Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are designed to ensure that the information required to be disclosed by us in the reports filed or submitted by us under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and such information is accumulated and communicated to management, including the Chief Executive Officer, Chief Financial Officer, and Principal Accounting Officer, to allow timely decisions regarding required disclosure. Disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable assurances of achieving the desired controls.
As of December 31, 2024, we carried out an evaluation over the effectiveness of the design and operation of our disclosure controls and procedures defined above. Based upon that evaluation, we have concluded that, as of December 31, 2024, our disclosure controls and procedures were effective at a reasonable assurance level.
Remediated Material Weaknesses
As of December 31, 2023, material weaknesses were identified in internal controls due to (i) a lack of segregation of duties due to limited administrative staff, (ii) limited reconciliation and review procedures over clinical contract accruals as we have rapidly expanded into new, late-stage clinical studies, and (iii) information technology matters regarding user access that aggregate to a material weakness. Prior to updating internal processes and implementing certain controls, the previous controls and procedures were not sufficient to ensure that financial information and financial statements could be prepared accurately and timely in accordance with U.S. GAAP and the SEC’s reporting requirements.
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Remedial Actions Implementation
In response to the above identified material weaknesses, together with a third-party internal controls consulting firm, we developed and implemented the following remediation measures:
• We reassessed our accounting procedures and, as part of the financial reporting process, implemented the use of supplementary checks and additional reviews and evaluations of transactions to improve the accuracy and reliability of our financial information.
• We added appropriate resources to ensure that such procedures are implemented and adequate reviews are performed.
• In December 2023, we hired a new Chief Financial Officer with extensive public-company reporting and technical accounting experience to provides additional financial reporting oversight and review.
• We engaged additional technical accounting consultants to provide additional resources for the preparation and review of our quarterly close procedures.
• We evaluate and implemented new accounting software systems to improve system controls, including a new accounting system, an equity management administration system, and a new financial reporting and filing software platform to leverage system-controls and streamline quarterly SEC filings controls.
Our Chief Executive Officer, Chief Financial Officer, Principal Accounting Officer, and third-party internal control consulting firm have actively participated in these remediation implementations as of December 31, 2023, and such processes have been subject to audit committee oversight.
Limitations on the Effectiveness of Controls
Our management recognizes that any set of controls and procedures, no matter how well-designed and operated, can provide only reasonable, not absolute, assurance of achieving the desired control objectives. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, with us have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of controls. For these reasons, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management’s Annual Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting for us. Internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) is a process to provide reasonable assurance regarding the reliability of our financial reporting for external purposes in accordance with U.S. generally accepted accounting principles. Internal control over financial reporting includes maintaining records that in reasonable detail accurately and fairly reflect our transactions; providing reasonable assurance that transactions are recorded as necessary for preparation of our consolidated financial statements; providing reasonable assurance that receipts and expenditures of company assets are made in accordance with management authorization; and providing reasonable assurance that unauthorized acquisition, use or disposition of company assets that could have a material effect on our consolidated financial statements would be prevented or detected on a timely basis. Because of its inherent limitations, internal control over financial reporting is not intended to provide absolute assurance that a misstatement of our consolidated financial statements would be prevented or detected.
Management conducted an evaluation of the effectiveness, as of December 31, 2024, of our internal control over financial reporting based on the framework in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission in 2013. Based on this evaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2024.
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Changes in Internal Control over Financial Reporting
Other than the remediations identified above, there have been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2024 covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
On December 5, 2024 , Lewis Bender , our President and Chief Executive Officer and Chairman of our board of directors, adopted a “Rule 10b5-1 trading arrangement” that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act (“Rule 10b5-1(c)”) for the sale of up to 150,000 shares of our Common Stock. The duration of the trading arrangement is from March 17, 2025 until November 14, 2025 .
On December 5, 2024 , Joseph Talamo , our Chief Financial Officer , adopted a “Rule 10b5-1 trading arrangement” that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) for the sale of up to 85,476 shares of our Common Stock. The duration of the trading arrangement is from March 7, 2025 until November 14, 2025 .
On December 5, 2024 , John Wesolowski , our Chief Accounting Officer and Controller , adopted a “Rule 10b5-1 trading arrangement” that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) for the sale of up to 64,191 shares of our Common Stock. The duration of the trading arrangement is from March 7, 2025 until November 14, 2025 .
During the quarter ended December 31, 2024, none of our non-employee directors adopted , modified or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement” as such terms are defined under Rule 408 of Regulation S-K.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The following table sets forth the name, age and position of our directors and executive officers as of March 1, 2025.
Name
Age Position
Lewis H. Bender 66 President, Chief Executive Officer and Chairman of the Board
Joseph Talamo 55 Chief Financial Officer
John Wesolowski 65 Principal Accounting Officer and Controller
Emer Leahy 59 Director
Mark A. Goldberg 64 Director
Daniel Donovan 60 Director
Thomas I. H. Dubin 62 Director
Executive Officers
Lewis H. Bender is our founder and has served as our President and Chief Executive Officer since April 2012. Prior to our founding, Mr. Bender was the CEO of publicly traded (AMEX & OTC) Interleukin Genetics, Inc. from 2008 until 2012. Interleukin was a personalized medicine company. Mr. Bender was successful in raising capital for us via a direct placement with institutional investors and partnered with the insurance industry for development of an IG product. Prior to joining Interleukin Genetics, Mr. Bender held numerous positions at Emisphere Technologies, Inc. at the time a publicly traded (Nasdaq) drug delivery company specializing in the development of oral delivery of poorly absorbed molecules. While at Emisphere from 1993 to December 2007, Mr. Bender held positions including Interim President & CEO, Chief Technology Officer, Senior Vice President of Business Development, and Vice President of Manufacturing and Process Development. Mr. Bender has over 26 years of biotech and pharmaceutical executive management experience. He has led development teams taking products from discovery to Phase 3 for compounds using novel drug delivery techniques. Mr. Bender has a both a BS and MS in Chemical Engineering from The Massachusetts Institute of Technology (MIT), an MBA from the University of Pennsylvania’s Wharton School, and an MA in International Studies also from the University of Pennsylvania. He is fluent in French and German. We believe that Mr. Bender’s immense experience in the biomedical and pharmaceutical industries, including at several publicly traded companies, qualifies him to serve on our Board.
Joseph Talamo has served as our Chief Financial Officer since December 2023. Prior to joining the Company, from August 2020 until November 2023, Mr. Talamo served as Senior Vice President and Chief Financial Officer of HiberCell, Inc., a clinical-stage biotechnology company developing therapeutics to address cancer relapse and metastasis. From June 2011 until July 2020, Mr. Talamo was employed by Lisata Therapeutics, Inc. (formerly known as Caladrius Biosciences, Inc.) where he served in various roles, including Corporate Controller and Chief Accounting Officer, and then later as the Company’s Senior Vice President and Chief Financial Officer. Mr. Talamo received a B.B.A. in Accounting from Hofstra University, and an M.B.A. in Finance from Hofstra University. Mr. Talamo is a Certified Public Accountant in the State of New York.
John Wesolowski has served as our Principal Accounting Officer and Controller since March 2017. In addition, Mr. Wesolowski served as our Interim Chief Financial Officer from June 2023 until December 2023. Prior to joining Intensity Therapeutics, from 1998 to 2016 Mr. Wesolowski was Director of Costing in the Yale University Controller’s office. In that role Mr. Wesolowski conducted financial reporting, property tax management, was responsible for calculations of overhead and benefit rates, and was involved in numerous special projects related to accounting process and controls. Also, at Yale, he was involved in financial reporting and the accounting matters related to clinical trials and other organized research. Prior to joining Yale Mr. Wesolowski was the Vice President and Controller for Automatic Fastener Corporation in Branford, CT from 1988 to 1998. In this role, Mr. Wesolowski oversaw all accounting, purchasing and human resource functions. John also has 5 years of experience in public accounting and auditing from working at KMG Main Hurdman, now KPMG. Mr. Wesolowski received a Bachelor of Science in Finance from The Pennsylvania State University (Penn State at University Park) and an MBA from the University of Connecticut in Management Science. He is a Certified Public Accountant since 1983.
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Non-Employee Directors
Dr. Emer Leahy has served on our board of directors since June 2016. Dr. Leahy received her Ph.D. in Neuropharmacology from University College Dublin, Ireland and her MBA from Columbia University. She has been with PsychoGenics Inc., a preclinical CNS service company, since 1999 and is currently serving as its Chief Executive Officer and Director. Prior to her appointment as the Chief Executive Officer in 2020, she was the vice president of business development. Dr. Leahy is also the Chief Executive Officer of PGI Drug Discovery LLC, since its founding in 2011, a company engaged in psychiatric drug discovery with multiple partnered clinical programs including one in Phase III. Additionally, Dr. Leahy served as a Board member and a member of both the compensation committee and the audit committee of Bright Minds Biosciences Inc. (NASDAQ: DRUG), a biotech company, until April 2022, and she has served as a Board member, Chair of the Compensation committee and a member of the Audit and Governance committees of Pasithea Therapeutics, Inc. since 2021. Dr. Leahy has more than 30 years of experience in drug discovery, clinical development and business development for pharmaceutical and biotechnology companies, including extensive knowledge of technology assessment, licensing, mergers and acquisitions, and strategic planning. She is an Adjunct Associate Professor of Neuroscience position at Mount Sinai School of Medicine since 2017. Dr. Leahy served on the Emerging Companies Section Governing Board of the Biotechnology Industry Organization, the Business Review Board for the Alzheimer’s Drug Discovery Foundation, and the Scientific Advisory Board of the International Rett Syndrome Foundation. She is currently Chair of the Board of Trustees of BioNJ having served on the Board since 2020. She is a recent finalist in the NJ Chapter of the EY Entrepreneur of the Year. We believe that Dr. Leahy is qualified to serve as a member of our board of directors due to her extensive pharmaceutical, biotechnology and business background.
Dr. Mark A. Goldberg has served as a member of our board of directors since May 2018. Since 2019, Dr. Goldberg has served as Chairman of Allucent, a global mid-sized clinical research organization, and has also served as Chief Executive Officer between 2019 and 2024. Dr. Goldberg has also served as the Executive Chairman of Thread, a decentralized research and electronic clinical outcome assessment provider, between 2019 and 2024. Previously, Dr. Goldberg has served as President and COO of PAREXEL International, one of the world’s largest global biopharmaceutical service providers, with consolidated revenue of approximately $2.4 billion in 2017, over 18,000 employees, and 86 locations in 51 countries. He was responsible for overseeing all revenue generating business segments including Clinical Research Services, Calyx, and PAREXEL Consulting as well as sales, marketing, corporate quality, and information technology. Dr. Goldberg helped to pioneer PAREXEL’s strategic partnering approach with some of the world’s leading pharmaceutical companies and to build out the company’s global infrastructure, particularly in the Asia Pacific region, through both organic growth and acquisitions. Earlier in his PAREXEL career, he founded the company’s Medical Imaging business and helped establish its technology subsidiary, Perceptive Informatics (now PAREXEL Informatics). Dr. Goldberg holds a BS degree in computer science from MIT and an MD from the University of Massachusetts Medical School. He completed residency training in Radiology at Massachusetts General Hospital, where he also served as Chief Resident and a staff physician with academic appointments at Harvard Medical School. We believe that Dr. Goldberg is qualified to serve as a member of our board of directors because of his medical background and experience as a director of a public company.
