Latest news with #EGFRi
Yahoo
28-05-2025
- Business
- Yahoo
Azitra, Inc. Announces Presentation at ASCO 2025 Highlighting Clinical Trial Investigating ATR-04 for EGFRi-Associated Rash
BRANFORD, Conn., May 28, 2025 /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 a poster describing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) being held May 30-June 3, 2025 in Chicago. The presentation titled, "Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound," will highlight Azitra's multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical trial investigating the safety and tolerability of ATR04-484 for the treatment of EGFRi-induced dermal toxicity in adult patients. ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484. Azitra has received Fast Track designation from the FDA for EGFRi-associated rash. Multiple cancers, including non-small cell lung cancer (NSCLC) and colorectal cancer, are treated with EGFRi therapies that work by blocking the activity of the EGFR protein, which plays a crucial role in cell growth and survival. However, EGFRis are also associated with unique dermatologic toxicities that can hamper treatment efforts and cause significant physical and psychological discomfort for patients, leading some to reduce or even stop these effective treatments. "We believe topical ATR04-484 has the potential to be an important advance in the treatment of EGFRi-associated skin rash, which is a painful and debilitating condition that often leads patients to suspend use of these life-saving cancer therapies," said Mary Spellman MD, CMO of Azitra. "As we prepare to dose the first patient in the Phase 1/2 clinical trial of ATR04-484, we are excited to present an overview of the study at ASCO 2025, which is the preeminent global oncology meeting. The product represents a unique and novel method for treating EGFRi-associated skin toxicities, and we look forward to presenting this technology to leaders in the cancer research community." Details of the presentation are as follows: Event: 2025 American Society of Clinical Oncology Annual Meeting Location: McCormick Place, Chicago, IL Track: Symptom Science and Palliative Care Poster Title: Epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity treated with topical application of a novel Staphylococcus epidermidis compound Presenter: Mary Spellman, MD, Chief Medical Officer Poster Number 162b 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, 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 United States. 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 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 and (iii), the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, 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 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 SEC on February 24, 2025 and our quarterly report on Form 10-Q filed on May13, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman StaskeyChief Financial Officerstaskey@ Investor Relations Tiberend Strategic Advisors, Nugent205-566-3026 jnugent@ Media Relations Tiberend Strategic Advisors, McDonald 646-577-8520 cmcdonald@ View original content to download multimedia: SOURCE Azitra, Inc.
Yahoo
14-05-2025
- Business
- Yahoo
Azitra, Inc. to Present Abstract at American Society of Gene and Cell Therapy Highlighting Phase 1/2 Study Targeting Cancer Therapy-Associated Rash
Azitra plans to dose first patient in a Phase 1/2 trial in the first half of 2025 for its precision dermatology candidate ATR04-484, designed for the treatment of EGFR inhibitor-associated rash BRANFORD, Conn., May 14, 2025 /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 a poster describing the Phase 1/2 clinical trial of ATR04-484 for EGFR inhibitor ("EGFRi")-associated rash at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). ASGCT is being held May 13-17, 2025, in New Orleans, Louisiana. Details of the presentation are as follows: Event: American Society of Gene and Cell Therapy Location: New Orleans Ernest N. Morial Convention Center, New Orleans, Louisiana When: May 15, 2025; 5:30-7:00PM CT Title: A Novel Staphylococcus epidermidis Compound for the Topical Treatment Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Dermal Toxicity Presenter: Mary Spellman, MD, Chief Medical Officer Registration: "The Annual Meeting of ASGCT is an important conference for researchers and industry leaders who are seeking to develop next-generation cell and gene therapies for patients in need," said Mary Spellman, MD, Chief Medical Officer of Azitra. "We are excited to present supporting evidence for the clinical development of topical ATR04-484 and our Phase 1/2 clinical study design, in anticipation of initiating dosing for the first patient in the coming month." 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, 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 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 the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, 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 that 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 SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman StaskeyChief Financial Officerstaskey@ Investor Relations Tiberend Strategic Advisors, Nugent205-566-3026jnugent@ Media Relations Tiberend Strategic Advisors, McDonald 646-577-8520cmcdonald@ View original content to download multimedia: SOURCE Azitra, Inc. Sign in to access your portfolio
