US Market News
20時間前
Azitra Announces Adjournment of 2026 Annual Meeting and Information for Reconvened MeetingJune 4, 2026 4:05 PM
PR Newswire (US) BRANFORD, Conn., June 4, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced its 2026 Annual Meeting, originally scheduled for and convened on June 4, 2026, has been adjourned until June 15, 2026, at 11:00 a.m. Eastern Time, because the Company did not have a sufficient number of shares of the Company's common stock present virtually or represented by proxy at the 2026 Annual Meeting to constitute a quorum and to provide stockholders additional time to review the proxy materials and vote at the 2026 Annual Meeting on the proposals outlined below and described in the Company's definitive proxy statement for the 2026 Annual Meeting filed with the U.S. Securities and Exchange Commission (the "SEC") on May 8, 2026 (the "Annual Meeting Proxy Statement"). A quorum would have been present if shares representing 33 1/3% of the common stock outstanding and entitled to vote were present at the 2026 Annual Meeting virtually or represented by proxy. At the time the 2026 Annual Meeting was adjourned, proxies had been submitted by stockholders representing approximately 17% of the outstanding shares of stock entitled to vote, so a quorum did not exist.The 2026 Annual Meeting will be reconvened on June 15, 2026, at 11:00 a.m. Eastern Time and will continue to be held in a virtual format. Stockholders will be able to listen and participate in the virtual annual meeting, as well as vote and submit questions during the live webcast of the meeting by visiting www.proxydocs.com/AZTR and entering the control number included in their proxy card.Stockholders of record at the close of business on April 24, 2026, which was the record date for the original 2026 annual meeting, will be entitled to attend and vote at the annual meeting. The Board of Directors and management of the Company request that stockholders as of the record date consider and submit their proxies as soon as possible on the meeting proposals, but no later than June 15, 2026, at 10:59 a.m. Eastern Time. The Board of Directors and management of the Company likewise request that beneficial owners contact their bank or broker to ensure that they have provided voting instructions.Stockholders who have previously submitted their proxy and who do not want to change their vote need not take any action.As described in the Annual Meeting Proxy Statement, prior to the Reconvened Annual Meeting, stockholders may use one of the following simple methods to vote their shares or change their previously submitted vote no later than June 15, 2026, at 10:59 a.m. Eastern Time with respect to the proposals:By mail. Complete and mail the proxy card in the postage prepaid envelope. If you return your signed proxy card to us before the Reconvened Annual Meeting, we will vote your shares as you direct. If you sign the proxy card but do not specify how you want your eligible shares voted, they will be voted as recommended by our Board.Over the Internet. To submit a proxy to vote your shares through the Internet, go to www.proxypush.com/AZTR to complete an electronic proxy card. You will be asked to provide the control number from the proxy card delivered to you.By telephone. To submit a proxy to vote your shares telephonically, please call the toll-free number listed on your proxy card and follow the instructions provided. Votes must be received by 10:59 a.m. Eastern Time on June 15, 2026, to be counted. After this time, votes can only be cast during the Reconvened Annual Meeting on June 15, 2026, at 11:00 a.m. Eastern Time at www.proxydocs.com/AZTR.About AzitraAzitra, 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. Azitra is also developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market. The new initiative is the first amongst others, which aims to leverage Azitra's microbial genetic engineering platform to manufacture innovative proteins and peptides for the cosmetic and research markets. For more information, please visit https://azitrainc.com. Forward-Looking StatementsThis press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as "believe," "can," "could," "design," "estimate," "expect," "intend," "may," "might," "objective," "plan," "potential," "predict," "should," "will," "would," or the negative of these terms and similar expressions intended to identify forward-looking statements. These forward-looking statements include statements related to the meeting proposals, the timing and the outcome of the Reconvened Annual Meeting, matters described above, the parties' expectations and related matters. Azitra cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially and adversely from those expressed in, or implied by, these forward-looking statements, including, but not limited to, the timing of the Reconvened Annual Meeting. These and other risks and uncertainties are described more fully in the sections titled "Risk Factors" and "Cautionary Notice" in the Company's annual report on Form 10-K, quarterly reports on Form 10-Q and other reports filed with the SEC. Forward-looking statements reflect the Company's analysis only on their stated date, and Azitra undertakes no obligation to update or revise these statements except as may be required by law.Additional Information and Where to Find ItIn connection with the solicitation of proxies, on May 8, 2026, Azitra filed the 2026 Annual Meeting Proxy Statement with the SEC with respect to the 2026 Annual Meeting. Promptly after filing the 2026 Annual Meeting Proxy Statement with the SEC, Azitra mailed the 2026 Annual Meeting Proxy Statement and a proxy card to each stockholder entitled to vote at the 2026 Annual Meeting to consider the proposals. STOCKHOLDERS ARE URGED TO READ THE 2026 ANNUAL MEETING PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT AZITRA HAS FILED OR WILL FILE WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders may obtain, free of charge, the 2026 Annual Meeting Proxy Statement, any amendments or supplements thereto, and any other relevant documents filed by Azitra with the SEC in connection with the proposals at the SEC's website (http://www.sec.gov) or at the Company's investor relations website (https://ir.azitrainc.com/financial-information/sec-filings). The information provided on, or accessible through, our website is not part of this communication, and therefore is not incorporated herein by reference.Contact:Norman Staskey
