Clinical Trials and Development Progress - ATR-12 Phase 1b trial advanced with clinical sites activated and initial Netherton syndrome patients identified for dosing, with primary endpoints focusing on safety and tolerability[2] - ATR-04 pre-IND meeting with FDA successfully completed, with IND submission planned for mid-2024 and Phase 1b trial initiation targeted for late 2024[2][3] - ATR-12 preclinical data presented at ASGCT shows superior LEKTI delivery and significant reduction of IL-36g, a pro-inflammatory cytokine implicated in Netherton syndrome[2][3] Financial and Funding Updates - Follow-on public offering completed in February 2024, raising $5.0 million in gross proceeds to support clinical programs[4] - Q1 2024 R&D expenses increased to $1.5 million compared to $0.8 million in Q1 2023[6] - Q1 2024 net loss was $2.9 million, compared to $2.5 million in Q1 2023[6] - Cash and cash equivalents as of March 31, 2024, totaled $3.0 million[6] Market Potential and Intellectual Property - ATR-12 estimated peak sales opportunity is ~$250 million, targeting a global prevalence of 20,000+ Netherton syndrome patients[4] - ATR-04 estimated peak sales opportunity exceeds $1 billion, targeting a U.S. prevalence of ~150,000 EGFRi-associated rash patients[5] - U.S. patent issued for treating skin diseases, including ichthyosis vulgaris, affecting approximately 1.3 million Americans[4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-41705 Azitra, Inc. (Exact name of registrant as specified in its charter) | --- | --- | --- | --- | |----------------- ...

BRANFORD, Conn.--(BUSINESS WIRE)--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ended December 31, 2023, and provided a business update. FY 2023 and Recent Business Highlights Completed an initial public offering, raising $7.5 million in gross proceeds. Obtained IND clearance of ATR-12 for a Phase 1b clinical trial in Netherton syndrome. Completed ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number: 001-41705 Azitra, Inc. (Exact name of registrant as specified in its charter) Delaware 46-4478536 (State or Other Jurisdiction of I ...

```markdown [FY 2023 and Recent Business Highlights](index=1&type=section&id=FY%202023%20and%20Recent%20Business%20Highlights) Azitra achieved significant milestones in 2023-2024, including successful financings and advancing its lead clinical programs - Completed an initial public offering (**IPO**) in 2023 raising **$7.5 million** and a follow-on public offering in February 2024 raising **$5.0 million** in gross proceeds[2](index=2&type=chunk)[3](index=3&type=chunk) - Obtained **IND** clearance for **ATR-12** for a Phase 1b clinical trial in Netherton syndrome and has selected the clinical research organization (**CRO**) and initial clinical sites[2](index=2&type=chunk)[3](index=3&type=chunk) - Advanced the **ATR-04** program for EGFRi-associated rash into **IND**-enabling studies, with plans to submit an **IND** in mid-2024[2](index=2&type=chunk)[3](index=3&type=chunk) - Strengthened its intellectual property portfolio with a new U.S. patent for treating skin diseases, including ichthyosis vulgaris[2](index=2&type=chunk) - Progress was made on the Joint Development Agreement with **Bayer**, with **Bayer** re-affirming its commitment to execute a license agreement[2](index=2&type=chunk)[4](index=4&type=chunk) [Pipeline and Upcoming Milestones](index=2&type=section&id=Pipeline%20and%20Upcoming%20Milestones) Azitra's pipeline features **ATR-12** in Phase 1b for Netherton syndrome and pre-IND **ATR-04**, alongside a **Bayer** collaboration for eczema-prone skin [ATR-12 - Netherton syndrome](index=2&type=section&id=ATR-12%20-%20Netherton%20syndrome) **ATR-12**, targeting Netherton syndrome, is in a Phase 1b trial with initial safety data expected late 2024 and estimated peak sales of **$250 million** - **Clinical Status**: Phase 1b - **Target Indication**: Netherton syndrome, a rare skin disease with no FDA-approved treatments - **Estimated Peak Sales**: **~$250 million**[5](index=5&type=chunk) - **Upcoming Milestones:** - Dosing of the first patient in the 12-patient clinical trial - Publication of preclinical data at major medical meetings in Q2 2024 - Release of initial clinical safety data in late 2024[5](index=5&type=chunk) [ATR-04 - EGFRi-associated rash](index=2&type=section&id=ATR-04%20-%20EGFRi-associated%20rash) **ATR-04**, a pre-IND program for EGFRi-associated rash, plans **IND** submission mid-2024 and targets over **$1 billion** in peak sales - **Clinical Status**: Pre-IND - **Target Indication**: EGFRi-associated rash in cancer patients - **Estimated Peak Sales**: **>$1 Billion**[5](index=5&type=chunk) - **Upcoming Milestones:** - Publication of preclinical data in Q2 2024 - **IND** submission in mid-2024 - Dosing of the first patient in a clinical trial in late 2024 or early 2025[5](index=5&type=chunk) [Bayer Joint Development Agreement](index=2&type=section&id=Bayer%20Joint%20Development%20Agreement) Azitra collaborates with **Bayer** on S. epidermidis for eczema-prone skin, with Azitra handling early research and **Bayer** clinical development - The agreement focuses on the joint development of S. epidermidis strains and products for eczema-prone skin[5](index=5&type=chunk) - Azitra is responsible for early research, with **Bayer** handling clinical development and commercialization[6](index=6&type=chunk) - An upcoming milestone is the execution of a licensing agreement with an upfront payment[6](index=6&type=chunk) [Financial Results for the Year Ended December 31, 2023](index=2&type=section&id=Financial%20Results%20for%20the%20Year%20Ended%20December%2031%2C%202023) Azitra reported a net loss of **$11.3 million** in 2023, with service revenue of **$0.7 million** and decreased R&D expenses [Financial Highlights](index=2&type=section&id=Financial%20Highlights) Azitra's 2023 financial highlights include increased service revenue, decreased R&D expenses, and a net loss of **$11.3 million** Full Year 2023 vs 2022 Financial Summary | Financial Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Service Revenue | $0.7 