Form 8-K

8-K — Ensysce Biosciences, Inc.

Accession: 0001493152-26-013622

Filed: 2026-03-30

Period: 2026-03-30

CIK: 0001716947

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

WASHINGTON,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d)

the Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): March 30, 2026 (March 30, 2026)

Ensysce

Biosciences, Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-38306

82-2755287

(State

or other jurisdiction

incorporation or organization)

(Commission

File

Number)

(I.R.S.

Employer

Identification

Number)

7946

Ivanhoe Avenue, Suite 201

Jolla, California

92037

(Address

of principal executive offices)

(Zip

Code)

(858)

263-4196

Registrant’s

telephone number, including area code

N/A

(Former

name or former address, if changed since last report)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to the registrant under

any of the following provisions:

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock, par value $0.0001 per share

ENSC

The

Nasdaq Stock Market LLC

Emerging

growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

2.02. Results of Operations and Financial Condition.

March 30, 2026, Ensysce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results

for the fiscal quarter and year ended December 31, 2025. A copy of the press release is included as Exhibit 99.1 to this Current Report

on Form 8-K.

The

information in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed to be “filed” for purposes of

Section 18 of the Securities Exchange Act of 1934, as amended, nor will they be deemed to be incorporated by reference in any filing

under the Securities Act of 1933, as amended, except as will be expressly set forth by specific reference in such a filing.

Forward-Looking

Statements

This

report contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section

21E of the Securities Exchange Act of 1934, as amended. These statements may be made directly in this report. Some of the forward-looking

statements can be identified by the use of forward-looking words. Statements that are not historical in nature, including the words “anticipate,”

“expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,”

“targets,” “projects,” “should,” “could,” “would,” “may,” “will,”

“forecast” and other similar expressions are intended to identify forward-looking statements. All forward-looking statements

are based upon management estimates and forecasts and reflect the views, assumptions, expectations, and opinions of the Company as of

the date of this report, and may include, without limitation, changes in general economic and political conditions, all of which are

accordingly subject to change. Any such estimates, assumptions, expectations, forecasts, views or opinions set forth in this report constitute

the Company’s judgments and should be regarded as indicative, preliminary and for illustrative purposes only. The forward-looking

statements and projections contained in this report are subject to a number of factors, risks and uncertainties, some of which are not

currently known to the Company, that may cause the Company’s actual results, performance or financial condition to be materially

different from the expectations of future results, performance of financial condition. Although such forward-looking statements have

been made in good faith and are based on assumptions that the Company believes to be reasonable, there is no assurance that the expected

results will be achieved. The Company’s actual results may differ materially from the results discussed in forward-looking statements.

Additional information on factors that may cause actual results and the Company’s performance to differ materially is included

in the Company’s filings with the Securities and Exchange Commission (the “SEC”). Copies of such filings with the SEC

are available publicly on the SEC’s website at www.sec.gov or may be obtained by contacting the Company. Readers are cautioned

not to place undue reliance upon any forward-looking statements, which speak only as of the date made. These forward-looking statements

are made only as of the date hereof, and the Company does not undertake any obligations to update or revise the forward-looking statements,

whether as a result of new information, future events or otherwise, except as required by law.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

Number

Description

99.1

Press

Release, dated March 30, 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant

to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its

behalf by the undersigned hereunto duly authorized.

Dated:

March 30, 2026

Ensysce

Biosciences, Inc.

By:

/s/

Lynn Kirkpatrick

Name:

Dr.

Lynn Kirkpatrick

Title:

President

and Chief Executive Officer

(Principal

Executive Officer)

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Ensysce

Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results

Fourth Quarter Highlighted by Clinical and Regulatory Milestones Positioning PF614 for Late-Stage Advancement ~

SAN

DIEGO, CA / March 30, 2026 / Ensysce Biosciences, Inc. (NASDAQ: ENSC) (“Ensysce” or the “Company”), a

clinical-stage pharmaceutical company developing innovative solutions for novel therapeutics while reducing the potential for abuse and

overdose, today reported financial and operational results for the fourth quarter and full year ended December 31, 2025.

