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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 5, 2026 (August 5, 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
1.01. |
Entry
into a Material Definitive Agreement. |
Agreement
and Plan of Merger
On
August 5, 2026, Ensysce Biosciences, Inc., a Delaware corporation (“we,” “us,” “our,” or
the “Company”), acquired Cy Biopharma, Inc., a Delaware corporation (“Cy”), in accordance with the terms of
an Agreement and Plan of Merger, dated August 5, 2026 (the “Merger Agreement”), by and among the Company, PHRMA Merger
Sub I, Inc., a Delaware corporation (“First Merger Sub”), PHRMA Merger Sub II, LLC, a Delaware limited liability
company (“Second Merger Sub”), and Cy. Pursuant to the Merger Agreement, First Merger Sub merged with and into Cy,
pursuant to which Cy was the surviving corporation and became a wholly owned subsidiary of the Company (the “First
Merger”). Immediately following the First Merger, Cy merged with and into Second Merger Sub, pursuant to which Second Merger
Sub was the surviving entity and a wholly owned subsidiary of the Company (the “Second Merger” and together with the
First Merger, the “Merger”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax
purposes.
Under
the terms of the Merger Agreement, upon the consummation of the Merger on August 5, 2026 (the “Closing”), in exchange for
the outstanding shares of capital stock of Cy immediately prior to the effective time of the First Merger, the Company issued to the
equityholders of Cy the right to receive 282,122 shares of Series C Preferred Stock of the Company, par value $0.0001 per share
(the “Series C Preferred Stock”). Each share of Series C Preferred Stock is convertible into 1,000 shares of common
stock of the Company, par value $0.0001 per share (“Common Stock”), subject to certain conditions described below.
Reference
is made to the discussion of the Series C Preferred Stock in Item 5.03 of this Current Report on Form 8-K (this “Current
Report”), which is incorporated into this Item 1.01 by reference.
Pursuant
to the Merger Agreement, the Company has agreed to hold a stockholders’ meeting to submit the following matters to its
stockholders for their consideration: (i) the approval of the conversion of shares of Series C Preferred Stock into shares
of Common Stock in accordance with the rules of the Nasdaq Stock Market LLC (the “Conversion Proposal”) and (ii) if
deemed necessary or appropriate by the Company or as otherwise required by applicable law or contract, the approval of an amendment
to the Company’s certificate of incorporation, as amended (the “Charter”), to authorize sufficient shares of
Common Stock for the conversion of Series C Preferred Stock issued pursuant to the Merger Agreement and/or to effectuate a reverse
stock split for the purpose of maintaining compliance with Nasdaq listing standards (the “Charter Amendment Proposal”
and together with the Conversion Proposal, the “Meeting Proposals”). In connection with these matters, the Company has
agreed to file a proxy statement on Schedule 14A with the Securities and Exchange Commission (the “SEC”).
The
Board of Directors of the Company (the “Board”) unanimously approved the Merger Agreement and the related transactions, and
the consummation of the Merger and the concurrent Financing (as defined and described below) was not subject to approval of Company stockholders.
The
foregoing description of the Merger and the Merger Agreement does not purport to be complete and is qualified in its entirety by reference
to the full text of the Merger Agreement, a copy of which is filed as Exhibit 2.1 to this Current Report and is incorporated herein
by reference.
The
Merger Agreement has been filed herewith to provide investors and security holders with information regarding its terms. It is not intended
to provide any other factual information about the Company or Cy. The Merger Agreement contains representations, warranties and covenants
that the Company and Cy made to each other as of specific dates. The assertions embodied in those representations, warranties and covenants
were made solely for purposes of the Merger Agreement between the Company and Cy and may be subject to important qualifications and limitations
agreed to by the Company and Cy in connection with negotiating its terms, including being qualified by confidential disclosures exchanged
between the parties in connection with the execution of the Merger Agreement. Moreover, the representations and warranties may be subject
to a contractual standard of materiality that may be different from what may be viewed as material to investors or security holders.
In addition, information concerning the subject matter of the representations and warranties may change after the date of the Merger
Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures. For the foregoing
reasons, no person should rely on the representations and warranties as statements of factual information at the time they were made
or otherwise.
Tungsten
Partners LLC (“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As compensation for
services rendered by Tungsten, the Company paid Tungsten $100,000, and issued 100,000 restricted stock units for Common Stock and a
$15,000 monthly advisory fee that has been paid since the engagement in March 2026. H.C. Wainwright & Co., LLC
(“Wainwright”) was engaged by the Company and received an advisory transaction fee of $250,000 and a fairness opinion
delivery fee of $400,000.
