aibioEnsysce reports first quarter 2026 results and starts strategic review
Tickers ENSC
Ensysce Biosciences reported first quarter 2026 results, said its PF614-301 Phase 3 trial reached 50% of its interim enrollment target, and began a review of strategic alternatives.
Key facts
- Company
- Ensysce Biosciences, Inc. (NASDAQ: ENSC)
- News type
- Company Updates
- Primary source
- Ensysce Biosciences, Inc. 8-K (2026-05-15)
Ensysce Biosciences, Inc. reported first quarter 2026 results on May 15, 2026, and said its board had started a formal review of strategic alternatives, including potential partnerships and licensing opportunities. The release, which the company furnished in an 8-K, also said the company enrolled 50% of the interim enrollment target in its pivotal PF614-301 Phase 3 trial and published the first peer-reviewed clinical data for its MPAR overdose protection technology. Chief Executive Officer Dr. Lynn Kirkpatrick said, "The first quarter of 2026 delivered meaningful operational and clinical momentum across our pipeline."
Clinical and regulatory progress
The release says PF614 is the lead product candidate and represents what the company believes could be a next-generation extended-release oxycodone with built-in abuse protection. PF614 remains inactive until it is swallowed and exposed to trypsin in the small intestine. The company said it announced in January 2026 that it had enrolled 50% of the subjects targeted for interim review in the PF614-301 Phase 3 trial. The study is a multicenter, randomized, double-blind, placebo-controlled trial of PF614 for moderate to severe pain following abdominoplasty. Enrollment began in late December 2025 at two U.S. clinical sites.
In March 2026, the company announced publication of its first peer-reviewed clinical manuscript on MPAR overdose protection, in the January/February 2026 issue of the Journal of Opioid Management. The paper, titled "Formulation and a Phase 1 Clinical Study of PF614-MPAR, an Oxycodone Prodrug with Oral Opioid Overdose Protection," reported that PF614-MPAR achieved appropriate opioid plasma levels under normal dosing while preventing large increases in exposure at supratherapeutic doses. In April 2026, the company received Institutional Review Board approval to begin Part 3 of the PF614-MPAR-102 study, the final stage of that evaluation. The release says the study continues with support from the National Institute on Drug Abuse.
Other programs
The company is also applying its TAAP and MPAR platforms to attention-deficit/hyperactivity disorder. Its ADHD pipeline includes PF8026, a novel immediate-release amphetamine prodrug, and PF8001, an extended-release candidate. In January 2026, the company received a Notice of Allowance from the European Patent Office for a patent covering PF8026, with both composition-of-matter and method-of-use claims. The release cites a 2023 figure of approximately 3.9 million people aged 12 or older who misused prescription stimulants.
In opioid use disorder, the company has selected PF9001 as its lead candidate and is evaluating it as a potential next-generation alternative to methadone. The release says the program has been supported by a multi-year HEAL grant and in collaboration with NIDA.
Financial results
Cash and cash equivalents were $0.7 million as of March 31, 2026, compared with $4.3 million as of December 31, 2025. After the quarter ended, the company closed a second tranche of $2.0 million in convertible preferred stock financing on April 7, 2026. That tranche was made under a commitment announced in November 2025 for up to $20 million over 24 months. Federal grant funding totaled $1.0 million for the first quarter of 2026, compared with $1.3 million a year earlier.
The annual report, filed March 30, 2026, gives the full-year 2025 figures. Revenue was $5.1 million for 2025, compared with $5.2 million for 2024. Research and development expense was $10.4 million in 2025, and cash used in operations was $7.8 million.
What the release does not show
The release reports no efficacy data from PF614-301. The 50% figure counts subjects enrolled toward an interim review, not results. The MPAR paper it cites is a Phase 1 study that reported plasma levels, not pain relief or clinical outcomes, and the description of those data as validating the technology is the company's own.
Cash fell from $4.3 million at year-end 2025 to $0.7 million at March 31, 2026, and federal grant funding fell to $1.0 million from $1.3 million a year earlier. Cash used in operations was $7.8 million in 2025. The $2.0 million tranche closed on April 7 is convertible preferred stock under a commitment of up to $20 million over 24 months, so more money depends on that facility and the preferred can convert into common shares. The board's review of strategic alternatives comes with no timetable and no named counterparty.