“2025

was a year of meaningful progress for Ensysce, marked by significant clinical advancement, productive regulatory engagement, and continued

strengthening of our intellectual property portfolio,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences.

“We initiated our Phase 3 trial for PF614 and had constructive dialogue with the FDA supporting our manufacturing

pathway.”

Dr.

Kirkpatrick continued, “Enrollment in the PF614-301 Phase 3 study has progressed rapidly, while PF614-MPAR remains on an

accelerated development path under Breakthrough Therapy designation. In parallel, we have advanced commercial manufacturing readiness

for PF614 and have generated additional data supporting overdose-protection labeling for our MPAR platform. Beyond our late-stage

programs, we strengthened the long-term value of our technology platforms through expanded patent protection and pipeline growth,

including the advancement of PF9001 for opioid use disorder (OUD) and leveraging our TAAP™ and MPAR® technologies for additional

indications such as attention deficit hyperactivity disorder (ADHD).”

Program

Updates

TAAPTM

(Opioid Abuse Deterrent) Program Update

Ensysce’s

lead drug candidate, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone designed to deliver

effective pain relief while incorporating built-in abuse protection. Through proprietary chemical modification of oxycodone, PF614 remains

pharmacologically inactive until swallowed and exposed to trypsin in the small intestine, where it is activated to release oxycodone.

This mechanism is designed to preserve therapeutic efficacy while significantly reducing the potential for tampering and abuse.

December 2025, Ensysce announced the enrollment of the first patient in its pivotal Phase 3 clinical trial (PF614-301) evaluating PF614

for the treatment of moderate-to-severe post-surgical pain following abdominoplasty. The multicenter, randomized, double-blind, placebo-controlled

study is designed to assess whether PF614 can deliver potent and consistent analgesia while leveraging its unique chemical design to

mitigate the risk of opioid misuse. Clinical sites currently enrolling patients include CenExel JBR in Salt Lake City, Utah, and CenExcel

Atlanta under experienced principal investigators in anesthesiology and pain medicine. Enrollment in PF614-301 represents a major milestone

in Ensysce’s strategy to introduce a next generation of safer opioid medicines and advance PF614 toward regulatory submission and

potential commercialization.

MPAR®

(Opioid Abuse Deterrent and Overdose Protection) Program Update

PF614-MPAR

combines Ensysce’s TAAP™ chemistry with its proprietary MPAR® (Multi-Pill Abuse Resistance) overdose-protection technology,

designed to actively limit opioid release when multiple pills are consumed beyond prescribed doses. PF614-MPAR incorporates a trypsin

inhibitor that automatically reduces opioid activation in overdose situations, effectively acting as a chemical “off-switch.”

Clinical data from the PF614-MPAR-101 study demonstrated that the MPAR® technology functioned as designed, providing overdose protection

at a 25 mg dose. These results supported the FDA’s Breakthrough Therapy designation granted in January 2024.

November 2025, the FDA provided encouraging feedback regarding the development pathway for PF614-MPAR, including support for

pursuing overdose-protection labeling and the potential use of a streamlined 505(b)(2) regulatory pathway, which could accelerate

development and market entry. The FDA and Ensysce are collaborating on a framework to define and communicate the safety benefits of

overdose-protection opioids, including development of a scientific whitepaper on overdose protection. This milestone, backed by

multi-year grants from the National Institute on Drug Abuse (NIDA), marks a significant step toward transforming opioid safety and

redefining pain management.

Opioid

Use Disorder (OUD) Program Update

addition to its pain management portfolio, Ensysce is developing treatments for opioid use disorder (OUD) designed to reduce cravings

and relapse risk while maintaining patient safety and quality of life. The Company selected PF9001 as its lead OUD candidate and is evaluating

the compound as a potential next-generation methadone alternative with built-in overdose protection, reduced cardiovascular risk and

an oral delivery profile. This program was supported by a multi-year HEAL (Helping to End Addiction Long-Term) grant and in collaboration

with NIDA.

