Item 9A. Controls and Procedures
Item
9A. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports that we file or submit
under the Securities Exchange Act of 1934 as amended (the “Exchange Act”) is recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our
management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required
disclosure. Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness
of our disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) as of December 31, 2025. Based
on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and
procedures were effective as of December 31, 2025.
Management’s
Annual Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over our financial reporting. Internal control over
financial reporting is defined in Rule 13a-15(f) under the Exchange Act as a process designed by, or under the supervision of, the company’s
executive and financial officers and effected by the company’s board of directors, management and other personnel, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes and includes
those policies and procedures that (a) pertain to the maintenance of records that in reasonable detail accurately and fairly reflect
the transactions and dispositions of the assets of the company; (b) provide reasonable assurance that transactions are recorded as necessary
to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures
of the company are being made only in accordance with authorizations of management and directors of the company; and (c) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that
could have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements, errors, or fraud. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
As
of December 31, 2025, our management assessed the effectiveness of our internal control over financial reporting using the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework (2013)
(the “2013 Framework”). In adopting the 2013 Framework, management assessed the applicability of the principles within each
component of internal control and determined whether they have been adequately addressed within the current system of internal control
and adequately documented. Based on this assessment, management, under the supervision and with the participation of our Chief Executive
Officer and Chief Financial Officer, concluded that, as of December 31, 2025, our internal control over financial reporting was effective
based on these criteria.
This
Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal
control over financial reporting. As a smaller reporting company, we were not required to have, nor have we, engaged our independent
registered public accounting firm to perform an audit of internal control over financial reporting pursuant to SEC rules that permit
us to provide only management’s report in this Annual Report on Form 10-K.
Changes
in Internal Control Over Financial Reporting
There
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, 2025, that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
Item
9B. Other Information
Not
applicable.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not
applicable.
78
PART
III
Item
10. Executive Officers and Directors
The
following persons are our executive officers and directors:
Name
Age*
Position
Executive
Officers
Lynn
Kirkpatrick, Ph.D.**
69
President,
Chief Executive Officer and Class III Director
Geoffrey
Birkett
63
Chief
Commercial Officer
David
Humphrey
57
Chief
Financial Officer, Secretary and Treasurer
Jeffrey
Millard, Ph.D.
50
Chief
Operating Officer
Linda
Pestano, Ph.D.
57
Chief
Development Officer
William
Schmidt, Ph.D.
75
Chief
Medical Officer
Directors**
William
Chang
69
Class
I Director
Bob
Gower, Ph.D.
88
Class
II Director and Chairman of the Board
Adam
S. Levin, M.D.
47
Class
III Director
Steve
R. Martin
64
Class
III Director
Lee
Rauch
72
Class
I Director
Curtis
Rosebraugh, M.D., MPH
68
Class
II Director
*Ages
presented as of December 31, 2025
**
Information about Dr. Kirkpatrick is set forth under “Executive Officers”
79
Information
about our Executive Officers and Directors
Executive
Officers
Lynn
Kirkpatrick, Ph.D. has served as our Chief Executive Officer since January 2009. Dr. Kirkpatrick has spent over 30 years in drug
discovery and development, has initiated the clinical development of four novel drug candidates and now strives to bring highly novel
and safe pain therapies to commercialization. She received a Doctor of Philosophy (“ Ph.D. ”) degree in Medicinal and
Biomedicinal Chemistry at the University of Saskatchewan, completed a Post-Doctoral Fellowship at the Yale University School of Medicine,
and became a tenured full professor in the Department of Chemistry at the University of Regina. She co-founded ProlX Pharmaceuticals,
Corp. (“ ProlX ”) an oncology discovery company, becoming Chief Executive Officer and successfully bringing three small
molecules from discovery into clinical development, two of these her own discoveries from academia. ProlX was acquired by Biomira Inc.,
and Dr. Kirkpatrick became the Chief Scientific Officer of the merged company to focus on the development of oncology products and vaccines.
In 2009, she co-founded PHusis Therapeutics, developing targeted small molecule precision medicines for oncology. At the same time, she
became our Chief Executive Officer. Dr. Kirkpatrick has published extensively in the area of targeted drug discovery, abuse deterrent
pain products and holds numerous patents for novel drugs and modalities. We believe Dr. Kirkpatrick is qualified to serve on our Board
because of her extensive executive experience in our industry and her service as our Chief Executive Officer.
Geoffrey
Birkett has served as our Chief Commercial Officer since October 2018. He has over 30 years of experience in the Pharmaceutical
and Biotechnology area. He started his career as a biochemist at the Royal Victoria Infirmary in Newcastle-upon-Tyne, England. He then
moved into the pharmaceutical industry, where he focused on pain/addiction and neuroscience throughout his career. He has developed and
launched several groundbreaking therapies, including Nicorette (POM) and (OTC), Lexapro and several other psychiatry agents with Lundbeck.
Mr. Birkett assisted on the launch of Prozac and Humatrope (human growth hormone) with Eli Lilly. He assisted in moving Seroquel from
Phase 2 to global market leader with multi-billion dollar sales and he also participated in the launch of Zomig for migraines, which
became a European market leader. He worked for most of his pharmaceutical career at AstraZeneca plc in both the United Kingdom and the
United States, where he held many roles including overseeing the global oncology division. When the AstraZeneca merger took place, Mr.
Birkett ran the merger process outside the United States across all markets, and ran a corporate change program to streamline research
and development involving 67,000 staff. Since leaving AstraZeneca, Mr. Birkett has held multiple roles in biotech companies as senior
officer or as a consultant. He is co-founder of a novel drug delivery company and has consulted for IPSOS, a large global research and
consulting firm. He also served as president for North America/Canada of INDIVIOR, a large company producing addiction treatment drugs.
Mr. Birkett joined us in 2018 and is focused on building a world class commercial team. Mr. Birkett attended Henley Business College
in London and INSEAD Business School in France where he studied general management and global leadership.
David
Humphrey has served as our Chief Financial Officer since February 2021. Prior to joining the Company, Mr. Humphrey was most recently
Chief Financial Officer of Senomyx, Inc. (“Senomyx”), a publicly held biotechnology company focused on taste science. In
his previous employment, he guided public company financial reporting, including Forms 10-K, 10-Q, 8-K, S-3, S-8, proxy statements and
SOX internal controls compliance, and acted as primary liaison with the audit committee and external auditors. Mr. Humphrey advised Senomyx’s
board of directors, as part of core executive management team, in a $75 million acquisition by Firmenich SA, a private Swiss multinational
flavor and fragrance company. Previously, he held finance and accounting leadership positions and consulted at numerous life sciences
companies, including ActivX Biosciences, Aurora Biosciences and Gensia. Mr. Humphrey started his career as an accountant at Price Waterhouse.
He holds a Bachelor of Science with Honors in Accountancy from the University of Illinois at Urbana-Champaign and is a Certified Public
Accountant (inactive) in California.
80
Jeffrey
Millard, Ph.D. has served as our Chief Operating Officer since January 2019. Dr. Millard has both academic and industrial experience
in chemistry and pharmaceutical sciences covering all aspects of chemistry, manufacturing, and controls, or CMC. He has been involved
in both start-up biotech as well as small and mid-sized public biopharmaceutical companies. Dr. Millard has been directly responsible
for research and development activities and writing of more than seven IND submissions and Investigational Medicinal Product Dossiers,
or IMPDs. He has directed the CMC efforts from discovery and in-licensing through commercial launch activities. His experience covers
the application programming interface, or API, lifecycle (from synthetic route scouting, process chemistry, analytical chemistry development
and validation, cGMP production and release of API, to QbD and process validation), and drug product development through manufacture.
Dr. Millard received a Bachelor of Arts from Rice University and a Ph.D. in Pharmaceutical Sciences from the University of Arizona.
Linda
Pestano, Ph.D. joined Ensysce in October 2021, as Chief Development Officer. Dr. Pestano has worked throughout her career to
guide the development of novel therapeutics to improve patient outcomes and quality of life. She has 20 years of experience developing
vaccines, drugs and novel biologics for a diverse range of indications. She has been instrumental in guiding new therapies, including
small molecules, nucleic acids, and biologicals through development into clinical trials. Dr. Pestano’s expertise spans lead development,
pre-clinical and translational studies, and interacting with multiple regulatory agencies. Dr. Pestano received her PhD from Tufts University
and undertook a Post-Doctoral Fellowship with Dana Farber Cancer Institute at the Harvard Medical School in Boston.
William
K. Schmidt, Ph.D ., has served as our Chief Medical Officer since January 2016. He is also the Head of NorthStar Consulting, the
Parliamentarian and a former president of the Eastern Pain Association, the largest regional affiliate of the American Pain Society.
He has over 25 years of pharmaceutical industry experience with a special emphasis on the discovery and development of novel analgesic
and narcotic antagonist drugs. He was previously Vice President of Clinical Development for CrystalGenomics (Seoul, South Korea) and
its United States subsidiary, CG Pharmaceuticals (Emeryville, CA); Senior Vice President of Development at Limerick BioPharma; Vice President,
Clinical Research, for Renovis, Inc.; and Vice President, Scientific Affairs and acting Vice President, Clinical Research and Development,
at Adolor Corporation. At Adolor Corporation, Dr. Schmidt was a key member of the team leading to the clinical development, NDA filing,
and FDA approval of Entereg® (alvimopan), a peripherally acting opioid antagonist. Currently Dr. Schmidt serves as an expert on pain
medicine pharmaceutical development with pharmaceutical and biotech companies throughout North America, Europe, Asia, Latin America,
and Australia. Dr. Schmidt received a Bachelor of Arts degree from the University of California Berkeley and his Ph.D. from the University
of California-San Francisco.
Directors
William
Chang serves as Chief Executive Officer of Westlake Realty Group and Chairman of Westlake International Group where he has worked
for more than 40 years. Mr. Chang is an investor in the San Francisco Giants of Major League Baseball. Mr. Chang was the former Chairman
of U.S. Rugby Football Union. He also served on the Board of the Asia Foundation and San Francisco Port and Social Services Commissions.
Mr. Chang holds a Bachelor’s degree in Economics from Harvard University. We believe that Mr. Chang’s extensive business
experience and expertise in corporate governance qualifies him to serve on our Board.
Bob
Gower, Ph.D. has served as our Chairman since 2008. Dr. Gower was Chief Executive Officer of Lyondell Petrochemical from 1985
through his retirement at the end of 1996. In 1997, he acquired businesses from Howell Corporation that became Specified Fuels and Chemicals.
Dr. Gower sold Specified in 2000 and, with Dr. Richard Smalley, founded Carbon Nanotechnologies, Inc. (“ CNI ”) that
same year to develop production capabilities and applications for single wall carbon nanotubes. CNI was acquired by Unidym in 2007. Dr.
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
department. Dr. Gower received his B.S. from SIU and his Ph.D. from the University of Minnesota. We believe that Mr. Gower’s previous
board and industry experience qualifies him to serve on our Board.
81
Adam
S. Levin, MD joined the Board in June 2021 and is the Vice Chair of Clinical Operations for the Department of Orthopaedic Surgery
at Johns Hopkins University, where he has been on faculty since 2014. He is an Associate Professor of Orthopaedic Surgery and Associate
Professor of Oncology, researching treatments related to musculoskeletal oncology, while also maintaining an active clinical practice.
Dr. Levin holds the Virginia M. Percy and William Algernon Percy Chair in Orthopaedic Surgery at Johns Hopkins University. He serves
in additional leadership roles related to billing, coding, and practice management for the Musculoskeletal Tumor Society, the American
Academy of Orthopaedic Surgeons, and the American Medical Association. Prior to joining Johns Hopkins University, Dr. Levin was an Assistant
Professor of Orthopaedic Surgery at the Zucker School of Medicine at Hofstra University in New York between 2012 and 2014. From 2010
to 2012, he was a fellow of musculoskeletal oncology and Clinical Instructor at Memorial Sloan-Kettering Cancer Center, following his
residency training at the North Shore/LIJ Health System (now Northwell Health) from 2005 to 2010. He has been a member of leadership
fellows programs through the North Shore/LIJ Physician High Potential Program, the American Academy of Orthopaedic Surgeons, and the
American Orthopaedic Association. Dr. Levin has also continued to serve as Associate Editor for CME for the Journal of Bone and Joint
Surgery since 2016, and is on the Steering Committee for the Musculoskeletal Tumor Registry. Dr. Levin served as a subject-matter consultant
to our predecessor, LACQ, during their initial review of our preclinical and Phase I clinical trial results. Dr. Levin holds a B.S. in
Biology with a concentration in Animal Physiology from Cornell University, an M.D. from New York Medical College, and is currently studying
at the Johns Hopkins University Carey School of Business for an M.B.A. with a specialization in Healthcare Management, Innovation, and
Technology. We believe that Dr. Levin is qualified to serve as a member of our Board based on his academic and practice experience and
his detailed knowledge of value-based care, acute and chronic pain management, novel drug design, and health care operations and management.
Steve
R. Martin has served as a member of our Board since August 2020. Mr. Martin was formerly Senior Vice President and Chief Financial
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. Martin served as Senior Vice President and Chief Financial
Officer of Applied Proteomics, Inc., a molecular diagnostics company, from December 2014 to August 2015. From June 2011 to December 2014,
Mr. Martin served as Senior Vice President and Chief Financial Officer of Apricus Biosciences, Inc. (“Apricus”), a publicly
traded pharmaceutical company, and served as the Interim Chief Executive Officer of Apricus from November 2012 through March 2013. From
2008 to January 2011, Mr. Martin served as Senior Vice President and Chief Financial Officer of BakBone Software (“BakBone”),
a publicly traded software company. During his final 10 months with BakBone until the company’s acquisition in January 2011, Mr.
Martin also served as BakBone’s Interim Chief Executive Officer. From 2005 to 2007, Mr. Martin served as Chief Financial Officer
of Stratagene Corporation, a publicly traded research products and clinical diagnostics company. Mr. Martin’s previous experience
also includes serving as Controller with Gen-Probe Incorporated, a publicly traded molecular diagnostics company, as well as 10 years
with Deloitte & Touche LLP, a public accounting firm. Mr. Martin holds a Bachelor of Science in Accounting from San Diego State University
and is a certified public accountant (inactive). We believe that Mr. Martin’s expertise in biopharmaceutical industry and accounting
expertise qualifies him to serve on our Board.
Lee
Rauch has served on our Board since February 2022. She is an experienced Chief Executive Officer and Strategy Advisor, has served
both public and private companies. During her near 40-year career, Ms. 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
public and private biotech companies. Among her many leadership roles, Ms. Rauch, was notably a founding member of McKinsey & Co.’s
International Pharmaceutical Practice and the Executive Chairman of Springboard Enterprises Health Innovation Hub. Most recently, Ms.
Rauch, served as President and CEO of Viridian Therapeutics, Inc. Ms. Rauch received a B.S. in Chemistry from Arizona State University
and an M.B.A. in Finance from the University of Chicago. We believe that Ms. Rauch’s biopharmaceutical industry experience and
expertise qualifies her to serve on our Board.
