Congenital Ichthyosiform Erythroderma

BRANFORD, Conn., Jan. 15, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the pricing of its previously announced public offering of 4,857,780 shares of common stock at a public offering price of $0.30 per share. The gross proceeds for the offering are expected to be approximately $1.5 million before deducting placement agent fees and other offering expenses. This offering is expected to close on January 16, 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 public 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 preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering has been filed with the SEC and is available on the SEC's website at www.sec.gov. A final 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 www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus, and when filed, the final prospectus supplement and accompanying prospectus, relating to the public 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@maximgrp.com. 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 https://azitrainc.com. 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 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 Staskey Chief Financial Officer staskey@azitrainc.com Tiberend Strategic Advisors, Inc. Jon Nugent 205-566-3026 jnugent@tiberend.com View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-announces-pricing-of-1-5-million-public-offering-of-common-stock-302351310.html SOURCE Azitra, Inc.

Continued Significant Improvement in Skin Appearance Observed in Study Subject’s Disease Classification Improved from “Severe” to “Mild” after 6 Weeks Dosing Treatment area expanded from 20% Body Surface Area to “Whole Body” ASHBURN, Va., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces positive interim clinical data from its ongoing Investigator Pediatric Netherton Syndrome clinical study. The Investigator Pediatric Study continues to demonstrate significant improvement in the skin area treated with QRX003 versus the non-treated area. At the mid-point of the testing period the Investigator’s Global Assessment (IGA) of the skin condition improved from “Severe” at baseline to “Mild” after six weeks of dosing twice a day with QRX003, indicating a very substantial improvement in a short period of testing. As a result of these positive results, the subject is being transitioned to having QRX003 applied to their whole body surface area (BSA) as opposed to the approximately 20% of their BSA that was being tested for the initial 6 weeks. In addition, there have been no adverse events or safety concerns reported to date for this subject, which is consistent with observations from each of Quoin’s ongoing clinical studies in Netherton Syndrome subjects. Quoin CEO, Dr. Michael Myers, said, “Earlier this week we shared positive data from our ongoing open label clinical study in subjects aged 14 years and older and provided photographic evidence of the improvement in that subject’s skin, which is accessible via this link. Today, we are very pleased to announce another positive update from our pediatric study across a number of clinical endpoints for the subject in this study. The significant improvement in the Investigator’s Global Assessment (IGA) from Severe at Baseline to Mild-Moderate after 12 days of dosing, and now to Mild after 6 weeks of dosing is truly remarkable, and we believe that the investigator’s decision to transition the subject to “whole body” treatment is an exciting step forward that will provide even more representative data on the potential safety and efficacy of QRX003 in Netherton Syndrome patients. We look forward to expanding this study to include additional pediatric subjects in other countries, and we believe each of these subjects may have an opportunity to move directly to whole body testing based on the positive nature of the results generated to date. With this study well underway and the adult “whole body” study cleared to proceed by the FDA, we are beginning to assemble what we hope will be very compelling clinical evidence that supports the potential of QRX003 as a safe and effective treatment for Netherton Syndrome patients.” About Netherton Syndrome Netherton Syndrome, a form of Ichthyosis, is a rare hereditary skin disorder caused by a mutation in the SPINK5 gene (serine protease inhibitor, Kazal Type 5) that leads to severe skin barrier defects and recurring infections, as well as a pronounced predisposition to allergies, asthma, and eczema. Patients often suffer from severe dehydration, chronic skin inflammation and stunted growth. Currently, there is no cure for Netherton Syndrome, nor are there any approved therapeutic treatments. About QRX003 QRX003 is a topical lotion formulated with a proprietary delivery technology that contains a broad-spectrum serine protease inhibitor, whose mechanism of action is intended to perform the function of a specific protein called LEKTI. The absence of LEKTI in Netherton patients leads to excessive skin shedding, resulting in a highly porous and compromised skin barrier. QRX003 is designed to promote a more normalized skin-shedding process and the formation of a stronger and more effective skin barrier. For more information about Quoin’s current clinical trials please visit: https://www.nethertonsyndromeclinicaltrials.com/ About Quoin Pharmaceuticals Ltd. Quoin Pharmaceuticals Ltd. is a clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises four products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates. Cautionary Note Regarding Forward Looking Statements The Company cautions that statements in this press release that are not descriptions of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances, such as “expect,” “intend,” “hope,” “plan,” “anticipate,” “look forward,” “believe,” “may,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the belief that the decision to transition the pediatric subject to “whole body” treatment will provide even more representative data on the safety and efficacy of QRX003 as a treatment for Netherton Syndrome; expanding the study to include other pediatric subjects in other countries, the belief that such subjects may may have an opportunity to move directly to whole body testing based on the results generated to date, beginning to assemble what we hope will be very compelling clinical evidence that supports the potential of QRX003 as a safe and effective treatment for Netherton Syndrome patients and Quoin’s products in development collectively having the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Scleroderma, Epidermolysis Bullosa and others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to deliver a safe and effective treatment for Netherton Syndrome; whether its studies successfully generate data that is sufficiently robust and comprehensive to support an NDA filing for QRXOO3 as an approved treatment for Netherton Syndrome; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law. For further information, contact: Quoin Pharmaceuticals Ltd. Michael Myers, Ph.D., CEO mmyers@quoinpharma.com Investor Relations PCG Advisory Jeff Ramson jramson@pcgadvisory.com (646) 863-6341

BRANFORD, Conn., Jan. 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 has commenced a public offering of shares of its common stock (or pre-funded warrants in lieu thereof). All of the shares of common stock (or pre-funded warrants in lieu thereof) to be sold in the proposed offering will be sold by Azitra. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Maxim Group LLC is acting as the sole placement agent for the proposed offering. Azitra intends to use the net proceeds of this offering for working capital and general corporate purposes. The public 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 preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering will be filed with the SEC and are available on the SEC's website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the public 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@maximgrp.com. 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 https://azitrainc.com. 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 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 Staskey Chief Financial Officer staskey@azitrainc.com Tiberend Strategic Advisors, Inc. Jon Nugent 205-566-3026 jnugent@tiberend.com View original content to download multimedia:https://www.prnewswire.com/news-releases/azitra-announces-proposed-public-offering-of-common-stock-302350978.html SOURCE Azitra, Inc.