What changed in this filing

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Item 9A. Controls and Procedures

2025-03-10 compared with 2024-03-15 · 633 added, 852 removed, 1218 unchanged (55% of the section changed)

41 unchanged sentences

in Internal Control Over Financial Reporting

worked with third-party accounting consultants to develop a control structure that can be consistently applied to period-end financial

reporting as well as to unusual and infrequent complex accounting transactions.

Testing of these remediations was satisfactorily completed

during the quarter ended December 31, 2023.

There were no other changes in our internal control over financial reporting (as such term

is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2023 that have materially affected,

or are reasonably likely to materially affect, our internal control over financial reporting.

were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the

Exchange Act) during the quarter ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect,

our internal control over financial reporting.

Other Information

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following persons are our executive officers and directors:

Executive Officers

Lynn Kirkpatrick, Ph.D.**

President, Chief Executive Officer

and Class III Director

Geoffrey Birkett

Chief Commercial Officer

David Humphrey

Chief Financial Officer, Secretary and Treasurer

Jeffrey Millard, Ph.D.

Chief Operating Officer (consultant)

Linda Pestano, Ph.D.

Chief Development Officer

William Schmidt, Ph.D.

Chief Medical Officer

Andrew Benton, J.D.

Class I Director

William Chang

Class I Director

Bob Gower, Ph.D.

Class II Director and Chairman of the Board

Class III Director

Class I Director

Curtis Rosebraugh, M.D., MPH

Class II Director

Kirkpatrick, Ph.D.**

Chief Executive Officer and Class III Director

Commercial Officer

Financial Officer, Secretary and Treasurer

Millard, Ph.D.

Operating Officer (consultant)

Pestano, Ph.D.

Development Officer

Schmidt, Ph.D.

Medical Officer

II Director and Chairman of the Board

Rosebraugh, M.D., MPH

presented as of December 31, 2024

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Birkett attended Henley Business College

in London and INSEAD Business School in France where he studied general management and a global leadership.

in London and INSEAD Business School in France where he studied general management and global leadership.

Humphrey has served as our Chief Financial Officer since February 2021.

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Schmidt received a Bachelor of Arts degree from the University of California Berkeley and his Ph.D.

University of

California-San Francisco.

from the University

of California-San Francisco.

has served as a member of our Board since December 2, 2019.

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CNI was acquired by Unidym in 2007.

Gower founded Ensysce in 2008 with the focus of using single wall carbon nanotubes in therapeutic areas.

Ensysce subsequently merged

with Signature Therapeutics, Inc.

and changed its focus to developing safe opioid pain drugs.

He has served on the Board of Directors

of several public companies, including Kirby Corporation, OmNova and Keystone.

He also has been and continues to be involved with several

not-for-profit organizations and has especially focused on Communities In Schools Houston, a leading dropout prevention and mental health

program, and on Southern Illinois University with focus on the chemistry department.

Gower founded Ensysce in 2008.

He has served on the Board of Directors of several public companies, including Kirby Corporation, OmNova

and Keystone.

He also has been and continues to be involved with several not-for-profit organizations and has especially focused on Communities

In Schools Houston, a leading dropout prevention and mental health program, and on Southern Illinois University with focus on the chemistry

Gower received his B.S.

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We believe that Mr.

Gower’s previous board and industry experience qualifies him to serve on

Gower’s previous

board and industry experience qualifies him to serve on our Board.

Levin, MD joined the Board in June 2021 and is the Vice Chair of Clinical Operations for the Department of Orthopaedic Surgery

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Martin was formerly Senior Vice President and Chief Financial

Officer of Armata Pharmaceuticals, Inc., a clinical development stage biotechnology company listed on New York Stock Exchange, from January

2016 until his retirement from the position on June 30, 2022.

Officer of Armata Pharmaceuticals, Inc., a clinical development stage biotechnology company listed on the New York Stock Exchange, from

January 2016 until his retirement from the position in June 2022.

Previously, Mr.

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with Deloitte & Touche LLP, a public accounting firm.

Martin holds a Bachelor in Science in Accounting from San Diego State University

Martin holds a Bachelor of Science in Accounting from San Diego State University

and is a certified public accountant (inactive).

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During her near 40-year career, Ms.

