Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
We
are required to maintain “disclosure controls and procedures” as such term is defined in Rule 13a-15(e) under the Securities
Exchange Act of 1934 (the “Exchange Act”). In designing and evaluating our disclosure controls and procedures, our management
recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of disclosure controls and procedures are met. The design of any disclosure controls and procedures is
also based, in part, upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions. We conducted an evaluation of the effectiveness of
our disclosure controls and procedures as of December 31, 2024. Based on this evaluation, our chief executive officer and chief financial
officer concluded that our disclosure controls and procedures were not effective as of the end of the reporting period covered in this
Annual Report on Form 10-K, as a result of the material weaknesses in our internal control over financial reporting described below.
Notwithstanding the identified material weaknesses, our management has concluded that the audited consolidated financial statements in
this filing on Form 10-K, fairly present, in all material respects, our financial position, results of operations and cash flows as of
and for the periods presented in conformity with GAAP.
Management’s
Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange
Act Rule 13a-15. Internal control over financial reporting is defined in Rule 13a-15(f) and 15(d)-15(f) under the Exchange Act as a process
designed to provide reasonable assurance to our management and Board of Directors regarding the preparation and fair presentation of
published financial statements.
A
control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of
the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the
benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances of error or fraud, if any, within our Company have been
detected. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design
safeguards into the process to reduce, though not eliminate, this risk.
30
As
previously disclosed, management identified material weaknesses in its internal controls over financial reporting at December 31, 2023
which continue to be unremediated as of December 31, 2024. Specifically, Management noted the Company did not properly document, implement
or operate a system of effective internal controls over financial reporting. A material weakness is a deficiency, or a combination of
deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement
of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.
Management
conducted an assessment of our internal control over financial reporting as of December 31, 2024 based on the framework and criteria
established by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013).
Based on the assessment, and the noted material weaknesses, management concluded that, as of December 31, 2024, our internal control
over financial reporting was not effective.
Ongoing
Remediation Efforts
Management
is in the process of implementing improvements to its internal controls over financial reporting. Namely the Company has and is continuing
to:
● transition
its day-to-day accounting processes to an external firm including automating its vendor payments;
● complete
the transfer of the overall accounting process to an enterprise type accounting platform;
● periodically
review the design and effectiveness of our controls including the creation of an annual risk
assessment and ongoing monitoring activities; and
● evaluate
all internal and external resources to ensure they are appropriate for the level and complexity
of our current operations. This includes the hiring of a Corporate Controller in 2024.
While
we believe that these efforts will improve our internal control over financial reporting, the implementation of these measures is ongoing
and will require validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial
reporting cycles. We will continue to monitor and evaluate the effectiveness of our internal control over financial reporting on an ongoing
basis and are committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds
allow. We cannot assure you that the measures we have taken to date, or that we may take in the future, will be sufficient to remediate
the material weaknesses we have identified or avoid potential future material weaknesses. Accordingly, there could continue to be a reasonable
possibility that a material misstatement of our financial statements would not be prevented or detected on a timely basis.
Changes
in Internal Control Over Financial Reporting
Other
than the material weaknesses and remediation efforts described above, there has been no change in the Company’s internal control
over financial reporting during the Company’s most recently completed fiscal quarter that has materially affected, or is reasonably
likely to materially affect, the Company’s internal control over financial reporting.
ITEM
9B. OTHER INFORMATION
Insider
Trading Plans
During
the quarter ended December 31, 2024, none of the Company’s directors or executive officers adopted , modified or terminated any
contract, instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense
conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement”. As previously discussed, in June 2023 , Vininder
Singh , the Chief Executive Officer and a Director of the Company , entered into a 10b5-1 sales plan (the “10b-5 Sales Plan”)
intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act. The 10b5 Sales Plan provides for the sale of up
to 1,000,000 shares of common stock and will remain in effect until the earlier of (1) August 31, 2025; or (2) the date on which an aggregate
of 1,000,000 shares of common stock have been sold under the 10b5 Sales Plan. Pursuant to the 10b5 Sales Plan, 50,000 shares were sold
under the plan in September 2023, 100,000 shares were sold under the plan in the first quarter of 2024, and 50,000 shares were sold under
the plan in each of the second, third, and fourth quarters of 2024.
ITEM 9C. DISCLOSURE
REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not
applicable.
31
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
Executive
Officers and Directors
The
following table sets forth the name, age and position of each of our executive officers, key employees and directors.
Name
Age
Position(s)
Executive Officers:
Vininder Singh
56
Chief Executive Officer and Director
Josh Blacher
52
Chief Financial Officer
Non-Executive Directors:
R. Donald Elsey
71
Director and Chair of Audit Committee
William Enright
61
Director and Chair of Compensation Committee
Jason D. Hanson
56
Director and Chair of Nominating and Corporate Governance
Committee
Vininder
(Vin) Singh is the founder of Bullfrog AI Holdings, Inc. and has served as its Chairman and CEO since its inception in August 2017.
Over the past seven years, he has built the Company from scratch and, during that time, he led strategy, built a highly experienced team
of leaders, spearheaded the acquisition and development of the Company’s core AI technology and drug assets, secured the first
revenue, and raised approximately $2 million in financing prior to the Company’s IPO in February 2023. In February of 2020, he
formed Bullfrog AI Holdings, Inc., and Bullfrog AI Inc. became a wholly owned subsidiary designated as the holder of core intellectual
property. Vin is a serial entrepreneur and experienced executive with 25 years of experience in the life sciences and biotechnology industries.
He has extensive start-up experience having founded and built several pioneering investor-backed companies including Bullfrog AI, which
uses AI/ML to enable drug development, Next Healthcare Inc., a personalized diagnostics and adult cell banking service, and MaxCyte Inc.
(NASDAQ: MXCT), a cell therapy company. He was also an executive at GlobalStem Inc. and ThermoFisher Scientific, leading their global
cell therapy services business. Vin has a B.S. in Electrical Engineering from Rutgers University, an M.S. in Biomedical Engineering from
Rensselaer Polytechnic Institute, and an M.B.A. from Johns Hopkins University. We believe that Mr. Singh is qualified to serve as a member
of our board of directors due to the perspective and experience that he brings as our founder and Chief Executive Officer, his extensive
experience in the science and biotechnology industries and in the management of startup companies.
Josh
Blacher has been the Chief Financial Officer of Bullfrog AI Holdings, Inc. since December 2024. Mr. Blacher has served as an employee
of Danforth Advisors since September 2022, where he has worked as a chief financial officer in a consulting capacity for a number of
life sciences companies as well as Managing Partner of Columbus Circle Capital LLC since August 2019. In his capacity as a consultant
of Danforth, he has served as Chief Financial Officer of Predictive Oncology since September 2023 as well as Rampart Bioscience and Excision
Bio Therapeutics, among others. During his tenure at Columbus Circle Capital, Mr. Blacher has served as chief financial officer at several
public and private companies. Prior to his tenure at Columbus Circle Capital, Mr. Blacher served as Chief Business Officer at Inmed Pharmaceuticals
(Nasdaq: INM) from April 2018 to August 2019, as Chief Financial Officer of Therapix Biosciences (Nasdaq: TRPX) from April 2017 to April
2018, and as Chief Financial Officer at Galmed Pharmaceuticals (Nasdaq: GLMD) from October 2014 to March 2017. Earlier in his career,
Mr. Blacher served in senior capacities at Teva Pharmaceuticals, Deutsche Asset Management and Morgan Stanley. Mr. Blacher holds a Bachelor
of Arts from Yeshiva University and a Master of Business Administration from Columbia Business School.
32
R.
Don Elsey has been a director and chair of the Audit Committee of our board since February 2023. Mr. Elsey was the Chief Financial
Officer of Lyra Therapeutics until his retirement in December 2020. Previously, from February 2015 to February 2019, Mr. Elsey served
as Chief Financial Officer at Senseonics, Inc., a medical device company. From May 2014 until February 2015, Mr. Elsey served as Chief
Financial Officer of Regado Biosciences, Inc., a biopharmaceutical company. From December 2012 to February 2014, Mr. Elsey served as
Chief Financial Officer of LifeCell Corporation, a privately held regenerative medicine company. Mr. Elsey holds a B.A. in economics
and an M.B.A. in finance from Michigan State University. We believe that Mr. Esley is qualified to serve as a member of our board of
directors because of his extensive professional experience in science and biotechnology companies.
William
“Bill” Enright has been a director and chair of the Compensation Committee of our board since February 2023. He
is a seasoned biotech executive with more than thirty-four years of experience in building and financing both privately held and publicly
held companies and he is currently the Chief Executive Officer and a Director of Barinthus Biotherapurtics plc (NASDAQ: BRNS), which
he helped to take public in April 2021. Prior to Barinthus, Mr. Enright spent more than ten years at Altimmune (NASDAQ: ALT) as a director,
president & chief executive officer, moving multiple programs into clinical testing, completing several acquisitions, and eventually
taking the company public. Prior to joining Altimmune, Mr. Enright spent six years with GenVec, Inc. (acquired by Precigen) with increasing
responsibilities, culminating as Head of Business Development. Mr. Enright brings a breadth of experiences in a variety of positions
within the life science/biotech industry, including time as a consultant, a bench scientist and 12 years with Life Technologies, Inc.
(acquired by Thermo-Fisher), working in various senior level licensing, business management, manufacturing and research roles. Mr. Enright
received a Master of Arts in Molecular Biology from SUNY at Buffalo and a Master of Science in Business Management from Johns Hopkins
University. We believe that Mr. Enright is qualified to serve as a member of our board of directors because of his extensive professional
experience in life science/biotech companies and in the management of public companies.
Jason
Hanson has served as a director and chair of the Nominating and Corporate Governance Committee since February 2023. Mr. Hanson
served as Chief Executive Officer and as a director of enGene Inc. from July 2018 to July 2024. He also served as President of enGene
Inc. from July 2018 to December 2022. Mr. Hanson effectively re-launched enGene from a small private company working in the GI discovery
space into a clinical stage gene therapy oncology company trading on Nasdaq, implementing a new scientific, technical and strategic vision
for the Company. From August 2016 to November 2017, Mr. Hanson served as President and Chief Executive Officer of Ohana Biosciences,
a biotechnology company based in Cambridge, MA, and as member of the Ohana Board of Directors and consultant to Ohana from November 2017
to June 2018. Mr. Hanson previously served as Executive Vice President and Chief Strategy Officer for NuVasive, Inc. from November 2015
to August 2016. Mr. Hanson served as Corporate Vice President of General Electric Company and member of the senior executive team of
GE Healthcare, a global pharmaceutical, medical device and healthcare services business from May 2014 to October 2015. In January 2013,
Mr. Hanson served as Company Group Chairman and Executive Vice President of Valeant Pharmaceuticals International, Inc. (now Bausch Health
Companies Inc.). Previously, he served in various roles at Medicis Pharmaceutical Corporation, including as Executive Vice President
and Chief Operating Officer between July 2006 and December 2012. Mr. Hanson also served in numerous roles at GE Healthcare, including
General Counsel roles, from April 1999 to July 2006. Mr. Hanson holds a B.S. from Cornell University and a J.D. from Duke University
School of Law. We believe that Mr. Hanson is qualified to serve as a member of our board of directors because of his extensive professional
experience in science and biotechnology companies.
Board
Diversity
The
table below provides certain information regarding the diversity of our board of directors as of the date of this annual report.
