STOCK TITAN

Azitra (NYSE: AZTR) wins back listing under new NYSE watch period

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Azitra, Inc. (AZTR) announced that NYSE Regulation has confirmed the company has regained compliance with all NYSE American continued listing standards set forth in Part 10 of the NYSE American Company Guide, resolving earlier deficiencies under Sections 1003(a)(ii) and 1003(a)(iii). The “below compliance” (.BC) indicator will be removed from Azitra’s trading symbol and the company will come off NYSE American’s list of noncompliant issuers. Azitra will remain subject to NYSE American’s continued listing monitoring procedures, and under Section 1009(h), any new noncompliance within 12 months could lead NYSE American to truncate normal compliance procedures or immediately initiate delisting proceedings.

Positive

  • Regains NYSE American compliance: NYSE Regulation confirmed Azitra now meets all continued listing standards in Part 10 of the NYSE American Company Guide, and the .BC indicator and noncompliant status will be removed.
  • Pipeline and regulatory positioning: Azitra highlights clinical programs ATR-COSF and ATR-04 and notes it has received Fast Track designation from the FDA for EGFR inhibitor-associated rash, which impacts about 150,000 people in the U.S.

Negative

  • Heightened delisting risk window: Under Section 1009(h), if Azitra falls below continued listing standards again within 12 months, NYSE American may shorten compliance procedures or immediately begin delisting proceedings.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Date of NYSE Regulation letter August 19, 2026 Letter informing Azitra it had resolved continued listing deficiencies
Monitoring period under Section 1009(h) 12 months Period during which a new noncompliance could trigger truncated procedures or delisting
Estimated U.S. EGFR inhibitor-associated rash population 150,000 people Addressable population for ATR-04 indication in the U.S.
Form 10-K filing date February 27, 2026 Date of the most recent annual report referenced for risk factors
Form 10-Q filing dates May 13, 2026 and August 12, 2026 Quarterly reports referenced for additional risks and updates
continued listing standards regulatory
"regained compliance with all of the NYSE American continued listing standards"
Ongoing rules a stock exchange requires a listed company to meet to keep its shares trading publicly, such as minimum share price, market value, timely financial reports, and governance practices. Think of it as a membership checklist for a club: falling short can lead to warnings or removal from the exchange, which can sharply reduce liquidity, investor confidence, and a stock’s value. Investors watch these standards to gauge regulatory risk and the stability of their holdings.
NYSE American Company Guide regulatory
"standards set forth in Part 10 of the NYSE American Company Guide"
A handbook of rules and requirements that govern companies listed on the NYSE American market, covering eligibility to list, ongoing disclosure duties, corporate governance expectations, and trading practices. It matters to investors because it sets the minimum standards companies must meet to join and remain on that exchange — like a routine safety inspection that signals basic reliability and transparency — helping investors judge regulatory compliance, quality of public information, and potential risks to a stock’s value.
Fast Track designation medical
"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"
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.
EGFR inhibitor-associated rash medical
"an investigational live biotherapeutic for EGFR inhibitor (“EGFRi”) associated rash"
cosmeceuticals medical
"novel products across therapeutics, cosmeceuticals and biotechnology applications"

FAQ

What did Azitra, Inc. (AZTR) announce regarding its NYSE American listing?

Azitra announced that NYSE Regulation notified the company it has regained compliance with all NYSE American continued listing standards, resolving prior deficiencies under Sections 1003(a)(ii) and 1003(a)(iii). The .BC indicator will be removed and Azitra will be taken off the noncompliant issuers list.

What happens to Azitra’s AZTR trading symbol after regaining compliance?

The NYSE American “below compliance” (.BC) indicator attached to Azitra’s AZTR trading symbol will be removed, and the company will no longer appear on NYSE American’s list of noncompliant issuers.

Is Azitra (AZTR) still being monitored by NYSE American after regaining compliance?

Yes. Azitra will remain subject to NYSE American’s continued listing monitoring procedures. If it again falls below any continued listing standard within 12 months, NYSE American may truncate normal compliance procedures or start delisting proceedings.

