New Risk • May 14
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Shareholders have been substantially diluted in the past year (over 5x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.51m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$22m net loss in 3 years). Announcement • Apr 30
Azitra, Inc. Presents New Preclinical Data For ATR-01 Program For Ichthyosis Vulgaris At ASGCT 2026 Azitra, Inc. 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. 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 Details · Title: An Engineered Human Filaggrin Secreting Staphylococcus epidermidis Strain for the Topical Treatment of Ichthyosis Vulgaris · Presenter: Roger Léger, Ph.D., Vice President of Chemistry, Formulation and Development, Azitra, Inc. · Abstract Number: 2691 · Session: Gene Addition: Non-Viral Vectors · Meeting: ASGCT 2026 Annual Meeting. Announcement • Apr 29
Azitra, Inc., Annual General Meeting, Jun 04, 2026 Azitra, Inc., Annual General Meeting, Jun 04, 2026. Announcement • Mar 20
Azitra, Inc. announced that it expects to receive $10.47 million in funding from Stonepine Capital Management LLC, Nantahala Capital Management, LLC and other investors. Azitra, Inc. announced that it has entered into a securities purchase agreement (the "SPA") with to issue 10,470 Series A convertible non-redeemable preferred stock at a price of $1,000 for gross proceeds of $10,470,000 and Series B Warrants to purchase up to 85,101,201 common shares, Series C Warrants to purchase up to 85,101,201 shares on private placement basis on March 19, 2026. The transaction includes participation from new and existing institutional investors 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. 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 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. ach 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. The company will receive $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. The issuance of the securities is being made pursuant to exemptions from the registration requirements of the federal and state securities laws. New Risk • Mar 20
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.21m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$25m net loss in 3 years). Announcement • Mar 14
Azitra, Inc. Receives Notification of Non-Compliance with Minimum Stockholders' Equity Requirement from NYSE American On March 13, 2026, Azitra, Inc. received notification from the NYSE American LLC stating that the Company is not in compliance with the minimum stockholders' equity requirement of Section 1003(a)(iii) of the NYSE American Company Guide requiring stockholders' equity of $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years. As of December 31, 2025, the Company had stockholders' equity of $3.8 million and has had losses in its five most recent fiscal years ended December 31, 2025. As previously reported, on October 1, 2025, the Company received a letter from the NYSE American stating that the Company 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. The Company submitted the Plan to the NYSE American on October 31, 2025 addressing how the Company intends to regain compliance with these requirements by April 1, 2027. On December 16, 2025, the Company received notice from the NYSE American that it had accepted the Company's plan to regain compliance with the NYSE American's continued listing standards regarding the minimum stockholders' equity requirement of Section 1003(a)(ii) of the Company Guide and granted a plan period through April 1, 2027. The Company now seeks to adhere to the Plan for the purpose of regaining compliance with Section 1003(a)(iii) of the Company Guide by the Plan Period Deadline. During the plan period, the Company must provide quarterly updates to NYSE American staff concurrent with its periodic filings. If the Company does not regain compliance with the NYSE American continued listing standards by the Plan Period Deadline, or if the Company does not make progress consistent with its Plan during the plan period, then the NYSE American may initiate delisting proceedings. The Company may appeal a staff delisting determination in accordance with the NYSE American rules. The Company can provide no assurances that it will be able to make progress with respect to its Plan that the NYSE American will determine to be satisfactory, that it will regain compliance with Section 1003(a)(ii) and Section 1003(a)(iii) of the Company Guide on or before the Plan Period Deadline, or that developments and events occurring subsequent to the Company's formulation of the Plan or its acceptance by the NYSE American, will not adversely affect the Company's ability to make sufficient progress and/or regain compliance with Section 1003(a)(ii) and Section 1003(iii) of the Company Guide on or before the Plan Period Deadline or result in the Company's failure to be in compliance with other NYSE American continued listing standards. New Risk • Mar 02