Curtis
Rosebraugh, M.D., MPH has served on our Board since 2021. He is a member of Griebel and Rosebraugh Consulting LLC since May 2018,
where he is a regulatory consultant for small molecule and biological drug development. 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 (“ODE II”)
within the Center for Drug Evaluation and Research (“ CDER ”) from 2007 until his retirement in 2018, with supervisory
responsibility for the evaluation of all drug products within 3 divisions: the Division of Pulmonary, Allergy and Rheumatology Products,
the Division of Metabolism and Endocrinology Products and the Division of Anesthesia, Analgesia, and Addiction Products. In this position,
he has overseen the development and approval of over 50 new drugs, was responsible for the planning of over 100 advisory committee meetings,
led ODE II through several controversial safety issues and has received many honors and awards. Dr. Rosebraugh has been involved in the
development of abuse deterrent opioid formulations and has also been involved in the development of the biosimilar program as well as
many other CDER initiatives. Dr. Rosebraugh received his undergraduate degree in pharmacy in 1981, his Medical Degree in 1986 and completed
a residency in Internal Medicine in 1989, all at the University of Kansas. He completed a Masters of Public Health at Johns Hopkins School
of Public Health in 1999 and a Clinical Pharmacology Fellowship at Georgetown University in 2000. We believe that Dr. Rosebraugh’s
regulatory experience in the biopharmaceutical industry qualifies him to serve on our Board.
82
Role
of Board in Risk Oversight
The
Board has extensive involvement in the oversight of risk management related to us and our business and accomplishes this oversight through
the regular reporting to the Board by the audit committee. The audit committee represents the Board by periodically reviewing our accounting,
reporting and financial practices, including the integrity of our financial statements, the surveillance of administrative and financial
controls and our compliance with legal and regulatory requirements. Through its regular meetings with management, including the finance,
legal, internal audit and information technology functions, the audit committee reviews and discuss all significant areas of our business
and summarize for the Board all areas of risk and the appropriate mitigating factors. In addition, our Board receives periodic detailed
operating performance reviews from management.
Composition
of the Board
Our
business and affairs are managed under the direction of the Board. Our Board consists of seven directors, which are divided into three
classes (Class I, II and III) with Class I and II each consisting of two directors and Class III consisting of three directors.
Board
Committees
The
standing committees of our Board consist of an audit committee, a compensation committee and a nominating and corporate governance committee.
Our Board may from time to time establish other committees. Each of the committees reports to the Board.
Our
president and chief executive officer and other executive officers regularly report to the non-executive directors and the audit, the
compensation and the nominating and corporate governance committees to ensure effective and efficient oversight of our activities and
to assist in proper risk management and the ongoing evaluation of management controls.
Audit
Committee
We
have an audit committee consisting of Steve R. Martin, who serves as the chairperson, Bob Gower and Lee Rauch. Each member of the audit
committee qualifies as an independent director under the Nasdaq corporate governance standards and the independence requirements of Rule
10A-3 of the Exchange Act. Our Board has determined that Steve R. Martin qualifies as an “ audit committee financial expert ”
as such term is defined in Item 407(d)(5) of Regulation S-K and possesses financial sophistication, as defined under the rules of Nasdaq.
The
purpose of the audit committee is to prepare the audit committee report required by the SEC to be included in our proxy statement and
to assist our Board in overseeing and monitoring (1) the quality and integrity of our financial statements, (2) our compliance with legal
and regulatory requirements, (3) our independent registered public accounting firm’s qualifications and independence, (4) the performance
of our internal audit function and (5) the performance of our independent registered public accounting firm.
Our
Board adopted a written charter for the audit committee, which is available on our website.
83
Compensation
Committee
We
have a compensation committee consisting of Adam Levin, who serves as the chairperson, Bob Gower, William Chang, and Lee Rauch.
The
purpose of the compensation committee is to assist our Board in discharging its responsibilities relating to (1) setting our compensation
program and compensation of our executive officers and directors, (2) monitoring our incentive and equity-based compensation plans and
(3) preparing the compensation committee report, if required to be included in our proxy statement under the rules and regulations of
the SEC.
Our
Board adopted a written charter for the compensation committee, which is available on our website.
Nominating
and Corporate Governance Committee
We
have a nominating and corporate governance committee, consisting of Lee Rauch, who serves as chairperson, Bob Gower, Steve R. Martin
and Curtis Rosebraugh. The purpose of our nominating and corporate governance committee is to assist our Board in discharging its responsibilities
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.
Our
Board adopted a written charter for the nominating and corporate governance committee, which is available on our website.
Delinquent
Section 16(a) Reports
None
to report.
Code
of Business Conduct
We
adopted a code of business conduct that applies to all our directors, officers and employees, including our principal executive officer,
principal financial officer and principal accounting officer, which is available on our website. Our code of business conduct is a “code
of ethics,” as defined in Item 406(b) of Regulation S-K. We will make any legally required disclosures regarding amendments to,
or waivers of, provisions of our code of ethics on our website.
Insider
Trading Policies and Procedures
We
have adopted an Insider Trading Policy governing the purchase, sale, and/or other dispositions of our securities by directors, officers
and employees, or by the Company itself. We believe that this policy is reasonably designed to promote compliance with insider trading
laws, rules and regulations, and Nasdaq listing standards.
Item
11. Executive & Director Compensation
This
section discusses the material components of the executive compensation program for our named executive officers. Our named executive
officers, consisting of our principal executive officer and the next two most highly compensated executive officers, for the year ended
December 31, 2025, were:
●
Lynn
Kirkpatrick, Ph.D., Chief Executive Officer;
●
David
Humphrey, Chief Financial Officer; and
●
Geoff
Birkett, Chief Commercial Officer.
84
This
discussion may contain forward-looking statements that are based on our current plans, considerations, expectations and determinations
regarding future compensation programs. Actual compensation programs that we adopt in the future may differ materially from the currently
planned programs summarized in this discussion.
Summary
Compensation Table
The
following table sets forth information concerning the compensation earned by our NEOs in respect of our fiscal years ended December 31,
2025 and December 31, 2024.
Name and Principal
Position
Year
Salary
($)
Bonus ($)
Stock and Option
Awards ($) (1)
Non-Equity
Incentive
Plan
Compensation ($)
All Other
Compensation ($) (2)
Total ($)
Dr. Lynn Kirkpatrick, PhD.
Chief Executive Officer
2025
453,667
-
22,624
-
10,500
486,791
2024
432,042
-
-
-
10,350
442,392
Dave Humphrey
Chief Financial Officer
2025
378,967
-
19,796
-
10,500
409,263
2024
360,917
-
-
-
10,350
371,267
Geoff Birkett
Chief Commercial Officer
2025
350,300
-
16,968
-
10,500
377,768
2024
333,625
-
-
-
10,009
343,634
(1)
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.
(2)
Amounts
shown represent 401(k) matching contributions.
Narrative
Disclosure to Summary Compensation Table
Elements
of Compensation in 2025
The
compensation of our NEOs generally consists of base salary, annual cash bonus opportunities and long-term incentive compensation in the
form of equity awards, as described below.
Base
Salary
The
base salary payable to each NEO is intended to provide a fixed component of compensation reflecting the executive’s skill set,
experience, role, responsibilities, and contributions. Base salaries were initially set at the time each NEO commenced employment with
us, are reviewed annually and may be increased based on the individual performance of the NEO, company performance, any change in the
executive’s position within our business, the scope of the executive’s responsibilities and any changes thereto. Effective
March 1, 2025, the NEO’s annual base salary rates were $457,300 for Dr. Kirkpatrick, $382,000 for Mr. Humphrey and $353,100 for
Mr. Birkett.
Annual
Performance-Based Bonuses
Each
of our NEOs’ performance-based cash bonus opportunity is expressed as a percentage of base salary that can be achieved at a target
level by meeting predetermined Company performance objectives established by the Board or the Compensation Committee. The annual bonus
for Dr. Kirkpatrick is targeted at 50% of her base salary, and Mr. Humphrey and Mr. Birkett’s annual bonuses are targeted at 30%
of their respective base salary. There are no amounts accrued for bonuses as of December 31, 2025.
85
Long-Term
Equity Incentives
In
2021, the Company maintained the Ensysce Biosciences, Inc. 2021 Omnibus Incentive Plan to provide equity-based incentive awards, designed
to align our interests and the interests of our stockholders with those of our employees and consultants, including our NEOs. On January
26, 2022, our stockholders approved the 2021 Amended and Restated Plan. All grants effectuated under predecessor equity plans were converted
to grants outstanding under the 2021 Amended and Restated Plan. In February 2025, the 2021 Amended and Restated Plan was amended to increase
the number of awards authorized from 53,668 to 121,457.
Employment
Agreements with our NEOs
Dr.
Lynn Kirkpatrick, Ph.D.
In
September 2021, we entered into an employment offer letter with Dr. Kirkpatrick. The offer letter provides for Dr. Kirkpatrick’s
at-will employment as our Chief Executive Officer and sets forth her annual base salary of $380,000. Additionally, the letter provides
for her initial target annual bonus opportunity of up to 50% of base salary. The offer letter also indicates that Dr. Kirkpatrick is
eligible to be granted certain stock awards under our equity incentive plan.
Dr.
Kirkpatrick’s offer letter provides for severance benefits upon a termination of her employment by the Company without “ cause ”,
or upon her resignation for “ good reason ”, in an amount equal to twelve (12) months of her then current base salary
(ignoring any decrease in base salary that forms the basis for good reason); provided, however, that the payment of such benefits is
subject to Dr. Kirkpatrick’s continued compliance with her obligations under her “ At-Will, Confidential Information and
Assignment of Inventions Agreement ” and her execution of a general release of claims. Additionally, if such termination without
cause or for good reason occurs within the one (1) month prior to, or during the twelve (12) month period immediately following a change
in control, then all outstanding equity awards subject to time-based vesting will become fully vested on the later of Dr. Kirkpatrick’s
termination date and the change in control. Cause and good reason are as defined in Dr. Kirkpatrick’s offer letter.
Dave
Humphrey
In
February 2021, we entered into an employment offer letter with Mr. Humphrey. The offer letter provided for Mr. Humphrey’s at-will
employment as our Chief Financial Officer at an initial annual base salary of $320,000. Additionally, the letter provided for his initial
target annual bonus opportunity of up to 30% of base salary. The offer letter also indicates that Mr. Humphrey is eligible to be granted
certain stock awards under our equity incentive plan.
Mr.
Humphrey’s offer letter provides for severance benefits upon a termination of his employment by the Company without “ cause ”,
or upon his resignation for “ good reason ”, in an amount equal to six (6) months of his then current base salary (ignoring
any decrease in base salary that forms the basis for good reason); provided, however, that the payment of such benefits is subject to
Mr. Humphrey’s continued compliance with his obligations under his “ Confidential Information and Assignment Agreement ”
and his execution of a general release of claims. Additionally, if such termination without cause or for good reason occurs within the
one (1) month prior to, or during the twelve (12) month period immediately following a change in control, then all outstanding equity
awards subject to time-based vesting will become fully vested on the later of Mr. Humphrey’s termination date and the change in
control. Cause and good reason are as defined in Mr. Humphrey’s offer letter.
Geoff
Birkett
In
July 2021, we entered into an employment offer letter with Mr. Birkett. The offer letter provides for Mr. Birkett’s at-will employment
as our Chief Commercial Officer and sets forth his annual base salary of $300,000. Additionally, the letter provides for his initial
target annual bonus opportunity of up to 30% of base salary. The offer letter also indicates that Mr. Birkett is eligible to be granted
certain stock awards under our equity incentive plan.
86
Mr.
Birkett’s offer letter provides for severance benefits upon a termination of his employment by the Company without “cause”,
or upon his resignation for “good reason”, in an amount equal to three (3) months of his then current base salary (ignoring
any decrease in base salary that forms the basis for good reason); provided, however, that the payment of such benefits is subject to
Mr. Birkett’s continued compliance with his obligations under his “ Confidential Information and Assignment Agreement ”
and his execution of a general release of claims. Additionally, if such termination without cause or for good reason occurs within the
one (1) month prior to, or the twelve (12) month period immediately following a change in control, then all outstanding equity awards
subject to time-based vesting will become fully vested on the later of Mr. Birkett’s termination date and the change in control.
Cause and good reason are as defined in the offer letter.
At-Will,
Confidential Information and Assignment of Inventions Agreement
In
connection with each respective offer letter, Dr. Kirkpatrick, Mr. Birkett and Mr. Humphrey entered into an “At-Will, Confidential
Information and Assignment of Inventions Agreement” (the “Confidentiality Agreement”). The Confidentiality Agreements
include customary prohibitions against solicitation of our customers and employees, both during employment and for two (2) years following
any cessation of employment. The Confidentiality Agreements also include standard provisions relating to the Company’s intellectual
property rights and prohibit the executive from disclosing confidential information. The Confidentiality Agreements are incorporated
by reference into the offer letters and payment of any severance benefits under each executive’s offer letter is conditioned on
continued compliance with his or her Confidentiality Agreement.
Other
Benefits
We
currently provide welfare benefits that are available to all of our employees, including our NEOs, including health, dental, vision and
group life insurance.
Effective
January 1, 2022, we put into place the Ensysce Biosciences, Inc. 401(k) Plan” (the “ 401(k) Plan ”). The 401(k)
Plan provides eligible employees with an opportunity to save for retirement on a tax-advantaged basis and under which we are permitted
to make safe harbor employer contributions. Employees’ pre-tax contributions are allocated to each participant’s individual
account and are then invested in selected investment alternatives according to the participants’ directions. The 401(k) Plan is
intended to be qualified under Section 401(a) of the Code, with the related trust intended to be tax exempt under Section 501(a) of the
Code. Under the 401(k) Plan, we make employer contributions to all employees – regardless of an employee’s contributions
(or lack thereof) – in an amount equal to 3% of the employee’s eligible compensation.
We
do not maintain any defined benefit pension plans or nonqualified deferred compensation plans.
Outstanding
Equity Awards at Fiscal Year-End
The
following table provides information regarding outstanding equity awards held by our NEOs as of December 31, 2025.
Option Awards
Stock Awards
Name
Grant Date
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 ($)
Dr. Lynn Kirkpatrick, PhD.
1/15/2016
74
0
11,484.00
1/15/2026
-
-
1/4/2017
128
0
6,588.00
1/4/2027
-
-
2/5/2018
228
0
6,048.00
2/5/2028
-
-
3/1/2019
183
0
9,324.00
2/28/2029
-
-
3/15/2019
2
0
9,324.00
3/14/2029
-
-
2/17/2022
53
3
5,040.00
2/17/2032
-
-
10/25/2023
6,667
0
17.70
10/25/2033
-
-
3/28/2025
6,000
2,000
3.12
3/28/2035
Dave Humphrey
2/4/2022
77
0
11,268.00
2/4/2032
-
-
2/17/2022
22
1
5,040.00
2/17/2032
-
-
10/25/2023
6,667
0
17.70
10/25/2033
-
-
3/28/2025
5,249
1,751
3.12
3/28/2035
Geoff Birkett
10/1/2018
6
0
9,324.00
9/30/2028
-
-
3/1/2019
92
0
9,324.00
2/28/2029
-
-
2/17/2022
13
1
5,040.00
2/17/2032
-
-
10/25/2023
5,001
0
17.70
10/25/2033
-
-
3/28/2025
4,500
1,500
3.12
3/28/2035
87
Pay
Versus Performance
In
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.
The
following table sets forth specified executive compensation and financial performance measures for our three most recently completed
fiscal years, as required under 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.
Year
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)
2025
$ 486,791
$ 470,295
$ 393,516
$ 380,113
$ 0.68
($ 10,175,700 )
2024
$ 442,392
$ 442,392
$ 357,451
$ 357,451
$ 6.03
($ 7,987,225 )
2023
$ 508,575
$ 507,187
$ 417,152
$ 416,177
$ 11.78
($ 10,626,011 )
(1)
For
all fiscal years presented, the principal executive officer (“PEO”) was our Chief Executive Officer, Dr. Lynn Kirkpatrick.