Support
Agreements
In
connection with the execution of the Merger Agreement, the Company and Cy entered into stockholder support agreements (the “Company
Stockholder Support Agreements”) with certain of the Company’s stockholders (solely in their capacity as stockholders of
the Company). Pursuant to the Company Stockholder Support Agreements, among other things, each of the Company stockholder parties thereto
has agreed to vote or cause to be voted all of the shares of Common Stock owned by such stockholder in favor of the Meeting Proposals.
The
foregoing description of the Company Stockholder Support Agreements does not purport to be complete and is qualified in its entirety
by reference to the full text of the form of the Company Stockholder Support Agreement, a copy of which is included as Exhibit D
to the Merger Agreement, which is filed as Exhibit 2.1 to this Current Report and incorporated herein by reference.
In
connection with the execution of the Merger Agreement, the Company and Cy entered into stockholder support agreements (the “Cy
Stockholder Support Agreements”) with certain Cy stockholders (solely in their capacity as stockholders of Cy). Pursuant to the
Cy Stockholder Support Agreements, among other things, each of the Cy stockholders has agreed to the terms and conditions of the Merger
Agreement, to waive any dissenters’ rights and to release any claims such stockholder may have against the Company and Cy.
The
foregoing description of the Cy Stockholder Support Agreements does not purport to be complete and is qualified in its entirety by reference
to the full text of the form of the Cy Stockholder Support Agreement, a copy of which is included as Exhibit E to the Merger Agreement,
which is filed as Exhibit 2.1 to this Current Report and incorporated herein by reference.
Lock-up
Agreements
Concurrently
and in connection with the execution of the Merger Agreement, certain Cy stockholders as of immediately prior to the Closing, and certain
directors and officers of the Company as of immediately prior to the Closing, entered into lock-up agreements with the Company and Cy,
pursuant to which each such stockholder agreed to be subject to a 180-day lock-up on the sale or transfer of shares of the Company held
by each such stockholder at the Closing, including those shares of Series C Preferred Stock (including the shares of Common Stock
into which such Series C Preferred Stock is convertible) received by each such stockholder in the Merger (the “Lock-up Agreements”).
The
foregoing description of the Lock-up Agreements does not purport to be complete and is qualified in its entirety by reference to the
full text of the form of the Lock-up Agreement, a copy of which is included as Exhibit B to the Merger Agreement, which is filed
as Exhibit 2.1 to this Current Report and incorporated herein by reference.
Private
Placement and Securities Purchase Agreement
On
August 5, 2026, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with the purchasers
party thereto (the “Investors”). Pursuant to the Securities Purchase Agreement, the Company agreed to issue and sell an aggregate
of 120,260 shares of Series C Preferred Stock (the “PIPE Securities”) for an aggregate purchase price of approximately
$43 million (the “Financing”) over two tranches. At the initial closing of the Financing (the “Initial Closing”),
the Company will issue to the Investors 66,811 shares of Series C Preferred Stock at a price of $321.79 per share (or $0.32179 per share
on an as-converted basis), and subject to achievement of a clinical trial milestone, the Company will issue to the Investors 53,449 shares
of Series C Preferred Stock at a price of $402.24 per share (or $0.40224 per share on an as-converted basis) (the “Milestone Closing”).
Each share of Series C Preferred Stock is convertible into 1,000 shares of Common Stock, subject to certain conditions described
in this Current Report. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series C
Preferred Stock are set forth in the Certificate of Designation (as defined and described below).
The
Initial Closing is expected to occur on August 7, 2026 (the “Financing Closing Date”), and the Milestone Closing will occur
subject to achievement of a clinical trial milestone.
The
foregoing summary of the Securities Purchase Agreement does not purport to be complete and is qualified in its entirety by reference
to the full text of the form of Securities Purchase Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report and
is incorporated herein by reference.
Registration
Rights Agreements
Registration
Rights Agreement with the Investors
On
August 5, 2026, in connection with the Securities Purchase Agreement, the Company entered into a Registration Rights Agreement (the “PIPE
Registration Rights Agreement”) with the Investors. Pursuant to the PIPE Registration Rights Agreement, the Company is required
to prepare and file a resale registration statement with the SEC within 90 calendar days following the Financing Closing Date (subject
to certain extensions set forth therein), with respect to the shares of Common Stock underlying the PIPE Securities. The Company will
use its commercially reasonable efforts to cause such registration statement to be declared effective by the SEC by the earlier of (i)
five business days after the SEC determines that it will not review the registration statement or will be subject to no further review
or (ii) 90 calendar days following the initial filing date of the registration statement if the SEC reviews the registration statement
(subject to applicable extensions under the PIPE Registration Rights Agreement).
