CONTROLS AND PROCEDURES
−Removed: Controls and Procedures
−Removed: are transitioning to and will maintain disclosure controls and procedures that are designed to ensure that information required to be
−Removed: disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and timely reported as provided
−Removed: in SEC rules and forms and that such information is accumulated and communicated to our management, as appropriate, to allow for timely
−Removed: decisions regarding required disclosure.
−Removed: We will periodically review the design and effectiveness of our disclosure controls and procedures,
−Removed: including compliance with various laws and regulations that apply to our operations.
−Removed: We will make modifications to improve the design
−Removed: and effectiveness of our disclosure controls and procedures and may take other corrective action if our reviews identify a need for such
−Removed: modifications or actions.
−Removed: In designing and evaluating the disclosure controls and procedures, we recognize that any controls and procedures,
−Removed: no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and we will
−Removed: apply judgment in evaluating the cost-benefit relationship of possible controls and procedures.
−Removed: In addition, the design of any system
−Removed: of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that
−Removed: any design will succeed in achieving its stated goals under all potential future conditions;
−Removed: over time, controls may become inadequate
−Removed: because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate.
−Removed: Because of the inherent limitations
−Removed: in a control system, misstatements due to error or fraud may occur and not be detected.
−Removed: in Internal Control Over Financial Reporting
−Removed: were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act)
−Removed: that occurred during the fiscal year ended December 31, 2023 which have materially affected, or are reasonably likely to materially affect,
−Removed: our internal control over financial reporting.
+Added: of Disclosure Controls and Procedures
+Added: are required to maintain “disclosure controls and procedures” as such term is defined in Rule 13a-15(e) under the Securities
+Added: Exchange Act of 1934 (the “Exchange Act”).
+Added: In designing and evaluating our disclosure controls and procedures, our management
+Added: recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute,
+Added: assurance that the objectives of disclosure controls and procedures are met.
+Added: The design of any disclosure controls and procedures is
+Added: also based, in part, upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will
+Added: succeed in achieving its stated goals under all potential future conditions.
+Added: We conducted an evaluation of the effectiveness of
+Added: our disclosure controls and procedures as of December 31, 2024.
+Added: Based on this evaluation, our chief executive officer and chief financial
+Added: officer concluded that our disclosure controls and procedures were not effective as of the end of the reporting period covered in this
+Added: Annual Report on Form 10-K, as a result of the material weaknesses in our internal control over financial reporting described below.
+Added: Notwithstanding the identified material weaknesses, our management has concluded that the audited consolidated financial statements in
+Added: this filing on Form 10-K, fairly present, in all material respects, our financial position, results of operations and cash flows as of
+Added: and for the periods presented in conformity with GAAP.
Report on Internal Control over Financial Reporting
−Removed: Annual Report does not include a report of management’s assessment regarding internal control over financial reporting due to a
−Removed: transition period established by the rules of the SEC for newly public companies.
−Removed: Report of Independent Registered Public Accounting Firm
−Removed: Annual Report does not include an attestation report of our registered independent public accounting firm regarding internal control
−Removed: over financial reporting due to an exemption established by the JOBS Act for “emerging growth companies.”
+Added: management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange
+Added: Act Rule 13a-15.
+Added: Internal control over financial reporting is defined in Rule 13a-15(f) and 15(d)-15(f) under the Exchange Act as a process
+Added: designed to provide reasonable assurance to our management and Board of Directors regarding the preparation and fair presentation of
+Added: published financial statements.
+Added: control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of
+Added: the control system are met.
+Added: Further, the design of a control system must reflect the fact that there are resource constraints, and the
+Added: benefits of controls must be considered relative to their costs.
+Added: Because of the inherent limitations in all control systems, no evaluation
+Added: of controls can provide absolute assurance that all control issues and instances of error or fraud, if any, within our Company have been
+Added: However, these inherent limitations are known features of the financial reporting process.
+Added: Therefore, it is possible to design
+Added: safeguards into the process to reduce, though not eliminate, this risk.
+Added: previously disclosed, management identified material weaknesses in its internal controls over financial reporting at December 31, 2023
+Added: which continue to be unremediated as of December 31, 2024.
+Added: Specifically, Management noted the Company did not properly document, implement
+Added: or operate a system of effective internal controls over financial reporting.
+Added: A material weakness is a deficiency, or a combination of
+Added: deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement
+Added: of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.
+Added: conducted an assessment of our internal control over financial reporting as of December 31, 2024 based on the framework and criteria
+Added: established by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013).
+Added: Based on the assessment, and the noted material weaknesses, management concluded that, as of December 31, 2024, our internal control
+Added: over financial reporting was not effective.
+Added: Remediation Efforts
+Added: is in the process of implementing improvements to its internal controls over financial reporting.
+Added: Namely the Company has and is continuing
+Added: its day-to-day accounting processes to an external firm including automating its vendor payments;
+Added: the transfer of the overall accounting process to an enterprise type accounting platform;
+Added: ● periodically
+Added: review the design and effectiveness of our controls including the creation of an annual risk
+Added: assessment and ongoing monitoring activities;
+Added: all internal and external resources to ensure they are appropriate for the level and complexity
+Added: of our current operations.
+Added: This includes the hiring of a Corporate Controller in 2024.
+Added: we believe that these efforts will improve our internal control over financial reporting, the implementation of these measures is ongoing
+Added: and will require validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial
+Added: reporting cycles.
+Added: We will continue to monitor and evaluate the effectiveness of our internal control over financial reporting on an ongoing
+Added: basis and are committed to taking further action and implementing additional enhancements or improvements, as necessary and as funds
+Added: 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
+Added: the material weaknesses we have identified or avoid potential future material weaknesses.
+Added: Accordingly, there could continue to be a reasonable
+Added: possibility that a material misstatement of our financial statements would not be prevented or detected on a timely basis.
+Added: in Internal Control Over Financial Reporting
+Added: than the material weaknesses and remediation efforts described above, there has been no change in the Company’s internal control
+Added: over financial reporting during the Company’s most recently completed fiscal quarter that has materially affected, or is reasonably
+Added: likely to materially affect, the Company’s internal control over financial reporting.
OTHER INFORMATION
−Removed: DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
+Added: Trading Plans
+Added: the quarter ended December 31, 2024, none of the Company’s directors or executive officers adopted , modified or terminated any
+Added: contract, instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense
+Added: conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement”.
+Added: As previously discussed, in June 2023 , Vininder
+Added: Singh , the Chief Executive Officer and a Director of the Company , entered into a 10b5-1 sales plan (the “10b-5 Sales Plan”)
+Added: intended to satisfy the affirmative defense of Rule 10b5-1(c) under the Exchange Act.
+Added: The 10b5 Sales Plan provides for the sale of up
+Added: to 1,000,000 shares of common stock and will remain in effect until the earlier of (1) August 31, 2025;
+Added: or (2) the date on which an aggregate
+Added: of 1,000,000 shares of common stock have been sold under the 10b5 Sales Plan.
+Added: Pursuant to the 10b5 Sales Plan, 50,000 shares were sold
+Added: 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
+Added: the plan in each of the second, third, and fourth quarters of 2024.
+Added: REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE
1 unchanged sentence
following table sets forth the name, age and position of each of our executive officers, key employees and directors.
−Removed: Executive Officer and Director
−Removed: Financial Officer
−Removed: Non-Executive
−Removed: and Chair Audit Committee
−Removed: and Chair of Compensation Committee
−Removed: and Chair of Nominating and Corporate Governance Committee
−Removed: (Vin) Singh is the Founder, Chairman, and CEO of BullFrog AI Holdings, Inc.
−Removed: since its inception in August 2017.
−Removed: Over the past five
−Removed: years, he has built the Company from scratch and during that time he led strategy, built a highly experienced team of leaders, spear
−Removed: headed the acquisition and development of BullFrog’s core AI technology and drug assets, secured the first revenue, and raised
−Removed: approximately $2M in financing.
−Removed: In February of 2020, he formed BullFrog AI Holdings, Inc.
−Removed: and BullFrog AI Inc.
−Removed: became a wholly owned
−Removed: subsidiary designated as the holder of core intellectual property.
−Removed: Vin is a serial entrepreneur and experienced executive with 25 years
−Removed: of experience in the life sciences and biotechnology industries.
−Removed: He has extensive start-up experience having founded and built several
−Removed: pioneering investor backed companies including BullFrog AI, which uses machine learning/AI to enable drug development, Next Healthcare
−Removed: Inc., a personalized diagnostics and adult cell banking service, and MaxCyte Inc.
+Added: Executive Officers:
+Added: Vininder Singh
+Added: Chief Executive Officer and Director
+Added: Chief Financial Officer
+Added: Non-Executive Directors:
+Added: Director and Chair of Audit Committee
+Added: William Enright
+Added: Director and Chair of Compensation Committee
+Added: Director and Chair of Nominating and Corporate Governance
+Added: (Vin) Singh is the founder of Bullfrog AI Holdings, Inc.
+Added: and has served as its Chairman and CEO since its inception in August 2017.
+Added: Over the past seven years, he has built the Company from scratch and, during that time, he led strategy, built a highly experienced team
+Added: of leaders, spearheaded the acquisition and development of the Company’s core AI technology and drug assets, secured the first
+Added: revenue, and raised approximately $2 million in financing prior to the Company’s IPO in February 2023.
+Added: In February of 2020, he
+Added: formed Bullfrog AI Holdings, Inc., and Bullfrog AI Inc.
+Added: became a wholly owned subsidiary designated as the holder of core intellectual
+Added: Vin is a serial entrepreneur and experienced executive with 25 years of experience in the life sciences and biotechnology industries.
+Added: He has extensive start-up experience having founded and built several pioneering investor-backed companies including Bullfrog AI, which
+Added: uses AI/ML to enable drug development, Next Healthcare Inc., a personalized diagnostics and adult cell banking service, and MaxCyte Inc.
MXCT), a cell therapy company.
−Removed: He was also an executive
−Removed: at GlobalStem Inc.
−Removed: and ThermoFisher Scientific, leading their global cell therapy services business.
−Removed: Vin has a BS in Electrical Engineering
−Removed: from Rutgers University, an MS in Biomedical Engineering from Rensselaer Polytechnic Institute, and an MBA from Johns Hopkins University.
+Added: He was also an executive at GlobalStem Inc.
+Added: and ThermoFisher Scientific, leading their global
+Added: cell therapy services business.
+Added: Vin has a B.S.
+Added: in Electrical Engineering from Rutgers University, an M.S.
+Added: in Biomedical Engineering from
+Added: Rensselaer Polytechnic Institute, and an M.B.A.
+Added: from Johns Hopkins University.
We believe that Mr.
−Removed: Singh is qualified to serve as a member of our board of directors due to the perspective and experience that he brings
−Removed: as our Founder and Chief Executive Officer, his extensive experience in the science and biotechnology industries and in the management
−Removed: of startup companies.
−Removed: Saglio joined BullFrog Holdings AI, Inc.
−Removed: as Chief Financial Officer in September 2021.
−Removed: Saglio brings more than 40 years of financial
−Removed: management experience in both public and private companies across a number of business sectors.
−Removed: Previously, Mr.
−Removed: Saglio has served as
−Removed: CFO at Seneca Biopharma, RegeneRx Biopharmaceuticals since 2011, New Generation Biofuels 2010 until 2011, and EntreMed from 2000 until
−Removed: 2008, all public companies in the biotechnology arena.
−Removed: Prior to joining the Company, Mr.
−Removed: Saglio was the CFO of Seneca Biopharma, initially
−Removed: as a consultant in August 2019 and then as an employee in April 2020 until the Company merged with Leading Bio Sciences, forming Palisades
−Removed: in April 2021.
−Removed: He previously served as CFO at Celios Corporation from October 2017 until July 2019 and Helomics Corporation,
−Removed: a personalized medicine company in cancer from October 2014 through July 2017.
−Removed: He began his career at Informatics Corp, now Computer
−Removed: Associates International and then at Bressler & Reiner, a DC-based real estate developer and homebuilder.
−Removed: Dane has a BS from the
−Removed: University of Maryland is a licensed CPA in Maryland (inactive).
+Added: Singh is qualified to serve as a member
+Added: of our board of directors due to the perspective and experience that he brings as our founder and Chief Executive Officer, his extensive
+Added: experience in the science and biotechnology industries and in the management of startup companies.
+Added: Blacher has been the Chief Financial Officer of Bullfrog AI Holdings, Inc.
+Added: since December 2024.
+Added: Blacher has served as an employee
+Added: of Danforth Advisors since September 2022, where he has worked as a chief financial officer in a consulting capacity for a number of
+Added: life sciences companies as well as Managing Partner of Columbus Circle Capital LLC since August 2019.
+Added: In his capacity as a consultant
+Added: of Danforth, he has served as Chief Financial Officer of Predictive Oncology since September 2023 as well as Rampart Bioscience and Excision
+Added: Bio Therapeutics, among others.
+Added: During his tenure at Columbus Circle Capital, Mr.
+Added: Blacher has served as chief financial officer at several
+Added: public and private companies.
+Added: Prior to his tenure at Columbus Circle Capital, Mr.
+Added: Blacher served as Chief Business Officer at Inmed Pharmaceuticals
+Added: INM) from April 2018 to August 2019, as Chief Financial Officer of Therapix Biosciences (Nasdaq:
+Added: TRPX) from April 2017 to April
+Added: 2018, and as Chief Financial Officer at Galmed Pharmaceuticals (Nasdaq:
+Added: GLMD) from October 2014 to March 2017.
+Added: Earlier in his career,
+Added: Blacher served in senior capacities at Teva Pharmaceuticals, Deutsche Asset Management and Morgan Stanley.
+Added: Blacher holds a Bachelor
+Added: of Arts from Yeshiva University and a Master of Business Administration from Columbia Business School.
Don Elsey has been a director and chair of the Audit Committee of our board since February 2023.
−Removed: Currently, Mr.
−Removed: Audit Chair of OpGen, Inc., a precision medicine company.
−Removed: Elsey was the CFO of Lyra until his retirement in December 2020.
−Removed: from February 2015 to February 2019, Mr.
−Removed: Elsey served as Chief Financial Officer at Senseonics, Inc., a medical device company.
−Removed: May 2014 until February 2015, Mr.
−Removed: Elsey served as Chief Financial Officer of Regado Biosciences, Inc., a biopharmaceutical company.
−Removed: December 2012 to February 2014, Mr.
−Removed: Elsey served as Chief Financial Officer of LifeCell Corporation, a privately held regenerative medicine
+Added: Elsey was the Chief Financial
+Added: Officer of Lyra Therapeutics until his retirement in December 2020.
+Added: Previously, from February 2015 to February 2019, Mr.
+Added: as Chief Financial Officer at Senseonics, Inc., a medical device company.
+Added: From May 2014 until February 2015, Mr.
+Added: Elsey served as Chief
+Added: Financial Officer of Regado Biosciences, Inc., a biopharmaceutical company.
+Added: From December 2012 to February 2014, Mr.
+Added: Elsey served as
+Added: Chief Financial Officer of LifeCell Corporation, a privately held regenerative medicine company.
Elsey holds a B.A.
−Removed: in economics and an M.B.A.
+Added: and an M.B.A.
in finance from Michigan State University.
We believe that Mr.
−Removed: Esley is qualified
−Removed: to serve as a member of our board of directors because of his extensive professional experience in science and biotechnology companies.
+Added: Esley is qualified to serve as a member of our board of
+Added: directors because of his extensive professional experience in science and biotechnology companies.
“Bill” Enright has been a director and chair of the Compensation Committee of our board since February 2023.
−Removed: a seasoned biotech executive with more than thirty-four years of experience in building and financing both privately held and publicly
−Removed: held companies and He is currently the CEO and a Director of Barinthus Biotherapurtics plc (NASDAQ:
−Removed: BRNS), which he helped to take public
−Removed: in April 2021.