Chief Financial Officer
staskey@azitrainc.comInvestor 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 View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-announces-adjournment-of-2026-annual-meeting-and-information-for-reconvened-meeting-302791937.htmlSOURCE Azitra, Inc. Original: Azitra Announces Adjournment of 2026 Annual Meeting and Information for Reconvened Meeting
US Market News
1週前
Azitra Announces Intention to Adjourn Annual Meeting and Reconvene Annual MeetingMay 27, 2026 4:30 PM
PR Newswire (US) BRANFORD, Conn., May 27, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it intends to convene its upcoming 2026 annual meeting of stockholders (the "2026 Annual Meeting") scheduled for June 4, 2026 at 11:00 a.m., Eastern Time, and then immediately adjourn proceedings, without conducting any other business. Azitra intends to reconvene the 2026 Annual Meeting on June 15, 2026 at 11:00 a.m., Eastern Time (the "Reconvened 2026 Annual Meeting"). The Company has determined to adjourn the 2026 Annual Meeting to allow additional time for stockholders to receive and submit their proxy materials, as a result of a minor administrative delay in mailing. The Reconvened 2026 Annual Meeting will continue to be held in a virtual format. Stockholders will be able to listen and participate in the virtual annual meeting, as well as vote and submit questions during the live webcast of the meeting by visiting www.proxydocs.com/AZTR and entering the control number included in their proxy card. The proposals at the Reconvened 2026 Annual Meeting will be the same as those at the 2026 Annual Meeting.Azitra encourages eligible stockholders as of the record date of April 24, 2026, who have not yet voted their shares on the meeting proposals, or are uncertain if their shares have been voted on, to contact their broker or bank to vote their shares. The Board of Directors and management of the Company request that these stockholders consider and vote their proxies as soon as possible on the meeting proposals, but no later than June 15, 2026, at 10:59 a.m. Eastern Time.Stockholders who have previously submitted their proxy and who do not want to change their vote need not take any action.As described in the 2026 Annual Meeting Proxy Statement, stockholders may use one of the following simple methods to, prior to the Reconvened 2026 Annual Meeting, vote their shares, or change their previously submitted vote, no later than June 15, 2026, at 10:59 a.m. Eastern Time with respect to the proposals:By mail. Complete and mail the proxy card in the postage prepaid envelope. If you return your signed proxy card to us before the Reconvened 2026 Annual Meeting, we will vote your shares as you direct. If you sign the proxy card but do not specify how you want your eligible shares voted, they will be voted as recommended by our Board.Over the Internet. To submit a proxy to vote your shares through the Internet, go to www.proxypush.com/AZTR to complete an electronic proxy card. You will be asked to provide the control number from the proxy card delivered to you.By telephone. To submit a proxy to vote your shares telephonically, please call the toll-free number listed on your proxy card and follow the instructions provided.Votes must be received by 10:59 a.m. Eastern Time on June 15, 2026, to be counted. After this time, votes can only be cast during the Reconvened 2026 Annual Meeting on June 15, 2026, at 11:00 a.m. Eastern Time at www.proxydocs.com/AZTR.About AzitraAzitra, 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. Azitra is also developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market. The new initiative is the first amongst others, which aims to leverage Azitra's microbial genetic engineering platform to manufacture innovative proteins and peptides for the cosmetic and research markets. For more information, please visit https://azitrainc.com.Forward-Looking StatementsThis press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as "believe," "can," "could," "design," "estimate," "expect," "intend," "may," "might," "objective," "plan," "potential," "predict," "should," "will," "would," or the negative of these terms and similar expressions intended to identify forward-looking statements. These forward-looking statements include statements related to the meeting proposals, the timing and the outcome of the Reconvened 2026 Annual Meeting, matters described above, the parties' expectations and related matters. Azitra cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially and adversely from those expressed in, or implied by, these forward-looking statements, including, but not limited to, the timing of the Reconvened 2026 Annual Meeting. These and other risks and uncertainties are described more fully in the sections titled "Risk Factors" and "Cautionary Notice" in the Company's annual report on Form 10-K, quarterly reports on Form 10-Q and other reports filed with the SEC. Forward-looking statements reflect the Company's analysis only on their stated date, and Azitra undertakes no obligation to update or revise these statements except as may be required by law.Additional Information and Where to Find ItIn connection with the solicitation of proxies, on May 8, 2026, Azitra filed the 2026 Annual Meeting Proxy Statement with the SEC with respect to the 2026 Annual Meeting. Promptly after filing the 2026 Annual Meeting Proxy Statement with the SEC, Azitra mailed the 2026 Annual Meeting Proxy Statement and a proxy card to each stockholder entitled to vote at the 2026 Annual Meeting to consider the proposals. STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT AZITRA HAS FILED OR WILL FILE WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders may obtain, free of charge, the 2026 Annual Meeting Proxy Statement, any amendments or supplements thereto, and any other relevant documents filed by Azitra with the SEC in connection with the proposals at the SEC's website (http://www.sec.gov) or at the Company's investor relations website (https://ir.azitrainc.com/financial-information/sec-filings). The information provided on, or accessible through, our website is not part of this communication, and therefore is not incorporated herein by reference.ContactNorman Staskey
Chief Financial Officer
staskey@azitrainc.comInvestor Relations
Tiberend Strategic Advisors, Inc.
