8-K
Azitra, Inc. (AZTR)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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, 2025
AZITRA,
INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41705 | 46-4478536 |
|---|---|---|
| (State or other jurisdiction of<br><br> <br>incorporation) | (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
21Business Park Drive
Branford,CT 06405
(Address of principal executive offices)(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 obligations of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock: Par value $0.0001 | AZTR | NYSE<br> American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§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. ☐
Item2.02 Results of Operations and Financial Condition.
On May 13, 2025, Azitra, Inc. (the “Company”) issued a press release announcing its financial results as of and for the three months ended March 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.
Item9.01 Financial Statements and Exhibits
| (d) | Exhibits | Method Filing |
|---|
The following exhibit is furnished with this report:
| Exhibit<br> 99.1 | Press release dated May 13, 2025 regarding the Registrant’s fiscal quarter ended March 31, 2025. | Filed<br> Electronically herewith |
|---|---|---|
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document). |
SIGNATURES
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.
| AZITRA, INC. | |
|---|---|
| Dated:<br> May 13, 2025 | /s/ Francisco D. Salva |
| Francisco<br> D. Salva | |
| Chief<br> Executive Officer |
Exhibit 99.1
Azitra,Inc. Announces Q1 2025 Results and Provides Business Updates
BRANFORD, Conn. – May 13, 2025 — Azitra, Inc. (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, 2025, and provided a business update.
Q12025 and Recent Business Highlights
| ● | Announced<br> acceptance of poster detailing the Phase 1/2 clinical trial of the ATR-04 program in EGFR<br> inhibitor (“EGFRi”)-associated rash at the 2025 American Society of Clinical<br> Oncology (ASCO) Annual Meeting |
|---|---|
| ● | Entered<br> into Purchase Agreement for up to $20 Million in Partnership with institutional investor<br> Alumni Capital LP, to fund clinical pipeline |
| ● | Announced<br> closing of two public offerings raising a total of $2.2M |
“The start of 2025 has been a vital period for Azitra as we build towards key milestones expected by mid-year for our first-in-class, precision, live biotherapeutic candidates designed for major undertreated dermatological diseases,” said Francisco Salva, CEO of Azitra. “For ATR-12, our lead program targeting the rare, chronic and devastating Netherton syndrome, we expect to provide initial safety data from our Phase 1b trial in the first half of 2025 with topline results expected by year-end 2025. There are no approved treatments for Netherton syndrome, and we believe this novel approach has potential to be life-changing for these patients.”
Salva continued: “Also by mid-2025, we look forward to dosing the first patient in our Phase 1/2 trial with our ATR-04 program, which contains a live biotherapeutic product candidate containing an isolated, naturally derived S. epidermidis strain being developed for the treatment of EGFRi-associated rash. EGFRi-associated rash is a dermatologic toxicity that often accompanies EGFRi treatments for cancer, impacting approximately 150,000 patients in the United States annually. These severe skin conditions can interfere with cancer treatment efforts, often causing significant physical and psychological discomfort for patients. Given the importance of EGFRi therapies to the cancer industry, Azitra was invited to present an update of our ATR-04 Phase 1/2 trial at ASCO 2025, which is the most prestigious cancer research conference in the world.”
Salva concluded: “The remainder of 2025 is expected to be a milestone-rich period for Azitra during which we look forward to showcasing the potential of ATR-12 and ATR-04, as well as our unique, proprietary platform for delivering engineered proteins using topical live biotherapeutic products.”
Pipelineand Anticipated Milestones
| ● | 1H<br> 2025: Initial safety data from first set of Netherton syndrome patients in the ATR-12 Phase<br> 1b trial |
|---|---|
| ● | 1H<br> 2025: First patient dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04 |
| ● | YE<br> 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients |
FinancialResults for the Quarter Ended March 31, 2025
| ● | Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31,<br> 2025, were $1.3 million compared to $1.5 million for the comparable period in 2024. |
|---|---|
| ● | General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31,<br> 2025, were $1.9 million compared to $1.5 million for the comparable period in 2024. |
| ● | Net Loss was $3.1 million for the quarter ended March 31, 2025, compared to $2.9 million<br> for the comparable period in 2024. |
| ● | Cash and cash equivalents: As of March 31, 2025, the Company had cash and cash equivalents<br> of $3.2 million. |
AboutAzitra, 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. For more information, please visit https://azitrainc.com.