(2)
The
amounts disclosed reflect the following adjustments to the amounts reported in the Summary Compensation Table for the PEO:
Year
Less: 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
Less: Fair Value as of Prior Year End of Awards Forfeited in the Year
Total Adjustments
2025
$ (22,624 )
$ 1,532
$ -
$ 4,596
$ -
$ -
$ (16,496 )
2024
$ -
$ -
$ -
$ -
$ -
$ -
$ -
2023
$ (93,800 )
$ -
$ (809 )
$ 93,800
$ (579 )
$ -
$ (1,388 )
(3)
For
all fiscal years presented, the Non-PEO NEOs were Dave Humphrey and Geoff Birkett.
(4)
The
amounts disclosed reflect the following adjustments to the amounts reported in the Summary Compensation Table for the Non-PEO NEOs:
Year
Less: 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
Less: Fair Value as of Prior Year End of Awards Forfeited in the Year
Total Adjustments
2025
$ (18,382 )
$ 1,245
$ -
$ 3,734
$ -
$ -
$ (13,403 )
2024
$ -
$ -
$ -
$ -
$ -
$ -
$ -
2023
$ (82,075 )
$ -
$ (362 )
$ 82,075
$ (613 )
$ -
$ (975 )
(5)
Total
Shareholder Return is calculated as the sum of (i) the cumulative amount of dividends for the measurement period, assuming reinvestment
of all dividends, if any, plus (ii) the cumulative increase or decrease in the price of our common stock each respective year,
divided by the price of our common stock at the beginning of the measurement period.
88
Relationship
Between Compensation Actually Paid and Company Total Shareholder Return (“TSR”)
Relationship
Between Compensation Actually Paid and Net Income (Loss)
Director
Compensation
The
following table provides summary information concerning compensation paid or accrued by us to or on behalf of our non-employee directors
for services rendered to us as of December 31, 2025.
Name
Fees Earned or Paid in Cash ($)
Option Awards
($)
Total
($)
Bob Gower
25,000
5,656
30,656
William Chang
7,500
5,656
13,156
Andrew Benton
7,500
5,656
13,156
Steve Martin
15,000
5,656
20,656
Adam Levin
10,000
5,656
15,656
Lee Rauch
10,000
5,656
15,656
Curt Rosebraugh
7,500
5,656
13,156
89
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The
following table sets forth information with respect to the beneficial ownership of shares of our common stock by (i) each director, (ii)
each named executive officer, (iii) all directors and executive officers as a group, and (iv) each person who we know beneficially owns
more than 5% of our common stock as of March 23, 2026, unless otherwise indicated below.
Beneficial
ownership is determined in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to
persons who possess sole or shared voting power or investment power with respect to those securities and include shares of common stock
issuable upon the exercise of stock options that are immediately exercisable or exercisable within 60 days after March 23, 2026, but excludes
unvested stock options. Except as otherwise indicated, all of the shares reflected in the table are shares of common stock and all persons
listed below have sole voting and investment power with respect to the shares beneficially owned by them, subject to applicable community
property laws. The information is not necessarily indicative of beneficial ownership for any other purpose.
In
computing the number of shares of common stock beneficially owned by a person and the percentage ownership of that person, we deemed
outstanding shares of common stock subject to options or warrants held by that person that are currently exercisable or exercisable within
60 days of March 23, 2026. We did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of
any other person.
Percentage
ownership calculations for beneficial ownership for each person or entity are based on 9,277,819 shares outstanding as of March 23, 2026.
Except as otherwise indicated in the table below, addresses of named beneficial owners are in care of Ensysce Biosciences, Inc., 7946
Ivanhoe Avenue, Suite 201, La Jolla, California 92037. All share amounts have been adjusted for prior reverse stock splits.
Beneficial
Ownership Table
Name and Address of Beneficial Owners
Number of Shares
Percentage
Officers and Directors
Dr. Lynn Kirkpatrick (1)
15,371
*
Geoff Birkett (2)
11,113
*
David Humphrey (3)
13,781
*
Jeff Millard (4)
2,500
*
Linda Pestano (5)
11,056
*
William Chang (6)
2,733
*
Bob Gower (7)
43,655
*
Adam Levin (8)
3,345
*
Steve R. Martin (9)
3,364
*
Lee Rauch (10)
3,345
*
Curtis Rosebraugh (11)
3,345
*
All directors and named executive officers as a group (eleven individuals)
113,608
1.2 %
Greater than 5% Holders
None
—
—
*
Indicates
less than 1%.
(1)
Includes
15,264 shares subject to options.
(2)
Consists
of shares subject to options.
(3)
Includes
13,767 shares subject to options.
(4)
Consists
of shares subject to options.
(5)
Consists
of shares subject to options.
(6)
Includes
2,011 shares subject to options, 209 shares owned directly by Mr. Chang and his wife and 513 shares owned through trusts in which
Mr. Chang has sole or shared voting and dispositive power. The business address for Mr. Chang is 520 El Camino Real, 9th Floor, San
Mateo, CA 94402.
(7)
Includes
2,013 shares subject to options, 8,126 shares held directly and 33,516 shares that may be acquired through the exercise of (i) warrants
acquired in connection with the October 2023 Securities Purchase Agreement and (ii) warrants acquired in 2022. The business address
for Mr. Gower is 101 Westcott, Unit 303, Houston, Texas 77007.
(8)
Consists
of shares subject to options.
(9)
Consists
of shares subject to options.
(10)
Consists
of shares subject to options.
(11)
Consists
of shares subject to options.
90
Item
13. Certain Relationships and Related Transactions and Director Independence
Other
than the agreements and arrangements described under the section entitled “ Executive & Director Compensation ”
and the transactions described below, since January 1, 2025, there has not been and there is not currently proposed, any transaction
or series of similar transactions to which (i) we were, or will be, a participant; (ii) the amount involved exceeded, or will exceed,
$120,000 or 1% of the average of our total assets at December 31, 2024 and 2025; and (iii) in which any director, executive officer,
holder of 5% or more of any class of our capital stock or any member of the immediate family of, or entities affiliated with, any of
the foregoing persons, had, or will have, a direct or indirect material interest.
Convertible
Notes
In
the 2023 Notes offering, Bob Gower, our Chairman, purchased an aggregate principal amount of Investor Notes of $216,000 for a purchase
price of $200,000 and Investor Warrants that may be exercised for an aggregate of 29,547 shares of common stock. The per share conversion
price of the Investor Notes and the per share exercise price of the Investor Warrants is $23.51.
Related
Party Transaction Policy
The
Board previously adopted a written related person transaction policy that sets forth the following policies and procedures for the review
and approval or ratification of related person transactions.
An
“ Immediate Family Member ” means a child, stepchild, parent, stepparent, spouse, sibling, mother-in-law, father-in-law,
son-in-law, daughter-in-law, brother-in-law, sister-in-law, or any person sharing the household (other than a tenant or employee).
A
“ Related Party ” means any (a) person who is or was (since the beginning of the last fiscal year for which we have
filed a Form 10-K and proxy statement, even if they do not presently serve in that role) an executive officer, director or nominee for
election as a director of the Company, (b) greater than 5% beneficial owner of the Company’s outstanding common stock, or (c) Immediate
Family Member of any of the foregoing.
A
“ Related Person Transaction ” is any Transaction involving the Company in which a Related Party has or will have a
direct or indirect material interest, as determined by the Audit Committee.
A
“ Transaction ” means any financial transaction, arrangement or relationship or any series of similar transactions,
arrangements or relationships, including indebtedness and guarantees of indebtedness and transactions involving employment and similar
relationships.
Under
the policy, the following types of Transactions are deemed not to create or involve a material interest on the part of the Related Party,
nor will they require approval or ratification, under the policy:
●
Transactions
involving the purchase or sale of products or services in the ordinary course of business, not exceeding $50,000 or, if the Company
is a “ smaller reporting company ” as defined under the Securities Act, if less, one percent of the average of the
Company’s total assets as of December 31st for the last two completed fiscal years.
●
Transactions
in which the Related Party’s interest derives solely from his or her service as a director of another corporation or organization
that is a party to the Transaction.
●
Transactions
in which the Related Party’s interest derives solely from his or her ownership of less than 5% of the equity interest in another
person (other than a general partnership interest) which is a party to the Transaction.
●
Transactions
in which the Related Party’s interest derives solely from his or her ownership of a class of equity securities of the Company
and all holders of that class of equity securities received the same benefit on a pro rata basis (e.g., dividends).
●
Transactions
in which the Related Party’s interest derives solely from his or her service as a director, trustee or officer (or similar
position) of a not-for-profit organization or charity that receives donations from the Company, which donations are made pursuant
to the Company’s matching program, as a result of contributions by employees, that is available on the same terms to all employees
of the Company.
●
Compensation
arrangements of any executive officer, other than an individual who is an Immediate Family Member of a Related Party, if such arrangements
have been approved or recommended to the Board for approval by the Compensation Committee.
91
●
Director
compensation arrangements, if such arrangements have been approved by the Board or the Compensation Committee of the Board.
●
Transactions
with a Related Party in which the rates or charges involved in the Transaction are determined by competitive bids, or the Transaction
involves the rendering of services as a common or contract carrier, or public utility, at rates or charges fixed in conformity with
law or governmental authority.
●
Indemnity
payments made to directors and executive officers in accordance with the Company’s then existing certificate of incorporation,
bylaws and applicable laws.
●
Transactions
with a Related Party involving services as a bank depositary of funds, transfer agent, registrar, trustee under a trust indenture
or similar services.
Pursuant
to its Audit Committee charter, the Audit Committee has the responsibility to review, approve or ratify any Related Person Transactions.
During 2025, no director or officer adopted or terminated any contract, instruction or written plan for the purchase or sale of our securities
as either a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement.
Director
Independence
Nasdaq
listing rules require that a majority of the board of directors of a company listed on Nasdaq be composed of “ independent directors ,”
which is defined generally as a person other than an officer or employee of the company or its subsidiaries or any other individual having
a relationship that, in the opinion of the company’s board of directors, would interfere with the director’s exercise of
independent judgment in carrying out the responsibilities of a director. Based on information provided by each director concerning his
or her background, employment and affiliations, including family relationships, the Board determined that each of Bob Gower, William
Chang, Steve R. Martin, Adam S. Levin, Lee Rauch and Curtis Rosebraugh is an independent director under the Nasdaq listing rules and
Rule 10A-3 of the Exchange Act. In making these determinations, the Board considered the current and prior relationships that each non-employee
director has and will have with us and all other facts and circumstances that the Board deems relevant in determining independence, including
the beneficial ownership of our common stock by each non- employee director (and related entities) and the transactions involving them
described in the section entitled “ Certain Relationships and Related Party Transactions.”
Item
14. Principal Accountant Fees and Services
On
April 10, 2023, the Audit Committee of our Board appointed Moss Adams LLP (“ Moss Adams ”) as our independent registered
public accounting firm to audit our consolidated financial statements beginning with the fiscal year ending December 31, 2023. On June
3, 2025, Moss Adams merged with Baker Tilly US, LLP (“Baker Tilly”) and now operates as Baker Tilly.
The
following table sets forth the aggregate fees incurred for our independent registered accounting firm for the fiscal years ended December
31, 2025 and 2024. These fees are categorized as audit fees, audit-related fees, tax fees, and all other fees. The nature of the services
provided in each category is described below the table.
2025
2024
Audit Fees
$ 477,030
$ 409,678
Audit-Related Fees
27,300
30,500
Tax Fees
—
—
All Other Fees
—
—
Total
$ 504,330
$ 440,178
Audit
fees . Consist of fees incurred for professional services rendered for the audit of the consolidated financial statements and review
of the quarterly interim consolidated financial statements. These fees also include the review of registration statements and the delivery
of consents in connection with registration statements.
Audit-related
fees . Consist of fees incurred for professional services rendered for the compliance audit in accordance with the audit requirements
of Title 2 U.S. Code of Federal Regulations Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for
Federal Awards related to funding under federal government grants.
Tax
fees . There were no fees billed for tax fees for the fiscal years ended December 31, 2025 and 2024.
All
other fees . There were no fees billed for professional services rendered for other compliance purposes for the fiscal years ended
December 31, 2025 and 2024.
All
audit-related and other non-audit services were pre-approved by the Audit Committee, which concluded that the provision of such services
was compatible with the maintenance of the respective firm’s independence in the conduct of its auditing functions.
92
PART
IV
Item
15. Exhibits and Financial Statement Schedules.
Financial
Statements
ENSYSCE
BIOSCIENCES, INC.
CONSOLIDATED
FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB No. 23 )
F-1
Consolidated Balance Sheets as of December 31, 2025 and 2024
F-2
Consolidated Statements of Operations for the years ended December 31, 2025 and 2024
F-3
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2025 and 2024
F-4
Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024
F-5
Notes to the Consolidated Financial Statements
F-6
to F-23
93
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Shareholders and the Board of Directors of
Ensysce
Biosciences Inc.
Opinion
on the Financial Statements
We have audited the accompanying consolidated balance sheets of Ensysce
Biosciences, Inc. (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations
and comprehensive loss, stockholders’ equity (deficit), and cash flows for the years then ended, and the related notes (collectively
referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly,
in all material respects, the consolidated financial position of the Company as of December 31, 2025 and 2024, and the consolidated
results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in
the United States of America.
Going
Concern Uncertainty
The accompanying consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company
has suffered recurring losses from operations and has an accumulated deficit. These circumstances raise substantial doubt about its ability
to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial
statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis
for Opinion
These consolidated financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based
on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform,
an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal
control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material
misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures to respond to those risks.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matters
The critical audit matter communicated below is a matter arising from
the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee
and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially
challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the
consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate
opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Accounting
for Series B Convertible Preferred Stock
As described in Note 9 to the consolidated financial statements, the Company entered into a Securities Purchase
Agreement in November 2025 with an institutional investor providing for a registered direct offering and concurrent private placement
for aggregate financing of $4 million. The Securities Purchase Agreement involved the issuance of 4,000 shares of Series B Convertible
Preferred Stock and 992,000 warrants of which 880,000 warrants were issued to certain institutional investors and 112,000 warrants were
issued to the placement agent. The Company determined both the Series B Convertible Preferred Stock and the warrants were equity-classified.
Additionally, certain embedded features were identified and assessed to determine whether separate recognition at fair value was required.
The Company determined that although certain embedded features contained in the Series B Convertible Preferred Stock were required to
be recognized separately and measured at fair value, presentation as separate derivative liabilities was immaterial. Management’s
determination of fair value of the embedded derivatives involved using complex valuation methodologies and significant assumptions, including
determining the probability of certain conditions or events occurring.
We identified the classification of the Series B Convertible Preferred
Stock and warrants and the classification and valuation of the embedded derivatives as a critical audit matter. Auditing the Company’s
evaluation of certain provisions within the relevant agreements for purposes of the financial statement classification for these financial
instruments, including the methods and assumptions used to estimate fair value of embedded features, involved especially challenging and
complex auditor judgment when performing audit procedures and evaluating the results of those procedures.
Addressing the matter involved performing procedures and evaluating
audit evidence in connection with forming our overall opinion on the consolidated financial statements. Our audit procedures related to
the evaluation of the financial statement classification of the Series B Convertible Preferred Stock and warrants and the classification
and valuation of the embedded derivatives included the following, among others:
● Obtaining and reviewing the underlying Series B Convertible Preferred Stock agreements to understand the
terms and conditions, economic substance, and the identification of embedded features.