Which NYSE American rules did Azitra previously fail to meet?

Azitra had previously disclosed deficiencies under Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. NYSE Regulation’s letter dated August 19, 2026, stated that these continued listing deficiencies have now been resolved.

What are Azitra’s key clinical programs mentioned in this AZTR filing?

Azitra references its pipeline programs ATR-COSF, a recombinant protein technology for cosmetic and skincare applications, and ATR-04, an investigational live biotherapeutic for EGFR inhibitor-associated rash. It also notes FDA Fast Track designation for this rash indication.

How large is the potential U.S. patient population for Azitra’s ATR-04 program?

The company states that EGFR inhibitor-associated rash, the indication targeted by its investigational product ATR-04, impacts approximately 150,000 people in the United States.

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

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false 0001701478 0001701478 2026-08-21 2026-08-21 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): August 21, 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 8.01 Other Events.

 

On August 21, 2026, Azitra, Inc. (the “Company”) issued a press release announcing that on August 19, 2026, the Company received a letter from NYSE Regulation confirming that the Company has regained compliance with the continued listing standards of the NYSE American LLC (“NYSE American”). A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

The letter stated that the Company is back in compliance with all of the NYSE American continued listing standards set forth in Part 10 of the NYSE American Company Guide (the “Company Guide”). Specifically, the Company resolved the previously identified deficiencies under Sections 1003(a)(ii) and (iii) of the Company Guide. As a result, the “below compliance” (“.BC”) indicator will be removed from the Company’s trading symbol for its common stock and the Company will be taken off NYSE American’s list of noncompliant issuers on its website. The Company will remain subject to NYSE American’s continued listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward. In accordance with Section 1009(h) of the Company Guide, if the Company is again determined to be below any of the continued listing standards within 12 months of the date of the letter, NYSE American will examine the relationship between the two incidents of noncompliance and re-evaluate the Company’s method of financial recovery from the first incident. NYSE American will then take the appropriate action, which, depending on the circumstances, may include truncating the compliance procedures described Section 1009 of the Company Guide or immediately initiating delisting proceedings.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including but not limited to risks related to NYSE American compliance, clinical development, regulatory approval, and other factors described in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update any forward-looking statements.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits.

 

99.1 Press release dated August 21, 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: August 21, 2026 By: /s/ Francisco D. Salva
    Francisco D. Salva
    Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

Azitra, Inc. Regains Compliance with NYSE American Continued Listing Standards

 

BRANFORD, Conn. – August 21, 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 it has received written notification from NYSE American LLC (“NYSE American”) confirming that the Company has regained compliance with all of the NYSE American continued listing standards set forth in Part 10 of the NYSE American Company Guide.

 

In a letter dated August 19, 2026, NYSE Regulation informed Azitra that the Company has resolved the previously disclosed continued listing deficiencies under Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. As a result, the “below compliance” (“.BC”) indicator will no longer be disseminated, and Azitra will be removed from the list of NYSE American noncompliant issuers on the NYSE American’s website. The Company will remain subject to NYSE Regulation’s continued listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward. In accordance with Section 1009(h) of the NYSE American Company Guide, if the Company is again determined to be below any of the continued listing standards within 12 months of the date of the letter, NYSE American will examine the relationship between the two incidents of noncompliance and re-evaluate the Company’s method of financial recovery from the first incident. NYSE American will then take the appropriate action, which, depending on the circumstances, may include truncating the compliance procedures described Section 1009 of the NYSE American Company Guide or immediately initiating delisting proceedings.

 

“We are pleased to have resolved this matter and regained full compliance with the NYSE American continued listing standards,” said Francisco Salva, Chief Executive Officer of Azitra. “Looking ahead, we remain focused on building momentum across our pipeline and are excited to advance our ATR-COSF and ATR-04 programs as we work to realize the potential of our platform and create value for shareholders.”

 

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: statements regarding the Company’s ability to maintain compliance with NYSE American’s continued listing standards; 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 reports 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

5 documents