The
Company has also agreed to, among other things, indemnify the Investors, and each of their respective directors, officers, partners,
employees, members, managers, agents, representatives and advisors, each Person who controls any Investor (within the meaning of Section 15
of the Securities Act of 1933, as amended (the “Securities Act”), or Section 20 of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”)) and the directors, officers, partners, employees, members, managers, agents, representatives
and advisors of each such controlling Person under such registration statement from certain liabilities.
Registration
Rights Agreement with Security Holders of the Company and Cy
On
August 5, 2026, the Company entered into a Registration Rights Agreement (the “3i/Cy Registration Rights Agreement”) with
certain security holders of the Company and Cy as of immediately prior to the Closing. Pursuant to the 3i/Cy Registration Rights Agreement,
the Company is required to prepare and file a resale registration statement with the SEC within 90 calendar days following the Closing
(subject to certain extensions set forth therein), with respect to the shares of Common Stock underlying the Series C Preferred Stock
issued to such security holders. The Company will use its commercially reasonable efforts to cause such registration statement to be
declared effective by the SEC by the earlier of (i) 5 business days after the SEC determines that it will not review the registration
statement or will be subject to no further review or (ii) 90 calendar days following the initial filing date of the registration statement
if the SEC reviews the registration statement (subject to applicable extensions under the 3i/Cy Registration Rights Agreement).
The
Company has also agreed to, among other things, indemnify the holders of the Series C Preferred Stock party to the 3i/Cy Registration
Rights Agreement, and each of their respective partners, members, directors, officers and stockholders; legal counsel and accountants
for each such stockholder; any underwriter (as defined in the Securities Act) for each such stockholder; and each Person, if any, who
controls such stockholder or underwriter within the meaning of the Securities Act or the Exchange Act from certain liabilities.
The
foregoing summaries of the PIPE Registration Rights Agreement and the 3i/Cy Registration Rights Agreement do not purport to be complete
and are qualified in their entirety by reference to the full texts of the form of PIPE Registration Rights Agreement and the form of
3i/Cy Registration Rights Agreement, copies of which are filed as Exhibit 10.2 and Exhibit 10.3, respectively, to this Current Report
and are incorporated herein by reference.
Omnibus
Amendment and Termination Agreement
On
August 5, 2026, the Company and 3i, LP (“3i”) entered into an Omnibus Amendment and Termination Agreement (the “OATA”)
pursuant to which the Company and 3i agreed, among other things, to terminate all continuing requirements under all agreements and understandings
among the Company, subsidiaries of the Company and 3i, including eliminating by amendment the Company’s Certificate of Designation
of Series B Preferred Stock (the “Series B Preferred Stock”), cancelling the securities purchase agreement entered into by
the Company and 3i on November 13, 2025 and converting any outstanding Series B Preferred Stock into Common Stock. The OATA will have
no effect if the Company does not acquire Cy within 30 days of August 5, 2026. Under the OATA, all outstanding shares of the Series B
Preferred Stock will be converted into 3,229,276 shares of Common Stock, of which 910,905 shares of Common Stock will be issued directly
to 3i and 2,318,371 shares of Common Stock will be issued to a bona fide financial institution to be held in an abeyance account.
In
addition, all warrants to purchase shares of Common Stock held by 3i will be converted into 7,182.517 shares of Series C Preferred Stock
at an initial conversion ratio of one share of Series C Preferred Stock to 1,000 shares of Common Stock. The OATA also includes a payment
of $250,000 to 3i and the imposition of a beneficial ownership limitation of 4.99% (or up to 9.99%, which increase shall not take effect
until notice of the increase is provided by 3i and 61 days then elapse) of the Company’s then outstanding shares of Common Stock
(the “Beneficial Ownership Limitation”), with the shares exceeding the Beneficial Ownership Limitation held in abeyance for
the benefit of 3i until such time, if ever, as 3i’s right to such shares would not result in 3i exceeding the Beneficial Ownership
Limitation.
The
OATA requires 3i to execute (i) a Company Stockholder Support Agreement and (ii) the 3i/Cy Registration Rights Agreement. The OATA includes
a mutual general release of claims by each of 3i and the Company against the other.
The
foregoing summary of the OATA does not purport to be complete and is qualified in its entirety by reference to the full text of the OATA,
a copy of which is filed as Exhibit 10.4 to this Current Report and is incorporated herein by reference.
| Item
2.01 |
Completion
of Acquisition or Disposition of Assets |
On
August 5, 2026, the Company completed its business combination with Cy. The information contained in Item 1.01 of this Current Report
is hereby incorporated by reference into this Item 2.01.
| Item
3.02 |
Unregistered
Sales of Equity Securities |
The
information contained in Item 1.01 and Item 2.01 of this Current Report is incorporated by reference into this Item 3.02.
