Core Insights - Azitra, Inc. announced positive preclinical progress for its ATR-01 program targeting ichthyosis vulgaris, a genetic disorder affecting approximately 1.3 million people in the U.S. [1][2] - The ATR-01 program utilizes an engineered strain of S. epidermidis, ATR01-616, which secretes functional filaggrin, showing promising results in preclinical models [2][3] - The company plans to present detailed data at the BIO-Europe conference in November 2025 and aims to submit an IND for ATR-01 in 2026 [1][3] Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [3] - The company also has an advanced program, ATR-04, for treating EGFR inhibitor-associated rash, which has received Fast Track designation from the FDA [3] - Azitra's programs are developed from a proprietary platform of engineered proteins and topical live biotherapeutic products, supported by artificial intelligence and machine learning [3]

Core Viewpoint - Azitra, Inc. has received a notice from NYSE American regarding non-compliance with continued listing standards due to insufficient stockholders' equity, requiring a plan for compliance by October 31, 2025 [1][2]. Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 aimed at treating Netherton syndrome, a rare skin disease [4]. - The company also has an advanced program ATR-04 for treating EGFR inhibitor-associated rash, which has received Fast Track designation from the FDA [4]. Compliance and Future Plans - Azitra plans to submit a compliance plan to the Exchange and is exploring multiple funding avenues to meet the listing requirements [2]. - If the plan is accepted, Azitra will undergo periodic reviews to ensure compliance [2]. Current Status - The notice from the Exchange does not immediately affect the listing or trading of Azitra's common stock and does not impact its business operations or reporting requirements [3].

Core Insights - Azitra, Inc. is a clinical stage biopharmaceutical company focused on innovative therapies for precision dermatology [4] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [3] - Recent updates include promising safety results from the Phase 1b clinical trial of the ATR-12 program for Netherton syndrome and the initiation of the Phase 1/2 trial for the ATR-04 program targeting EGFR inhibitor-associated dermal toxicity [2][4] Company Overview - Azitra's lead program, ATR-12, targets Netherton syndrome, a rare skin disease with no approved treatments, and is currently in a Phase 1b clinical trial [4] - The ATR-04 program addresses EGFR inhibitor-associated rash, which affects approximately 150,000 people in the U.S., and has received Fast Track designation from the FDA [4] - The company utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning for drug discovery [4] Presentation Details - The virtual presentation by Travis Whitfill, Cofounder and COO, is scheduled for 7:00 AM ET on September 8, 2025 [3] - During the conference, one-on-one meetings will be held with registered investors and potential partners to discuss the company's business and clinical development strategy [3]

Core Insights - Azitra, Inc. has initiated the dosing of the first patient in its Phase 1/2 clinical trial for ATR04-484, targeting EGFR inhibitor-associated rash, which affects approximately 150,000 individuals annually in the U.S. [1][5] - The company has received Fast Track designation from the FDA for this treatment, highlighting the critical medical need to address dermatologic toxicities associated with EGFR inhibitor therapies [2][5] Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 aimed at treating Netherton syndrome, a rare skin disease [5] - The ATR-04 program, which includes ATR04-484, is designed to mitigate skin toxicity from EGFR inhibitors, with a Phase 1/2 clinical trial currently underway [5] Clinical Trial Details - The Phase 1/2 clinical study is a multicenter, randomized, double-blind, vehicle-controlled trial aimed at evaluating the safety and tolerability of ATR04-484 for treating EGFRi-associated dermal toxicity [3] - The study will assess key objectives including safety, tolerability, and efficacy signals such as disease severity, pruritus, and pain [3] Product Candidate Information - ATR04-484 is a live biotherapeutic product candidate derived from a naturally occurring Staphylococcus epidermidis strain, engineered for safety and efficacy in reducing IL-36γ and S. aureus levels [4] - The product candidate was selected based on its preclinical profile, which indicates potential benefits for patients suffering from EGFRi-associated skin rash [4]