● Utilizing a subject matter expert on technical accounting matters to assist in (i) evaluating relevant
terms of the agreements in relation to the appropriate accounting literature, and (ii) assessing the appropriateness of conclusions reached
by the Company.
● Obtaining an understanding of management’s process for estimating fair value of the embedded features,
including:
○ Evaluating the appropriateness of the method selected;
○ Identifying the significant assumptions used to determine fair value and;
○ Verifying the application of those assumptions in the method selected.
● Testing the data and significant assumptions used to determine fair value of the embedded features, including
performing procedures to determine whether the data used was complete and accurate and whether management’s estimation of the probability
of certain conditions or events were reasonable.
● Utilizing a valuation specialist to assist in evaluating the reasonableness of the valuation methodology
and the underlying assumptions.
/s/
Baker Tilly US, LLP
San
Diego, California
March
30, 2026
We
have served as the Company’s auditor since 2023.
F- 1
Ensysce
Biosciences, Inc.
Consolidated
Balance Sheets
2025
2024
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$ 4,310,354
$ 3,502,077
Unbilled receivable
420,345
124,115
Prepaid expenses and other current assets
2,511,769
1,718,490
Total current assets
7,242,468
5,344,682
Property and equipment, net
124,129
–
Other assets
85,882
252,550
Total assets
$ 7,452,479
$ 5,597,232
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
$ 3,267,610
$ 1,357,079
Accrued expenses and other liabilities
993,411
548,458
Notes payable and accrued interest
306,708
301,660
Total current liabilities
4,567,729
2,207,197
Long-term liabilities:
Other long-term liabilities
–
10,096
Total long-term liabilities
–
10,096
Total liabilities
$ 4,567,729
$ 2,217,293
Commitments and contingencies (Note 7)
-
Stockholders’ equity
Preferred stock, $ 0.0001 par value, 1,500,000 shares authorized, 4,000 shares issued, 3,305 shares outstanding, and $ 3,635,500 liquidation preference at December 31, 2025; no shares issued and outstanding at December 31, 2024
$ –
$ –
Common stock, $ 0.0001 par value, 250,000,000 shares authorized at December 31, 2025 and December 31, 2024; 4,574,983 and 1,355,779 shares issued at December 31, 2025 and December 31, 2024, respectively; 4,574,977 and 1,355,773 shares outstanding at December 31, 2025 and December 31, 2024, respectively
459
136
Additional paid-in capital
142,933,260
133,252,585
Accumulated deficit
( 139,719,999 )
( 129,544,299 )
Total Ensysce Biosciences, Inc. stockholders’ equity
3,213,720
3,708,422
Noncontrolling interests in stockholders’ deficit
( 328,970 )
( 328,483 )
Total stockholders’ equity
2,884,750
3,379,939
Total liabilities and stockholders’ equity
$ 7,452,479
$ 5,597,232
The
accompanying notes are an integral part of these consolidated financial statements.
F- 2
Ensysce
Biosciences, Inc.
Consolidated
Statement of Operations
2025
2024
Year Ended December 31,
2025
2024
Federal grants
$ 5,066,650
$ 5,210,031
Operating expenses:
Research and development
10,376,895
7,219,437
General and administrative
4,930,701
4,720,728
Total operating expenses
15,307,596
11,940,165
Loss from operations
( 10,240,946 )
( 6,730,134 )
Other income (expense):
Change in fair value of liability classified warrants
10,096
16,292
Interest expense, net
( 18,767 )
( 1,290,444 )
Other income and expense, net
73,430
17,277
Total other income (expense), net
64,759
( 1,256,875 )
Net loss
$ ( 10,176,187 )
$ ( 7,987,009 )
Net loss attributable to noncontrolling interests
( 487 )
( 74 )
Deemed dividend related to warrants down round provision
–
290
Net loss attributable to common stockholders
$ ( 10,175,700 )
$ ( 7,987,225 )
Net loss per basic and diluted share:
Net loss per share attributable to common stockholders, basic and diluted
$ ( 3.98 )
$ ( 11.45 )
Weighted average common shares outstanding, basic and diluted
2,557,377
697,686
The
accompanying notes are an integral part of these consolidated financial statements.
F- 3
Ensysce
Biosciences, Inc.
Consolidated
Statement of Changes in Stockholders’ Equity
Number
of
Shares
Amount
Number
of
Shares
Amount
Additional
Paid-In
Capital
Accumulated
Deficit
Noncontrolling
interests
Total
Stockholders’ Equity (Deficit)
Preferred Stock
Common Stock
Number
of
Shares
Amount
Number
of
Shares
Amount
Additional
Paid-In
Capital
Accumulated
Deficit
Noncontrolling
interests
Total
Balance on December 31, 2023
–
$ –
209,739
$ 21
$ 121,234,195
$ ( 121,557,074 )
$ ( 328,409 )
$ ( 651,267 )
Settlement of restricted stock units
–
–
5
–
–
–
–
–
Conversion of convertible notes
–
–
49,702
5
1,168,595
–
–
1,168,600
Public offering
–
–
236,880
24
1,669,977
–
–
1,670,001
Issuance of common stock upon exercise of warrants
–
–
139,028
14
2,433,066
–
2,433,080
Issuance of common stock upon warrant inducements
–
–
720,357
72
8,103,870
8,103,942
Transaction costs associated with public offering and warrant inducements
–
–
–
–
( 1,468,131 )
–
–
( 1,468,131 )
Stock-based compensation
–
–
–
–
110,723
–
–
110,723
Reverse split fractional shares
–
–
62
–
–
–
–
–
Deemed dividend related to warrants down round provision
–
–
–
–
290
( 290 )
–
–
Net loss
–
–
–
–
–
( 7,986,935 )
( 74 )
( 7,987,009 )
Balance on December 31, 2024
–
$ –
1,355,773
$ 136
$ 133,252,585
$ ( 129,544,299 )
$ ( 328,483 )
$ 3,379,939
Balance
–
$ –
1,355,773
$ 136
$ 133,252,585
$ ( 129,544,299 )
$ ( 328,483 )
$ 3,379,939
Public offering
–
–
239,594
25
1,099,982
–
–
1,100,007
Issuance of common stock upon exercise of warrants
–
–
1,295,519
130
2,571,937
–
–
2,572,067
Issuance of common stock upon warrant inducements
–
–
630,376
63
2,199,949
–
–
2,200,012
Transaction costs associated with public offering and warrant inducements
–
–
–
–
( 501,214 )
–
–
( 501,214 )
Issuance of Series B Preferred Stock
4,000
–
3,975,000
–
–
3,975,000
Transaction costs associated with Series B Preferred Stock
–
–
( 510,642 )
–
–
( 510,642 )
Conversions of preferred stock into common stock
( 695 )
–
560,365
56
( 56 )
–
–
–
Consultant compensation
–
–
493,350
49
668,633
–
–
668,682
Stock-based compensation
–
–
–
–
177,086
–
–
177,086
Net loss
–
–
–
–
–
( 10,175,700 )
( 487 )
( 10,176,187 )
Balance on December 31, 2025
3,305
$ –
4,574,977
$ 459
$ 142,933,260
$ ( 139,719,999 )
$ ( 328,970 )
$ 2,884,750
Balance
3,305
$ –
4,574,977
$ 459
$ 142,933,260
$ ( 139,719,999 )
$ ( 328,970 )
$ 2,884,750
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
Ensysce
Biosciences, Inc.
Consolidated
Statement of Cash Flows
2025
2024
Year Ended December 31,
2025
2024
Cash flows from operating activities:
Net loss
$ ( 10,176,187 )
$ ( 7,987,009 )
Adjustments to reconcile net loss to net cash used in operating activities:
Accrued interest
12,393
43,927
Amortization of original issue discount and debt issuance costs
–
1,197,200
Change in fair value of liability classified warrants
( 10,096 )
( 16,292 )
Consultant compensation
668,682
–
Stock-based compensation
177,086
110,723
Depreciation expense
6,533
–
Changes in operating assets and liabilities
Unbilled receivable
( 296,230 )
( 26,554 )
Prepaid expenses and other assets
( 438,565 )
( 251,965 )
Accounts payable
1,815,658
( 578,928 )
Accrued expenses and other liabilities
434,434
6,198
Net cash used in operating activities
( 7,806,292 )
( 7,502,700 )
Cash flows from investing activities:
Investment in property and equipment
( 123,643 )
–
Net cash flows used in investing activities
( 123,643 )
–
Cash flows from financing activities:
Proceeds from public offerings
1,100,007
1,670,001
Proceeds from warrant exercises
2,572,067
2,433,080
Proceeds from warrant inducement, net of issuance costs
2,200,012
8,103,942
Proceeds from issuance of Series B Preferred Stock
3,975,000
–
Transaction costs associated with public offering and warrant inducements
( 501,214 )
( 1,468,131 )
Transaction costs associated with Series B Preferred Stock issuance
( 391,376 )
–
Repayment of convertible notes
–
( 485,190 )
Repayment of financed insurance premiums
( 216,284 )
( 372,529 )
Net cash provided by financing activities
8,738,212
9,881,173
Increase in cash and cash equivalents
808,277
2,378,473
Cash and cash equivalents beginning of period
3,502,077
1,123,604
Cash and cash equivalents end of period
$ 4,310,354
$ 3,502,077
Supplemental cash flow information:
State minimum tax payments
$ 2,500
$ 3,200
Supplemental disclosure of non-cash investing and financing activities:
Incremental fair value of August 2024 Warrant Inducement
$ –
$ 10,210,616
Incremental fair value of February 2024 Warrant Inducement
$ –
$ 5,167,372
Incremental fair value of April 2025 Warrant Inducement
$ 3,483,420
$ –
Transaction costs under accounts payable and accrued expenses
$ 119,266
$ –
Investment in property and equipment under accounts payable
$ 7,091
$ –
Conversion of convertible notes into common stock
$ –
$ 1,168,600
Financed insurance premiums
$ 188,046
$ 232,155
Deemed dividend related to warrants down round provision
$ –
$ 290
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
Ensysce
Biosciences, Inc.
Notes
to the Consolidated Financial Statements
NOTE
1 – ORGANIZATION AND PRINCIPAL ACTIVITIES
Ensysce
Biosciences, Inc. (“Ensysce”), along with its 79.2 %-owned subsidiary, EBIR, Inc. (“EBIR”, formerly known as Covistat,
Inc.) and its wholly-owned subsidiaries EBI Operating, Inc. and EBI OpCo, Inc. (collectively, the “Company”), is a clinical-stage
biotech company using its proprietary technology platforms to develop safer prescription drugs. The primary focus of the Company is its
program developing abuse and overdose resistant pain technology with a clinical stage program being the abuse resistant, TAAP (Trypsin
Activated Abuse Protection) opioid product candidate, PF614. In addition, the Company is developing its MPAR® (Multi-Pill Abuse Resistance)
technology for overdose protection which will be applied to the PF614 program. The Company is also applying its TAAP and MPAR® technology
to a methadone prodrug for use in the treatment of Opioid Use Disorder.
In
2020, the Company commenced an initiative to develop a therapeutic for the treatment of certain coronavirus infections through the formation
of a separate entity, EBIR, a Delaware corporation. Pursuant to the articles of incorporation, EBIR was authorized to issue 1,000,000
shares of common stock, $ 0.001 par value per share, and 100,000 shares of preferred stock, $ 0.001 par value per share. Ensysce is a 79.2 %
stockholder in EBIR, with 19.8 % and 1.0 % of the shares held by certain key personnel of the Company and an unrelated party, respectively.
The non-Ensysce owned shares and the activity are reflected on the financial statements as noncontrolling interests.
NOTE
2 - BASIS OF PRESENTATION
The
consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States
of America (“GAAP”) and pursuant to the rules and regulations of the United States Securities Exchange Commission (“SEC”).
The consolidated financial statements include the accounts of Ensysce Biosciences, Inc. and its subsidiaries. All intercompany balances
and transactions have been eliminated in the consolidation.
Reverse
Stock Split
In
December 2024, the Company completed a 1-for-15 reverse split of its outstanding common stock.
All
references in these consolidated financial statements to shares and per share amounts in all periods have been retrospectively restated
to reflect the effects of both reverse splits noted above. The number of authorized shares and the par value of the shares did not change
as a result of the reverse stock splits.
Going
Concern
The
accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates,
among other things, the realization of assets and satisfaction of liabilities in the normal course of business.
The
Company has not generated any product revenue. There is no assurance that profitable operations will ever be achieved, and, if achieved,
would be sustained on a continuing basis. Product development activities, clinical and pre-clinical testing, and commercialization of
the Company’s product candidates are necessary to develop the Company’s products and will require significant additional
financing. There can be no assurance the Company will be able to obtain such funds. These matters, among others, raise substantial doubt
about the Company’s ability to continue as a going concern.
While
the Company believes in the viability of its strategy to ultimately realize revenues and in its ability to raise additional funds, management
cannot be certain that additional funding will be available on acceptable terms, or at all. The Company’s ability to continue as
a going concern is dependent upon its ability to obtain adequate financing and achieve profitable operations. As a result, these plans
do not alleviate substantial doubt about the Company’s ability to continue as a going concern for a period of 12 months following
the date these consolidated financial statements were issued.
F- 6
The
consolidated financial statements do not include any adjustments that might be necessary should the Company be unable to continue as
a going concern.
NOTE
3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use
of Estimates and Assumptions
Preparation
of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the
amounts reported in the consolidated financial statements and disclosed in the accompanying notes. Actual results may differ from those
estimates and such differences may be material to the consolidated financial statements. The more significant estimates and assumptions
by management include, but are not limited to, the expense recognition for certain accrued research and development services.
Cash
and Cash Equivalents
For
purposes of the consolidated balance sheets and consolidated statements of cash flows, the Company considers all highly liquid instruments
with maturity of three months or less at the time of issuance to be cash equivalents.
Concentrations
of Credit Risk and Off-Balance Sheet Risk
Cash
and cash equivalents are financial instruments that are potentially subject to concentrations of credit risk. The Company’s cash
and cash equivalents are deposited in accounts at large financial institutions and amounts currently exceed federally insured limits.
The Company has no financial instruments with off-balance sheet risk of loss. Additionally, the Company had a concentration in accounts
payable, as three research and development vendors made up greater than 10% individually, and 82 % and 74 % in aggregate , of the outstanding
accounts payable balance as of December 31, 2025 and 2024, respectively.
Segments
The
Company operates and manages its business as one reportable and operating segment. Operating segments are defined as components of an
enterprise where separate financial information is evaluated regularly by the chief operating decision maker (CODM) in deciding how to
allocate resources and assess performance. The Company’s CODM is the Chief Executive Officer, who reviews consolidated financial
information on a company-wide basis for purposes of allocating resources and assessing financial performance and does not regularly review
expenses or financial results on a more granular level.
Property
and Equipment
Property
and equipment are recorded at cost and depreciated using the straight-line method over an estimated useful life of five years . As of
December 31, 2025, property and equipment consists of laboratory equipment. During the year ended December 31, 2025, the Company recognized
depreciation expense of $ 6,533 . There was no property and equipment as of December 31, 2024 and as such no depreciation expense recognized
during the year ended December 31, 2024.
Fair
Value Measurement
ASC
820, Fair Value Measurements , (“ASC 820”) provides guidance on the development and disclosure of fair value measurements.
Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset
or paid to transfer a liability in an orderly transaction between willing market participants at the measurement date. As such, fair
value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset
or a liability.
F- 7
The
accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes:
Level
1:
Quoted
prices in active markets for identical assets or liabilities.
Level
2:
Inputs
other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace.
Level
3:
Unobservable
inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies,
or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
The
Company evaluates assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level at
which to classify them for each reporting period. This determination requires significant judgments to be made by the Company.
As
of December 31, 2025 and 2024, the recorded values of cash and cash equivalents, prepaid expenses, accounts payable, and accrued expenses
and other liabilities approximate their fair values due to the short-term nature of these items.
Warrants
The
Company issued liability classified warrants in connection with the issuance of the 2021 Notes and 2022 Notes. The warrants were liability
classified due to certain cash settlement features and included in “Other long-term liabilities” on the consolidated balance
sheets. The Company uses a Black Scholes model to estimate the fair value of the warrants. Changes in the fair value of the warrants
are recognized in other income (expense) for each reporting period. Refer to Note 9 for additional details of the warrants.
The
following tables present assets and liabilities measured and recorded at fair value on the Company’s consolidated balance sheet
as of December 31, 2025 and 2024. The Company’s Level 3 liabilities as of December 31, 2025, are de minimis.
SCHEDULE OF ASSETS AND LIABILITIES MEASURED AT FAIR VALUE
Total
Level 1
Level 2
Level 3
December 31, 2024
Total
Level 1
Level 2
Level 3
Liability classified warrants
10,096
–
–
10,096
Total
$ 10,096
$ –
$ –
$ 10,096
The
following table summarizes the change in fair value of the Company’s Level 3 liabilities for the year ended December 31, 2025 (no
level 3 assets as of the year ended December 31, 2025):
SCHEDULE OF CHANGE IN FAIR VALUE OF LIABILITIES
Liability classified warrants
Fair value, December 31, 2024
$ 10,096
Change in fair value
( 10,096 )
Fair value, December 31, 2025
$ –
Federal
Grants
In
September 2018, the NIH through NIDA awarded the Company a research and development MPAR Grant. The initial grant was extended several
times and cumulative funding under this grant of approximately $ 10.7
million was completed in December 2023. A new multi-year MPAR
Grant was awarded by NIH through NIDA in August 2024, providing total funding of $ 15.1
million through May 2027, as adjusted. As of December 31, 2025,
remaining funding under the grant is $ 7.4
million.
F- 8
In
September 2019, the NIH/NIDA awarded the Company a second research and development grant related to the development of its TAAP/MPAR
abuse deterrent technology for OUD Grant. The total approved budget was approximately $ 5.4 million, and the grant period ended August
31, 2024.
The
Company recognizes revenue when costs related to the grants are incurred and assessed as reimbursable. The Company believes this policy
is consistent with the overarching premise in Accounting Standards Codification Topic 606, Revenue from Contracts with Customers
(“ASC 606”), applied by analogy, to ensure that it recognizes revenues to reflect the transfer of promised goods or services
to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services,
even though there is no “exchange” as defined in ASC 606. The Company believes the recognition of revenue as costs are incurred
and reimbursable amounts become due is analogous to the concept of transfer of control of a service over time under ASC 606.
The
revenue recognized under the MPAR Grant and OUD Grant was as follows:
SCHEDULE OF REVENUE RECOGNITION UNDER GRANTS
2025
2024
Year Ended December 31,
2025
2024
MPAR
$ 5,066,650
$ 3,086,464
TAAP/OUD
–
2,123,567
Total
$ 5,066,650
$ 5,210,031
Amounts
requested or eligible to be requested through the NIH payment management system, but for which cash has not been received, are presented
as an unbilled receivable on the Company’s consolidated balance sheet. As all amounts are expected to be remitted timely, no valuation
allowances are recorded.
Research
and Development Costs
The
Company’s research and development expenses consist primarily of third-party research and development expenses, consulting expenses,
preclinical and clinical studies, and any allocable direct overhead, including facilities and depreciation costs, as well as salaries,
payroll taxes, and employee benefits for those individuals directly involved in ongoing research and development efforts. Research and
development expenses are charged to expense as incurred. Payments made prior to the receipt of goods or services to be used in research
and development are capitalized until the goods or services are received.
General
and Administrative Expenses
General
and administrative expenses consist primarily of personnel costs associated with the Company’s executive, finance, human resources,
compliance, and other administrative personnel, as well as accounting and legal professional services fees.
Stock-based
Compensation
The
Company expenses stock-based compensation over the requisite service period based on the estimated grant-date fair value of the awards
using a graded amortization approach. The Company accounts for forfeitures as they occur.
The
Company estimates the fair value of stock option grants using the Black-Scholes option pricing model. The assumptions used in calculating
the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application
of management’s judgment. Stock-based compensation costs are recorded in research and development and general and administrative
expenses in the consolidated statements of operations.
F- 9
From
time-to-time equity classified awards may be modified. On the modification date, the Company estimates the fair value of the awards immediately
before and immediately after modification. The incremental increase in fair value is recognized as expense immediately to the extent
the underlying equity awards are vested and on a straight-line basis over the same remaining amortization schedule as the unvested underlying
equity awards.
Income
Taxes
Income
taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an
asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of
events that have been included in the consolidated financial statements or tax returns. Deferred tax assets and liabilities are determined
based on the difference between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates
in effect for the year in which the differences are expected to reverse. Valuation allowances are provided if, based upon the weight
of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The
Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company
recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination
by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical
merits of the tax position as well as consideration of the available facts and circumstances. The Company recognizes any interest and
penalties accrued related to unrecognized tax benefits as income tax expense.
Earnings
per Share
The
basic earnings per share is calculated by dividing the Company’s net income or loss attributable to common stockholders by the
weighted average number of common shares outstanding during the period. The diluted earnings per share is calculated by dividing the
Company’s net earnings attributable to common stockholders by the diluted weighted average number of common shares outstanding
during the period, determined using the treasury stock method and the average stock price during the period.
The
following weighted average shares have been excluded from the calculations of diluted weighted average common shares outstanding because
they would have been anti-dilutive (the Company has utilized the principal balance outstanding and the end of period conversion price
for the Convertible Notes for the purposes of the weighted average share calculation below):
SCHEDULE OF WEIGHTED AVERAGE SHARES OF ANTI-DILUTIVE SECURITIES
2025
2024
Year Ended December 31,
2025
2024
Stock options
87,048
38,734
Warrants
2,958,425
551,287
Convertible Notes
9,187
9,187
Consultant Shares
4,298
–
Conversions from Series B Preferred Stock
3,758,719
–
Total
6,817,677
599,208
F- 10
Recently
Issued Accounting Pronouncements
In
December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which focuses on the
rate reconciliation and income taxes paid. ASU No. 2023-09 requires public business entities to disclose, on an annual basis, specific
categories in the effective tax rate reconciliation and provide additional information for reconciling items that meet a quantitative
threshold. In addition, ASU No. 2023-09 requires companies to disclose further information about income taxes paid. The standard is effective
for annual periods beginning after December 15, 2024, and may be applied prospectively or retrospectively. We adopted the ASU retrospectively
for the period ending December 31, 2025, and it affects only our disclosures under Note 11, Income taxes, and does not impact our results
of operations or financial condition.
In
November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic 220-40): Disaggregation of Income Statement Expenses (“ASU 2024-03”), which requires disclosure about the types
of costs and expenses included in certain expense captions presented on the income statement. The new disclosure requirements are effective
for the Company’s annual periods beginning after December 15, 2026, and interim periods beginning after December 15, 2027, with
early adoption permitted. The Company is currently evaluating the impact of this pronouncement on our related disclosures.
In
November 2024, the FASB issued ASU 2024-04, “Debt – Debt with Conversion and other Options (Subtopic 470-20) “, which
set forth to improve the relevance and consistency in the application of induced conversion guidance in Subtopic 470-20, Debt—
Debt with Conversion and Other Options such as clarifying the requirements for determining whether certain settlements of convertible
debt instruments should be accounted for as an induced conversion. ASU 2024-04 is effective for all entities for annual reporting periods
beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of this guidance on
its consolidated financial statements.
In
December 2025, the FASB issued ASU 2025-10, Government Grants (Topic 832): Accounting for Government Grants by Business Entitie s ,
which set forth new amendments that require entities to recognize government grants when it is probable that the grant conditions will
be met and the grant will be received, and to provide enhanced disclosures regarding the nature, terms, and financial statement effects
of such grants. The new amendments are effective for public companies with annual reporting periods beginning after December 15, 2028
with early adoption permitted. The Company is currently evaluating the impact of this guidance on its consolidated financial statements.
NOTE
4 – PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
2025
2024
December 31,
2025
2024
Prepaid research and development
$ 2,088,078
$ 1,342,461
Prepaid insurance
300,600
315,306
Other prepaid expenses
105,091
42,723
Other current assets
18,000
18,000
Total prepaid expenses and other current assets
$ 2,511,769
$ 1,718,490
F- 11
NOTE
5 – OTHER ASSETS
Other
assets consisted of the following:
SCHEDULE OF OTHER ASSETS
2025
2024
December 31,
2025
2024
Prepaid insurance
$ 83,332
$ 250,000
Deposits
2,550
2,550
Total other assets
$ 85,882
$ 252,550
NOTE
6 – ACCRUED EXPENSES AND OTHER LIABILITIES
Accrued
expenses and other liabilities consisted of the following:
SCHEDULE OF ACCRUED EXPENSES AND OTHER LIABILITIES
2025
2024
December 31,
2025
2024
Accrued research and development
$ 554,680
$ 324,521
Accrued consultant compensation
180,000
–
Accrued professional fees
65,497
88,995
Other accrued liabilities
193,234
134,942
Total accrued expenses and other liabilities
$ 993,411
$ 548,458
NOTE
7 - COMMITMENTS AND CONTINGENCIES
Purchase
Commitments
As
of December 31, 2025, the Company’s commitments included an estimated $ 18.7 million related to the Company’s open purchase
orders and contractual obligations that occurred in the ordinary course of business, including commitments with contract research organizations
for multi-year pre-clinical and clinical research studies. Although open purchase orders are considered enforceable and legally binding,
the terms generally allow the Company the option to cancel, reschedule, and adjust its requirements based on its business needs prior
to the delivery of goods or the performance of services.
Litigation
As
of December 31, 2025 and 2024, there were no pending legal proceedings against the Company that are expected to have a material adverse
effect on cash flows, financial condition or results of operations. From time to time, the Company could become involved in disputes
and various litigation matters that arise in the normal course of business. These may include disputes and lawsuits related to intellectual
property, licensing, contract law and employee relations matters. Periodically, the Company reviews the status of significant matters,
if any exist, and assesses its potential financial exposure. If the potential loss from any claim or legal claim is considered probable
and the amount can be estimated, the Company accrues a liability for the estimated loss. Legal proceedings are subject to uncertainties,
and the outcomes are difficult to predict. Because of such uncertainties, accruals are based on the best information available at the
time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation.
Consultant
Dispute
In
April 2025, the Company entered into an agreement with a former independent contractor to resolve a dispute over payment. The Company
denied the allegations but agreed to settle the matter. In connection with the settlement agreement, the Company issued 20,000 shares
of common stock to the consultant in April 2025. As of December 31, 2025, the Company accrued a total settlement value of $ 0.2 million.
F- 12
Galephar
Agreement
In
January 2025, the Company entered into a product development and supply agreement with Galephar Pharmaceutical Research, Inc., a Puerto
Rico specialty drug manufacturer (“Galephar”), to support the development, manufacture, packaging and testing of the Company’s
PF614 and PF614-MPAR drug products for use in clinical trials and potential future commercial launch.
Upon
execution of the agreement, the Company committed to issue 13,801 restricted shares of common stock (representing approximately 1 % of
the Company’s outstanding common stock), subject to vesting in three tranches upon the achievement of specific operational and
regulatory milestones. The Company accounts for this share grant as nonemployee share-based compensation in accordance with ASC 718.
One-third
of the restricted shares vested immediately upon grant, and the remaining two-thirds will vest as services are performed. During the
year ended December 31, 2025, the Company recognized $ 25,806 of stock-based compensation related to the immediate vesting of 4,600 shares
upon the grant date. As of December 31, 2025, 4,600 shares had been issued and outstanding.
The
agreement also provides for milestone-based payments to be settled in shares of the Company’s common stock, with 50% of the shares
issued as restricted stock and 50% issued as freely tradeable shares. The number of shares issuable upon achievement of each milestone
is based on the trailing five-day average closing price at the time of each milestone achievement.
Share-based
expense for these milestone grants is recognized as services are rendered. These awards are classified as liabilities until the shares
are issued, at which point the awards are reclassified to equity. During the year ended December 31, 2025, the Company recognized $ 600,000
of research and development expense related to milestone progression for awards to be settled in shares. As of December 31, 2025, 468,750
shares had been issued pursuant to these milestone-based awards.
Lease
The
Company’s current lease agreement (as amended) has a term that extends through October 31, 2026, with no option to renew. As of
December 31, 2025, the future lease payments totaled $ 30,726 . The Company recognized total rent expense of $ 36,590 and $ 35,217 in the
years ended December 31, 2025, and 2024, respectively.
NOTE
8 - NOTES PAYABLE
The
following table provides a summary of the Company’s outstanding debt as of December 31, 2025:
SCHEDULE OF DEBT
Principal
balance
Accrued
interest
Net debt
balance
2023 Notes
$ 216,000
26,761
$ 242,761
Financed insurance
63,947
–
63,947
Total
$ 279,947
$ 26,761
$ 306,708
The
following table provides a summary of the Company’s outstanding debt as of December 31, 2024:
Principal
balance
Accrued
interest
Net debt
balance
2023 Notes
$ 216,000
14,368
$ 230,368
Financed insurance
71,292
–
71,292
Total
$ 287,292
$ 14,368
$ 301,660
F- 13
Interest
expense
The
interest expense recognized for financed insurance was $ 6,375 and $ 8,848 for the year ended December 31, 2025 and 2024, respectively.
Interest expense recognized for the 2023 Notes was $ 12,393 and $ 1,281,597 for the year-ended December 31, 2025 and 2024, respectively,
which consists of amortization of the debt discount and debt issuance costs and accrued interest.
2023
Notes
On
October 23, 2023, the Company entered into a Securities Purchase Agreement (“SPA”) for an aggregate financing of $ 1.8 million
with investors, including $ 0.2 million with a board member. At the first closing under the SPA, which occurred on October 25, 2023, the
Company issued to the investors (i) senior secured convertible promissory notes in the aggregate principal amount of $ 612,000 for an
aggregate purchase price of $ 566,667 and (ii) warrants to purchase 83,714 shares of the Company’s common stock, par value $ 0.0001
per share in the aggregate. At the second closing under the SPA, which occurred on November 29, 2023, the Company issued to the investors
referenced above, (i) additional notes in the aggregate principal amount of $ 1,224,000 for an aggregate purchase price of $ 1,133,333
and (i) additional warrants to purchase 167,427 shares of the common stock in the aggregate.
The
Company reflected the outstanding principal amount, the remaining unamortized discount (both original issue discount and the relative
fair value discount associated with the warrants discussed below) and the remaining debt issuance costs as a net amount on the face of
the balance sheet. The amortization of the original debt discount (approximately $ 0.1 million) and issuance costs (approximately $ 0.3
million) were recorded as interest expense within the consolidated statements of operations. As of December 31, 2024, the original debt
discount and issuance costs were fully amortized to interest expense.