Pursuant
to the Merger Agreement and the OATA, the Company issued shares of Common Stock and Series C Preferred Stock. The Company issued
the Common Stock and Series C Preferred Stock to 3i pursuant to the OATA as consideration for the transactions contemplated by the Merger
Agreement. Separately, to satisfy a contractual obligation the Company issued 2,175.368 shares of Series C Preferred Stock (the “Galephar
Transaction”). Such issuances were exempt from the registration requirements of the Securities Act in reliance on Section 3(a)(9)
of the Securities Act.
Pursuant
to the Securities Purchase Agreement, the Company issued or will issue the PIPE Securities to the Investors, each of which represented
that it was a sophisticated investor with such knowledge and experience in financial and business matters as to be able to protect its
own interests in connection with the investment, and was acquiring the PIPE Securities for investment only and not with a view towards,
or for resale in connection with, the public sale or distribution thereof. Such issuances were exempt from the registration requirements
of the Securities Act in reliance on Section 4(a)(2) of the Securities Act.
Neither
the shares of Common Stock and Series C Preferred Stock issued in the Merger and in connection with the OATA, the shares of Series
C Preferred Stock issued in the Galephar Transaction, nor the PIPE Securities have been registered under the Securities Act and none
of such securities may be offered or sold in the United States absent registration or an exemption from registration under the Securities
Act and any applicable state securities laws.
Neither
this Current Report nor any of the exhibits attached hereto will constitute an offer to sell or the solicitation of an offer to buy shares
of Common Stock, Series C Preferred Stock or any other securities of the Company.
| Item
3.03 |
Material
Modification to Rights of Security Holders. |
To
the extent required by Item 3.03 of Form 8-K, the information contained in Item 5.03 of this Current Report is incorporated by reference
into this Item 3.03.
| Item
5.02 |
Departure
of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
Resignation
of Lynn Kirkpatrick as President and Appointment of James Morrison as President and Director
Pursuant
to the Merger Agreement, on August 5, 2026, Lynn Kirkpatrick resigned from her position as President of the Company, effective immediately
upon the Closing. Dr. Kirkpatrick will continue to serve as the Company’s Chief Executive Officer until stockholder approval of
the Meeting Proposals.
Appointment
of James Morrison as President and Director
Pursuant
to the Merger Agreement, on August 4, 2026, the Board, upon the recommendation of the Nominating and Corporate Governance Committee of
the Board, appointed James Morrison as President and as a director of the Company effective immediately upon the Closing and appointed
Mr. Morrison as Chief Executive Officer effective upon approval of the Meeting Proposals.
James
Morrison is the Founder of Cy and served as President of Cy from October 2019 until the closing of the Merger and as its Chief Executive
Officer from 2021 until the closing of the Merger. Mr. Morrison founded Cy to develop innovative therapies for neurological and neuropsychiatric
disorders and led the company’s scientific, financing and corporate development strategies. Previously, Mr. Morrison worked in
the commodities trading and financial services industries. Mr. Morrison holds a Bachelor of Civil Law degree from the University of Oxford.
There
are no arrangements or understandings between Mr. Morrison and any other person pursuant to which he was selected as a director and an
executive officer other than in connection with the Merger as described herein and his expected appointment as the Company’s Chief
Executive Officer following stockholder approval of the Meeting Proposals, and there are no family relationships between Mr. Morrison
and any of the Company’s directors or executive officers. Mr. Morrison has no direct or indirect material interest in any existing
or currently proposed transaction that would require disclosure under Item 404(a) of Regulation S-K.
In
connection with his appointment, Mr. Morrison entered into the Company’s standard form of indemnification agreement, a copy of
which was initially filed as Exhibit 10.6 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on November
15, 2021.
| Item
5.03. |
Amendments
to Articles of Incorporation or Bylaws; Change in Fiscal Year. |
Certificate
of Designation (Elimination of Series B Preferred Stock)
On
August 5, 2026, the Company filed with the Secretary of State of the State of Delaware a Certificate of Elimination of Series B Preferred
Stock (the “Certificate of Elimination”). The Certificate of Elimination has the effect of eliminating from the Company’s
Third Amended and Restated Certificate of Incorporation, as amended, all matters set forth in the Certificate of Designation of Series
B Preferred Stock previously filed by the Company. The sole holder of the Series B Preferred Stock consented to an amendment of the Series
B Preferred Stock to eliminate such certificate.
All
shares of Series B Preferred Stock previously issued or issuable have been converted into shares of Common Stock. The shares of preferred
stock previously designated as Series B Preferred Stock, having been redeemed, purchased or acquired, have been eliminated and returned
to the status of authorized but unissued shares of preferred stock, without designation. No shares of Series B Preferred Stock were issued
and outstanding as of the date of filing of the Certificate of Elimination.