Intellectual

Property Expansion

December 2025, the U.S. Patent and Trademark Office allowed a new patent covering Ensysce’s MPAR® technology, further strengthening

the Company’s intellectual property protection through 2042. The patent, titled “Compositions Comprising Enzyme-Cleavable

Prodrugs and Controlled Release Nafamostat and Methods of Use Thereof,” includes both composition-of-matter and method-of-use

claims.

Ensysce

is also exploring the application of MPAR technology beyond opioids, including potential programs in amphetamines for ADHD and methadone

for OUD. In early January, Ensysce announced that the European patent office Provided Notice of Allowance in December 2025, for the issuance

of a Patent ‘Compositions Comprising Enzyme-Cleavable Amphetamine Prodrugs and Inhibitors Thereof’ for PF8026 protected by

the TAAP and MPAR technologies. These two issuances expand the potential reach of Ensysce’s platforms across multiple therapeutic

areas where abuse and overdose risk remain significant clinical challenges.

Fourth

Quarter and Full Year 2025 Financial Results

Cash

- Cash and cash equivalents were $4.3 million as of December 31, 2025, compared to $3.5 million as of December 31, 2024. Cash used

in operating activities totaled $7.8 million in 2025 compared to $7.5 million in 2024.

Federal

Grants - Funding under federal grants totaled $1.9 million for the fourth quarter of 2025 compared to $1.3 million in the comparable

year ago quarter. For the full year, funding from federal grants totaled $5.1 million in 2025, compared to $5.2 million in 2024. The

differences are due to the timing of research activities eligible for funding under the OUD and MPAR grants, as decreases in funding

under the OUD grant that ended in August 2024 were offset by increases in funding under the MPAR grant which began in September 2024.

Research

& Development Expenses - R&D expenses were $3.6 million for the fourth quarter of 2025 compared to $3.8 million for

the same period in 2024. Research and development expenses were $10.4 million for the year ended December 31, 2025, compared to $7.2

million for the year ended December 31, 2024, respectively, representing an increase of $3.2 million. The increase was primarily the

result of external research and development costs related to increased clinical and pre-clinical programs for PF614 and PF614-MPAR.

General

& Administrative Expenses - G&A expenses were $1.1 million in the fourth quarter of 2025, consistent with $1.1 million for

the fourth quarter of 2024. For 2025, G&A expenses were $4.9 million, representing an increase of $0.2 million compared to $4.7 million

for 2024.

Other

Income (Expense) - Total other income (expense) was income of $13,856 for the fourth quarter of 2025 compared to income of $12,054

in the same period of 2024. For 2025, total other income (expense), net was income of $64,759 compared to expense of $1.3 million for

2024. Other income and expense for the year ended December 31, 2025, consisted primarily of interest income from cash and cash equivalents.

Other income and expense for the year ended December 31, 2024, consisted primarily of interest expense associated with the amortization

of the original issue discount and the debt issuance costs associated with convertible notes issued in 2023.

Net

Income (Loss) - Net loss attributable to common stockholders for the fourth quarter of 2025 was $2.8 million compared to a net loss

of $3.6 million for the fourth quarter of 2024. For 2025, net loss was $10.2 million compared to $8.0 million for 2024. As a clinical

stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected

to result in losses for the foreseeable future.

About

Ensysce Biosciences

Ensysce

Biosciences is a clinical-stage pharmaceutical company dedicated to disrupting the analgesic landscape through the development of a new

class of safer opioid medicines for the treatment of severe pain. Leveraging its proprietary Trypsin-Activated Abuse Protection (TAAP™)

and Multi-Pill Abuse Resistance (MPAR®) platforms, Ensysce is advancing tamper-resistant therapeutic options designed to minimize

the risk of opioid abuse and oral overdose while preserving strong analgesic efficacy. For more information, visit www.ensysce.com.

