Ensysce Biosciences(ENSC) - 2023 Q4 - Annual Results

Financial Performance - Ensysce reported a net loss of $3.5 million for Q4 2023, a decrease from $5.5 million in Q4 2022, and a full-year net loss of $10.6 million compared to $25.1 million in 2022[15]. - Cash and cash equivalents decreased to $1.1 million as of December 31, 2023, down from $1.5 million as of September 30, 2023[10]. - Total operating expenses for Q4 2023 were $3.7 million, a decrease from $7.6 million in Q4 2022, with full-year operating expenses at $12.9 million compared to $26.7 million in 2022[18]. - Federal grants funding totaled $0.5 million in Q4 2023, down from $1.4 million in the same quarter of 2022, with full-year funding at $2.2 million compared to $2.5 million in 2022[11]. - Ensysce's total assets decreased to $2.7 million as of December 31, 2023, from $5.9 million a year earlier[22]. - The company’s total liabilities were $3.4 million as of December 31, 2023, down from $9.9 million in 2022[22]. Research and Development - Research and development expenses for Q4 2023 were $2.2 million, significantly lower than $6.4 million in Q4 2022, with full-year R&D expenses at $7.6 million compared to $19.8 million in 2022[12]. - Ensysce received FDA Breakthrough Therapy designation for PF614-MPAR in January 2024, which is a significant milestone for the company's clinical programs[8]. - The company expects to initiate enrollment for the Phase 3 clinical trial of PF614 in the second half of 2024, following positive FDA guidance[2]. - Ensysce's product candidates are currently in clinical trials and have not yet received regulatory approval[26]. - The company emphasizes the importance of regulatory submissions and approvals for its product candidates[26]. Risks and Uncertainties - The company acknowledges potential risks and uncertainties that may affect the success of its clinical programs[26]. - Ensysce's management believes that their estimates and assumptions are reasonable, but they remain inherently uncertain[26]. - The company is subject to risks related to the initiation and conduct of preclinical studies and clinical trials[26]. - Ensysce's ability to fund its continued operations, including planned clinical trials, is a significant concern[26]. - The potential dilutive effect of stock issuances from fundraising activities is noted[26]. - Ensysce's forward-looking statements are based on management's expectations and are subject to change[26]. - The company has no obligation to publicly update or revise any forward-looking statements unless required by law[26]. Funding and Capital - The company received $2.1 million from warrant exercises after year-end and an additional $4.7 million from warrant exercises in February 2024[10].