The
foregoing is a summary of the terms of the Certificate of Elimination. The summary does not purport to be complete and is qualified in
its entirety by reference to the Certificate of Elimination, a copy of which is filed with this Form 8-K as Exhibit 3.1 and is incorporated
by reference herein.
Certificate
of Designation (Issuance of Series C Non-Voting Convertible Preferred Stock)
On
August 5, 2026, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series C Non-Voting
Convertible Preferred Stock (the “Series C Certificate of Designation”) with the Secretary of State of the State of Delaware
in connection with the Merger referenced in Item 1.01 above. The Series C Certificate of Designation provides for the designation of
shares of the Company’s Series C Non-Voting Convertible Preferred Stock, par value $0.0001 per share (the “Series C
Preferred Stock”).
The
Series C Preferred Stock is redeemable for cash at the option of the holder thereof at any time following approval of the Conversion
Proposal if there is any failure to deliver shares of Common Stock in accordance with the terms of the Series C Preferred Stock,
at a price per share equal to the then-current fair value of the Series C Preferred Stock, as described in the Series C Certificate
of Designation.
Holders
of Series C Preferred Stock are entitled to receive dividends on shares of Series C Preferred Stock equal to, on an as-if-converted-to-Common-Stock
basis, and in the same form as dividends actually paid on shares of the Common Stock.
Except
as otherwise required by law, the Series C Preferred Stock does not have voting rights. However, as long as any shares of Series C
Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding
shares of the Series C Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series C
Preferred Stock or alter or amend the Series C Certificate of Designation, amend or repeal any provision of, or add any provision to,
the Charter or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative
rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges
or powers of, or restrictions provided for the benefit of the Series C Preferred Stock, regardless of whether any of the foregoing
actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or
otherwise, (ii) issue further shares of Series C Preferred Stock, (iii) prior to the earlier of stockholder approval of
the Conversion Proposal or at any time while at least 30% of the originally issued Series C Preferred Stock remains issued and outstanding,
consummate either: (A) any Fundamental Transaction (as defined in the Series C Certificate of Designation) or (B) any stock
sale to, or any merger, consolidation or other business combination of the Company with or into, another entity in which the stockholders
of the Company immediately before such transaction do not hold at least a majority of the capital stock of the Company immediately after
such transaction, (iv) prior to the stockholder approval, authorize or issue any class or series of stock that has powers, preferences
or rights that are senior to those of the Series C Preferred Stock, (v) amend, waive or modify the Merger Agreement in any manner that
would be reasonably likely to prevent, impede or materially delay the stockholder approval or the automatic conversion of the Series
C Preferred Stock into shares of Common Stock or (vi) enter into any agreement with respect to any of the foregoing.
The
Series C Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.
Following
stockholder approval of the Conversion Proposal, each share of Series C Preferred Stock will automatically convert into 1,000 shares
of Common Stock, subject to certain limitations, including that a holder of Series C Preferred Stock is prohibited from converting
shares of Series C Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its
affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total
number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
The
foregoing description of the Series C Preferred Stock does not purport to be complete and is qualified in its entirety by reference
to the full text of the Series C Certificate of Designation, a copy of which is filed as Exhibit 3.2 to this Current Report and
is incorporated herein by reference.
| Item
7.01. |
Regulation
FD Disclosure. |
Press
Release
On
August 6, 2026, the Company issued a press release announcing the Merger and the Financing. A copy of the press release is furnished
as Exhibit 99.1 to this Current Report.
A
copy of the corporate presentation used in connection with the Financing is furnished as Exhibit 99.2 to this Current Report.
The
information in Item 7.01 of this Current Report, including the information in the press release attached as Exhibit 99.1 and the
corporate presentation attached as Exhibit 99.2 to this Current Report, is furnished pursuant to Item 7.01 of Form 8-K and shall
not be deemed “filed” for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of
that section. Furthermore, the information in Item 7.01 of this Current Report, shall not be deemed to be incorporated by reference in
the filings of the Company under the Securities Act.
| Item
9.01 |
Financial
Statements and Exhibits. |
(a)
Financial statements of business acquired
The
financial statements required by this Item, with respect to the Merger described in Item 2.01 herein, are expected to be filed by amendment
as soon as practicable, and in any event not later than 71 days after the date on which this Current Report on Form 8-K is required
to be filed related to Item 2.01.
(b)
Pro forma financial information
The
pro forma financial information required by this Item, with respect to the Merger described in Item 2.01 herein, is expected to be filed
by amendment as soon as practicable, and in any event not later than 71 days after the date on which this Current Report is required
to be filed related to Item 2.01.