Jon Nugent
205-566-3026
jnugent@tiberend.comMedia Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520 View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-announces-intention-to-adjourn-annual-meeting-and-reconvene-annual-meeting-302783478.htmlSOURCE Azitra, Inc. Original: Azitra Announces Intention to Adjourn Annual Meeting and Reconvene Annual Meeting
US Market News
1月前
Azitra, Inc. Announces Poster Presentation at ASGCT 2026 Highlighting ATR-01 Program for Ichthyosis VulgarisApril 28, 2026 8:02 AM
PR Newswire (US)
Preclinical data demonstrate ATR-01 delivers functional filaggrin, restoring skin barrier integrity and supporting advancement toward first-in-human studiesBRANFORD, Conn., April 28, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the presentation of new preclinical data from its ATR-01 program at the 2026 Annual Meeting of the American Society of Gene & Cell Therapy ("ASGCT 2026").
The poster highlights Azitra's engineered live biotherapeutic candidate ATR01-616, which is designed to treat ichthyosis vulgaris (IV) by delivering recombinant human filaggrin directly into the skin using a modified Staphylococcus epidermidis strain. IV is a common genetic skin disorder caused by filaggrin deficiency, leading to impaired skin barrier function and increased trans-epidermal water loss (TEWL).The data being presented at ASGCT 2026 highlight ATR01-616's mechanism of action and translational potential, including its ability to elicit robust secretion of a recombinant human filaggrin domain, with peak production observed 6–8 hours following application. In an ex vivo pig skin model, ATR01-616 significantly reduced transepidermal water loss across all dose levels (p < 0.001), with levels returning near baseline within 20 hours. In parallel, studies in reconstructed human epidermis showed restoration of key structural features such as increased filaggrin levels and co-localization with keratin proteins, supporting functional integration into the skin barrier."These data provide compelling validation of our ATR-01 program and its potential to address the underlying cause of ichthyosis vulgaris," said Francisco Salva, Chief Executive Officer of Azitra. "By using the skin's natural bacteria to deliver functional filaggrin domains deeper into the epidermis, we are advancing a differentiated approach designed to restore skin barrier function and target the protein to where it is needed to address this genetically driven disease. The findings presented at ASGCT build on our previously reported positive preclinical data for ATR-01 and further support the program's advancement toward IND-enabling studies and a first-in-human clinical trial in patients with ichthyosis vulgaris."ATR01-616 is a topical formulation containing a genetically engineered S. epidermidis strain designed as an auxotroph for controlled growth and optimized to secrete therapeutic filaggrin fragments. This approach enables localized, sustained delivery of protein therapeutics directly to affected skin, potentially overcoming limitations of existing treatments that do not address underlying disease biology and positioning ATR-01 as a novel, microbiome-based modality within dermatology.Poster DetailsTitle: An Engineered Human Filaggrin Secreting Staphylococcus epidermidis Strain for the Topical Treatment of Ichthyosis VulgarisPresenter: Roger Léger, Ph.D., Vice President of Chemistry, Formulation and Development, Azitra, Inc.Abstract Number: 2691Session: Gene Addition: Non-Viral VectorsMeeting: ASGCT 2026 Annual MeetingAbout Azitra, 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, ATR-04, 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. Azitra is also developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market. The new initiative is the first amongst others, which aim to leverage Azitra's microbial genetic engineering platform to manufacture innovative proteins and peptides for the cosmetic and research markets. For more information, please visit https://azitrainc.com.Forward-Looking StatementsThis 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 closing of the private placement, development of the Company's proprietary filaggrin protein and peptide technologies, 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: failure to successfully complete our Phase 1b trial for ATR-12 program; delays in the dosing of our first patient in our Phase 1/2 trial for our ATR-04 program; ineffective product candidates; delays in regulatory approval or changes in regulatory framework outside of our control; inaccurate estimation of addressable markets of our product candidates; failure to timely raise additional required funding; emergence of more efficient competitors or more effective competing treatments; involvement in disputes surrounding the use of our intellectual property crucial to our success; inability to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and dependence 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 27, 2026. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.ContactNorman Staskey
Chief Financial Officer
staskey@azitrainc.comInvestor Relations
Tiberend Strategic Advisors, Inc.
David Irish
231-632-0002
dirish@tiberend.comMedia Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-announces-poster-presentation-at-asgct-2026-highlighting-atr-01-program-for-ichthyosis-vulgaris-302755095.htmlSOURCE Azitra, Inc.
Original: Azitra, Inc. Announces Poster Presentation at ASGCT 2026 Highlighting ATR-01 Program for Ichthyosis Vulgaris
US Market News
3月前
Azitra Announces Pricing of Private Placement Financing of up to Approximately $10.5 Million with up to an Additional Approximately $20.9 MillionMarch 19, 2026 1:13 PM
PR Newswire (US)
Initial funding of approximately $10.5MM in convertible preferred stock and up to an additional $20.9MM upon cash exercise of warrants Financing marks launch of Azitra new innovative protein and peptide research programs for the cosmetic and cosmeceutical marketsLeverages untapped potential of Azitra's genetic engineering platform to accelerate time to commercializationBRANFORD, Conn., March 19, 2026 /PRNewswire/ -- Azitra, Inc. (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 (the "SPA") with new and existing healthcare focused institutional investors. The financing is for gross proceeds of up to approximately $31.4 million to the Company, including initial gross proceeds of approximately $10.5 million and up to an additional $20.9 million in gross proceeds upon the potential cash exercise of accompanying warrants at the election of the investors. The transaction is expected to close on or about March 20, 2026, subject to the satisfaction of customary closing conditions.