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Shareholders have been substantially diluted in the past year (378% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.88m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$12m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Announcement • Feb 24
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 Azitra, Inc. 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 (ATR-04-484). ATR-04 is a first-in-class, topically applied live biotherapeutic product candidate designed to treat EGFR inhibitor ("EGFRi")-associated rash. 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-associatedmal 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. 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 EGFRa-associated rash, recognizing the high unmet medical need for the approximately 150,000 patients affected annually in the United States. Announcement • Dec 18
Azitra Receives Notice of Acceptance of the Listing Standards Compliance Plan from NYSE American Azitra, Inc. announced it received a notice from the staff of NYSE American LLC (the “Exchange”) approving Azitra’s plan (the “Plan”) to come into compliance with the Exchange’s continued listing standards under Section 1003(a)(ii) of the NYSE American Company Guide. As previously reported, on October 1, 2025, Azitra received a letter from the NYSE American stating that Azitra 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 Azitra has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years. Azitra must regain compliance with the continued listing standards by April 1, 2027. 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. Announcement • Nov 25
Azitra, Inc. announced that it expects to receive $1.5 million in funding Azitra, Inc. entered into a securities purchase agreement with a single institutional investor for a private placement to issue 4,687,500 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 4,687,500 shares of common stock at an issue price of $0.32 for the proceeds of $1,500,000 on November 24 2025. The warrants will have an exercise price of $0.32 per share, will be exercisable upon shareholder approval and will expire on the five-year anniversary from such date of shareholder approval. The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. The Offering is expected to close on or about November 25, 2025, subject to the satisfaction of customary closing conditions. Announcement • Oct 21
Azitra, Inc. Announces Positive Preclinical Data for ATR-01 Program, Designed to Treat Ichthyosis Vulgaris Azitra, Inc. announced that Cofounder and Chief Operating Officer, Travis Whitfill, PhD, MPH, will present positive preclinical progress for its ATR-01 program, targeting the treatment of ichthyosis vulgaris, a disease caused by missing or abnormal filaggrin levels. The detailed data will be presented virtually to the BIO-Europe®? conference, which is being held in Vienna, Austria, November 3-5, 2025. The ATR-01 program utilizes a strain of S. epidermidis called ATR01-616. The strain has been engineered to secrete a functional unit of the human filaggrin protein. In the data being presented at BIO-Europe, ATR01-616 was found to have a positive pharmacology profile across multiple preclinical models. in vitro models, ATR01-616 secreted functional filaggrin, as measured by keratin binding assays. Together, these data demonstrate positive pharmacological activity biodistribution. In addition to presenting the preclinical progress of ATR-01, Dr. Whitfill will also provide updates on Azitra's two clinical programs, ATR-12 and ATR-04. During the conference, Dr. Whit fill will also conduct one-on-one meetings with registered investors and potential partners. Announcement • Oct 14
Azitra, Inc. has withdrawn its Follow-on Equity Offering in the amount of $9.999999 million. Azitra, Inc. has withdrawn its Follow-on Equity Offering in the amount of $9.999999 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 10,204,081
Price\Range: $0.98
Discount Per Security: $0.0686
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 10,204,081 Announcement • Oct 04