Daniel J. Donovan has served as a member of our board of directors since January 2023. Mr. Daniel Donovan is an entrepreneur with extensive experience within the biotech industry. Since 2014 to present he has been the Chief Executive Officer of rareLife Solutions, Inc., a company creating the connections to engage, unify, and amplify the voices of patients, advocates, and caregivers to inform and accelerate the development and commercialization of emerging treatments especially in rare diseases. Dan was a member of the Board of Directors and Chief Business Officer at Cancer Prevention Pharmaceuticals (CPP), a late-stage pharmaceutical development company with compounds targeted at several rare diseases. Prior to rareLife and CPP, Dan established Envision Pharma in 2001, serving as President through June 2011. He was the visionary behind the creation and development of Datavision, the market leader in medical publications technology. Envision Pharma was acquired by the United BioSource Corporation (UBC) in April 2008. At UBC Mr. Daniel Donovan was Senior Vice President Strategy and Market Development. Dan began his career at Pfizer serving in a variety of positions of increasing responsibility, ranging from sales to market research and marketing in the US domestic and international market place, culminating in his position as Director and European Team Leader. During his time at Pfizer, he played a pivotal role in the commercialization of some of the pharmaceutical industry’s most successful product launches. Dan earned a Bachelor of Science degree in Finance at Lehigh University. We believe that Mr. Donovan is qualified to serve as a member of our board of directors because of his background in cancer and rare disease, finance, drug development, patient advocacy and small company board.
Thomas I. H. Dubin has served on our board of directors since May 2024. Mr. Dubin is a pharmaceutical executive and attorney. Over the past five years, he has served as an advisor and board member to various biopharma and other companies. From 2001 through 2013, Mr. Dubin was the Chief Legal Officer and member of the core executive team that grew Alexion Pharmaceuticals (“Alexion”) from development stage to membership in the S&P 500. At Alexion, Mr. Dubin
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led legal, government affairs, pricing and reimbursement, human resources, corporate communications, and other functions, and held commercial responsibility for the company’s Australasia region. Prior to Alexion, Mr. Dubin served as Vice President and General Counsel of ChiRex, Inc. and Assistant General Counsel of Warner-Lambert Company. Mr. Dubin began his career as a corporate attorney with Cravath, Swaine & Moore in New York City. Mr. Dubin currently serves as Executive Chair of Cellphire Therapeutics, board member of Notable Laboratories (Nasdaq: NTBL), board member of Norwalk Hospital, board member of Connecticut Innovations, member of the Yale School of Public Health Leadership Council, and advisory board member of Mythic Pharmaceuticals. Mr. Dubin was a board member of BioBlast Pharmaceuticals (Nasdaq: ORPN) from 2015 to 2018, and a trustee of American Jewish World Service from 2014 to 2021. Mr. Dubin received his J.D. from New York University School of Law, his M.P.H. from Yale University School of Public Health and his B.A. from Amherst College, cum laude. We believe that Mr. Dubin is qualified to serve as a member of our board of directors because of his extensive legal and business skills and experience in the biotechnology industry.
Family Relationships
There are no family relationships between any of our executive officers and directors.
Arrangements between Officers and Directors
Except as set forth herein, to our knowledge, there is no arrangement or understanding between any of our officers or directors and any other person pursuant to which the officer or director was selected to serve as an officer or director.
Involvement in Certain Legal Proceedings
We are not aware of any of our directors or officers being involved in any legal proceedings in the past ten years relating to any matters in bankruptcy, insolvency, criminal proceedings (other than traffic and other minor offenses), or being subject to any of the items set forth under Item 401(f) of Regulation S-K.
Code of Business Conduct and Ethics
Our board of directors established a Code of Business Conduct and Ethics applicable to our directors, officers and employees. The Code of Business Conduct and Ethics is accessible on our website at www.intensitytherapeutics.com . If we make any substantive amendments to the Code of Business Conduct and Ethics or grant any waiver, including any implicit waiver, from a provision of the Code of Business Conduct and Ethics to our officers, we will disclose the nature of such amendment or waiver on that website or in a report on Form 8-K.
Insider Trading Policy
We have adopted insider trading policies and procedures (the “Insider Trading Policy”) that apply to our employees, directors and designated consultants. The Insider Trading Policy governs the purchase and sale or other dispositions of certain investment products and is reasonably designed to promote compliance with insider trading laws, rules and regulations. A copy of the Insider Trading Policy is attached hereto as Exhibit 19.1.
Board Composition and Election of Directors
Our business and affairs are managed under the direction of our board of directors. The primary responsibilities of our board of directors are to provide oversight, strategic guidance, counseling and direction to our management. Our board of directors meets on a regular basis and additionally as required.
The number of directors is fixed by our board of directors, subject to the terms of our amended and restated certificate of incorporation and our second amended and restated bylaws. Our board of directors consists of five (5) directors, four (4) of whom qualify as “independent” under Nasdaq listing standards.
Directors are (except for the filling of vacancies and newly created directorships) elected by the holders of a plurality of the votes cast by the holders of shares present in person or represented by proxy at the meeting and entitled to vote on the election of such directors. In accordance with our amended and restated certificate of incorporation and our second amended and restated bylaws, our board of directors is divided into three classes with staggered three-year terms. Only one
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class of directors is elected at each annual meeting of our stockholders, with the other classes continuing for the remainder of their respective three-year terms. Our directors are divided among the three classes as follows:
• the Class I directors are Mr. Daniel Donovan and Mr. Thomas I. H. Dubin, and their terms will expire at the 2027 annual meeting of stockholders;
• the Class II director is Dr. Mark A. Goldberg, and his term will expire at the 2025 annual meeting of stockholders; and
• the Class III directors are Dr. Emer Leahy and Lewis H. Bender, and their terms will expire at the 2026 annual meeting of stockholders.
Each director’s term will continue until the election and qualification of his or her successor, or his or her earlier death, resignation or removal. Any increase or decrease in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors. This classification of our board of directors may have the effect of delaying or preventing changes in control of our company.
Director Independence
Our board of directors has undertaken a review of the independence of each director. Based on information provided by each director concerning his or her background, employment and affiliations, our board of directors has determined that Mr. Daniel Donovan, Dr. Emer Leahy, Dr. Mark A. Goldberg and Mr. Thomas I. H. Dubin do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities of a director and that each of these directors is “independent” as that term is defined under the applicable rules and regulations of the SEC and the listing standards of Nasdaq. In making these determinations, our board of directors considered the current and prior relationships that each non-employee director has with our company and all other facts and circumstances our board of directors deemed relevant in determining their independence, including the beneficial ownership of our capital stock by each non-employee director, and the transactions involving them described in the section titled “Certain Relationships and Related Party Transactions.”
Committees of the Board of Directors
Our board of directors has established an audit committee, a compensation committee and a nominating and corporate governance committee. The composition and responsibilities of each of the committees of our board of directors is described below. Members will serve on these committees until their resignation or until as otherwise determined by our board of directors.
Audit Committee
Our audit committee consists of Dr. Emer Leahy, Dr. Mark A. Goldberg, and Mr. Thomas I. H. Dubin, with Dr. Emer Leahy serving as Chairperson. The composition of our audit committee meets the requirements for independence under current Nasdaq listing standards and SEC rules and regulations. Each member of our audit committee meets the financial literacy requirements of Nasdaq listing standards. In addition, our board of directors has determined that Dr. Emer Leahy is an audit committee financial expert within the meaning of Item 407(d) of Regulation S-K under the Securities Act of 1933. Our audit committee, among other things:
• reviews our consolidated financial statements and our critical accounting policies and practices;
• selects a qualified firm to serve as the independent registered public accounting firm to audit our consolidated financial statements;
• helps to ensure the independence and performance of the independent registered public accounting firm;
• discusses the scope and results of the audit with the independent registered public accounting firm and reviews, with management and the independent registered public accounting firm, our interim and year-end results of operations;
• pre-approves all audit and all permissible non-audit services to be performed by the independent registered public accounting firm;
• oversees the performance of our internal audit function when established;
• reviews the adequacy of our internal controls;
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• develops procedures for employees to submit concerns anonymously about questionable accounting or audit matters;
• reviews our policies on risk assessment and risk management; and
• reviews related party transactions.
Our audit committee operates under a written charter that satisfies the applicable rules of the SEC and the listing standards of Nasdaq.
Compensation Committee
Our compensation committee consists of Mr. Daniel Donovan, Dr. Emer Leahy and Dr. Mark A. Goldberg, with Mr. Daniel Donovan serving as Chairperson. The composition of our compensation committee meets the requirements for independence under Nasdaq listing standards and SEC rules and regulations. Each member of the compensation committee is also a non-employee director, as defined pursuant to Rule 16b-3 promulgated under the Exchange Act. The purpose of our compensation committee is to discharge the responsibilities of our board of directors relating to compensation of our executive officers. Our compensation committee, among other things:
• reviews, approves and determines, or makes recommendations to our board of directors regarding, the compensation of our executive officers;
• administers our stock and equity incentive plans;
• reviews and approves, or make recommendations to our board of directors regarding, incentive compensation and equity plans; and
• establishes and reviews general policies relating to compensation and benefits of our employees.
Our compensation committee operates under a written charter that satisfies the applicable rules of the SEC and the listing standards of Nasdaq.
Nominating and Corporate Governance Committee
Our nominating and corporate governance committee consists of Mr. Daniel Donovan, and Dr. Mark A. Goldberg, with Dr. Mark A. Goldberg serving as Chairperson. The composition of our corporate governance committee meets the requirements for independence under Nasdaq listing standards and SEC rules and regulations. Our nominating and corporate governance committee, among other things:
• identifies, evaluates and selects, or makes recommendations to our board of directors regarding, nominees for election to our board of directors and its committees;
• evaluates the performance of our board of directors and of individual directors;
• considers and makes recommendations to our board of directors regarding the composition of our board of directors and its committees;
• reviews developments in corporate governance practices;
• oversees environmental, social and governance (ESG) matters;
• evaluates the adequacy of our corporate governance practices and reporting; and
• develops and makes recommendations to our board of directors regarding corporate governance guidelines and matters.
The nominating and corporate governance committee operates under a written charter that satisfies the applicable listing requirements and rules of Nasdaq.