Participating investors include institutional healthcare focused funds, Stonepine Capital and Nantahala Capital as well as other institutional funds and individual healthcare professionals, along with certain Company insiders, including the Company's Chief Executive Officer.The financing enables Azitra to utilize its expertise in skin science and leverage its microbial genetic engineering platform to produce high value proteins and peptides for the cosmetic market. The market for biotech oriented cosmetic ingredients reached $2.3 billion in 2024 and is projected to grow to $3.7 billion by 20301. The new initiatives drive near term value creation opportunities by streamlining the time to commercialization and opening up a new universe of new potential strategic partners."Azitra is thrilled to be accelerating its new program focused on developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market," said Chief Executive Officer, Francisco Salva. "We are confident these technologies offer an exciting new way to address the appearance of fine lines and wrinkles as well as dry sensitive skin and eczema-like rashes. Over the last two decades, research has evolved to understand that such issues are not just the result of immune system overdrive but are commonly driven by a physical barrier deficiency caused by a lack of sufficient filaggrin protein and subsequent breakdown into peptides and natural moisturizing factors."Pursuant to the terms of the SPA, the Company is selling to investors in the financing an aggregate of (i) 10,470 shares of Series A convertible non-redeemable preferred stock (the "Series A Preferred Stock"), (ii) Series B warrants (the "Series B Warrants") to purchase up to 85,101,201 shares of the Company's common stock, par value $0.0001 ("Common Stock") and (iii) Series C warrants (the "Series C Warrants") to purchase up to 85,101,201 shares of Common Stock, (the Series B Warrants together with the Series C Warrants, the "Warrants"). Each share of Series A Preferred Stock is being sold together with a Series B Warrant to purchase 8,129 shares of Common Stock and a Series C Warrant to purchase 8,129 shares of Common Stock. The Series A Preferred Stock was sold at a purchase price of $1,000 per share to the investors. The Warrants will each have an exercise price of $0.123 per share, subject to adjustment in certain circumstances. In accordance with the terms of the Warrants, in certain circumstances, pre-funded warrants to purchase shares of Common Stock may be issued upon exercise of the Warrants (the "Pre-Funded Warrants").Each share of Series A Preferred Stock will automatically convert into approximately 8,129 shares of Common Stock upon the approval of the Company's stockholders and subject to certain beneficial ownership limitations set by each holder. Holders will receive Pre-Funded Warrants in lieu of shares of Common Stock upon conversion of the Series A Preferred Stock to avoid going above the beneficial ownership limitation. The Warrants will be exercisable following the receipt of approval by the Company's stockholders. The Series B Warrants will terminate 18 months following the date of stockholder approval. The Series C Warrants will terminate, subject to certain exceptions, upon the 30th calendar day following the date on which the Company publicly announces data from its planned human cosmetic study testing the effect of the filaggrin technology.The issuance of the securities is being made pursuant to exemptions from the registration requirements of the federal and state securities laws. Pursuant to the transaction documents, the Company must register the resale of the shares of common stock issuable upon conversion of the Series A Preferred Stock and exercise of the Warrants.The Company intends to use the initial net proceeds from the financing, together with the Company's existing cash and cash equivalents to provide financing for research and development, general corporate expenses, and working capital needs.This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.About Azitra, 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, ATR-04, 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. Azitra is also developing its proprietary filaggrin protein and peptide technologies for the consumer, cosmeceutical market. The new initiative is the first amongst others, which aim to leverage Azitra's microbial genetic engineering platform to manufacture innovative proteins and peptides for the cosmetic and research markets. For more information, please visit https://azitrainc.com.Forward-Looking StatementsThis 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 closing of the private placement, development of the Company's proprietary filaggrin protein and peptide technologies, 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: conditions to the closing of the private placement, the receipt of stockholder approval, the exercise of the Warrants upon receipt of stockholder approval, we may fail to successfully complete our Phase 1b trial for ATR-12 program; we may experience delays in the dosing of our first patient in our Phase 1/2 trial for our ATR-04 program; 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 27, 2026. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.ContactNorman Staskey
Chief Financial Officer
staskey@azitrainc.comInvestor Relations
Tiberend Strategic Advisors, Inc.
David Irish
231-632-0002
dirish@tiberend.comMedia Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com1 Source: Grand View Research
View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-announces-pricing-of-private-placement-financing-of-up-to-approximately-10-5-million-with-up-to-an-additional-approximately-20-9-million-302719064.htmlSOURCE Azitra, Inc.