Azitra, Inc. Receives Notice of Non-Compliance from NYSE American On October 1, 2025, Azitra, Inc. received notification from the NYSE American LLC stating that the Company is not in compliance with the minimum stockholders’ equity requirement of Section 1003(a)(ii) of the NYSE American 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. As of June 30, 2025, the Company had stockholders’ equity of $2.2 million and has had losses in three of its four most recent fiscal years ended December 31, 2024. The Company is now subject to the procedures and requirements of Section 1009 of the Company Guide. The Company has until October 31, 2025, to submit a plan (the “Plan”) of actions it has taken or will take to regain compliance with the continued listing standards by April 1, 2027. The Company intends to submit a plan to regain compliance with NYSE American listing standards. If the NYSE American accepts the Plan, the Company will be notified in writing and will be subject to periodic reviews including quarterly monitoring for compliance with the Plan. If the Company does not submit a Plan or if the Plan is not accepted by the NYSE American, delisting proceedings will commence. Additionally, if the Plan is accepted but the Company is not in compliance with the listing standards set forth in the Company Guide by April 1, 2027, or does not make progress consistent with the Plan during the plan period, then delisting proceedings will be initiated as appropriate. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide. The Letter has no immediate effect on the listing or trading of the Company’s common stock on the NYSE American. The Company’s receipt of the Letter from the NYSE American does not affect the Company’s business, operations or reporting requirements with the U.S. Securities and Exchange Commission. Announcement • Aug 30
Azitra, Inc. has filed a Follow-on Equity Offering in the amount of $9.999999 million. Azitra, Inc. has filed a Follow-on Equity Offering in the amount of $9.999999 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 10,204,081
Price\Range: $0.98
Discount Per Security: $0.0686
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 10,204,081 New Risk • Aug 28
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 17% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (208% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.63m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$15m net loss in 2 years). Share price has been volatile over the past 3 months (15% average weekly change). Announcement • Aug 28
Azitra, Inc. Announces First Patient Dosed in Phase 1/2 Trial for ATR-04 Program Targeting Oncology Patients with EGFRi-Associated Rash Azitra, Inc. announced the dosing of the first patient in its Phase 1/2 clinical trial of ATR04-484, a topically applied live biotherapeutic product candidate designed to treat 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. annually. Targeted cancer therapies, like EGFRis, have produced significant treatment advances for patients diagnosed with a variety of tumor types including non-small cell lung cancer (NSCLC) and colorectal cancer, but they are also associated with unique dermatologic toxicities. These side effects can severely hamper treatment efforts, causing significant physical and psychological discomfort for patients. The papulopustular rash is often the earliest and most common dermatologic adverse event of EGFRi treatment and can occur in 50-80% of patients, often impacting quality of life severely enough to interrupt or stop cancer treatment. 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 efficacy signals including severity of disease, pruritus, and pain. The bioavailability of ATR04-484 and pharmacodynamic parameters will also be studied. This clinical study will establish the basis for continued clinical development of ATR04-484. ATR04-484 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 S. 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. New Risk • Aug 26
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Shareholders have been substantially diluted in the past year (208% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.25m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Announcement • Jun 18
Azitra Reports Promising Safety Data from Phase 1B Trial in Netherton Syndrome Azitra, Inc. announced encouraging safety data from the initial clinical trial of its live biotherapeutic candidate, ATR12-351, targeting Netherton syndrome. Netherton syndrome is a rare, autosomal recessive disease that affects the skin, hair, and immune system, often with severe consequences including chronic skin inflammation and dehydration throughout life. The trial is halfway enrolled, as six patients have been dosed with ATR12-351. In this clinical trial, patients with genetically confirmed Netherton syndrome are randomly assigned to receive applications of ATR12-351 on preidentified affected areas on one side of the body, and its vehicle (without ATR12-351) on the opposite side of the body. There have been no reports of severe or serious adverse events in the ongoing clinical trial. Application site reactions have been transient and self-resolving and included mild to moderate localized itch, redness, and a burning sensation with application. Azitra will discuss the Phase 1b trial for ATR12-351 targeting Netherton syndrome, as well as its Phase 1/2 trial for ATR04-484, designed for the treatment of EGFR inhibitor-associated rash, in its presentation at the BIO International Convention in Boston, Massachusetts. A Phase 1b clinical trial is actively recruiting adult Netherton syndrome patients (NCT06137157). Announcement • May 28