million | $0.3 million | +$0.4 million | | R&D Expenses | $3.8 million | $6.1 million | -$2.3 million | | G&A Expenses | $4.5 million | $3.6 million | +$0.9 million | | Net Loss | $11.3 million | $10.7 million | +$0.6 million | | Cash and cash equivalents (Year-End) | $1.8 million | N/A | N/A | - Cash and cash equivalents as of December 31, 2023, were **$1.8 million**. This figure does not include approximately **$4.4 million** in net proceeds from a follow-on offering completed on February 15, 2024[7](index=7&type=chunk) [Condensed Consolidated Statement of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) Azitra's 2023 statement of operations shows total operating expenses of **$8.3 million**, a net loss of **$11.3 million**, and improved net loss per share due to increased shares outstanding Condensed Consolidated Statement of Operations (Audited) | (in thousands) | 2023 | 2022 | | :--- | :--- | :--- | | Total revenue | $686 | $284 | | Total operating expenses | $8,302 | $9,738 | | Loss from operations | $(7,616) | $(9,454) | | Total non-operating expenses | $(3,650) | $(1,227) | | **Net loss** | **$(11,284)** | **$(10,680)** | | Net loss attributable to common shareholders | $(12,639) | $(13,449) | | **Net loss per Share, basic and diluted** | **$(1.83)** | **$(12.74)** | | Weighted average common stock outstanding | 6,924,453 | 1,055,399 | [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of December 31, 2023, Azitra's balance sheet shows total assets of **$5.1 million**, total liabilities of **$2.2 million**, and a positive stockholders' equity of **$2.9 million** Condensed Consolidated Balance Sheets (Audited) | (in thousands) | 2023 | 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $1,796 | $3,493 | | Total current assets | $2,536 | $4,136 | | **Total assets** | **$5,115** | **$7,167** | | Total current liabilities | $1,603 | $2,222 | | **Total liabilities** | **$2,202** | **$9,733** | | **Total stockholders' equity (deficit)** | **$2,913** | **$(36,260)** | [About Azitra, Inc. and Forward-Looking Statements](index=2&type=section&id=About%20Azitra%2C%20Inc.%20and%20Forward-Looking%20Statements) Azitra is a clinical biopharmaceutical company focused on precision dermatology, with forward-looking statements subject to inherent risks and uncertainties - Azitra is an early-stage clinical biopharmaceutical company developing therapies for precision dermatology using engineered proteins and topical live biotherapeutic products[8](index=8&type=chunk) - The company's proprietary platform includes a microbial library of approximately 1,500 unique bacterial strains, augmented by artificial intelligence and machine learning[8](index=8&type=chunk) - Forward-looking statements in the report relate to the timing of clinical data, **IND** filings, and the **Bayer** license agreement, and are subject to risks such as trial failure, regulatory delays, and funding challenges[9](index=9&type=chunk)[10](index=10&type=chunk) ```

BRANFORD, Conn.--(BUSINESS WIRE)--Azitra, Inc. (NYSE American: AZTR) (the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the closing of its previously announced public offering of 16,667,000 shares of common stock, at a public offering price of $0.30 per share. Total gross proceeds from the offering, before deducting underwriting discounts and other offering expenses, were approximately $5 million. All of the share ...

Group 1 - Azitra is conducting a public share offering of 16,667,000 shares at a price of 30 cents per share, expecting gross proceeds of $5 million [1] - Underwriters have a 45-day option to acquire an additional 2.5 million shares at the public offering price, with ThinkEquity as the sole book-running manager [1] - The funds raised will be allocated for clinical trials, product development, research and development, clinical manufacturing, working capital, and other general corporate purposes [1] Group 2 - The public stock offering increases the total number of AZTR shares available, leading to dilution of current shareholders' stakes, contributing to the stock's decline [2] - The offering price represents a significant discount compared to the previous closing price of 87 cents, further impacting the stock negatively [2] - AZTR stock has experienced heavy trading, with over 1.5 million shares changing hands, significantly above the daily average of about 39,000 shares [2] - As of Wednesday morning, AZTR stock is down 69.5% [2]

Core Viewpoint - Azitra, Inc. has announced a public offering of 16,667,000 shares of common stock at a price of $0.30 per share, aiming to raise approximately $5 million for clinical trials, product development, and general corporate purposes [1][2]. Group 1: Offering Details - The public offering is priced at $0.30 per share, with gross proceeds expected to be around $5 million before deductions [1]. - Azitra has granted underwriters a 45-day option to purchase an additional 2,500,000 shares to cover over-allotments at the public offering price [1]. - The offering is expected to close on February 16, 2024, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for clinical trials, product development, research and development, clinical manufacturing, and working capital [1]. Group 3: Company Overview - Azitra, Inc. is a clinical-stage biopharmaceutical company focused on precision dermatology, utilizing engineered proteins and topical live biotherapeutic products [4]. - The company has developed a proprietary platform that includes a microbial library of approximately 1,500 unique bacterial strains, enhanced by AI and machine learning technologies [4].

BRANFORD, Conn.--(BUSINESS WIRE)--Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent No. 11,850,267 covering future potential pipeline candidates for indications including ichthyosis vulgaris, titled “Methods and compositions for treating skin disease with recombinant microorganisms.” Travis Whitfill, Azitra’s COO, co-fo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-41705 Azitra, Inc. (Exact name of registrant as specified in its charter) Delaware 46-4478536 (State or other juri ...