33
Board
Diversity Matrix
Country of
Principal Executive Officers:
United States
Foreign Private Issuer
No
Disclosure Prohibited under
Home Country Law
N/A
Total Number of Directors
4
Female
Male
Non-Binary
Did
Not Disclose Gender
Part I: Gender Identity
Directors
0
4
0
0
Part II: Demographic
Background
Underrepresented Individual
in Home Country Jurisdiction
N/A
LGBTQ+
N/A
Did Not Disclose Demographic
Background
N/A
Our
Board seeks members from diverse professional backgrounds who combine a solid professional reputation and knowledge of our business and
industry with a reputation for integrity. Our Board does not have a formal policy concerning diversity and inclusion but is in the process
of establishing a policy on diversity. Diversity of experience, expertise, and viewpoints is one of many factors the Nominating and Corporate
Governance Committee considers when recommending director nominees to our Board. Further, our Board is committed to actively seeking
highly qualified women and individuals from minority groups and the LGBTQ+ community to include in the pool from which new candidates
are selected. Our Board also seeks members that have experience in positions with a high degree of responsibility or are, or have been,
leaders in the companies or institutions with which they are, or were, affiliated, but may seek other members with different backgrounds,
based upon the contributions they can make to our Company. While the Board has continued its efforts to identify candidates that have
such experience, they have currently been unable to identify any such candidates which fulfill the diversity requirement with the requisite
professional experience.
Role
of Board of Directors in Risk Oversight Process
The
board of directors has extensive involvement in the oversight of risk management related to us and our business and accomplishes this
oversight through the regular reporting by the Audit Committee. The information set forth in Item 1C is incorporated herein by reference.
Director
Independence
Messrs.
Elsey, Enright and Hanson, three members of our Board of Directors, are independent using the definition of independence under Nasdaq
Listing Rule 5605(a)(2) and the standards established by the SEC.
Committees
of our Board
Audit
Committee
Our
audit committee consists of Don Elsey, William Enright and Jason Hanson, with Mr. Elsey serving as chair. Our board of directors has
affirmatively determined that each meets the definition of “independent director” under the rules of The Nasdaq Capital Market,
and that they meet the independence standards under Rule 10A-3. Each member of our audit committee meets the financial literacy requirements
of Nasdaq rules, and qualify as a financial expert within the meaning of SEC regulations and meets the financial sophistication requirements
of the pertinent listing standards of Nasdaq, as in effect from time to time. In making this determination, our board of directors has
considered the members’ formal education and previous and current experience in financial roles. Our board of directors has adopted
a written charter for the audit committee, which can be found on our website at https://ir.bullfrogai.com/corporate-governance/governance-documents .
The
audit committee is appointed by the board of directors to assist the board of directors in its duty to oversee the Company’s accounting,
financial reporting, and internal control functions and the audit of the Company’s financial statements. The role of the audit
committee is to oversee management in the performance of its responsibility for the integrity of the Company’s accounting and financial
reporting and its systems of internal controls, the performance and qualifications of the Company’s independent auditor, including
the independent auditor’s independence, the performance of the Company’s internal audit function; and the Company’s
compliance with legal and regulatory requirements. The audit committee met 5 times in 2024.
Compensation
Committee
Our
compensation committee consists of William Enright, Don Elsey and Jason Hanson, with Mr. Enright serving as chair. Our board of directors
has adopted a written charter for the compensation committee, which can be found on our website at https://ir.bullfrogai.com/corporate-governance/governance-documents .
34
The
compensation committee is responsible for reviewing and recommending, among other things:
● the
adequacy and form of compensation of the board;
● the
compensation of the Chief Executive Officer, including base salary, incentive bonus, stock
option and other grant awards, and benefits upon hiring and on an annual basis;
● the
compensation of other senior management upon hiring and on an annual basis; and
● the
Company’s incentive compensation and other equity-based plans and recommending changes
to such plans to our board of directors, when necessary.
The
compensation committee met 4 times in 2024.
Nominating
& Corporate Governance Committee
Our
nominating and corporate governance committee consists of Jason Hanson, William Enright and Don Elsey, with Mr. Hanson serving as chair.
Our board of directors has adopted a written charter for the nominating and corporate governance committee, which can be found on our
website at https://ir.bullfrogai.com/corporategovernance/governance-documents .
The
nominating committee is responsible for, among other things:
● developing
criteria for membership on the board of directors and committees;
● identifying
individuals qualified to become members of the board of directors;
● recommending
persons to be nominated for election as directors and to each committee of the board of directors;
● annually
reviewing our corporate governance guidelines; and
● monitoring
and evaluating the performance of the board of directors and leading the board in an annual
self-assessment of its practices and effectiveness.
The
nominating and corporate governance committee met 4 times in 2024.
Term
of office
All
directors hold office until the next annual meeting of the stockholders of the company and until their successors have been duly elected
and qualified. Officers are elected by and serve at the discretion of our Board.
Code of Business
Conduct and Ethics
We
have adopted a Code of Business Conduct and Ethics that applies to our principal executive officer, principal financial officer, principal
accounting officer or controller, employees or persons performing similar functions. Our code of ethics can be found at https://ir.bullfrogai.com/corporate-governance/governance-documents .
Clawback
Policy
The
Board has adopted the Bullfrog AI Clawback Policy (the “Clawback Policy”), effective December 1, 2023, providing for the
recovery of certain incentive-based compensation from current and former executive officers of the Company in the event the Company is
required to restate any of its financial statements filed with the SEC under the Exchange Act in order to correct an error that is material
to the previously-issued financial statements, or that would result in a material misstatement if the error were corrected in the current
period or left uncorrected in the current period. Adoption of the Clawback Policy was mandated by new Nasdaq listing standards introduced
pursuant to Exchange Act Rule 10D-1. The Clawback Policy is in addition to Section 304 of the Sarbanes-Oxley Act of 2002 which permits
the SEC to order the disgorgement of bonuses and incentive-based compensation earned by a registrant issuer’s chief executive officer
and chief financial officer in the year following the filing of any financial statement that the issuer is required to restate because
of misconduct, and the reimbursement of those funds to the issuer. A copy of the Clawback Policy is attached as an exhibit to this annual
report and can be found at www.bullfrogai.com.
35
Family
Relationships
There
are no family relationships among and between the issuer’s directors, officers, persons nominated or chosen by the issuer to become
directors or officers, or beneficial owners of more than ten percent of any class of the issuer’s equity securities.
Involvement
in Certain Legal Proceedings
Our
directors and executive officers have not been involved in any of the following events during the past ten years:
1. any
bankruptcy petition filed by or against such person or any business of which such person
was a general partner or executive officer either at the time of the bankruptcy or within
two years prior to that time;
2. any
conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding
traffic violations and other minor offenses);
3. being
subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated,
of any court of competent jurisdiction, permanently or temporarily enjoining him from or
otherwise limiting his involvement in any type of business, securities or banking activities
or to be associated with any person practicing in banking or securities activities;
4. being
found by a court of competent jurisdiction in a civil action, the SEC or the Commodity Futures
Trading Commission to have violated a Federal or state securities or commodities law, and
the judgment has not been reversed, suspended, or vacated;
5. being
subject of, or a party to, any Federal or state judicial or administrative order, judgment
decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged
violation of any Federal or state securities or commodities law or regulation, any law or
regulation respecting financial institutions or insurance companies, or any law or regulation
prohibiting mail or wire fraud or fraud in connection with any business entity; or
6. being
subject of or party to any sanction or order, not subsequently reversed, suspended, or vacated,
of any self-regulatory organization, any registered entity or any equivalent exchange, association,
entity or organization that has disciplinary authority over its members or persons associated
with a member.
Section
16(a) Beneficial Ownership Compliance
Based
solely upon a review of copies of such forms filed on Forms 3, 4 and 5, and amendments thereto furnished to us, we believe that as of
the date of this Report, our executive officers, directors and greater than 10 percent beneficial owners have complied on a timely basis
with all Section 16(a) filing requirements, except for one Form 4 by each of Messrs. Elsey, Enright and Hanson concerning the annual
grant of stock options in September 2024.
Nomination
Process
As
of December 31, 2024, we did not affect any material changes to the procedures by which stockholders may recommend nominees to the Board
of Directors.
Insider
Trading Policies
We
have adopted an insider trading policy governing the purchase, sale, and other dispositions of our securities by directors, senior management,
and employees. A copy of the insider trading policy is attached as an exhibit to this Annual Report on Form 10-K.
36
ITEM
11. EXECUTIVE COMPENSATION
Summary
Compensation Table
The
following table sets forth all plan and non-plan compensation for the last two fiscal years paid to individuals who served as the Company’s
principal executive officers and the Company’s two other most highly compensated executive officers serving as executive officers
at the end of the last completed fiscal year, as required by Item 402(m)(2) of Regulation S-K of the Securities Act. We refer to these
individuals collectively as our “named executive officers.”
Name and Principal Position
Year
Salary
Bonus
Stock Awards
Option Awards
All Other Compensation
Nonequity Incentive Plan Compensation
Nonqualified Deferred Compensation Earnings
Total Compensation
Vininder Singh
2024
$ 400,000
$ -
$ -
$ 230,680
$ -
$ -
$ -
$ 630,680
Chief Executive Officer and Director
2023
$
707,666 (1)
$ -
$ -
$ -
$ -
$ -
$ -
$ 707,666
Dane Saglio
2024
$ 252,581
$ -
$ -
$ 100,740
$ -
$ -
$ -
$ 353,321
Chief Financial Officer
2023
$ 310,000 (2)
$ 50,000
$ -
$ 147,000
$ -
$ -
$ -
$ 507,000
Josh Blacher
2024
$ 10,631
$ -
$ -
$ -
$ -
$ -
$ -
$ 10,631
Chief Financial Officer
2023
$ -
$ -
$ -
$ -
$ -
$ -
$ -
$ -
(1)
Comprised of $380,000 related to Mr. Singh’s 2023 salary, and salary amounts of $240,000 and $87,666 deferred in 2022 and years
prior to 2022, respectively, and paid in 2023.
(2)
Comprised of $220,000 related to Mr. Saglio’s 2023 consulting fees, and consulting fees of $90,000 deferred in 2022 and paid in
2023.
Employment
Agreements
On
May 16, 2022, we entered into an employment agreement with Vininder Singh, pursuant to which he received an annual base salary of $400,000,
which is subject to bi-annual review by the Company. Mr. Singh is also eligible for an annual bonus based on the achievement of certain
goals and performance criteria established by the Board. Mr. Singh’s target annual bonus for the fiscal years ended 2022 through
2025 will be a minimum of twenty (20%) percent of the current base salary, with a maximum payout of up to one-hundred (100%) percent
based on target achievement. Mr. Singh will also be eligible to participate in the Company’s stock incentive plan, subject to Board
approval. The agreement with Mr. Singh shall continue until either his resignation, termination for cause by the Company, or death or
disability of Mr. Singh.
Consulting
Agreements
On
December 7, 2024, Dane Saglio, the Company’s former Chief Financial Officer, passed away. Mr. Saglio served as the Company’s
Chief Financial Officer since September 2021. Mr. Saglio was a valued member of the Company’s executive management team and will
be greatly missed. Prior to his passing, Mr. Saglio served as Chief Financial Officer pursuant to a consulting agreement with the Company
that provided for annual compensation of $270,000. Under the agreement, Mr. Saglio was also entitled to a cash bonus and to participate
in the Company’s stock incentive plan, each as determined by the Board.