Forward-Looking
Statements
This
Current Report contains certain forward-looking statements within the meaning of Section 27A of the Securities Act, 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. These forward-looking statements
include, but are not limited to: statements regarding the Company, Cy, the Financing (including expectations regarding the achievement
of the clinical trial milestone required for the Milestone Closing) and the Merger, and the expected effects, perceived benefits or opportunities
and related timing with respect thereto; statements regarding stockholder approval of the Meeting Proposals and changes in Company management
in connection with such stockholder approval; expectations regarding or plans for the combined company’s pipeline, including clinical
trials and research and development programs; and expectations regarding the use of proceeds from the Financing and cash runway expectations
therefrom, including such proceeds funding the combined company through key clinical milestones and the expected timing of such milestones.
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 Current 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 Current 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 Current Report are subject to several 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 or 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 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 obligation to update or revise the forward-looking statements, whether as
a result of new information, future events or otherwise, except as required by law.
No
Offer or Solicitation; Important Information About the Merger and Where to Find It
This
Current Report is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect
of the Merger and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of the Company or Cy, nor
shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful
prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made,
except by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom.
The
Company expects to file a proxy statement with the SEC relating to the Meeting Proposals. The definitive proxy statement will be sent
to all Company stockholders. Before making any voting decision, investors and security holders of the Company are urged to read the proxy
statement and all other relevant documents filed or that will be filed with the SEC in connection with the Meeting Proposals as they
become available because they will contain important information about the Merger Agreement and related transactions and the Meeting
Proposals to be voted upon. Investors and security holders will be able to obtain free copies of the proxy statement and all other relevant
documents filed or that will be filed with the SEC by the Company through the website maintained by the SEC at www.sec.gov.
Participants
in Solicitation
The
Company, Cy, and their respective directors, executive officers and employees may be deemed to be participants in the solicitation of
proxies in respect of the Merger. Information regarding the persons who may, under the rules of the SEC, be deemed participants
in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained
in the proxy statement and other relevant materials to be filed with the SEC when they become available.
(d)
Exhibits
| Exhibit
Number |
|
Description |
| 2.1* |
|
Agreement and Plan of Merger, dated August 5, 2026, by and among Ensysce Biosciences, Inc., PHRMA Merger Sub I, Inc., PHRMA Merger Sub II, LLC and Cy Biopharma, Inc. |
| |
|
|
| 3.1 |
|
Certificate of Elimination of Series B Preferred Stock of Ensysce Biosciences, Inc., dated August 5, 2026. |
| |
|
|
| 3.2 |
|
Certificate of Designation of Series C Non-Voting Convertible Preferred Stock of Ensysce Biosciences, Inc., dated August 5, 2026. |
| |
|
|
| 10.1* |
|
Form of Securities Purchase Agreement. |
| |
|
|
| 10.2* |
|
Form of Registration Rights Agreement with the Investors. |
| |
|
|
| 10.3* |
|
Form of Registration Rights Agreement with certain security holders of Ensysce Biosciences, Inc. and Cy Biopharma, Inc. |
| |
|
|
| 10.4 |
|
Omnibus Amendment and Termination Agreement, dated August 5, 2026, between Ensysce Biosciences, Inc. and 3i, LP. |
| |
|
|
| 99.1 |
|
Press Release of Ensysce Biosciences, Inc. |
| |
|
|
| 99.2 |
|
Corporate Presentation, dated July 2026. |
| |
|
|
| 104 |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document). |
| * |
Certain
annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish
supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request. |
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
6, 2026 |
Ensysce
Biosciences, Inc. |
| |
|
|
| |
By: |
/s/
Lynn Kirkpatrick |
| |
Name:
|
Dr.
Lynn Kirkpatrick |
| |
Title: |
Chief
Executive Officer |
| |
|
(Principal
Executive Officer) |
Exhibit 99.1
Ensysce
Biosciences Announces Acquisition of Cy Biopharma and up to $77 Million Private Financing
Acquisition
includes clinical-stage neuroplastogenic therapy with U.S. FDA Orphan Drug Designation for the treatment of Complex Regional Pain Syndrome
(CRPS)
$21.5
million in private placement financing at initial close plus $17.1 million of Cy Biopharma’s cash and cash equivalents from a pre-acquisition
convertible note financing and up to $38.6 million upon achievement of clinical trial milestone
Pro
forma cash expected to fund CY-200 through Phase 2 proof-of-concept data and into registrational development
SAN
DIEGO, CA, August 6, 2026 — Ensysce Biosciences, Inc. (NASDAQ: ENSC) (“Ensysce” or the “Company”)
today announced it has completed the acquisition of Cy Biopharma, Inc. (“Cy Biopharma”), a privately held clinical-stage
biotechnology company developing novel neuroplastogenic therapies for Complex Regional Pain Syndrome (“CRPS”). Concurrent
with the acquisition that brought in $17.1 million in cash from a pre-acquisition convertible note financing, Ensysce entered into a
definitive agreement for the sale of Series C non-voting convertible preferred stock (with a conversion ratio of preferred to common
at 1:1,000) (the “Series C Preferred Stock”) in a private placement financing, which is expected to result in gross proceeds
to the Company of approximately $21.5 million at the initial close before deducting placement agent fees and other offering and transaction
expenses, and includes up to a $38.6 million follow-on tranche that is expected to fund development of CY-200 into 2028.