Yahoo
13-05-2025
- Business
- Yahoo
Azitra, Inc. Announces Q1 2025 Results and Provides Business Updates
BRANFORD, Conn., May 13, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter ended March 31, 2025, and provided a business update. Q1 2025 and Recent Business Highlights 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 Purchase Agreement for up to $20 Million in Partnership with institutional investor Alumni Capital LP, to fund clinical pipeline Announced closing of two public offerings raising a total of $2.2M "The start of 2025 has been a vital period for Azitra as we build towards key milestones expected by mid-year for 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 expect to provide initial safety data from our Phase 1b trial in the first half of 2025 with topline results expected by year-end 2025. There are no approved treatments for Netherton syndrome, and we believe this novel approach has potential to be life-changing for these patients." Salva continued: "Also by mid-2025, we look forward to dosing the first patient in our Phase 1/2 trial with our ATR-04 program, which contains 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. These severe skin conditions can interfere with cancer treatment efforts, often causing significant physical and psychological discomfort for patients. Given the importance of EGFRi therapies to the cancer industry, Azitra was invited to present an update of our ATR-04 Phase 1/2 trial at ASCO 2025, which is the most prestigious cancer research conference in the world." Salva concluded: "The remainder of 2025 is expected 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 1H 2025: Initial safety data from first set of Netherton syndrome patients in the ATR-12 Phase 1b trial 1H 2025: First patient dosed with for EGFRi-associated rash in a Phase 1/2 trial for ATR-04 YE 2025: Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients Financial Results for the Quarter Ended March 31, 2025 Research and Development (R&D) expenses: R&D expenses for the quarter ended March 31, 2025, were $1.3 million compared to $1.5 million for the comparable period in 2024. General and Administrative (G&A) expenses: G&A expenses for the quarter ended March 31, 2025, were $1.9 million compared to $1.5 million for the comparable period in 2024. Net Loss was $3.1 million for the quarter ended March 31, 2025, compared to $2.9 million for the comparable period in 2024. Cash and cash equivalents: As of March 31, 2025, the Company had cash and cash equivalents of $3.2 million. About 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, 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 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 and (iii), the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, 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 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 SEC on February 24, 2025. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Norman StaskeyChief Financial Officerstaskey@ Investor Relations Tiberend Strategic Advisors, Nugent205-566-3026jnugent@ Media Relations Tiberend Strategic Advisors, McDonald 646-577-8520cmcdonald@ Condensed Statement of Operations(Unaudited) Three months Ended March 31,2025 2024Operating expenses: General and administrative$ 1,850,138 $ 1,488,527Research and development 1,250,1001,472,970Total operating expenses 3,100,2382,961,497 Loss from operations (3,100,238)(2,961,497) Other income (expense): Interest income 37,1647,609Interest expense (1,293)(915)Change in fair value of warrants 14328,255Other expense (4,121)(6,327)Total other income 31,89328,622) Net loss before income taxes (3,068,345)(2,932,875) Income tax expense -- Net loss$ (3,068,345) $ (2,932,875)Net loss attributable to common shareholders$ (3,068,345)(2,932,875)Net loss per Share, basic and diluted$ (0.23) $ (4.32)Weighted average common stock outstanding, basic and diluted 13,171,516678,885 Condensed Balance Sheets(Unaudited) March 31, December 31,2025 2024Assets Current Assets: Cash and cash equivalents$ 3,206,710 $ 4,554,719Other receivables 103,046101,896Prepaid expenses and other current assets 561,798571,675Total current assets$ 3,871,554 $ 5,228,290 Property and equipment, net 621,012653,957Other assets 1,415,3251,476,555Total assets$ 5,907,891 $ 7,358,802 Liabilities, and stockholders' equity Current liabilities: Accounts payable$ 558,924 $ 490,255Current financing lease liability 16,45616,066Current operating lease liability 237,647255,177Accrued expenses 467,394614,359Total current liabilities 1,280,4211,375,857Long-term financing lease liability 5,84310,105Long-term operating lease liability 213,765274,161Warrant liability 238381Total liabilities 1,500,2671,660,504Stockholders' equity Common stock 1,498763Additional paid-in capital 65,040,29663,263,360Accumulated deficit (60,634,170)(57,565,825)Total stockholders' equity 4,407,6245,698,298Total liabilities and stockholders' equity$ 5,907,891 $ 7,358,802 View original content to download multimedia: SOURCE Azitra, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24-04-2025
- Business
- Yahoo