On
December 12, 2024, the Board of Directors appointed Josh Blacher to serve as the Company’s Chief Financial Officer. In such capacity,
Mr. Blacher will serve as the principal financial officer and principal accounting officer of the Company. Mr. Blacher provides services
to the Company as an independent contractor pursuant to a master services agreement entered into on December 13, 2024 (the “Consulting
Agreement”) by the Company and Danforth Advisors, LLC (“Danforth”). Pursuant to the Consulting Agreement, the Company
will pay Danforth cash compensation at a rate of $525 per hour for Mr. Blacher’s services, which is subject to an optional increase
by Danforth of up to 5% on January 1 of each year. Mr. Blacher will receive no compensation directly from the Company.
37
Director
Compensation
The
following table summarizes the compensation paid to our executive and non-executive directors during the year ended December 31, 2024.
Name
Fees
Earned or Paid in Cash (1)
Stock Awards
Option
Awards (2)
All Other Compensation
Nonequity Incentive Plan Compensation
Nonqualified Deferred Compensation
Earnings
Total Compensation
Vininder Singh (3)
$ -
$ -
$ -
$ -
$ -
$ -
$ -
R. Donald Elsey
$ 45,000
$ -
$ 34,050
$ -
$ -
$ -
$ 79,050
William Enright
$ 45,000
$ -
$ 34,050
$ -
$ -
$ -
$ 79,050
Jason D. Hanson
$ 45,000
$ -
$ 34,050
$ -
$ -
$ -
$ 79,050
(1)
Represents cash compensation for service as a director and as chair of a board committee during the fiscal year 2024.
(2)
Represents annual value of stock options issued during fiscal year 2024 under our 2022 Equity Incentive Plan.
(3)
Mr. Singh did not receive additional compensation for his service as a director of our Company during the fiscal year 2024.
Pension,
Retirement or Similar Benefit Plans
There
are no arrangements or plans in which we provide pension, retirement or similar benefits for directors or executive officers. We have
no material bonus or profit-sharing plans pursuant to which cash or non-cash compensation is or may be paid to our directors or executive
officers, except that stock options may be granted at the discretion of the Board or a committee thereof.
Indebtedness
of Directors, Senior Officers, Executive Officers and Other Management
None
of our directors, executive officers or any associate or affiliate of our Company during the last two fiscal years is or has been indebted
to our Company by way of guarantee, support agreement, letter of credit or other similar agreement or understanding currently outstanding.
Equity
Compensation Plans
On
November 30, 2022, our Board of Directors and shareholders adopted the 2022 Equity Incentive Plan (the “Plan”). Pursuant
to the Plan, we are authorized to grant options and other equity awards to officers, directors, employees and consultants. The exercise
price of each share of common stock purchasable under an award issued pursuant to the Plan, shall be determined by our compensation committee,
in its sole discretion, at the time of grant, but shall not be less than 100% of the fair market value of such share of common stock
on the date the award is granted, subject to adjustment and conditions further described in the Plan. Our compensation committee shall
also have sole authority to set the terms of all awards at the time of grant. As of December 31, 2024, there are 150,682 shares available
under the Plan.
Outstanding
Equity Awards at Fiscal Year-End
The
following table summarizes the outstanding equity awards held by each named executive officer as of December 31, 2024. This table includes
unexercised and unvested options and equity awards.
Outstanding Equity Awards as of December
31, 2024
Option Awards
Name
Date of Grant
Number of securities underlying unexercised
options (#) exercisable
Number of securities underlying unexercised
options (#) unexerciseable (1)
Equity
incentive plan awards:
Number of securities underlying unexercised unearned options (#)
Option exercise price ($)
Option expiration date
Dane Saglio
March 17, 2023
75,000
-
-
$ 2.80
December 7, 2025
Dane Saglio
January 18, 2024
34,500
-
-
$ 3.89
December 7, 2025
Vininder Singh
January 18, 2024
26,860
52,140
-
$ 3.89
January 18, 2034
(1) The
standard vesting schedule for all stock option grants is vesting over two years with one-third
vesting on the date of grant, one-third vesting on the first anniversary of the date of grant,
and one-third vesting on the second anniversary of the date of grant.
38
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
following table sets forth certain information regarding the beneficial ownership of our common stock as of March 4, 2025 by:
● each
of our named executive officers;
● each
of our directors;
● all
of our current directors and executive officers as a group; and
● each
stockholder known by us to own beneficially more than 5% of our common stock.
Beneficial
ownership is determined in accordance with the rules of the SEC and includes voting or investment power with respect to the securities.
Shares of common stock that may be acquired by an individual or group within 60 days of March 4, 2025, pursuant to the exercise of options
or warrants, vesting of common stock or conversion of convertible debt, are deemed to be outstanding for the purpose of computing the
percentage ownership of such individual or group, but are not deemed to be outstanding for the purpose of computing the percentage ownership
of any other person shown in the table. Percentage of ownership is based on 9,415,525 shares of common stock issued and outstanding as
of March 4, 2025.
Except as otherwise
indicated, all shares are owned directly. Unless otherwise indicated, the address of each of the persons shown is c/o Bullfrog AI Holdings,
Inc., 325 Ellington Blvd., Unit 317, Gaithersburg, MD 20878.
Name of Beneficial
Owner
Common
Stock Beneficially Owned
Percentage
of Common Stock
Directors and Officers:
Vininder Singh
Chief Executive Officer and Director (1)
2,470,376
26.09
%
Dane Saglio
Chief Financial Officer (2)
156,642
1.64
%
Josh Blacher
Chief Financial Officer
0
-
R. Donald Elsey (3)
36,664
*
William Enright (3)
36,664
*
Jason D. Hanson (3)
36,664
*
All officers and directors as a group (6 persons)
2,737,010
28.20
%
Beneficial owners of more than 5%
Tivoli Trust (4)
904,391
8.81
%
Empery Asset Management, LP (5)
929,857
9.88
%
* Less than
1%
39
(1) Comprised
of 2,392,446 shares of Common Stock, 77,930 Stock Options currently exercisable, and 0 Stock
Options exercisable within 60 days.
(2) Comprised
of 47,142 shares of Common Stock, 109,500 Stock Options currently exercisable, and 0 Stock
Options exercisable within 60 days.
(3) Comprised
of 34,442 Stock Options currently exercisable and 2,222 Stock Options exercisable within
60 days.
(4) Comprised
of 73,449 shares of non-voting Series A Preferred Stock, 115,185 warrants exercisable at
$2.50 per share and 54,714 shares of Common Stock. Assumes the conversion of all Series A
Preferred Stock into common stock in an amount equal to ten shares of common stock for each
one share of Series A Preferred Stock.
(5) Based
on information provided in a Schedule 13G filed on January 14, 2025 by Empery Asset Management,
LP (“Empery”), Ryan M. Lane, and Martin D. Hoe, Empery and Messrs. Lane and Hoe
have shared voting and dispositive power over 929,857 shares of common stock of the Company.
Messrs. Lane and Hoe each disclaim beneficial ownership of the shares reported herein except
to the extent of their pecuniary interests therein.
Securities
Authorized for Issuance under Equity Compensation Plans
General .
In November 2022, our Board of Directors adopted our 2022 Equity Incentive Plan (the “2022 Plan”) and the 2022 Plan was submitted
to our stockholders for approval. Our 2022 Plan became effective immediately on adoption. Our 2022 Plan replaces our previous incentive
plan. However, awards outstanding under our previous incentive plan will continue to be governed by their existing terms.
Share
Reserve . The number of shares of our common stock originally available for issuance under our 2022 Plan was 900,000 shares. Notwithstanding
the number of shares available for issuance, on the first day of each year commencing January 1, 2023, or the first business day of the
calendar year if the first day of the calendar year falls on a Saturday or Sunday, the number of shares eligible for awards under the
2022 Plan will automatically increase to an amount equal to 15% of the total number of shares of common stock outstanding as of December
31 st of the preceding fiscal year. Accordingly, as of January 1, 2025, there were 603,456 shares available for issuance under
the 2022 Plan.
Plan Category
Number
of securities to be issued upon exercise of outstanding options, warrants and rights
(a)
Weighted-average
exercise price of outstanding options, warrants and rights
(b)
Number of securities remaining available
for future issuance under equity compensation plans (excluding securities reflected in column (a))
Equity compensation plans approved by security holders
763,514
$ 4.04
150,682
Equity compensation plans not approved by security holders
747,376
$ 1.69
0
Total
1,510,890
$ 2.88
150,682
40
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Other
than with respect to compensation arrangements, including employment, and indemnification arrangements, discussed in this Annual Report
on Form 10-K, there have been no transactions since January 1, 2023, in which the amount involved in the transaction exceeded or will
exceed the lesser of $120,000 or one percent of the average of our total assets as at the year-end for the last two completed fiscal
years, and to which any of our directors, executive officers or beneficial holders of more than 5% of our capital stock, or any immediate
family member of, or person sharing the household with, any of these individuals, had or will have a direct or indirect material interest.
In
July 2021, the Company entered into a Simple Agreement for Future Equity (SAFE) with a related party, Tivoli Trust (the “Investor”),
for an amount of $150,000, with 0% interest. Under the SAFE agreement, if there is an Equity Financing before the termination of this
SAFE, on the initial closing of such Equity Financing, this SAFE will terminate and automatically convert into shares of common stock.
Upon the closing of the Company’s IPO in February 2023, the SAFE terminated and converted into 32,967 shares of common stock according
to its terms. The conversion was considered a redemption for accounting purposes and consequently, the Company recognized a $63,626 loss
on the conversion.
In
August 2021, the Company entered into a convertible loan agreement with a related party in the amount of $99,900 at 9% interest. In February
2023, the related party elected to convert the convertible loan into 21,747 shares of common stock according to its terms upon the closing
of the Company’s IPO. The conversion was considered a redemption for accounting purposes and consequently, the Company recognized
a $29,333 loss on the conversion.
In
October 2022, the Company entered into an exchange agreement with the Investor whereby all of his common stock, 734,493 shares of common
stock, were exchanged into 73,449 shares of Series A Convertible Preferred Stock that converts to common at a rate of 10 common for one
preferred. The Series A Preferred Stock is the economic equivalent of the common stock but has no voting rights and is subject to a blocker
which prohibits the conversion into common stock if it would result in the Investor owning more than 4.99% of the Company’s outstanding
common stock at such time.
Policies
and Procedures for Related Party Transactions
For
purposes of our policy only, a related person transaction is a transaction, arrangement or relationship, or any series of similar transactions,
arrangements, or relationships, in which we and any related person are, were or will be participants in which the amount involved exceeds
the lesser of $120,000 or 1% of the average of our total assets at year-end. Transactions involving compensation for services provided
to us as an employee or director are not covered by this policy. A related person is any executive officer, director, or beneficial owner
of more than 5% of any class of our voting securities, including any of their immediate family members and any entity owned or controlled
by such persons.
Under
the policy, if a transaction has been identified as a related person transaction, including any transaction that was not a related person
transaction when originally consummated or any transaction that was not initially identified as a related person transaction prior to
consummation, our management must present information regarding the related person transaction to our audit committee, or, if audit committee
approval would be inappropriate, to another independent body of our Board of Directors, for review, consideration and approval or ratification.
The presentation must include a description of, among other things, the material facts, the interests, direct and indirect, of the related
persons, the benefits to us of the transaction and whether the transaction is on terms that are comparable to the terms available to
or from, as the case may be, an unrelated third party or to or from employees generally. Under the policy, we will collect information
that we deem reasonably necessary from each director, executive officer and, to the extent feasible, significant stockholder to enable
us to identify any existing or potential related-person transactions and to effectuate the terms of the policy. In addition, under our
code of business conduct and ethics, our employees and directors will have an affirmative responsibility to disclose any transaction
or relationship that reasonably could be expected to give rise to a conflict of interest. In considering related person transactions,
our audit committee, or other independent body of our Board of Directors, will take into account the relevant available facts and circumstances
including, but not limited to:
● the
risks, costs and benefits to us;
41
● the
impact on a director’s independence in the event that the related person is a director,
immediate family member of a director or an entity with which a director is affiliated;
● the
availability of other sources for comparable services or products; and
● the
terms available to or from, as the case may be, unrelated third parties or to or from employees
generally.