−Removed: Prior to Barinthus, Bill spent more than ten years at Altimmune (NASDAQ:
−Removed: ALT) as a Director, President & CEO, moving
−Removed: multiple programs into clinical testing, completing several acquisitions, and eventually taking the company public.
−Removed: Prior to joining
−Removed: Altimmune, Bill spent six years with GenVec, Inc.
−Removed: (acquired by Precigen) with increasing responsibilities, culminating as Head of Business
−Removed: Bill brings a breadth of experiences in a variety of positions within the life science/biotech industry, including time
−Removed: as a consultant, a bench scientist and 12 years with Life Technologies, Inc.
−Removed: (acquired by Thermo-Fisher), working in various senior level
−Removed: licensing, business management, manufacturing and research roles.
−Removed: Bill received a Master of Arts in Molecular Biology from SUNY at Buffalo
−Removed: and a Master of Science in Business Management from Johns Hopkins University.
+Added: is a seasoned biotech executive with more than thirty-four years of experience in building and financing both privately held and publicly
+Added: held companies and he is currently the Chief Executive Officer and a Director of Barinthus Biotherapurtics plc (NASDAQ:
+Added: he helped to take public in April 2021.
+Added: Prior to Barinthus, Mr.
+Added: Enright spent more than ten years at Altimmune (NASDAQ:
+Added: ALT) as a director,
+Added: president & chief executive officer, moving multiple programs into clinical testing, completing several acquisitions, and eventually
+Added: taking the company public.
+Added: Prior to joining Altimmune, Mr.
+Added: Enright spent six years with GenVec, Inc.
+Added: (acquired by Precigen) with increasing
+Added: responsibilities, culminating as Head of Business Development.
+Added: Enright brings a breadth of experiences in a variety of positions
+Added: within the life science/biotech industry, including time as a consultant, a bench scientist and 12 years with Life Technologies, Inc.
+Added: (acquired by Thermo-Fisher), working in various senior level licensing, business management, manufacturing and research roles.
+Added: received a Master of Arts in Molecular Biology from SUNY at Buffalo and a Master of Science in Business Management from Johns Hopkins
We believe that Mr.
−Removed: Enright is qualified to serve as a
−Removed: member of our board of directors because of his extensive professional experience in life science/biotech companies and in the management
−Removed: of public companies.
+Added: Enright is qualified to serve as a member of our board of directors because of his extensive professional
+Added: experience in life science/biotech companies and in the management of public companies.
Hanson has served as a director and chair of the Nominating and Corporate Governance Committee since February 2023.
−Removed: has served as Chief Executive Officer and as a Director of enGene Inc.
−Removed: since July 2018.
−Removed: He also served as President of enGene Inc.
−Removed: July 2018 to December 2022.
−Removed: Hanson effectively re-launched enGene from a small private company working in the GI discovery space
−Removed: into a clinical stage gene therapy oncology company trading on Nasdaq, implementing a new scientific, technical and strategic vision
+Added: served as Chief Executive Officer and as a director of enGene Inc.
+Added: from July 2018 to July 2024.
+Added: He also served as President of enGene
+Added: from July 2018 to December 2022.
+Added: Hanson effectively re-launched enGene from a small private company working in the GI discovery
+Added: space into a clinical stage gene therapy oncology company trading on Nasdaq, implementing a new scientific, technical and strategic vision
for the Company.
20 unchanged sentences
School of Law.
−Removed: table below provides certain information regarding the diversity of our board of directors as the date of this annual report.
−Removed: Board Diversity Matrix
−Removed: Country of Principal Executive Offices:
+Added: We believe that Mr.
+Added: Hanson is qualified to serve as a member of our board of directors because of his extensive professional
+Added: experience in science and biotechnology companies.
+Added: table below provides certain information regarding the diversity of our board of directors as of the date of this annual report.
+Added: Diversity Matrix
+Added: Principal Executive Officers:
United States
Foreign Private Issuer
−Removed: Disclosure Prohibited under Home Country Law
+Added: Disclosure Prohibited under
+Added: Home Country Law
Total Number of Directors
−Removed: Did Not Disclose Gender
+Added: Not Disclose Gender
Gender Identity
−Removed: Demographic Background
−Removed: Underrepresented Individual in Home Country Jurisdiction
−Removed: Did Not Disclose Demographic Background
+Added: Underrepresented Individual
+Added: in Home Country Jurisdiction
+Added: Did Not Disclose Demographic
Board seeks members from diverse professional backgrounds who combine a solid professional reputation and knowledge of our business and
39 unchanged sentences
compliance with legal and regulatory requirements.
−Removed: The Audit Committee met four times in 2023.
+Added: The audit committee met 5 times in 2024.
compensation committee consists of William Enright, Don Elsey and Jason Hanson, with Mr.
4 unchanged sentences
adequacy and form of compensation of the board;
−Removed: compensation of Chief Executive Officer, including base salary, incentive bonus, stock option
−Removed: and other grant, award and benefits upon hiring and on an annual basis;
+Added: compensation of the Chief Executive Officer, including base salary, incentive bonus, stock
+Added: option and other grant awards, and benefits upon hiring and on an annual basis;
compensation of other senior management upon hiring and on an annual basis;
1 unchanged sentence
to such plans to our board of directors, when necessary.
+Added: compensation committee met 4 times in 2024.
& Corporate Governance Committee
12 unchanged sentences
self-assessment of its practices and effectiveness.
+Added: nominating and corporate governance committee met 4 times in 2024.
directors hold office until the next annual meeting of the stockholders of the company and until their successors have been duly elected
1 unchanged sentence
Officers are elected by and serve at the discretion of our Board.
−Removed: of Business Conduct and Ethics
+Added: Code of Business
+Added: Conduct and Ethics
have adopted a Code of Business Conduct and Ethics that applies to our principal executive officer, principal financial officer, principal
1 unchanged sentence
Our code of ethics can be found at https://ir.bullfrogai.com/corporate-governance/governance-documents .
−Removed: December 1, 2023, the Board adopted the BullFrog AI Clawback Policy (the “Clawback Policy”), effective December 1, 2023,
−Removed: providing for the recovery of certain incentive-based compensation from current and former executive officers of the Company in the event
−Removed: 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
−Removed: that is material to the previously-issued financial statements, or that would result in a material misstatement if the error were corrected
−Removed: in the current period or left uncorrected in the current period.
−Removed: Adoption of the Clawback Policy was mandated by new Nasdaq listing standards
−Removed: introduced pursuant to Exchange Act Rule 10D-1.
−Removed: The Clawback Policy is in addition to Section 304 of the Sarbanes-Oxley Act of 2002 which
−Removed: permits the SEC to order the disgorgement of bonuses and incentive-based compensation earned by a registrant issuer’s chief executive
−Removed: officer and chief financial officer in the year following the filing of any financial statement that the issuer is required to restate
−Removed: because of misconduct, and the reimbursement of those funds to the issuer.
−Removed: A copy of the Clawback Policy has been filed herewith, and
−Removed: can also be found at www.bullfrogai.com.
+Added: Board has adopted the Bullfrog AI Clawback Policy (the “Clawback Policy”), effective December 1, 2023, providing for the
+Added: recovery of certain incentive-based compensation from current and former executive officers of the Company in the event the Company is
+Added: 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
+Added: to the previously-issued financial statements, or that would result in a material misstatement if the error were corrected in the current
+Added: period or left uncorrected in the current period.
+Added: Adoption of the Clawback Policy was mandated by new Nasdaq listing standards introduced
+Added: pursuant to Exchange Act Rule 10D-1.
+Added: The Clawback Policy is in addition to Section 304 of the Sarbanes-Oxley Act of 2002 which permits
+Added: the SEC to order the disgorgement of bonuses and incentive-based compensation earned by a registrant issuer’s chief executive officer
+Added: and chief financial officer in the year following the filing of any financial statement that the issuer is required to restate because
+Added: of misconduct, and the reimbursement of those funds to the issuer.
+Added: A copy of the Clawback Policy is attached as an exhibit to this annual
+Added: report and can be found at www.bullfrogai.com.
Relationships
3 unchanged sentences
directors and executive officers have not been involved in any of the following events during the past ten years:
−Removed: bankruptcy petition filed by or against such person or any business of which such person was a general partner or executive officer
−Removed: either at the time of the bankruptcy or within two years prior to that time;
−Removed: conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor
−Removed: subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction,
−Removed: permanently or temporarily enjoining him from or otherwise limiting his involvement in any type of business, securities or banking
−Removed: activities or to be associated with any person practicing in banking or securities activities;
−Removed: found by a court of competent jurisdiction in a civil action, the SEC or the Commodity Futures Trading Commission to have violated
−Removed: a Federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
−Removed: subject of, or a party to, any Federal or state judicial or administrative order, judgment decree, or finding, not subsequently reversed,
−Removed: suspended or vacated, relating to an alleged violation of any Federal or state securities or commodities law or regulation, any law
−Removed: or regulation respecting financial institutions or insurance companies, or any law or regulation prohibiting mail or wire fraud or
−Removed: fraud in connection with any business entity;
−Removed: subject of or party to any sanction or order, not subsequently reversed, suspended, or vacated, of any self-regulatory organization,
−Removed: any registered entity or any equivalent exchange, association, entity or organization that has disciplinary authority over its members
−Removed: or persons associated with a member.
+Added: bankruptcy petition filed by or against such person or any business of which such person
+Added: was a general partner or executive officer either at the time of the bankruptcy or within
+Added: two years prior to that time;
+Added: conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding
+Added: traffic violations and other minor offenses);
+Added: subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated,
+Added: of any court of competent jurisdiction, permanently or temporarily enjoining him from or
+Added: otherwise limiting his involvement in any type of business, securities or banking activities
+Added: or to be associated with any person practicing in banking or securities activities;
+Added: found by a court of competent jurisdiction in a civil action, the SEC or the Commodity Futures
+Added: Trading Commission to have violated a Federal or state securities or commodities law, and
+Added: the judgment has not been reversed, suspended, or vacated;
+Added: subject of, or a party to, any Federal or state judicial or administrative order, judgment
+Added: decree, or finding, not subsequently reversed, suspended or vacated, relating to an alleged
+Added: violation of any Federal or state securities or commodities law or regulation, any law or
+Added: regulation respecting financial institutions or insurance companies, or any law or regulation
+Added: prohibiting mail or wire fraud or fraud in connection with any business entity;
+Added: subject of or party to any sanction or order, not subsequently reversed, suspended, or vacated,
+Added: of any self-regulatory organization, any registered entity or any equivalent exchange, association,
+Added: entity or organization that has disciplinary authority over its members or persons associated
+Added: with a member.
16(a) Beneficial Ownership Compliance
1 unchanged sentence
the date of this Report, our executive officers, directors and greater than 10 percent beneficial owners have complied on a timely basis
−Removed: with all Section 16(a) filing requirements, except Messrs.
−Removed: Elsey, Enright and Hanson did not file Form 3s upon their appointment to the
+Added: with all Section 16(a) filing requirements, except for one Form 4 by each of Messrs.
+Added: Elsey, Enright and Hanson concerning the annual
+Added: grant of stock options in September 2024.
of December 31, 2024, we did not affect any material changes to the procedures by which stockholders may recommend nominees to the Board
3 unchanged sentences
and employees.
−Removed: A copy of the insider trading policy is attached as an exhibit to this annual report.
+Added: A copy of the insider trading policy is attached as an exhibit to this Annual Report on Form 10-K.
EXECUTIVE COMPENSATION
14 unchanged sentences
Chief Financial Officer
−Removed: May 16, 2022, we entered into an employment agreement with Vininder Singh, pursuant to which he will receive received an annual base
−Removed: salary of $400,000, which is subject to bi-annual review by the Company.
−Removed: Singh will also be eligible for an annual bonus based on
−Removed: the achievement of certain goals and performance criteria established by the Board.
−Removed: Singh’s target annual bonus for the fiscal
−Removed: 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
−Removed: (100%) percent based on target achievement.
−Removed: For 2023, the criteria to determine Mr.
−Removed: Singh’s bonus will include the following:
−Removed: the Company achieves $500,000 in sales;
−Removed: (ii) the filing of an Investigational New Drug (IND) Application with the FDA for mebendazole;
−Removed: (iii) the Company enters into two (2) strategic partnerships;
−Removed: and (iv) the Company commences partner negotiations with a third party
−Removed: for HSV-1, bf-114 or bf-222.
+Added: $ 310,000 (2)
+Added: Chief Financial Officer
+Added: Comprised of $380,000 related to Mr.
+Added: Singh’s 2023 salary, and salary amounts of $240,000 and $87,666 deferred in 2022 and years
+Added: prior to 2022, respectively, and paid in 2023.
+Added: Comprised of $220,000 related to Mr.
+Added: Saglio’s 2023 consulting fees, and consulting fees of $90,000 deferred in 2022 and paid in
+Added: May 16, 2022, we entered into an employment agreement with Vininder Singh, pursuant to which he received an annual base salary of $400,000,
+Added: which is subject to bi-annual review by the Company.
+Added: Singh is also eligible for an annual bonus based on the achievement of certain
+Added: goals and performance criteria established by the Board.
+Added: Singh’s target annual bonus for the fiscal years ended 2022 through
+Added: 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
+Added: based on target achievement.
Singh will also be eligible to participate in the Company’s stock incentive plan, subject to Board
2 unchanged sentences
disability of Mr.
+Added: December 7, 2024, Dane Saglio, the Company’s former Chief Financial Officer, passed away.
+Added: Saglio served as the Company’s
+Added: Chief Financial Officer since September 2021.
+Added: Saglio was a valued member of the Company’s executive management team and will
+Added: be greatly missed.
+Added: Prior to his passing, Mr.
+Added: Saglio served as Chief Financial Officer pursuant to a consulting agreement with the Company
+Added: that provided for annual compensation of $270,000.
+Added: Under the agreement, Mr.
+Added: Saglio was also entitled to a cash bonus and to participate
+Added: in the Company’s stock incentive plan, each as determined by the Board.
+Added: December 12, 2024, the Board of Directors appointed Josh Blacher to serve as the Company’s Chief Financial Officer.
+Added: In such capacity,
+Added: Blacher will serve as the principal financial officer and principal accounting officer of the Company.
+Added: Blacher provides services
+Added: to the Company as an independent contractor pursuant to a master services agreement entered into on December 13, 2024 (the “Consulting
+Added: Agreement”) by the Company and Danforth Advisors, LLC (“Danforth”).
+Added: Pursuant to the Consulting Agreement, the Company
+Added: will pay Danforth cash compensation at a rate of $525 per hour for Mr.
+Added: Blacher’s services, which is subject to an optional increase
+Added: by Danforth of up to 5% on January 1 of each year.
+Added: Blacher will receive no compensation directly from the Company.
following table summarizes the compensation paid to our executive and non-executive directors during the year ended December 31, 2024.
−Removed: Fees Earned or Paid in Cash ( 1)
−Removed: Option Awards (2)
+Added: Earned or Paid in Cash (1)
All Other Compensation
Nonequity Incentive Plan Compensation
−Removed: Nonqualified Deferred Compensation Earnings
+Added: Nonqualified Deferred Compensation
Total Compensation
15 unchanged sentences
price of each share of common stock purchasable under an award issued pursuant to the Plan, shall be determined by our compensation committee,
−Removed: in its sole discretion, at the time of grant, but shall not be less than 100% of the fair market of such share of common stock on the
−Removed: date the award is granted, subject to adjustment and conditions further described in the Plan.
−Removed: Our compensation committee shall also
−Removed: have sole authority to set the terms of all awards at the time of grant.
+Added: 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
+Added: on the date the award is granted, subject to adjustment and conditions further described in the Plan.