Azitra, Inc. Announces Presentation at ASCO 2025 Highlighting Clinical Trial Investigating ATR-04 for EGFRi-Associated Rash Azitra, Inc. 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 Staphylcus 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. Announcement • May 06
Azitra, Inc., Annual General Meeting, Jun 23, 2025 Azitra, Inc., Annual General Meeting, Jun 23, 2025. Announcement • Apr 26
Azitra, Inc. announced that it expects to receive $20 million in funding from Alumni Capital Management Azitra, Inc. announced that it has entered into a share purchase agreement with Alumni Capital LP managed by Alumni Capital Management, pursuant to which it will issue common shares of the company 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 for the gross proceeds of up to $20,000,000 on April 25, 2025. 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. Announcement • Apr 25
Azitra, Inc. to Present ATR-04 Program Update at ASCO 2025 Azitra, Inc. announced that an abstract detailing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30-June 3, 2025 in Chicago. ATR04-484 is in development for EGFRi-associated skin rash, which is associated with the suppression of skin immunity by EGFR inhibitors and subsequent inflammation, often accompanied by elevated levels of IL-36g and S. aureus. Azitra has received Fast Track designation from the FDA for EGFRi associated rash and has initiated a Phase 1/2 clinical study in patients with EGFRi rash with the first patient expected to be dosed in the first half of 2025. EGFR inhibitors are a class of cancer drugs that target and block the activity of the EGFR protein, which plays a crucial role in cell growth and survival. They are primarily used to treat certain types of cancer, including non-small cell lung cancer (NSCLC) and colorectal cancer. Reported Earnings • Feb 25
Full year 2024 earnings: EPS and revenues miss analyst expectations Full year 2024 results: US$2.37 loss per share (improved from US$54.76 loss in FY 2023). Net loss: US$8.97m (loss narrowed 29% from FY 2023). Revenue missed analyst estimates by 6.3%. Earnings per share (EPS) also missed analyst estimates by 16%. Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Announcement • Feb 06
Azitra, Inc. has filed a Follow-on Equity Offering in the amount of $0.929995 million. Azitra, Inc. has filed a Follow-on Equity Offering in the amount of $0.929995 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,339,300
Price\Range: $0.2785
Discount Per Security: $0.019495
Transaction Features: Registered Direct Offering New Risk • Jan 13
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$10m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Shareholders have been substantially diluted in the past year (over 17x increase in shares outstanding). Revenue is less than US$1m (US$98k revenue). Market cap is less than US$10m (US$2.75m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$21m net loss in 3 years). Announcement • Jan 06
Azitra, Inc., Annual General Meeting, Feb 20, 2025 Azitra, Inc., Annual General Meeting, Feb 20, 2025. Reported Earnings • Nov 14
Third quarter 2024 earnings released: US$0.17 loss per share (vs US$4.82 loss in 3Q 2023) Third quarter 2024 results: US$0.17 loss per share (improved from US$4.82 loss in 3Q 2023). Net loss: US$1.01m (loss narrowed 48% from 3Q 2023). Revenue is forecast to grow 87% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Announcement • Oct 10
Azitra, Inc., Annual General Meeting, Nov 20, 2024 Azitra, Inc., Annual General Meeting, Nov 20, 2024. Announcement • Aug 28