The
policy requires that, in determining whether to approve, ratify or reject a related person transaction, our audit committee, or other
independent body of our Board of Directors, must consider, in light of known circumstances, whether the transaction is in, or is not
inconsistent with, our best interests and those of our stockholders, as our audit committee, or other independent body of our Board of
Directors, determines in the good faith exercise of its discretion.
ITEM
14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The
following table summarizes the fees billed by M&K CPAs for the fiscal years ended December 31, 2024 and 2023, inclusive of out-of-pocket
expenses.
Pre-Approval
Policy
Our
audit committee was formed upon the consummation of our initial public offering. As a result, the audit committee did not pre-approve
all of the foregoing services, although any services rendered prior to the formation of our audit committee were approved by our board
of directors. Since the formation of our audit committee, and on a going-forward basis, the audit committee has and will pre-approve
all auditing services and permitted non-audit services to be performed for us by our auditors, including the fees and terms thereof (subject
to the de minimis exceptions for non-audit services described in the Exchange Act which are approved by the audit committee prior to
the completion of the audit).
Year Ended December 31,
Fee Category
2024
2023
Audit fees (1)
$ 44,725
$ 35,200
Audit-related fees (2)
26,820
36,550
Tax fees (3)
-
-
All other
fees (4)
-
-
Total fees
$ 71,545
$ 71,750
(1)
Audit fees consist of fees
for professional services rendered in connection with the annual audit of our consolidated financial statements, the review of our
quarterly condensed consolidated financial statements and consultations on accounting matters directly related to the audit.
(2)
Audit-related fees consist
of fees for professional services rendered in connection with submissions of Registration Statements on Form S-1 or Form S-3 for
our initial public offering and subsequent financings.
(3)
Tax fees consist of fees
for professional services for tax compliance, tax advice and tax planning.
(4)
All other fees consist
of fees related to engagement administration.
42
PART
IV
Item
15. Exhibits, Financial Statement Schedules
a)
Financial Statements
For
a list of the consolidated financial statements included herein, see Index to Consolidated Financial Statements on page F-1 of this Annual
Report, which is incorporated into this Item by reference.
b)
Exhibits
Exhibit
No.
Description
1.1
Underwriting Agreement between the Company and WallachBeth Capital LLC dated January 31, 2024, incorporated by reference to Exhibit 1.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2024.
3.1
Amended
and Restated Articles of Incorporation of Bullfrog AI Holdings, Inc. incorporated by reference to Exhibit 3.1 to the Company’s
Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February
13, 2023.
3.2
Bylaws
of Bullfrog AI Holdings, Inc. incorporated by reference to Exhibit 3.2 to the Company’s Amendment to the Registration Statement
on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
4.1
Form of Bullfrog AI Holdings, Inc. Common Stock certificate, incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on October 19, 2022.
4.2
Form of Common Stock Purchase Warrant to be issued to Holders of the Registrant’s Convertible Promissory Notes, incorporated by reference to Exhibit 4.3 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
4.3
Form of Warrant Agent Agreement for the Warrants to be issued as part of the Units to be sold in the Offering, incorporated by reference to Exhibit 1.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 21, 2023.
4.4
Form of (Tradeable) Common Stock Purchase Warrant to be issued as part of the Units to be sold in the Offering pursuant to the Warrant Agent Agreement, incorporated by reference to Exhibit 4.5 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
4.5
Form of (Non-tradeable) Common Stock Purchase Warrant to be issued as part of the Units to be sold in the Offering pursuant to the Warrant Agent Agreement, incorporated by reference to Exhibit 4.8 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
4.6
Form of Pre-Funded Warrant issued February 5, 2024, incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2024.
4.7
Form of Representative Warrant issued February 5, 2024, incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2024.
4.8
Form of Warrant Agency Agreement, incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2024.
4.9
Form of Common Stock Purchase Warrant issued February 5, 2024, incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 6, 2024.
4.10
Form of Pre-Funded Warrant issued to the investor party thereto on October 21, 2024 incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2024.
4.11
Form of Common Warrant issued to the investor party thereto on October 21, 2024 incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2024.
4.12
Form of Placement Agent Warrant issued to WallachBeth Capital, LLC on October 21, 2024, incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2024.
4.13●
Description of Securities.
10.1
Acquisition Agreement with Bullfrog AI, Inc. incorporated by reference to Exhibit 10.1 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
10.2
Advisor Agreement between the Company and Greentree Financial Group, Inc. incorporated by reference to Exhibit 10.3 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
10.3
Consulting Agreement between the Company and Garrett Newman incorporated by reference to Exhibit 10.4 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
10.4
Employment Agreement with Vininder Singh incorporated by reference to Exhibit 10.5 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
10.5
Patent
License Agreement between the Company and George Washington University, dated January 14, 2022 incorporated by reference to Exhibit
10.6 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange
Commission on February 13, 2023.
43
10.6
Exclusive
License Agreement between the Company and Johns Hopkins University, dated February 22, 2022 incorporated by reference to Exhibit
10.7 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange
Commission on February 13, 2023.
10.7
License
Agreement between the Company and Johns Hopkins Applied Physics Laboratory LLC, dated July 8, 2022 incorporated by reference to Exhibit
10.8 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange
Commission on February 13, 2023.
10.8
License
Agreement between the Company and Johns Hopkins Applied Physics Laboratory LLC, dated February 7, 2018 incorporated by reference
to Exhibit 10.5 to the Company’s Amendment to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities
and Exchange Commission on February 13, 2023.
10.9
License
Agreement between the Company and Johns Hopkins University (JHU) and the Institute of Organic Chemistry and Biochemistry (IOCB) of
the Czech Academy of Sciences, dated October 13, 2022 incorporated by reference to Exhibit 10.9 to the Company’s Amendment
to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
10.10
Amendment No. 1 to License Agreement between Bullfrog AI, Inc. and the John’s Hopkins University Applied Physics Laboratory LLC dated June 1, 2023, incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 5, 2023.
10.11
Data Use and Technology Partnership Agreement dated September 7, 2023 by and between the Company and the Lieber Institute for Brain Development (LIBD), incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 14, 2023.
10.12
Commercial Agreement by and between the Company and the Lieber Institute for Brain Development dated October 13, 2023, incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 20, 2023.
10.13
2022
Equity Compensation Plan, incorporated by reference to Exhibit 10.10 to the Company’s Annual Report on Form 10-K filed with
the Securities and Exchange Commission on April 25, 2023.
10.14●
Form of Indemnification Agreement between Bullfrog AI Holdings, Inc. and each of its directors and officers
10.15●
Form of Stock Option Grant Agreement
10.16
Master Services Agreement, dated December 13, 2024, by and between the Company and Danforth Advisors, LLC, incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 17, 2024.
10.17
Form of Securities Purchase Agreement, dated October 18, 2024, by and between the Company and the investor party thereto, incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2024.
10.18
Form of Placement Agency Agreement, dated October 18, 2024, by and between the Company and WallachBeth Capital, LLC, incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2024.
14.1
Code of Ethics
19.1
Insider Trading Policy
21.1
List
of significant subsidiaries of Bullfrog AI Holdings, Inc., incorporated by reference to Exhibit 21.1 to the Company’s Amendment
to the Registration Statement on Form S-1 (No. 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
23.1
Consent of M&K CPAS PLLC, an independent registered public accounting firm
31.1
Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act, as amended.
31.2
Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act, as amended.
32.1
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14(b) or 15d-14(b) of the Securities Exchange Act, as amended, and 18 U.S.C. Section 1350.
97.1
Clawback Policy
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema With Embedded
Linkbase Documents
104
Cover Page Interactive Data File (embedded within the
Inline XBRL document)
●
Filed herewith.
ITEM
16. FORM 10-K SUMMARY
None.
44
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
March 14, 2025
Bullfrog AI Holdings, Inc.
By:
/s/ Vininder
Singh
Vininder Singh
Chief Executive Officer
and Director (Principal Executive Officer)
By:
/s/ Josh
Blacher
Josh Blacher
Chief Financial Officer
(Principal Financial and Accounting Officer)
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
Title
Date
By:
/s/
Vininder Singh
Chief
Executive Officer and Chairman
(Principal
Executive Officer)
March 14, 2025
Vininder Singh
By:
/s/
Josh Blacher
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
March 14, 2025
Josh Blacher
By:
/s/
R. Donald Elsey
Director
March 14, 2025
R. Donald Elsey
By:
/s/
William Enright
Director
March 14, 2025
William Enright
By:
/s/
Jason D. Hanson
Director
March 14, 2025
Jason D. Hanson
45
BULLFROG
AI HOLDINGS, INC.
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm PCAOB ID: 2738
F-2
Consolidated Balance Sheets as of December 31, 2024 and 202 3
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023
F-4
Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the Years Ended December 31, 2024 and 2023
F-5
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-6
Notes to Consolidated Financial Statements
F-7
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Stockholders of Bullfrog AI Holdings, Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Bullfrog AI Holdings, Inc. (the “Company”) as of December 31,
2024 and 2023, and the related consolidated statements of operations, changes in stockholders’ equity (deficit), and cash flows
for the years ended December 31, 2024 and 2023, 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 financial position of the Company
as of December 31, 2024 and 2023 and the results of its operations and its cash flows for the two-year period ended December 31, 2024,
in conformity with accounting principles generally accepted in the United States of America.
Going
Concern
The
accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed
in Note 1 to the financial statements, the company has incurred recurring losses from operations and had not yet achieved profitable
operations as of December 31, 2024 which raises substantial doubt about its ability to continue as a going concern. Management’s
plans regarding these matters are also described in Note 1. The 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) (the “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 audit 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 that 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 Matter
The
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
were communicated or required to be communicated to the audit committee and that: (1) relate 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 a critical audit matter 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 separate opinions on the critical audit matter or on the accounts or
disclosures to which they relate.
Going
Concern
In
prior years, the Company reported continued net losses from operations and negative cash flows from operations. As of December 31, 2024,
management determined their cash and cash equivalents balance may not sufficiently cover operating expenditures for the next twelve-month
period without raising additional funds. Auditing management’s evaluation of a going concern can be a significant judgment given
the fact that the Company uses management estimates on future expenditures, which are difficult to substantiate.
We
evaluated the appropriateness of management’s evaluation of the company’s going concern, we examined and evaluated the financial
information along with management’s plans to mitigate the going concern consideration and management’s disclosure on going
concern.
/s/ M&K CPAS, PLLC
We have served as the Company’s auditor since 2021.
The Woodlands, Texas
March 14, 2025
F- 2
BULLFROG
AI HOLDINGS, INC.
CONSOLIDATED
BALANCE SHEETS
2024
2023
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$ 5,435,983
$ 2,624,730
Prepaid expenses
111,597
145,882
Total current assets
5,547,580
2,770,612
Property and equipment, net
4,250
5,974
Total assets
$ 5,551,830
$ 2,776,586
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$ 435,934
$ 103,656
Accrued expenses
152,156
80,694
Total current liabilities
588,090
184,350
Total liabilities
588,090
184,350
Stockholders’ equity:
Series A Convertible Preferred stock, $ 0.00001 par value, 5,500,000 shares authorized;
73,449 shares issued and outstanding as of December 31, 2024 and 2023.