The
warrants have an exercise price of $ 23.5125 , the same as the conversion price, and are exercisable for five years following the issuance
date. The warrants were equity classified as they are indexed to the Company’s stock and only settleable in shares. The warrants
were initially measured at fair value using a Black-Scholes valuation model and were allocated along with the 2023 Notes using the relative
fair value method. The initial fair value of $ 1.1 million allocated to the warrants was considered a debt discount and was amortized
to interest expense over the remaining term of the notes. As of December 31, 2024, the discount associated with the warrants was fully
amortized to interest expense.
During
2024, the Company converted 49,702 shares of common stock with a conversion value of $ 1.2 million related to the 2023 Notes. In addition,
in connection with the SPA, the Company incurred a $ 1.0 million waiver fee as a result of the 2024 February Warrant Inducement (see Note
8) to pay down $ 0.5 million of the 2023 Notes and incurred $ 0.5 million in transaction costs recorded as such in the consolidated statement
of stockholders’ equity. As of December 31, 2025, the remaining amount of the 2023 Notes relates to senior secured convertible
promissory notes held by a Company board member (see Note 12).
Financed
Insurance Premiums
In
June 2025, the Company renewed and financed its directors’ and officers’ liability insurance in the amount of $ 0.2 million.
Monthly payments are scheduled from July 2025 through March 2026.
F- 14
NOTE
9 - STOCKHOLDERS’ EQUITY
The
Company’s current Certificate of Incorporation authorizes 250,000,000 shares of common stock and 1,500,000 shares of preferred
stock, both with par value equal to $ 0.0001 . As of December 31, 2025, 4,500 shares have been designated as Series B Preferred Stock.
The remaining authorized preferred shares are undesignated and available for future issuance. As of December 31, 2025, the Company had
convertible preferred stock as follows:
SCHEDULE OF CONVERTIBLE PREFERRED STOCK
Shares Issued
Shares
Outstanding
Net Carrying
Value
Aggregate
Liquidation
Preference
Series B
4,000
3,305
$ 3,489,359
$ 3,635,500
Total
4,000
3,305
$ 3,489,359
$ 3,635,500
As
of December 31, 2024, there were no shares of preferred stock issued and outstanding.
Series
B Preferred Stock Financing
On
November 13, 2025, the Company entered into a Securities Purchase Agreement with an institutional investor (the “Purchaser”)
providing for (i) a registered direct offering and (ii) a concurrent private placement (collectively, the “Offerings”) for
aggregate financing of $ 4.0 million.
In
the registered direct offering, the Company issued 1,513 shares of Series B Preferred Stock convertible to 665,922 shares of the Company’s
common stock. In the concurrent private placement, the Company issued 2,487 unregistered shares of Preferred Stock convertible into 1,094,078
shares of common stock, subject to adjustment, and warrants to purchase up to 880,000 shares of common stock, subject to adjustment.
The Series B Preferred Stock has a stated value of $ 1,100 per share. The preferred stock and common stock both have par values of $ 0.0001
per share.
The
Warrants have an exercise price of $ 2.50 per share, subject to customary anti-dilution adjustments, are exercisable beginning six months
after issuance, and expire on the fifth anniversary of the later of (i) the effectiveness of a resale registration statement covering
the Warrants and (ii) receipt of required stockholder approval.
The
Series B Preferred Stock has the following rights and privileges:
Voting
- Holders of preferred shares shall have no voting rights, except as required by Delaware law and Company’s Certificate of
Designation. To the extent required under the Delaware General Corporation Law, holders of the preferred shares are entitled to vote
as a separate class (or series, if applicable) to approve certain corporate actions. Approval of such matters requires the affirmative
vote or written consent of the holders of a majority of the outstanding preferred shares voting together as a single class, unless separate
series voting is required by law. In matters where preferred shareholders are entitled to vote together with common shareholders as a
single class, each preferred share is entitled to the number of votes equal to the number of shares of common stock into which it is
then convertible, subject to applicable beneficial ownership limitations.
Dividends
- Holders of preferred shares shall accrue dividends at a rate of 4.0 % per annum, computed on the basis of a 360-day year consisting
of twelve 30-day months. Dividends accrue daily and are payable in arrears on the first trading day of each fiscal quarter. Dividends
are not payable in cash but are capitalized and added to the stated value of the preferred shares on each dividend payment date. Accrued
dividends are included in the conversion amount upon conversion of the preferred shares and are payable upon certain bankruptcy triggering
events. Upon the occurrence and continuation of a triggering event, as defined in the agreement, the dividend rate increases to 8.0%
per annum until such triggering event is cured.
Liquidation
- In the event of a liquidation, dissolution or winding up of the Company, holders of preferred shares are entitled to receive, prior
to any distribution to holders of Junior Stock (shares of capital stock that are junior in rank to all preferred shares with respects
to preferences of dividends, distributions and payments upon distribution.) and pari passu with holders of any outstanding Parity Stock,
a cash payment per Preferred Share equal to the greater of (i) 125 % of the applicable Conversion Amount or (ii) the amount that would
have been received if such Preferred Shares had been converted into Common Stock immediately prior to the Liquidation Event. If available
assets are insufficient to pay the full liquidation preference to holders of Preferred Shares and Parity Stock, such amounts will be
distributed ratably among such holders in proportion to their respective full liquidation preference entitlements. The Company is required
to take all actions, including causing its subsidiaries to distribute available proceeds to the extent permitted by law, to ensure that
such liquidation preferences are satisfied before any distributions are made to holders of Junior Stock.
F- 15
Conversion
Price Per Share: Each share of Series B Preferred Stock is convertible, at the option of the holder, into shares of common stock.
The number of shares issuable upon conversion is determined by dividing the conversion amount by the conversion price. The conversion
amount equals the stated value of $ 1,100 per share, plus accrued and unpaid dividends and any other amounts owed under the applicable
transaction documents. Upon receipt of a valid conversion notice, the Company is required to issue the applicable number of shares of common stock within one
trading day, subject to applicable settlement requirements. Conversions are subject to a beneficial ownership limitation following conversion.
The
conversion price is initially $ 2.50 per share, subject to adjustment. At the holder’s election, the conversion price may be adjusted
to 95% of the lowest volume-weighted average price (“VWAP”) of the Company’s common stock during the five trading days
preceding conversion, subject to a floor price of $0.4104. Conversions are subject to customary beneficial ownership limitations.
Alternate
Conversion Upon a Triggering Event - Following the occurrence of a triggering event, holders may elect to convert Series B Preferred
Stock at an alternate conversion price equal to 90 %
of the lowest VWAP over the five trading days preceding the conversion date, subject to a floor price of $ 0.4104 .
Exchange Right - The holder has the right,
in connection with a subsequent financing by the Company, to apply the stated value of the preferred stock at 120 % of the applicable
conversion amount toward the purchase price of securities issued in such subsequent placement.
Additional
Purchase Right - The Preferred Stock includes participation rights that entitle each holder of preferred stock to participate in
any pro rata distribution of options, convertible securities, warrants or other purchase rights granted to holders of Common Stock (other
than equity awards issued under the Omnibus Incentive Plan). In such events, each holder is entitled to receive the amount of such rights
the holder would have received if all Preferred Shares were converted into Common Stock at the Alternate Conversion Price as of the applicable
record date, without regard to conversion limitations. Participation is subject to the beneficial ownership limitation. To the extent
participation would cause a holder and its attribution parties to exceed such limitation, the excess portion is held in abeyance and
becomes exercisable when such participation would no longer result in exceeding the beneficial ownership limitation.
Anti-dilution:
The Series B Preferred Stock includes price-based anti-dilution protections that adjust the conversion price upon future issuances
of equity or equity-linked securities at prices below the then-effective conversion price, including issuances of options or convertible
securities and variable-price securities.
The
Company evaluated the terms of the Series B Preferred Stock for embedded features that may require bifurcation as derivative instruments
under ASC 815. Certain features were identified that met the definition of a derivative. However, the Company concluded that the fair
value of such features was not material to the financial statements and accordingly did not recognize them as separate derivative liabilities.
The Company will continue to reassess this conclusion at each reporting period.
2025
April Warrant Inducement
In
April 2025, the Company entered into an Inducement Letter with certain warrant holders for the exercise of certain outstanding warrants
to purchase up to an aggregate of 630,376 shares of common stock of the Company, par value $ 0.0001 per share. The warrants were issued
in March 2025 and have an exercise price of $ 3.24 share. The shares of common stock issuable upon exercise of such outstanding warrants
are registered pursuant to an effective registration statement on Form S-3.
In
consideration for the immediate exercise of the warrants for cash and the payment of an additional $ 0.125 per new unregistered warrant
(an additional $ 157,594 included in the gross proceeds to the Company), pursuant to the Inducement Agreement, the Company agreed to issue
and sell unregistered warrants to purchase shares of common stock. The new warrants (the “ Common Warrants ”) are exercisable
for an aggregate of up to 1,260,752 shares of common stock. The Common Warrants have an exercise price of $ 1.90 per share and are immediately
exercisable for shares of common stock. One half of the Common Warrants will expire after eighteen ( 18 ) months and the other half will
expire after five ( 5 ) years. The gross proceeds to the Company from the exercise of the warrants and payment for Common Warrants was
approximately $ 2.2 million, prior to deducting placement agent fees and estimated offering expenses.
F- 16
The
Company utilized a placement agent for the 2025 April Warrant Inducement and incurred approximately $ 0.3 million in legal fees and other
closing costs. Additionally, the Company issued to the placement agent as compensation unregistered warrants to purchase up to 44,126
shares of common stock, equal to 7.0% of the aggregate number of shares of Common Stock (or warrants) placed in the transaction. The
placement agent warrants expire on April 24, 2030 , and have an exercise price of $ 4.05 per share of common stock. The closing of the
offering occurred on April 24, 2025.
2025
Registered Direct Offering and 2025 March Warrant Offering
In
March 2025, the Company entered into a definitive SPA with certain institutional investors, pursuant to which the Company agreed to issue
and sell in a registered direct offering, (i) an aggregate of 239,594 shares of common stock, par value $ 0.0001 per share at an offering
price of $ 3.49 per share, (ii) pre-funded warrants to purchase up to 75,594 shares of common stock, at a price per pre-funded warrant
equal to $ 3.4899 , the price per share less $ 0.0001 , for gross proceeds of approximately $ 1.1 million before the deduction of placement
agent fees and offering expenses. The pre-funded warrants were fully exercised as of March 31, 2025, and the related common shares were
issued in April 2025.
In
a concurrent private placement, pursuant to the terms of the SPA, the Company also agreed to issue and sell unregistered warrants to
purchase up to 315,188 shares of Common Stock (the “ Series A-5 Warrants ”), and Series A-6 warrants to purchase up
to 315,188 shares of Common Stock (the “ Series A-6 Warrants ”), to purchase up to an aggregate 630,376 shares of Common
Stock. The warrants have an exercise price of $ 3.24 per share and are exercisable immediately. The Series A-5 Warrants will expire eighteen
(18) months after issuance and the Series A-6 Warrants will expire five ( 5 ) years after issuance.
2024
Registered Direct Offering and 2024 August Warrant Inducement
In
August 2024, the Company entered into a definitive Securities Purchase Agreement with certain institutional investors, pursuant to which
the Company agreed to issue and sell in a registered direct offering, (i) an aggregate of 166,054 shares of common stock, par value $ 0.0001
per share at an offering price of $ 7.05 per share, (ii) pre-funded warrants to purchase up to 70,827 shares of common stock, at a price
per pre-funded warrant equal to $ 7.0485 , the price per share less $ 0.0015 , for gross proceeds of approximately $ 1.67 million before the
deduction of placement agent fees and offering expenses. The pre-funded warrants were subsequently exercised in full and were not outstanding
as of December 31, 2024.
The
Company also entered into the August Inducement Letter with certain warrant holders for the exercise of certain outstanding warrants
to purchase up to an aggregate of 480,234 shares of common stock of the Company originally issued in February 2024, having an exercise
price of $ 15.90 per share, at a reduced exercise price of $ 7.05 per share. The Company also agreed to amend certain existing warrants
to purchase up to an aggregate of 133,334 shares of common stock that were previously issued in November 2023 and have an exercise price
of $ 23.51 per share such that the amended warrants will have a reduced exercise price of $ 7.05 per share effective upon the closing of
the offering and will be exercisable from the date on which stockholder approval is received with respect to the issuance of the shares
of common stock issuable upon exercise of such warrants. As the existing November 2023 and February 2024 warrants and their related newly
issued warrants upon inducement were equity classified before and after the exchange, and as the exchange is directly attributable to
an equity offering, the Company recognized the effect of the modification of approximately $ 10.2 million as an equity issuance cost.
In
a concurrent private placement, pursuant to the terms of the August Inducement Letter and Securities Purchase Agreement, the Company
utilized an exclusive placement agent for the 2024 Registered Direct Offering and 2024 August Warrant Inducement and incurred approximately
$ 0.6 million in legal fees and other closing costs. Additionally, the Company issued to the placement agent as compensation unregistered
warrants to purchase up to 50,200 shares of Common Stock. The placement agent warrants expire on August 28, 2029 , and have an exercise
price of $ 8.81 per share of Common Stock. The warrants will become exercisable upon stockholder approval and contain customary anti-dilution
adjustments to the exercise price, including for share splits, share dividends, rights offering and pro rata distributions.
F- 17
2024
February Warrant Inducement
In
February 2024, the Company executed an Inducement Letter with certain holders of existing warrants to purchase up to an aggregate of
240,120 shares of the Company’s common stock issued to the holders in connection with the 2023 May Offering. Pursuant to the Inducement
Letter, the holders agreed to exercise for cash their existing warrants to purchase an aggregate of 240,120 shares of Common Stock at
a reduced exercise price of $ 15.90 per share in consideration of the Company’s agreement to issue new unregistered Series A Warrants
(the “Series A Warrants”) to purchase up to 240,120 shares of Common Stock and new unregistered Series B Warrants (the “Series
B Warrants”) to purchase up to 240,120 shares of Common Stock (collectively, the “New Warrant Shares”). The Series
A Warrants have an exercise price of $ 15.90 per share and have a term equal to eighteen months from the date of issuance. The Series
B Warrants have an exercise price of $ 15.90 per share and will expire on May 12, 2028 . The gross proceeds to the Company from the exercise
of the warrants were approximately $ 4.7 million, prior to deducting placement agent fees and estimated offering expenses. As the existing
warrants and the new warrants were equity classified before and after the exchange, and as the exchange is directly attributable to an
equity offering, the Company recognized the effect of the modification of approximately $ 5.2 million as an equity issuance cost.
In
connection with the execution of the Inducement Letter, the Company executed a waiver related to the 2023 Notes’ SPA it had entered
into as of October 23, 2023. The SPA contained restrictions on the Company’s ability to undertake certain transactions, which included
the execution of the Inducement Letter. The Waiver permitted the Company to execute the Inducement Letter but required repayment of the
certain investor held notes issued under the SPA with a premium following closing of the transaction contemplated thereby. Refer to Note
7 for the details of the waiver fee and the application of the amounts to the outstanding notes and as a transaction cost of the warrant
inducement.
The
Company utilized an exclusive placement agent for the 2024 Warrant Inducement and incurred approximately $ 0.3 million in legal fees and
other closing costs. Additionally, the Company issued to the placement agent as compensation unregistered warrants to purchase up to
16,811 shares of Common Stock, equal to 7.0% of the aggregate number of shares of Common Stock (or warrants) placed in the transaction.