Azitra, Inc Announces First Patient Dosed in Phase 1B Trial of ATR-12 for Netherton Syndrome Azitra, Inc. announced that it has initiated dosing the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary and exploratory endpoints assessing efficacy signals and biomarkers. Azitra expects to report interim safety data from the Phase 1b trial in early 2025 with full results anticipated in the second half of 2025. ATR-12 is Azitra's lead candidate, a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of an active subunit of the LEKTI protein to treat Netherton syndrome, a chronic genetic skin disease that can be life threatening. The Phase 1b trial (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in approximately 12 adult patients with Netherton syndrome. Patients will be treated with 109 CFU /g twice daily with ATR-12 or its vehicle control on the contralateral side of the body twice daily for 14 days. The primary objective is to assess the safety and tolerability of topical ATR-12 application. Secondary objectives include evaluating efficacy signals (e.g., investigator and patient global assessments) and skin pharmacokinetics of the LEKTI subunit. Additional exploratory objectives include evaluating pharmacodynamic parameters, biomarkers, anti-LEKTI response, and cytokine responses. Announcement • Aug 23
Azitra, Inc. Receives Study May Proceed Letter from the FDA for IND to Treat Skin Rash from EGFR Inhibitors Azitra, Inc. announced the clearance of an investigational new drug (IND) application to U.S. Food and Drug Administration (FDA) for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi associated dermal toxicity. ATR-04 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFRi-associated skin rash, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often promoted levels of IL-36? and S. aureus. There are approximately 150,000 patients suffering from EGFRi-induced skin toxicity in the United States, representing a >$1 billion market opportunity. Earlier this year, Azitra announced the preclinical data around ATR-04 at the Society for Investigative Dermatology (SID) annual meeting and the Annual Meeting for the American Society of Cell and Gene Therapy, showing significant reductions in IL-36? and methicillin-resistant S. aureus (MRSA) in preclinical models. Following the clearance of the IND, Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients undergoing EGFR inhibitors with dermal toxicity by the end of 2024. Announcement • Aug 21
Azitra, Inc. Announces First Patient Screened and Scheduled to Enroll in Phase 1B Trial of ATR-12 for Netherton Syndrome Azitra, Inc. announced that it has successfully screened the first patient in its Phase 1b clinical trial evaluating ATR-12 for the treatment of Netherton syndrome. The patient is scheduled to initiate treatment by the end of the month. The study is designed to enroll approximately 12 adult patients with twice-daily treatment for 14 days, with primary endpoints focusing on safety and tolerability, and secondary and exploratory endpoints assessing efficacy signals and biomarkers. Azitra expects to report interim safety data from the Phase 1b trial in early 2025 with full results anticipated in the second half of 2025. ATR-12 is Azitra's lead candidate, a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of an active subunit of the LEKTI protein to treat Netherton syndrome, a chronic genetic skin disease that can be life threatening. The Phase 1b trial (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in approximately 12 adult patients with Netherton syndrome. Patients will be treated with 109 CFU /g twice daily with ATR-12 or its vehicle control on the contralateral side of the body twice daily for 14 days. The primary objective is to assess the safety and tolerability of topical ATR-12 application. Secondary objectives include evaluating efficacy signals (e.g., investigator and patient global assessments) and skin pharmacokinetics of the LEKTI subunit. Additional exploratory objectives include evaluating pharmacodynamic parameters, biomarkers, anti-LEKTI response, and cytokine responses. The trial design is supported by compelling preclinical data recently presented at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting. Key findings included: Topical application of ATR-12 in preclinical models reduced IL-36? by 93% compared to skin extracts induced to overexpress IL-36?; ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01); ATR-12 produced higher amounts of LEKTI subunit compared to topical application of LEKTI protein alone (6.0 µg vs. 2.3 µg, respectively, p<0.01) after 24 hours and resulted in deeper skin penetration of LEKTI. Reported Earnings • Aug 13
Second quarter 2024 earnings released: US$2.74 loss per share (vs US$70.87 loss in 2Q 2023) Second quarter 2024 results: US$2.74 loss per share (improved from US$70.87 loss in 2Q 2023). Revenue: US$7.5k (down 96% from 2Q 2023). Net loss: US$2.63m (loss narrowed 48% from 2Q 2023). Revenue is forecast to grow 76% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. New Risk • Jul 26
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (70% average weekly change). Earnings are forecast to decline by an average of 2.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (138% increase in shares outstanding). Revenue is less than US$1m (US$573k revenue). Market cap is less than US$10m (US$1.09m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Announcement • Jul 26