Core Insights - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, reporting significant progress in its clinical programs for treating major dermatological diseases [1][3]. Q2 2025 and Recent Business Highlights - The first half of 2025 was crucial for Azitra, achieving key milestones in its live biotherapeutic candidates, particularly for ATR-12 targeting Netherton syndrome, with promising safety data reported [3]. - Azitra announced the design of a Phase 1/2 trial for ATR-04, aimed at treating EGFRi-associated rash, which affects approximately 150,000 patients annually in the U.S. [3][8]. - The company expects to begin dosing the first patient in the ATR-04 trial in Q3 2025, indicating a milestone-rich remainder of the year [3]. Pipeline and Anticipated Milestones - Azitra's lead program, ATR-12, is in a Phase 1b clinical trial for Netherton syndrome, a rare skin disease with no approved treatments [5]. - ATR-04 is also in a Phase 1/2 clinical trial for EGFRi-associated skin toxicity, with Fast Track designation from the FDA [5][6]. - Key upcoming milestones include the first patient dosing for ATR-04 in Q3 2025 and topline data for ATR-12 in Q1 2026 [7]. Financial Results for the Quarter Ended June 30, 2025 - Research and Development (R&D) expenses were $1.4 million, up from $1.1 million in the same period of 2024 [7]. - General and Administrative (G&A) expenses remained stable at $1.5 million compared to the previous year [7]. - The net loss for the quarter was $2.9 million, compared to $2.6 million in Q2 2024, with cash and cash equivalents at $1.0 million as of June 30, 2025 [7][12].

Company Overview - Azitra, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [7] - The company's lead program, ATR-12, targets Netherton syndrome, a rare chronic skin disease with no approved treatment options [7] - Azitra's ATR-04 program addresses EGFR inhibitor-associated skin toxicity and has received Fast Track designation from the FDA [7] Reverse Stock Split Announcement - Azitra announced a reverse stock split at a ratio of 1 post-split share for every 6.66 pre-split shares, effective August 21, 2025 [1][2] - The reverse stock split will reduce the number of issued shares from approximately 23,476,354 to about 3,524,978 shares [5] - Stockholders will not need to exchange existing stock certificates, as shares held in brokerage accounts will be automatically adjusted [3][4] Stockholder Impact - The reverse stock split will affect all stockholders uniformly, maintaining their percentage interest in the company's equity, except for fractional shares [4] - Stockholders entitled to fractional shares will receive cash in lieu of those shares, calculated based on the average closing sales prices for the five trading days preceding the effective date [4] Additional Information - Further details regarding the reverse stock split can be found in the definitive proxy statement filed with the SEC on January 14, 2025 [6]

```markdown PART I - FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) Azitra, Inc.'s unaudited condensed financial statements and notes detail financial position and performance for the reported periods [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Balance sheets show decreased cash, assets, and equity from December 2024 to June 2025, reflecting operational losses | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------- | :------------------------ | :------------------ | | Cash and cash equivalents | $1,045,730 | $4,554,719 | | Total current assets | $1,799,690 | $5,228,290 | | Total assets | $3,956,022 | $7,358,802 | | Total current liabilities | $1,452,361 | $1,375,857 | | Total liabilities | $1,727,051 | $1,660,504 | | Total stockholders' equity | $2,228,971 | $5,698,298 | [Condensed Statements of Operations](index=6&type=section&id=Condensed%20Statements%20of%20Operations) No revenue for Q2/H1 2025; increased net losses driven by higher operating expenses, especially R&D | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenue | $— | $7,500 | $— | $7,500 | | General and administrative | $1,469,513 | $1,549,228 | $3,319,651 | $3,037,755 | | Research and development | $1,401,839 | $1,118,552 | $2,651,939 | $2,591,522 | | Total operating expenses | $2,871,352 | $2,667,780 | $5,971,590 | $5,629,277 | | Net loss attributable to common shareholders | $(2,888,993) | $(2,631,993) | $(5,957,338) | $(5,564,868) | | Net loss per share, basic and diluted | $(0.18) | $(2.74) | $(0.40) | $(6.82) | [Condensed Statements of Preferred Stock and Stockholders' Equity](index=7&type=section&id=Condensed%20Statements%20of%20Preferred%20Stock%20and%20Stockholders'%20Equity) Stockholders' equity shows increased common stock and paid-in capital from offerings/ELOC, with a growing accumulated deficit | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Common stock shares issued/outstanding | **17,976,354** | **7,626,056** | | Additional paid-in capital | **$65,750,337** | **$63,263,360** | | Accumulated deficit | **$(63,523,164)** | **$(57,565,825)** | | Total stockholders' equity | **$2,228,971** | **$5,698,298** | - The company completed several follow-on public offerings in January and February **2025**, and drew on an Equity Line of Credit (ELOC) in April **2025**, significantly increasing common stock shares and additional paid-in capital[18](index=18&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) [Condensed Statements of Cash Flows](index=9&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) H1 2025 saw significant cash drain from operations, partially offset by financing, leading to a net decrease in cash | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | **$(5,886,798)** | **$(5,121,955)** | | Net cash used in investing activities | **$(57,973)** | **$(155,826)** | | Net cash provided by financing activities | **$2,435,782** | **$4,284,874** | | Net change in cash and cash equivalents | **$(3,508,989)** | **$(992,907)** | | Cash and cash equivalents at end of period | **$1,045,730** | **$803,082** | [Notes to Unaudited Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes provide detailed disclosures on organization, accounting policies, equity, commitments, and contingencies, offering crucial context [Note 1. Organization and Nature of Operations](index=11&type=section&id=1.%20Organization%20and%20Nature%20of%20Operations) Azitra, Inc. develops skin disease therapeutics; public offerings fund operations, but accumulated deficit raises going concern doubt - Azitra, Inc. is a synthetic biology company focused on screening and genetically engineering microbes of the skin to discover and develop novel therapeutics for skin disease[24](index=24&type=chunk) - The company completed an IPO in June **2023** and multiple follow-on public offerings in February **2024**, July **2024**, January **2025**, and February **2025**, along with an Equity Line of Credit (ELOC) in April **2025**, to raise capital[25](index=25&type=chunk)[27](index=27&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk)[36](index=36&type=chunk) - As of June **30**, **2025**, the company has an accumulated deficit of **$63.5 million**, a loss from operations of **$6.0 million**, and used **$5.9 million** to fund operations, raising substantial doubt about its ability to continue as a going concern[39](index=39&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=12&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Financial statements follow U.S. GAAP, relying on estimates; risks include CRO/CMO dependence and regulatory approvals; evaluating ASU 2024-03 - Financial statements are prepared in accordance with U.S. GAAP, with significant estimates related to research and development expenses, valuation of warrants, and valuation of equity awards[42](index=42&type=chunk)[46](index=46&type=chunk) - The company is dependent on contract research organizations (CROs) and contract manufacturing organizations (CMOs) for clinical trials and product supply, and its products require FDA or international regulatory approvals[48](index=48&type=chunk)[49](index=49&type=chunk) - Azitra, Inc. operates and manages its business as one operating segment, focused on discovering and developing novel therapeutics for skin diseases[51](index=51&type=chunk) - The company is evaluating ASU **2024**-**03**, effective for fiscal years beginning after December **15**, **2026**, which requires more detailed expense disaggregation disclosures[63](index=63&type=chunk) [Note 3. Property and Equipment](index=15&type=section&id=3.