Role of Board of Directors in Risk Oversight Process
Our board of directors has responsibility for the oversight of our risk management processes and, either as a whole or through its committees, regularly discusses with management our major risk exposures, their potential impact on our business and the steps we take to manage them. The risk oversight process includes receiving regular reports from board committees and members of senior management to enable our board of directors to understand our risk identification, risk
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management and risk mitigation strategies with respect to areas of potential material risk, including operations, finance, legal, regulatory, cybersecurity, strategic and reputational risk.
ITEM 11. EXECUTIVE COMPENSATION
The following table presents information regarding the total compensation awarded to, earned by, or paid to our chief executive officer and the two most highly compensated executive officers who were serving as executive officers as of December 31, 2024 for services rendered in all capacities to us for the years ended December 31, 2024 and 2023. These individuals are our named executive officers (“NEOs”) for 2024.
Summary Compensation Table
Name and Principal Position Year Salary ($) Bonus ($) Warrant and Option Awards (1) ($)
All Other Compensation (2) ($)
Total ($)
Lewis H. Bender 2024 544,121 — 1,889,162 52,886 (3)
2,486,169
President and Chief Executive Officer 2023 553,173 (4)
392,250 (5)
— 290,317 (6)
1,235,740
Joseph Talamo (7)
2024 370,000 — 1,245,646 46,930 (8)
1,662,576
Chief Financial Officer 2023 14,231 — 442,140 — 456,371
John Wesolowski 2024 251,347 — 308,231 9,551 (9)
569,129
Principal Accounting Officer and Controller 2023 186,154 67,015 254,920 19,202 (10)
527,291
(1) In accordance with SEC rules, this column reflects the aggregate grant date fair value of the option awards granted during 2024 and 2023 computed in accordance with Financial Accounting Standard Board ASC Topic 718 for stock-based compensation transactions (“ASC 718”). These amounts do not reflect the actual economic value that will be realized by the Named Executive Officer upon the vesting of stock options, the exercise of stock options or the sale of shares of our Common Stock. For a discussion of the assumptions used to value option awards, see the Notes to Financial Statements included in Part II, Item 8 of our Annual Report on Form 10-K.
(2) Information includes perquisite and personal benefit received by each Named Executive Officer.
(3) The amounts reported represent $42,536 of Company-paid portion of health and dental insurance and $10,350 in matching 401(k) contributions.
(4) The amounts reported reflect the deferral of $30,173 of Mr. Bender’s 2022 salary, which was ultimately paid in 2023.
(5) Of this amount, which represents the target bonus paid pursuant to Mr. Bender’s employment agreement, Mr. Bender received $261,500 in cash and the remainder in options to purchase 33,574 shares of Common Stock at an exercise price of $5.19, which options vested in full when granted on March 6, 2024, reflected at the aggregate grant date fair value of the option awards granted computed in accordance with ASC 718.
(6) The amounts reported represent $239,383 of accrued vacation payout in cash, $41,034 of Company-paid portion of health and dental insurance and $9,900 in matching 401(k) contributions.
(7) Mr. Talamo was appointed as Chief Financial Officer effective December 11, 2023.
(8) The amounts reported represent $36,580 of company-paid portion of health and dental insurance and $10,350 in matching 401(k) contributions.
(9) Consists entirely of matching 401(k) contributions.
(10) The amounts reported represent $13,406 of accrued vacation payout in cash and $5,796 in matching 401(k) contributions.
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Narrative Disclosure to Summary Compensation Table
Annual Base Salary
Our NEOs each receive a base salary to compensate them for services rendered to our company. The base salary payable to each named executive officer is intended to provide a fixed component of compensation reflecting the executive’s skill set, experience, role and responsibilities. Base salaries are reviewed annually, typically in connection with our annual performance review process, approved by our board of directors or the compensation committee, and may be adjusted from time to time to realign salaries with market levels after taking into account individual responsibilities, performance, and experience.
For fiscal year 2024, the annual base salaries for each of Mr. Bender, Mr. Talamo, and Mr. Wesolowski were $549,150, $370,000 and $260,000 respectively. For fiscal year 2023, the annual base salaries for each of Mr. Bender, Mr. Talamo and Mr. Wesolowski were $523,000, $370,000 and $215,000 respectively.
Equity-Based Incentive Awards
Our equity award program is the primary vehicle for offering long-term incentives to our executives. We believe that equity awards provide our executives with a strong link to our long-term performance, create an ownership culture and help to align the interests of our executives and our stockholders. The use of options also can provide tax and other advantages relative to other forms of equity compensation.
We award equity grants broadly to our employees, including to our non-executive employees. Grants to our executives, including the NEOs, and other employees are made at the discretion of our board of directors and are generally made upon commencement of employment, promotion or annually. We believe that our equity awards are an important retention tool for our NEOs, as well as for our other employees.
Employment Agreements with our Named Executive Officers
Employment Agreement with Lew Bender
On November 24, 2021, we entered into an Amended and Restated Employment Agreement with Mr. Bender (the “Bender Agreement”). Pursuant to the Bender Agreement, Mr. Bender is entitled to receive a base salary, which is subject to annual review and adjustment by our compensation committee. Mr. Bender’s base salary was $523,000 for the fiscal year ended December 31, 2023 and was increased to $549,150 on March 4, 2024. Mr. Bender’s base salary may not be decreased without his consent. Further, Mr. Bender is eligible to receive an annual lump sum cash bonus not to exceed 75% of his current base salary, to be determined based on the achievement of performance targets, as determined annually by our compensation committee. Mr. Bender is also eligible to receive equity grants pursuant to the 2021 Plan, at the discretion of and with terms and conditions to be set by our compensation committee.
Under the Bender Agreement, Mr. Bender may terminate his employment at any time and for any reason with 90 days’ prior notice. If Mr. Bender’s employment is terminated for Cause or resigns for Good Reason (each term as defined below), he shall be entitled to receive accrued base salary, benefits and vacation time in addition to any unreimbursed expenses (the “Accrued Amounts”).
If Mr. Bender is terminated without Cause or resigns for Good Reason, he shall be entitled to receive (i) subject to his execution and non-revocation of a release, (a) severance payments totaling an amount double Mr. Bender’s base salary and target bonus at the time of his termination or resignation, to be paid in bi-weekly installments over the course of two years following such termination or resignation and (b) a lump sum payment to be made no later than March 15 of the calendar year following the year of termination or resignation in an amount equal to Mr. Bender’s target bonus for the year of termination or registration, prorated by the number of days he was employed by the Company during such year (collectively, the “Severance Pay”), and (ii) (a) the Accrued Amounts and (b) if his termination or resignation occurs between January 1 and March 15, the amount of any unpaid annual bonus from the prior calendar year (the “Accrued Bonus”). However, if Mr. Bender is terminated without Cause or resigns for Good Reason within six months following a Change of Control (as defined below), he shall be entitled to receive the Accrued Amounts and the Accrued Bonus, but in lieu of Severance Pay he shall be entitled to receive (i) a lump sum severance payment, payable at the time of termination or resignation, in an amount equal to two and one-half times the sum of his base salary target annual
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bonus, each as in effect at the time of such termination or resignation, plus (ii) a payment equal to his target annual bonus in effect at the time of termination or resignation, prorated by the number of days he was employed by the Company during such year. If Mr. Bender’s employment is terminated due to death or a certain period of disability, he or his estate shall be entitled to receive (i) the Accrued Amounts, (ii) a payment equal to his target bonus in effect during the year of termination, prorated by the number of days he was employed by the Company during such year, and (iii) if his termination occurs between January 1 and March 15, the amount of any unpaid annual bonus from the prior calendar year.
Pursuant to the Bender Agreement, Mr. Bender is subject to a non-competition provision for the duration of his employment and for a two-year period following such employment. This provision prohibits Mr. Bender from (i) becoming employed by or rendering services to a competitor, (ii) engaging in any competitive business for his own account, (iii) becoming associated with or interested in a competitor by retaining or employing such competitor in certain capacities and (iv) taking any efforts to entice away from the Company any of its customers, employees, consultants, service providers, strategic partners or suppliers. The Bender Agreement also includes customary confidentiality provisions as well as provisions relating to assignment of inventions.
The definitions below are applicable to the Bender Agreement:
Termination for “Cause” is termination by the Company occasioned by (i) the failure by Mr. Bender to cure a breach of a material duty imposed on him under the Bender Agreement or any other written agreement between Executive and the Company, or any policy of the Company, within 10 business days after written notice thereof by the Company, if curable in the reasonable discretion of the board of the directors, (ii) acts by Mr. Bender of fraud, embezzlement, theft, willful misconduct, gross negligence, or other material dishonesty directed against the Company, (iii) the failure or refusal by Mr. Bender to perform any material duties under the Bender Agreement or to follow any lawful and reasonable direction of the Company, which, if curable in the reasonable discretion of the board of directors, has not been cured within 10 business days after written notice thereof by the Company, and (iv) Mr. Bender’s having been formally charged with the commission of a felony (other than a traffic offense) or a crime involving moral turpitude.
Resignation for “Good Reason” is resignation by Mr. Bender due to (i) a material reduction in Mr. Bender’s duties, authority or responsibilities, (ii) relocation of Mr. Bender’s place of employment without his consent to a location more than fifty miles from the Company’s current executive offices or (iii) any material breach by the Company of the Bender Agreement; provided that Mr. Bender cannot terminate employment for Good Reason unless he has provided written notice to the Company of the existence of the circumstances providing grounds for resignation for Good Reason within 90 days of the initial existence of such grounds and the Company has had at least 30 days from the date of such notice to cure such circumstances and fails to do so.
Employment Agreement with Joseph Talamo
On December 11, 2023, we entered into an employment agreement with Joseph Talamo (the “Talamo Agreement”), pursuant to which he serves as Chief Financial Officer of the Company on an at-will basis. Pursuant to the Talamo Agreement, Mr. Talamo is entitled to receive a base salary of $370,000, which is subject to review and adjustment from time to time. Mr. Talamo is also eligible to receive equity grants pursuant to the 2021 Plan, at the discretion of and with terms and conditions to be set by our compensation committee.
Pursuant to the Talamo Agreement, if Mr. Talamo is terminated without Cause or resigns for Good Reason (each term as defined below), he shall be entitled, subject to execution of a release, to receive a lump sum severance payment equal to one month of base salary per year of employment up to a maximum of six months. If he is terminated for Cause, he will not receive any severance. If there is a Change in Control (as defined below) of the Company and Mr. Talamo is terminated without Cause or resigns for Good Reason within six months following such Change in Control, then Mr. Talamo shall be entitled, subject to execution of a release, to receive a lump sum severance payment equal to (i) four months of base month salary if such termination or resignation occurs following one year of employment, (ii) five months of base month salary if such termination or resignation occurs following two years of employment, or (iii) six months of base month salary if such termination or resignation occurs following three or more years of employment.
The definitions below are applicable to the Talamo Agreement:
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Termination for “Cause” is termination by the Company occasioned by actions of Mr. Talamo that are against Company policy, that are illegal or that may lead to serious repercussions for the Company, our employees or our corporate partners. Termination for “Cause” may be necessitated by a serious violation of our code of conduct, inappropriate disclosure of confidential information or trade secrets, or continuous poor performance as determined by our board of directors. “Cause” may also include dereliction of duties, poor relationships with other employees, sexual harassment, or treatment of external parties or partner companies that results in negative outcomes for the Company.