Forward-LookingStatements
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 and (iii), the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and 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 that we may experience delays in the provision of initial safety data and topline results for ATR-12 or, if we do, that such data may not be favorably received, we may fail to present this abstract detailing the Phase 1/2 clinical trial or, if we are able to do so, that the abstract will be favorably received; we may experience delays in the dosing the first patient in this Phase 1/2 trial; our product candidates may not be effective; there may be 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 SEC on February 24, 2025. 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
CondensedStatement of Operations
(Unaudited)
| Three months Ended March 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | |||||
| Operating expenses: | ||||||
| General and administrative | $ | 1,850,138 | $ | 1,488,527 | ||
| Research and development | 1,250,100 | 1,472,970 | ||||
| Total operating expenses | 3,100,238 | 2,961,497 | ||||
| Loss from operations | (3,100,238 | ) | (2,961,497 | ) | ||
| Other income (expense): | ||||||
| Interest income | 37,164 | 7,609 | ||||
| Interest expense | (1,293 | ) | (915 | ) | ||
| Change in fair value of warrants | 143 | 28,255 | ||||
| Other expense | (4,121 | ) | (6,327 | ) | ||
| Total other income | 31,893 | 28,622 | ) | |||
| Net loss before income taxes | (3,068,345 | ) | (2,932,875 | ) | ||
| Income tax expense | - | - | ||||
| Net loss | $ | (3,068,345 | ) | $ | (2,932,875 | ) |
| Net loss attributable to common shareholders | $ | (3,068,345 | ) | (2,932,875 | ) | |
| Net loss per Share, basic and diluted | $ | (0.23 | ) | $ | (4.32 | ) |
| Weighted average common stock outstanding, basic and diluted | 13,171,516 | 678,885 |
CondensedBalance Sheets
(Unaudited)
| March 31, | December 31, | |||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | |||||
| Assets | ||||||
| Current Assets: | ||||||
| Cash and cash equivalents | $ | 3,206,710 | $ | 4,554,719 | ||
| Other receivables | 103,046 | 101,896 | ||||
| Prepaid expenses and other current assets | 561,798 | 571,675 | ||||
| Total current assets | $ | 3,871,554 | $ | 5,228,290 | ||
| Property and equipment, net | 621,012 | 653,957 | ||||
| Other assets | 1,415,325 | 1,476,555 | ||||
| Total assets | $ | 5,907,891 | $ | 7,358,802 | ||
| Liabilities, and stockholders’ equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 558,924 | $ | 490,255 | ||
| Current financing lease liability | 16,456 | 16,066 | ||||
| Current operating lease liability | 237,647 | 255,177 | ||||
| Accrued expenses | 467,394 | 614,359 | ||||
| Total current liabilities | 1,280,421 | 1,375,857 | ||||
| Long-term financing lease liability | 5,843 | 10,105 | ||||
| Long-term operating lease liability | 213,765 | 274,161 | ||||
| Warrant liability | 238 | 381 | ||||
| Total liabilities | 1,500,267 | 1,660,504 | ||||
| Stockholders’ equity | ||||||
| Common stock | 1,498 | 763 | ||||
| Additional paid-in capital | 65,040,296 | 63,263,360 | ||||
| Accumulated deficit | (60,634,170 | ) | (57,565,825 | ) | ||
| Total stockholders’ equity | 4,407,624 | 5,698,298 | ||||
| Total liabilities and stockholders’ equity | $ | 5,907,891 | $ | 7,358,802 |