%20Property%20and%20Equipment) Net property and equipment decreased from $653,957 (Dec 2024) to $601,504 (June 2025) due to depreciation | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Total property and equipment, net | **$601,504** | **$653,957** | | Depreciation and amortization expense (six months) | **$62,076** | **$59,870** | [Note 4. Intangible Assets](index=15&type=section&id=4.%20Intangible%20Assets) Net intangible assets (patents, trademarks) slightly increased from December 2024 to June 2025, with ongoing amortization | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Intangible assets, net | **$258,665** | **$246,420** | | Amortization expense (six months) | **$6,217** | **$5,082** | [Note 5. Accrued Expenses](index=16&type=section&id=5.%20Accrued%20Expenses) Total accrued expenses decreased from $602,787 (Dec 2024) to $513,166 (June 2025), mainly from reduced payroll and R&D | Accrued Expense Category | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- |\ | Employee payroll and bonuses | **$289,055** | **$410,781** | | Research and development projects | **$55,105** | **$75,047** | | Total accrued expenses | **$513,166** | **$602,787** | [Note 6. Stockholders' Equity](index=16&type=section&id=6.%20Stockholders'%20Equity) Stockholders' equity reflects multiple stock splits and public offerings in 2024-2025, increasing common and authorized shares; further split evaluated - The company effected a **7.1**-for-**1** Forward Stock Split in May **2023** and a **30**-for-**1** Reverse Stock Split in July **2024**, retroactively adjusting share and per share amounts[72](index=72&type=chunk)[75](index=75&type=chunk) - Multiple follow-on public offerings in February **2024**, July **2024**, January **2025**, and February **2025**, along with an Equity Line of Credit (ELOC) in April **2025**, have increased common stock shares and capital[73](index=73&type=chunk)[76](index=76&type=chunk)[80](index=80&type=chunk)[82](index=82&type=chunk)[84](index=84&type=chunk) - In July **2025**, the number of authorized common shares was increased from **100,000,000** to **200,000,000**. A further reverse stock split is being evaluated by the Board[38](index=38&type=chunk)[86](index=86&type=chunk)[90](index=90&type=chunk) [Note 7. Warrants](index=18&type=section&id=7.%20Warrants) Various warrants are outstanding; fair value of liability-classified common stock warrants decreased from $381 (Dec 2024) to $184 (June 2025) - Warrants issued in **2018** with a redemption provision are classified as a liability and marked to market each reporting period[93](index=93&type=chunk) - The company issued Class A Warrants in July **2024** with a reset provision, initially classified as a liability, but reclassified to equity after the exercise price reset[96](index=96&type=chunk)[98](index=98&type=chunk) | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Common stock warrants (liability) | **$184** | **$381** | | Total warrants outstanding | **16,368,593** | **33,014** | [Note 8. Stock Options](index=20&type=section&id=8.%20Stock%20Options) Company operates under 2023 and 2016 Stock Incentive Plans, with 41,608 options outstanding; H1 2025 stock-based compensation was $46,433 - The **2023** Stock Incentive Plan allows for grants of up to **1,211,068** shares, with **1,209,734** shares available for grant as of June **30**, **2025**, after amendments approved in November **2024**[107](index=107&type=chunk) | Metric | June 30, 2025 | | :----------------------------------- | :------------ | | Options outstanding | **41,608** | | Vested and Exercisable | **40,902** | | Stock-based compensation expense (six months) | **$46,433** | [Note 9. Fair Value Measurements](index=21&type=section&id=9.%20Fair%20Value%20Measurements) Fair value of Level 3 common stock warrants decreased from $381 (Dec 2024) to $184 (June 2025), driven by stock value and volatility, using Black-Scholes | Metric | June 30, 2025 | December 31, 2024 | | :----------------------------------- | :------------ | :---------------- | | Common stock warrants (Level 3) | **$184** | **$381** | | Black-Scholes Assumption | June 30, 2025 | December 31, 2024 | | :----------------------- | :------------ | :---------------- | | Underlying common stock value | **$0.26** | **$0.43** | | Expected term (years) | **2.79** | **3.29** | | Expected volatility | **178%** | **172%** | | Risk free interest rate | **4%** | **4%** | | Dividend yield | —% | —% | [Note 10. Net Loss Per Share](index=22&type=section&id=10.