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Form 8-K

sec.gov

8-K — Ensysce Biosciences, Inc.

Accession: 0001493152-26-037794

Filed: 2026-08-13

Period: 2026-08-13

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)

of

the Securities Exchange Act of 1934

Date

of Report (Date of earliest event reported): August 13, 2026 (August 13, 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

August 13, 2026, Ensysce Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the

fiscal quarter ended June 30, 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 August 13, 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: August 13, 2026

Ensysce Biosciences, Inc.

By:

/s/ Lynn

Kirkpatrick

Name:

Dr. Lynn Kirkpatrick

Title:

President and Chief Executive Officer

(Principal Executive Officer)

EX-99.1

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Ensysce

Biosciences Reports Second Quarter 2026 Financial Results and Recent Business Highlights

~

Acquisition of Cy Biopharma Completed, Adding CY200 for Complex Regional Pain Syndrome ~

~

Up to $77 million in new funding with the acquisition of Cy Biopharma ~

~

Company to host a Corporate Update Call on Tuesday, August 18, 2026, at 11:00 a.m. ET ~

SAN

DIEGO, CA / August 13, 2026 / Ensysce Biosciences, Inc. (NASDAQ: ENSC) (“Ensysce” or the “Company”), a clinical-stage

biotechnology company developing novel neuroplastogenic therapies beyond mood disorders, with an initial focus on complex pain, today

reported financial and operational results for the second quarter ended June 30, 2026.

On

August 6, 2026, we completed the acquisition of Cy Biopharma, Inc. (“Cy Biopharma”) with private placement financings of

$38.6 million, adding CY200, an Orphan Drug-designated candidate for Complex Regional Pain Syndrome (CRPS), to be our lead pipeline asset.

We now have cash runway into late 2027, and a second financing tranche of up to $38.6 million, triggered upon achievement of certain

clinical milestones, would carry the company into 2028.

The

acquisition was a stock-for-stock merger that brought in $17.1 million in cash from Cy Biopharma’s pre-acquisition convertible

note financing. Concurrent with the acquisition, Ensysce entered into a definitive agreement for the sale of Series C non-voting

convertible preferred stock in a private placement financing with gross proceeds to the Company of approximately $21.5 million before

deducting transaction expenses. The private placement financing was led by Ally Bridge Group and included participation from Perceptive

Advisors, Dellora Investments, Ikarian Capital and Adage Capital Partners, L.P.

Complex

Regional Pain Syndrome (CRPS) Program Update

With

the acquisition of Cy Biopharma, the Company added CY200, a clinical-stage neuroplastogenic candidate for the treatment of CRPS Type

1, which has received U.S. FDA Orphan Drug Designation. CRPS is among the most severe chronic pain disorders, with few effective treatment

options and significant physical, psychological, and socioeconomic burden, and there is currently no approved therapy for the condition.

Rather than managing symptoms alone, CY200 is designed to address the underlying neurobiology of CRPS. The Company intends to apply proceeds

from the private placement financings primarily to advance CY200 through a randomized Phase 2 trial evaluating efficacy, safety and tolerability

for symptom alleviation in participants with CRPS Type 1, and to prepare for registrational development.

“Cy

Biopharma’s neuroplastogenic approach to complex pain was the most compelling strategic opportunity we explored, and we believe

this acquisition represents a significant value creation opportunity for Ensysce stockholders. The concurrent private placement financing

was intentionally sized to support our immediate strategic objectives while maintaining financial discipline and allow us to progress

our lead candidate in a pain market valued over $1 billion for which there is currently no approved therapy,” said Dr. Lynn Kirkpatrick,

Chief Executive Officer of Ensysce. “During the second quarter of 2026 we also advanced the clinical development of PF614-MPAR,

the first opioid engineered with built-in overdose protection. To support this clinical development, we were awarded the third year of

funding under a $15.1 million grant from the National Institute on Drug Abuse (NIDA), completing the award, a powerful vote of confidence

from a leading federal agency that has backed this program with two major awards totaling over $26 million over six years.”

TAAP™

and MPAR® (Opioid Abuse Deterrent and Overdose Protection Programs) Update

Trypsin-Activated

Abuse Protection (TAAP™) PF614 represents what we believe 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, where it “switches on”

to release oxycodone in a controlled manner, providing what we believe is improved safety. Development of PF614 continues with the 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.

PF614-MPAR

is a combination product that integrates both the TAAP™ and MPAR® (Multi-Pill Abuse Resistance) technologies to

deliver effective opioid analgesia with the added benefit of built-in oral overdose protection, and has received FDA’s Breakthrough

Therapy designation. Ensysce has continued to enroll subjects in the PF614-MPAR-102 study, supported by the NIDA grant, reflecting ongoing

external validation of the program’s potential impact. As of June 30, 2026, $5.3 million of funding remained available through

May 2027 under the grant.

Ensysce

also strengthened its intellectual property position for MPAR® during the quarter. In May 2026, the Taiwan Intellectual

Property Office issued a patent titled “Compositions Comprising Enzyme-Cleavable Prodrugs and Controlled Release Nafamostat and

Methods of Use Thereof,” extending MPAR® patent protection through 2042 in that jurisdiction and expanding on U.S.

Patent No. 12,599,578, which issued April 14, 2026.

Q2

2026 Financial Results

Cash

- Cash and cash equivalents were $0.7 million as of June 30, 2026, compared to $4.3 million as of December 31, 2025. The decrease

reflects $5.5 million of cash used in operating activities during the first six months of 2026, partially offset by $1.8 million of net

proceeds from a preferred stock financing. Following quarter-end, the acquisition of Cy Biopharma and related financings provided cash

of approximately $31 million, net of transaction expenses.