+Added: Our compensation committee shall
+Added: 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
7 unchanged sentences
Date of Grant
−Removed: Number of securities underlying unexercised options (#) exercisable
−Removed: Number of securities underlying unexercised options (#) unexerciseable
−Removed: Equity incentive plan awards:
+Added: Number of securities underlying unexercised
+Added: options (#) exercisable
+Added: Number of securities underlying unexercised
+Added: options (#) unexerciseable (1)
+Added: incentive plan awards:
Number of securities underlying unexercised unearned options (#)
2 unchanged sentences
March 17, 2023
−Removed: March 17, 2033
+Added: December 7, 2025
+Added: January 18, 2024
+Added: December 7, 2025
+Added: Vininder Singh
+Added: January 18, 2024
+Added: January 18, 2034
+Added: standard vesting schedule for all stock option grants is vesting over two years with one-third
+Added: vesting on the date of grant, one-third vesting on the first anniversary of the date of grant,
+Added: and one-third vesting on the second anniversary of the date of grant.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
2 unchanged sentences
of our directors;
−Removed: of our current directors and named executive officers as a group;
+Added: of our current directors and executive officers as a group;
stockholder known by us to own beneficially more than 5% of our common stock.
6 unchanged sentences
of March 4, 2025.
−Removed: as otherwise indicated, all shares are owned directly.
−Removed: Unless otherwise indicated, the address of each of the persons shown is c/o Bullfrog
−Removed: AI Holdings, Inc., 325 Ellington Blvd., Unit 317, Gaithersburg, MD 20878.
−Removed: Name of Beneficial Owner
−Removed: Common Stock Beneficially Owned
−Removed: Percentage of Common Stock
+Added: Except as otherwise
+Added: indicated, all shares are owned directly.
+Added: Unless otherwise indicated, the address of each of the persons shown is c/o Bullfrog AI Holdings,
+Added: Inc., 325 Ellington Blvd., Unit 317, Gaithersburg, MD 20878.
+Added: Name of Beneficial
+Added: Stock Beneficially Owned
+Added: of Common Stock
Directors and Officers:
2 unchanged sentences
Chief Financial Officer (2)
−Removed: Don Elsey (3)
+Added: Chief Financial Officer
+Added: Donald Elsey (3)
William Enright (3)
−Removed: Jason Hanson (3)
All officers and directors as a group (6 persons)
1 unchanged sentence
Tivoli Trust (4)
−Removed: of 2,592,446 shares of Common Stock and 26,333 Stock Options exercisable within 60 days.
−Removed: of 47,142 shares of Common Stock and 65,676 Stock Options exercisable within 60 days.
−Removed: of 23,332 Stock Options exercisable within 60 days.
−Removed: of 73,449 shares of non-voting Series A Preferred Stock, 115,185 warrants exercisable at $2.50 per shares and 54,714 shares of Common
−Removed: Assumes the conversion of all Series A Preferred Stock into common stock in an amount equal to ten shares of common stock
−Removed: for each one share of Series A Preferred Stock.
+Added: Empery Asset Management, LP (5)
+Added: (1) Comprised
+Added: of 2,392,446 shares of Common Stock, 77,930 Stock Options currently exercisable, and 0 Stock
+Added: Options exercisable within 60 days.
+Added: (2) Comprised
+Added: of 47,142 shares of Common Stock, 109,500 Stock Options currently exercisable, and 0 Stock
+Added: Options exercisable within 60 days.
+Added: (3) Comprised
+Added: of 34,442 Stock Options currently exercisable and 2,222 Stock Options exercisable within
+Added: (4) Comprised
+Added: of 73,449 shares of non-voting Series A Preferred Stock, 115,185 warrants exercisable at
+Added: $2.50 per share and 54,714 shares of Common Stock.
+Added: Assumes the conversion of all Series A
+Added: Preferred Stock into common stock in an amount equal to ten shares of common stock for each
+Added: one share of Series A Preferred Stock.
+Added: on information provided in a Schedule 13G filed on January 14, 2025 by Empery Asset Management,
+Added: LP (“Empery”), Ryan M.
+Added: Lane, and Martin D.
+Added: Hoe, Empery and Messrs.
+Added: have shared voting and dispositive power over 929,857 shares of common stock of the Company.
+Added: Lane and Hoe each disclaim beneficial ownership of the shares reported herein except
+Added: to the extent of their pecuniary interests therein.
Authorized for Issuance under Equity Compensation Plans
4 unchanged sentences
However, awards outstanding under our previous incentive plan will continue to be governed by their existing terms.
−Removed: The number of shares of our common stock available for issuance under our 2022 Plan is 900,000 shares.
−Removed: Notwithstanding the
−Removed: number of shares available for issuance, on the first day of each month commencing January 1, 2023, or the first business day of the
+Added: The number of shares of our common stock originally available for issuance under our 2022 Plan was 900,000 shares.
+Added: Notwithstanding
+Added: 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
−Removed: 2022 Plan will automatically increase in an amount equal to 15% of the total number of shares of common stock outstanding as of December
+Added: 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.
+Added: Accordingly, as of January 1, 2025, there were 603,456 shares available for issuance under
+Added: the 2022 Plan.
Plan Category
−Removed: Number of securities to be issued upon exercise of outstanding options, warrants and rights
−Removed: Weighted-average exercise price of outstanding options, warrants and rights
−Removed: Number of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a)
+Added: of securities to be issued upon exercise of outstanding options, warrants and rights
+Added: Weighted-average
+Added: exercise price of outstanding options, warrants and rights
+Added: Number of securities remaining available
+Added: for future issuance under equity compensation plans (excluding securities reflected in column (a))
Equity compensation plans approved by security holders
1 unchanged sentence
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
−Removed: than as set forth below and compensation arrangements, including employment, and indemnification arrangements, discussed, there have
−Removed: been no transactions since January 1, 2021, in which the amount involved in the transaction exceeded or will exceed the lesser of $120,000
−Removed: 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
−Removed: directors, executive officers or beneficial holders of more than 5% of our capital stock, or any immediate family member of, or person
−Removed: sharing the household with, any of these individuals, had or will have a direct or indirect material interest.
−Removed: July 8, 2021, the Company entered into a Simple Agreement for Future Equity (SAFE), with a related party, Tivoli Trust, our second largest
−Removed: shareholder (the “Investor”), with an amount of $150,000, with 0% interest.
−Removed: Under the SAFE agreement, if there is an Equity
−Removed: Financing before the termination of this SAFE, on the initial closing of such Equity Financing, this SAFE will automatically convert
−Removed: into the number of shares of SAFE Preferred Stock equal to the Purchase Amount divided by the Conversion Price, which means either:
−Removed: the Safe Price (the price per share equal to the Post-Money Valuation Cap divided by the Company Capitalization) or (2) the Discount
−Removed: Price (the price per share of the Standard Preferred Stock sold in the Equity Financing multiplied by the Discount Rate), whichever calculation
−Removed: results in a greater number of shares of Safe Preferred Stock.
−Removed: there is a Liquidity Event before the termination of this SAFE, this SAFE will automatically be entitled (subject to the liquidation
−Removed: priority set forth in Section 1(d) below) to receive a portion of Proceeds, due and payable to the Investor immediately prior to, or
−Removed: concurrent with, the consummation of such Liquidity Event, equal to the greater of (i) the Purchase Amount (the “Cash-Out Amount”)
−Removed: or (ii) the amount payable on the number of shares of Common Stock equal to the Purchase Amount divided by the Liquidity Price (the “Conversion
−Removed: If any of the Company’s securityholders are given a choice as to the form and amount of Proceeds to be received
−Removed: in a Liquidity Event, the Investor will be given the same choice, provided that the Investor may not choose to receive a form of consideration
−Removed: that the Investor would be ineligible to receive as a result of the Investor’s failure to satisfy any requirement or limitation
−Removed: generally applicable to the Company’s securityholders, or under any applicable laws.
−Removed: SAFE will automatically terminate (without relieving the Company of any obligations arising from a prior breach of or non-compliance
−Removed: with this SAFE) immediately following the earliest to occur of:
−Removed: (i) the issuance of Capital Stock to the Investor pursuant to the automatic
−Removed: conversion of this SAFE under agreement;
−Removed: or (ii) the payment, or setting aside for payment, of amounts due the Investor pursuant to the
−Removed: of December 31, 2021, the $150,000 received from SAFE was recorded at 6% imputed interest.
−Removed: The maturity date of the loan is defined by
−Removed: the SAFE agreement as discussed above.
−Removed: The SAFE was converted into 32,967 shares of common stock (post reverse stock split) upon the
−Removed: Company’s IPO in February 2023.
−Removed: August 19, 2021, the company entered into a convertible loan agreement with a related party, with a principal balance of $99,900 at 9%
−Removed: The noteholder has the right to convert the principal and interest into common shares of the Company.
−Removed: This loan included an
−Removed: original issuance discount of 5% and included 99,900 Warrants at an exercise price of $1, exercisable for 5 years from the issue date
−Removed: on the face of the Warrant.
−Removed: The maturity date of the loan was February 19, 2022.
−Removed: In May 2022, the Company and the note holder agreed
−Removed: to cancel and void previous warrants and entered into a new agreement for 115,185 warrants with an exercise price of $2.50.
−Removed: As of December
−Removed: 31, 2022, the $99,900 principal and the $4,950 overpayment of the note remained outstanding and had accrued interest of $12,463.
−Removed: warrants discussed above were initially discounted against the notes, subsequent to year end December 31, 2021, they were deemed voided
−Removed: and new warrants in accordance with the new terms were issued.
−Removed: We assessed the differences in fair value and determined that they were
−Removed: de minimis and expensed the full value of the new warrants.
−Removed: The noteholder elected to convert the loan into 21,747 shares of common stock
−Removed: (post reverse stock split) upon the Company’s IPO in February 2023.
−Removed: June 15, 2021, the company entered into a unsecured short term loan agreement with the Investor for an aggregate principal balance of
−Removed: $34,000, with a one-year maturity date, accruing interest at 5% and imputing an additional 1% interest.
−Removed: November 19, 2021, 2021, the company entered into an unsecured short term loan agreement with the Investor for an aggregate principal
−Removed: balance of $5,000, with a one-year maturity date, accruing interest at 5% and imputing an additional 1% interest.
−Removed: December 13, 2021, the company entered into an unsecured short term loan agreement with the Investor for an aggregate principal balance
−Removed: of $10,000, with a one-year maturity date, accruing interest at 5% and imputing an additional 1% interest.
−Removed: October 5, 2022, the Company entered into an exchange agreement with the Investor whereby all of his common stock, 734,493 shares of
−Removed: common stock (post reverse split shares), were exchanged into 73,449 shares of Series A Convertible Preferred Stock that converts to
−Removed: common at a rate of 10 common for one preferred.
−Removed: The Series A Preferred Stock is the economic equivalent of the common stock but has
−Removed: no voting rights and is subject to a blocker which prohibits the conversion into common stock if it would result in the Investor owning
−Removed: more than 4.99% of the Company’s outstanding common stock at such time.
−Removed: For a description of the rights and preferences of the
−Removed: Series A Preferred Stock, see “Description of Securities- Series A Convertible Preferred Stock”.
−Removed: Elsey, Enright and Hanson, three members of our Board of Directors, are independent using the definition of independence under Nasdaq
−Removed: Listing Rule 5605(a)(2) and the standards established by the SEC.
+Added: than with respect to compensation arrangements, including employment, and indemnification arrangements, discussed in this Annual Report
+Added: on Form 10-K, there have been no transactions since January 1, 2023, in which the amount involved in the transaction exceeded or will
+Added: 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
+Added: years, and to which any of our directors, executive officers or beneficial holders of more than 5% of our capital stock, or any immediate
+Added: family member of, or person sharing the household with, any of these individuals, had or will have a direct or indirect material interest.
+Added: July 2021, the Company entered into a Simple Agreement for Future Equity (SAFE) with a related party, Tivoli Trust (the “Investor”),
+Added: for an amount of $150,000, with 0% interest.
+Added: Under the SAFE agreement, if there is an Equity Financing before the termination of this
+Added: SAFE, on the initial closing of such Equity Financing, this SAFE will terminate and automatically convert into shares of common stock.
+Added: Upon the closing of the Company’s IPO in February 2023, the SAFE terminated and converted into 32,967 shares of common stock according
+Added: to its terms.
+Added: The conversion was considered a redemption for accounting purposes and consequently, the Company recognized a $63,626 loss
+Added: on the conversion.
+Added: August 2021, the Company entered into a convertible loan agreement with a related party in the amount of $99,900 at 9% interest.
+Added: 2023, the related party elected to convert the convertible loan into 21,747 shares of common stock according to its terms upon the closing
+Added: of the Company’s IPO.
+Added: The conversion was considered a redemption for accounting purposes and consequently, the Company recognized
+Added: a $29,333 loss on the conversion.
+Added: October 2022, the Company entered into an exchange agreement with the Investor whereby all of his common stock, 734,493 shares of common
+Added: 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
+Added: The Series A Preferred Stock is the economic equivalent of the common stock but has no voting rights and is subject to a blocker
+Added: which prohibits the conversion into common stock if it would result in the Investor owning more than 4.99% of the Company’s outstanding
+Added: common stock at such time.
and Procedures for Related Party Transactions
24 unchanged sentences
risks, costs and benefits to us;
−Removed: impact on a director’s independence in the event that the related person is a director, immediate family member of a director
−Removed: or an entity with which a director is affiliated;
+Added: impact on a director’s independence in the event that the related person is a director,
+Added: immediate family member of a director or an entity with which a director is affiliated;
availability of other sources for comparable services or products;
−Removed: terms available to or from, as the case may be, unrelated third parties or to or from employees generally.
+Added: terms available to or from, as the case may be, unrelated third parties or to or from employees
policy requires that, in determining whether to approve, ratify or reject a related person transaction, our audit committee, or other
15 unchanged sentences
Audit-related fees (2)
−Removed: All other fees (4)
−Removed: fees consist of fees for professional services rendered in connection with the annual audit of our consolidated financial statements,
−Removed: the review of our quarterly condensed consolidated financial statements and consultations on accounting matters directly related
−Removed: to the audit.
−Removed: Audit-related
−Removed: fees consist of fees for professional services rendered in connection with the submission of our Registration Statement on Form S-1
−Removed: in connection with our initial public offering.
−Removed: fees consist of fees for professional services for tax compliance, tax advice and tax planning.
−Removed: other fees consist of fees related to engagement administration.
+Added: Audit fees consist of fees
+Added: for professional services rendered in connection with the annual audit of our consolidated financial statements, the review of our
+Added: quarterly condensed consolidated financial statements and consultations on accounting matters directly related to the audit.
+Added: Audit-related fees consist
+Added: of fees for professional services rendered in connection with submissions of Registration Statements on Form S-1 or Form S-3 for
+Added: our initial public offering and subsequent financings.
+Added: Tax fees consist of fees
+Added: for professional services for tax compliance, tax advice and tax planning.
+Added: All other fees consist
+Added: of fees related to engagement administration.
Exhibits, Financial Statement Schedules
+Added: Financial Statements
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.
−Removed: Underwriting Agreement between the Company and WallachBeth Capital LLC dated February 14, 2023, incorporated by reference to Exhibit 1.1 of the Current Report on Form 8-K filed with the Securities and Exchange Commission on February 21, 2023.
−Removed: Amended and Restated Articles of Incorporation of Bullfrog AI Holdings, Inc.
−Removed: incorporated by reference to Exhibit 3.1 to the Company’s Amendment to the Registration Statement on Form S-1 (No.
+Added: 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.
+Added: and Restated Articles of Incorporation of Bullfrog AI Holdings, Inc.
+Added: incorporated by reference to Exhibit 3.1 to the Company’s
+Added: Amendment to the Registration Statement on Form S-1 (No.
333-267951) filed with the Securities and Exchange Commission on February
−Removed: Bylaws of Bullfrog AI Holdings, Inc.
−Removed: incorporated by reference to Exhibit 3.2 to the Company’s Amendment to the Registration Statement on Form S-1 (No.
+Added: of Bullfrog AI Holdings, Inc.
+Added: incorporated by reference to Exhibit 3.2 to the Company’s Amendment to the Registration Statement
+Added: on Form S-1 (No.
333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
+Added: Form of Bullfrog AI Holdings, Inc.
+Added: 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.
+Added: 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.
