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Azitra to outline ATR-04, ATR-COSF at HCW conference

Azitra will present a virtual pipeline and strategy update at a major investor conference, highlighting ATR-COSF cosmetic data and ATR-04’s ongoing Phase 1/2 trial.

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Azitra, Inc. (AZTR) announced that Co-founder and Chief Operating Officer Dr. Travis Whitfill will deliver a virtual presentation at the H.C. Wainwright 28th Annual Global Investment Conference, held September 14-16, 2026 in New York City.

He will provide an update on recent progress and key pipeline activities, including initial data from the ATR-COSF cosmetic protein program, which leverages Azitra’s microbial genetic engineering platform for applications such as fine lines and wrinkles. The presentation will also cover continued enrollment in the first cohort of the Phase 1/2 clinical trial of ATR-04, an investigational live biotherapeutic for EGFR inhibitor-associated rash, a condition impacting approximately 150,000 people in the U.S. During the conference, Dr. Whitfill plans one-on-one meetings with investors and potential partners to discuss business strategy, recent achievements, and anticipated milestones.

Positive

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Negative

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Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Conference dates September 14–16, 2026 H.C. Wainwright 28th Annual Global Investment Conference where Azitra will present
EGFR inhibitor-associated rash U.S. patient impact Approximately 150,000 people Population affected by EGFR inhibitor-associated rash in the United States
Form type Form 8-K Current report furnishing Regulation FD disclosure about the conference presentation
Conference iteration 28th Annual H.C. Wainwright Global Investment Conference edition
Press release date September 8, 2026 Date of Azitra’s press release announcing the conference presentation
Regulation FD regulatory
"Item 7.01 Regulation FD Disclosure"
Regulation FD is a rule that prevents company insiders, like executives, from sharing important information with some people before others get it. It matters because it helps ensure all investors have equal access to key news, making the stock market fairer and reducing chances of insider trading.
Phase 1/2 clinical trial medical
"continued enrollment in the first cohort of the Phase 1/2 clinical trial"
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
"Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash"
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.
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.
recombinant protein technology technical
"ATR-COSF, a recombinant protein technology designed for cosmetic and skincare"

FAQ

What did Azitra, Inc. (AZTR) announce in this 8-K filing?

Azitra announced a virtual presentation at the H.C. Wainwright 28th Annual Global Investment Conference, where its COO will provide pipeline updates on ATR-COSF and ATR-04 and discuss recent corporate progress, strategy, and anticipated milestones with investors and potential partners.

When and where will Azitra’s (AZTR) conference presentation take place?

The presentation will be part of the H.C. Wainwright 28th Annual Global Investment Conference, held September 14-16, 2026, in New York City. Azitra’s COO will deliver a prerecorded virtual presentation accessible via an online conference link.

What is Azitra’s ATR-COSF program mentioned in the filing for AZTR?

ATR-COSF is described as a recombinant protein technology for cosmetic and skincare applications. Initial data highlighted in the presentation supports Azitra’s strategy to use its microbial genetic engineering platform for cosmetic uses, including applications targeting fine lines and wrinkles.

What is ATR-04 and what trial status did Azitra (AZTR) report?

ATR-04 is an investigational live biotherapeutic for EGFR inhibitor-associated rash. Azitra reports continued enrollment in the first cohort of a Phase 1/2 clinical trial evaluating ATR-04 in this indication.

What patient population does Azitra (AZTR) target with ATR-04?

Azitra states it has received Fast Track designation from the FDA for EGFR inhibitor-associated rash, which it notes impacts approximately 150,000 people in the U.S. ATR-04 is being developed to address this treatment-related dermatologic condition.

What broader strategy does Azitra (AZTR) describe for its technology platforms?

Azitra describes technology platforms that combine engineered proteins, topical live biotherapeutics, artificial intelligence, and a proprietary microbial library to develop products for consumer, research, and healthcare markets, spanning therapeutics, cosmeceuticals, and biotechnology applications.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001701478 0001701478 2026-09-08 2026-09-08 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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): September 8, 2026

 

 

 

AZITRA, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-41705   46-4478536
(State or other jurisdiction   (Commission   (IRS Employer
of incorporation)   File Number)   Identification No.)

 

21 Business 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 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(s)   Name of each exchange on which registered
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 (§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.

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On September 8, 2026, Azitra, Inc. (the “Company”) issued a press release announcing that it will provide a virtual presentation at the H.C. Wainwright 28th Annual Global Investment Conference. The press release includes a link to the pre-recorded presentation by Dr. Travis Whitfill, the Company’s Chief Operating Officer. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 of this Current Report on Form 8-K, including the information contained in Exhibit 99.1 is being furnished to the U.S. Securities and Exchange Commission, and shall not be deemed to be “filed” 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, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits.

 

99.1 Press release dated September 8, 2026.
104 Cover Page Interactive Data File (embedded within 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: September 8, 2026 By: /s/ Francisco D. Salva
    Francisco D. Salva
    Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

 

Azitra, Inc. to Present at the H.C. Wainwright 28th Annual Global Investment Conference

 

BRANFORD, Conn. – September 8, 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 announced that Travis Whitfill Ph.D., MPH, Azitra’s Co-founder and Chief Operating Officer, will deliver a virtual presentation at the H.C. Wainwright 28th Annual Global Investment Conference, to be held from September 14-16, 2026, in New York City.

 

In the prerecorded presentation, Dr. Whitfill will provide an update on Azitra’s recent progress and key pipeline activities, including initial data from the ATR-COSF program supporting the Company’s strategy to leverage its microbial genetic engineering platform beyond traditional therapeutics, including cosmetic applications targeting fine lines and wrinkles. He will also discuss continued enrollment in the first cohort of the Phase 1/2 clinical trial evaluating ATR-04 for EGFR inhibitor-associated rash.

 

Details of the presentation are as follows:

 

Event: H.C. Wainwright 28th Annual Global Investment Conference
Date: September 14-16, 2026
Presenter: Travis Whitfill Ph.D., MPH, Co-founder and Chief Operating Officer
Link: https://journey.ct.events/view/e79c38bd-e846-43ef-9594-230c8c543204

 

During the conference, Dr. Whitfill will conduct one-on-one meetings with registered investors and potential partners, highlighting the Company’s business and clinical development strategy, recent corporate achievements, and anticipated milestones.

 

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

 

 

 

Filing Exhibits & Attachments

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