Welcome to our dedicated page for Ensysce Biosciences SEC filings (Ticker: enscw), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Our SEC filing database is enhanced with expert analysis from Rhea-AI, providing insights into the potential impact of each filing on Ensysce Biosciences's stock performance. Each filing includes a concise AI-generated summary, sentiment and impact scores, and end-of-day stock performance data showing the actual market reaction. Navigate easily through different filing types including 10-K annual reports, 10-Q quarterly reports, 8-K current reports, proxy statements (DEF 14A), and Form 4 insider trading disclosures.
Designed for fundamental investors and regulatory compliance professionals, our page simplifies access to critical SEC filings. By combining real-time EDGAR feed updates, Rhea-AI's analytical insights, and historical stock performance data, we provide comprehensive visibility into Ensysce Biosciences's regulatory disclosures and financial reporting.
Ensysce Biosciences Inc. reported that board member Dr. Curtis Rosebraugh resigned from its Board of Directors, effective April 1, 2026. He also stepped down from the Board’s Nominating and Corporate Governance Committee. His written resignation notice is included as Exhibit 17 to the report.
Ensysce Biosciences is a clinical-stage pharmaceutical company developing abuse-resistant and overdose-protective opioid pain therapies using its TAAP and MPAR platforms. Lead drug PF614, an extended-release oxycodone prodrug, has completed multiple Phase 1 trials and human abuse potential studies, and a pivotal Phase 3 post-surgical pain trial began enrollment in December 2025.
Combination candidate PF614-MPAR, which adds nafamostat for overdose protection, has shown reduced oxycodone exposure in simulated overdose settings and received FDA Breakthrough Therapy designation in January 2024. The company highlights substantial ongoing losses, a need for significant additional funding, reliance on PF614 and PF614-MPAR, Nasdaq delisting risk, and extensive regulatory and intellectual property uncertainties.
Ensysce Biosciences reported fourth quarter and full year 2025 results alongside clinical and regulatory progress for its opioid safety pipeline. The company advanced lead pain candidate PF614 into a pivotal Phase 3 post‑surgical pain trial and continued development of PF614‑MPAR, which has FDA Breakthrough Therapy designation for its overdose‑protection technology.
PF614‑301 Phase 3 enrollment is underway, and the FDA provided supportive feedback for PF614‑MPAR, including potential use of a streamlined 505(b)(2) pathway and overdose‑protection labeling. Ensysce also expanded its intellectual property, with a new U.S. patent on MPAR® technology extending protection to 2042 and a European notice of allowance for an amphetamine prodrug patent.
Financially, federal grant funding was $5.1 million in 2025, while research and development expenses rose to $10.4 million and general and administrative costs were $4.9 million. Net loss attributable to common stockholders increased to $10.2 million for 2025, with fourth quarter loss of $2.8 million. Cash and cash equivalents were $4.3 million at December 31, 2025, supported by $8.7 million of net cash provided by financing activities. As a clinical‑stage biotech, the company expects continued losses as it invests in late‑stage trials and pipeline growth.
Ensysce Biosciences, Inc. filed a Certificate of Correction with the State of Delaware on March 18, 2026 to fix a scrivener’s error in its Certificate of Designation for Series B Preferred Stock, which is part of its Certificate of Incorporation. The full correction text is provided in Exhibit 3.1.
Ensysce Biosciences received a Nasdaq notice that its common stock no longer meets the exchange’s minimum bid price requirement, because the share price has closed below $1.00 for 30 consecutive business days. This puts the company at risk of eventually losing its Nasdaq listing.
The company has 180 calendar days, until August 24, 2026, to regain compliance by having its stock close at or above $1.00 for at least ten consecutive business days. The notice does not immediately affect trading, and the shares continue to trade on the Nasdaq Capital Market under the symbol ENSC while the company monitors its bid price and evaluates options.