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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)
of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 15, 2026 (May 15, 2026)
Ensysce
Biosciences, Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-38306 |
|
82-2755287 |
(State
or other jurisdiction
of
incorporation or organization) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
Number) |
7946
Ivanhoe Avenue, Suite 201
La
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 ☐
If
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.
On
May 15, 2026, Ensysce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for
the fiscal quarter ended March 31, 2026. 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 May 15, 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:
May 15, 2026 |
Ensysce
Biosciences, Inc. |
| |
|
|
| |
By: |
/s/
Lynn Kirkpatrick |
| |
Name: |
Dr.
Lynn Kirkpatrick |
| |
Title: |
President
and Chief Executive Officer |
| |
|
(Principal
Executive Officer) |
Exhibit
99.1
Ensysce
Biosciences Reports First Quarter 2026 Financial Results
~
IRB Approval Secured for PF614-MPAR-102 Part 3 ~
~
Clinical Peer-Reviewed Data Published for First Overdose Protected Opioid PF614-MPAR®; Patent Estate Expanded ~
~Company Launches Formal Review of Strategic Alternatives ~
SAN
DIEGO, CA / May 15, 2026 / Ensysce Biosciences, Inc. (NASDAQ: ENSC) (“Ensysce” or the “Company”), a clinical-stage
pharmaceutical company pioneering next-generation pain and central nervous system therapeutics engineered to minimize abuse and overdose
risk, today reported financial and operational results for the first quarter ended March 31, 2026.
“The
first quarter of 2026 delivered meaningful operational and clinical momentum across our pipeline, underscoring the strength of our strategy
and the discipline of our execution,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. We achieved 50% of
the interim enrollment target in our pivotal PF614-301 Phase 3 trial, published the first peer-reviewed clinical data validating our
MPAR® overdose-protection technology, and expanded our patent estate across both our opioid and ADHD programs. Together
these milestones reinforce what we believe is the next evolution of opioid safety.”
Dr.
Kirkpatrick continued, “Following quarter-end, we closed a second financing tranche under an existing facility and secured IRB
approval to initiate Part 3 of PF614-MPAR-102, the final stage of that study. Advancing this program strengthens the clinical evidence
supporting a product we believe can fundamentally reshape how overdose risk is managed. In parallel, our Board has initiated a formal
review of strategic alternatives, including potential partnerships and licensing opportunities, to accelerate the development of our
TAAP™ and MPAR® platforms and unlock additional shareholder value.”
TAAPTM
(Opioid Abuse Deterrent Program) Update
PF614
is the Company’s lead product candidate and represents what we believe could be a next-generation extended-release oxycodone with
built-in abuse protection. Developed using our proprietary Trypsin-Activated Abuse Protection (TAAP™) technology, PF614 remains
inactive until it is swallowed and exposed to trypsin in the small intestine, where it “switches on” to release oxycodone
in a controlled manner.
This
targeted activation is designed to deliver effective pain relief while significantly reducing the potential for manipulation or
non-oral abuse. By making the active drug inaccessible until it reaches the digestive tract, TAAP™ aims to provide a safer opioid
option for patients with severe pain who require opioid-strength therapy. The Company believes this approach has the potential to meaningfully
differentiate PF614 within the multi-billion-dollar pain management market and address longstanding concerns around tampering and misuse.
In
January, Ensysce announced that it had enrolled 50% of the subjects targeted for interim review in its pivotal PF614-301 Phase 3 clinical
trial, a multicenter, randomized, double-blind, placebo-controlled study evaluating PF614 for the treatment of moderate to severe pain
following abdominoplasty. Enrollment, which began in late December 2025, progressed across two U.S. clinical sites; CenExel JBR
(Salt Lake City, Utah) and CenExel Atlanta (Decatur, Georgia), under principal investigators Dr. Todd Bertoch and Dr. Jessica McCoun,
recognized experts in anesthesiology and pain management. The study is designed to demonstrate PF614’s ability to deliver consistent,
clinically meaningful post-surgical pain relief using twice-daily dosing while leveraging its built-in abuse protection chemistry. Achieving
the interim enrollment milestone in the early stages of the program brings Ensysce meaningfully closer to delivering interim data and
advancing what the Company believes could be a new standard in acute pain management.