1
1
Common stock, $ 0.00001 par value, 100,000,000 shares authorized; 9,113,139 and
6,094,644 shares issued and outstanding as of December 31, 2024 and 2023, respectively.
91
61
Additional paid-in capital
21,757,204
12,347,098
Accumulated deficit
( 16,793,556 )
( 9,754,924 )
Total stockholders’ equity
4,963,740
2,592,236
Total liabilities and stockholders’ equity
$ 5,551,830
$ 2,776,586
The
accompanying notes are an integral part of these consolidated financial statements.
F- 3
BULLFROG
AI HOLDINGS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
2024
2023
Year Ended December 31,
2024
2023
Revenue:
Revenue
$ -
$ 65,000
Total revenue
-
65,000
Cost of goods sold:
Cost of goods sold
-
5,200
Total cost of goods sold
-
5,200
Gross profit
-
59,800
Operating expenses:
Research and development
2,223,265
1,432,614
General and administrative
5,013,118
3,994,710
Total operating expenses
7,236,383
5,427,324
Loss from operations
( 7,236,383 )
( 5,367,524 )
Other income (expense), net
Interest expense
( 18,158 )
( 79,089 )
Loss on conversion of notes
-
( 92,959 )
Interest income
260,894
183,703
Total other income (expense), net
242,736
11,655
Net loss
( 6,993,647 )
( 5,355,869 )
Deemed dividend related to warrant exercise price adjustment
( 44,985 )
-
Net loss attributable to common stockholders
$ ( 7,038,632 )
$ ( 5,355,869 )
Net loss per common share attributable to common stockholders - basic and diluted
$ ( 0.85 )
$ ( 0.89 )
Weighted average number of shares outstanding - basic and diluted
8,245,353
6,049,819
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
BULLFROG
AI HOLDINGS, INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
Shares
Amount
Shares
Amount
Capital
Deficit
Equity
(Deficit)
Series A Preferred Stock
Common Stock
Additional Paid-in
Accumulated
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
Deficit
Equity (Deficit)
Balance at December 31, 2022
73,449
$ 1
4,021,935
$ 40
$ 1,341,662
$ ( 4,399,055 )
$ ( 3,057,352 )
Stock-based compensation
-
-
-
-
631,533
-
631,533
Issuance of common stock (initial public offering), net of issuance costs
-
-
1,297,318
13
7,293,638
-
7,293,651
Issuance of common stock for services
-
-
7,692
1
49,999
-
50,000
Conversion of convertible debt to common stock
-
-
331,166
3
1,535,612
-
1,535,615
Issuance of common stock pursuant to warrant exercises
-
-
436,533
4
1,494,654
-
1,494,658
Net loss
-
-
-
-
-
( 5,355,869 )
( 5,355,869 )
Balance at December 31, 2023
73,449
1
6,094,644
61
12,347,098
( 9,754,924 )
2,592,236
Balance
73,449
1
6,094,644
61
12,347,098
( 9,754,924 )
2,592,236
Stock-based compensation
-
-
-
-
943,649
-
943,649
Issuance of common stock and warrants, net of issuance costs
-
-
2,109,694
21
8,315,665
-
8,315,686
Issuance of common stock pursuant to warrant exercises
-
-
908,801
9
105,807
-
105,816
Deemed dividend related to warrant price adjustment
-
-
-
-
44,985
( 44,985 )
-
Net loss
-
-
-
-
-
( 6,993,647 )
( 6,993,647 )
Balance at December 31, 2024
73,449
$ 1
9,113,139
$ 91
$ 21,757,204
$ ( 16,793,556 )
$ 4,963,740
Balance
73,449
$ 1
9,113,139
$ 91
$ 21,757,204
$ ( 16,793,556 )
$ 4,963,740
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
BULLFROG
AI HOLDINGS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
2024
2023
Year Ended December 31,
2024
2023
Cash flows from operating activities:
Net loss
$ ( 6,993,647 )
$ ( 5,355,869 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
1,724
1,725
Stock-based compensation
943,649
631,533
Shares issued for services
-
50,000
Loss on conversion of notes
-
92,959
Amortization of debt discount
-
20,000
Changes in operating assets and liabilities:
Prepaid expense
34,285
( 130,882 )
Accounts payable
332,278
( 440,337 )
Accrued expenses
71,462
( 838,428 )
Deferred revenue
-
( 32,000 )
Net cash used in operating activities
( 5,610,249 )
( 6,001,299 )
Cash flows from investing activities:
Purchases of property and equipment
-
-
Net cash used in investing activities
-
-
Cash flows from financing activities:
Proceeds from issuance of common stock and warrants, net of issuance costs
8,315,686
7,293,651
Proceeds from exercise of warrants
105,816
1,494,658
Proceeds from notes payable
-
100,000
Payments of notes payable
-
( 319,950 )
Proceeds from short term insurance financing
561,885
697,534
Payments of short term insurance financing
( 561,885 )
( 697,534 )
Net cash provided by financing activities
8,421,502
8,568,359
Net increase in cash and cash equivalents
2,811,253
2,567,060
Cash and cash equivalents, beginning of period
2,624,730
57,670
Cash and cash equivalents, end of period
$ 5,435,983
$ 2,624,730
Supplemental cash flow information:
Cash paid for interest
$ 18,158
$ 93,916
Cash paid for taxes
-
-
Supplemental non-cash activity
Issuance of common stock upon conversion of notes payable
$ -
$ 1,535,615
The
accompanying notes are an integral part of these consolidated financial statements.
F- 6
BULLFROG
AI HOLDINGS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2024 and 2023
1. Organization and Nature of Business
Description
of Business
Bullfrog
AI Holdings, Inc. (“we”, “our” or the “Company”) was incorporated in the State of Nevada on February
6, 2020. Bullfrog AI Holdings, Inc. is the parent company of Bullfrog AI, Inc. and Bullfrog AI Management, LLC, which were incorporated
in Delaware and Maryland, in 2017 and 2021, respectively. All the Company’s operations are currently conducted through Bullfrog
AI Holdings, Inc., which began operations on February 6, 2020. The Company is focused specifically on advanced AI/ML-driven analysis
of complex data sets in medicine and healthcare. The Company’s objective is to utilize its AI/ML platform to provide a precision
medicine approach to drug asset enablement through external partnerships and selective internal development.
Most
new therapeutics will fail at some point in preclinical or clinical development. These failures are the primary drivers for the high
cost of developing new therapeutics. A major part of the difficulty in developing new therapeutics is efficient integration of complex
and highly dimensional data generated at each stage of development to de-risk subsequent stages of the development process. Artificial
intelligence and machine learning (“AI/ML”) has emerged as a digital solution to help address this problem.
The
Company uses artificial intelligence and machine learning to advance medicines for both internal and external projects. Most current
AI/ML platforms still fall short in their ability to synthesize disparate, high-dimensional data for actionable insight. The Company’s
analytical platform is composed of an ensemble of state-of-the-art machine learning and artificial intelligence models. The Company’s
core platform technology, named bfLEAP™, is an analytical AI/ML platform developed at The Johns Hopkins University Applied Physics
Laboratory (JHU-APL) which we believe is able to surmount the challenges of scalability and flexibility currently hindering researchers
and clinicians by providing a more precise, multi-dimensional understanding of their data. The Company is deploying its analytical platform,
including bfLEAP™, for use in several critical stages of development of internal programs and through strategic partnerships and
collaborations with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs
by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may otherwise not receive the therapies
they need.
The
proprietary analytical platform utilizes both supervised and unsupervised machine learning. As such, it is able to reveal real and meaningful
connections in the data without the need for a priori hypothesis. Algorithms used in the platform are designed to handle highly imbalanced
data sets and successfully identify combinations of factors that are associated with outcomes of interest. The Company’s platform
leverages models that use both correlative and causative machine learning and artificial intelligence approaches which provide a comprehensive
approach to predictive analysis which is expected to lead to meaningful insights including the molecular drivers of disease. In this
regard, with the Company’s access to proprietary data sets such as its strategic data and commercialization agreements with the
Lieber Institute for Brain Development (“LIBD”), the Company has increased its internal efforts on target discovery.
The
Company’s goal is to improve the odds of success at all stages of pre-clinical and clinical therapeutics development for in-house
programs and for its strategic partners and collaborators. The Company’s business model includes enabling the success of ongoing
clinical trials and rescuing late stage failed drugs (i.e., Phase II or Phase III clinical trial failures) by bringing them in-house
for development prior to eventual divestiture; although, the Company also considers entering collaborations for earlier stage drugs.
The Company pursues its drug asset enhancement business by leveraging the powerful and proven bfLEAP™ AI/ML platform initially
developed at JHU-APL. The Company believes the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical
and clinical data sets, such as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical
trial settings.
Liquidity
and Going Concern
The
Company has had negative cash flows from operations and operated at a net loss since inception. As of December 31, 2024, the Company
has a cash balance of approximately $ 5.4 million. In February 2024 and October 2024, the Company received net proceeds of approximately
$ 5.7 million and $ 2.7 million, respectively, from the sale of its common stock and warrants. As of December 31, 2024, the Company’s
cash and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the filing
date of the consolidated financial statements. These factors raise substantial doubt about the Company’s ability to continue as
a going concern. The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing and/or revenues
to meet its obligations arising from normal business operations when they become due.
F- 7
Accordingly,
the Company will require additional capital to continue to execute its strategy. The Company anticipates raising this additional
capital through various avenues including sales of equity securities, debt transactions, licensing agreements and collaborative arrangements.
Although management believes that such funding sources will be available, there can be no assurance that any such arrangements will be
consummated to provide sufficient capital when needed to allow the Company to continue its operations, or if available, on terms acceptable
to it. If the Company does not raise sufficient funds in a timely manner, among other things, it may be forced to delay, scale back or
eliminate some or all of its research and product development programs and/or capital expenditures or to enter into arrangements on unfavorable
terms. The Company currently does not have commitments for future funding from any source.
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates
continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. Accordingly, these
consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
2. Summary of Significant Accounting Policies
Basis
of Presentation
The
accompanying consolidated financial statements include the accounts of Bullfrog AI Holdings, Inc. and its wholly owned subsidiaries and
have been prepared in conformity with United States generally accepted accounting principles (“GAAP”). All intercompany accounts
and transactions have been eliminated in consolidation.
In
February 2023, the Company completed a 1-for-7 reverse split of its common stock . Stockholders’ equity and all references to shares
and per share amounts in the accompanying consolidated financial statements have been adjusted to reflect the reverse stock split for
all periods presented.
Use
of Estimates
The
preparation of consolidated financial statements in conformity with GAAP requires the Company to make estimates and assumptions that
affect the amounts reported in the consolidated financial statements and accompanying notes. These estimates include, but are not limited
to, revenue recognition, stock-based compensation, allowances for doubtful accounts, recoverability of deferred tax assets and certain
other accrued liabilities. Actual results could differ from these estimates.
Segment
Reporting
The
Company’s chief operating decision maker (“CODM”) is the Company’s Chief Executive Officer. The CODM is assisted
in his responsibilities of making decisions regarding resource allocation and performance assessment by the leadership team, consisting
of executives and vice presidents.
The
Company views its operations and manages its business as one operating segment, focused on advancing drug development using AI/ML to
analyze complex data sets in medicine and healthcare. Segment profit or loss is measured as the Company’s net loss as reported
on the Company’s Statement of Operations. The Company monitors its cash and cash equivalents, as reported on the Company’s
Balance Sheets, to determine funding for its research and development.
