# EDGAR Filing Document

**Accession Number:** 0001701478
**File Stem:** 0001701478-25-000041
**Filing Date:** 2025-8
**Character Count:** 17607
**Document Hash:** 85dc7a061be00c6f6d113bb618cb7654
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001701478-25-000041.hdr.sgml**: 20250811

**ACCESSION NUMBER**: 0001701478-25-000041

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250811

**ITEM INFORMATION**: Results of Operations and Financial Condition

**FILED AS OF DATE**: 20250811

**DATE AS OF CHANGE**: 20250811

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Azitra, Inc.
- **CENTRAL INDEX KEY:** 0001701478
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 464478536
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41705
- **FILM NUMBER:** 251201906

**BUSINESS ADDRESS:**
- **STREET 1:** 21 BUSINESS PARK DRIVE, SUITE 6
- **CITY:** BRANFORD
- **STATE:** CT
- **ZIP:** 06405
- **BUSINESS PHONE:** (203) 489-0183

**MAIL ADDRESS:**
- **STREET 1:** 21 BUSINESS PARK DRIVE, SUITE 6
- **CITY:** BRANFORD
- **STATE:** CT
- **ZIP:** 06405

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Azitra Inc
- **DATE OF NAME CHANGE:** 20170320

?xml version='1.0' encoding='ASCII'? aztr-20250811

**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**

**August 11, 2025**

**Date of Report (date of earliest event reported)**

**___________________________________**

**AZITRA, INC.**

**(Exact name of registrant as specified in its charter)**

**___________________________________**

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| | | |
|:---|:---|:---|
| **Delaware**<br>**(State or other jurisdiction of** <br>**incorporation or organization)** | **001-41705**<br>**(Commission File Number)** | **46-4478536**<br>**(I.R.S. Employer Identification Number)** |
| **21 Business Park Drive**<br>**Branford, CT 06405** | **21 Business Park Drive**<br>**Branford, CT 06405** | **21 Business Park Drive**<br>**Branford, CT 06405** |
| **(Address of principal executive offices and zip code)** | **(Address of principal executive offices and zip code)** | **(Address of principal executive offices and zip code)** |
| **(203) 646-6446** | **(203) 646-6446** | **(203) 646-6446** |
| **(Registrant's telephone number, including area code)** | **(Registrant's telephone number, including area code)** | **(Registrant's telephone number, including area code)** |
| **(Former name or former address, if changed since last report.)** | **(Former name or former address, if changed since last report.)** | **(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:** | **Securities registered pursuant to Section 12(b) of the Act:** | **Securities registered pursuant to Section 12(b) of the Act:** |
| **<u>Title of each class</u>** | **<u>Trading Symbol</u>** | **<u>Name of each exchange on which registered</u>** |
| **Common Stock, par value $0.0001** | **AZTR** | **NYSE American** |

---

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

Emerging growth company&nbsp;&nbsp;&nbsp;&nbsp;☒

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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 11, 2025, Azitra, Inc. (the "Company") issued a press release announcing its financial results as of and for the quarter ended June 30, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

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

**Item 9.01 - Financial Statements and Exhibits**

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

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| | |
|:---|:---|
| <u>Exhibit No.</u> | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>Description</u> |
| 99.1 | <u>[Press release dated August 1](aztrpressrelease06302025-e.htm)[1](aztrpressrelease06302025-e.htm)[, 2025 regarding the Registrant's financial results for the fiscal quarter ended June 30, 2025.](aztrpressrelease06302025-e.htm)</u> |
| 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 11, 2025.

---

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

---

## Exhibit 99.1

**Exhibit 99.1**

![image_0a.jpg](image_0a.jpg)

**Azitra, Inc. Announces Q2 2025 Results and Provides Business Updates**

BRANFORD, Conn. – August 11, 2025 — Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended June 30, 2025, and provided a business update.

**Q2 2025 and Recent Business Highlights**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Announced initial safety results and 50% enrollment of the Phase 1b clinical trial of the ATR-12 program in Netherton syndrome, demonstrating a promising safety profile

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Announced acceptance of poster detailing the Phase 1/2 clinical trial of the ATR-04 program in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Entered into a purchase agreement for up to $20 million to establish an equity line of credit in partnership with institutional investor Alumni Capital LP, to fund clinical pipeline

"The first half of 2025 was a vital period for Azitra as we hit a key milestone in 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 announced promising safety data in the first five patients dosed with ATR12-351, and we believe this novel approach has potential to be life-changing for these patients. Netherton syndrome has a high unmet need with no approved treatment options."

Mr. Salva continued: "We also announced the design of our Phase 1/2 trial with our ATR-04 program at ASCO, which is investigating 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. We expect to dose the first patient in our Phase 1/2 trial in the third quarter of this year."