Original: Azitra Announces Pricing of Private Placement Financing of up to Approximately $10.5 Million with up to an Additional Approximately $20.9 Million
US Market News
3月前
Azitra Receives Notice of Non-Compliance from NYSE American and Makes NYSE American Section 610(b) Public AnnouncementMarch 13, 2026 5:15 PM
PR Newswire (US)
BRANFORD, Conn., March 13, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced it received a notice from the staff of NYSE American LLC (the "Exchange") that Azitra was not in compliance with the Exchange's continued listing standards under Section 1003(a)(iii) of the NYSE American Company Guide (the "Company Guide"). Section 1003(a)(iii) requires a listed company to have stockholders' equity of $6 million or more if the listed company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. As previously reported, on October 1, 2025, Azitra received a letter from the NYSE American stating that it is not in compliance with the minimum stockholders' equity requirement of Section 1003(a)(ii) of the Company Guide requiring stockholders' equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years.
On October 31, 2025, the Company submitted a plan (the "Plan") to the NYSE American addressing how the Company intends to regain compliance with the requirements under Section 1003(a)(ii) by April 1, 2027, which Plan was accepted on December 16, 2025. In accordance with the notice from the Exchange, Azitra has until April 1, 2027 to regain compliance with the NYSE American's listing standards regarding the minimum stockholders' equity requirements of Section 1003(a)(ii) and Section 1003(a)(iii) of the Company Guide. If Azitra is not in compliance with the continued listing standards by April 1, 2027, or if Azitra does not make progress consistent with the Plan during the plan period, NYSE Regulation staff will initiate delisting proceedings as appropriate.Azitra will continue its listing on NYSE American during the plan period and will be subject to periodic reviews, including quarterly monitoring for compliance with the Plan until it has regained compliance. Azitra is assessing and exploring multiple funding avenues and is committed to achieving compliance with the Exchange's requirements.Receipt of the notice from the Exchange has no immediate effect on the listing or trading of Azitra's common stock on the Exchange, and does not affect Azitra's business, operations or reporting requirements with the U.S. Securities and Exchange Commission (the "SEC").Azitra also advises that as previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2025, filed February 27, 2026, with the SEC, the audited financial statements contained an audit opinion from its independent registered public accounting firm that included a Substantial Doubt Regarding the Company's Ability to Continue as a Going Concern paragraph. This announcement is made pursuant to NYSE American Company Guide Sections 410(h) and 610(b), which requires separate public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company's consolidated financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2025.About AzitraAzitra, 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-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 Azitra's ability to continue operations, Azitra's expectations for compliance with the Plan and applicable Exchange requirements, Azitra locating or acquiring funding in the future, and actions of Azitra and/or the Exchange to be taken with respect to matters discussed in the notices referenced herein.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 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; our actions and/or the Exchange's actions to be taken with respect to matters discussed in the notices from the Exchange; 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 27, 2026. 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.comInvestor Relations
Tiberend Strategic Advisors, Inc.
David Irish
231-632-0002
dirish@tiberend.comMedia Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-receives-notice-of-non-compliance-from-nyse-american-and-makes-nyse-american-section-610b-public-announcement-302713763.htmlSOURCE Azitra, Inc.
Original: Azitra Receives Notice of Non-Compliance from NYSE American and Makes NYSE American Section 610(b) Public Announcement
US Market News
3月前
Azitra, Inc. Announces Full Year 2025 Results and Provides Business UpdatesFebruary 27, 2026 5:30 PM
PR Newswire (US)
BRANFORD, Conn., Feb. 27, 2026 /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 full year ended December 31, 2025, and provided a business update.
FY 2025 and Recent Business HighlightsInitiated Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash; presented ATR-04 trial design and update at ASCO 2025Announced positive preclinical data for ATR-01 program, targeting the treatment of ichthyosis vulgarisReported promising safety data from Phase 1b Trial of ATR12 in Netherton SyndromeCompleted financings of $8.5 million through private placements, follow-on financings and utilization of an equity line of credit."2025 was an exciting year for Azitra as we continued our work to revolutionize the treatment of dermatological diseases with our pipeline of first-in-class, engineered products delivered using topical live biotherapeutics," said Francisco Salva, CEO of Azitra. "A key highlight in 2025 was the progress made in our Phase 1/2 trial for ATR-04 targeting oncology patients with EGFRi-associated rash and the dosing of the trial's first patient. We were thrilled to have the opportunity to present this technology and the trial design to leaders in the field at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, where we received positive feedback and encouraging interest.""ATR-04 has previously been granted Fast Track designation from the FDA, signaling the potential for this candidate to help the approximately 150,000 people in the United States annually who are impacted by major dermatologic toxicities associated with EGFR inhibitor treatments. Though an impactful treatment for various serious cancers, EGFR inhibition can result in adverse skin reactions that can make it difficult for patients to stay on these effective therapies."Mr. Salva added: "For our lead program, ATR-12, we continue to be encouraged by the promising safety data generated thus far in our