Rauch successful built companies ranging in focus from pre-clinical

Rauch successfully built companies ranging in focus from pre-clinical

research to advanced clinical development, took the lead in mergers and acquisitions and used her experience to secure financing for

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Prior to forming a consulting firm, he was employed

by the Food and Drug Administration since 2000, holding the position of Director of the Office of Drug Evaluation II (“ODEII”)

by the Food and Drug Administration since 2000, holding the position of Director of the Office of Drug Evaluation II (“ODE II”)

within the Center for Drug Evaluation and Research (“ CDER ”) from 2007 until his retirement in 2018, with supervisory

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relating to (1) identifying individuals qualified to become new Board members, consistent with criteria approved by the Board, (2) reviewing

the qualifications of incumbent directors to determine whether to recommend them for re-election and selecting, or recommending that the

Board select, the director nominees for the next annual meeting of stockholders, (3) identifying Board members qualified to fill vacancies

on any Board committee and recommending that the Board appoint the identified member or members to the applicable committee, (4) reviewing

and recommending to the Board corporate governance principles applicable to us, (5) overseeing the evaluation of the Board and management

and (6) handling such other matters that are specifically delegated to the committee by the Board from time to time.

the qualifications of incumbent directors to determine whether to recommend them for re-election and selecting, or recommending that

the Board select, the director nominees for the next annual meeting of stockholders, (3) identifying Board members qualified to fill

vacancies on any Board committee and recommending that the Board appoint the identified member or members to the applicable committee,

(4) reviewing and recommending to the Board corporate governance principles applicable to us, (5) overseeing the evaluation of the Board

and management and (6) handling such other matters that are specifically delegated to the committee by the Board from time to time.

Board adopted a written charter for the nominating and corporate governance committee, which is available on our website.

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December 31, 2024, were:

Lynn Kirkpatrick, Ph.D.,

Chief Executive Officer;

David Humphrey, Chief Financial

Geoff Birkett, Chief Commercial

Kirkpatrick, Ph.D., Chief Executive Officer;

Humphrey, Chief Financial Officer;

Birkett, Chief Commercial Officer.

discussion may contain forward-looking statements that are based on our current plans, considerations, expectations and determinations

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2024 and December 31, 2023.

Name and Principal

Stock and Option

and Principal

Awards ($) (1)

1 unchanged sentence

Compensation ($) (2)

Lynn Kirkpatrick, PhD.

Lynn Kirkpatrick,

Chief Executive Officer

Dave Humphrey

Chief Financial Officer

Financial Officer

Geoff Birkett

Chief Commercial Officer

In accordance

with SEC rules, this column reflects the aggregate grant date fair value of the restricted stock awards and stock option awards granted.

This amount has been computed in accordance with Financial Accounting Standards Board (“FASB”), Accounting Standards

Codification (“ASC”) Topic 718.

This amount does not reflect the actual economic value that will be realized by a named

executive officer upon the vesting of the stock awards or stock options, the exercise of the stock options, or the sale of the common

stock underlying such awards.

Amounts shown represent

401(k) matching contributions.

Commercial Officer

accordance with SEC rules, this column reflects the aggregate grant date fair value of the restricted stock awards and stock option

awards granted.

This amount has been computed in accordance with Financial Accounting Standards Board (“FASB”), Accounting

Standards Codification (“ASC”) Topic 718.

This amount does not reflect the actual economic value that will be realized

by a named executive officer upon the vesting of the stock awards or stock options, the exercise of the stock options, or the sale

of the common stock underlying such awards.

shown represent 401(k) matching contributions.

Disclosure to Summary Compensation Table

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executive’s position within our business, the scope of the executive’s responsibilities and any changes thereto.

July 1, 2023, the NEO’s annual base salary rates were $414,750 for Dr.

March 1, 2024, the NEO’s annual base salary rates were $435,500 for Dr.

Kirkpatrick, $363,800 for Mr.

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to grants outstanding under the 2021 Amended and Restated Plan.

In August 2023, the 2021 Amended and Restated Plan was amended to increase

In February 2024, the 2021 Amended and Restated Plan was amended to increase

the number of awards that may be granted from 41,139 to 51,626.

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following table provides information regarding outstanding equity awards held by our NEOs as of December 31, 2024.

