ENSCW · Ensysce Biosciences, Inc.

Ensysce Biosciences' 2025 financial results reflect the company's transition into late-stage clinical development, with a net loss of $10.2 million representing a $2.2 million increase from 2024. This widening loss was primarily driven by a $3.2 million increase in research and development expenses to $10.4 million, as the company accelerated clinical and pre-clinical programs for its lead candidates PF614 and PF614-MPAR. Management highlighted meaningful progress in 2025, including the December 2025 initiation of the pivotal Phase 3 trial PF614-301 for PF614 in post-surgical pain, with enrollment progressing rapidly at clinical sites in Utah and Georgia. The company also received encouraging FDA feedback in November 2025 regarding PF614-MPAR's development pathway, including support for pursuing overdose-protection labeling and potential use of a streamlined 505(b)(2) regulatory pathway. Financially, the company ended 2025 with $4.3 million in cash and equivalents, up from $3.5 million at the end of 2024, while cash used in operating activities totaled $7.8 million for the year. Federal grant funding remained substantial at $5.1 million, though slightly decreased from $5.2 million in 2024 due to timing differences between the OUD and MPAR grants. The company strengthened its intellectual property position with new U.S. and European patents covering its MPAR technology, extending protection through 2042. Management noted that continued research and development efforts toward regulatory approvals are expected to result in losses for the foreseeable future as the company advances its pipeline of abuse-deterrent opioid therapies.