Resignation for “Good Reason” is resignation by Mr. Talamo due to a significant reduction in his responsibilities or authority as an executive, a decrease in his material benefits or compensation not due to financial distress of the Company, or relocation of Company’s current corporate offices to more than 50 miles further away from his current home. Once grounds for resignation for Good Reason arise, Mr. Talamo shall have 60 days to report such grounds and shall provide the Company with 30 days written notice of his resignation for Good Reason.
A “Change in Control” occurs if (i) one person (or more than one person acting as a group) acquires ownership of stock of the Company that, together with the stock held by such person or group, constitutes more than 50% of the total fair market value or total voting power of the Company’s stock, provided that a Change in Control shall not occur if any person (or more than one person acting as a group) owns more than 50% of the total fair market value or total voting power of the Company’s stock and acquires additional stock; (ii) one person (or more than one person acting as a group) acquires (or has acquired during the twelve-month period ending on the date of the most recent acquisition) ownership of the Company’s stock possessing 50% or more of the total voting power of the Company’s stock; or (iii) a majority of the members of our board of directors are replaced during any twelve-month period by directors whose appointment or election is not endorsed by a majority of the board of directors before the date of appointment or election.
The Talamo Agreement includes customary confidentiality provisions as well as provisions relating to assignment of inventions. The Talamo Agreement also includes a non-competition provision that applies for the duration of his employment and for a one-year period following such employment.
Employment Agreement with John Wesolowski
On June 20, 2023, we entered into an employment agreement with John Wesolowski (the “Wesolowski Agreement”), pursuant to which he serves as Principal Accounting Officer and Controller of the Company on an at-will basis. Pursuant to the Wesolowski Agreement, Mr. Wesolowski is entitled to receive a base salary which is subject to review and adjustment from time to time. Mr. Wesolowski’s initial base salary pursuant to the Wesolowski Agreement was $165,000, and it was increased to $215,000 on July 22, 2023, and to $260,000 on March 4, 2024. Mr. Wesolowski is also eligible to receive equity grants pursuant to the 2021 Plan, at the discretion of and with terms and conditions to be set by our compensation committee.
The Wesolowski Agreement includes customary confidentiality provisions as well as provisions relating to assignment of inventions. The Wesolowski Agreement also includes a non-competition provision that applies for the duration of his employment and for a one-year period following such employment.
All Other Compensation
All other compensation includes: 1) medical and dental insurance; and 2) 401(k) plan matching contribution reflecting 3% of eligible earnings.
Outstanding Equity Awards at Fiscal Year End
The following table presents the outstanding equity awards held by each of our named executive officers as of December 31, 2024:
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Option Awards
Name Number of securities underlying unexercised options exercisable (#) Number of securities underlying unexercised options
unexercisable (#) Option exercise price ($) Option expiration date
Lewis H. Bender 75,000 – 9.00 8/6/2029
75,000 – 11.50 7/31/2030
75,000 – 11.50 8/13/2031
56,250 18,750 (1)
9.00 12/13/2032
116,201 348,604 (2)
5.19 3/6/2034
33,574 – 5.19 3/6/2034
Joseph Talamo 20,000 60,000 (3)
6.88 12/11/2033
85,476 341,903 (4)
3.44 10/21/2034
John Wesolowski 14,000 – 4.00 3/27/2027
7,500 – 8.00 2/6/2028
2,500 – 9.00 7/11/2029
6,250 – 11.50 7/31/2030
4,500 1,500 (5)
11.50 8/13/2031
4,875 1,625 (6)
11.50 9/5/2031
6,250 6,250 (7)
9.00 12/13/2032
25,000 25,000 (8)
6.43 7/19/2033
– 25,000 (9)
5.19 3/6/2034
14,006 56,022 (10)
3.44 10/21/2034
(1) Consists of options granted to Mr. Bender by our compensation committee on December 13, 2022, vesting in four equal annual installments beginning on the grant date.
(2) Consists of options granted to Mr. Bender by our compensation committee on March 6, 2024, vesting in four equal annual installments beginning on the grant date.
(3) Consists of options granted to Mr. Talamo by our compensation committee on December 11, 2023, vesting in four equal annual installments beginning on the first anniversary of the date of grant.
(4) Consists of options granted to Mr. Talamo by our compensation committee on October 21, 2024, vesting in five equal annual installments beginning on the date of grant.
(5) Consists of options granted to Mr. Wesolowski by our compensation committee on August 13, 2021, vesting in four equal annual installments beginning on the first anniversary of the date of grant.
(6) Consists of options granted to Mr. Wesolowski by our compensation committee on September 5, 2021, vesting in four equal annual installments beginning on the first anniversary of the date of grant.
(7) Consists of options granted to Mr. Wesolowski by our compensation committee on December 13, 2022, vesting in four equal annual installments beginning on the first anniversary of the date of grant.
(8) Consists of options granted to Mr. Wesolowski by our compensation committee on July 19, 2023, vesting in four equal annual installments beginning on the grant date.
(9) Consists of options granted to Mr. Wesolowski by our compensation committee on March 6, 2024, vesting in four equal annual installments beginning on the first anniversary date of grant.
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(10) Consists of options granted to Mr. Wesolowski by our compensation committee on October 21, 2024, vesting in five equal annual installments beginning on the date of grant.
2013 Stock and Option Plan
Under our 2013 Stock and Option Plan (the “2013 Plan”), 4,500,000 shares of Common Stock have been reserved for issuance in the form of incentive stock options, non-qualified stock options, restricted stock, unrestricted stock, stock appreciation rights or any combination of the foregoing. The shares issuable pursuant to awards granted under the 2013 Plan are authorized but unissued shares.
The 2013 Plan is administered by our board or at the discretion of the board, which has full power to select the individuals to whom awards will be granted and to determine the specific terms and conditions of each award, subject to the provisions of the 2013 Plan. Pursuant to the 2013 Plan and subject to applicable law, our board of directors has delegated to the compensation committee the power to make recommendations to the board of directors relating to management compensation, the adoption of employee benefit plans, stock option or equity incentive plans and other similar matters.
The option exercise price of each option granted under the 2013 Plan is determined by our board of directors and may not be less than the fair market value of a share of Common Stock on the date of grant. The term of each option is fixed by the board and may not exceed 10 years from the date of grant. The board determines at what time or times each option may be exercised when granting the option.
The 2013 Plan provides that, upon the consummation of a sale event, unless provision is made in connection with the sale event for the assumption or continuation of the awards by the successor entity or substitution of the awards with new awards of the successor entity, with appropriate adjustment, the 2013 Plan and all outstanding and unexercised options issued thereunder will terminate upon the effective time of the sale event. We may make or provide for cash payment to holders of options equal to the difference between (i) the per share cash consideration in the sale event multiplied by the number of shares subject to outstanding options being cancelled, and (ii) the aggregate exercise price to the holders of all vested and exercisable options.
Our board of directors may amend the 2013 Plan but no such action may adversely affect the rights of an award holder without such holder’s consent. Approval by our stockholders of amendments to the 2013 Plan must be obtained if required by law.
The 2013 Plan terminated in August 2023 on the tenth anniversary of the 2013 Plan’s date of adoption by the board. No new awards were made under the 2013 Plan after such termination date, but awards previously granted may extend beyond such date.
2021 Stock Incentive Plan
On November 12, 2021, we adopted a new equity incentive plan, the 2021 Stock Incentive Plan (the “2021 Plan”). Under the 2021 Plan, we may grant cash and equity incentive awards to eligible service providers in order to attract, motivate and retain the talent for which we compete. The material terms of the 2021 Plan are summarized below.
Types of Awards. The 2021 Plan provides for the grant of non-qualified stock options (“NQSOs”), incentive stock options (“ISOs”), restricted stock awards, restricted stock units (“RSUs”), unrestricted stock awards, stock appreciation rights and other forms of stock-based compensation.
Eligibility and Administration. Employees, officers, consultants, directors, and other service providers of the Company and its affiliates are eligible to receive awards under the 2021 Plan. The 2021 Plan is administered by the board with respect to awards to non-employee directors and by the Compensation Committee with respect to other participants, each of which may delegate its duties and responsibilities to committees of the company’s directors and/or officers (all such bodies and delegates referred to collectively as the plan administrator), subject to certain limitations that may be imposed under Section 16 of the Exchange Act, and/or other applicable law or stock exchange rules, as applicable. The plan administrator has the authority to make all determinations and interpretations under, prescribe all forms for use with, and adopt rules for the administration of, the 2021 Plan, subject to its express terms and conditions. The plan administrator also sets the terms and conditions of all awards under the 2021 Plan, including any vesting and vesting acceleration conditions.
Share Reserve. Pursuant to the 2021 Plan, we have reserved 3,000,000 shares of the Common Stock for issuance thereunder, which reserve shall be increased annually beginning on January 1, 2022 and ending on and including January 1, 2031, equal to the lesser of (A) 3.5% of the aggregate number of shares of Common Stock outstanding on the final day of
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the immediately preceding calendar year or (B) such smaller number of shares as is determined by our board. The share reserve is subject to the following adjustments:
• The share limit is increased by the number of shares subject to awards granted that later are forfeited, expire or otherwise terminate without issuance of shares, or that are settled for cash or otherwise do not result in the issuance of shares.
• Shares that are withheld upon exercise to pay the exercise price of a stock option or satisfy any tax withholding requirements are added back to the share reserve and again are available for issuance under the 2021 Plan.
Pursuant to the provisions of the 2021 Plan, the authorized shares were increased from 3,000,000 to 3,238,700 effective January 1, 2023. On January 1, 2024, pursuant to the provisions of the 2021 Plan, authorized shares increased by 479,828 shares. As of December 31, 2024, options to purchase 1,881,649 shares of Common Stock were available to be issued under the 2021 Plan. On January 1, 2025, pursuant to the provisions of the 2021 Plan, authorized shares increased by 529,300 shares.
Awards issued in substitution for awards previously granted by a company that merges with, or is acquired by, the Company do not reduce the share reserve limit under the 2021 Plan.
Director Compensation. The 2021 Plan provides for an annual limit on non-employee director compensation of $500,000, increased to $750,000 in the fiscal year of a non-employee director’s initial service as a non-employee member of the board of directors of the Company. This limit applies to the sum of both equity grants that could be awarded to non-employee directors during a fiscal year (based on their value under ASC Topic 718 on the grant date) and cash compensation, such as cash retainers and meeting fees earned during a fiscal year. Notwithstanding the foregoing, the board reserves the right to make an exception to these limits due to extraordinary circumstances without the participation of the affected director receiving the additional compensation.