+Added: 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
+Added: 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.
+Added: 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.
+Added: 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
+Added: 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.
+Added: 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Description of Securities.
Acquisition Agreement with Bullfrog AI, Inc.
8 unchanged sentences
333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
−Removed: 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.
−Removed: 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
−Removed: 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.
−Removed: 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
−Removed: 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.
−Removed: 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
−Removed: 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.
−Removed: 333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
−Removed: 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.
+Added: License Agreement between the Company and George Washington University, dated January 14, 2022 incorporated by reference to Exhibit
+Added: 10.6 to the Company’s Amendment to the Registration Statement on Form S-1 (No.
+Added: 333-267951) filed with the Securities and Exchange
+Added: Commission on February 13, 2023.
+Added: License Agreement between the Company and Johns Hopkins University, dated February 22, 2022 incorporated by reference to Exhibit
+Added: 10.7 to the Company’s Amendment to the Registration Statement on Form S-1 (No.
+Added: 333-267951) filed with the Securities and Exchange
+Added: Commission on February 13, 2023.
+Added: Agreement between the Company and Johns Hopkins Applied Physics Laboratory LLC, dated July 8, 2022 incorporated by reference to Exhibit
+Added: 10.8 to the Company’s Amendment to the Registration Statement on Form S-1 (No.
+Added: 333-267951) filed with the Securities and Exchange
+Added: Commission on February 13, 2023.
+Added: Agreement between the Company and Johns Hopkins Applied Physics Laboratory LLC, dated February 7, 2018 incorporated by reference
+Added: to Exhibit 10.5 to the Company’s Amendment to the Registration Statement on Form S-1 (No.
+Added: 333-267951) filed with the Securities
+Added: and Exchange Commission on February 13, 2023.
+Added: Agreement between the Company and Johns Hopkins University (JHU) and the Institute of Organic Chemistry and Biochemistry (IOCB) of
+Added: the Czech Academy of Sciences, dated October 13, 2022 incorporated by reference to Exhibit 10.9 to the Company’s Amendment
+Added: to the Registration Statement on Form S-1 (No.
333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
−Removed: 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.
+Added: Amendment No.
+Added: 1 to License Agreement between Bullfrog AI, Inc.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: Equity Compensation Plan, incorporated by reference to Exhibit 10.10 to the Company’s Annual Report on Form 10-K filed with
+Added: the Securities and Exchange Commission on April 25, 2023.
+Added: Form of Indemnification Agreement between Bullfrog AI Holdings, Inc.
+Added: and each of its directors and officers
+Added: Form of Stock Option Grant Agreement
+Added: 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.
+Added: 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.
+Added: 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.
Code of Ethics
Insider Trading Policy
−Removed: 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.
+Added: of significant subsidiaries of Bullfrog AI Holdings, Inc., incorporated by reference to Exhibit 21.1 to the Company’s Amendment
+Added: to the Registration Statement on Form S-1 (No.
333-267951) filed with the Securities and Exchange Commission on February 13, 2023.
5 unchanged sentences
Clawback Policy
−Removed: XBRL Instance Document
−Removed: XBRL Taxonomy Extension Schema Document
−Removed: XBRL Taxonomy Extension Calculation Document
−Removed: XBRL Taxonomy Extension Definition Linkbase Document
−Removed: XBRL Taxonomy Extension Label Linkbase Document
−Removed: XBRL Taxonomy Extension Presentation Linkbase Document
−Removed: Page Interactive Data File (embedded within the Inline XBRL document)
+Added: Inline XBRL Instance Document
+Added: Inline XBRL Taxonomy Extension Schema With Embedded
+Added: Linkbase Documents
+Added: Cover Page Interactive Data File (embedded within the
+Added: Inline XBRL document)
+Added: Filed herewith.
FORM 10-K SUMMARY
1 unchanged sentence
on its behalf by the undersigned, thereunto duly authorized.
−Removed: AI Holdings, Inc.
+Added: March 14, 2025
+Added: Bullfrog AI Holdings, Inc.
Vininder Singh
−Removed: Executive Officer and Director (Principal Executive Officer)
−Removed: Financial Officer (Principal Financial and Accounting Officer)
+Added: Chief Executive Officer
+Added: and Director (Principal Executive Officer)
+Added: Chief Financial Officer
+Added: (Principal Financial and Accounting Officer)
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
2 unchanged sentences
Executive Officer and Chairman
−Removed: (Principal Executive Officer)
+Added: Executive Officer)
+Added: March 14, 2025
+Added: Vininder Singh
Financial Officer
−Removed: (Principal Financial and Accounting Officer)
+Added: Financial and Accounting Officer)
+Added: March 14, 2025
+Added: March 14, 2025
William Enright
+Added: March 14, 2025
+Added: William Enright
+Added: March 14, 2025
AI HOLDINGS, INC.
TO CONSOLIDATED FINANCIAL STATEMENTS
−Removed: of Independent Registered Public Accounting Firm PCAOB ID:
+Added: Report of Independent Registered Public Accounting Firm PCAOB ID:
Consolidated Balance Sheets as of December 31, 2024 and 202 3
4 unchanged sentences
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: the Board of Directors and
−Removed: of Bullfrog AI Holdings, Inc.
−Removed: on the Financial Statements
+Added: the Board of Directors and Stockholders of Bullfrog AI Holdings, Inc.
+Added: on the Consolidated Financial Statements
have audited the accompanying consolidated balance sheets of Bullfrog AI Holdings, Inc.
−Removed: (the Company) as of December 31, 2023 and 2022,
−Removed: and the related consolidated statements of operations, changes in stockholders’ deficit, and cash flows for the years ended December
−Removed: 31, 2023 and 2022, and the related notes (collectively referred to as the financial statements).
−Removed: In our opinion, the financial statements
−Removed: present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022 and the results of its
−Removed: operations and its cash flows for flows for the two-year period ended December 31, 2023, in conformity with accounting principles generally
−Removed: accepted in the United States of America.
+Added: (the “Company”) as of December 31,
+Added: 2024 and 2023, and the related consolidated statements of operations, changes in stockholders’ equity (deficit), and cash flows
+Added: for the years ended December 31, 2024 and 2023, and the related notes (collectively referred to as the consolidated financial statements).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company
+Added: 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,
+Added: in conformity with accounting principles generally accepted in the United States of America.
+Added: accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern.
+Added: in Note 1 to the financial statements, the company has incurred recurring losses from operations and had not yet achieved profitable
+Added: operations as of December 31, 2024 which raises substantial doubt about its ability to continue as a going concern.
+Added: plans regarding these matters are also described in Note 1.
+Added: The financial statements do not include any adjustments that might result
+Added: from the outcome of this uncertainty.
consolidated financial statements are the responsibility of the Company’s management.
Our responsibility is to express an opinion
−Removed: on the Company’s financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting
−Removed: Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
−Removed: securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: on the Company’s consolidated financial statements based on our audits.
+Added: We are a public accounting firm registered with the Public
+Added: Company Accounting Oversight Board (United States) (the “PCAOB”) and are required to be independent with respect to the Company
+Added: in accordance with the U.S.
+Added: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
+Added: and the PCAOB.
conducted our audit in accordance with the standards of the PCAOB.
8 unchanged sentences
Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts and disclosures in the financial statements.
−Removed: Our audits also included evaluating the accounting principles used
−Removed: and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: that our audits provide a reasonable basis for our opinion.
+Added: regarding the amounts and disclosures in the consolidated financial statements.
+Added: Our audits also included evaluating the accounting principles
+Added: used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audits provide a reasonable basis for our opinion.
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
1 unchanged sentence
(1) relate to accounts or disclosures that are material
−Removed: to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of a critical
−Removed: 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
−Removed: the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which
−Removed: discussed in Note 2, the Company had a going concern disclosure in the previous year due to continued net losses from operations and
−Removed: negative cash flows in operations.
−Removed: Auditing management’s evaluation of a going concern can be a significant judgment given the
−Removed: fact that the Company uses management estimates on future revenues and expenses, which are difficult to substantiate.
−Removed: evaluated the appropriateness of the removal of the going concern, we examined and evaluated the financial information along with management’s
−Removed: plans to mitigate the going concern and management’s disclosure on going concern.
−Removed: M&K CPAS, PLLC
−Removed: have served as the Company’s auditor since 2021.
+Added: to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication
+Added: 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
+Added: not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or
+Added: disclosures to which they relate.
+Added: prior years, the Company reported continued net losses from operations and negative cash flows from operations.
+Added: As of December 31, 2024,
+Added: management determined their cash and cash equivalents balance may not sufficiently cover operating expenditures for the next twelve-month
+Added: period without raising additional funds.
+Added: Auditing management’s evaluation of a going concern can be a significant judgment given
+Added: the fact that the Company uses management estimates on future expenditures, which are difficult to substantiate.
+Added: evaluated the appropriateness of management’s evaluation of the company’s going concern, we examined and evaluated the financial
+Added: information along with management’s plans to mitigate the going concern consideration and management’s disclosure on going
+Added: /s/ M&K CPAS, PLLC
+Added: We have served as the Company’s auditor since 2021.
+Added: The Woodlands, Texas
+Added: March 14, 2025
AI HOLDINGS, INC.
9 unchanged sentences
Accrued expenses
−Removed: Deferred revenue
−Removed: Convertible notes
−Removed: Convertible notes - related party
−Removed: Convertible notes
Total current liabilities
−Removed: Stockholders’ equity (deficit):
+Added: Total liabilities
+Added: Stockholders’ equity:
Series A Convertible Preferred stock, $ 0.00001 par value, 5,500,000 shares authorized;
1 unchanged sentence
Common stock, $ 0.00001 par value, 100,000,000 shares authorized;
−Removed: 6,094,644 and 4,021,935 shares issued and outstanding as of December 31, 2023 and 2022, respectively.
+Added: 9,113,139 and
+Added: 6,094,644 shares issued and outstanding as of December 31, 2024 and 2023, respectively.
Additional paid-in capital
2 unchanged sentences
( 9,754,924 )
−Removed: Total stockholders’ equity (deficit)
−Removed: ( 3,057,352 )
−Removed: Total liabilities and stockholders’ equity (deficit)
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
accompanying notes are an integral part of these consolidated financial statements.
1 unchanged sentence
STATEMENTS OF OPERATIONS
−Removed: Ended December 31,
−Removed: of goods sold:
−Removed: of goods sold
+Added: Year Ended December 31,
+Added: Total revenue
Cost of goods sold:
−Removed: and development
−Removed: and administrative
+Added: Cost of goods sold
+Added: Total cost of goods sold
Operating expenses:
−Removed: from operations
+Added: Research and development
+Added: General and administrative
+Added: Total operating expenses
+Added: Loss from operations
( 7,236,383 )
( 5,367,524 )
−Removed: income (expense), net
−Removed: on conversion of notes
−Removed: Interest income
Other income (expense), net
+Added: Interest expense
+Added: Loss on conversion of notes
+Added: Interest income
+Added: Total other income (expense), net
( 6,993,647 )
( 5,355,869 )
−Removed: loss per common share attributable to common stockholders - basic and diluted
−Removed: average number of shares outstanding - basic and diluted
+Added: Deemed dividend related to warrant exercise price adjustment
+Added: Net loss attributable to common stockholders
+Added: $ ( 7,038,632 )
+Added: $ ( 5,355,869 )
+Added: Net loss per common share attributable to common stockholders - basic and diluted
+Added: Weighted average number of shares outstanding - basic and diluted
accompanying notes are an integral part of these consolidated financial statements.
1 unchanged sentence
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
−Removed: THE YEARS ENDED DECEMBER 31, 2023 AND 2022
−Removed: Preferred Stock
+Added: Series A Preferred Stock
Additional Paid-in
Total Stockholders’
+Added: Equity (Deficit)
Balance at December 31, 2022
1 unchanged sentence
$ ( 3,057,352 )
−Removed: Imputed interest
Stock-based compensation
−Removed: Reclassification of warrant
−Removed: Conversion of convertible notes
−Removed: Shares cancellation
−Removed: Shares issuance for license
−Removed: Common stock converted to Series A Preferred Stock
+Added: Issuance of common stock (initial public offering), net of issuance costs
+Added: Issuance of common stock for services
+Added: Conversion of convertible debt to common stock
+Added: Issuance of common stock pursuant to warrant exercises
( 5,355,869 )
3 unchanged sentences
( 9,754,924 )
−Removed: ( 4,399,055 )
−Removed: ( 3,057,352 )
Stock-based compensation
−Removed: Issuance of common stock (initial public offering), net of issuance costs
−Removed: Issuance of common stock for services
−Removed: Conversion of convertible debt to common stock
+Added: Issuance of common stock and warrants, net of issuance costs
Issuance of common stock pursuant to warrant exercises
+Added: Deemed dividend related to warrant price adjustment
( 6,993,647 )
12 unchanged sentences
Stock-based compensation
−Removed: Shares issued for license
Shares issued for services
1 unchanged sentence
Amortization of debt discount
−Removed: Imputed interest
Changes in operating assets and liabilities:
2 unchanged sentences
Accrued expenses
−Removed: Accrued expenses - related party
Deferred revenue
1 unchanged sentence
( 5,610,249 )
+Added: ( 6,001,299 )
Cash flows from investing activities:
2 unchanged sentences
Cash flows from financing activities:
−Removed: Proceeds from issuance of common stock (initial public offering), net of issuance costs
+Added: Proceeds from issuance of common stock and warrants, net of issuance costs
Proceeds from exercise of warrants
−Removed: Proceeds from convertible notes payable
Proceeds from notes payable
Payments of notes payable
−Removed: Repayment of note payable and interest - related party
Proceeds from short term insurance financing
8 unchanged sentences
Supplemental non-cash activity
−Removed: Reclassification of warrant
Issuance of common stock upon conversion of notes payable
−Removed: Conversion of convertible note payable
−Removed: Cancellation of common stock
accompanying notes are an integral part of these consolidated financial statements.
AI HOLDINGS, INC.
−Removed: TO FINANCIAL STATEMENTS
+Added: TO CONSOLIDATED FINANCIAL STATEMENTS
31, 2024 and 2023
6 unchanged sentences
in Delaware and Maryland, in 2017 and 2021, respectively.
−Removed: All of our operations are currently conducted through BullFrog AI Holdings,
−Removed: Inc., which began operations on February 6, 2020.
−Removed: We are a company focused specifically on advanced AI/ML-driven analysis of complex
−Removed: data sets in medicine and healthcare.
−Removed: Our objective is to utilize our platform for precision medicine approach to drug asset enablement
−Removed: through external partnerships and selective internal development.
+Added: All the Company’s operations are currently conducted through Bullfrog
+Added: AI Holdings, Inc., which began operations on February 6, 2020.
+Added: The Company is focused specifically on advanced AI/ML-driven analysis
+Added: of complex data sets in medicine and healthcare.
+Added: The Company’s objective is to utilize its AI/ML platform to provide a precision
+Added: medicine approach to drug asset enablement through external partnerships and selective internal development.
new therapeutics will fail at some point in preclinical or clinical development.
−Removed: This is the primary driver of the high cost of developing
−Removed: new therapeutics.
−Removed: A major part of the difficulty in developing new therapeutics is efficient integration of complex and highly dimensional
−Removed: data generated at each stage of development to de-risk subsequent stages of the development process.
−Removed: Artificial Intelligence and Machine
−Removed: Learning (AI/ML) has emerged as a digital solution to help address this problem.
−Removed: use artificial intelligence and machine learning to advance medicines for both internal and external projects.
−Removed: Most current AI/ML platforms
−Removed: still fall short in their ability to synthesize disparate, high-dimensional data for actionable insight.
−Removed: Our platform technology, named,
−Removed: bfLEAP™ is an analytical AI/ML platform developed at The Johns Hopkins University Applied Physics Laboratory (JHU-APL) which is
−Removed: able to surmount the challenges of scalability and flexibility currently hindering researchers and clinicians by providing a more precise,
−Removed: multi-dimensional understanding of their data.