MPAR®
(Opioid Abuse Deterrent and Overdose Protection Program) Update
PF614-MPAR
is the Company’s next-generation combination product that integrates both the TAAPTM and MPAR® (Multi-Pill
Abuse Resistance) technology to deliver effective opioid analgesia with the added benefit of built-in oral overdose protection. By pairing
the PF614 prodrug with a trypsin inhibitor, PF614-MPAR is designed to “switch off” opioid release when supratherapeutic doses
are taken, offering a differentiated safety profile aimed at reducing overdose risk while maintaining therapeutic efficacy for patients
with severe pain.
Initial
clinical data from the PF614-MPAR-101 study demonstrated that the MPAR® mechanism performed as intended at a 25 mg dose,
providing the desired overdose protection. These results supported the FDA’s decision to grant Breakthrough Therapy designation
in January 2024, a key regulatory milestone that underscores the potential for PF614-MPAR to address a significant unmet need in opioid
safety.
In
March, Ensysce announced the publication of the first peer-reviewed clinical manuscript describing its MPAR® overdose
protection technology in the January/February 2026 issue of the Journal of Opioid Management. The paper, “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 conditions while preventing large increases in exposure at supratherapeutic doses— reinforcing
the potential for a fundamentally new safety paradigm in opioid analgesia.
Following
quarter end, in April 2026, Ensysce received Institutional Review Board (IRB) approval to initiate Part 3 of the PF614-MPAR-102
study, the final stage in evaluating the MPAR® overdose-protection technology. Part 3 is designed to further characterize
PF614-MPAR‘s protective effect across multiple dosing scenarios, building on the previously published data demonstrating that the
product delivers therapeutic plasma levels under normal use while significantly limiting additional opioid exposure when higher-than-prescribed
doses are taken. The study continues with support from the National Institute on Drug Abuse (NIDA), reflecting ongoing external validation
of the program’s potential impact.
ADHD
Program Update
Ensysce
is leveraging its TAAP™ and MPAR® platforms beyond pain management to develop what could become the first abuse-deterrent,
overdose-protected stimulant therapies for attention-deficit/hyperactivity disorder (ADHD). The Company’s ADHD pipeline includes
PF8026, a novel immediate-release amphetamine prodrug, and PF8001, an extended-release candidate. In January 2026, Ensysce 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.
This strengthens the Company’s intellectual property position and supports long-term value creation as it allows advancement of
safer stimulant options for a large and growing market. The need for innovation in ADHD therapeutics is significant. In 2023, approximately
3.9 million people aged 12 or older misused prescription stimulants, highlighting the limitations of current treatments and the urgency
for products engineered to resist common routes of abuse and incorporate overdose protection mechanisms. By applying TAAP™ and
MPAR® to stimulant medications, Ensysce has the ability to address this unmet need and expand its platform into another
major therapeutic category with substantial commercial potential.
Opioid
Use Disorder (OUD) Program Update
Beyond
its pain management portfolio, Ensysce is advancing treatments for opioid use disorder (OUD) aimed at reducing cravings, lower relapse
risk, and improving long-term patient outcomes while maintaining patient safety and quality of life. The Company has selected PF9001
as its lead OUD candidate and is evaluating it as a potential next-generation alternative to methadone, with the added advantage of built-in
overdose protection, reduced cardiovascular risk and convenient oral delivery profile. The PF9001 program has been supported by a multi-year
HEAL (Helping to End Addiction Long-Term) grant and in collaboration with NIDA. This program support provides both scientific validation
and non-dilutive funding, reinforcing the potential of PF9001 to address critical gaps in current OUD treatment options and expand the
application of Ensysce’s TAAP™ and MPAR® technologies into another major public health challenge.
Q1
2026 Financial Results
Cash
- Cash and cash equivalents were $0.7 million as of March 31, 2026, compared to $4.3 million as of December 31, 2025. Subsequent
to March 31, 2026, on April 7, 2026, the Company closed a second tranche of $2.0 million in convertible preferred stock financing under
its previously announced November 2025 commitment for up to $20 million over 24 months.