Phase 1b trial and are optimistic that this candidate has the potential to be a life-changing innovation for people with Netherton syndrome, a rare, autosomal recessive disease, a chronic condition characterized by severe inflammation, pruritus, scaling, red, and dehydrated skin with no known cure and limited treatment options."Mr. Salva continued: "Also in 2025, we presented positive preclinical data for our ATR-01 program targeting ichthyosis vulgaris. Impacting approximately 1.3 million in the United States with no treatment options beyond symptom management, ichthyosis vulgaris, is an autosomal semidominant genetic disorder caused by missing or abnormal filaggrin levels. The condition is characterized by generalized xerosis and fine, white to gray scales that are prominent on the abdomen, chest, and extensor surfaces of the extremities."Mr. Salva concluded: "2026 promises to be an important year for Azitra with several anticipated milestones including topline data for both our Phase 1b study in Netherton Syndrome and the Phase 1/2 study in EGFRi-associated rash. We also look forward to completing IND-enabling studies for ATR-01. We remain excited and optimistic as we work towards these key events, which we believe can help build significant value for our shareholders in 2026, while we progress innovative and potentially transformative treatments for patients with severe and life-altering dermatological conditions."Pipeline Achievements and Upcoming MilestonesATR-12 - Advancing Phase 1b Clinical Trial in Netherton SyndromeIn June 2025, Azitra reported promising safety data with 50% of patients enrolled.ATR12-351, a live precision dermatology therapeutic candidate has been generally safe and well-tolerated with occasional, transient, mild to moderate symptoms at application site to date.Topline data from the Phase 1b trial is anticipated H2 2026.ATR-04 – Addressing an Unmet Need for Cancer Patients in a Multi-billion Dollar Market OpportunityDosed first patient in Phase 1/2 Trial for ATR-04 program targeting oncology patients with EGFRi-associated rash in Q3 2025.Topline data from first cohort of Phase 1/2 trial expected around mid-2026.ATR-01 – Targeting Ichthyosis Vulgaris Which Impacts 1.3 million in the United StatesAnnounced positive preclinical data for ATR-01 program in Q3 2025, demonstrating delivery of active, functional filaggrin through human stratum corneum and repair of damaged model skinIND-enabling studies continue in 2026.Financial Results for the Year Ended December 31, 2025Research and Development (R&D) expenses: R&D expenses for the year ended December 31, 2025, were $4.8 million compared to $4.7 million for the fiscal year 2024.General and Administrative (G&A) expenses: G&A expenses for the year ended December 31, 2025, were $6.2 million compared to $6.3 million for the fiscal year 2024.Net Loss was $11.0 million for the year ended December 31, 2025, compared to $9.0 million for the fiscal year 2024.Cash and cash equivalents: As of December 31, 2025, Azitra had cash and cash equivalents of $2.1 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 StatementsThis 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; we may experience delays in the provision of initial safety data and topline results for ATR-12 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 on February 27, 2026. 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 OperationsAudited
December 31,
2025
2024
Service revenue – related party
$—
$7,500
Total revenue
—
—
Operating expenses:
General and administrative
6,130,657
6,269,262
Research and development
4,836,008
4,723,378
Total operating expenses
10,966,665
10,992,640
Loss from operations
(10,966,665)
(10,985,140)
Other income (expense):
Interest income
70,209
122,553
Interest expense
(7,587)
(12,160)
Change in fair value of warrants
381
4,034,072
Loss on issuance of common stock
—
(2,132,800)
Other income
(43,389)
15,014
Total other income
19,614
2,026,679
Loss before income taxes
(10,947,051)
(8,958,461)
Income tax expense
(8,319)
(9,031)
Net loss
$(10,955,370)
$(8,967,492)
Net loss attributable to common shareholders
$(10,955,370)
$(8,967,492)
Net loss per Share, basic and diluted
$(2.25)
$(15.70)
Weighted average common stock outstanding, basic and diluted
4,873,552
571,162
Condensed Balance SheetsAudited
December 31,
December 31,
2025
2024
Assets
Current Assets:
Cash and cash equivalents
$2,068,083
$4,554,719
Other receivables
141,295
101,896
Prepaid expenses and other current assets
809,949
571,675
Total current assets
$3,019,327
$5,228,290
Property and equipment, net
548,591
653,957
Other assets
1,457,468
1,476,555
Total assets
$5,025,386
$7,358,802
Liabilities, and stockholders' equity
Current liabilities:
Accounts payable
$399,356
$490,255
Current financing lease liability
10,111
16,066
Current operating lease liability
255,776
255,177
Insurance premium financing liability
198,983
—
Accrued expenses
203,740
614,359
Total current liabilities
1,067,966
1,375,857
Long-term financing lease liability
—
10,105
Long-term operating lease liability
156,190
274,161
Warrant liability
—
381
Total liabilities
1,224,156
1,660,504
Stockholders' equity
Common stock
1,074
114
Additional paid-in capital
72,321,352
63264009
Accumulated deficit
(68,521,196)
(57,565,825)
Total stockholders' equity
3,801,230
5,698,298
Total liabilities and stockholders' equity
$5,025,386
$7,358,802
View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-announces-full-year-2025-results-and-provides-business-updates-302699417.htmlSOURCE Azitra, Inc.
Original: Azitra, Inc. Announces Full Year 2025 Results and Provides Business Updates
US Market News
3月前
Azitra, Inc. Announces Addition of MD Anderson Cancer Center as Clinical Site for Phase 1/2 Trial of ATR-04 Targeting EGFRi-Associated Skin RashFebruary 24, 2026 8:00 AM
PR Newswire (US)
MD Anderson Cancer Center expands ATR-04 clinical trial site footprint, offering potential to accelerate enrollment and patient treatment milestonesBRANFORD, Conn., Feb. 24, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the addition of The University of Texas MD Anderson Cancer Center as a clinical site for its ongoing Phase 1/2 clinical trial evaluating ATR-04 (ATR04-484). ATR-04 is a first-in-class, topically applied live biotherapeutic product candidate designed to treat EGFR inhibitor ("EGFRi")-associated rash.