Stock Options. ISOs may be granted only to employees of the Company, or to employees of a parent or subsidiary of the Company, determined as of the date of grant of such options. An ISO granted to a prospective employee upon the condition that such person becomes an employee shall be deemed granted effective on the date such person commences employment. The exercise price of an ISO shall not be less than 100% of the fair market value of the shares covered by the awards on the date of grant of such option or such other price as may be determined pursuant to the Internal Revenue Code of 1986, as amended from time to time (the “Code”). Notwithstanding the foregoing, an ISO may be granted with an exercise price lower than the minimum exercise price set forth above if such award is granted pursuant to an assumption or substitution for another option in a manner that complies with the provisions of Section 424(a) of the Code. Notwithstanding any other provision of the 2021 Plan to the contrary, no ISO may be granted under the 2021 Plan after 10 years from the date that the 2021 Plan was adopted. No ISO shall be exercisable after the expiration of 10 years after the effective date of grant of such award, subject to the following sentence. In the case of an ISO granted to a ten percent stockholder, (i) the exercise price shall not be less than 110% of the fair market value of a share on the date of grant of such ISO, and (ii) the exercise period shall not exceed 5 years from the effective date of grant of such ISO.
Restricted Stock and Restricted Stock Units. The committee may award restricted stock and RSUs under the 2021 Plan. Restricted stock awards consist of shares of stock that are transferred to the participant subject to restrictions that may result in forfeiture if specified vesting conditions are not satisfied. RSU awards result in the transfer of shares of stock to the participant only after specified vesting conditions are satisfied. A holder of restricted stock is treated as a current stockholder and shall be entitled to dividend and voting rights, whereas the holder of a restricted stock unit is treated as a stockholder with respect to the award only when the shares are delivered in the future. RSUs may include dividend equivalents. Specified vesting conditions may include performance goals to be achieved during any performance period and the length of the performance period. The committee may, in its discretion, make adjustments to performance goals based on certain changes in the Company’s business operations, corporate or capital structure or other circumstances. When the participant satisfies the conditions of an RSU award, the Company may settle the award (including any related dividend equivalent rights) in shares, cash or other property, as determined by the committee, in its sole discretion.
Other Shares or Share-Based Awards. The committee may grant other forms of equity-based or equity-related awards other than stock options, restricted stock or restricted stock units. The terms and conditions of each stock-based award shall be determined by the committee.
Clawback Rights. Awards granted under the 2021 Plan will be subject to recoupment or clawback under the Company’s clawback policy or applicable law, both as in effect from time to time.
Sale of the Company. Awards granted under the 2021 Plan automatically accelerate and vest, become exercisable (with respect to stock options), or have performance targets deemed earned at target level if there is a sale of the Company.
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The Company does not use a “liberal” definition of change in control as defined in Institutional Shareholder Services’ proxy voting guidelines.
No Repricing. The 2021 Plan prohibits the amendment of the terms of any outstanding award, and any other action taken in a manner to achieve (i) the reduction of the exercise price of NQSOs, ISOs or stock appreciation rights (collectively, “Stock Rights”); (ii) the cancellation of outstanding Stock Rights in exchange for cash or other awards with an exercise price that is less than the exercise price or base price of the original award; (iii) the cancellation of outstanding Stock Rights with an exercise price or base price that is less than the then current fair market value of a share of Common Stock in exchange for other awards, cash or other property; or (iv) otherwise effect a transaction that would be considered a “repricing” for the purposes of the stockholder approval rules of the applicable securities exchange or inter-dealer quotation system on which the Common Stock is listed or quoted without stockholder approval.
Transferability of Awards. Except as described below, awards under the 2021 Plan generally are not transferable by the recipient other than by will or the laws of descent and distribution. Any amounts payable or shares issuable pursuant to an award generally will be paid only to the recipient or the recipient’s beneficiary or representative. The committee has discretion, however, to permit certain transfer of awards to other persons or entities.
Adjustments. As is customary in incentive plans of this nature, each share limit and the number and kind of shares available under the 2021 Plan and any outstanding awards, as well as the exercise price or base price of awards, and performance targets under certain types of performance-based awards, are subject to adjustment in the event of certain reorganizations, mergers, combinations, recapitalizations, stock splits, stock dividends, or other similar events that change the number or kind of shares outstanding, and extraordinary dividends or distributions of property to the stockholders. The number of shares available under the 2021 Plan was not adjusted as part of the Reverse Split.
Amendment and Termination. The board of directors may amend, modify or terminate the 2021 Plan without stockholder approval, except that stockholder approval must be obtained for any amendment that, in the reasonable opinion of the board or the committee, constitute a material change requiring stockholder approval under applicable laws, policies or regulations or the applicable listing or other requirements of a stock exchange on which shares of Common Stock are then listed. The 2021 Plan will terminate upon the earliest of (1) termination of the 2021 Plan by the board of directors, or (2) the tenth anniversary of the board adoption of the 2021 Plan. Awards outstanding upon expiration of the 2021 Plan shall remain in effect until they have been exercised or terminated, or have expired.
Director Compensation
The following table provides certain information concerning compensation for each person who served as a non-employee member of our board of directors for the year ended December 31, 2024. Lewis H. Bender, our President and Chief Executive Officer, serves as a member of our board of directors and receives no additional compensation for his services as a member of our board of directors. See the section titles “Executive Compensation” in Item 11 for more information about Mr. Bender’s compensation for the year ended December 31, 2024. We reimburse non-employee members of our board of directors for reasonable travel and out-of-pocket expenses incurred in attending meetings of our board of directors and committees of our board of directors. All fees under the director compensation policy are paid on a quarterly basis in arrears and no meeting fees are paid.
Name Fees Earned or
Paid in Cash
($) Option
Awards
($) (1)
Total
($)
Dr. Emer Leahy 67,000 203,220 (2)
270,220
Dr. Mark A. Goldberg 67,000 203,220 (3)
270,220
Mr. Daniel Donovan 62,500 203,220 (4)
265,720
Mr. Thomas I. H. Dubin 31,250 183,700 (5)
214,950
(1) Amounts shown under “Option Awards” represent the aggregate grant date fair value computed in accordance with FASB ASC Topic 718, in accordance with SEC rules. See Note 9 to the Notes to the Consolidated
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Financial Statements in our 2024 Form 10-K for a discussion of assumptions made in such valuations. All stock awards, option awards and other shares discussed in this table were issued under Intensity’s 2021 Plan.
(2) On March 6, 2024, Dr. Leahy was granted 50,000 options, vesting in four equal annual installments beginning on the grant date.
(3) On March 6, 2024, Dr. Goldberg was granted 50,000 options, vesting in four equal annual installments beginning on the grant date.
(4) On March 6, 2024, Mr. Donovan was granted 50,000 options, vesting in four equal annual installments beginning on the grant date.
(5) On May 14, 2024, Mr. Dubin was granted 50,000 options, vesting in four equal annual installments beginning on the grant date.
Non-Employee Director Compensation Policy
Our board of directors has adopted a non-employee director compensation policy that is designed to enable us to attract and retain, on a long-term basis, highly qualified non-employee directors. Under the policy, each director who is not an employee will be paid cash compensation as set forth below:
ANNUAL RETAINER
Board of Directors:
All non-employee members
$ 40,000
Audit Committee:
Chair
$ 20,000
Members
$ 10,000
Compensation Committee:
Chair
$ 15,000
Members
$ 7,000
Nominating and Corporate Governance Committee:
Chair
$ 10,000
Members
$ 5,000
Compensation Committee Interlocks and Insider Participation
The Compensation Committee of the Board of Directors is currently composed of the following three non-employee directors: Dr. Emer Leahy, Dr. Mark Goldberg, and Mr. Daniel Donovan. No member of the Compensation Committee is or was formerly an officer or employee of the Company during the last fiscal year. In addition, no executive officer of the Company serves on the compensation committee or board of directors of a company for which any of the Company’s directors serve as an executive officer. See Item 13.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth the number of shares of Common Stock beneficially owned as of March 1, 2025 by:
• each of our stockholders who is known by us to beneficially own 5% or more of our Common Stock;
• each of our named executive officers;
• each of our directors; and
• all of our directors and current executive officers as a group.
Beneficial ownership is determined based on the rules and regulations of the SEC. A person has beneficial ownership of shares if such individual has the power to vote and/or dispose of shares. This power may be sole or shared and direct or indirect. Applicable percentage ownership in the following table is based on 15,180,945 shares outstanding as of March 1, 2025. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of Common Stock that are subject to options or warrants held by that person and exercisable as of, or within
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60 days of March 1, 2025, are counted as outstanding. These shares, however, are not counted as outstanding for the purposes of computing the percentage ownership of any other person(s). Except as may be indicated in the footnotes to this table and pursuant to applicable community property laws, each person named in the table has sole voting and dispositive power with respect to the shares of Common Stock set forth opposite that person’s name. Unless indicated below, the address of each individual listed below is c/o Intensity Therapeutics Inc., 1 Enterprise Drive, Suite 430, Shelton, CT 06484-4779.
Name of Beneficial Owner Number of Shares
Beneficially Owned Percentage of Shares
Beneficially Owned
Directors and Executive Officers
Lewis H. Bender (1)
2,567,227 16.3 %
Joseph Talamo (2)
105,476 *
John Wesolowski (3)
97,822 *
Emer Leahy (4)
116,500 *
Mark A. Goldberg (5)
106,500 *
Daniel Donovan (6)
43,750 *
Thomas I. H. Dubin (7)
12,500 *
Directors and Executive Officers as a group (7 persons) (8)
3,049,775 18.8 %
5% Stockholders
Leonard Batterson (9)
2,476,213 16.3 %
Armistice Capital, LLC (10)
1,126,868 7.4 %
Craig J. Duchossois (11)
1,062,753 7.0 %
* Less than 1%
(1) Includes 547,227 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 251,153 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
(2) Includes 105,476 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 401,903 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
(3) Includes 91,131 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 109,147 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
(4) Includes 116,500 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 31,250 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
(5) Includes 106,500 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 31,250 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
(6) Includes 43,750 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 31,250 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
(7) Includes 12,500 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 37,500 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
(8) Includes 1,023,084 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025. Does not include 893,453 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.
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(9) Consists of (i) 2,023,227 shares of Common Stock held by VCapital Intensity LLC, (ii) 427,986 shares of Common Stock held by BVC — Intensity LLC and (iii) 25,000 shares of Common Stock issuable upon the exercise of warrants exercisable within 60 days after March 1, 2025. Batterson may be deemed to beneficially own such shares. The principal business address of VCapital Intensity LLC and BVC — Intensity LLC is 901 W. Jackson Blvd., Suite 503 Chicago, IL 60607.
(10) This information is based solely on a Schedule 13G filed with the SEC on February 14, 2025. Consists of 1,126,868 shares of Common Stock directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master Fund”), and may be deemed to be beneficially owned by: (i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. The address of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022. Does not include 1,237,113 shares of common stock issuable upon the exercise of warrants held by the Master Fund that are subject to a beneficial ownership limitation of 4.99% and are not exercisable within sixty days of March 1, 2025.
