Azitra, Inc. Announces Pricing of $1.5 Million Private Placement Priced At a Premium To Market Under NYSE Rules

Dow Jones Newswires

BRANFORD, Conn., Nov. 24, 2025 /PRNewswire/ — Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it has entered into a securities purchase agreement with a single institutional investor to purchase 4,687,500 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 4,687,500 shares of common stock, in a private placement priced at a premium to market under NYSE rules (the "Offering"). The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrant is $0.32. The warrants will have an exercise price of $0.32 per share, will be exercisable upon shareholder approval and will expire on the five-year anniversary from such date of shareholder approval.

The gross proceeds to the Company from the Offering are estimated to be approximately $1.5 million before deducting the placement agent's fees and other estimated Offering expenses. The Offering is expected to close on or about November 25, 2025, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the Offering.

The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

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 Company's ability to satisfy closing conditions for the offering, 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: the satisfaction of the conditions to closing of the private placement, the timing of clinical trials and their results as 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; 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 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

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SOURCE Azitra, Inc.

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Azitra, Inc. Announces Q3 2025 Results and Provides Business Updates

Dow Jones Newswires

Azitra

-9.57%

BRANFORD, Conn., Nov. 12, 2025 /PRNewswire/ — 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 September 30, 2025, and provided a business update.

Q3 2025 and Recent Business Highlights

Dosed first patient in Phase 1/2 trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in August 2025
Presented positive preclinical data at BIO-Europe(R) for ATR-01 program, targeting the treatment of ichthyosis vulgaris
Raised $2.8M in gross proceeds through our established equity line of credit with institutional investor Alumni Capital LP

"The third quarter of 2025 was an impactful period for Azitra as we continued to progress our live biotherapeutic programs, including dosing the first patient in our Phase 1/2 trial for ATR-04 targeting oncology patients with EGFRi-associated rash," said Francisco Salva, CEO of Azitra. "This candidate previously received Fast Track designation from the FDA as there is an incredible opportunity to help alleviate a major dermatologic toxicity associated with EGFR inhibitor treatments, which impacts approximately 150,000 people in the U.S. annually. The skin toxicity that can accompany EGFRi treatment often leads to interruption or discontinuation of the treatment, profoundly impacting patients as they seek live-saving care across a variety of cancers."

Mr. Salva added: "In addition, we were thrilled to present positive preclinical data for our ATR-01 program at BIO-Europe. ATR-01 is designed to treat ichthyosis vulgaris, an autosomal semidominant genetic disorder that impacts approximately 1.3 million people in the U.S., with no treatment options beyond symptom management. The disease is caused by missing or abnormal filaggrin levels. Our preclinical data showed production of active, functional filaggrin delivery through human stratum corneum and repair of damage in a skin model of disease."

Mr. Salva continued: "We continue to progress our lead program, ATR-12, targeting the rare, chronic and devastating Netherton syndrome. We are optimistic that this novel approach has potential to be life-changing for these patients, in an area of severe unmet need with no approved treatment options."

Mr. Salva concluded: "The second half of 2025 has already proven to be a positive period for Azitra, and we continue to look forward to showcasing the potential of our three development programs ATR-12, ATR-04, and ATR-01. All three programs were generated from our unique, proprietary platform to deliver engineered proteins using topical live biotherapeutic products."

Financial Results for the Quarter Ended September 30, 2025

Research and Development (R&D) expenses: R&D expenses for the quarter ended September 30, 2025, were $1.2 million compared to $1.0 million for the comparable period in 2024./PRNewswire/ --
General and Administrative (G&A) expenses: G&A expenses for the quarter ended September 30, 2025, were $1.6 million compared to $1.9 million for the comparable period in 2024.
Net Loss was $2.8 million for the quarter ended September 30, 2025, compared to $1.0 million for the comparable period in 2024.
Cash and cash equivalents: As of September 30, 2025, Azitra had cash and cash equivalents of $1.4 million.

About Azitra, Inc.

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: the timing of clinical trials and their results as 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; 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 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

 
                  Condensed Statement of Operations 
                              (Unaudited) 
 
                                    Three months Ended September 30, 
                                  ------------------------------------ 
                                         2025               2024 
                                                       --------------- 
Service revenue -- related 
party                              $               --  $            -- 
                                      ---------------   -------------- 
Total revenue                                      --               -- 
 
Operating expenses: 
General and administrative                  1,588,406        1,913,400 
Research and development                    1,180,078        1,015,807 
                                      ---------------   -------------- 
 Total operating expenses                   2,768,484        2,929,207 
                                      ---------------   -------------- 
 
Loss from operations                      (2,768,484)      (2,929,207) 
 
Other income (expense): 
 Interest income                                4,823           47,389 
 Interest expense                               (372)          (3,851) 
 Change in fair value of 
  warrants                                        133        4,001,469 
 Loss on issuance of common 
  stock                                            --      (2,132,800) 
 Other (expense) income                         (628)            7,509 
                                      ---------------   -------------- 
 Total other income                             3,956        1,919,716 
                                      ---------------   -------------- 
 
Loss before income taxes                  (2,764,528)      (1,009,491) 
 
Income tax expense                                 --               -- 
                                      ---------------   --------------

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Azitra stock soars after positive preclinical data for ichthyosis treatment

Investing.com

Advanced Micro Devices

+0.67%

Bio-Rad Laboratories

-1.16%

Investing.com -- Azitra Inc (NYSE:AZTR) stock surged 42.3% in premarket trading Monday following the announcement of positive preclinical data for its ATR-01 program targeting ichthyosis vulgaris, a skin condition caused by missing or abnormal filaggrin levels.