As
the Company did not generate revenues in 2024, the CODM assessed Company performance through the achievement of target identification
goals. In addition to the Company’s Statement of Operations, the CODM is regularly provided with budgeted and forecasted expense
information which is used to determine the Company’s liquidity needs and cash allocation.
Revenue
Recognition
The
Company recognizes revenue based on the following five step model:
● Identification
of the contract with a customer
This
step outlines the criteria that must be met when establishing a contract with a customer to supply goods or services.
● Identification
of the performance obligations in the contract
This
step describes how distinct performance obligations in the contract must be handled.
F- 8
● Determination
of the transaction price
This
step outlines what must be considered when establishing the transaction price, which is the amount the business expects to receive for
transferring the goods and services to the customer.
● Allocation
of the transaction price to the performance obligations in the contract
This
step outlines guidelines for allocating the transaction price across the contract’s separate performance obligations, and is what
the customer agrees to pay for the goods and services.
● Recognition
of revenue when, or as, the Company satisfies a performance obligation
Revenue
can be recognized as the business meets each performance obligation. This step specifies how that should happen.
Contract Services
The
Company anticipates that the majority of its revenues to be recognized in the near future will result from discovery and monetization
of new drug targets and intellectual property from data use partnerships focused on analysis of rich proprietary data sets. The target
market for monetization will primarily be mid-size to large biopharmaceutical organizations seeking to build their new drug target pipeline.
A secondary revenue channel is fee for service partnerships with biopharmaceutical companies and other organizations of all sizes that
have challenges analyzing data throughout the drug development process. The Company provides the customer with an analysis of large complex
data sets using the Company’s proprietary AI/ML platform. This platform is aimed at predicting targets of interest, patterns, relationships,
anomalies, and molecular drivers of disease. The Company believes that there will be additional on-going work requested from partners;
therefore, the service model utilizes a master services agreement with work or task orders issued for discrete analysis performed at
the discovery, preclinical, or clinical stages of drug development. The Company will receive fees in cash, equity or other consideration
and, in some instances, the potential for rights to new intellectual property generated from the analysis. Once data analysis and the
analysis report are complete, the Company delivers the analysis set to the customer and recognizes revenue at that point in time.
Financial
Instruments
The
carrying value of short-term instruments, including cash and cash equivalents, accounts payable and accrued expenses approximate fair
value due to the relatively short period to maturity for these instruments. Fair value is defined as the exchange price that would be
received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability
in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize
the use of observable inputs and minimize the use of unobservable inputs. The Company utilizes a three-level valuation hierarchy for
disclosures of fair value measurements, defined as follows:
Level
1 - inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level
2 - inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are
observable for the assets or liabilities, either directly or indirectly, for substantially the full term of the financial instruments.
Level
3 - inputs to the valuation methodology are unobservable and significant to the fair value. The Company does not have any assets or liabilities
that are required to be measured and recorded at fair value on a recurring basis.
Cash
and Cash Equivalents and Concentration of Credit Risk
The
Company considers cash to consist of cash on hand and temporary investments having an original maturity of 90 days or less that are readily
convertible into cash.
The
Company’s financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable. Occasionally,
the Company’s cash in interest-bearing accounts may exceed FDIC insurance limits. The financial stability of these institutions
is periodically reviewed by senior management.
Cost
of Sales
Cost
of sales is comprised of royalties and the cost of outsourced services provided to the Company related to customer service contracts.
F- 9
Property
and Equipment
Property
and equipment are stated at cost. When retired or otherwise disposed, the related carrying value and accumulated depreciation are removed
from the respective accounts and the net difference less any amount realized from disposition is reflected in earnings. For financial
statement purposes, property and equipment are recorded at cost and depreciated using the straight-line method over their estimated useful
lives.
Advertising
The
Company follows the policy of charging the costs of advertising to expense as incurred.
Income
Taxes
Deferred
income tax assets and liabilities are determined based on the estimated future tax effects of net operating loss, credit carryforwards,
and temporary differences between the tax basis of assets and liabilities and their respective financial reporting amounts measured at
the current enacted tax rates. The Company records an estimated valuation allowance on its deferred income tax assets if it is not more
likely than not that these deferred income tax assets will be realized.
The
Company recognizes a tax benefit from an uncertain tax position if it is more likely than not that the tax position will be sustained
on examination by taxing authorities. Interest and penalties associated with such uncertain tax positions are classified as a component
of income tax expense.
Stock-Based
Compensation
Employee
and non-employee share-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as an
expense over the requisite service period. Forfeitures are recognized as they occur.
Net Loss per
Share
The
Company calculates basic net loss per common share by dividing the net loss available to common stockholders by the weighted-average
number of shares of common stock outstanding during the period.
Diluted
earnings per share is computed by giving effect to all potentially dilutive common stock equivalents in the period, including unvested
stock options and warrants. As the Company has reported losses for all periods presented, all potentially dilutive securities have been
excluded from the calculation of diluted net loss per common share as their effect would be antidilutive.
Recent Accounting
Pronouncements
In
January 2024, the Company adopted Accounting Standards Update (ASU) 2023-07, Improvements to Reportable Segment Disclosures (Topic
280). The new standard improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant
segment expenses that are regularly provided to the chief operating decision maker. ASU 2023-07 also clarifies that entities with a single
reportable segment are subject to both new and existing reporting requirements under Topic 280. See the Segment Reporting section
within Note 2 .
In
December 2023, the FASB issued ASU No. 2023-09: Income Taxes (Topic 740): Improvements to Income Tax Disclosures that
requires entities to disclose additional information about federal, state, and foreign income taxes primarily related to the income tax
rate reconciliation and income taxes paid. The new standard also eliminates certain existing disclosure requirements related to uncertain
tax positions and unrecognized deferred tax liabilities. The guidance is effective for the Company’s fiscal year ending December
31, 2025. The guidance does not affect recognition or measurement in the Company’s consolidated financial statements.
The
Company does not believe that any other recently issued effective pronouncements, or pronouncements issued but not yet effective, if
adopted, would have a material effect on the accompanying financial statements.
3. Property and Equipment
Property and
equipment consisted of $ 8,744 of equipment at both December 31, 2024 and 2023 and accumulated depreciation of $ 4,494 and $ 2,770 , as of
December 31, 2024 and 2023, respectively.
Depreciation
expense totaled $ 1,724 and $ 1,725 in the years ended December 31, 2024 and 2023, respectively.
F- 10
4. Accrued Expenses
Accrued
expenses consist of the following at December 31:
Schedule
of Acrrued Expenses
2024
2023
Accured payroll and related
$ 80,705
$ 32,000
Accrued legal fees
27,601
-
Accrued licensing and royalty fees
20,000
-
Accrued Board fees
16,875
16,875
Accrued research and development project costs
-
28,937
Accrued other expenses
6,975
2,882
Total Accrued expenses
$ 152,156
$ 80,694
5. Convertible Notes
August 2021
Note
In August 2021,
the Company entered into a convertible loan agreement with an unrelated party for a commitment of up to $ 195,000 with a 5 % original issue
discount and a 9 % interest rate. The loan was repaid in its entirety in February 2023.
December 2021
Note
In
December 2021, the Company entered into a loan agreement with an unrelated party with a principal amount of $ 25,000 , a 10 % original issue
discount and a 6 % interest rate. Concurrent with the closing of the Company’s initial public offering (“IPO”) in February
2023, the note converted according to its terms into 6,939 shares of common stock. No gain or loss was recognized on the conversion.
Convertible
Bridge Notes
In
2022, the Company received approximately $ 991,000 of gross proceeds from the issuance of Convertible Bridge Notes from several offerings.
Concurrent with the closing of the Company’s IPO in February 2023, all of the Convertible Bridge Notes converted according to their
terms into 269,513 shares of common stock. No gain or loss was recognized on the conversions.
6. Convertible Notes – Related Party
SAFE Agreement
In
July 2021, the Company entered into a Simple Agreement for Future Equity (“SAFE”) with a related party at a purchase price
of $ 150,000 . In February 2023, the SAFE terminated and converted into 32,967 shares of common stock according to its terms upon the closing
of the Company’s IPO. The conversion was considered a redemption for accounting purposes and consequently, the Company recognized
a $ 63,626 loss on the conversion.
August 2021
Note
In
August 2021, the Company entered into a convertible loan agreement with a related party in the amount of $ 99,900 . In February 2023, the
related party elected to convert the convertible loan into 21,747 shares of common stock according to its terms upon the closing of the
Company’s IPO. The conversion was considered a redemption for accounting purposes and consequently, the Company recognized a $ 29,333
loss on the conversion.
7. Notes Payable
In
January 2023, the Company entered into a short-term note payable with a principal balance of $ 100,000 , an original issue discount of
20 % and a 9 % interest rate. The note was repaid in its entirety in February 2023.
In
February 2023, the Company entered into an agreement to finance a portion of the premium for its Directors and Officers Insurance. The
agreement provided for financing of $ 697,534 of the premium, repayments in 10 equal monthly installments of $ 71,485 each through December
2023 and accrued interest at 6.5 % . The note was repaid in its entirety in 2023.
In
February 2024, the Company again entered into an agreement to finance a portion of the premium for its Directors and Officers Insurance.
The agreement provided for financing of $ 561,885 of the premium, repayments in 10 equal monthly installments of $ 58,005 each through
December 2024 and accrued interest at 6.99 % . The note was repaid in its entirety in 2024.
F- 11
8. Stockholders’ Equity
Preferred
Stock
The
Company has 10,000,000 shares of preferred stock authorized at a par value of $ 0.00001 with 5,500,000 being designated as Series A Convertible
Preferred Stock. Of the 5,500,000 authorized shares of Series A Convertible Preferred Stock, 73,449 were issued and outstanding as of
December 31, 2024. Each share of Series A Convertible Preferred Stock is convertible at any time into 10 shares of the Company’s
common stock. The Series A Preferred Stock is the economic equivalent of the common stock but has no voting rights and is subject to
a blocker which prohibits the conversion into common stock if it would result in the investor owning more than 4.99 % of the Company’s
outstanding common stock at such time.
Common
Stock
The
Company has 100,000,000 shares of common stock authorized at a par value of $ 0.00001 .
In
February 2023, the Company completed its IPO for the sale of 1,297,318 units (each, a “Unit,” collectively, the “Units”)
at a price of $ 6.50 per Unit generating approximately $ 8.4 million of gross proceeds. Each Unit consisted of one share of the Company’s
common stock, one tradeable warrant (each, a “Tradeable Warrant,” collectively, the “Tradeable Warrants”) to
purchase one share of common stock at an exercise price of $ 7.80 per share , and one non-tradeable warrant (each, a “Non-tradeable
Warrant,” collectively, the “Non-tradeable Warrants”; together with the Tradeable Warrants, each, a “Warrant,”
collectively, the “Warrants”) to purchase one share of the Company’s common stock at an exercise price of $ 8.125 .
In
connection with the completion of its IPO, the Company issued an aggregate of 331,166 shares of common stock upon the conversion of certain
outstanding convertible debt (see Notes 5 and 6).
In
connection with the IPO, in February 2023, the Company completed a 1-for-7 reverse split of its common stock . Stockholders’ equity
and all references to shares and per share amounts in the accompanying consolidated financial statements have been retroactively adjusted
to reflect the reverse stock split for all periods presented.
In
February 2023, the Company issued 7,692 shares of common stock for consulting services and recognized $ 50,000 of compensation expense
related to these shares.