%20Net%20Loss%20Per%20Share) Potential common stock equivalents (options, warrants) were excluded from diluted net loss per share due to anti-dilutive effect | Potential Common Stock Equivalents | June 30, 2025 | June 30, 2024 | | :--------------------------------- | :------------ | :------------ | | Options to purchase shares | **41,608** | **41,608** | | Warrants outstanding | **16,368,593** | **33,014** | | Total | **16,410,201** | **74,622** | [Note 11. Commitments and Contingencies](index=22&type=section&id=11.%20Commitments%20and%20Contingencies) Company has commitments for legal, license, and leases; future minimum operating lease payments total $587,638, finance leases $19,217 - The company holds an exclusive license agreement for certain patents and a non-exclusive license for know-how, effective January **26**, **2022**[119](index=119&type=chunk) | Lease Type | Total Future Undiscounted Lease Payments (June 30, 2025) | | :--------- | :------------------------------------------------------- | | Operating | **$587,638** | | Finance | **$19,217** | [Note 12. Retirement Plan](index=23&type=section&id=12.%20Retirement%20Plan) Company sponsors a 401(k) safe harbor plan; H1 2025 employer matching contributions totaled $8,273 - The company sponsors a **401**(k) plan covering substantially all employees, with a safe harbor matching contribution structure[132](index=132&type=chunk) | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :----------------------------------- | :------------------------------- | :----------------------------- | | Total employer matching contributions | **$3,692** | **$8,273** | [Note 13. Concentration of Credit Risk](index=25&type=section&id=13.%20Concentration%20of%20Credit%20Risk) Primary credit risk is concentrated in cash balances held in federally insured U.S. financial institutions, potentially exceeding FDIC limits - The company's significant concentrations of credit risk consist principally of cash and cash equivalents, deposited with a federally insured U.S. financial institution, sometimes in excess of FDIC limits[134](index=134&type=chunk) [Note 14. Related Parties](index=25&type=section&id=14.%20Related%20Parties) No related party revenue for Q2/H1 2025, down from $7,500 in 2024; Bayer ceased being a related party after July 2024 | Metric | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :---------------------- | :------------------------------- | :----------------------------- | | Related party revenue | $— | $— | - Bayer ceased to be considered a related party in July **2024**, as its holdings no longer exceeded **5%** of the total outstanding common stock[136](index=136&type=chunk) [Note 15. Segment Information](index=25&type=section&id=15.%20Segment%20Information) Azitra, Inc. operates as a single segment developing skin disease therapeutics, with fixed assets in the US and Canada - The company operates and manages its business as a single reportable segment, focused on discovering and developing novel therapeutics for treating skin diseases[137](index=137&type=chunk) - As of June **30**, **2025**, the company's fixed assets were located in the United States (**$893,238** original cost) and Canada (**$283,169** original cost)[138](index=138&type=chunk) [Note 16. Subsequent Events](index=25&type=section&id=16.%20Subsequent%20Events) Post-June 30, 2025, authorized shares increased to 200,000,000, with additional common shares and warrants issued under ELOC - In July **2025**, the company amended its Certificate of Incorporation to increase the number of authorized shares from **100,000,000** to **200,000,000**[139](index=139&type=chunk) - Subsequent to June **30**, **2025**, the company issued an additional **5,500,000** common shares and **460,000** warrants under the ELOC, generating estimated gross proceeds of **$888,714**[140](index=140&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Azitra, Inc.'s financial condition, operations, early-stage status, funding, and strategic focus on precision dermatology for the reported periods [Cautionary Statement](index=26&type=section&id=Cautionary%20Statement) This cautionary statement highlights that forward-looking statements involve risks and uncertainties, and future results may differ materially - The report contains forward-looking statements, and actual future results may differ materially due to various risks and uncertainties, including those detailed in the company's Form **10**-K[143](index=143&type=chunk)[144](index=144&type=chunk) [General