−Removed: We are deploying bfLEAP™ for use at several critical stages of development for internal
−Removed: programs and through strategic partnerships and collaborations with the intention of streamlining data analytics in therapeutics development,
−Removed: decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients
−Removed: that may otherwise not receive the therapies they need.
−Removed: bfLEAP™ platform utilizes both supervised and unsupervised machine learning – as such, it is able to reveal real/meaningful
+Added: These failures are the primary drivers for the high
+Added: cost of developing new therapeutics.
+Added: A major part of the difficulty in developing new therapeutics is efficient integration of complex
+Added: and highly dimensional data generated at each stage of development to de-risk subsequent stages of the development process.
+Added: intelligence and machine learning (“AI/ML”) has emerged as a digital solution to help address this problem.
+Added: Company uses artificial intelligence and machine learning to advance medicines for both internal and external projects.
+Added: AI/ML platforms still fall short in their ability to synthesize disparate, high-dimensional data for actionable insight.
+Added: The Company’s
+Added: analytical platform is composed of an ensemble of state-of-the-art machine learning and artificial intelligence models.
+Added: The Company’s
+Added: core platform technology, named bfLEAP™, is an analytical AI/ML platform developed at The Johns Hopkins University Applied Physics
+Added: Laboratory (JHU-APL) which we believe is able to surmount the challenges of scalability and flexibility currently hindering researchers
+Added: and clinicians by providing a more precise, multi-dimensional understanding of their data.
+Added: The Company is deploying its analytical platform,
+Added: including bfLEAP™, for use in several critical stages of development of internal programs and through strategic partnerships and
+Added: collaborations with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs
+Added: by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may otherwise not receive the therapies
+Added: proprietary analytical platform utilizes both supervised and unsupervised machine learning.
+Added: As such, it is able to reveal real and meaningful
connections in the data without the need for a priori hypothesis.
−Removed: Algorithms used in the bfLEAP™ platform are designed to handle
−Removed: highly imbalanced data sets to successfully identify combinations of factors that are associated with outcomes of interest.
−Removed: primary goal is to improve the odds of success at any stage of pre-clinical and clinical therapeutics development, for in house programs,
−Removed: and our strategic partners and collaborators.
−Removed: Our primary business model is enabling the success of ongoing clinical trials or rescue
−Removed: of late stage failed drugs (i.e., Phase 2 or Phase 3 clinical trial failures) for development and divestiture;
−Removed: although, we will also
−Removed: consider collaborations for earlier stage drugs.
−Removed: We hope to accomplish this through strategic acquisitions of current clinical stage
−Removed: and failed drugs for in-house development, or through strategic partnerships with biopharmaceutical industry companies.
−Removed: We are able to
−Removed: pursue our drug asset enhancement business by leveraging a powerful and proven AI/ML platform (trade name:
−Removed: bfLEAP™) initially developed
−Removed: We believe the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical and/or clinical
−Removed: data sets, such as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical trial settings.
+Added: Algorithms used in the platform are designed to handle highly imbalanced
+Added: data sets and successfully identify combinations of factors that are associated with outcomes of interest.
+Added: The Company’s platform
+Added: leverages models that use both correlative and causative machine learning and artificial intelligence approaches which provide a comprehensive
+Added: approach to predictive analysis which is expected to lead to meaningful insights including the molecular drivers of disease.
+Added: regard, with the Company’s access to proprietary data sets such as its strategic data and commercialization agreements with the
+Added: Lieber Institute for Brain Development (“LIBD”), the Company has increased its internal efforts on target discovery.
+Added: Company’s goal is to improve the odds of success at all stages of pre-clinical and clinical therapeutics development for in-house
+Added: programs and for its strategic partners and collaborators.
+Added: The Company’s business model includes enabling the success of ongoing
+Added: clinical trials and rescuing late stage failed drugs (i.e., Phase II or Phase III clinical trial failures) by bringing them in-house
+Added: for development prior to eventual divestiture;
+Added: although, the Company also considers entering collaborations for earlier stage drugs.
+Added: The Company pursues its drug asset enhancement business by leveraging the powerful and proven bfLEAP™ AI/ML platform initially
+Added: developed at JHU-APL.
+Added: The Company believes the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical
+Added: and clinical data sets, such as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical
+Added: trial settings.
and Going Concern
Company has had negative cash flows from operations and operated at a net loss since inception.
−Removed: In the first quarter of 2023, we completed
−Removed: our initial public offering (“IPO”).
−Removed: In February 2024 the Company received net proceeds of approximately $ 4.9 million dollars
−Removed: from an underwritten public offering of 1,507,139 shares of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants
−Removed: to purchase 1,507,139 shares of common stock at an offering price of $ 3.782 .
−Removed: The 5 year warrants have an exercise price of $ 4.16 .
−Removed: February 21, 2024, the underwriters elected to take an overallotment of 218,382 common shares and the Company received net proceeds of
−Removed: approximately $ 750,000 .
−Removed: In the absence of significant revenues in 2024 the Company believes that its capital resources are sufficient
−Removed: to fund planned operations for more than 12 months from the date of this filing.
+Added: As of December 31, 2024, the Company
+Added: has a cash balance of approximately $ 5.4 million.
+Added: In February 2024 and October 2024, the Company received net proceeds of approximately
+Added: $ 5.7 million and $ 2.7 million, respectively, from the sale of its common stock and warrants.
+Added: As of December 31, 2024, the Company’s
+Added: cash and cash equivalents position is not sufficient to fund the Company’s planned operations for at least a year beyond the filing
+Added: date of the consolidated financial statements.
+Added: These factors raise substantial doubt about the Company’s ability to continue as
+Added: a going concern.
+Added: The ability to continue as a going concern is dependent upon the Company obtaining the necessary financing and/or revenues
+Added: to meet its obligations arising from normal business operations when they become due.
+Added: the Company will require additional capital to continue to execute its strategy.
+Added: The Company anticipates raising this additional
+Added: capital through various avenues including sales of equity securities, debt transactions, licensing agreements and collaborative arrangements.
+Added: Although management believes that such funding sources will be available, there can be no assurance that any such arrangements will be
+Added: consummated to provide sufficient capital when needed to allow the Company to continue its operations, or if available, on terms acceptable
+Added: If the Company does not raise sufficient funds in a timely manner, among other things, it may be forced to delay, scale back or
+Added: eliminate some or all of its research and product development programs and/or capital expenditures or to enter into arrangements on unfavorable
+Added: The Company currently does not have commitments for future funding from any source.
+Added: accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates
+Added: continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business.
+Added: Accordingly, these
+Added: consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Summary of Significant Accounting Policies
1 unchanged sentence
accompanying consolidated financial statements include the accounts of Bullfrog AI Holdings, Inc.
−Removed: and our wholly owned subsidiaries and
+Added: and its wholly owned subsidiaries and
have been prepared in conformity with United States generally accepted accounting principles (“GAAP”).
1 unchanged sentence
and transactions have been eliminated in consolidation.
−Removed: February 13, 2023, we completed a 1-for-7 reverse split of our common stock .
+Added: February 2023, the Company completed a 1-for-7 reverse split of its common stock .
Stockholders’ equity and all references to shares
1 unchanged sentence
all periods presented.
−Removed: preparation of consolidated financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the
−Removed: amounts reported in the consolidated financial statements and accompanying notes.
−Removed: These estimates include, but are not limited to, revenue
−Removed: recognition, allowances for doubtful accounts, recoverability of deferred tax assets and certain other of our accrued liabilities.
−Removed: results could differ from these estimates.
+Added: preparation of consolidated financial statements in conformity with GAAP requires the Company to make estimates and assumptions that
+Added: affect the amounts reported in the consolidated financial statements and accompanying notes.
+Added: These estimates include, but are not limited
+Added: to, revenue recognition, stock-based compensation, allowances for doubtful accounts, recoverability of deferred tax assets and certain
+Added: other accrued liabilities.
+Added: Actual results could differ from these estimates.
+Added: Company’s chief operating decision maker (“CODM”) is the Company’s Chief Executive Officer.
+Added: The CODM is assisted
+Added: in his responsibilities of making decisions regarding resource allocation and performance assessment by the leadership team, consisting
+Added: of executives and vice presidents.
+Added: Company views its operations and manages its business as one operating segment, focused on advancing drug development using AI/ML to
+Added: analyze complex data sets in medicine and healthcare.
+Added: Segment profit or loss is measured as the Company’s net loss as reported
+Added: on the Company’s Statement of Operations.
+Added: The Company monitors its cash and cash equivalents, as reported on the Company’s
+Added: Balance Sheets, to determine funding for its research and development.
+Added: the Company did not generate revenues in 2024, the CODM assessed Company performance through the achievement of target identification
+Added: In addition to the Company’s Statement of Operations, the CODM is regularly provided with budgeted and forecasted expense
+Added: information which is used to determine the Company’s liquidity needs and cash allocation.
Company recognizes revenue based on the following five step model:
16 unchanged sentences
This step specifies how that should happen.
−Removed: Company anticipates that the majority of revenues to be recognized in the near future will result from our fee for service partnership
−Removed: offering, designed for biopharmaceutical companies, as well as other organizations, of all sizes that have challenges analyzing data
−Removed: throughout the drug development process.
−Removed: The Company provides the customer with an analysis of large complex data sets using the Company’s
−Removed: proprietary Artificial Intelligence / Machine Learning platform called bfLEAP™.
−Removed: This platform is designed to predict targets of
−Removed: interest, patterns, relationships, and anomalies.
+Added: Contract Services
+Added: Company anticipates that the majority of its revenues to be recognized in the near future will result from discovery and monetization
+Added: of new drug targets and intellectual property from data use partnerships focused on analysis of rich proprietary data sets.
+Added: market for monetization will primarily be mid-size to large biopharmaceutical organizations seeking to build their new drug target pipeline.
+Added: A secondary revenue channel is fee for service partnerships with biopharmaceutical companies and other organizations of all sizes that
+Added: have challenges analyzing data throughout the drug development process.
+Added: The Company provides the customer with an analysis of large complex
+Added: data sets using the Company’s proprietary AI/ML platform.
+Added: This platform is aimed at predicting targets of interest, patterns, relationships,
+Added: anomalies, and molecular drivers of disease.
The Company believes that there will be additional on-going work requested from partners;
−Removed: therefore the service model utilizes a master services agreement with work or task orders issued for discrete analysis performed at the
−Removed: discovery, preclinical, or clinical stages of drug development.
−Removed: The Company receives a cash fee and in some instances the potential for
−Removed: rights to new intellectual property generated from the analysis.
−Removed: Once data analysis and the analysis report are complete, the Company
−Removed: delivers the analysis set to the customer and recognizes revenue at that point in time.
+Added: therefore, the service model utilizes a master services agreement with work or task orders issued for discrete analysis performed at
+Added: the discovery, preclinical, or clinical stages of drug development.
+Added: The Company will receive fees in cash, equity or other consideration
+Added: and, in some instances, the potential for rights to new intellectual property generated from the analysis.
+Added: Once data analysis and the
+Added: analysis report are complete, the Company delivers the analysis set to the customer and recognizes revenue at that point in time.
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.
−Removed: 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
−Removed: or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
−Removed: Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs.
−Removed: Company utilizes a three-level valuation hierarchy for disclosures of fair value measurements, defined as follows:
+Added: Fair value is defined as the exchange price that would be
+Added: 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
+Added: in an orderly transaction between market participants on the measurement date.
+Added: Valuation techniques used to measure fair value maximize
+Added: the use of observable inputs and minimize the use of unobservable inputs.
+Added: The Company utilizes a three-level valuation hierarchy for
+Added: disclosures of fair value measurements, defined as follows:
1 - inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.
2 - inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are
−Removed: observable for the assets or liability, either directly or indirectly, for substantially the full term of the financial instruments.
+Added: observable for the assets or liabilities, either directly or indirectly, for substantially the full term of the financial instruments.
3 - inputs to the valuation methodology are unobservable and significant to the fair value.
−Removed: The Company does not have any assets or
−Removed: liabilities that are required to be measured and recorded at fair value on a recurring basis.
+Added: The Company does not have any assets or liabilities
+Added: that are required to be measured and recorded at fair value on a recurring basis.
+Added: and Cash Equivalents and Concentration of Credit Risk
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.
−Removed: As of December 31, 2023 and 2022, cash balances were $ 2,624,730 and $ 57,670 , respectively.
−Removed: Concentrations
−Removed: of Credit Risk
Company’s financial instruments that are exposed to a concentration of credit risk are cash and accounts receivable.
11 unchanged sentences
Company follows the policy of charging the costs of advertising to expense as incurred.
−Removed: income tax assets and liabilities are determined based on the estimated future tax effects of net operating loss and credit carry forwards
+Added: 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
8 unchanged sentences
expense over the requisite service period.
−Removed: Loss per Share
−Removed: calculate basic net loss per share by dividing the net loss by the weighted-average number of shares of common stock outstanding during
+Added: Forfeitures are recognized as they occur.
+Added: Company calculates basic net loss per common share by dividing the net loss available to common stockholders by the weighted-average
+Added: number of shares of common stock outstanding during the period.
earnings per share is computed by giving effect to all potentially dilutive common stock equivalents in the period, including unvested
stock options and warrants.
−Removed: As we have reported losses for all periods presented, all potentially dilutive securities have been excluded
−Removed: from the calculation of diluted net loss per share as their effect would be antidilutive.
−Removed: Accounting Pronouncements
+Added: As the Company has reported losses for all periods presented, all potentially dilutive securities have been
+Added: excluded from the calculation of diluted net loss per common share as their effect would be antidilutive.
+Added: Recent Accounting
+Added: Pronouncements
+Added: January 2024, the Company adopted Accounting Standards Update (ASU) 2023-07, Improvements to Reportable Segment Disclosures (Topic
+Added: The new standard improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant
+Added: segment expenses that are regularly provided to the chief operating decision maker.
+Added: ASU 2023-07 also clarifies that entities with a single
+Added: reportable segment are subject to both new and existing reporting requirements under Topic 280.
+Added: See the Segment Reporting section
+Added: within Note 2 .
December 2023, the FASB issued ASU No.
Income Taxes (Topic 740):
−Removed: Improvements to Income Tax Disclosures that requires entities
−Removed: to disclose additional information about federal, state, and foreign income taxes primarily related to the income tax rate reconciliation
−Removed: and income taxes paid.
−Removed: The new standard also eliminates certain existing disclosure requirements related to uncertain tax positions and
−Removed: unrecognized deferred tax liabilities.
−Removed: The guidance is effective for our fiscal year ending December 31, 2025.
−Removed: The guidance does not
−Removed: affect recognition or measurement in our consolidated financial statements.
+Added: Improvements to Income Tax Disclosures that
+Added: requires entities to disclose additional information about federal, state, and foreign income taxes primarily related to the income tax
+Added: rate reconciliation and income taxes paid.
+Added: The new standard also eliminates certain existing disclosure requirements related to uncertain
+Added: tax positions and unrecognized deferred tax liabilities.
+Added: The guidance is effective for the Company’s fiscal year ending December
+Added: The guidance does not affect recognition or measurement in the Company’s consolidated financial statements.
Company does not believe that any other recently issued effective pronouncements, or pronouncements issued but not yet effective, if
1 unchanged sentence
Property and Equipment
−Removed: and equipment consisted of $ 8,744 of equipment and has accumulated depreciation of $ 2,770 and $ 1,045 , as of December 31, 2023 and 2022,
−Removed: respectively.
+Added: 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
+Added: December 31, 2024 and 2023, respectively.
expense totaled $ 1,724 and $ 1,725 in the years ended December 31, 2024 and 2023, respectively.
+Added: Accrued Expenses
+Added: expenses consist of the following at December 31:
+Added: of Acrrued Expenses
+Added: Accured payroll and related
+Added: Accrued legal fees
+Added: Accrued licensing and royalty fees
+Added: Accrued Board fees
+Added: Accrued research and development project costs
+Added: Accrued other expenses
+Added: Total Accrued expenses
Convertible Notes
−Removed: March 27, 2020, the Company entered into a convertible loan agreement with the Maryland Technology Development Corporation with a principal
−Removed: balance of $ 200,000 at 6 % interest.