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.
The
proceeds from the investment will support the advancement of CY-200 as a novel approach to treating CRPS Type 1, which has received U.S.
Food and Drug Administration (FDA) Orphan Drug Designation. The funds are expected to carry CY-200 through key clinical milestones, including
topline data from a randomized Phase 2 clinical trial assessing the efficacy, safety and tolerability of CY-200 for symptom alleviation
in participants with CRPS Type 1, and to prepare for registrational development. Importantly, the Company believes the Orphan Drug Designation
will provide critical regulatory and commercial advantages.
“Cy
Biopharma’s neuroplastogenic approach to CRPS was the most compelling opportunity we evaluated, and the Board of Directors of Ensysce
believes this acquisition represents a significant value creation opportunity for Ensysce stockholders. The clinical data supporting
CY-200 and Cy Biopharma’s approach to treating the devastating condition of Complex Regional Pain Syndrome reinforced our conviction
for this program. The concurrent private placement financing was intentionally sized to support Cy Biopharma’s immediate strategic
objectives while maintaining financial discipline, and allow Cy Biopharma to progress its lead candidate in a pain market valued over
$1 billion for which there is currently no approved therapy. Concurrently, Ensysce intends to continue progressing PF614-MPAR, which
represents what we believe is a fundamentally new approach to opioid safety, through its PF614-MPAR-102 study with the financial support
of the National Institute on Drug Abuse,” said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce.
CRPS
is among the most severe chronic pain disorders, with few effective treatment options and significant physical, psychological and socioeconomic
burden. Cy Biopharma has developed therapies designed to address the underlying neurobiology of CRPS rather than simply managing symptoms.
Cy Biopharma’s development strategy combines rigorous clinical science with an efficient regulatory pathway intended to accelerate
the delivery of innovative therapies to patients with significant unmet medical need.
“Our
mission has always been straightforward: to develop a therapy capable of meaningfully changing the lives of patients living with Complex
Regional Pain Syndrome,” said James Morrison, Founder and Chief Executive Officer of Cy Biopharma. “This transaction provides
the capital, public market platform and strategic flexibility to help us execute that mission. We believe the upcoming Phase 2 topline
data for CY-200 will demonstrate the potential of this approach for patients who today have no approved treatment option. Beyond CY-200,
our pipeline of differentiated new chemical entities is designed to increase stress resilience, strengthen descending pain control and
promote neuroplasticity. We believe we are entering the public markets at the point where clinical execution – not financing –
can be our primary near-term focus, and we are looking forward to an exciting second half of the year.”
Management
and Organization
Following
completion of the transaction, James Morrison, Founder and Chief Executive Officer of Cy Biopharma, will serve as President of the Company
and will join its Board of Directors.
About
the Acquisition and Private Placement Financing
The
acquisition is structured as a stock-for-stock merger, pursuant to which all outstanding equity interests of Cy Biopharma will be exchanged
based on a fixed exchange ratio for an aggregate of 282,122 shares of Series C Preferred Stock (representing 282,122,000 shares on an
as-converted-to-common basis and without giving effect to any beneficial ownership limitations). Concurrent with the acquisition, the
Company entered into a definitive agreement for a private placement financing to raise an aggregate of approximately $43 million in gross
proceeds over two tranches, in which the investors will be issued an aggregate of 120,260 shares of Series C Preferred Stock (representing
120,260,000 shares on an as-converted-to-common basis and without giving effect to any beneficial ownership limitations) at a price of
$321.79 per share (or $0.32179 per share on an as-converted basis) for the initial tranche of 66,811 shares of Series C Preferred Stock,
and a price of $402.24 per share (or $0.40224 per share on an as-converted basis) for the second tranche of up to 53,449 shares of Series
C Preferred Stock (the “Milestone Closing”). The first tranche of the private placement is expected to close on August 7,
2026, and the Milestone Closing will close subject to achievement of a clinical trial milestone. Concurrently, the Company also resolved
all existing contractual matters with a third party in exchange for the conversion of its outstanding Series B Preferred Stock and warrants
into common stock and Series C Preferred Stock, subject to beneficial ownership limitations. Subject to Company stockholder approval
in accordance with Nasdaq listing rules, each share of Series C Preferred Stock will automatically convert into 1,000 shares of common
stock, subject to beneficial ownership limitations. Following stockholder approval, ownership of the Company, on a fully diluted basis
not including any shares that may be issued in the Milestone Closing, will be approximately 73.86% for Cy Biopharma’s former equityholders,
approximately 7.57% for the Company and approximately 17.49% for new investors in the private placement with a combined fully diluted
equity value of approximately $101.4 million (excluding transaction fees).