Overview](index=26&type=section&id=General) Azitra, Inc., formed in 2014, is an early-stage biopharmaceutical company focused on dermatology, funded by private placements, IPO, and public offerings/ELOC - Azitra, Inc. was formed in January **2014** as an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology[145](index=145&type=chunk) - The company has capitalized operations through an IPO in June **2023**, follow-on public offerings in February and July **2024**, and January and February **2025**, and an Equity Line of Credit (ELOC) in April **2025**[146](index=146&type=chunk)[147](index=147&type=chunk) - As of August **11**, **2025**, the company had **23,476,354** shares of common stock issued and outstanding, with a **30**-for-**1** reverse stock split effected on July **1**, **2024**[150](index=150&type=chunk) [Business Overview and Strategy](index=28&type=section&id=Overview) Azitra, Inc. develops precision dermatology therapies using engineered proteins and live biotherapeutics, leveraging a microbial library and AI; strategy focuses on advancing lead programs and partnerships - The company's proprietary platform includes a microbial library of approximately **1,500** unique bacterial strains, augmented by AI and machine learning technology, to develop genetically engineered therapies for dermatology[151](index=151&type=chunk)[156](index=156&type=chunk) - Lead product candidates include ATR-**12** for Netherton syndrome (Phase **1**b clinical trial initiated August **2024**), ATR-**04** for EGFRi-associated rash (IND clearance August **2024**, Fast Track designation September **2024**, Phase **1**/**2** expected Q**3** **2025**), and ATR-**01** for ichthyosis vulgaris (IND-enabling studies planned for **2025**)[152](index=152&type=chunk)[153](index=153&type=chunk) - Strategic goals include building a sustainable precision dermatology company, advancing lead programs through clinical trials, broadening the platform through partnerships, leveraging academic collaborations, and expanding other product candidates[158](index=158&type=chunk)[159](index=159&type=chunk)[160](index=160&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) As an early-stage biopharmaceutical company with no revenue, Azitra, Inc. reported increased net losses for Q2/H1 2025, driven by higher R&D expenses Three Months Ended June 30, 2025 vs. 2024 Financial Highlights Q2 2025 revenue decreased by 100% to $0; operating expenses increased by 8% to $2.87 million (driven by 25% R&D increase), leading to 10% higher net loss of $(2.89) million | Metric | 2025 | 2024 | $ Change | % Change | | :-------------------------- | :------------ | :------------ | :------------ | :------- | | Total revenue | $— | $7,500 | $(7,500) | (100)% | | General and administrative | $1,469,513 | $1,549,228 | $(79,715) | (5)% | | Research and development | $1,401,839 | $1,118,552 | $283,287 | 25% | | Total operating expenses | $2,871,352 | $2,667,780 | $203,572 | 8% | | Net loss | $(2,888,993) | $(2,631,993) | $(257,000) | 10% | - The decrease in service revenue is attributable to a decrease in reimbursable development costs incurred in **2025**, with no further service revenue expected[164](index=164&type=chunk) - R&D expenses increased by **$283,287** (**25%**) due to increased clinical trial costs for ATR-**12** and ATR-**04** programs, and R&D costs for ATR-**01**[167](index=167&type=chunk) Six Months Ended June 30, 2025 vs. 2024 Financial Highlights H1 2025 revenue decreased by 100% to $0; operating expenses increased by 6% to $5.97 million (driven by 9% G&A, 2% R&D), resulting in 7% higher net loss of $(5.96) million | Metric | 2025 | 2024 | $ Change | % Change | | :-------------------------- | :------------ | :------------ | :------------ | :------- | | Total revenue | $— | $7,500 | $(7,500) | (100)% | | General and administrative | $3,319,651 | $3,037,755 | $281,896 | 9% | | Research and development | $2,651,939 | $2,591,522 | $60,417 | 2% | | Total operating expenses | $5,971,590 | $5,629,277 | $342,313 | 6% | | Net loss | $(5,957,338) | $(5,564,868) | $(392,470) | 7% | - General and administrative costs increased by **$281,896** (**9%**) due to higher accounting, business consultant, legal, and public relations fees, partially offset by decreased financing and insurance costs[174](index=174&type=chunk) - Research and development expenses increased by **$60,417** (**2%**) due to increased R&D and clinical