−Removed: The maturity date of the loan was September 27, 2021 .
−Removed: During the year ended December 31, 2022, the
−Removed: full amount of the loan and interest totaling $ 226,138 was converted into 205,984 shares of common stock of the Company, in accordance
−Removed: with the conversion notice submitted by the noteholder.
−Removed: Pursuant to the note agreement, the number of shares that the note converted
−Removed: into was based on the note balance plus accrued interest, divided by $ 5,000,000 , times the fully diluted equity of the company, excluding
−Removed: convertible securities issued for capital raising purposes.
−Removed: There was no gain or loss due to conversion being within the terms of the
−Removed: August 2021, the Company entered into a convertible loan agreement with an unrelated party for a commitment of up to $ 195,000 with a
−Removed: 5 % original issue discount and a 9 % interest rate.
−Removed: The loan provided for a maturity date of February 9, 2022 .
−Removed: We borrowed $ 72,000 and
−Removed: $ 123,000 of principal in the years ended December 31, 2021 and 2022, respectively.
−Removed: The noteholder had the right to convert the principal
−Removed: and interest into common shares of the Company at the IPO at a 20 % discount to the IPO price.
−Removed: of December 31, 2022, the loan was outstanding with a principal balance of $ 195,000 and accrued interest of $ 35,078 .
−Removed: The loan was paid
−Removed: in its entirety in February 2023.
−Removed: connection with the convertible loan agreement, the Company also issued 195,000 Warrants with an exercise price of $ 1.00 exercisable
−Removed: for five years from issuance.
−Removed: In May 2022, the Company and the note holder agreed to cancel and void the warrants and enter into a new
−Removed: agreement for 225,000 warrants with an exercise price of $ 2.50 .
−Removed: The Company assessed the differences in fair value and determined that
−Removed: they were de minimis and expensed the full value of the new warrants.
−Removed: December 20, 2021, the Company entered into a loan agreement with an unrelated party.
−Removed: The loan provided for a December 19, 2022 maturity,
−Removed: a 10 % original issue discount and a 6 % interest rate.
−Removed: The Company received $ 25,000 of proceeds from this note.
−Removed: note was automatically convertible into shares of common stock at a discount to the IPO price or based on the valuation of the Company,
−Removed: whichever was more favorable to the holder.
−Removed: the loan was estimated to be issued with 355,114 warrants.
−Removed: Subsequent to the closing of the loan agreement, the Company enhanced the
−Removed: terms of the Bridge Note Offering under which the loan was closed and in April 2022 closed on the sale of approximately $ 1 million in
−Removed: face value of convertible bridge notes.
−Removed: Pursuant to the enhanced terms, the warrants were issued concurrently with the conversion of
−Removed: with the closing of the Company’s IPO, the note converted according to its terms into 6,939 shares of common stock.
−Removed: loss was recognized on the conversion.
−Removed: April 11, 2022, the Company entered into an Exclusive placement agent and/or underwriter agreement with WallachBeth Capital LLC in connection
−Removed: with a proposed private and/or public offerings by the Company.
−Removed: On April 28, 2022, the Company received approximately $ 775,000 of proceeds,
−Removed: net of approximately $ 91,000 of fees and a 10 % original issue discount from the sale of Convertible Bridge Notes and Warrants to several
−Removed: institutional investors and several individual accredited investors.
−Removed: In addition, the Company also received $ 100,000 from the sale of
−Removed: a Convertible Bridge Note and Warrants to a related party earlier in April.
−Removed: In September 2022, the Company received an additional $ 25,000
−Removed: of proceeds, net of a 10 % original issue discount from the sale of an additional Convertible Bridge Note and Warrant to an unrelated
−Removed: Convertible Bridge Notes were initially convertible at the IPO at a 20 % discount to the IPO price.
−Removed: The Convertible Bridge Notes provided
−Removed: for an original maturity date of October 31, 2022 .
−Removed: connection with the Convertible Bridge Notes, the purchasers were also entitled to conditional warrants to be issued upon completion
−Removed: of the Company’s IPO.
−Removed: The agreement provided for the warrants to be exercisable for a period of five years from issuance at an
−Removed: exercise price equal to 110% of the IPO price or, if the Company failed to complete the IPO before October 22, 2022, 90% of the IPO price .
−Removed: the fourth quarter of 2022, the Company amended the Convertible Bridge Notes to (a) extend the maturity date until December 31, 2022,
−Removed: (b) provide that the conversion right would include interest through November 30, 2022, with interest accruing beyond that date being
−Removed: paid in cash and (c) revise the conversion price to be $ 4.27 based on a $25 million Company valuation .
−Removed: with the closing of the Company’s IPO in February 2023, all of the Convertible Bridge Notes converted according to their terms
−Removed: into 269,513 shares of common stock.
+Added: In August 2021,
+Added: 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
+Added: discount and a 9 % interest rate.
+Added: The loan was repaid in its entirety in February 2023.
+Added: December 2021
+Added: December 2021, the Company entered into a loan agreement with an unrelated party with a principal amount of $ 25,000 , a 10 % original issue
+Added: discount and a 6 % interest rate.
+Added: Concurrent with the closing of the Company’s initial public offering (“IPO”) in February
+Added: 2023, the note converted according to its terms into 6,939 shares of common stock.
No gain or loss was recognized on the conversion.
+Added: 2022, the Company received approximately $ 991,000 of gross proceeds from the issuance of Convertible Bridge Notes from several offerings.
+Added: Concurrent with the closing of the Company’s IPO in February 2023, all of the Convertible Bridge Notes converted according to their
+Added: terms into 269,513 shares of common stock.
+Added: No gain or loss was recognized on the conversions.
Convertible Notes – Related Party
−Removed: July 8, 2021, the Company entered into a Simple Agreement for Future Equity (SAFE), with a related party, at a purchase price of $ 150,000 .
−Removed: The SAFE provided for no interest and terminated after conversion upon completion of the Company’s IPO.
−Removed: The SAFE provided for automatic
−Removed: conversion into the number of shares of SAFE Preferred Stock equal to the Purchase Amount divided by the Conversion Price, defined as
−Removed: (1) the SAFE Price (the price per share equal to the Post-Money Valuation Cap divided by the Company Capitalization) or (2) the
−Removed: Discount Price (the price per share of the Standard Preferred Stock sold in the Equity Financing multiplied by the Discount Rate),whichever
−Removed: calculation results in a greater number of shares of SAFE Preferred Stock.
−Removed: February 2023, the SAFE terminated and converted into 32,967 shares of common stock according to its terms upon the Company’s closing
−Removed: The conversion was considered a redemption for accounting purposes and consequently, the Company recognized a $ 63,626 loss
−Removed: on the conversion.
−Removed: of December 31, 2022, the $ 150,000 received from the SAFE was recorded at 6 % imputed interest.
−Removed: August 19, 2021, the Company entered into a convertible loan agreement with a related party, with a principal balance of $ 99,900 , an
−Removed: original issuance discount of 5 % and a 9 % interest rate.
−Removed: The loan provided for a maturity date of February 19, 2022.
−Removed: The noteholder had
−Removed: the right to convert the principal and interest into common shares of the Company at a conversion price based on a discount to the IPO
−Removed: February 2023, the related party elected to convert the convertible loan into 21,747 shares of common stock according to its terms upon
−Removed: the Company’s closing of its IPO.
−Removed: The conversion was considered a redemption for accounting purposes and consequently, the Company
−Removed: recognized a $ 29,333 loss on the conversion.
−Removed: connection with the convertible loan agreement, the Company also issued 99,000 warrants with an exercise price of $ 1.00 exercisable for
−Removed: five years from issuance.
−Removed: In May 2022, the Company and the note holder agreed to cancel and void previous warrants and enter into a new
−Removed: agreement for 115,185 warrants with an exercise price of $ 2.50 .
−Removed: The Company assessed the differences in fair value and determined that
−Removed: they were de minimis and expensed the full value of the new warrants.
−Removed: Related Party
−Removed: the year ended December 31, 2023, the Company issued 75,000 stock options to its Chief Financial Officer for services rendered.
−Removed: the year ended December 31, 2021, the Company issued 29,286 common stock options to related parties for services rendered.
−Removed: have an original life of 10 years and vest over different periods for up to 24 months .
−Removed: During the years ended December 31, 2023 and 2022,
−Removed: the Company recognized $ 1,707 and $ 1,803 , respectively of stock-based compensation related to these options.
−Removed: At various times in 2021, the Company entered into unsecured short term loan agreements with a related party for
−Removed: an aggregate principal balance of $ 49,000 , each with a one-year maturity date, accruing interest at 5 % and imputing an additional 1 % interest.
−Removed: The full amount of the loans and interest was repaid in 2022.
+Added: SAFE Agreement
+Added: July 2021, the Company entered into a Simple Agreement for Future Equity (“SAFE”) with a related party at a purchase price
+Added: of $ 150,000 .
+Added: In February 2023, the SAFE terminated and converted into 32,967 shares of common stock according to its terms upon the closing
+Added: of the Company’s IPO.
+Added: The conversion was considered a redemption for accounting purposes and consequently, the Company recognized
+Added: a $ 63,626 loss on the conversion.
+Added: August 2021, the Company entered into a convertible loan agreement with a related party in the amount of $ 99,900 .
+Added: In February 2023, the
+Added: related party elected to convert the convertible loan into 21,747 shares of common stock according to its terms upon the closing of the
+Added: Company’s IPO.
+Added: The conversion was considered a redemption for accounting purposes and consequently, the Company recognized a $ 29,333
+Added: loss on the conversion.
Notes Payable
−Removed: January 2023 the Company entered into a short-term note payable with a principal balance of $ 100,000 , an original discount of 20 % and
−Removed: a 9 % interest rate.
−Removed: The note was paid in its entirety in February 2023.
+Added: January 2023, the Company entered into a short-term note payable with a principal balance of $ 100,000 , an original issue discount of
+Added: 20 % and a 9 % interest rate.
+Added: The note was repaid in its entirety in February 2023.
February 2023, the Company entered into an agreement to finance a portion of the premium for its Directors and Officers Insurance.
−Removed: agreement provides for financing of $ 697,534 of the premium, repayments in 10 equal monthly installments of $ 71,485 each through December
+Added: 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 % .
−Removed: The financing was repaid during 2023.
+Added: The note was repaid in its entirety in 2023.
+Added: February 2024, the Company again entered into an agreement to finance a portion of the premium for its Directors and Officers Insurance.
+Added: The agreement provided for financing of $ 561,885 of the premium, repayments in 10 equal monthly installments of $ 58,005 each through
+Added: December 2024 and accrued interest at 6.99 % .
+Added: The note was repaid in its entirety in 2024.
Stockholders’ Equity
1 unchanged sentence
Preferred Stock.
−Removed: On October 5, 2022, the Company entered into an exchange agreement with an Investor providing for the exchange of 734,492
−Removed: shares of commons stock into 73,449 shares of Series A Convertible Preferred Stock.
−Removed: Each share of Series A Convertible Preferred Stock
−Removed: is convertible at any time into 10 shares of the Company’s common stock.
−Removed: The Series A Preferred Stock is the economic equivalent
−Removed: 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
−Removed: result in the Investor owning more than 4.99 % of the Company’s outstanding common stock at such time.
−Removed: The Company evaluated the
−Removed: terms of the exchange and determined there was no significant change in fair value and therefore the Series A Preferred Stock was valued
−Removed: at $ 315,000 which is the Investor’s basis in the common stock that was exchanged.
+Added: Of the 5,500,000 authorized shares of Series A Convertible Preferred Stock, 73,449 were issued and outstanding as of
+Added: December 31, 2024.
+Added: Each share of Series A Convertible Preferred Stock is convertible at any time into 10 shares of the Company’s
+Added: common stock.
+Added: The Series A Preferred Stock is the economic equivalent of the common stock but has no voting rights and is subject to
+Added: 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
+Added: outstanding common stock at such time.
Company has 100,000,000 shares of common stock authorized at a par value of $ 0.00001 .
−Removed: During the year ended December 31, 2022, the Company:
−Removed: 734,429 shares of common stock for shares of Series A Convertible Preferred stock as noted
−Removed: 205,984 shares of common stock pursuant to a conversion of $ 226,138 worth of convertible
−Removed: notes principal and interest,
−Removed: 112,225 shares of common stock as the change in number of shares issued as part of the cancellation
−Removed: of the prior agreements and new agreements with advisors, and
−Removed: 39,879 shares of common stock pursuant to a license agreement valued at $189,828.
−Removed: the Company signed two licenses for two drug programs from universities in the first half of 2022 it engaged an independent valuation
−Removed: firm to perform an Enterprise-Equity valuation.
−Removed: The results of this engagement resulted in an increase in the value per share of common
−Removed: stock used in the Black Scholes option pricing model employed to value the Company’s equity grants and warrant issuances.
February 2023, the Company completed its IPO for the sale of 1,297,318 units (each, a “Unit,” collectively, the “Units”)
−Removed: at a price of $ 6.50 per Unit for a total of approximately $ 8.4 million of gross proceeds.
+Added: 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
5 unchanged sentences
connection with the completion of its IPO, the Company issued an aggregate of 331,166 shares of common stock upon the conversion of certain
−Removed: outstanding convertible debt.
−Removed: connection with the IPO, in February 2023, the Company completed a 1-for-7 reverse split of our common stock.
+Added: outstanding convertible debt (see Notes 5 and 6).
+Added: connection with the IPO, in February 2023, the Company completed a 1-for-7 reverse split of its common stock .
Stockholders’ equity
3 unchanged sentences
related to these shares.
−Removed: the second quarter of 2023, we issued 436,533 shares of common stock following the exercise of 436,533 warrants for proceeds of $ 1,494,658 .
−Removed: securities are excluded from the diluted earnings per share calculation because their effect is anti-dilutive.
+Added: April 2023, the Company issued 436,533 shares of common stock following the exercise of 436,533 warrants for proceeds of $ 1,494,658 .
+Added: 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
+Added: pre-funded warrants and 1,725,521 warrants (collectively the “Units”).
+Added: The Units were sold at a price of $ 3.782 and the sale
+Added: was completed via an underwritten secondary public offering and includes the underwriter’s exercise of their overallotment option.
+Added: The warrants have an exercise price of $ 4.16 and expire five years from issuance.
+Added: The pre-funded warrants had an exercise price of $ 0.001
+Added: and were exercised in their entirety in the first quarter of 2024.
+Added: October 2024, the Company received approximately $ 3.13 million of gross proceeds from the sale of (i) 862,602 shares of the Company’s
+Added: 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
+Added: 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
+Added: 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
+Added: after six (6) months from the date of issuance for a five-year period from the initial exercise date in a concurrent private placement.
+Added: In conjunction with the transactions, the Company paid the placement agent an aggregate cash fee of 8.0% of the gross proceeds from the
+Added: sale of securities in the transaction, reimbursed the placement agent for certain out-of-pocket expenses and issued to the placement
+Added: 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
+Added: and pre-funded warrants sold in the registered direct offering.
+Added: The warrants have an exercise price of $2.00 per share and are exercisable
+Added: six (6) months from the date of issuance for a five-year period from the initial exercise date.
+Added: securities are excluded from the diluted earnings per share calculation when their effect is anti-dilutive.
As of December 31, 2024,
−Removed: and December 31, 2022, 3,521,880 and 927,373 warrants were not included in the calculation of net loss per share, respectively.
−Removed: 527,717 and 69,217 options for common shares were not included in the calculation of net loss per share, respectively.
+Added: 73,449 shares of preferred stock, 6,935,042 warrants and 832,731 options for common shares were excluded from the calculation of net
+Added: loss per common share.
+Added: As of December 31, 2023, 73,449 shares of preferred stock, 3,521,880 warrants and 527,717 options for common shares
+Added: were excluded from the calculation of net loss per common share.