Definitions

TAAP™:

trypsin activated abuse protection - designed to protect against prescription drug abuse.

MPAR®:

multi-pill abuse resistance - designed to protect against abuse and accidental overdose.

Forward-Looking

Statements

contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the

safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting

the foregoing, the use of words such as “may,” “intends,” “can,” “might,” “will,”

“expect,” “plan,” “possible,” “believe” and other similar expressions are intended to

identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that

the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays

in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking

statements are based on estimates and assumptions by Ensysce’s management that, although Ensysce believes to be reasonable, are

inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially

from those that Ensysce expected. In addition, Ensysce’s business is subject to additional risks and uncertainties, including among

others, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies

and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce’s

product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations,

including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce’s and its partners’

ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of

material risks and uncertainties that are described in Ensysce’s most recent annual report on Form 10-K and current reports on

Form 8-K, which are available, free of charge, at the SEC’s website at www.sec.gov. Any forward-looking statement speaks only as

of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether

as a result of new information, future events or otherwise, except as required under applicable law.

Ensysce

Biosciences Company Contact:

Lynn

Kirkpatrick, Ph.D.

Chief

Executive Officer

(858)

263-4196

Ensysce

Biosciences Investor Relations Contact:

Shannon

Devine

North America

Main:

203-741-8811

ENSC@mzgroup.us

Ensysce

Biosciences, Inc.

Condensed

Consolidated Statements of Operations

Three Months Ended

December 31,

Year

Ended

December 31,

2025

2024

2025

2024

Federal grants

$ 1,882,336

$ 1,303,659

$ 5,066,650

$ 5,210,031

Operating expenses:

Research and development

3,613,029

3,802,630

10,376,895

7,219,437

General and administrative

1,051,132

1,077,505

4,930,701

4,720,728

Total operating expenses

4,664,161

4,880,135

15,307,596

11,940,165

Loss from operations

(2,781,825 )

(3,576,476 )

(10,240,946 )

(6,730,134 )

Total other income (expense), net

13,856

12,054

64,759

(1,256,875 )

Net loss

$ (2,767,969 )

$ (3,564,422 )

$ (10,176,187 )

$ (7,987,009 )

Adjustments to net loss

321

—

487

(216 )

Net loss attributable to common stockholders

$ (2,767,648 )

$ (3,564,422 )

$ (10,175,700 )

$ (7,987,225 )

Net

loss per share attributable to common stockholders, basic and diluted

(0.75

)

(2.90

)

(3.98

)

(11.45

)

Ensysce

Biosciences, Inc.

Condensed

Consolidated Statements of Cash Flows

Year Ended December 31,

2025

2024

Net cash used in operating activities

$ (7,806,292 )

$ (7,502,700 )

Net cash used in investing activities

(123,643 )

—

Net cash provided by financing activities

8,738,212

9,881,173

Change in cash and cash equivalents

808,277

2,378,473

Cash and cash equivalents at beginning of period

3,502,077

1,123,604

Cash and cash equivalents at end of period

$ 4,310,354

$ 3,502,077

Ensysce

Biosciences, Inc.

Condensed

Consolidated Balance Sheets

(Unaudited)

December 31,

2025

2024

Assets

Current assets:

Cash and cash equivalents

$ 4,310,354

$ 3,502,077

Prepaid expenses and other current assets

2,932,114

1,842,605

Total current assets

7,242,468

5,344,682

Property and equipment, net and other assets

210,011

252,550

Total assets

$ 7,452,479

$ 5,597,232

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$ 3,267,610

$ 1,357,079

Accrued expenses and other liabilities

993,411

548,458

Notes payable and accrued interest

306,708

301,660

Total current liabilities

4,567,729

2,207,197

Long-term liabilities

—

10,096

Total liabilities

4,567,729

2,217,293

Stockholders’ equity

2,884,750

3,379,939

Total liabilities and stockholders’ equity

$ 7,452,479

$ 5,597,232

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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