(11) Consists of (i) 1,010,753 shares of Common Stock and (ii) 52,000 shares of Common Stock issuable upon the exercise of warrants exercisable within 60 days after March 1, 2025. All shares are held by Craig J. Duchossois Revocable Trust UAD 9/11/1989. Mr. Duchossois may be deemed to beneficially own such shares. The principal business address of Craig J. Duchossois is 444 W. Lake St, Suite 2000, Chicago, Illinois 60606.
The following table summarizes information about our equity compensation plans as of December 31, 2024.
Plan Category Number of Shares of
Common Stock to be
Issued upon Exercise of
Outstanding Options (1) Weighted-Average
Exercise Price of
Outstanding Options Number of
Options
Remaining
Available for
Future Issuance
Under Equity
Compensation
Plans (excluding
securities
reflected in
column (a))(2)
(a) (b) (c)
Equity compensation plans approved by stockholders 2,587,129 $ 6.14 1,881,649
Equity compensation plans not approved by stockholders - - -
Total 2,587,129 $ 6.14 1,881,649
(1) The amounts shown in this column include securities under both the 2013 Plan and 2021 Plan.
(2) Consists entirely of securities under the 2021 Plan. In accordance with the provisions in our 2021 Plan, the Board authorized that an additional 529,300 shares would become available for issuance on January 1, 2025, which represents approximately 3.5% of the shares outstanding on December 31, 2024. These shares are excluded from this calculation.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
In addition to the compensation arrangements, including employment, termination of employment and change in control arrangements and indemnification arrangements, discussed, when required, in the sections titled “Management” and “Executive Compensation,” the following is a description of each transaction since January 1, 2024 and each currently proposed transaction in which:
• we have been or are to be a participant;
• the amount involved exceeded or exceeds the lesser of $120,000 or 1% of our assets; and
• any of our directors, executive officers or holders of more than 5% of our capital stock, or any immediate family member of, or person sharing the household with, any of these individuals, had or will have a direct or indirect material interest.
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Convertible Note with Shareholder
On September 20, 2021, we entered into a convertible debt agreement (the “2021 Convertible Note”) for aggregate principal of $2,000,000. On November 29, 2022, and again February 8, 2023, we amended the 2021 Convertible Note to reflect new terms upon the Company’s IPO or equity financing (the “2021 Amended Note”). Pursuant to the terms of the 2021 Amended Note, the maturity date is October 1, 2025, and has the following conversion terms. The outstanding principal balance together with the unpaid and accrued interest of the note will be automatically converted upon the earliest of (i) an IPO in excess of $8,000,000 gross proceeds, (ii) a sale event of all or substantially all of the company’s assets or a majority of its equity securities, (iii) non-IPO financing by selling preferred stock in an equity offering other than an IPO or (iv) the maturity date of October 1, 2025. If an IPO, sale event or non-IPO financing occurs between November 29, 2022 through March 20, 2023 a conversion price discount of 30% would be assessed, if between March 20, 2023 through October 1, 2025 a conversion price discount of 35% would be assessed. Otherwise at the maturity date a conversion price of $11.50 per share would be assessed. The 2021 Amended Note accrues interest at 3% per annum, but will increase to 6% per annum after October 1, 2023, and is convertible to shares of our Common Stock. The occurrence of any of the following shall constitute an event of default: a) failure to pay when due any principal payment; b) voluntary bankruptcy or insolvency proceedings; c) involuntary bankruptcy or insolvency proceedings; d) judgements in excess of $500,000; or e) defaults under other indebtedness. Under these occurrences, the holder may declare all outstanding principal and interest payable to be immediately due and payable. The 2021 Amended Note automatically converted upon the IPO into 648,109 shares of Common Stock.
On November 29, 2022, we entered into a convertible debt agreement (the “2022 Convertible Note”) for $1,500,000. On February 8, 2023, we amended the 2022 Convertible Note (the “2022 Convertible Note Amendment”) to reflect new terms upon the Company’s IPO or equity financing. The outstanding principal balance together with the unpaid and accrued interest of the note will be automatically converted upon the earliest of (i) an IPO of no less than $8,000,000 gross proceeds, (ii) a sale event of all or substantially all of the company’s assets or a majority of its equity securities, (iii) non-IPO financing by selling preferred stock in an equity offering other than an IPO or (iv) the maturity date of October 1, 2025. If an IPO, sale event or non-IPO financing occurs prior to October 1, 2025, a conversion price discount of 30% would be assessed. Otherwise at the maturity date a conversion price would be $11.50 per share be assessed. The 2022 Amended Note automatically converted upon the IPO into 453,463 shares of Common Stock.
On March 30, 2023, we entered into a convertible debt agreement (the “2023 Convertible Note”) for $155,000. The outstanding principal balance together with the unpaid and accrued interest would be automatically converted upon the earliest of (i) an IPO of no less than $7,000,000 in gross proceeds, (ii) a sale event of all or substantially all of the Company’s assets or a majority of its equity securities, (iii) non-IPO financing by selling preferred stock in an equity offering other than an IPO or (iv) the maturity date of March 30, 2026. If an IPO, sale event or non-IPO financing occurs prior to March 30, 2026, a conversion price discount of 30% would be assessed; otherwise at the maturity date a conversion price would be $11.50 per share would be assessed. This note converted into 45,389 shares of Common Stock at our IPO.
The 2021 Amended Note, the 2022 Convertible Note Amendment and the 2023 Convertible Note were entered into with Leonard Batterson, one of our 10% shareholders.
Indemnification Agreements
We entered into indemnification agreements with our directors and executive officers. The indemnification agreements provide for indemnification against expenses, judgments, fines and penalties actually and reasonably incurred by an indemnitee in connection with threatened, pending or completed actions, suits or other proceedings, subject to certain limitations. The indemnification agreements also provide for the advancement of expenses in connection with a proceeding prior to a final, non-appealable judgment or other adjudication, provided that the indemnitee provides an undertaking to repay to us any amounts advanced if the indemnitee is ultimately found not to been titled to indemnification by us. The indemnification agreement set forth procedures for making and responding to a request for indemnification or advancement of expenses, as well as dispute resolution procedures that apply to any dispute between us and an indemnitee arising under the Indemnification Agreements.
Policies and Procedures for Related Party Transactions
We have adopted a policy that our executive officers, directors, nominees for election as a director, beneficial owners of more than 5% of any class of our Common Stock, any members of the immediate family of any of the foregoing persons and any firms, corporations or other entities in which any of the foregoing persons is employed or is a partner or principal or in a similar position or in which such person has a 5% or greater beneficial ownership interest, which we refer
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to collectively as related parties, are not permitted to enter into a transaction with us without the prior consent of our board of directors acting through the audit committee or, in certain circumstances, the chairman of the audit committee. Any request for us to enter into a transaction with a related party, in which the amount involved exceeds $100,000 and such related party would have a direct or indirect interest must first be presented to our audit committee, or in certain circumstances the chairman of our audit committee, for review, consideration and approval. In approving or rejecting any such proposal, our audit committee, or the chairman of our audit committee, is to consider the material facts of the transaction, including, but not limited to, whether the transaction is on terms no less favorable than terms generally available to an unaffiliated third party under the same or similar circumstances, the extent of the benefits to us, the availability of other sources of comparable products or services and the extent of the related party’s interest in the transaction.
Director Independence
Based on information requested from and provided by each of our directors, our board of directors has determined that Messrs. Mark Goldberg and Daniel Donovan and Ms. Emer Leahy are “independent directors” as such term is defined in the rules of the Nasdaq’s corporate governance requirements and Rule 10A-3 promulgated under the Securities Exchange Act of 1934, as amended.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table represents aggregate fees billed to the Company for fiscal years ended December 31, 2024 and 2023, by EisnerAmper LLP, the Company’s independent registered public accounting firm. Amounts are rounded to thousands.
Years Ended December 31,
2024 2023
Audit Fees $ 364,875 $ 467,250
Audit-Related Fees - -
Tax Fees - -
All Other Fees - -
Total Fees $ 364,875 $ 467,250
Audit Fees consist of fees billed for professional services rendered for the audit of our annual financial statements, review of our interim financial statements, comfort and consent letters. Audit fees include fees for consents and comfort letters of $112,875 in 2024 and $195,000 in 2023.
Audit-Related Fees consist of fees billed for professional services rendered for assurance related services that are reasonably related to the performance of the audit or review of our financial services.
Tax Fees are for tax-related services related primarily to tax consulting and planning.
All Other Fees consist of the aggregate fees billed for any other products and services provided by the principal accountants.
Pre-Approval Policies and Procedures
The Audit Committee pre-approves all auditing services and any non-audit services that the independent registered public accounting firm is permitted to render under Section10A (h) of the Exchange Act. The Audit Committee may delegate the pre-approval to one of its members, provided that if such delegation is made, the full Audit Committee must be presented at its next regularly scheduled meeting with any pre-approval decision made by that member.
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PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a) The following documents are filed as part of this report:
(1) Financial Statements
See Index to Consolidated Financial Statements as Part II Item 8 “Financial Statements and Supplementary Data.”
(2) Financial Statement Schedules
The financial statement schedules are omitted as they are either not applicable or the information required is presented in the financial statements and notes thereto under Part II Item 8. “Financial Statements and Supplementary Data.”
Exhibit No. Description
3.1 Sixth Amended and Restated Certificate of Incorporation of the Registrant, dated June 30, 2023 (incorporated by reference to Exhibit 3.1 of our Form 8-K filed on July 5, 2023).
3.2 Second Amended and Restated Bylaws, dated November 21, 2023 (incorporated by reference to Exhibit 3.1 of our Form 8-K filed on November 22, 2023).
4.1* Description of Securities
4.2 Specimen Common Stock Certificate evidencing the shares of Common Stock (incorporated by reference to Exhibit 4.1 of our Form S-1 filed on June 29, 2023).
4.3 Representative’s Warrant (incorporated by reference to Exhibit 4.1 of our Form 8-K filed on July 5, 2023).
4.4 Form of Common Warrant (incorporated by reference to Exhibit 4.1 of our Form 8-K filed on November 22, 2024).
10.1 Form of Indemnification Agreement by and between the Registrant and each of its directors and executive officers (incorporated by reference to Exhibit 10.1 of our Form S-1 filed on June 29, 2023).
10.2# 2013 Stock and Option Plan, as amended (incorporated by reference to Exhibit 10.2 of our Form S-1 filed on June 29, 2023).
10.3# 2021 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 of our Form S-1 filed on June 29, 2023).
10.4# Amended and Restated Employment Agreement between the Registrant and Lewis H. Bender (incorporated by reference to Exhibit 10.4 of our Form S-1 filed on June 29, 2023).
10.5† Clinical Trial Collaboration and Supply Agreement, dated April 13, 2020, between the Registrant and Bristol-Myers Squibb Company (incorporated by reference to Exhibit 10.8 of our Form S-1 filed on June 29, 2023).