Federal
Grants - Funding under federal grants totaled $1.0 million for the first quarter of 2026 compared to $1.3 million in the comparable
year ago quarter. This $0.3 million decrease is primarily due to the timing of research activities eligible for funding under the MPAR
grant.
Research
& Development Expenses - R&D expenses were $3.3 million for the first quarter of 2026 compared to $1.9 million for the same
period in 2025, representing an increase of $1.4 million. The increase was primarily the result of external research and development
costs related to Phase 3 clinical trial activity for PF614.
General
& Administrative Expenses - G&A expenses were $1.2 million in the first quarter of 2026 and $1.4 million for the first quarter
of 2025, representing a decrease of $0.2 million.
Net
Income (Loss) - Net loss attributable to common stockholders for the first quarter of 2026 was $3.6 million compared to a net loss
of $1.9 million for the first quarter of 2025. 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 company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel
opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance
(MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of
both drug abuse and overdose. Ensysce’s products are anticipated to provide safer options to treat patients suffering from severe
pain and assist in preventing deaths caused by medication abuse. For more information, please 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
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, possible NASDAQ delisting, 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; continuation
of government funding; 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, 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
MZ
North America
Main:
203-741-8811
ENSC@mzgroup.us
Ensysce
Biosciences, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| | |
| | |
| |
| Federal grants | |
$ | 960,999 | | |
$ | 1,319,772 | |
| Operating expenses: | |
| | | |
| | |
| Research and development | |
| 3,346,881 | | |
| 1,885,528 | |
| General and administrative | |
| 1,176,348 | | |
| 1,401,756 | |
| Total operating expenses | |
| 4,523,229 | | |
| 3,287,284 | |
| Loss from operations | |
| (3,562,230 | ) | |
| (1,967,512 | ) |
| Total other income (expense), net | |
| 5,815 | | |
| 21,939 | |
| Net loss | |
$ | (3,556,415 | ) | |
$ | (1,945,573 | ) |
| Net loss per share, basic and diluted | |
$ | (0.52 | ) | |
$ | (1.39 | ) |
Ensysce
Biosciences, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
| | |
Three Months Ended March 31, | |
| | |
2026 | | |
2025 | |
| | |
| | |
| |
| Net cash used in operating activities | |
$ | (3,500,925 | ) | |
$ | (1,707,412 | ) |
| Net cash (used in) provided by financing activities | |
| (63,947 | ) | |
| 1,257,826 | |
| Change in cash and cash equivalents | |
| (3,564,872 | ) | |
| (449,586 | ) |
| Cash and cash equivalents at beginning of period | |
| 4,310,354 | | |
| 3,502,077 | |
| Cash and cash equivalents at end of period | |
$ | 745,482 | | |
$ | 3,052,491 | |
Ensysce
Biosciences, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
| | |
March 31, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| | |
| | |
| |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 745,482 | | |
$ | 4,310,354 | |
| Prepaid expenses and other current assets | |
| 1,263,058 | | |
| 2,934,664 | |
| Total current assets | |
| 2,008,540 | | |
| 7,245,018 | |
| Other assets | |
| 159,263 | | |
| 207,461 | |
| Total assets | |
$ | 2,167,803 | | |
$ | 7,452,479 | |
| | |
| | | |
| | |
| Liabilities and stockholders’ equity (deficit) | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 1,610,186 | | |
$ | 3,267,610 | |
| Accrued expenses and other liabilities | |
| 980,780 | | |
| 993,411 | |
| Notes payable and accrued interest | |
| 245,849 | | |
| 306,708 | |
| Total current liabilities | |
| 2,836,815 | | |
| 4,567,729 | |
| Long-term liabilities | |
| — | | |
| — | |
| Total liabilities | |
| 2,836,815 | | |
| 4,567,729 | |
| Stockholders’ equity (deficit) | |
| (669,012 | ) | |
| 2,884,750 | |
| Total liabilities and stockholders’ equity | |
$ | 2,167,803 | | |
$ | 7,452,479 | |