In
April 2023, the Company issued 436,533 shares of common stock following the exercise of 436,533 warrants for proceeds of $ 1,494,658 .
In
February 2024, the Company received approximately $ 6.5 million of gross proceeds from the sale of 1,247,092 shares of common stock, 478,429
pre-funded warrants and 1,725,521 warrants (collectively the “Units”). The Units were sold at a price of $ 3.782 and the sale
was completed via an underwritten secondary public offering and includes the underwriter’s exercise of their overallotment option.
The warrants have an exercise price of $ 4.16 and expire five years from issuance. The pre-funded warrants had an exercise price of $ 0.001
and were exercised in their entirety in the first quarter of 2024.
In
October 2024, the Company received approximately $ 3.13 million of gross proceeds from the sale of (i) 862,602 shares of the Company’s
common stock and pre-funded warrants to purchase up to 702,398 shares of Common Stock with an exercise price of $ 0.0001 per share, at
a purchase price of $2.00 per share of common stock and a purchase price of $ 1.9999 per pre-funded warrant in a registered direct offering
and (ii) warrants to purchase an aggregate of 1,565,000 shares of common stock with an exercise price of $ 2.00 per share exercisable
after six (6) months from the date of issuance for a five-year period from the initial exercise date in a concurrent private placement.
In conjunction with the transactions, the Company paid the placement agent an aggregate cash fee of 8.0% of the gross proceeds from the
sale of securities in the transaction, reimbursed the placement agent for certain out-of-pocket expenses and issued to the placement
agent warrants to purchase an aggregate of 62,600 shares of Common Stock, equal to 4% of the aggregate number of shares of common stock
and pre-funded warrants sold in the registered direct offering. The warrants have an exercise price of $2.00 per share and are exercisable
six (6) months from the date of issuance for a five-year period from the initial exercise date.
F- 12
Dilutive
securities are excluded from the diluted earnings per share calculation when their effect is anti-dilutive. As of December 31, 2024,
73,449 shares of preferred stock, 6,935,042 warrants and 832,731 options for common shares were excluded from the calculation of net
loss per common share. As of December 31, 2023, 73,449 shares of preferred stock, 3,521,880 warrants and 527,717 options for common shares
were excluded from the calculation of net loss per common share. For the year ended December 31, 2024, 430,108 pre-funded warrants are
included in the calculation of net loss per common share.
2022
Equity Incentive Plan
In
November 2022, the Company’s Board of Directors adopted, and its shareholders approved the 2022 Equity Incentive Plan (the “Plan”).
The Plan provides for the granting of equity-based awards to employees, directors, and consultants. The Plan provides for equity-based
awards including incentive stock options, non-qualified stock options, stock appreciation rights, performance share awards, cash awards
and other equity-based awards. Awards are limited to a maximum term of 10 years and any exercise prices shall not be less than 100% of
the fair market value of one share of common stock on the grant date. The Plan authorized an initial maximum number of shares underlying
awards of 900,000 with an automatic annual increase to an amount equal to 15 % of the total number of shares outstanding as of the end
of the preceding fiscal year. As of December 31, 2024, there are 150,682 awards authorized but unissued available under the Plan.
Stock
Options
The
following table summarizes the stock option activity for the years ended December 31, 2024 and 2023:
Schedule of Stock Options Activity
Number of Shares
Weighted-Average Exercise Price
Weighted- Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value
Outstanding at December 31, 2022
69,217
$ 3.06
7.1
$ -
Granted
458,500
$ 4.34
Exercised
-
$ -
Forfeited / canceled
-
$ -
Outstanding at December 31, 2023
527,717
$ 4.17
9.0
$ 112,141
Granted
392,000
$ 3.64
Exercised
-
$ -
Forfeited / canceled
( 86,986 )
$ 3.83
Outstanding at December 31, 2024
832,731
$ 3.96
8.5
$ -
Vested at December 31, 2024
522,191
$ 4.04
8.1
$ -
The
fair value of options granted and modified in the year ended December 31, 2024 was estimated using the Black-Scholes option pricing model
based on the assumptions in the table below:
Schedule of Black Scholes Option Pricing Model
2024
2023
Expected dividend yield
0 %
0 %
Expected volatility
85 %
- 107 %
87 %
- 92 %
Risk-free interest rate
3.5 %
- 5.3 %
3.4 %
- 4.4 %
Expected life (in years)
0.5
- 6.0
5.0
- 6.0
● Volatility
- The trading volatility was determined by calculating the volatility of the Company’s
peer group.
● Expected
life of options – The expected life of options granted to employees was determined
using the simplified method.
● Risk-free
interest rate – This is the U.S. Treasury rate, having a term comparable to the
expected life of the stock option.
● Dividend
yield – The Company does not expect to pay a dividend in the foreseeable future.
The
weighted-average grant-date fair value of options granted during the years ended December 31, 2024 and 2023 was $ 2.78 and $ 3.15 , respectively.
The total grant-date fair value of options vested during the years ended December 31, 2024 and 2023 was approximately $ 819,077 and $ 585,500 ,
respectively.
F- 13
During
the year ended December 31, 2024, certain stock option awards granted to related parties were modified as follows:
● In
July 2024, the Company modified 131,927 vested stock option awards granted to the former
Chief Marketing Officer by extending his period to exercise these awards from 6 months to
12 months following termination. This modification resulted in additional stock-based compensation
expense of $ 28,666 .
● In
December 2024, the Company modified stock option awards granted the former Chief Financial
Officer by (i) accelerating the vesting of 31,103 unvested options, and (ii) extending the
period to exercise all now-vested 109,500 awards from 6 months to 12 months following his
passing. These modifications resulted in additional stock-based compensation expense of $ 51,696 .
No
options were exercised in any of the periods presented.
During
the years ended December 31, 2024 and 2023, the Company recognized approximately $ 940,642 and $ 592,268 , respectively of compensation
expense related to stock options.
As
of December 31, 2024, the total unrecognized compensation expense related to unvested stock options was approximately $ 770,862 which
the Company expects to recognize over a weighted-average period of approximately 1.4 years.
Warrants
The
following table provides details over the Company’s outstanding warrants including those issued as consideration for services and
those issued in conjunction with transactions as of December 31, 2024:
Schedule
of Outstanding Warrants
Exercise Price
Expiration
Number of Warrants
$ 0.0001
N/A
302,398
$ 0.0007
2030
274,286
$ 2.00 - $ 2.66
2026 - 2032
2,164,179
$ 3.36 - $ 4.16
2028 - 2029
1,842,807
$ 6.51 - $ 7.80
2026 - 2032
1,484,829
$ 8.125
2028
1,443,227
7,511,726
Warrants
Issued in Conjunction with Transactions
During
the year ended December 31, 2023, the Company issued the following warrants as part of the Company’s February 2023 IPO:
● 276,452
contingent warrants to certain debt holders with an exercise price of $ 4.27 and an expiration
date 5 years from issuance. As of December 31, 2024, 204,033 warrants have been exercised
and 72,419 remain outstanding. As a result of the February 2024 and October 2024 secondary
offerings, the exercise price of the remaining outstanding warrants was initially reduced
to $ 3.782 and subsequently to $ 2.00 pursuant to the anti-dilution provision contained in
the warrants. The effect of the changes in price was recognized as deemed dividends of $ 28,245
which increases net loss available to common stockholders for the year ended December 31,
2024.
● 18,000
contingent warrants as fees to the Company’s underwriters with an exercise price of
$ 8.125 and an expiration date 4 years from issuance. As of December 31, 2024, none of these
warrants have been exercised. As a result of the February 2024 and October 2024 secondary
offerings, the exercise price of the remaining outstanding warrants was initially reduced
to $ 3.782 and subsequently to $ 2.00 pursuant to the anti-dilution provision contained in
the warrants. The effect of the changes in price was recognized as deemed dividends of $ 16,740
which increases net loss available to common stockholders for the year ended December 31,
2024.
● 1,297,318
tradable warrants with an exercise price of $ 7.80 and an expiration date 5 years from issuance.
As of December 31, 2024, 100 warrants have been exercised and 1,297,218 remain outstanding.
● 1,297,318
non-tradable warrants with an exercise price of $ 8.125 and an expiration date 5 years from
issuance. As of December 31, 2024, 7,500 warrants have been exercised and 1,289,818 remain
outstanding.
F- 14
● 153,409
tradeable warrants to our underwriters pursuant to the overallotment options with an exercise
price of $ 7.80 and an expiration date 5 years from issuance. As of December 31, 2024, none
of these warrants have been exercised.
● 153,409
non-tradeable warrants to our underwriters pursuant to the overallotment options with an
exercise price of $ 8.125 and an expiration date 5 years from issuance. As of December 31,
2024, none of these warrants have been exercised.
During
the year ended December 31, 2024, the Company issued the following warrants as part of two secondary offerings:
● In
February 2024, 1,507,139 warrants with an exercise price of $ 4.16 per share and an expiration
date 5 years from issuance. In addition, the Company issued an additional 218,382 warrants
with an exercise price of $ 4.16 and an expiration date 5 years from issuance pursuant to
the underwriters’ overallotment option. As of December 31, 2024, 16,000 of these warrants
have been exercised and 1,709,521 remain outstanding.
● In
February 2024, 478,429 pre-funded warrants with an exercise price of $ 0.0001 . As of December
31, 2024, all of these pre-funded warrants have been exercised.
● In
February 2024, 90,428 warrants with an exercise price of $ 4.16 per share and an expiration
date 5 years from issuance to the underwriters. The warrants were valued at approximately
$ 263,145 , and as of December 31, 2024, none of these warrants have been exercised.
● In
October 2024, 1,565,000 warrants to purchase shares of the Company’s common stock at
an exercise price of $ 2.00 per share and expiration date of 5.5 years from issuance. As of
December 31, 2024, none of these warrants have been exercised.
● In
October 2024, 702,398 pre-funded warrants with an exercise price of $ 0.0001 . As of December
31, 2024, 400,000 shares have been exercised in a cashless transaction and 399,987 shares
of common stock were issued.
● In
October 2024, 62,600 warrants with an exercise price of $ 2.00 and an expiration date 5.5
years from issuance to the underwriters. The warrants were valued at approximately $ 116,436
and as of December 31, 2024, none of these warrants have been exercised.
Warrants
Issued as Consideration for Services
The
following table summarizes the activity for warrants issued as consideration for services for the years ended December 31, 2024 and 2023:
Schedule
of Warrant Activity
Number of Warrants
Weighted-Average Exercise Price
Weighted-Average Remaining Contractual Term (Years)
Aggregate Intrinsic Value
Outstanding at December 31, 2022
678,176
$ 1.57
7.6
$ 2,131,123
Granted
-
$ -
Exercised
-
$ -
Forfeited / canceled
-
$ -
Outstanding at December 31, 2023
678,176
$ 1.57
6.6
$ 1,209,136
Granted
-
$ -
Exercised
( 14,285 )
$ 2.66
Forfeited / canceled
-
$ -
Outstanding at December 31, 2024
663,891
$ 1.55
5.6
$ 548,380
Vested at December 31, 2024
663,891
$ 1.55
5.6
$ 548,380
During
the years ended December 31, 2024 and 2023, the Company recognized $ 3,007 and $ 39,265 , respectively of compensation expense related to
certain warrants.
As
of December 31, 2024, there was no unrecognized compensation expense as no unvested warrants remain.
The
total grant-date fair value of warrants vested during the year ended December 31, 2024 was approximately $ 3,007 .