"Expanding our clinical footprint to include MD Anderson Cancer Center, a world-renowned institution, is a significant milestone for the ATR-04 program," said Francisco Salva, CEO of Azitra. "As a leading cancer site that treats thousands of patients a year, oncologists at MD Anderson understand the impact of EGFRi-associated rash, which impacts up to 80% of patients receiving EGFRi therapies. As this major side effect frequently leads to treatment interruptions or discontinuations, the field is in need of innovative solutions like ATR-04, a topically applied product with the potential to help patients stay on their primary cancer treatments. We're glad to be working with the committed staff at MD Anderson, our sixth clinical site, as we aim to accelerate the development of our ATR-04 program."The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical study (NCT06830863) is designed to evaluate the safety and tolerability of topical ATR04-484 for the treatment of EGFRi-associated dermal toxicity affecting the face of adult patients. ATR04-484 or its vehicle (3:1 randomization) will be applied to the face as well as affected areas on the neck, chest, back, and areas around nailbeds. The key objectives of the study will be to assess the safety and tolerability of topical ATR04-484 and to evaluate early efficacy signals. The study is currently enrolling patients for Cohort 1, which is anticipated to enroll a total of eight patients.About ATR04-484ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain in development for EGFRi-associated skin rash. The candidate was selected based on its preclinical profile of reducing IL-36? and Staphylococcus aureus levels, both of which are elevated in patients with EGFRi-associated skin rash. The strain was then engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484. Preclinical data have shown that ATR-04 can reduce levels of IL-36?, a key pro-inflammatory cytokine elevated in these rashes. In addition, ATR-04 has also been shown to inhibit the growth of S. aureus in preclinical studies, which often colonizes the skin of affected patients. The FDA has granted Fast Track designation to ATR-04 for the treatment of EGFRi-associated rash, recognizing the high unmet medical need for the approximately 150,000 patients affected annually in the United States.About AzitraAzitra, 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 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-Looking StatementsThis 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 results for the Phase 1b clinical trial for our ATR-12, (ii) the development for the Phase 1/2 clinical trial for our ATR-04 program and the initiation of dosing and anticipated enrollment in the Phase 1/2 clinical trial for our ATR-04 program, and (iii) statements about our clinical and preclinical programs, including ATR-01, 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 results for ATR-12 and/or ATR-04 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.ContactNorman 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-announces-addition-of-md-anderson-cancer-center-as-clinical-site-for-phase-12-trial-of-atr-04-targeting-egfri-associated-skin-rash-302694951.htmlSOURCE Azitra, Inc.
Original: Azitra, Inc. Announces Addition of MD Anderson Cancer Center as Clinical Site for Phase 1/2 Trial of ATR-04 Targeting EGFRi-Associated Skin Rash
US Market News
3月前
Azitra, Inc. to Present at BIO Investment & Growth SummitFebruary 19, 2026 8:00 AM
PR Newswire (US)
BRANFORD, Conn., Feb. 19, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it will present at the BIO Investment & Growth Summit taking place in Miami Beach, Florida, March 2-3, 2026.
The presentation will highlight recent updates and progress in Azitra's pipeline, including ATR-12, currently in a Phase 1b clinical trial in adult patients with Netherton syndrome; ATR-04, being developed in a Phase 1/2 trial for the treatment of moderate to severe EGFRi-associated dermal toxicity in adults; and ATR-01 targeting ichthyosis vulgaris, which is undergoing IND-enabling studies.Details are as follows:Event:BIO Investment & Growth SummitDate & Time:Monday, March 2, 2026, 2:15 PM ETLocation:Ballroom 2C, Eden Roc Miami Beach HotelPresenter:Travis Whitfill, Chief Operating OfficerRegistration:https://bigs.bio.org/registrationDuring the events, members of Azitra's management team will conduct one-on-one meetings with registered investors and potential partners, showcasing the Company's clinical development strategy, recent corporate achievements, and anticipated milestones.About AzitraAzitra, 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-Looking StatementsThis 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 results for the Phase 1b clinical trial for our ATR-12, (ii) the development for the Phase 1/2 clinical trial for our ATR-04 program and the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, and (iii) statements about our clinical and preclinical programs, including ATR-01, 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 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.ContactNorman Staskey
Chief Financial Officer
staskey@azitrainc.comInvestor Relations
Tiberend Strategic Advisors, Inc.
Jon Nugent
205-566-3026
jnugent@tiberend.comMedia Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-inc-to-present-at-bio-investment--growth-summit-302692104.htmlSOURCE Azitra, Inc.
Original: Azitra, Inc. to Present at BIO Investment & Growth Summit
US Market News
4月前
Azitra Announces Adjournment of Special Meeting and Information for Reconvened Special MeetingFebruary 6, 2026 4:15 PM
PR Newswire (US)
BRANFORD, Conn., Feb. 6, 2026 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced its Special Meeting scheduled for and convened on February 6, 2026, (the "Special Meeting") has been adjourned until March 6, 2026, at 11:00 a.m. Eastern Time (the "Reconvened Special Meeting") for the purpose of soliciting additional votes with respect to the proposals outlined below and described in the Company's definitive proxy statement for the Special Meeting filed with the U.S. Securities and Exchange Commission (the "SEC") on January 2, 2026 (the "Special Meeting Proxy Statement") because a quorum was not present at the Special Meeting.