+Added: For the year ended December 31, 2024, 430,108 pre-funded warrants are
+Added: included in the calculation of net loss per common share.
Equity Incentive Plan
6 unchanged sentences
the fair market value of one share of common stock on the grant date.
−Removed: The Plan authorizes an initial maximum number of shares underlying
−Removed: awards of 900,000 with an automatic annual 15 % increase beginning in 2024.
−Removed: As of December 31, 2023, there were 441,500 awards authorized
−Removed: but unissued available under the Plan.
−Removed: following tables summarizes the stock option activity for the years ended December 31, 2023 and 2022:
+Added: The Plan authorized an initial maximum number of shares underlying
+Added: 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
+Added: of the preceding fiscal year.
+Added: As of December 31, 2024, there are 150,682 awards authorized but unissued available under the Plan.
+Added: following table summarizes the stock option activity for the years ended December 31, 2024 and 2023:
Schedule of Stock Options Activity
9 unchanged sentences
Vested at December 31, 2024
−Removed: fair value of options granted in the year ended December 31, 2023 was estimated using the Black-Scholes option pricing model based on
−Removed: the assumptions in the table below:
−Removed: Schedule of Options Valuation Assumptions
+Added: fair value of options granted and modified in the year ended December 31, 2024 was estimated using the Black-Scholes option pricing model
+Added: based on the assumptions in the table below:
+Added: Schedule of Black Scholes Option Pricing Model
Expected dividend yield
9 unchanged sentences
yield – The Company does not expect to pay a dividend in the foreseeable future.
−Removed: weighted-average grant-date fair value of options granted during the year ended December 31, 2023 was $ 3.15 .
−Removed: The total grant-date fair
−Removed: value of options granted and vested during the year ended December 31, 2023 was approximately $ 1,445,200 and $ 585,500 , respectively.
+Added: 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.
+Added: 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 ,
+Added: respectively.
+Added: the year ended December 31, 2024, certain stock option awards granted to related parties were modified as follows:
+Added: July 2024, the Company modified 131,927 vested stock option awards granted to the former
+Added: Chief Marketing Officer by extending his period to exercise these awards from 6 months to
+Added: 12 months following termination.
+Added: This modification resulted in additional stock-based compensation
+Added: expense of $ 28,666 .
+Added: December 2024, the Company modified stock option awards granted the former Chief Financial
+Added: Officer by (i) accelerating the vesting of 31,103 unvested options, and (ii) extending the
+Added: period to exercise all now-vested 109,500 awards from 6 months to 12 months following his
+Added: These modifications resulted in additional stock-based compensation expense of $ 51,696 .
options were exercised in any of the periods presented.
−Removed: the years ended December 31, 2023 and 2022, the Company recognized $ 592,268 and $ 2,010 , respectively of compensation expense related
−Removed: to stock options.
+Added: the years ended December 31, 2024 and 2023, the Company recognized approximately $ 940,642 and $ 592,268 , respectively of compensation
+Added: expense related to stock options.
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.
−Removed: the years ended December 31, 2023 and 2022, the Company granted a total of 3,195,906 and 415,247 warrants, respectively.
−Removed: have an original life of ten years and vest over varying periods up to 24 months from the grant date .
−Removed: During the year ended December
−Removed: 31, 2023, warrants to purchase 27,867 shares vested and had a fair value of $ 39,265 .
−Removed: During the year ended December 31, 2022, 350,908
−Removed: shares of warrants vested and amended with a fair value of $ 337,269 , 51,941 shares of warrants were reclassified with a fair value of
−Removed: $ 11,097 , and 42,057 shares of warrants with a fair value of $ 1,883 were forfeited.
−Removed: the year ended December 31, 2021, the Company granted a total of 431,659 warrants.
−Removed: Of this amount, 200,000 warrants, with a fair value
−Removed: of $ 12,462 , were granted to advisors related to the Company’s IPO objective.
−Removed: The warrants have an original life of five years and
−Removed: vest 30 days before the intended IPO.
−Removed: During the year ended December31, 2021, 0 shares of these warrants were vested.
−Removed: As of June 30,
−Removed: 2022, the warrants for 200,000 shares were cancelled and voided per agreement of the warrant holder and the Company.
−Removed: There was no gain
−Removed: or loss recognized due to this cancellation.
−Removed: the year ended December 31, 2021, the Company issued 92,859 warrants with a fair value of $ 12,980 , in connection with convertible bridge
−Removed: debt agreements with multiple parties including a related party.
−Removed: The warrants had an original life of five years .
−Removed: During the period ending
−Removed: June 30, 2022, the Company determined that 50,735 warrants, with a fair value of $ 11,097 , should not have been issued.
−Removed: The fair value
−Removed: was reclassified to additional paid in capital.
−Removed: In May 2022, the Company and the noteholders agreed to cancel and void the previous 99,000
−Removed: warrants and entered into a new agreement for 115,185 warrants and the exercise price increased to $ 2.50 from $ 1.00 , with a fair value
−Removed: of $ 15,412 .
−Removed: In May 2022, the Company and the note holders agreed to cancel and void the previous 195,000 warrants and entered into a
−Removed: new agreement for 225,000 warrants with an exercise price of $ 2.50 , with a fair value of $ 64,978 .
−Removed: 92,859 warrants discussed above were initially discounted against the notes, subsequent to the year ended December 31, 2021, they were
−Removed: deemed voided and these individuals were issued new warrants in accordance with the new terms as stated above.
−Removed: We assessed the differences
−Removed: in fair values and determined the values were de minimis and expensed the full value of the new warrants.
−Removed: the year ended December 31, 2023, the Company issued the following warrants:
−Removed: February 2023, in connection with the completion of the initial public offering, the Company
−Removed: issued 276,452 contingent warrants to certain debt holders with an exercise price of $ 4.27
−Removed: and an expiration date 5 years from issuance.
−Removed: February 2023, in connection with the completion of the initial public offering, the Company
−Removed: issued 18,000 contingent warrants as fees to the Company’s underwriters with an exercise
−Removed: price of $ 8.125 and an expiration date 4 years from issuance.
−Removed: part of the sale of units in the Company’s initial public offering the Company issued
−Removed: 1,297,318 tradable warrants with an exercise price of $ 7.80 and an expiration date 5 years
−Removed: from issuance.
−Removed: Also, as part of the sale of units in the Company’s initial public offering,
−Removed: the Company issued 1,297,318 non-tradable warrants with an exercise price of $ 8.125 and an
−Removed: expiration date 5 years from issuance.
−Removed: February 2023, as part of the Company’s initial public offering, the Company issued
−Removed: 153,409 tradeable warrants to our underwriters pursuant to the overallotment options with
−Removed: an exercise price of $ 7.80 and an expiration date 5 years from issuance.
−Removed: Also in February
−Removed: 2023, as part of the Company’s initial public offering the Company issued 153,409 non-tradeable
−Removed: warrants to our underwriters pursuant to the overallotment options with an exercise price
−Removed: of $ 8.125 and an expiration date 5 years from issuance.
following table provides details over the Company’s outstanding warrants including those issued as consideration for services and
6 unchanged sentences
$ 6.51 - $ 7.80
−Removed: the years ended December 31, 2023 and 2022, the Company recognized $ 39,265 and $ 338,142 , respectively of compensation expense related
−Removed: to certain warrants.
+Added: Issued in Conjunction with Transactions
+Added: the year ended December 31, 2023, the Company issued the following warrants as part of the Company’s February 2023 IPO:
+Added: contingent warrants to certain debt holders with an exercise price of $ 4.27 and an expiration
+Added: date 5 years from issuance.
+Added: As of December 31, 2024, 204,033 warrants have been exercised
+Added: and 72,419 remain outstanding.
+Added: As a result of the February 2024 and October 2024 secondary
+Added: offerings, the exercise price of the remaining outstanding warrants was initially reduced
+Added: to $ 3.782 and subsequently to $ 2.00 pursuant to the anti-dilution provision contained in
+Added: the warrants.
+Added: The effect of the changes in price was recognized as deemed dividends of $ 28,245
+Added: which increases net loss available to common stockholders for the year ended December 31,
+Added: contingent warrants as fees to the Company’s underwriters with an exercise price of
+Added: $ 8.125 and an expiration date 4 years from issuance.
+Added: As of December 31, 2024, none of these
+Added: warrants have been exercised.
+Added: As a result of the February 2024 and October 2024 secondary
+Added: offerings, the exercise price of the remaining outstanding warrants was initially reduced
+Added: to $ 3.782 and subsequently to $ 2.00 pursuant to the anti-dilution provision contained in
+Added: the warrants.
+Added: The effect of the changes in price was recognized as deemed dividends of $ 16,740
+Added: which increases net loss available to common stockholders for the year ended December 31,
+Added: tradable warrants with an exercise price of $ 7.80 and an expiration date 5 years from issuance.
+Added: As of December 31, 2024, 100 warrants have been exercised and 1,297,218 remain outstanding.
+Added: non-tradable warrants with an exercise price of $ 8.125 and an expiration date 5 years from
+Added: As of December 31, 2024, 7,500 warrants have been exercised and 1,289,818 remain
+Added: tradeable warrants to our underwriters pursuant to the overallotment options with an exercise
+Added: price of $ 7.80 and an expiration date 5 years from issuance.
+Added: As of December 31, 2024, none
+Added: of these warrants have been exercised.
+Added: non-tradeable warrants to our underwriters pursuant to the overallotment options with an
+Added: exercise price of $ 8.125 and an expiration date 5 years from issuance.
+Added: As of December 31,
+Added: 2024, none of these warrants have been exercised.
+Added: the year ended December 31, 2024, the Company issued the following warrants as part of two secondary offerings:
+Added: February 2024, 1,507,139 warrants with an exercise price of $ 4.16 per share and an expiration
+Added: date 5 years from issuance.
+Added: In addition, the Company issued an additional 218,382 warrants
+Added: with an exercise price of $ 4.16 and an expiration date 5 years from issuance pursuant to
+Added: the underwriters’ overallotment option.
+Added: As of December 31, 2024, 16,000 of these warrants
+Added: have been exercised and 1,709,521 remain outstanding.
+Added: February 2024, 478,429 pre-funded warrants with an exercise price of $ 0.0001 .
+Added: As of December
+Added: 31, 2024, all of these pre-funded warrants have been exercised.
+Added: February 2024, 90,428 warrants with an exercise price of $ 4.16 per share and an expiration
+Added: date 5 years from issuance to the underwriters.
+Added: The warrants were valued at approximately
+Added: $ 263,145 , and as of December 31, 2024, none of these warrants have been exercised.
+Added: October 2024, 1,565,000 warrants to purchase shares of the Company’s common stock at
+Added: an exercise price of $ 2.00 per share and expiration date of 5.5 years from issuance.
+Added: December 31, 2024, none of these warrants have been exercised.
+Added: October 2024, 702,398 pre-funded warrants with an exercise price of $ 0.0001 .
+Added: As of December
+Added: 31, 2024, 400,000 shares have been exercised in a cashless transaction and 399,987 shares
+Added: of common stock were issued.
+Added: October 2024, 62,600 warrants with an exercise price of $ 2.00 and an expiration date 5.5
+Added: years from issuance to the underwriters.
+Added: The warrants were valued at approximately $ 116,436
+Added: and as of December 31, 2024, none of these warrants have been exercised.
Issued as Consideration for Services
11 unchanged sentences
Vested at December 31, 2024
−Removed: fair value of options granted in the years ended 2022 were estimated using the Black-Scholes option pricing model based on the assumptions
−Removed: in the table below:
−Removed: of Warrants Valuation Assumptions
−Removed: Expected dividend yield
−Removed: Expected volatility
−Removed: Risk-free interest rate
−Removed: Expected life (in years)
−Removed: - The trading volatility was determined by calculating the volatility of the Company’s
−Removed: life of options – The expected life of options granted to employees was determined
−Removed: using the simplified method.
−Removed: interest rate – This is the U.S.
−Removed: Treasury rate, having a term comparable to the
−Removed: expected life of the stock option.
−Removed: yield – The Company does not expect to pay a dividend in the foreseeable future.
−Removed: warrants were issued in the year ended December 31, 2023.
−Removed: of December 31, 2023, the total unrecognized compensation expense related to unvested warrants was approximately $ 3,000 , which the Company
−Removed: expects to recognize over a weighted-average period of approximately 0.2 years.
+Added: the years ended December 31, 2024 and 2023, the Company recognized $ 3,007 and $ 39,265 , respectively of compensation expense related to
+Added: certain warrants.
+Added: of December 31, 2024, there was no unrecognized compensation expense as no unvested warrants remain.
total grant-date fair value of warrants vested during the year ended December 31, 2024 was approximately $ 3,007 .
−Removed: income taxes reflect the net tax effects of loss and credit carryforwards and temporary differences between the carrying amounts of assets
−Removed: and liabilities for financial reporting purposes and the amounts used for income tax purposes.
−Removed: Significant components of our deferred
−Removed: tax assets for federal and state income taxes are as follows:
+Added: income taxes reflect the net tax effects of net operating loss, credit carryforwards, and temporary differences between the carrying
+Added: amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.
+Added: Significant components
+Added: of the Company’s deferred tax assets for federal and state income taxes are as follows:
Schedule of Deferred Tax Assets And Liabilities
6 unchanged sentences
( 3,656,627 )
+Added: ( 2,073,459 )
Net deferred tax asset
3 unchanged sentences
Net deferred tax asset / (liability)
−Removed: of our deferred tax assets is dependent upon future earnings, if any, the timing, and amount of which are uncertain.
−Removed: Because of our lack
+Added: of the Company’s deferred tax assets is dependent upon future earnings, if any, the timing, and amount of which are uncertain.
+Added: Because of the Company’s lack of U.S.
earnings history, the net U.S.
−Removed: deferred tax assets have been fully offset by a valuation allowance.
−Removed: The valuation allowance increased
−Removed: by $ 1,151,827 and $ 585,000 during the years ended December 31, 2023 and 2022, respectively.
−Removed: of December 31, 2023, the Company has available for federal income tax purposes a net operating loss carry forward of approximately $ 6.1
−Removed: million and a total state net operation loss carryforward of approximately $ 2 million.
−Removed: The net operating loss carryforwards do not expire
−Removed: and may be used to offset future taxable income.
−Removed: Utilization of some of the federal and state net operating loss carryforwards are subject
−Removed: to annual limitations due to the “change in ownership” provisions of the Internal Revenue Code of 1986 and similar state
−Removed: The annual limitations may result in the expiration of net operating losses and credits before utilization.
−Removed: Company has provided a valuation reserve against the full amount of the net operating loss benefit, since in the opinion of management,
−Removed: based upon the earnings history of the Company;
−Removed: it is more likely than not that the benefits will not be realized.
−Removed: All or portion of
−Removed: the remaining valuation allowance may be reduced in future years based on an assessment of earnings sufficient to fully utilize these
−Removed: potential tax benefits.
−Removed: have incurred net operating losses since inception and we do not have any significant unrecognized tax benefits.
−Removed: Our policy is to include
−Removed: interest and penalties related to unrecognized tax benefits, if any, within the provision for taxes in the consolidated statements of
−Removed: If we are eventually able to recognize our uncertain positions, our effective tax rate would be reduced.
−Removed: We currently have
−Removed: a full valuation allowance against out net deferred tax asset which would impact the timing of the effective tax rate benefit should
−Removed: any of these uncertain tax positions be favorably settled in the future.
−Removed: Any adjustments to our uncertain tax positions would result
−Removed: in an adjustment of our net operating loss or tax credit carry forwards rather than resulting in a cash outlay.
−Removed: file income tax returns in the U.S.
+Added: deferred tax assets have been fully offset by a valuation
+Added: The valuation allowance increased by $ 1,583,168 and $ 1,151,827 during the years ended December 31, 2024 and 2023, respectively.
+Added: of December 31, 2024, the Company has available for federal income tax purposes a gross net operating loss carryforward of approximately
+Added: $ 10.8 million and a gross state net operating loss carryforward of approximately $ 4.7 million.