The
acquisition was approved by the Board of Directors of the Company and the Board of Directors and stockholders of Cy Biopharma. The closings
of the acquisition and the private placement are not subject to the approval of the Company’s stockholders. The approval of the
Company’s stockholders is required, among other things, under Nasdaq listing rules in order for the Series C Preferred Stock to
be converted into shares of Company common stock, and the Company is required under the terms of the financing to hold a stockholder
meeting to obtain this vote.
Advisors
Troutman
Pepper Locke LLP served as legal counsel to Ensysce. Orrick, Herrington & Sutcliffe LLP served as legal counsel to Cy Biopharma.
Wedbush Securities Inc. served as the exclusive financial advisor to Cy Biopharma. Tungsten Advisors served as the exclusive financial
advisor to Ensysce. H.C. Wainwright provided the fairness opinion for the transaction.
Cantor
and UBS Investment Bank served as placement agents for the private placement financing. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo,
P.C. served as legal counsel to the placement agents.
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.
About
Cy Biopharma
Cy
Biopharma is a clinical-stage biotechnology company developing novel neuroplastogenic therapies for severe chronic pain disorders. The
company is advancing innovative treatments designed to address the underlying mechanisms of Complex Regional Pain Syndrome with the goal
of delivering durable clinical benefit for patients with significant unmet medical need. For more information, please visit www.cybiopharma.com.
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,” “might,” “will,” “expect,”
“plan,” “possible,” “believe” and other similar expressions are intended to identify forward-looking
statements. All forward-looking statements are based upon management’s estimates and forecasts and reflect the current views, assumptions,
expectations and opinions of the Company as of the date hereof. All forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those expected, including (i) possible Nasdaq delisting; (ii) failure to obtain
stockholder approval for the conversion of the Series C non-voting convertible preferred stock into shares of common stock of the combined
company; (iii) risks related to the combined company’s ability to manage its operating expenses and its expenses associated with
the acquisition; (iv) unexpected costs, charges or expenses resulting from the acquisition; (v) potential adverse reactions or changes
to business relationships resulting from the announcement or completion of the acquisition; (vi) the uncertainties associated with the
combined company’s product candidates, as well as risks associated with the clinical development and regulatory approval of product
candidates, including potential delays in the commencement and completion of clinical trials, studies and evaluations; (vii) risks related
to the inability of the combined company to obtain sufficient additional capital, including the continuation of government funding, to
continue to advance these or other product candidates; (viii) failure to achieve the clinical trial milestone for the Milestone Closing;
(ix) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (x)
risks related to the failure to realize any value from product candidates currently being developed and anticipated to be developed in
light of inherent risks and difficulties involved in successfully bringing product candidates to market; and (xi) risks associated with
the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating
results. These statements are also subject to risks and uncertainties described in Ensysce’s most recent annual report on Form
10-K and quarterly report on Form 10-Q and in other filings that it makes with the U.S. Securities and Exchange Commission (the “SEC”),
available 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, except as required under applicable law.
No
Offer or Solicitation; Important Information About the Acquisition and Where to Find It
This
press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect
of the acquisition and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of the Company or Cy
Biopharma, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale
would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities
shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act or an exemption therefrom.
The
Company expects to file a proxy statement with the SEC relating to the approval of the conversion of the Series C Preferred Stock and
other matters related to the conversion of the Series C Preferred Stock. The definitive proxy statement will be sent to all Company stockholders.
Before making any voting decision, investors and security holders of the Company are urged to read the proxy statement and all other
relevant documents filed or that will be filed with the SEC in connection with the approval of the conversion of the Series C Preferred
Stock and other matters related to the conversion of the Series C Preferred Stock as they become available because they will contain
important information. Stockholders will be able to obtain free copies of the proxy statement and all other relevant documents filed
or that will be filed with the SEC by the Company through the website maintained by the SEC at www.sec.gov.
Participants
in Solicitation
The
Company, Cy Biopharma, and their respective directors, executive officers and employees may be deemed to be participants in the solicitation
of proxies in respect of the acquisition. Information regarding the persons who may, under the rules of the SEC, be deemed participants
in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained
in the proxy statement and other relevant materials to be filed with the SEC when they become available.
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
Source: Ensysce
Biosciences Inc.