Azitra, Inc. has completed a Follow-on Equity Offering in the amount of $9.9975 million. Azitra, Inc. has completed a Follow-on Equity Offering in the amount of $9.9975 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,665,000
Price\Range: $1.5
Discount Per Security: $0.105
Security Name: Class A Warrants
Security Type: Equity Warrant
Securities Offered: 13,330,000 Reported Earnings • May 12
First quarter 2024 earnings released: US$0.14 loss per share (vs US$3.00 loss in 1Q 2023) First quarter 2024 results: US$0.14 loss per share (improved from US$3.00 loss in 1Q 2023). Net loss: US$2.93m (loss narrowed 7.5% from 1Q 2023). Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the US. Announcement • May 11
Azitra, Inc. Announces Positive Preclinical Data of ATR-12 and Clinical Design in Netherton Syndrome Presented at the ASGCT Annual Meeting Azitra, Inc. announced preclinical data from the Company’s platform and pipeline. The data are being presented on May 10, 2024, in two oral sessions entitled “Engineered Staphylococcus Epidermidis as a Protein Delivery System for Treating Skin Diseases” and “Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR12-351) for Netherton Syndrome” at the American Society of Gene and Cell Therapy (ASGCT) 2024 Annual Meeting in Baltimore, MD. The data in the two oral presentations showcase the preclinical development of ATR-12 and the clinical study design of a Phase 1b study in Netherton syndrome patients. In vitro data show that LEKTI (lympho-epithelial Kazal-type-related inhibitor) protein secreted by ATR-12 has nanomolar inhibition of a key protease that drives Netherton syndrome, kallikrein (KLK) 5 (IC50=26 nM). Additionally, in human ex vivo Netherton syndrome models, ATR-12 supernatant reduces protease activity nearly 7-fold to levels comparable to healthy skin. Furthermore, in ex vivo human skin models, ATR-12 led to a higher amount of LEKTI delivery to the skin compared to topically applied LEKTI alone (6.1 µg/cm2 vs. 2.3 µg/cm2, p=0.008) after 24 hours and resulted in deeper biodistribution of LEKTI. Application of ATR-12 in human skin cell culture reduced IL-36? by 92% compared to skin extracts induced to overexpress IL-36?. Topical application of ATR-12 to in vitro human skin treated with erlotinib reduced IL-36? by 69%. In studies conducted in minipigs with abraded skin, topical application of ATR-12 resulted in 11.9 ng/cm2 of LEKTI on the surface of the skin vs. 2.6 ng/cm2 in the vehicle group at day 14. ATR-12 application was safe and well-tolerated in GLP toxicology studies with minipigs. The oral presentation entitled “Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR-12) for Netherton Syndrome” also provides the study design for an active clinical trial of ATR-12 in Netherton syndrome patients. The Phase 1b study (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in adults (n=12) with Netherton syndrome. Patients will be treated twice daily with 109 CFU /g ATR-12 for 14 days. The primary objective is to assess the safety and tolerability of topical application of ATR-12, and the secondary objectives are to evaluate efficacy signals (e.g., investigator and patient global assessments) and to evaluate the skin pharmacokinetics of LEKTI. Exploratory objectives include the evaluation of pharmacodynamic parameters, including anti-LEKTI response, cytokine responses, biomarkers such as KLK5, KLK7, IL-36?, trypsin-like activity, and chymotrypsin-like activity. Announcement • Apr 23
Azitra, Inc. Announces New Preclinical Data to be Presented at the American Society of Gene and Cell Therapy Meeting Azitra, Inc. announced preclinical data from the company’s platform and pipeline. The data will be presented on May 10, 2024, in two oral sessions entitled Engineered Staphylococcus Epidermidis as a Protein Delivery System for Treating Skin Diseases and Staphylococcus epidermidis Strain Expressing LEKTI-D6 (ATR12-351) for Netherton Syndrome. ATR-12 is an engineered strain of S. epidermidis that expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately one to nine in every 100,000. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients. Azitra has an open IND for a Phase 1b clinical trial in adult patients (NCT06137157). The data in the abstracts released online show that topical application of ATR-12 in preclinical models reduced produced reduced IL-36 by 93% compared to skin extracts induced to overexpress IL-36. Additionally, topical application of ATR-12 significantly reduced protease activity in skin samples compared to a Netherton syndrome model skin (p<0.01). Finally, ATR-12 produced higher amounts of LEKTI compared to topical application of LEKTI protein alone (6.0 µg vs. 2.3 µg, respectively, p<0.01) after 24 hours and resulted in deeper skin penetration of LEKTI. Reported Earnings • Mar 17