10.6† Clinical Trial Collaboration and Supply Agreement, dated June 21, 2019, between the Registrant and MSD International GmbH (incorporated by reference to Exhibit 10.9 of our Form S-1 filed on June 29, 2023).
10.7† Material Transfer and Collaboration Agreement, dated March 18, 2021, between the Registrant and Ontario Institute for Cancer Research, Ottawa Hospital Research Institute and Dr. Angel Arnaout (incorporated by reference to Exhibit 10.10 of our Form S-1 filed on June 29, 2023).
10.8# Employment Agreement, dated June 20, 2023, between Registrant and John Wesolowski (incorporated by reference to Exhibit 10.15 of our Form S-1 filed on June 29, 2023).
10.9 Underwriting Agreement, dated June 29, 2023 (incorporated by reference to Exhibit 10.1 of our Form 8-K filed on July 5, 2023)
10.10# Employment Agreement, dated December 11, 2023 between Registrant and Joseph Talamo (incorporated by reference to Exhibit 10.1 of our Form 8-K filed on December 12, 2023)
10.11# Incentive Compensation Plan (incorporated by reference to Exhibit 10.1 of our Form 8-K filed on February 7, 2024)
10.12 Collaboration Agreement, dated May 6, 2024, between the Registrant and The Swiss Group for Cancer Research SAKK (incorporated by reference to Exhibit 10.1 of our Form 10-Q filed on August 8, 2024).
10.13 Intensity Therapeutics, Inc. 2024 Employee Stock Purchase Plan (incorporated by reference to Appendix A to our Definitive Proxy Statement on Schedule 14A, filed on June 4, 2024).
10.14 Form of Placement Agent Agreement dated November 21, 2024, by and between the Company and A.G.P./Alliance Global Partners and Brookline Capital Markets, a division of Arcadia Securities, LLC (incorporated be reference to Exhibit 1.1 of our Form 8-K filed on November 22, 2024).
10.15 Form of Securities Purchase Agreement, dated as of November 21, 2024, by and between Intensity Therapeutics, Inc. and the purchasers party thereto (incorporated by reference to Exhibit 10.1 of our Form 8-K filed on November 22, 2024).
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19.1* Insider Trading Policy.
21.1 List of subsidiaries of the Company (incorporated by reference to Exhibit 21.1 of our Form S-1 filed on June 29, 2023)
23.1* Consent of Independent Registered Public Accounting Firm
31.1* Certification of CEO Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of CFO Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1** Certification of CEO Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2** Certification of CFO Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
97.1 Clawback Polic y (in corporated by reference to Exhibit 97.1 of our Form 10-K filed on March 14, 2024)
101.INS* Inline XBRL Instance Document
101.SCH* Inline XBRL Taxonomy Extension Schema Document.
101.CAL* Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF* Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB* Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE* Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104* Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
______________________________________
# Indicates a management contract or compensatory plan or arrangement.
† Certain information has been excluded from the exhibit because it both (i) is not material and (ii) would likely cause competitive harm to the Registrant if publicly disclosed.
* Filed herewith.
** Furnished herewith.
ITEM 16. FORM 10-K SUMMARY
None
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .
Intensity Therapeutics, Inc.
Date: March 13, 2025
By: /s/ Lewis H. Bender
Lewis H. Bender
President, Chief Executive Officer and Chairman
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name Title Date
/s/ Lewis H. Bender President, Chief Executive Officer and Chairman March 13, 2025
Lewis H. Bender (principal executive officer)
/s/ Joseph Talamo Chief Financial Officer March 13, 2025
Joseph Talamo (principal financial officer)
/s/ John Wesolowski
Principal Accounting Officer and Controller March 13, 2025
John Wesolowski (principal accounting officer)
/s/ Daniel Donovan Director March 13, 2025
Daniel Donovan
/s/ Dr. Emer Leahy Director March 13, 2025
Dr. Emer Leahy
/s/ Dr. Mark A. Goldberg Director March 13, 2025
Dr. Mark A. Goldberg
/s/ Thomas I. H. Dubin Director March 13, 2025
Thomas I. H. Dubin
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INTENSITY THERAPEUTICS, INC.
INDEX TO FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB # 274 )
Financial Statements
Balance sheets as of December 31, 202 4 and 202 3
F- 3
Statements of operations for the years ended December 31, 202 4 and 202 3
F- 4
Statements of changes in redeemable convertible preferred stock and stockholders’ equity (deficiency) for the years ended December 31, 202 4 and 202 3
F- 5
Statements of cash flows for the years ended December 31, 202 4 and 202 3
F- 6
Notes to December 31, 202 4 and 202 3 financial statements
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Intensity Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Intensity Therapeutics, Inc. (the “Company”) as of December 31, 2024 and 2023, and the related statements of operations, changes in redeemable convertible preferred stock and stockholders’ equity (deficiency), and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has incurred losses from operations and negative cash flows that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
We have served as the Company’s auditor since 2017.
/s/ EisnerAmper LLP
EISNERAMPER LLP
New York, New York
March 13, 2025
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INTENSITY THERAPEUTICS, INC.
BALANCE SHEETS
(in thousands, except share and per share amounts)
December 31,
2024 2023
ASSETS
Current assets:
Cash and cash equivalents $ 2,590 $ 8,556
Marketable debt securities — 6,220
Prepaid expenses and other current assets 773 688
Total current assets 3,363 15,464
Right-of-use asset, net 122 147
Other assets 1,298 1,684
Total assets $ 4,783 $ 17,295
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 1,219 $ 3,048
Accrued expenses 508 891
Lease liability, current portion 28 20
Total current liabilities 1,755 3,959
Other long-term liabilities — 36
Lease liability, net of long-term portion 110 138
Total liabilities $ 1,865 $ 4,133
Commitments and contingencies
STOCKHOLDERS’ EQUITY
Preferred stock, par value $ .0001 . Authorized shares of 15,000,000 as of both December 31, 2024 and 2023, respectively. None issued and outstanding as of both December 31, 2024 and 2023, respectively.
— —
Common stock, par value $ .0001 . Authorized shares of 135,000,000 as of both December 31, 2024 and 2023, respectively. Issued and outstanding shares of 15,122,873 and 13,709,377 as of December 31, 2024 and 2023, respectively.
2 1
Additional paid-in capital 69,699 63,676
Accumulated deficit ( 66,783 ) ( 50,515 )
Total stockholders’ equity $ 2,918 $ 13,162
Total liabilities and stockholders’ equity $ 4,783 $ 17,295
The accompanying notes are an integral part of these financial statements.
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INTENSITY THERAPEUTICS, INC.
STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
Years Ended December 31,
2024 2023
Operating expenses:
Research and development $ 10,496 $ 4,786
General and administrative 6,089 3,533
Total operating expenses 16,585 8,319
Loss from operations ( 16,585 ) ( 8,319 )
Other income (expense):
Interest income 314 324
Interest expense - ( 305 )
Loss on debt extinguishment - ( 2,262 )
Other income, net 3 24
Net loss $ ( 16,268 ) $ ( 10,538 )
Preferred stock deemed dividend - ( 1,324 )
Net loss attributable to common stockholders $ ( 16,268 ) $ ( 11,862 )
Loss per share, basic and diluted $ ( 1.17 ) $ ( 1.38 )
Weighted average number of shares of common stock, basic and diluted 13,906,973 8,616,324
The accompanying notes are an integral part of these financial statements.
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INTENSITY THERAPEUTICS, INC.
STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
(in thousands, except share amounts)
Series A Redeemable Convertible Preferred Stock Series B Convertible Preferred Series C Convertible Preferred Common Stock Additional Paid in Capital Accumulated Deficit Stockholders’ Equity (Deficiency)
Shares Amount Shares Amount Shares Amount Shares Amount
Balances at December 31, 2022 5,000,000 $ 10,000 1,449,113 $ - 1,800,606 $ - 3,410,103 $ - $ 23,555 $ ( 38,653 ) $ ( 15,098 )
Issuance of common stock in public offering for cash, net of $ 3,403 issuance costs
- - - - - - 4,485,000 1 19,022 - 19,023
Issuance of warrants underwriters in connection with public offering - - - - - - - - 1,170 - 1,170
Conversion of preferred stock into common stock ( 5,000,000 ) ( 10,000 ) ( 1,449,113 ) - ( 1,800,606 ) - 4,124,851 - 10,000 - 10,000
Conversion of convertible notes into common stock - - - - - - 1,399,716 - 6,998 - 6,998
Issuance of warrants to convertible note holders - - - - - - - - 159 - 159
Exercise of options - - - - - - 25,000 - 50 - 50
Deemed dividend - - - - - - 264,707 - 1,324 ( 1,324 ) -
Stock-based compensation expense - - - - - - - - 1,398 - 1,398
Net loss - - - - - - - - ( 10,538 ) ( 10,538 )
Balances at December 31, 2023 - $ - - $ - - $ - 13,709,377 $ 1 $ 63,676 $ ( 50,515 ) $ 13,162
Issuance of common stock in registered direct offering, net of $ 321 issuance costs
- - - - - - 1,237,113 1 1,360 - 1,361
Issuance of warrants in registered direct offering, net of $ 252 issuance costs
- - - - - - - - 1,068 - 1,068
Issuance of common stock in ATM offering, net of $ 82 issuance costs
- - - - - - 51,820 - 150 - 150
Issuance of common stock in exchange for services - - - - - - 11,750 - 51 - 51
Exercise of options - - - - - - 88,500 - 266 - 266
Exercise of warrants - - - - - - 24,313 - 55 - 55
Stock-based compensation expense - - - - - - - - 3,073 - 3,073
Net loss - - - - - - - - - ( 16,268 ) ( 16,268 )
Balances at December 31, 2024 - $ - - $ - - $ - 15,122,873 $ 2 $ 69,699 $ ( 66,783 ) $ 2,918
The accompanying notes are an integral part of these financial statements.