The clinical stage biopharmaceutical company revealed that its engineered strain of S. epidermidis, ATR01-616, demonstrated encouraging results across multiple preclinical models. The strain, which secretes functional human filaggrin protein, showed positive pharmacology in laboratory tests and effectively delivered filaggrin through the skin barrier in ex vivo human skin models.

According to the company, ATR01-616 significantly reduced transepidermal water loss compared to vehicle control in an ex vivo damaged pig skin model. This suggests potential effectiveness in addressing the underlying pathophysiology of ichthyosis vulgaris, which affects approximately 1.3 million people in the U.S. who currently have limited treatment options beyond symptom management.

"We’re thrilled to announce positive preclinical data for our ATR-01 program during BIO-EUROPE as we advance towards a first-in-human clinical trial in ichthyosis vulgaris," said Francisco Salva, CEO of Azitra. The company plans to provide further updates on this program in 2026, including details about first-in-human studies.

The data will be presented virtually by Azitra’s Cofounder and Chief Operating Officer, Travis Whitfill, at the BIO-Europe conference in Vienna, Austria, taking place November 3-5, 2025. Dr. Whitfill will also provide updates on Azitra’s two clinical programs, ATR-12 and ATR-04, and conduct meetings with registered investors and potential partners during the conference.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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Azitra stock soars after first patient dosed in Phase 1/2 trial

Investing.com

Advanced Micro Devices

+0.67%

Azitra

-9.57%

Investing.com -- Azitra Inc (NYSE:AZTR) stock surged 67% premarket Wednesday after the clinical-stage biopharmaceutical company announced dosing of the first patient in its Phase 1/2 clinical trial of ATR04-484, a treatment candidate for EGFR inhibitor-associated rash.

The company’s topically applied live biotherapeutic product candidate is designed to address a condition that affects approximately 150,000 people annually in the U.S. The treatment has received Fast Track designation from the FDA, highlighting the unmet medical need in this area.

"Dosing the first patient is an important milestone in the advancement of ATR04-484 as a potential treatment for EGFRi associated rash and in the development of our broader ATR-04 technology program," said Francisco Salva, CEO of Azitra.

The multicenter, randomized, double-blind, vehicle-controlled study will evaluate the safety and tolerability of topical ATR04-484 for treating EGFRi-associated dermal toxicity affecting the face of adult patients. The trial will also assess efficacy signals including disease severity, pruritus, and pain.

EGFR inhibitors are targeted cancer therapies used to treat various tumor types including non-small cell lung cancer and colorectal cancer. However, these treatments frequently cause dermatologic side effects, with papulopustular rash occurring in 50-80% of patients. These side effects can be severe enough to interrupt or discontinue cancer treatment.

ATR04-484 is derived from a naturally occurring Staphylococcus epidermidis strain and was selected based on its preclinical profile of reducing IL-36γ and S. aureus levels, both of which are elevated in patients with EGFRi-associated skin rash.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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

Dow Jones Newswires

Azitra

-9.57%

BRANFORD, Conn., Aug. 11, 2025 /PRNewswire/ — 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

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
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
Entered into a purchase agreement for up to $20 million to establish an equitly 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."

Pipeline and Anticipated Milestones

Q3 2025: First patient to be dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04
Q1 2026: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients

Financial Results for the Quarter Ended June 30, 2025

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.
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.
Net Loss was $2.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the comparable period in 2024.
Cash and cash equivalents: As of June 30, 2025, Azitra had cash and cash equivalents of $1.0 million.

About Azitra, Inc.

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 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.

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

 
                  Condensed Statement of Operations 
                              (Unaudited) 
 
                                     Three months Ended June 30, 
                                     ------------------------------- 
                                           2025            2024 
                                     ----------------  ------------- 
Service revenue -- related party      $             -  $       7,500 
                                         ------------   ------------ 
Total revenue                                       -          7,500 
 
Operating expenses: 
General and administrative                  1,469,513      1,549,228 
Research and development                    1,401,839      1,118,552 
                                         ------------   ------------ 
Total operating expenses                    2,871,352      2,667,780 
                                         ------------   ------------ 
 
Loss from operations                      (2,871,352)    (2,660,280) 
 
Other income (expense): 
Interest income                                15,461         16,268 
Interest expense                                (468)        (1,782) 
Change in fair value of warrants                   54          4,272 
Other expense                                (32,688)          9,529 
                                         ------------   ------------ 
Total other income (expense)                 (17,641)         28,287 
                                         ------------   ------------ 
 
Net loss before income taxes              (2,888,993)    (2,631,993) 
 
Income tax expense                                  -              - 
                                         ------------   ------------ 
 
Net loss                              $   (2,888,993)  $ (2,631,993) 
                                         ============   ============ 
Net loss attributable to common