Full year 2023 earnings released: US$1.83 loss per share (vs US$12.74 loss in FY 2022) Full year 2023 results: US$1.83 loss per share (improved from US$12.74 loss in FY 2022). Revenue: US$686.0k (up 142% from FY 2022). Net loss: US$12.6m (loss narrowed 6.0% from FY 2022). Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. New Risk • Feb 15
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$6.53m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (31% average weekly change). Revenue is less than US$1m (US$627k revenue). Market cap is less than US$10m (US$6.53m market cap). Announcement • Feb 14
Azitra, Inc. has completed a Follow-on Equity Offering in the amount of $5.0001 million. Azitra, Inc. has completed a Follow-on Equity Offering in the amount of $5.0001 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 16,667,000
Price\Range: $0.3 Announcement • Jan 19
Azitra, Inc. has filed a Follow-on Equity Offering. Azitra, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,000,000
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 3,000,000 Reported Earnings • Nov 17
Third quarter 2023 earnings released: US$0.16 loss per share (vs US$2.95 loss in 3Q 2022) Third quarter 2023 results: US$0.16 loss per share (improved from US$2.95 loss in 3Q 2022). Revenue: US$310.7k (up US$262.2k from 3Q 2022). Net loss: US$1.94m (loss narrowed 38% from 3Q 2022). Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in the US. Reported Earnings • Aug 20
Second quarter 2023 earnings released Second quarter 2023 results: US$2.36 loss per share. Net loss: US$5.07m (flat on 2Q 2022). Announcement • Jul 22
Azitra Adds Barbara Ryan and John Schroer to Its Board of Directors Azitra, Inc. announced the addition of two members to its board of directors, Barbara Ryan and John Schroer. Barbara Ryan is a Board Member of Indivior PLC and MiNK Therapeutics, the CEO of Barbara Ryan Advisors, and a Senior Advisor at Ernst & Young. Previously, Ms. Ryan was a Wall Street research analyst, a Managing Director, and Head of Pharmaceutical Research at Deutsche Bank. She began her career covering the pharmaceutical industry at Bear Stearns. She has been the lead analyst on high-profile transactions and has raised over $1.5 billion for emerging biopharma companies in IPOs, follow-ons, PIPEs, and convertible debt transactions. She has led the IR/PR programs, or served as senior strategic investor relations counsel, to firms including Shire, Cardinal Health, Zoetis, Allergan, and Perrigo Agenus, Radius Health, Rafael Holdings, Centrexion, Esperion, ContraFect, Relypsa, Syndax, Barbara is a member of the Editorial Advisory Board of Pharmaceutical Executivemagazine where she authors a monthly finance column and is a faculty member at the GLG Institute. John Schroer is the chief financial officer at Alumis, where he started in March 2022. Previously, he was chief financial officer at ArsenalBio from February 2021 to February 2022. Prior to that role, Mr. Schroer served as chief financial officer and treasurer at Translate Bio. From January 2014 to April 2018, Mr. Schroer served as a director and sector head -- healthcare at Allianz Global Investors, a global asset management company. From 2009 to December 2013, he served as president and chief investment officer at Schroer Capital, LP, a financial services company that he founded. Mr. Schroer received a B.S. in history and international relations and an MBA from the University of Wisconsin-Madison. Announcement • Jul 13
Azitra, Inc. Appoints Travis Whitfill as Chief Operating Officer Azitra, Inc. announced the appointment of Travis Whitfill as Chief Operating Officer. Whitfill is the cofounder of Azitra and joins from Bios Partners, a venture capital firm focused on investing in early-stage biopharmaceutical companies. Whitfill is a biotech leader and entrepreneur. He cofounded Azitra in 2014 and has served on the company's board of directors since 2014. Previously, he was a partner at Bios Partners, a biotechnology-focused venture capital firm, for nine years. Announcement • Jun 17
Azitra Inc has completed an IPO in the amount of $7.5 million. Azitra Inc has completed an IPO in the amount of $7.5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,500,000
Price\Range: $5
Discount Per Security: $0.375
Transaction Features: Sponsor Backed Offering Board Change • Jun 15
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Director Andrew McClary was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. 
