Ensysce Biosciences(US:ENSC)2025-11-14 21:15Financial Performance - Ensysce reported a net loss attributable to common stockholders of $3.7 million for Q3 2025, compared to a gain of $0.7 million in Q3 2024, reflecting a significant decline in profitability [13]. - Cash and cash equivalents decreased to $1.7 million as of September 30, 2025, down from $3.5 million at the end of 2024 [9]. - Total operating expenses for Q3 2025 were $4.2 million, compared to $2.8 million in Q3 2024, reflecting increased investment in R&D [20]. - Ensysce's total assets decreased to $3.2 million as of September 30, 2025, down from $5.6 million at the end of 2024 [24]. Research and Development - Research and development expenses increased to $3.0 million in Q3 2025, up from $1.7 million in the same period of 2024, driven by heightened clinical and pre-clinical activities [11]. - The initiation of the pivotal Phase 3 PF614-301 trial in July 2025 marks a major milestone in Ensysce's development of PF614, aimed at providing effective pain relief while minimizing abuse risk [5]. - The FDA granted Breakthrough Therapy designation for the PF614-MPAR program, which combines overdose protection with pain management capabilities [7]. - The company is advancing its opioid use disorder (OUD) program, with PF9001 selected as the lead candidate, supported by a multi-year HEAL grant [8]. Funding and Capital - Federal grants funding totaled $0.5 million in Q3 2025, a decrease of $2.9 million compared to $3.4 million in Q3 2024, primarily due to the timing of research activities [10]. - Ensysce completed a convertible preferred stock offering in November 2025, raising gross proceeds of $4 million, with an additional $16 million potentially available through future tranches [9].