trial costs for ATR-**12** and ATR-**01**, and higher payroll and benefits, partially offset by decreased clinical consultant expenditures[177](index=177&type=chunk) - The company is an early-stage clinical biopharmaceutical company with limited operating history and has not commenced revenue-producing operations, focusing primarily on research and development[161](index=161&type=chunk) [Financial Condition and Liquidity](index=34&type=section&id=Financial%20Condition) As of June 30, 2025, Azitra, Inc. had $4.0 million in assets, $0.3 million working capital, and $1.0 million cash, raising substantial doubt about going concern without more financing - As of June **30**, **2025**, the company had total assets of approximately **$4.0 million**, working capital of approximately **$0.3 million**, and **$1.0 million** in cash and cash equivalents[181](index=181&type=chunk) - Management has determined there is substantial doubt about the company's ability to continue as a going concern due to lack of revenue, significant losses, and the need for additional capital[184](index=184&type=chunk) - The company intends to seek additional funds through equity/debt financing, federal grants, licensing fees, and joint ventures, but there is no assurance such funds will be available on reasonable terms[181](index=181&type=chunk)[182](index=182&type=chunk) [Cash Flows Analysis](index=35&type=section&id=Cash%20Flows) H1 2025 cash flows: $5.9 million used in operations, $58,000 in investing, $2.4 million provided by financing, leading to $3.5 million net cash decrease | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(5,886,798) | $(5,121,955) | | Net cash used in investing activities | $(57,973) | $(155,826) | | Net cash provided by financing activities | $2,435,782 | $4,284,874 | | Net decrease in cash | $(3,508,989) | $(992,907) | - Operating activities used **$5.9 million** in cash, primarily driven by the net loss of **$6.0 million**[186](index=186&type=chunk) - Financing activities provided **$2.4 million**, mainly from January and February **2025** public offerings and draws on the equity line of credit[188](index=188&type=chunk) [Critical Accounting Policies and Estimates](index=35&type=section&id=Critical%20Accounting%20Policies) Revenue recognition and common stock fair value are no longer critical policies; no material changes to critical accounting estimates occurred - Revenue recognition and estimating the fair value of common stock are no longer considered critical accounting policies due to the absence of revenue-producing transactions and the company's public trading status[189](index=189&type=chunk) - There were no material changes to the company's critical accounting estimates as reported in its Form **10**-K for the year ended December **31**, **2024**[190](index=190&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No quantitative or qualitative disclosures about market risk are applicable to the company for the reported period - This item is not applicable to the company[191](index=191&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management identified a material weakness in disclosure controls due to inadequate segregation of accounting functions; no material changes to internal control - Management identified a material weakness in disclosure controls and procedures as of June **30**, **2025**, due to a lack of adequate segregation of accounting functions[191](index=191&type=chunk) - The company intends to increase staffing within its accounting infrastructure to address the material weakness[191](index=191&type=chunk) - There were no changes in internal control over financial reporting that materially affected or are reasonably likely to materially affect internal control over financial reporting during the six months ended June **30**, **2025**[192](index=192&type=chunk) PART II - OTHER INFORMATION [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) This section highlights Form 10-K risk factors and introduces a new risk regarding adverse impacts of changes in U.S. and international trade policies - The report contains forward-looking statements, and readers should carefully consider the risk factors discussed in the company's Form **10**-K for the year ended December **31**, **2024**[194](index=194&type=chunk) - A new risk factor highlights that changes in U.S. and international trade policies, such as tariffs, could adversely impact the