Option Awards

Number of Securities Underlying Unexercised Options Exercisable (#)

Number of Securities Underlying Unexercised Options Unexercisable (#)

Option Exercise Price ($)

Option Expiration Date

Number of Shares of Stock That Have Not Vested (#)

Market Value of Shares of Stock That Have Not Vested ($)

Lynn Kirkpatrick, PhD.

of Securities Underlying Unexercised Options Exercisable (#)

of Securities Underlying Unexercised Options Unexercisable (#)

Exercise Price ($)

Expiration Date

of Shares of Stock That Have Not Vested (#)

Value of Shares of Stock That Have Not Vested ($)

Lynn Kirkpatrick,

Dave Humphrey

1 unchanged sentence

Versus Performance

In August 2022, the SEC adopted additional disclosure

requirements regarding the relationship between a registrant’s executive compensation and its financial performance.

Item 402(v) of Regulation S-K require certain adjustments be made to the Summary Compensation Table totals to determine Compensation

Actually Paid as reported in the Pay Versus Performance Table.

Compensation Actually Paid does not necessarily represent cash and/or equity

value earned by or paid to the applicable named executive officer without restriction, but rather is a valuation calculated under applicable

For further information concerning our executive compensation program and our pay-for-performance philosophy, refer to

the preceding compensation discussion.

The following table sets forth specified executive

compensation and financial performance measures for our two most recently completed fiscal years, as required under transitional guidance

for Smaller Reporting Companies provided by the SEC.

We have not paid dividends and do not sponsor any pension arrangements;

adjustments are made for these items.

Summary Compensation Table Total for PEO (1)

Compensation Actually Paid to PEO (2)

Average Summary Compensation Table Total for Non-PEO NEOs (3)

Average Compensation Actually Paid to Non-PEO NEOs (4)

Value of Initial Fixed $100 Investment Based on Total Shareholder Return (5)

Net Income (Loss)

August 2022, the SEC adopted additional disclosure requirements regarding the relationship between a registrant’s executive compensation

and its financial performance.

SEC rules in Item 402(v) of Regulation S-K require certain adjustments be made to the Summary Compensation

Table totals to determine Compensation Actually Paid as reported in the Pay Versus Performance Table.

Compensation Actually Paid does

not necessarily represent cash and/or equity value earned by or paid to the applicable named executive officer without restriction, but

rather is a valuation calculated under applicable SEC rules.

For further information concerning our executive compensation program and

our pay-for-performance philosophy, refer to the preceding compensation discussion.

following table sets forth specified executive compensation and financial performance measures for our two most recently completed fiscal

years, as required under transitional guidance for Smaller Reporting Companies provided by the SEC.

We have not paid dividends and do

not sponsor any pension arrangements;

thus, no adjustments are made for these items.

Compensation Table Total for PEO (1)

Actually Paid to PEO (2)

Summary Compensation Table Total for Non-PEO NEOs (3)

Compensation Actually Paid to Non-PEO NEOs (4)

of Initial Fixed $100 Investment Based on Total Shareholder Return (5)

Income (Loss)

($ 7,987,225 )

($ 10,626,011 )

For fiscal years 2023 and 2022, the principal executive officer (“PEO”) was our Chief Executive Officer, Dr.

($ 25,085,496 )

all fiscal years presented, the principal executive officer (“PEO”) was our Chief Executive Officer, Dr.

Lynn Kirkpatrick.

The amounts disclosed reflect the following adjustments to the amounts reported in the Summary Compensation Table for the PEO:

amounts disclosed reflect the following adjustments to the amounts reported in the Summary Compensation Table for the PEO:

Grant Date Value of Equity Awards

Fair Value as of Year End of Awards Granted in the Year and Outstanding and Unvested as of Year End

Change in Fair Value of Awards Granted in Prior Years and Outstanding and Unvested as of Year End

Fair Value as of Vesting Date of Awards Granted and Vested in the Year

Change in Fair Value of Awards Granted in Prior Years that Vested in the Year

Value as of Year End of Awards Granted in the Year and Outstanding and Unvested as of Year End

in Fair Value of Awards Granted in Prior Years and Outstanding and Unvested as of Year End

Value as of Vesting Date of Awards Granted and Vested in the Year

in Fair Value of Awards Granted in Prior Years that Vested in the Year

Fair Value as of Prior Year End of Awards Forfeited in the Year

Total Adjustments

For fiscal years 2023 and 2022, the Non-PEO NEOs were Dave Humphrey and Geoff Birkett.

The amounts disclosed reflect the following adjustments to the amounts reported in the Summary Compensation Table for the Non-PEO NEOs:

all fiscal years presented, the Non-PEO NEOs were Dave Humphrey and Geoff Birkett.

amounts disclosed reflect the following adjustments to the amounts reported in the Summary Compensation Table for the Non-PEO NEOs: