Azitra Inc(AZTR) - 2025 Q1 - Quarterly Report

IPO and Stock Information - The company completed its IPO on June 21, 2023, issuing 50,000 shares at $150 per share, converting all convertible preferred stock and notes into 298,384 common shares[136]. - As of May 13, 2025, the company had 16,476,354 shares of common stock outstanding, reflecting a 30-for-1 reverse stock split on July 1, 2024[137]. Product Development and Pipeline - The company has a proprietary microbial library of approximately 1,500 unique bacterial strains, with over 60 distinct species identified for potential therapeutic engineering[139]. - ATR-12, a genetically modified strain for treating Netherton syndrome, received FDA clearance for a Phase 1b trial, with initial safety results expected in the first half of 2025[140]. - ATR-04, targeting EGFRi-associated rash in cancer patients, obtained IND clearance in August 2024, with the first patient expected to be dosed in the first half of 2025[140]. - The company plans to perform IND-enabling studies for ATR-01, targeting ichthyosis vulgaris, with an IND filing anticipated in early 2026[140]. - The company has established a Joint Development Agreement with Bayer for two bacterial strains, focusing on preclinical properties and potential licensing[140]. - The company holds an exclusive license for SyngenicDNA Minicircle Plasmid technologies, which is expected to enhance genetic transformations of microbial species[144]. - The company aims to build a sustainable precision dermatology company with a diverse pipeline of product candidates, leveraging its proprietary microbial library[145]. - The company is exploring strategic partnerships to accelerate development and expand its research and development pipeline, while maintaining significant rights to core technologies[149]. Financial Performance - General and administrative costs increased by $361,611, or 24%, to $1,850,138 compared to the prior year period[152]. - Research and development expenses decreased by $222,870, or 15%, to $1,250,100, primarily due to a decrease in CMC costs and consultant costs[154]. - Total operating expenses rose by $138,741, or 5%, to $3,100,238, resulting in a loss from operations of $3,100,238[151]. - Interest income surged by $29,555, or 388%, to $37,164, contributing to a total other income increase of $3,271, or 11%[156]. - As of March 31, 2025, total assets were approximately $5.9 million, with working capital of approximately $2.6 million[157]. - Net cash used in operating activities was $3,071,762, compared to $3,020,008 in the prior year[161]. - Financing activities provided $1,745,439 in cash, primarily from follow-on public offerings[164]. - The company anticipates a significant increase in research and development expenses due to planned clinical trial activities[155]. Management and Operational Concerns - Management expressed substantial doubt about the company's ability to continue as a going concern due to significant losses and the need for additional capital[160]. - The company identified a material weakness in its disclosure controls and procedures related to accounting functions[168].