company's business and operating results, potentially increasing manufacturing costs or affecting raw material imports[195](index=195&type=chunk)[196](index=196&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including corporate governance documents, warrant forms, purchase agreements, and certifications - The exhibits include corporate documents like the Second Amended and Restated Certificate of Incorporation and Bylaws, various warrant forms, and the Purchase Agreement with Alumni Capital LP[197](index=197&type=chunk) - Certifications under Section **302** and Section **906** of the Sarbanes-Oxley Act of **2002** are also filed electronically[197](index=197&type=chunk) SIGNATURES This section contains the duly authorized signatures of Azitra, Inc.'s President/CEO and CFO, affirming the report filing - The report is signed by Francisco D. Salva, President and Chief Executive Officer, and Norman Staskey, Chief Financial Officer, on August **11**, **2025**[201](index=201&type=chunk) ```

Core Insights - Azitra, Inc. announced positive safety data from the Phase 1b clinical trial of its live biotherapeutic candidate ATR12-351, aimed at treating Netherton syndrome, a rare skin condition with no known cure [1][5]. Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on innovative therapies for precision dermatology, with its lead program ATR-12 targeting Netherton syndrome [9]. - The company is also developing ATR-04, which addresses EGFR inhibitor-associated rash, and has received Fast Track designation from the FDA for this program [9]. Clinical Trial Details - The Phase 1b trial of ATR12-351 is designed to evaluate the safety and tolerability of the treatment, which involves applying an engineered strain of S. epidermidis to replace deficient LEKTI protein in patients with genetically confirmed Netherton syndrome [3][6]. - The trial is currently halfway enrolled, with six patients having received the treatment, and no severe adverse events reported thus far [4][8]. Disease Background - Netherton syndrome is a rare, autosomal recessive disease affecting approximately one in every 200,000 persons, characterized by severe skin inflammation and dehydration [2][7]. - The disease is caused by mutations in the SPINK5 gene, leading to a deficiency in the LEKTI protein, which is crucial for skin health [7]. Future Plans - Azitra plans to present findings from the Phase 1b trial of ATR12-351 and the Phase 1/2 trial of ATR04 at the BIO International Convention in Boston on June 17, 2025 [5].

Core Insights - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with a presentation scheduled at the BIO International Convention from June 16-19, 2025, in Boston [1][2] Company Overview - Azitra's lead program, ATR-12, targets Netherton syndrome, a rare skin disease with no approved treatments, currently in a Phase 1b clinical trial [3] - ATR-04, another program, is in development for treating moderate to severe EGFRi-associated dermal toxicity, with Fast Track designation from the FDA [3] - The company utilizes a proprietary platform of engineered proteins and a microbial library of approximately 1,500 bacterial strains, enhanced by AI and machine learning for drug discovery [3] Upcoming Events - The presentation at the BIO International Convention will be on June 17, 2025, at 12:00 PM ET, led by Dr. Travis Whitfill, showcasing the company's clinical development strategy and recent achievements [2]

Core Insights - Azitra, Inc. is presenting a poster on its Phase 1/2 clinical trial of ATR04-484 for treating EGFR inhibitor-associated rash at ASCO 2025 [1][2] - ATR04-484 is a live biotherapeutic product derived from Staphylococcus epidermidis, engineered for safety and efficacy [2][4] - The FDA has granted Fast Track designation for ATR04-484, which addresses a significant dermatologic toxicity affecting approximately 150,000 patients in the U.S. [5] Company Overview - Azitra, Inc. focuses on innovative therapies for precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [5] - The company utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning [5] Clinical Trial Details - The Phase 1/2 trial is multicenter, randomized, double-blind, and vehicle-controlled, assessing the safety and tolerability of ATR04-484 [2][3] - The presentation at ASCO 2025 will be led by Mary Spellman, MD, Chief Medical Officer, and will focus on the treatment of EGFRi-induced dermal toxicity [4]