders’ equity | ||||||||||||||||||||||||||
| Common stock | 606 | 107 | ||||||||||||||||||||||||
| Additional paid-in capital | 83,142,766 | 72,322,319 | ||||||||||||||||||||||||
| Accumulated deficit | (78,745,875) | (68,521,196) | ||||||||||||||||||||||||
| Total stockholders’ equity | 4,397,497 | 3,801,230 | ||||||||||||||||||||||||
| Total liabilities and stockholders’ equity | $ | 5,973,593 | $ | 5,025,386 | ||||||||||||||||||||||