F- 15
9. Income Taxes
Deferred
income taxes reflect the net tax effects of net operating loss, credit carryforwards, and temporary differences between the carrying
amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components
of the Company’s deferred tax assets for federal and state income taxes are as follows:
Schedule of Deferred Tax Assets And Liabilities
2024
2023
December 31,
2024
2023
Deferred tax assets:
Net operating losses
$ 2,650,540
$ 1,432,634
Capitalized research and development
647,602
283,353
Stock-based compensation
183,856
175,213
Intangibles
162,701
173,273
Other
12,374
9,438
Total deferred tax assets
3,657,073
2,073,911
Valuation allowance
( 3,656,627 )
( 2,073,459 )
Net deferred tax asset
446
452
Deferred tax liabilities:
Property and equipment
( 446 )
( 452 )
Total deferred tax liabilities
( 446 )
( 452 )
Net deferred tax asset / (liability)
$ -
$ -
Realization
of the Company’s deferred tax assets is dependent upon future earnings, if any, the timing, and amount of which are uncertain.
Because of the Company’s lack of U.S. earnings history, the net U.S. deferred tax assets have been fully offset by a valuation
allowance. The valuation allowance increased by $ 1,583,168 and $ 1,151,827 during the years ended December 31, 2024 and 2023, respectively.
As
of December 31, 2024, the Company has available for federal income tax purposes a gross net operating loss carryforward of approximately
$ 10.8 million and a gross state net operating loss carryforward of approximately $ 4.7 million. The federal net operating loss carryforward
does not expire and may be used to offset future taxable income. The state gross net operating loss begins to expire in 2043. Utilization
of some of the federal and state net operating loss carryforwards are subject to annual limitations due to the “change in ownership”
provisions of the Internal Revenue Code of 1986 and similar state provisions. The annual limitations may result in the expiration of
net operating losses and credits before utilization.
The
Company has provided a valuation allowance against the full amount of the net operating loss benefit and its other net deferred tax assets
since, in the opinion of management, based upon the earnings history of the Company, it is more likely than not that the future tax benefits
of the Company’s net deferred tax assets will not be realized. All or portion of the remaining valuation allowance may be reduced
in future years based on an assessment of earnings sufficient to fully utilize these potential tax benefits.
The
Company has incurred net operating losses since inception and it did not have unrecognized tax benefits as of December 31, 2024 and 2023,
and does not anticipate this to change significantly over the next 12 months. The Company will recognize interest and penalties accrued
on any unrecognized tax benefits as a component of income tax expense.
The
Company files income tax returns in the U.S. and certain state jurisdictions. The Company is not currently under examination in these
jurisdictions for any tax year. The Company’s tax years beginning with 2021 are open tax years. Because of net operating losses
and research credit carryovers, substantially all the Company’s tax years remain open to examination.
F- 16
Reconciliations
between the statutory federal income tax rate and the effective income tax rate of income tax expense for the years ended December 31,
2024 and 2023 are as follows:
Effective Income Tax Rate of Income Tax Expense
December 31,
December 31,
2024
2023
U.S. Federal statutory tax rate
21.0 %
21.0 %
Stock-based compensation
( 1.6 )
( 1.1 )
Other
( 1.1 )
( 3.3 )
Change in valuation allowance
( 18.3 )
( 16.6 )
- %
- %
10. Material Agreements
JHU-APL
Technology License
In
February 2018, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL. The license covers three (3)
issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of algorithms and other trade
secrets, as well as modifications and improvements. In October 2021, the Company executed an amendment to the original license for improvements
and new advanced analytics capabilities. In consideration of the rights granted to the Company under the license agreement, JHU-APL received
a warrant equal to five percent ( 5 %) of the then fully diluted equity base of the Company, which was diluted following the closing of
the Company’s initial public offering. Under the terms of the license agreement, JHU-APL will be entitled to an eight percent ( 8 %)
royalty on net sales for the services provided by the Company as well as fifty percent ( 50 %) of all sublicense revenues received by the
Company on services and sublicenses in which the JHU-APL licensed technology was utilized. In addition, the Company is required to pay
JHU-APL an annual maintenance fee of $ 1,500 . Minimum annual royalty payments are $ 20,000 for 2022, $ 80,000 for 2023, and $ 300,000 per
year for 2024 and beyond. If cumulative annual royalty payments do not reach these levels, the amount due to JHU-APL to reach the annual
minimum is due by January 1 st of the following year. Failure to make annual royalty payments is considered a material breach
under the agreement and, upon notice from JHU-APL of a material breach, the Company will have 60 days to cure the material breach. In
July 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed
to enhance the bfLEAP™ platform. The new license provides additional intellectual property rights including patents, copyrights,
and knowhow to be utilized under the Company’s bfLEAP™ analytical AI/ML platform. This license supersedes the previous 2018
license. In consideration of the new license, the Company issued 39,879 shares of common stock to JHU-APL. Under the terms of the new
license agreement, JHU-APL will be entitled to eight percent ( 8 %) of net sales for the services provided by the Company to other parties
and three percent ( 3 %) for internally developed drug projects in which the JHU-APL license is utilized. The new license also contains
tiered sub licensing fees that start at 50 % and reduce to 25 % based on revenues. In addition, under the new license agreement, the minimum
annual royalty payments are $ 30,000 for 2022, $ 80,000 for 2023, and $ 300,000 per year for 2024 and beyond.
In
May 2023, the Company and JHU-APL entered into Amendment Number 1 of the July 2022 License Agreement whereby the Company gained access
to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $ 275,000 . The first of
these payments of $ 75,000 was paid in July 2023 and the remaining payments of $ 75,000 , $ 75,000 , and $ 50,000 are due in years 2025, 2026
and 2027, respectively. The amendment also reduced the 2023 minimum annual royalty payment to $ 60,000 , all other financial terms remain
the same. As of December 31, 2024, we have accrued $ 300,000 of the 2024 minimum annual royalty payments, and the entire accrued balance
was paid in January 2025.
George
Washington University - Beta2-spectrin siRNA License
In
January 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from George Washington University (“GWU”)
for rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including hepatocellular carcinoma (“HCC”).
The license covers methods claimed in three U.S. and worldwide patent applications, and also includes use of this approach for treatment
of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.
In
consideration of the rights granted to the Company under the license agreement, the Company paid GWU a $ 20,000 license initiation fee.
Under the terms of the license agreement, GWU will be entitled to a three percent ( 3 %) royalty on net sales subject to quarterly minimums
once the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event the Company sublicenses
or assigns their rights to use the technology. The Company will also reimburse GWU for previously incurred and ongoing patent costs.
The sublicense and assignment fee amounts decline as the Company advances the clinical development of the licensed technology. The license
agreement also contains milestone payments for clinical development through the approval of an NDA and commercialization. As of December
31, 2024, there has been no accrual for royalties since the Company has not begun to generate applicable revenue. The Company assessed
whether the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable;
the Company expensed the license fee and will expense development costs until commercial viability is likely.
F- 17
Johns
Hopkins University – Mebendazole License
In
February 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (“JHU”)
for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease. This formulation shows
potent activity in animal models with different types of cancer and has been evaluated in a Phase I clinical trial in patients with high-grade
glioma (NCT01729260). The trial, an open-label dose-escalation study, assessed the safety and efficacy of the improved formulation with
adjuvant temozolomide in 24 patients with newly diagnosed gliomas. Investigators observed no dose-limiting toxicity in patients receiving
all but the highest tested dose (200mg/kg/day). Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced
dose-limiting toxicity, all of which were reversed by decreasing or eliminating the dose given. There were no serious adverse events
attributed to Mebendazole at any dose during the trial. 41.7% of patients who received Mebendazole were alive at two years after enrollment,
and 25% were alive at four years (Gallia et al., 2021).
The
license covers six (6) issued patents and one (1) pending application. In consideration of the rights granted to the Company under the
license agreement, JHU will receive a staggered upfront license fee of $ 250,000 . The Company initially paid $ 50,000 and the remaining
balance of $ 200,000 was paid in 2023. The Company will also reimburse JHU for previously incurred and ongoing patent costs. Under the
terms of the license agreement, JHU will be entitled to three and one-half percent ( 3.5 %) royalty on net sales by the Company in which
the JHU license was utilized. In addition, the Company is required to pay JHU minimum annual royalty payments of $ 5,000 for 2022, $ 10,000
for 2023, $ 20,000 for 2024, $ 30,000 for 2025 and $ 50,000 for 2026 and each year after until the first commercial sale after which the
annual minimum royalty shall be $ 250,000 . The license agreement also contains milestone payments for clinical development steps through
the approval of an NDA and commercialization. As of December 31, 2024 and 2023, the balance of accrued expense related to this license
agreement was $ 20,000 and $ 10,000 , respectively. The Company assessed whether the license should be capitalized and determined that the
licensed program is in the early stage and therefore may not be recoverable; the Company expensed the license fee and will expense development
costs until commercial viability is likely.
Johns
Hopkins University – Mebendazole Prodrug License
In
October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU and the Institute of Organic Chemistry
and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of Mebendazole
that demonstrate improved solubility and bioavailability. The license covers prodrug compositions and use for treating disease as claimed
in multiple U.S. and worldwide patent applications. In consideration for the rights granted to the Company under the license agreement,
JHU and IOCB will receive a staggered upfront license fee of $ 100,000 . The Company will also reimburse JHU and IOCB for previously incurred
patent costs. Under the terms of the license agreement, JHU and IOCB will be entitled to four percent ( 4.0 %) royalty on net sales by
the Company in which the JHU and IOCB license was utilized. In addition, the Company is required to pay JHU and IOCB minimum annual royalty
payments of $ 5,000 for 2026, $ 10,000 for 2027, $ 20,000 for 2028, $ 30,000 for 2029 and $ 50,000 for 2030 and each year after until the
first commercial sale, after which, the annual minimum royalty shall be $ 150,000 . The license agreement also contains milestone payments
for patent grants, clinical development steps through the approval of an NDA and commercialization. As of December 31, 2024 and 2023,
the balance of accrued expense related to this license agreement was $ 0 . The Company assessed whether the license should be capitalized
and determined that the licensed program is in the early stage and therefore may not be recoverable; the Company expensed the license
fee and will expense development costs until commercial viability is likely.
11. Commitments and Contingencies
While
not assured, management does not believe, based upon information available at this time, that a loss contingency will have a material
adverse effect on the Company’s financial position, results of operations or cash flows. Additionally, the Company does not have
any material commitments.
12. Subsequent Events
The
Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the consolidated financial
statements are issued.
Other
than as disclosed in this Note 12 and as may be disclosed elsewhere in the notes to the accompanying consolidated financial statements,
there have been no subsequent events that require adjustment or disclosure in the accompanying consolidated financial statements.
In
February 2025, the Company announced its entry into a collaboration agreement with Eleison Pharmaceuticals Inc. (“Eleison”),
a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers. Through this collaboration, the Company will
apply its proprietary Bullfrog Data Networks™ solution, powered by the bfLEAP® platform, to analyze clinical data from Eleison’s
ongoing Phase III trial and previous clinical studies of glufosfamide, an investigational treatment for pancreatic cancer. The platform
will evaluate the current trajectory of the trial with respect to safety signals, extract predictive biomarkers for efficacy and safety
performance from prior studies to support future trial design, and provide data-driven insights to optimize Eleison’s planned clinical
trials for inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD). These insights are expected to streamline trial efficiency
and improve decision-making for Eleison’s broader oncology pipeline.
In
March 2025, the Company anticipates making a severance payment to a former employee for approximately $ 45,000 .
F- 18