A quorum would have been present if shares representing 33 1/3% of the common stock outstanding and entitled to vote were present at the Special Meeting virtually or represented by proxy. At the time the Special Meeting was adjourned, proxies had been submitted by stockholders representing approximately 13% of the outstanding shares of stock entitled to vote, so a quorum did not exist.Adjournment of Special MeetingThe Reconvened Special Meeting will be on March 6, 2026, at 11:00 a.m. Eastern Time and will continue to be held in a virtual format. Stockholders will be able to listen and participate in the virtual special meeting, as well as vote and submit questions during the live webcast of the meeting by visiting www.proxydocs.com/AZTR and entering the control number included in their proxy card. The proposals at the Reconvened Special Meeting will be the same as those at the Special Meeting:Proposal One: Approval, for purposes of complying with NYSE American Company Guide Section 713(a) and Section 713(b), of the issuance of more than 19.99% of our issued and outstanding shares of common stock, comprised of shares of common stock underlying warrants, pursuant to the Securities Purchase Agreement with Alumni Capital LP, dated November 24, 2025 (the "Purchase Agreement").Proposal Two: To adjourn the Special Meeting, if necessary, to solicit additional proxies if there are insufficient votes in favor of the foregoing proposal.Azitra encourages eligible stockholders as of the record date of January 2, 2026, who have not yet voted their shares on the meeting proposals, or are uncertain if their shares have been voted on, to contact their broker or bank to vote their shares. The Board of Directors and management of the Company request that these stockholders consider and vote their proxies as soon as possible on the meeting proposals, but no later than March 6, 2026, at 10:59 a.m. Eastern Time.Stockholders who have previously submitted their proxy and who do not want to change their vote need not take any action.As described in the Special Meeting Proxy Statement, stockholders may use one of the following simple methods to, prior to the Adjourned Special meeting, vote their shares, or change their previously submitted vote, no later than March 6, 2026, at 10:59 a.m. Eastern Time with respect to the proposals:By mail. Complete and mail the proxy card in the postage prepaid envelope. If you return your signed proxy card to us before the Reconvened Special Meeting, we will vote your shares as you direct. If you sign the proxy card but do not specify how you want your eligible shares voted, they will be voted as recommended by our Board.Over the Internet. To submit a proxy to vote your shares through the Internet, go to www.proxypush.com/AZTR to complete an electronic proxy card. You will be asked to provide the control number from the proxy card delivered to you.By telephone. To submit a proxy to vote your shares telephonically, please call the toll-free number listed on your proxy card and follow the instructions provided.Votes must be received by 10:59 a.m. Eastern Time on March 6, 2026, to be counted. After this time, votes can only be cast during the Reconvened Special Meeting on March 6, 2026, at 11:00 a.m. Eastern Time at www.proxydocs.com/AZTR.About AzitraAzitra, 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-Looking StatementsThis press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as "believe," "can," "could," "design," "estimate," "expect," "intend," "may," "might," "objective," "plan" "potential," "predict," "should," "will," "would," or the negative of these terms and similar expressions intended to identify forward-looking statements. These forward-looking statements include statements related to the meeting proposals, the timing and the outcome of the Reconvened Special Meeting, matters described above, the parties' expectations and related matters. Azitra cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to certain risks and uncertainties that could cause actual results to differ materially and adversely from those expressed in, or implied by, these forward-looking statements, including, but not limited to, the timing of the Reconvened Special Meeting. These and other risks and uncertainties are described more fully in the sections titled "Risk Factors" and "Cautionary Notice" in the Company's annual report on Form 10-K, quarterly reports on Form 10-Q and other reports filed with the SEC. Forward-looking statements reflect the Company's analysis only on their stated date, and Azitra undertakes no obligation to update or revise these statements except as may be required by law.Additional Information and Where to Find ItIn connection with the solicitation of proxies, on January 2, 2026, Azitra filed the Special Meeting Proxy Statement with the SEC with respect to the Special Meeting. Promptly after filing the Special Meeting Proxy Statement with the SEC, Azitra mailed the Special Meeting Proxy Statement and a proxy card to each stockholder entitled to vote at the Special Meeting to consider the proposals. STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT TRANSCODE HAS FILED OR WILL FILE WITH THE SEC BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders may obtain, free of charge, the Special Meeting Proxy Statement, any amendments or supplements thereto, and any other relevant documents filed by Azitra with the SEC in connection with the proposals at the SEC's website (http://www.sec.gov) or at the Company's investor relations website (https://ir.azitrainc.com/financial-information/sec-filings). The information provided on, or accessible through, our website is not part of this communication, and therefore is not incorporated herein by reference.ContactNorman Staskey
Chief Financial Officer
staskey@azitrainc.comInvestor Relations
Tiberend Strategic Advisors, Inc.
Jon Nugent
205-566-3026
jnugent@tiberend.comMedia Relations
Tiberend Strategic Advisors, Inc.
Casey McDonald
646-577-8520
cmcdonald@tiberend.com
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Original: Azitra Announces Adjournment of Special Meeting and Information for Reconvened Special Meeting