Ensysce Biosciences(US:ENSC)2025-11-14 21:16Financial Performance - Ensysce has incurred significant operating losses since its inception and expects to continue incurring net losses for the foreseeable future [108]. - The company has not generated any revenue from product sales and may never be able to commercialize a marketable product [106]. - Net loss attributable to common stockholders was $3.7 million for the three months ended September 30, 2025, compared to a net income of $0.7 million in the same period of 2024, representing a change of $4.4 million [147]. - Net loss for the nine months ended September 30, 2025, was $7.4 million, compared to a net loss of $4.4 million in the same period of 2024, reflecting an increase of $3.0 million [152]. - The company anticipates continued significant operating losses and has raised substantial doubt about its ability to continue as a going concern without additional capital [161]. Research and Development - Ensysce's lead product candidate, PF614, is in Phase 3 clinical development, while PF614-MPAR is in Phase 1b, and nafamostat has completed Phase 1 clinical development [107]. - Research and development expenses increased by $1.3 million to $3.0 million for the three months ended September 30, 2025, primarily due to increased clinical and pre-clinical activity for PF614 and PF614-MPAR [149]. - For the nine months ended September 30, 2025, research and development expenses totaled $6.8 million, an increase of $3.3 million from $3.4 million in the same period of 2024 [152]. - The company expects future research and development expenses to increase once it begins the Phase 3 clinical trial for PF614, contingent on raising sufficient capital [149]. - Research and development expenses increased to $6.8 million for the nine months ended September 30, 2025, from $3.4 million in 2024, representing an increase of approximately 97% [154]. Funding and Capital Requirements - The company requires substantial additional funding to support ongoing operations and growth strategy, with current cash expected to last until late Q4 2025 [113]. - Ensysce has entered into various financing agreements, including a registered direct offering in March 2025 that raised approximately $1.1 million before fees [119]. - The company has issued unregistered warrants to purchase up to 1,863,706 shares of common stock as part of a concurrent private placement [124]. - The remaining funding under the MPAR federal research grant was $8.7 million as of September 30, 2025, expected to be utilized by May 31, 2027 [160]. - The company expects to incur elevated expenses related to ongoing research and development activities, including preclinical and clinical trials [166]. Grants and Federal Funding - Ensysce has received federal grants from the NIH, including a research and development MPAR Grant awarded in September 2018 and August 2024 [130]. - Federal grants decreased by $2.9 million to $0.5 million for the three months ended September 30, 2025, compared to $3.4 million in the same period of 2024 [148]. - Federal grant funding for the nine months ended September 30, 2025, totaled $3.2 million, a decrease of approximately $0.7 million from $3.9 million in 2024 [153]. Operating Expenses - Total operating expenses increased by $1.5 million to $4.2 million for the three months ended September 30, 2025, compared to $2.8 million in 2024 [147]. - Total operating expenses for the nine months ended September 30, 2025, were $10.6 million, up by $3.6 million from $7.1 million in 2024 [152]. - General and administrative expenses were $1.3 million for the three months ended September 30, 2025, compared to $1.1 million in the same period of 2024 [150]. - General and administrative expenses were $3.9 million for the nine months ended September 30, 2025, compared to $3.6 million in 2024, with expectations to maintain current levels [155]. Cash Flow - As of September 30, 2025, the company had $1.7 million in cash and cash equivalents and completed a convertible preferred stock offering with gross proceeds of $4 million in November 2025 [158]. - Net cash used in operating activities was $6.3 million for the nine months ended September 30, 2025, a slight decrease from $6.7 million in 2024 [163]. - Net cash provided by financing activities was $4.6 million for the nine months ended September 30, 2025, down from $9.8 million in 2024 [164]. Commitments and Obligations - Commitments as of September 30, 2025, included an estimated $7.3 million related to open purchase orders and contractual obligations [167].