The placement agent warrants expire on May 12, 2028, and have an exercise price of $ 24.56 per share of Common Stock (equal to 125% of
the reduced exercise price per Existing Warrant). The closing of the offering occurred on February 14, 2024.
Warrants
The
following table provides a summary of outstanding warrants to purchase shares of common stock as of December 31, 2025:
SCHEDULE OF OUTSTANDING WARRANT
Reference
Shares Underlying
Outstanding
Warrants
Exercise Price
Description
Classification
(a)
992,000
$ 2.50 - $ 3.125
November 2025 Warrants
Equity
(b)
134,314
$ 1.90 - $ 4.05
April 2025 Warrants
Equity
(c)
22,063
$ 4.3625
March 2025 Warrants
Equity
(d)
1,864,545
$ 7.05 - $ 8.8125
August 2024 Warrants
Equity
(e)
16,811
$ 24.56
February 2024 Warrants
Equity
(f)
162,881
$ 7.05 - $ 23.51
2023 Notes Warrants
Equity
(g)
73,474
$ 54.56 - $ 41,400
Other Warrants
Equity & Liability
3,266,088
(a)
On
November 14, 2025, the Company issued 880,000 equity classified warrants to certain institutional investors with the Series B Preferred
Stock Financing. The warrants have an exercise price of $ 2.50 per share and are immediately exercisable for shares of common stock
and expire on January 7, 2031 . In connection with the Series B Preferred Stock Financing, there were 112,000 warrants issued to placement
agent. The placement agent warrants were immediately exercisable with an exercise price of $ 3.125 per share and expire on January
7, 2031 .
F- 18
(b)
On
April 24, 2025, the Company issued 1,304,878 equity classified warrants (Common Warrants and placement agent warrants) in connection
with the Inducement Letter of the 2025 April warrant inducement. The Common Warrants have an exercise price of $ 1.90 per share and
are immediately exercisable for shares of common stock. One half of the Common Warrants will expire on October 26, 2026 , and the
other half will expire on April 24, 2030 . The placement agent warrants were immediately exercisable with an exercise price of $ 4.05
per share and expire on April 24, 2030 . During the year ended December 31, 2025, there were 1,170,564 warrants exercised at an exercise
price of $ 1.90 per share.
(c)
On
March 31, 2025, in connection with the 2025 Registered Direct Offering and 2025 March Warrant Offering, the Company issued equity
classified warrants to purchase 652,439 shares to certain institutional investors and the placement agent. The warrants were issued
in connection with the 2025 Registered Direct Offering and 2025 March Warrant Offering. The 630,376 investor warrants have an exercise
price of $ 3.24 per share. One half of the warrants will expire on October 1, 2026 , and the other half will expire on March 31, 2030.
The 22,063 placement agent warrants have an exercise price of $ 4.3625 per share and expire on March 30, 2030 . In connection with
the 2025 April Warrant Inducement, 630,376 investor warrants were exercised. As of December 31, 2025, the placement agents remain
outstanding.
(d)
On
August 29, 2024, in connection with the 2024 Registered Direct Offering and 2024 August Warrant Inducement , the Company
issued equity classified warrants to purchase 1,964,666 shares to certain institutional investors and the placement agent. The warrants
were issued in connection with the 2024 Registered Direct Offering and the 2024 August Warrant Inducement. The 1,914,466 investor
warrants have an exercise price of $ 7.05 per share. One half of the warrants expire on May 21, 2026 , and the other half expire on
November 21, 2029 . The 50,200 placement agent warrants have an exercise price of $ 8.8125 per share and expire on August 28, 2029 .
In December 2024 and January 2025, investor warrants of 50,760 and 49,361 , respectively, were exercised.
(e)
On
February 12, 2024, the Company issued 497,047 equity classified warrants (Series A Warrants, Series B Warrants and placement agent
warrants) in connection with the Inducement Letter for the 2024 February warrant inducement and related warrant restructuring. The
Series A and Series B Warrants were immediately exercisable with an exercise price of $ 15.90 per share and expire on August 14, 2025
and May 12, 2028 , respectively. The placement agent warrants were immediately exercisable with an exercise price of $ 24.56 per share
and expire on May 12, 2028. In connection with the 2024 August Warrant Inducement, 480,236 Series A and Series B warrants were exercised.
As of December 31, 2025, the placement agents remain outstanding.
(f)
On
October 25, 2023, and November 28, 2023, the Company issued warrants to purchase 83,714 shares and 167,428 shares, respectively.
The warrants were immediately exercisable with an exercise price of $ 23.51 per share and expire on October 25, 2028, and November
28, 2028 , respectively. In January 2024, a holder of the warrants exercised 88,261 warrants at an exercise price of $ 23.51 per share.
In August 2024, an inducement letter was issued to a holder of 133,334 warrants to reduce the exercise price from $ 23.51 to $ 7.05
per share.
(g)
At
various dates from the Closing of the Business Combination through September 30, 2023, the Company assumed or issued a total of 73,474
warrants to provide holders the right to purchase common stock at exercise prices ranging from $ 54.60 - $ 41,400 per share. A total
of 2,778 of the outstanding warrants are public warrants which trade on the Pink Limited Market operated by OTC Markets Group Inc.
under the ticker symbol ENSCW. A total of 2,901 outstanding warrants (issued in connection with the 2021 and 2022 Notes) are liability-classified
due to certain cash settlement features embedded within the warrant agreements. The remaining warrants are equity classified. The
warrants expire beginning June 30, 2026, through August 7, 2028 .
F- 19
NOTE
10 - STOCK-BASED COMPENSATION
In
connection with the Business Combination, the Company assumed the 2021 Omnibus Incentive Plan. In February 2025, the Company’s
Board approved an annual increase of 67,789 shares available for future grant under the 2021 Omnibus Plan.
The
Company recognized within general and administrative expense stock-based compensation expense of $ 118,674 and $ 75,494 for the years ended
December 31, 2025 and 2024, respectively. During the years ended December 31, 2025 and 2024, the company recognized within research and
development expense stock-based compensation expense of $ 691,893 and $ 35,229 , respectively.
Option
Activity
During
the year ended December 31, 2025, the Company granted stock options to employees and members of the board of directors to purchase an
aggregate of 64,000 shares of common stock. The options vest over one to four years and have an exercise price of $ 2.00 to $ 3.12 per
share. The following table summarizes the Company’s stock option activity during the year ended December 31, 2025:
SCHEDULE OF STOCK OPTION ACTIVITY
Weighted average
Options
Exercise price
Remaining
contractual
life
Intrinsic value
Outstanding at December 31, 2024
38,785
$ 501.65
8.58
$ –
Granted
64,000
2.94
9.25
–
Exercised
–
–
–
–
Expired / Forfeited
–
–
–
–
Outstanding at December 31, 2025
102,785
191.13
8.62
–
Exercisable at December 31, 2025
77,776
251.29
8.42
–
Vested and expected to vest
102,785
191.13
8.62
–
Option
Valuation
The
fair value of each stock option granted has been determined using the Black-Scholes option-pricing model. The material assumptions used
in the Black-Scholes model in estimating the fair value of the options granted for the periods presented were as follows:
SCHEDULE OF SHARE-BASED PAYMENT AWARD, STOCK OPTIONS, VALUATION ASSUMPTIONS
December 31, 2025
Exercise price
$ 2.00 - 3.12
Expected stock price volatility
114.21 % - 141.65 %
Expected term (years)
5.27 - 6.08
Risk-free interest rate
3.83 %
- 4.00 %
Expected dividend yield
0 %
F- 20
●
Expected
stock-price volatility. The expected volatility is derived from the historical volatilities of comparable publicly traded companies
within the Company’s industry that the Company considers comparable to the Company’s business over a period approximately
equal to the expected term.
●
Expected
term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s
historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term due to a
lack of sufficient data. Therefore, the Company estimates the expected term for employees by using the simplified method provided
by the Securities and Exchange Commission. The simplified method calculates the expected term as the average of the time-to-vesting
and the contractual life of the options.
●
Risk-free
interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon
U.S. Treasury notes with maturities approximately equal to the expected term.
●
Expected
dividend yield. The expected dividend is assumed to be zero as the Company has never paid dividends and has no current plans
to pay any dividends on the Company’s common stock.
The
weighted-average grant date fair value of options granted during the year ended December 31, 2025 was $ 2.63 .
As
of December 31, 2025, the Company had an aggregate of $ 19,342 of unrecognized share-based compensation cost, which is expected to be
recognized over the weighted average period of 1.19 years.
Shares
Reserved for Future Issuance
The
following shares of common stock are reserved for future issuance:
SCHEDULE OF COMMON STOCK FUTURE ISSUANCE
December 31, 2025
Awards outstanding under the Plan
102,785
Awards available for future grant under the Plan
14,385
Warrants outstanding
3,266,088
Shares for consultant compensation agreement outside the Plan
9,201
Conversion of Series B preferred stock
3,758,719
Total shares of common stock reserved for future issuance
7,151,178
NOTE
11 - INCOME TAXES
Loss
before provision for income taxes consisted of the following:
SCHEDULE OF INCOME TAXES BENEFIT
Year ending December 31,
2025
2024
United States
$ ( 10,176,187 )
$ ( 7,987,009 )
The
Company has not recorded a current or deferred tax expense or benefit, nor has it paid cash income taxes or received cash income tax
refunds from any jurisdiction for the years ended December 31, 2025 or 2024.
F- 21
The
effective tax rate of the Company’s provision (benefit) for income taxes differs from the federal statutory rate as follows:
SCHEDULE OF FEDERAL INCOME TAX RATE RECONCILIATION
Nontaxable or nondeductible items:
Year ending December 31,
2025
2024
Income taxes (benefit) at statutory rates
$ ( 2,136,999 )
21.0 %
$ ( 1,677,271 )
21.0 %
State and local income taxes, net of federal benefit *
( 8,188 )
0.1
( 7,848 )
0.1
Tax credits:
–
R&D credits
( 510,959 )
5.0
( 529,890 )
6.6
Change in valuation allowance
1,987,393
( 19.5 )
1,846,380
( 23.1 )
Nontaxable or nondeductible items:
Permanent items
26,033
( 0.3 )
46,173
( 0.6 )
Changes in unrecognized tax benefits
135,928
( 1.3 )
139,627
( 1.7 )
Other, net:
Expiration of attributes
506,099
( 5.0 )
182,137
( 2.3 )
Other
693
–
692
–
Provision for income taxes
$ –
0.0 %
$ –
0.0 %
* State taxes in
California made up the majority (greater than 50 %) of the tax effect in this category for 2025 and 2024.
Deferred
income taxes reflect the net tax effects of (a) temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes, and (b) operating losses and tax credit carryforwards.
The
Company’s deferred tax assets were comprised of the following:
SCHEDULE OF DEFERRED TAX ASSETS
2025
2024
As of December 31,
2025
2024
Deferred tax assets:
Net operating loss tax carryforwards
$ 32,769,238
$ 29,728,009
Tax credits
5,620,329
5,212,263
Capitalized research costs
3,255,201
4,655,425
Stock-based compensation
741,865
729,318
Other
81,455
36,630
Gross deferred tax assets
42,468,088
40,361,645
Valuation allowance
( 42,463,797 )
( 40,361,645 )
Total deferred tax assets
4,291
–
Deferred tax liabilities:
Fixed assets
( 4,291 )
–
Total deferred tax liabilities
( 4,291 )
–
Net deferred tax assets
$ –
$ –
F- 22
A
valuation allowance of approximately $ 42.5 million as of December 31, 2025 has been established to offset the deferred tax assets as
the Company has determined that it is not more likely than not that these assets will be realized. The valuation allowance increased
by approximately $ 2.1 million during 2025.
As
of December 31, 2025, the Company had federal and California net operating loss (NOL) carryforwards of $ 130.5 million and $ 76.9 million,
respectively, net of the NOLs that will expire due to Internal Revenue Code (IRC) Section 382 limitations. The federal net operating
losses generated in 2018 and after of $ 51.3 million will carryforward indefinitely and be available to offset up to 80% of future taxable
income each year . The federal net operating losses generated prior to 2018 of $ 79.1 million will begin to expire in 2026 unless previously
utilized. The California NOL carryforwards will begin to expire in 2028 , unless previously utilized.
In
addition, as of December 31, 2025, the Company had federal and state research and development (R&D) tax credit carryforwards of $ 6.1
million and $ 1.7 million, respectively. The federal tax credit carryforwards will begin to expire in 2026 unless previously utilized.
The California research tax credits do not expire .
Pursuant
to IRC Sections 382 and 383, annual use of the Company’s NOL and R&D credit carryforwards may be limited in the event that
a cumulative change in ownership of more than 50% occurs within a three-year period. Although the Company has not completed an IRC Section
382/383 analysis regarding the limitation of NOL and R&D credit carryforwards as of December 31, 2025, the Company estimates that
approximately $ 1.5 million of tax benefits related to NOL and R&D carryforwards acquired in 2015 will expire unused. Accordingly,
the related NOL and R&D credit carryforwards have been removed from deferred tax assets accompanied by a corresponding reduction
of the valuation allowance. Due to the existence of the valuation allowance, limitations created by current and future ownership changes,
if any, related to the Company’s operations in the United States will not impact its effective tax rate. Any additional ownership
changes may further limit the ability to use the NOL and R&D credit carryforwards.
The
following table summarizes the activity related to the Company’s unrecognized tax benefits:
SCHEDULE OF UNRECOGNIZED TAX BENEFITS
2025
2024
Year ending December 31,
2025
2024
Balance at beginning of year
$ 1,826,993
$ 1,685,360
Increases related to current year tax positions
165,811
141,023
Increases related to prior year tax positions
–
1,054
Decreases related to prior year tax positions
( 27,587 )
( 444 )
Balance at end of year
$ 1,965,217
$ 1,826,993
As
of December 31, 2025 and 2024, the Company had unrecognized tax benefits of $ 2.0 million and $ 1.8 million, respectively. Due to the existence
of the valuation allowance, none of the unrecognized tax benefits would affect the effective tax rate. The Company’s policy is
to recognize interest and penalties from uncertain tax positions in income tax expense. The Company did not record any interest or penalties
for the years ended December 31, 2025 or 2024 and had no accrued interest on the consolidated balance sheets as of December 31, 2025
or 2024.
The
Company and its subsidiaries are subject to U.S. federal income tax as well as income tax in multiple state jurisdictions. With few exceptions,
the Company is no longer subject to United States federal income tax examinations for years before 2022 and state and local income tax
examinations before 2021. However, to the extent allowed by law, the tax authorities may have the right to examine prior periods where
net operating losses were generated and carried forward, and make adjustments up to the amount of the NOL carryforward amount. The Company
is not currently under examination by the Internal Revenue Service or any state or local tax authority.
On
July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, which enacts significant changes to U.S. tax
and related laws. Some of the provisions of the new tax law affecting corporations include, but are not limited to, expensing of domestic
research expenses, increasing the limit of the deduction of interest expense deduction to thirty percent of EBITDA, and one hundred percent
bonus depreciation on eligible property acquired after January 19, 2025. The provisions of the OBBBA became effective for the Company
during the three months ended September 30, 2025. The new tax law did not have a material impact on the Company’s current or future
effective rate for income taxes or cash taxes paid.
