Welcome to our dedicated page for Ensysce Biosciences SEC filings (Ticker: ENSC), 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.
Ensysce Biosciences, Inc. filings document the formal disclosures of a clinical-stage pharmaceutical issuer developing abuse-resistant and overdose-protection opioid technologies. Recent 8-K reports cover financial results, material financing agreements, registered direct and private-placement securities transactions, and amendments or corrections tied to Series B preferred stock, common-stock issuance and warrants.
The company’s regulatory record also includes Nasdaq listing-compliance notices, annual-meeting voting results, incentive-plan amendments, auditor ratification, director elections, board resignations, committee roles and retention-related compensation arrangements. These filings describe Ensysce’s capital structure, governance, public-company compliance obligations and risk-related corporate events while its TAAP™ and MPAR® platforms remain the core operating focus.
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 announced that board member Lee Rauch resigned from the Board of Directors effective March 24, 2026. She previously served on the Audit and Compensation Committees and chaired the Nominating and Corporate Governance Committee. Rauch’s resignation follows her disagreement with new retention and severance arrangements for certain managers and the Chief Financial Officer.
The company is considering strategic alternatives and approved three‑month severance packages for three managers and extended CFO Mr. Humphrey’s retention package from six to nine months. These protections apply if they are not retained in a strategic transaction or for one year afterward and provide releases of claims and reaffirmed restrictive covenants. The total estimated cost of these measures is about $205,475. Rauch voted against the packages and had expressed other disagreements with board actions before resigning.
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.
Ensysce Biosciences, Inc. held its annual stockholder meeting on January 7, 2026. Stockholders approved, for purposes of Nasdaq Listing Rule 5635(d), the full issuance of shares of common stock and the exercise of warrants for common stock issued to an investor. They also approved an amendment to the Ensysce Biosciences, Inc. Amended and Restated 2021 Omnibus Incentive Plan, increasing the total number of shares that may be issued under the plan from 121,457 shares to 721,457 shares.
Stockholders elected two Class I directors, William Chang and Lee Rauch, to terms expiring at the 2028 annual meeting. In addition, they ratified the appointment of Baker Tilly US, LLP as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2025. A fifth proposal to adjourn the meeting, if needed, was included in the proxy materials but was not submitted to a vote.
Ensysce Biosciences, Inc. is asking stockholders to approve several key items at its virtual annual meeting on December 23, 2025. The centerpiece is approval, under Nasdaq Listing Rule 5635(d), of the full issuance of common stock tied to a November 2025 financing, including preferred stock that converts into common shares and warrants with a $2.50 exercise price. If all preferred shares and 880,000 warrants are converted and exercised at current terms, the institutional purchaser would hold 2,640,000 common shares, or 75% of shares outstanding on a pre-transaction basis and 43% on a post-transaction basis using 6,181,262 shares. Ensysce also seeks to amend its 2021 Omnibus Incentive Plan to raise the share reserve from 121,457 to 721,457 shares, roughly 20% of outstanding stock, elect two Class I directors, ratify its auditor, and approve a possible adjournment to solicit more proxies.
Ensysce Biosciences, Inc. entered into a Securities Purchase Agreement with an institutional investor to raise capital through a registered direct offering and concurrent private placement of Series B Preferred Stock and warrants. In the registered direct offering, the company sold 1,513 shares of Series B Preferred Stock, convertible into up to 665,922 shares of common stock, for gross proceeds of about $1.7 million. In the private placement, it agreed to sell 2,487 additional preferred shares, convertible into 1,094,078 common shares, plus warrants to purchase up to 880,000 common shares at $2.50 per share. Net proceeds from the combined offerings are estimated at about $3.6 million, to be used for general corporate purposes including development of the TAAP and MPAR® programs and working capital. The preferred stock has a stated value of $1,100 per share and pays a 4% annual dividend, increasing to 8% upon certain events, and the transactions are subject to an exchange cap of 19.99% absent stockholder approval and warrant beneficial ownership limits of 4.99% or 9.99%.
Ensysce Biosciences (ENSC) reported a Q3 2025 update via Form 8-K. The company furnished a press release announcing financial results for the fiscal quarter ended September 30, 2025, included as Exhibit 99.1.
The information under Item 2.02, including Exhibit 99.1, is furnished and not deemed “filed” under the Exchange Act, nor incorporated by reference except as expressly stated in future filings. The 8-K includes customary forward-looking statement cautions. The filing lists Exhibit 99.1 (press release) and Exhibit 104 (Cover Page Inline XBRL).
Ensysce Biosciences (ENSC) launched a registered direct offering of 1,513 shares of Series B Preferred Stock and up to 665,922 shares of common stock issuable upon conversion. The preferred shares are priced at $1,000 each, carry a stated value of $1,100, and are convertible at $2.50 per share, subject to adjustment. Ensysce expects net proceeds of approximately $1.5 million, earmarked for general corporate purposes, including continued clinical development and working capital.
A 19.99% Exchange Cap limits the total Underlying Shares and Warrant Shares issuable to the purchaser until stockholder approval. In a concurrent private placement (not registered here), the company agreed to sell an additional 2,487 preferred shares (convertible into 1,094,078 common shares, subject to adjustment) and warrants for up to 880,000 shares at an exercise price of $2.50, exercisable only after stockholder approval, with a five-year term from that approval date. Shares outstanding were 3,541,262 as of November 12, 2025; the company estimates 4,207,184 would be outstanding after full conversion of the registered preferred shares.