Ensysce books $79.9m acquisition charge as UK regulators query psilocybin pain trial plan

Ensysce Biosciences swung to an $82.3 million net loss for the third quarter of 2026, but most of that stems from a $79.9 million non-cash in-process research and development (IPR&D) charge tied to its purchase of Cy Biopharma, rather than from day-to-day spending. The company reported the figures on 12 November and said it held $29.7 million in cash.

The acquisition, completed in August, gives Ensysce CY200, a psilocybin-based candidate for complex regional pain syndrome. That broadens a pipeline that had centred on opioid technology, and it adds a psychedelic-derived asset in a pain indication. The company did not disclose commercial projections for CY200 in the material reviewed.

The next milestone is regulatory. Ensysce filed the Phase 2a protocol, named CYBIO 001, with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in September. On 6 November, the agency and an ethics committee came back with questions, and Ensysce says it is drafting its reply. No start date for the study has been given. As general context, such exchanges are common during trial reviews, though the pace of any clearance will depend on the quality and speed of the company's answers.

Elsewhere in the pipeline, Ensysce has completed enrolment in Part 3 of PF614-MPAR-102, a study of its opioid candidate engineered to guard against overdose. The company did not provide results or a timeline for data in the facts available.