Federal

Grants - Funding under federal grants totaled $1.2 million for the second quarter of 2026 compared to $1.4 million in the comparable

year ago quarter. This $0.2 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 $2.5 million for the second quarter of 2026 compared to $1.9 million for the same

period in 2025, representing an increase of $0.5 million. The increase was primarily the result of external research and development

costs related to increased clinical activity for PF614.

General

& Administrative Expenses - G&A expenses were $1.3 million in the second quarter of 2026 and $1.2 million for the second

quarter of 2025, representing an increase of $0.1 million.

Other

Income (Expense) - Total other income (expense) was income of $5,514 for the second quarter of 2026 compared to income of $16,998

in the same period of 2025. Total other income (expense) for the quarters ended June 30, 2026 and June 30, 2025, consisted primarily

of interest income from cash and cash equivalents.

Net

Income (Loss) - Net loss attributable to common stockholders for the second quarter of 2026 was $2.6 million compared to a net loss

of $1.7 million for the second 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. Results for periods after

June 30, 2026, will reflect the acquisition of Cy Biopharma and related transaction expenses, and are therefore not comparable to the

periods presented.

Corporate

Update Conference Call

CEO,

Dr. Lynn Kirkpatrick, President, James Morrison, and Cy Biopharma CMO, Professor Richard Langford, will host a conference call on Tuesday,

August 18, 2026, at 11:00 a.m. ET to provide a corporate update, including the recently completed acquisition of Cy Biopharma.

Date:

Tuesday, August 18, 2026

Time:

11:00 a.m. ET

U.S.

Dial-in: 1-877-407-9716

International

Dial-in: 1-201-493-6779

Webcast:

https://viavid.webcasts.com/starthere.jsp?ei=1772527&tp_key=742e115fc1

Please

dial in at least 10 minutes before the start of the call to ensure timely participation. A playback of the call will be available through

Friday, September 18, 2026. To listen, call 1-844-512-2921 within the United States and Canada or 1-412-317-6671 when calling internationally.

Please use the replay access ID 13762262.

About

Ensysce Biosciences

Ensysce

Biosciences is a clinical-stage biotechnology company developing novel neuroplastogenic therapies using psychedelics that go beyond mood

disorders and address the root cause of chronic pain through central nervous system modulation. The company is also developing a new

class of highly novel opioids for the treatment of severe pain while minimizing the risk of both drug abuse and overdose. For more information,

please visit www.ensysce.com.

Definitions

CRPS:

complex regional pain syndrome - a severe chronic pain disorder for which there is currently no approved therapy.

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 quarterly report on Form 10-Q 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

June 30,

Six Months Ended

June 30,

2026

2025

2026

2025

Federal grants

$ 1,164,315

$ 1,371,438

$ 2,125,313

$ 2,691,210

Operating expenses:

Research and development

2,471,752

1,923,430

5,818,633

3,808,957

General and administrative

1,268,952

1,198,523

2,445,299

2,600,279

Total operating expenses

3,740,704

3,121,953

8,263,932

6,409,236

Loss from operations

(2,576,389 )

(1,750,515 )

(6,138,619 )

(3,718,026 )

Total other income (expense), net

5,514

16,998

11,329

38,936

Net loss

$ (2,570,875 )

$ (1,733,517 )

$ (6,127,290 )

$ (3,679,090 )

Adjustments to net loss

166

166

166

166

Net loss attributable to common stockholders

$ (2,570,709 )

$ (1,733,351 )

$ (6,127,124 )

$ (3,678,924 )

Net loss per share attributable to common stockholders, basic and diluted

$ (0.20 )

$ (0.79 )

$ (0.62 )

$ (2.04 )

Ensysce

Biosciences, Inc.

Condensed

Consolidated Statements of Cash Flows

(Unaudited)

Six Months Ended June 30,

2026

2025

Net cash used in operating activities

$ (5,463,383 )

$ (4,414,280 )

Net cash provided by financing activities

1,829,733

3,123,778

Change in cash and cash equivalents

(3,633,650 )

(1,290,502 )

Cash and cash equivalents at beginning of period

4,310,354

3,502,077

Cash and cash equivalents at end of period

$ 676,704

$ 2,211,575

Ensysce

Biosciences, Inc.

Condensed

Consolidated Balance Sheets

(Unaudited)

June 30,

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 676,704

$ 4,310,354

Prepaid expenses and other current assets

2,169,506

2,934,664

Total current assets

2,846,210

7,245,018

Other assets

111,063

207,461

Total assets

$ 2,957,273

$ 7,452,479

Liabilities and stockholders’ equity (deficit)

Current liabilities:

Accounts payable

$ 1,977,629

$ 3,267,610

Accrued expenses and other liabilities

1,893,635

993,411

Notes payable and accrued interest

196,842

306,708

Total current liabilities

4,068,106

4,567,729

Long-term liabilities

Total liabilities

4,068,106

4,567,729

Stockholders’ equity (deficit)

(1,110,833 )

2,884,750

Total liabilities and stockholders’ equity (deficit)

$ 2,957,273

$ 7,452,479

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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Namespace Prefix:

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Balance Type:

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Period Type:

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- Definition

Title of a 12(b) registered security.

+ References

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

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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Balance Type:

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Period Type:

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X

- 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

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

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Data Type:

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Balance Type:

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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

+ Details

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Data Type:

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Balance Type:

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Period Type:

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X

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

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Data Type:

dei:tradingSymbolItemType

Balance Type:

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Period Type:

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X

- 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

+ Details

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