Azitra Inc(US:AZTR)2025-11-12 22:00Financial Performance - The company reported a net loss of $2,764,528 for the three months ended September 30, 2025, representing a 174% increase compared to a net loss of $1,009,491 for the same period in 2024 [186]. - Total operating loss of $8,740,074 for the nine months ended September 30, 2025, compared to a loss of $8,550,984 in the prior year, reflecting a 2% increase [195]. - The company has not commenced revenue-producing operations and reported total revenue of $0 for the three months ended September 30, 2025, consistent with the prior year [186]. - The company generated no service revenue during the first nine months of fiscal 2025, a decrease of $7,500 compared to $7,500 in the same period of fiscal 2024 [196]. - Other income decreased by $1,958,417, or 99%, during the first nine months of fiscal 2025 compared to the same period in fiscal 2024 [201]. - Net cash used in operating activities was $8,331,514 for the first nine months of fiscal 2025, compared to $7,597,539 in the prior year [207]. - Financing activities provided $5,277,724 in cash during the first nine months of fiscal 2025, a decrease from $13,325,498 in the prior year [210]. - Management has expressed substantial doubt about the company's ability to continue as a going concern due to significant losses and the need for additional capital [206]. Research and Development - The company has a proprietary microbial library of approximately 1,500 unique bacterial strains, focusing on genetically engineered strains of Staphylococcus epidermidis for dermatologic therapies [168]. - ATR-12, a genetically modified strain for treating Netherton syndrome, received FDA clearance for a Phase 1b clinical trial, with the first patient dosed in August 2024 [175]. - ATR-04, targeting papulopustular rash in cancer patients, received IND clearance in August 2024 and Fast Track designation, with the first patient dosed in Q3 2025 [175]. - The company plans to conduct lead optimization and IND-enabling studies for ATR-01 in 2025, targeting ichthyosis vulgaris, with an estimated patient population of 1.3 million in the U.S. [175]. - Research and development expenses increased by 16% to $1,180,078 for the three months ended September 30, 2025, primarily due to increased clinical trial costs for the ATR-04 program [190]. - Research and development expenses for preclinical and clinical activities were $2,238,518 for the first nine months of fiscal 2025, up from $1,379,317 in the prior year [199]. - The company expects a significant increase in research and development expenses in the future due to planned clinical trial activities and continued development of product candidates [191]. - Research and development expenses increased by $224,688, or 6%, to $3,832,017 for the first nine months of fiscal 2025, driven by clinical trial costs related to the ATR-12 and ATR-04 programs [199]. - The company received IND clearance from the FDA for the ATR-04 program and initiated dosing the first patient in the ATR-04 Phase 1/2 clinical trial in the third quarter of 2025 [184]. - The company is focused on advancing its lead programs, ATR-12 and ATR-04, through clinical trials and exploring strategic partnerships to enhance its precision dermatology platform [184]. Capital and Financing - The company completed its IPO on June 21, 2023, issuing 7,508 shares at a price of $999 per share, converting all outstanding convertible preferred stock and promissory notes into 44,802 shares of common stock [162]. - A follow-on public offering in February 2024 raised $5 million by selling 83,404 shares at $59.94 per share, and another offering on July 25, 2024, raised approximately $10 million by selling 1,000,750 shares at $9.99 per share [162]. - As of November 12, 2025, the company has sold 7,955,823 shares and issued 795,579 warrants to Alumni Capital LP, generating estimated gross proceeds of $6.0 million, with $2.4 million received after September 30, 2025 [166]. - Total assets as of September 30, 2025, were approximately $4.3 million, with working capital of approximately $0.4 million [203]. - Cash and cash equivalents as of September 30, 2025, included approximately $1.4 million, which is insufficient to cover the proposed plan of operations for the next twelve months [203]. Compliance and Regulatory - The company received a deficiency letter from NYSE American on October 1, 2025, indicating non-compliance with continued listing standards due to stockholders' equity being below $4.0 million [177]. - General and administrative expenses decreased by 1% to $4,908,057 for the nine months ended September 30, 2025, from $4,951,155 in the prior year [195]. - General and administrative costs decreased by $43,098, or 1%, to $4,908,057 for the first nine months of fiscal 2025 compared to the prior year [197]. - The company expects a modest increase in general and administrative expenses due to personnel and facility operating costs [198].