Azitra Inc(AZTR) - 2023 Q4 - Annual Results

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)