Azitra Announces Share Purchase Agreement for up to $20 Million in Partnership with Alumni Capital to Fund Clinical Pipeline
BRANFORD, Conn., April 24, 2025 /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 share purchase agreement (SPA) with Alumni Capital LP (Alumni), an institutional investor. Azitra anticipates that this partnership will provide Azitra with a flexible source of funding, enabling the Company to progress its pipeline of live biotherapeutic precision products delivered topically to treat rare and severe dermatologic conditions. As Azitra works towards key clinical milestones, the Company anticipates the SPA will allow the Company to minimize dilution while creating and sustaining shareholder value, enabling Azitra to be judicious and plan for the timing and amount of any equity sales, which will be critical as it strategically develops its pipeline focused on Netherton Syndrome, a rare skin disorder and EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Under the terms of the agreement, Azitra has the right to sell, and Alumni has the obligation to purchase up to $20 million worth of common stock and warrants to purchase shares of common stock over a 20-month period at prices that are based on the market price at the time of each sale to Alumni. Azitra, at its sole discretion, controls the timing and amount of all sales of common stock and warrants associated with the SPA, subject to the limitations contained in the SPA. The issuance of the shares of common stock to Alumni is being made pursuant to exemptions from the registration requirements of the federal and state securities laws. Pursuant to the SPA, the Company must register Alumni's resale of the shares of the Company's common stock purchased. The exercise of the warrants will be subject to shareholder approval. 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. For more information, please visit 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 the abstract detailing the Phase 1/2 clinical trial for our ATR-04 program, the initiation of dosing in the Phase 1/2 clinical trial for our ATR-04 program, 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 that, we may not satisfy the conditions required in the SPA to sell shares to Alumni, we may not successfully sell any shares of common stock to Alumni, 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 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@ Investor Relations Tiberend Strategic Advisors, Inc. Jon Nugent 205-566-3026 jnugent@ Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald 646-577-8520 cmcdonald@ View original content to download multimedia: SOURCE Azitra, Inc. Sign in to access your portfolio
Yahoo
04-02-2025
- Business
- Yahoo
Azitra Announces Pricing of $930.0 Thousand Registered Direct Offering of Common Stock
BRANFORD, Conn., Feb. 4, 2025 /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 with certain institutional investor(s) to purchase 3,339,300 shares of common stock at an offering price of $0.2785 per share, in a registered direct offering. The gross proceeds for the offering are expected to be approximately $930.0 thousand before deducting placement agent fees and other offering expenses. This offering is expected to close on February 5, 2025, subject to customary closing conditions. Azitra intends to use the net proceeds of this offering for working capital and general corporate purposes. Maxim Group LLC is acting as sole placement agent in connection with the offering. The offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280648), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2024, as amended, and declared effective on July 8, 2024. The shares may be offered only by means of a prospectus. A prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at When available, copies of the prospectus supplement and accompanying prospectus, relating to the offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at syndicate@ This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 product, ATR-12, is an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome is often fatal in infancy with those living beyond a year having profound lifelong challenges. ATR-12 is being evaluated in a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's next most advanced product, is being developed 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 a Phase 1/2 clinical trial with ATR-04 in patients with EGFRi associated rash. ATR-12 and ATR-04 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 Forward-Looking Statements: This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, 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 use of proceeds from the offering, the expected timing of the presentation of data from the Phase 1b study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical 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 fail to successfully complete our Phase 1b trial for ATR-12; we may experience delays in the initiation of our Phase 1/2 trial for ATR-04; 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 in our Annual Report on Form 10-K, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact: Norman StaskeyChief Financial Officerstaskey@ Tiberend Strategic Advisors, Nugent205-566-3026jnugent@ View original content to download multimedia: SOURCE Azitra, Inc.