Mr. Salva concluded: "The remainder of 2025 is anticipated 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."

**<u>Pipeline and Anticipated Milestones</u>**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;<u>•</u> Q3 2025: First patient to be dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• Q1 2026: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients

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**Financial Results for the Quarter Ended June 30, 2025**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Research and Development (R&D) expenses:** Research and Development (R&D) expenses: R&D expenses for the quarter ended June 30, 2025, were $1.4 million compared to $1.1 million for the comparable period in 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **General and Administrative (G&A) expenses:** General and Administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2025, were $1.5 million compared to $1.5 million for the comparable period in 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Net Loss** was $2.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the comparable period in 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;• **Cash and cash equivalents:** As of June 30, 2025, Azitra had cash and cash equivalents of $1.0 million.

**About Azitra, Inc.**

Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. Azitra's lead program, ATR-12, uses an engineered strain of *S. epidermidis* designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adults with Netherton syndrome. ATR-04, Azitra's additional clinical program, utilizes another engineered strain of *S. epidermidis* for the treatment of EGFR inhibitor ("EGFRi") associated skin toxicity; a Phase 1/2 clinical trial has been initiated for this program. Azitra has received Fast Track designation from the United States Food and Drug Administration for this program to treat EGFRi associated rash, which impacts approximately 150,000 people in the United States. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit https://azitrainc.com.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of (i) our provision of initial safety data and topline results for the phase 1b trial for our ATR-12, (ii) the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, (iii) the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and (iv) statements about our clinical and preclinical programs, and corporate and clinical/preclinical strategies.

Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to 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

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able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the United States Securities and Exchange Commission on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

**<u>Contact</u>**

Norman Staskey

Chief Financial Officer

<u>staskey@azitrainc.com</u>

Investor Relations

<u>Tiberend Strategic Advisors, Inc.</u>

Jon Nugent

205-566-3026

<u>jnugent@tiberend.com</u>

Media Relations

<u>Tiberend Strategic Advisors, Inc.</u>

Casey McDonald

646-577-8520

cmcdonald@tiberend.com

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**Condensed Statement of Operations**

**(Unaudited)**

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| | | |
|:---|:---|:---|
| | Three months Ended June 30, | Three months Ended June 30, |
| | **2025** | **2024** |
| Service revenue – related party | $- | $7500 |
| Total revenue | - | 7500 |
| Operating expenses: |  |  |
| General and administrative | 1469513 | 1549228 |
| Research and development | 1401839 | 1118552 |
| Total operating expenses | 2871352 | 2667780 |
| Loss from operations | (2871352) | (2660280) |
| Other income (expense): |  |  |
| Interest income | 15461 | 16268 |
| Interest expense | (468) | (1782) |
| Change in fair value of warrants | 54 | 4272 |
| Other expense | (32688 | 9529 |
| Total other income (expense) | (17641) | 28287 |
| Net loss before income taxes | (2888993) | (2631993) |
| Income tax expense | - | - |
| Net loss | $(2888993) | $(2631993) |
| Net loss attributable to common shareholders | $(2888993 | $(2631993) |
| Net loss per Share, basic and diluted | $(0.18) | $(2.74) |
| Weighted average common stock outstanding, basic and diluted | 16279574 | 960146 |

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**Condensed Balance Sheets**

**(Unaudited)**

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| | | |
|:---|:---|:---|
| | **June 30,**<br>**2025** | **December 31,**<br>**2024** |
| **Assets** |  |  |
| Current Assets: |  |  |
| Cash and cash equivalents | $1045730 | $4554719 |
| Other receivables | 78407 | 101896 |
| Prepaid expenses and other current assets | 675553 | 571675 |
| Total current assets | $1799690 | $5228290 |
| Property and equipment, net | 601504 | 653957 |
| Other assets | 1554828 | 1476555 |
| Total assets | $3956022 | $7358802 |
| **Liabilities, and stockholders' equity** |  |  |
| Current liabilities: |  |  |
| Accounts payable | $635842 | $490255 |
| Current financing lease liability | 16854 | 16066 |
| Current operating lease liability | 286499 | 255177 |
| Accrued expenses | 513166 | 614359 |
| Total current liabilities | 1452361 | 1375857 |
| Long-term financing lease liability | 1479 | 10105 |
| Long-term operating lease liability | 273027 | 274161 |
| Warrant liability | 184 | 381 |
| Total liabilities | 1727051 | 1660504 |
| Stockholders' equity |  |  |
| Common stock | 1798 | 763 |
| Additional paid-in capital | 65750337 | 63263360 |
| Accumulated deficit | (63523164) | (57565825) |
| Total stockholders' equity | 2228971 | 5698298 |
| Total liabilities and stockholders' equity | $3956022 | $7358802 |

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