Pasithea Therapeutics (KTTA) - 2024 Q1 - Quarterly Report

Financial Performance - For the three months ended March 31, 2024, general and administrative expenses increased by approximately $175,380, or 8.3$3,860,840, an increase of 18.2% compared to a net loss of $3,265,810 in the same period in 2023[109]. - Net loss for the three months ended March 31, 2024, was$3,860,840, compared to a net loss of $3,537,679 for the same period in 2023[119]. - Working capital decreased by approximately$3.3 million from December 31, 2023, to March 31, 2024, primarily due to cash used to fund operations[118]. - Cash and cash equivalents decreased by approximately $4.3 million for the three months ended March 31, 2024, compared to a decrease of approximately$3.2 million for the same period in 2023[119]. - The accumulated deficit as of March 31, 2024, was approximately $39.1 million, indicating significant operating losses and negative cash flows from operations[120]. Research and Development - Research and development expenses for the three months ended March 31, 2024 were$1,749,128, representing a significant increase of 59.6% from $1,096,286 in the same period in 2023[109]. - Research and development expenses increased by approximately$652,000, or 60%, for the three months ended March 31, 2024, compared to the same period in 2023[114]. - The company expects research and development expenses to increase in fiscal year 2024 compared to fiscal year 2023, primarily due to clinical development activities[115]. - The company has ceased further development of the PAS-002 program for multiple sclerosis due to high costs and the availability of effective treatment options[101]. - The FDA cleared the IND for PAS-004 in December 2023, allowing the company to proceed with a Phase 1 clinical trial for patients with MAPK pathway-driven advanced tumors[100]. - The company plans to open three additional clinical trial sites in Eastern Europe in the third quarter of 2024[100]. Operational Challenges - The company expects to incur significant operating losses for the foreseeable future as it advances its product candidates through development and clinical trials[102]. - The company anticipates that inflation will negatively impact its operations throughout 2024, particularly in employee compensation and outside services[106]. - The company requires significant additional funds to meet operational needs and capital requirements for clinical trials and other research and development expenditures[122]. Strategic Focus - The company aims to establish a sales, marketing, and distribution infrastructure to commercialize any approved product candidates[107]. - The company has discontinued support services to anti-depression clinics in the U.K. and related at-home services in New York, resulting in a focus on the Therapeutics segment[117]. Stock and Capital Structure - A one-for-20 reverse stock split was executed on January 2, 2024, reducing the number of authorized shares from 495 million to 100 million[104]. - Other income (expense), net increased by approximately $233,000 for the three months ended March 31, 2024, primarily due to dividend income of$153,000[116].