NOTE
12 - RELATED PARTIES
As
of December 31, 2025, the Company held a $ 0.2 million senior secured convertible promissory note plus accrued interest and 29,547 warrants
exercisable for common stock at $ 23.51 per share issued to a board member in connection to the issuance of the 2023 Notes. On April 25,
2025, the Company and the board member entered into a forbearance agreement that will expire on April 25, 2026 . Upon termination of the
forbearance period, the Company will owe the remaining outstanding principal balance together with unpaid interest. The Company may pay
the notes in full at any time prior to the conclusion of the forbearance period.
NOTE
13 - SUBSEQUENT EVENTS
In
January 2026, shareholders approved an increase of 600,000 shares available for future grant under the 2021 Omnibus Incentive Plan. In
February 2026, the Board approved an annual increase of 228,749 shares available for future grant per terms of the 2021 Omnibus Incentive
Plan.
Since
January 1, 2026, the Company issued 4.7 million shares of common stock upon the conversion of 1,900 shares of Series B Preferred Stock.
F- 23
Exhibit
Index No.
Description
of Exhibit
2.1†
Agreement and Plan of Merger, dated January 31, 2021, by and among Leisure Acquisition Corp., Ensysce Biosciences, Inc. and EB Merger Sub, Inc. (incorporated by reference to Exhibit 2.1 filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021).
3.1(a)
Third Amended and Restated Certificate of Incorporation of Ensysce Biosciences, Inc. (incorporated by reference to Exhibit 3.1 filed with the registrant’s Current Report on Form 8-K on July 7, 2021).
3.1(b)
Certificate of amendment to Third Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1(b) filed with the registrant’s Registration Statement on Form S-1 (File No. 333-268038) on October 28, 2022)
3.1(c)
Certificate of Second Amendment to Third Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on October 27, 2022)
3.1(d)
Certificate of Designation of Series B Preferred Stock of Ensysce Biosciences, Inc., dated November 14, 2025, including Certificate of Correction to the Certificate of Designation dated November 14, 2025 (incorporated by reference to Exhibit 4.1 to the registrant’s Current Report on Form 8-K filed on November 17, 2025)
3.2(a)
Amended and Restated Bylaws of Ensysce Biosciences, Inc. (incorporated by reference to Exhibit 3.2 filed with the registrant’s Current Report on Form 8-K on July 7, 2021)
3.2(b)
Amendment to Amended and Restated Bylaws of Ensysce Biosciences, Inc. (incorporated by reference to Exhibit 3.2(b) filed with the registrant’s Current Report on Form 8-K on October 15, 2024)
4.1
Warrant Agreement, dated December 1, 2017, between the Leisure Acquisition Corp. and Continental Stock Transfer & Trust Company (incorporated by reference to Exhibit 4.1 filed with the registrant’s Current Report on Form 8-K on December 5, 2017)
4.2
Investor Rights Agreement between Ensysce Biosciences, Inc. and the Investors listed on the signature pages thereto dated as of May 11, 2018 (incorporated by reference to Exhibit 4.6 filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
4.3
Form of Warrant Certificate issued to previous holders of Private Placement Warrants and other private warrants (incorporated by reference to Exhibit 4.8 filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
4.4
Form of Common Stock Purchase Warrant to be issued by the Company pursuant to and in accordance with the Securities Purchase Agreement (incorporated by reference to Exhibit 4.7 filed with the registrant’s Current Report on Form 8-K initially filed on September 27, 2021)
4.5
Form of Common Stock Purchase Warrant issued by Ensysce Biosciences, Inc. pursuant to and in accordance with a 2022 Securities Purchase Agreement (incorporated by reference to Exhibit 4.7 filed with the registrant’s Current Report on Form 8-K on August 9, 2022)
4.6
Form of warrant delivered by Ensysce Biosciences, Inc. in December 2022 in connection with an underwritten offering (incorporated by reference to Exhibit 4.10 filed with the registrant’s Post-Effective Amendment No. 1 to the registrant’s Registration Statement on Form S-1 filed December 8, 2022)
4.7
Form of warrant issued in connection with a private placement conducted concurrently with a public offering (incorporated by reference to Exhibit 4.1 filed with the registrant’s Current Report on Form 8-K on February 7, 2023)
4.8
Form of warrant issued to a placement agent or its designees in connection with a private placement conducted concurrently with a public offering (incorporated by reference to Exhibit 4.2 filed with the registrant’s Current Report on Form 8-K on February 7, 2023)
4.9
Form of common warrant (incorporated by reference to Exhibit 4.12 filed with the registrant’s Post-Effective Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-271480) on May 17, 2023)
4.10
Form of placement agent warrant (incorporated by reference to Exhibit 4.14 filed with the registrant’s Post-Effective Amendment on Form S-1 (File No. 333-271480) on May 17, 2023)
4.11
Form of warrants amended in connection with the execution of a Securities Purchase Agreement on May 10, 2023 (incorporated by reference to Exhibit 4.15 filed with the registrant’s Post-Effective Amendment No. 1 to the Registration Statement on Form S-1 (File No. 333-271480) on May 17, 2023)
4.12
Form of common warrant issued in October 2023 and November 2023 (incorporated by reference to Exhibit 4.16 filed with the registrant’s Registration Statement on Form S-1 (File No. 333-275456) on November 9, 2023)
4.13
Form of October 2023 Secured Convertible Promissory Note (incorporated by reference to Exhibit 4.6 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on October 24, 2023).
4.14
Form of Series A/B common stock purchase warrant issued February 14, 2024 (incorporated by reference to Exhibit 4.1 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on February 14, 2024)
4.15
Form of placement agent warrant issued February 14, 2024 (incorporated by reference to Exhibit 4.2 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on February 14, 2024)
4.16
Form of Series A-3/A-4 common stock purchase warrant issued August 29, 2024 (incorporated by reference to Exhibit 4.2 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on August 30, 2024)
4.17
Form of Series A-5/A-6 common stock purchase warrant issued March 31, 2025 (incorporated by reference to Exhibit 4.2 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on March 31, 2025)
4.18
Form of placement agent warrant issued March 31, 2025 (incorporated by reference to Exhibit 4.3 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on March 31, 2025)
4.19
Form of Series A-7/A-8 common stock purchase warrant issued April 24, 2025 (incorporated by reference to Exhibit 4.1 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on April 24, 2025)
4.20
Form of placement agent warrant issued April 24, 2025 (incorporated by reference to Exhibit 4.2 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on April 24, 2025)
4.21
Form of Common Stock Purchase Warrant issued November 13, 2025 (incorporated by reference to Exhibit 4.2 filed with the registrant’s Current Report on Form 8-K on November 17, 2025
4.22
Form of Common Stock Purchase Warrant issued November 13, 2025 to a financial advisor or its designees (incorporated by reference to Exhibit 4.24 filed with the registrant’s Registration Statement on Form S-3 (File No. 333-291892) filed on December 2, 2025)
10.1
Registration Rights Agreement, dated December 1, 2017, among Leisure Acquisition Corp. and certain securityholders (incorporated by reference to Exhibit 10.2 filed with the registrant’s Current Report on Form 8-K on December 5, 2017)
10.2
Warrant Purchase Agreement, dated December 1, 2017, between Leisure Acquisition Corp. and certain security holders (incorporated by reference to Exhibit 10.3 filed with the registrant’s Current Report on Form 8-K on December 5, 2017)
94
10.3(a)
Form of Director and Officer Indemnity Agreement (incorporated by reference to Exhibit 10.8 filed with the registrant’s Registration Statement on Form S-1 (File No.333-221330) initially filed on November 3, 2017)
10.3(b)
Form of Indemnification Agreement executed by each of the Ensysce directors and executive officers (incorporated by reference to Exhibit 10.6 filed with the registrant’s Form 10-Q initially filed on November 15, 2021)
10.4+
Executive Employment Agreement, by and between the Company and Dr. Lynn Kirkpatrick, dated September 14, 2021 (incorporated by reference to Exhibit 10.44 filed with the registrant’s Amendment Number 1 to its Registration Statement on Form S-1 (File No.333-260478) filed on October 29, 2021)
10.5
Agreement and Plan of Merger by and among the Signature Therapeutics, Inc., Signature Acquisition Corp. and the Company dated December 28, 2015 (incorporated by reference to Exhibit 10.21 filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
10.6+
Executive Employment Agreement, by and between the Company and Geoffrey Birkett, dated August 21, 2021 (incorporated by reference to Exhibit 10.45 filed with the registrant’s Amendment Number 1 to its Registration Statement on Form S-1 (File No.333-260478) filed on October 29, 2021)
10.7+
Employment Agreement between the Company and David Humphrey dated February 11, 2021 (incorporated by reference to Exhibit 10.26 filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
10.8+
Amendment to Offer Letter between the Company and David Humphrey dated February 23, 2021 (incorporated by reference to Exhibit 10.27 filed with the the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
10.9(a)+
Amended and Restated 2021 Omnibus Incentive Plan (incorporated by reference to Exhibit Notes filed with the registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.9(b)+
Amended and Restated 2021 Omnibus Incentive Plan Form of Stock Option Grant Notice and Award Agreement (incorporated by reference to Exhibit 10.22(a) filed with the registrant’s Annual Report on Form 10-K filed on March 31, 2022)
10.10†
Technology Transfer Agreement by and among the Company, Covistat, Inc., Mucokinetica, Ltd., Roderick Hall and Peter Cole dated August 5, 2020 (incorporated by reference to Exhibit 10.30, filed on April 16, 2021 in an amendment to the registrant’s Registration Statement on Form S-4 (File No.333-254279))
10.11
Manufacturing Agreement between Recro Gaineville LLC and the Company dated September 11, 2019 (incorporated by reference to Exhibit 10.35 filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
10.12(a)
Form of Exchange Agreement between Leisure Acquisition Corp. and the holders of Private Placement Warrants (incorporated by reference to Exhibit 10.36(a) filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
10.12(b)
Form of Exchange Agreement to be entered into by the Company with each of the Sponsors and the Strategic Investor (incorporated by reference to Exhibit 10.36(b) filed with the registrant’s Registration Statement on Form S-4 (File No.333-254279) initially filed on March 15, 2021)
10.13(a)†
Securities Purchase Agreement, dated September 24, 2021 by and among the Company and the purchasers signatory thereto (incorporated by reference to Exhibit 10.1 filed with the registrant’s Current Report on Form 8-K initially filed on September 27, 2021)
10.13(b)
Registration Rights Agreement, dated September 24, 2021, by and among the Company and the parties signatory thereto (incorporated by reference to Exhibit 10.2 filed with the registrant’s Current Report on Form 8-K initially filed on September 27, 2021)
10.13(c)
Subsidiary Guarantee, dated September 24, 2021, by and among the Company and the purchasers signatory thereto (incorporated by reference to Exhibit 10.3 filed with the registrant’s Current Report on Form 8-K initially filed on September 27, 2021)
95
10.13(d)†
Security Agreement, dated September 24, 2021, by and among the Company, EBI OpCo, Inc., Covistat, Inc. and the other parties signatory thereto (incorporated by reference to Exhibit 10.4 filed with the registrant’s Current Report on Form 8-K initially filed on September 27, 2021)
10.13(e)
Patent Security Agreement, dated September 24, 2021, by and among the Company, EBI OpCo, Inc., Covistat, Inc. and the other parties signatory thereto (incorporated by reference to Exhibit 10.5 filed with the registrant’s Current Report on Form 8-K initially filed on September 27, 2021)
10.14(a)
Securities Purchase Agreement, dated June 30, 2022, by and among the Company and the purchasers signatory thereto (incorporated by reference to Exhibit 10.1 filed with the registrant’s Current Report on Form 8-K on July 6, 2022)
10.14(b)
Registration Rights Agreement, dated June 30, 2022, by and among the Company and the parties signatory thereto (incorporated by reference to Exhibit 10.2 filed with the registrant’s Current Report on Form 8-K on July 6, 2022)
10.14(c)
Subsidiary Guarantee, dated June 30, 2022, by and among the Company and the purchasers signatory thereto (incorporated by reference to Exhibit 10.3 filed with the registrant’s Current Report on Form 8-K on July 6, 2022)
10.14(d)
Security Agreement, dated June 30, 2022, by and among the Company, EBI OpCo, Inc., Covistat, Inc. and the other parties signatory thereto (incorporated by reference to Exhibit 10.4 filed with the registrant’s Current Report on Form 8-K on July 6, 2022)
10.14(e)
Patent Security Agreement, dated June 30, 2022, by and among the Company, EBI OpCo, Inc., Covistat, Inc. and the other parties signatory thereto (incorporated by reference to Exhibit 10.5 filed with the registrant’s Current Report on Form 8-K on July 6, 2022)
10.15
October 2023 Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on October 24, 2023)
10.16
Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on October 24, 2023)
10.17
Form of Subsidiary Guaranty (incorporated by reference to Exhibit 10.3 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on October 24, 2023)
10.18
Form of Security Agreement (incorporated by reference to Exhibit 10.4 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on October 24, 2023)
10.19
Form of Patent Security Agreement (incorporated by reference to Exhibit 10.5 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on October 24, 2023)
10.21
Product Development and Commercial Manufacturing Supply Master Services Agreement with Galephar Pharmaceutical Research, Inc. (incorporated by reference to Exhibit 10.1 filed with the registrant’s Current Report on Form 8-K (File No. 001-38306) on February 4, 2025)
14
Company’s Code of Business Conduct (incorporated by reference to Exhibit 14 filed with the registrant’s Annual Report on Form 10-K (File No. 001-38306) on March 30, 2023)
19*
Company’s Insider Trading Policy
21.1
List of Subsidiaries (incorporated by reference to Exhibit 21 filed with the Registration Statement on Form S-1 (333-268038) filed on October 28, 2022)
23.1*
Consent of Baker Tilly US, LLP, Independent Registered Public Accounting Firm
31.1*++
Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*++
Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*++
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*++
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
97
Policy relating to recovery of erroneously awarded compensation (incorporated by reference to Exhibit 97 filed with the registrant’s Annual Report on Form 10-K (File No. 001-38306) on March 15, 2024)
(101)
Interactive
Data File
(104)
Cover
Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)
*
Filed
herewith.
†
Certain
schedules (or similar attachments) to this Exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5) or 601(b)(2),
as applicable. The registrant agrees to furnish supplementally a copy of all omitted schedules to the Securities and Exchange Commission
upon its request.
+
Denotes
compensatory plans or arrangements or management contracts.
++
This
certificate accompanies this report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed filed by Ensysce
for purposes of Section 18 or any other provisions of the Exchange Act.
Item
16. Form 10-K Summary.
Not
applicable.
96
SIGNATURES
Pursuant
to the requirements of the Securities Act, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized, in San Diego, State of California, on March 30, 2026.
ENSYSCE
BIOSCIENCES, INC.
By:
/s/
Dr. Lynn Kirkpatrick
Name:
Dr.
Lynn Kirkpatrick
Title:
President,
Chief Executive Officer and Director
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities indicated
on March 30, 2026.
Name
Title
By:
/s/
Dr. Lynn Kirkpatrick
President,
Chief Executive Officer and Director
Dr.
Lynn Kirkpatrick
(Principal
Executive Officer)
By:
/s/
David Humphrey
Chief
Financial Officer, Secretary and Treasurer
David
Humphrey
(Principal
Financial and Accounting Officer)
By:
/s/
William Chang
Director
William
Chang
By:
/s/
Bob Gower
Director
and Chairman of the Board
Bob
Gower
By:
/s/
Adam Levin
Director
Adam
Levin
By:
/s/
Steve Martin
Director
Steve
Martin
By:
/s/
Curtis Rosebraugh
Director
Curtis
Rosebraugh
97
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.