+Added: The federal net operating loss carryforward
+Added: does not expire and may be used to offset future taxable income.
+Added: The state gross net operating loss begins to expire in 2043.
+Added: of some of the federal and state net operating loss carryforwards are subject to annual limitations due to the “change in ownership”
+Added: provisions of the Internal Revenue Code of 1986 and similar state provisions.
+Added: The annual limitations may result in the expiration of
+Added: net operating losses and credits before utilization.
+Added: Company has provided a valuation allowance against the full amount of the net operating loss benefit and its other net deferred tax assets
+Added: 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
+Added: of the Company’s net deferred tax assets will not be realized.
+Added: All or portion of the remaining valuation allowance may be reduced
+Added: in future years based on an assessment of earnings sufficient to fully utilize these potential tax benefits.
+Added: Company has incurred net operating losses since inception and it did not have unrecognized tax benefits as of December 31, 2024 and 2023,
+Added: and does not anticipate this to change significantly over the next 12 months.
+Added: The Company will recognize interest and penalties accrued
+Added: on any unrecognized tax benefits as a component of income tax expense.
+Added: Company files income tax returns in the U.S.
and certain state jurisdictions.
−Removed: We are not currently under examination in these jurisdictions for
−Removed: any tax year.
+Added: The Company is not currently under examination in these
+Added: jurisdictions for any tax year.
The Company’s tax years beginning with 2021 are open tax years.
−Removed: Because of net operating losses and research credit
−Removed: carryovers, substantially all of our tax years remain open to examination.
−Removed: Company did not have unrecognized tax benefits as of December 31, 2023 and 2022, and does not anticipate this to change significantly
−Removed: over the next 12 months.
−Removed: The Company will recognize interest and penalties accrued on any unrecognized tax benefits as a component of
−Removed: income tax expense.
−Removed: Reconciliations between the statutory federal income tax rate and the effective income tax rate of income tax expense
−Removed: is as follows:
+Added: Because of net operating losses
+Added: and research credit carryovers, substantially all the Company’s tax years remain open to examination.
+Added: Reconciliations
+Added: between the statutory federal income tax rate and the effective income tax rate of income tax expense for the years ended December 31,
+Added: 2024 and 2023 are as follows:
Effective Income Tax Rate of Income Tax Expense
4 unchanged sentences
Technology License
−Removed: February 7, 2018, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the technology.
−Removed: covers three (3) issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of algorithms
−Removed: and other trade secrets, the license also includes modifications and improvements.
−Removed: In October of 2021, the Company executed an amendment
−Removed: to the original license which represents improvements and new advanced analytics capabilities.
−Removed: In consideration of the rights granted
−Removed: to the Company under the License Agreement JHU received a warrant equal to five percent ( 5 %) of the then fully diluted equity base of
−Removed: the Company, which shall be diluted following the closing of the IPO.
−Removed: Under the terms of the License Agreement, JHU will be entitled
−Removed: to eight percent ( 8 %) royalty on net sales for the services provided by the Company in which the JHU licensed technology was utilized,
−Removed: as well as fifty percent ( 50 %) of all sublicense revenues received by the Company.
−Removed: In addition, the Company is required to pay JHU an
−Removed: annual maintenance fee of $ 1,500 .
−Removed: Minimum annual royalty payments are $ 20,000 for 2022, $ 80,000 for 2023, and $ 300,000 for 2024 and beyond,
−Removed: if cumulative annual royalty payments do not reach these levels, the amount due to JHU to reach the annual minimum is due by January
−Removed: 31st of the following year.
−Removed: Failure to make annual royalty payments is considered a material breach under the agreement and upon notice
−Removed: from JHU of a material breach, the Company shall have 60 days to cure the material breach.
−Removed: On July 8, 2022, the company entered into
−Removed: an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform.
−Removed: The new license provides additional intellectual property rights including patents, copyrights, and knowhow to be utilized under the
−Removed: Company’s bfLEAP™ analytical AI/ML platform.
−Removed: This license supersedes the previous license.
−Removed: In consideration of the new license,
−Removed: the Company issued 39,879 shares of common stock.
−Removed: Under the terms of the new License Agreement, JHU will be entitled to eight percent
−Removed: ( 8 %) of net sales for the services provided by the Company to other parties and three percent ( 3 %) for internally development drug projects
−Removed: in which the JHU license was utilized.
−Removed: The new license also contains tiered sub licensing fees that start at 50 % and reduce to 25 % based
−Removed: In addition, under the new license agreement, the minimum annual royalty payments are $ 30,000 for 2022, $ 60,000 for 2023,
−Removed: and $ 300,000 for 2024 and beyond.
−Removed: May 31, 2023, the Company and JHU-APL entered into Amendment number 1 of the July 8, 2022 License Agreement whereby the Company gained
−Removed: access to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $ 275,000 .
−Removed: of these payments for $ 75,000 was due in July 2023 followed by payments of $ 75,000 , $ 75,000 , and $ 50,000 in years 2025, 2026 and 2027,
−Removed: respectively.
−Removed: The amendment also reduced the 2023 minimum annual royalty payment to $ 60,000 , all other financial terms remain the same.
−Removed: As of December 31, 2023, we have accrued $ 60,000 of the 2023 minimum annual royalty payments.
+Added: February 2018, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL.
+Added: The license covers three (3)
+Added: issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of algorithms and other trade
+Added: secrets, as well as modifications and improvements.
+Added: In October 2021, the Company executed an amendment to the original license for improvements
+Added: and new advanced analytics capabilities.
+Added: In consideration of the rights granted to the Company under the license agreement, JHU-APL received
+Added: a warrant equal to five percent ( 5 %) of the then fully diluted equity base of the Company, which was diluted following the closing of
+Added: the Company’s initial public offering.
+Added: Under the terms of the license agreement, JHU-APL will be entitled to an eight percent ( 8 %)
+Added: royalty on net sales for the services provided by the Company as well as fifty percent ( 50 %) of all sublicense revenues received by the
+Added: Company on services and sublicenses in which the JHU-APL licensed technology was utilized.
+Added: In addition, the Company is required to pay
+Added: JHU-APL an annual maintenance fee of $ 1,500 .
+Added: Minimum annual royalty payments are $ 20,000 for 2022, $ 80,000 for 2023, and $ 300,000 per
+Added: year for 2024 and beyond.
+Added: If cumulative annual royalty payments do not reach these levels, the amount due to JHU-APL to reach the annual
+Added: minimum is due by January 1 st of the following year.
+Added: Failure to make annual royalty payments is considered a material breach
+Added: under the agreement and, upon notice from JHU-APL of a material breach, the Company will have 60 days to cure the material breach.
+Added: July 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed
+Added: to enhance the bfLEAP™ platform.
+Added: The new license provides additional intellectual property rights including patents, copyrights,
+Added: and knowhow to be utilized under the Company’s bfLEAP™ analytical AI/ML platform.
+Added: This license supersedes the previous 2018
+Added: In consideration of the new license, the Company issued 39,879 shares of common stock to JHU-APL.
+Added: Under the terms of the new
+Added: license agreement, JHU-APL will be entitled to eight percent ( 8 %) of net sales for the services provided by the Company to other parties
+Added: and three percent ( 3 %) for internally developed drug projects in which the JHU-APL license is utilized.
+Added: The new license also contains
+Added: tiered sub licensing fees that start at 50 % and reduce to 25 % based on revenues.
+Added: In addition, under the new license agreement, the minimum
+Added: annual royalty payments are $ 30,000 for 2022, $ 80,000 for 2023, and $ 300,000 per year for 2024 and beyond.
+Added: May 2023, the Company and JHU-APL entered into Amendment Number 1 of the July 2022 License Agreement whereby the Company gained access
+Added: to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $ 275,000 .
+Added: 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
+Added: and 2027, respectively.
+Added: The amendment also reduced the 2023 minimum annual royalty payment to $ 60,000 , all other financial terms remain
+Added: As of December 31, 2024, we have accrued $ 300,000 of the 2024 minimum annual royalty payments, and the entire accrued balance
+Added: was paid in January 2025.
Washington University - Beta2-spectrin siRNA License
1 unchanged sentence
for rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including hepatocellular carcinoma (“HCC”).
−Removed: covers methods claimed in three US and worldwide patent applications, and also includes use of this approach for treatment of obesity,
−Removed: non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.
+Added: The license covers methods claimed in three U.S.
+Added: and worldwide patent applications, and also includes use of this approach for treatment
+Added: of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.
consideration of the rights granted to the Company under the license agreement, the Company paid GWU a $ 20,000 license initiation fee.
6 unchanged sentences
As of December
−Removed: 31, 2023 and 2022, there has been no accrual for royalties since we have not begun to generate applicable revenue.
+Added: 31, 2024, there has been no accrual for royalties since the Company has not begun to generate applicable revenue.
The Company assessed
2 unchanged sentences
Hopkins University – Mebendazole License
−Removed: February 22, 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (JHU) for
−Removed: the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease.
+Added: February 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (“JHU”)
+Added: for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease.
This formulation shows
−Removed: potent activity in animal models of different types of cancer and has been evaluated in a Phase I clinical trial in patients with high-grade
+Added: 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).
12 unchanged sentences
license agreement, JHU will receive a staggered upfront license fee of $ 250,000 .
−Removed: The initial payment for $ 50,000 was paid and the remaining
−Removed: balance of $ 200,000 was paid after the Company completed its IPO.
−Removed: The Company will also reimburse JHU for previously incurred and ongoing
−Removed: patent costs.
−Removed: Under the terms of the License Agreement, JHU will be entitled to three and one-half percent ( 3.5 %) royalty on net sales
−Removed: by the Company.
−Removed: In addition, the Company is required to pay JHU minimum annual royalty payments of $ 5,000 for 2023, $ 10,000 for 2024,
−Removed: $ 20,000 for 2025, $ 30,000 for 2026 and $ 50,000 for 2027 and each year after until the first commercial sale after which the annual minimum
−Removed: royalty shall be $ 250,000 .
−Removed: The license agreement also contains milestone payments for clinical development steps through the approval
−Removed: of an NDA and commercialization.
−Removed: As of December 31, 2023 and 2022, the balance of accrued expense related to this license agreement was
−Removed: $ 10,000 and $ 242,671 , respectively.
−Removed: The Company assessed whether the license should be capitalized and determined that the licensed program
−Removed: is in the early stage and therefore may not be recoverable;
−Removed: the Company expensed the license fee and will expense development costs until
−Removed: commercial viability is likely.
−Removed: Hopkins University – Prodrug License
+Added: The Company initially paid $ 50,000 and the remaining
+Added: balance of $ 200,000 was paid in 2023.
+Added: The Company will also reimburse JHU for previously incurred and ongoing patent costs.
+Added: 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
+Added: the JHU license was utilized.
+Added: In addition, the Company is required to pay JHU minimum annual royalty payments of $ 5,000 for 2022, $ 10,000
+Added: 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
+Added: annual minimum royalty shall be $ 250,000 .
+Added: The license agreement also contains milestone payments for clinical development steps through
+Added: the approval of an NDA and commercialization.
+Added: As of December 31, 2024 and 2023, the balance of accrued expense related to this license
+Added: agreement was $ 20,000 and $ 10,000 , respectively.
+Added: The Company assessed whether the license should be capitalized and determined that the
+Added: licensed program is in the early stage and therefore may not be recoverable;
+Added: the Company expensed the license fee and will expense development
+Added: costs until commercial viability is likely.
+Added: Hopkins University – Mebendazole Prodrug License
October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU and the Institute of Organic Chemistry
−Removed: and Biochemistry (IOCB) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of Mebendazole that demonstrate
−Removed: improved solubility and bioavailability.
−Removed: The license covers prodrug compositions and use for treating disease as claimed in multiple
−Removed: US and worldwide patent applications.
−Removed: In consideration for the rights granted to the Company under the License Agreement JHU and IOCB
−Removed: will receive a staggered upfront license fee of $ 100,000 .
−Removed: The Company will also reimburse JHU and IOCB for previously incurred patent
−Removed: 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.
−Removed: In addition, the Company is required to pay JHU and IOCB minimum annual royalty payments of $ 5,000 for 2027, $ 10,000 for 2028, $ 20,000
−Removed: for 2029, $ 30,000 for 2030 and $ 50,000 for 2031 and each year after until the first commercial sale after which the annual minimum royalty
−Removed: shall be $ 150,000 .
−Removed: The license agreement also contains milestone payments for patent grants, clinical development steps through the approval
−Removed: of an NDA and commercialization.
−Removed: As of December 31, 2023 and 2022, the balance of accrued expense related to this license agreement was
−Removed: $ 0 and $ 133,238 , respectively.
−Removed: The Company assessed whether the license should be capitalized and determined that the licensed program
−Removed: is in the early stage and therefore may not be recoverable;
−Removed: the Company expensed the license fee and will expense development costs until
−Removed: commercial viability is likely.
+Added: and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of Mebendazole
+Added: that demonstrate improved solubility and bioavailability.
+Added: The license covers prodrug compositions and use for treating disease as claimed
+Added: in multiple U.S.
+Added: and worldwide patent applications.
+Added: In consideration for the rights granted to the Company under the license agreement,
+Added: JHU and IOCB will receive a staggered upfront license fee of $ 100,000 .
+Added: The Company will also reimburse JHU and IOCB for previously incurred
+Added: patent costs.
+Added: Under the terms of the license agreement, JHU and IOCB will be entitled to four percent ( 4.0 %) royalty on net sales by
+Added: the Company in which the JHU and IOCB license was utilized.
+Added: In addition, the Company is required to pay JHU and IOCB minimum annual royalty
+Added: 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
+Added: first commercial sale, after which, the annual minimum royalty shall be $ 150,000 .
+Added: The license agreement also contains milestone payments
+Added: for patent grants, clinical development steps through the approval of an NDA and commercialization.
+Added: As of December 31, 2024 and 2023,
+Added: the balance of accrued expense related to this license agreement was $ 0 .
+Added: The Company assessed whether the license should be capitalized
+Added: and determined that the licensed program is in the early stage and therefore may not be recoverable;
+Added: the Company expensed the license
+Added: fee and will expense development costs until commercial viability is likely.
Commitments and Contingencies
4 unchanged sentences
Subsequent Events
−Removed: February 5, 2024 the Company received net proceeds of approximately $ 4.9 million dollars from an underwritten public offering of 1,507,139
−Removed: shares of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase 1,507,139 shares of common stock
−Removed: at an offering price of $ 3.782 .
−Removed: The 5 year warrants have an exercise price of $ 4.16 .
−Removed: On February 21, 2024, the underwriters elected to
−Removed: take an overallotment of 218,382 common shares and the Company received net proceeds of approximately $ 750,000 .
+Added: Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the consolidated financial
+Added: statements are issued.
+Added: than as disclosed in this Note 12 and as may be disclosed elsewhere in the notes to the accompanying consolidated financial statements,
+Added: there have been no subsequent events that require adjustment or disclosure in the accompanying consolidated financial statements.
+Added: February 2025, the Company announced its entry into a collaboration agreement with Eleison Pharmaceuticals Inc.
+Added: a Phase III oncology company focused on novel chemotherapeutic treatments for rare cancers.
+Added: Through this collaboration, the Company will
+Added: apply its proprietary Bullfrog Data Networks™ solution, powered by the bfLEAP® platform, to analyze clinical data from Eleison’s
+Added: ongoing Phase III trial and previous clinical studies of glufosfamide, an investigational treatment for pancreatic cancer.
+Added: will evaluate the current trajectory of the trial with respect to safety signals, extract predictive biomarkers for efficacy and safety
+Added: performance from prior studies to support future trial design, and provide data-driven insights to optimize Eleison’s planned clinical
+Added: trials for inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD).
+Added: These insights are expected to streamline trial efficiency
+Added: and improve decision-making for Eleison’s broader oncology pipeline.
+Added: March 2025, the Company anticipates making a severance payment to a former employee for approximately $ 45,000 .
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.