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INTENSITY THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
(in thousands)
Years Ended December 31,
2024 2023
Cash flows from operating activities:
Net loss $ ( 16,268 ) $ ( 10,538 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of discount on convertible notes - 159
Change in carrying value of right-of-use asset 25 147
Stock-based compensation expense 3,073 1,398
Stock issued in exchange for services 51 -
Loss on debt extinguishment - 2,262
Changes in operating assets and liabilities, net:
Accrued interest on marketable debt securities ( 134 ) ( 197 )
Prepaid expenses, other current assets, and other assets 301 ( 2,067 )
Accounts payable, accrued expenses and other liabilities ( 2,268 ) 1,631
Net cash used in operating activities ( 15,220 ) ( 7,205 )
Cash flows from investing activities:
Purchase of marketable debt securities ( 3,056 ) ( 15,053 )
Redemption of marketable debt securities 9,410 9,030
Net cash provided by (used in) investing activities 6,354 ( 6,023 )
Cash flows from financing activities:
Proceeds from Registered Direct Offering 3,000 -
Issuance costs related to Registered Direct Offering ( 571 ) -
Proceeds from ATM offering 232 -
Issuance costs related to ATM offering ( 82 ) -
Proceeds from Initial Public Offering and overallotment - 22,425
Issuance costs related to Initial Public Offering and overallotment - ( 2,233 )
Proceeds from issuance of convertible note - 230
Proceeds from exercise of options and warrants 321 50
Net cash provided by financing activities 2,900 20,472
Net (decrease) increase in cash and cash equivalents ( 5,966 ) 7,244
Cash and cash equivalents at beginning of period 8,556 1,312
Cash and cash equivalents at end of period $ 2,590 $ 8,556
Supplemental disclosure of non-cash financing activities:
Right-of-use lease asset and operating lease liability $ - $ 155
Convertible notes issued in exchange for services $ - 13
Conversion of convertible notes and accrued interest into common stock $ - $ 4,737
Warrants issued in relation to issuance of convertible notes $ - $ 159
Warrants issued to underwriter in connection with stock issuance $ 1,068 $ 1,170
Preferred stock deemed dividend $ - $ 1,324
The accompanying notes are an integral part of these financial statements.
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INTENSITY THERAPEUTICS, INC.
NOTES TO FINANCIAL STATEMENTS
Note 1. Description of Business
Intensity Therapeutics, Inc. (“the Company”) is a biotechnology company whose treatment approach addresses both the regional and systemic nature of a patient’s cancer. The Company’s DfuseRx SM technology platform has identified a lead drug, INT230-6. The Company is based in Connecticut and was incorporated in Delaware in December 2012.
As a result of its initial public offering (the “IPO”) that priced on June 29, 2023, the Company began trading on the Nasdaq Capital Market under the symbol “INTS” on June 30, 2023. The IPO closed on July 5, 2023 at the IPO price of $ 5.00 per share, at which time the Company issued 3,900,000 shares of our common stock for gross proceeds of $ 19.5 million. After deducting offering expenses of $ 2.0 million, the Company received net proceeds received of $ 17.5 million. On July 7, 2023, the Company sold the full over-allotment shares at the IPO price of $ 5.00 per share, resulting in the issuance of 585,000 shares of our common stock for gross proceeds of $ 2.9 million. After deducting offering expenses of $ 0.2 million, the Company received an additional $ 2.7 million in net cash proceeds. The Company has used the net proceeds from the IPO to initiate clinical studies, conduct manufacturing suitable for phase 3 studies, submit regulatory filings to the United States Food & Drug Administration (“FDA”) and for general and corporate purposes.
Note 2. Liquidity and Plan of Operation
The accompanying financial statements have been prepared in conformity with generally accepted accounting principles, which contemplate continuation of the Company as a going concern.
The Company is a research and development company and has not generated any revenue from its product candidates. The Company has experienced net losses and negative cash flows from operations each year since its inception. Through December 31, 2024, the Company has an accumulated deficit of $ 66.8 million. The Company’s operations have been financed primarily through the sale of equity securities and convertible notes. The Company’s net loss for the year ended December 31, 2024 was $ 16.3 million. The Company expects to incur significant expenses to complete development of its product candidates. The Company may never be able to obtain regulatory approval for the marketing of any of its product candidates in the United States or internationally and there can be no assurance that the Company will generate revenues or ever achieve profitability. The Company does not expect to receive significant product revenue in the near term. The Company, therefore, expects to continue to incur substantial losses for the foreseeable future.
Cash and cash equivalents totaled $ 2.6 million as of December 31, 2024. Until such time the Company can generate substantial product revenue, the Company expects to finance its operations through a combination of equity offerings and convertible debt financings. The Company does not have any committed external source of funds. To the extent that the Company can raise additional capital through the sale of equity or convertible debt securities, the ownership interest of the Company stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of the common stockholders. If the Company is unable to raise additional funds through equity or debt financings when needed, the Company may be required to delay, limit, reduce or terminate its research and product development.
Based on the cash and cash equivalents as of December 31, 2024, the Company believes that it has sufficient cash through the end of the first quarter of 2025 for its current operations. As a result, the Company believes there is substantial doubt about its ability to continue as a going concern.
Note 3. Basis of Presentation and Summary of Significant Accounting Policies
Basis of presentation
The accompanying financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and reflect the operations of the Company. The Company neither owns nor controls any subsidiary companies.
Use of estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
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Certain accounting principles require subjective and complex judgments to be used in the preparation of financial statements. Accordingly, a different financial presentation could result depending on the judgments, estimates, or assumptions that are used.
The Company utilizes significant estimates and assumptions in valuing its stock-based awards and accruals of research and development expenses. An additional significant estimate is that these financial statements are based on the assumption of the Company continuing as a going concern.
Concentration of credit risk
The Company’s financial instruments that are exposed to concentrations of credit risk consist entirely of cash and investments in U.S. Treasury bills. These financial instruments are held at two U.S. financial institutions. The cash accounts are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to regulatory limits. During the years ended December 31, 2024 and 2023, the Company’s cash balances exceeded the FDIC insurance limit. The investments in the U.S. Treasury securities and U.S. Treasury bills are not FDIC insured but are backed by the U.S. government. U.S. Treasury securities are subject to market risk if they are sold prior to maturity. The Company has not experienced any losses in such accounts. Although the Company believes that the financial institutions with whom the Company does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so beyond amounts guaranteed by the FDIC.
Cash and cash equivalents
The Company considers all liquid investments acquired with a maturity of three months or less to be cash equivalents.
Marketable debt securities
Investments in U.S. Treasury bills purchased with a maturity over three months but less than twelve months are classified separately from cash and cash equivalents in current assets. Investments in U.S. Treasury bills are classified as available for sale. Under the classification of available for sale, securities are reported at fair value. Unrealized gains or losses would be included in accumulated other comprehensive income within the equity section of the Balance Sheet. At December 31, 2024, there were no marketable securities or unrealized gains or losses, and all accrued interest was recognized as interest income in the Statement of Operations.
Fair value measurement
The Company reports its investments at fair value. Fair value is an estimate of the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants (i.e., the exit price at the measurement date). Fair value measurements are not adjusted for transaction costs. A fair value hierarchy provides for prioritizing inputs to valuation techniques used to measure fair value into three levels:
Level 1 Unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 Inputs other than quoted market prices that are observable, either directly or indirectly, and reasonably available. Observable inputs reflect the assumptions market participants would use in pricing the asset or liability and are developed based on market data obtained from sources independent of the Company.
Level 3 Unobservable inputs. Unobservable inputs reflect the assumptions that the Company develops based on available information about what market participants would use in valuing the asset or liability.
An asset’s or liability’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Availability of observable inputs can vary and is affected by a variety of factors. The Company uses judgment in determining fair value of assets and liabilities and Level 3 assets and liabilities involve greater judgment than Level 1 or Level 2 assets or liabilities.
As of December 31, 2023, the Company invested $ 6.2 million in U.S. Treasury Bills, included in marketable debt securities. U.S. Treasury bills are valued at market prices obtained from independent vendor services, which we believe to be reliable. In some cases, the pricing vendor may provide prices quoted by a single broker or market maker. U.S. Treasury Bills are categorized in Level 2 of the fair value hierarchy. As of December 31, 2024, there were no investments in U.S. Treasury Bills.
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The Company’s financial instruments, including cash equivalents and current liabilities are carried at cost, which approximates fair value due to the short-term nature of these instruments.
Stock-based compensation
The Company accounts for stock-based compensation to employees and non-employees, which consists of stock option grants, through the Statements of Operations based on their fair values at the date of grant.
The Company calculates the fair value of option grants utilizing the Black-Scholes pricing model. The resulting stock-based compensation expense for both employee and non-employee awards is generally recognized on a straight-line basis over the requisite service period of the award. Forfeitures are recognized as they occur.
The Company had been a private company and lacked company-specific historical and implied volatility information for its shares. Therefore, the Company estimated its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price.
Research and development and patent costs
The Company is required to estimate its expenses resulting from its obligations under contracts with vendors, consultants, contract research organizations (“CRO”), and contract manufacturing organizations (“CMO”) in connection with conducting research and development activities. The financial terms of these contracts vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts.
Research and development costs are expensed in the period in which they are incurred. External costs consist primarily of payments to outside consultants, third-party CROs, CMOs, clinical trial sites and central laboratories in connection with the Company’s clinical manufacturing and clinical development activities. External expenses are recognized based on an evaluation of the progress to completion of specific tasks using information provided to the Company by its service providers or its estimate of the level of service that has been performed at each reporting date. The Company tracks external costs based on research and development activities, including preclinical, individual clinical study, and manufacturing for our product candidate. Internal costs consist primarily of employee-related costs and costs related to compliance with regulatory requirements. The Company does not track internal or consulting costs by research and development initiative because these costs are deployed across multiple initiatives and, as such, are not separately classified.
The Company makes estimates of accrued expenses as of each balance sheet date based on facts and circumstances known at that time. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. The significant estimates in its accrued research and development expenses include the costs incurred for services performed by vendors in connection with research and development activities for which the Company has not yet been invoiced.
In July 2024, the Company initiated a Phase 3 open-label, randomized study for certain soft tissue sarcoma subtypes, which is expected to span several years. In connection with this study, the Company recorded an advance payment of $ 1.7 million in December 2023, which will be applied to future invoices during and at the end of the study. As of December 31, 2024 and 2023, the advance payment balances were $ 1.2 million and $ 1.7 million, respectively, and were recorded in Other Assets in the Balance Sheet.
Income taxes
The Company accounts for income taxes through the use of the asset-and-liability method whereby deferred tax assets and liabilities are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company utilizes a valuation allowance to reduce deferred tax assets to their estimated realizable value.
The Company accounts for uncertain tax positions. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2024, the Company does not have any uncertain tax positions.
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There are no estimated interest costs and penalties provided for in the Company’s financial statements for the year ended December 31, 2024. If at any time the Company should record interest and penalties in connection with income taxes, the interest and penalties will be expensed within the income tax line.
Leases
The Company determines if an arrangement contains a lease at contract inception. With the exception of short-term leases (leases with terms less than 12 months), all leases with contractual fixed costs are recorded on the balance sheet on the commencement date as a right-of-use (ROU) asset and a lease liability. Lease liabilities to be paid over the next twelve months are classified as current lease liability and all other lease obligations are classified as long-term lease liability. Lease liabilities are initially measured at the present value of the future minimum lease payments and subsequently increased to reflect the interest accrued and reduced by the lease payments made. The Company’s building leases require a pro-rata share of operating expenses and real estate taxes, which are variable in nature and excluded from the measurement of lease liabilities. ROU assets are initially measured at the present value of the future minimum lease payments adjusted for any prior lease prepayments, lease incentives and initial direct costs. Certain leases contain escalation, renewal and/or termination options that are factored into the ROU asset as appropriate. Operating leases result in a straight-line rent expense over the expected lease term.
The Company uses its estimated incremental borrowing rate, which is derived from information available at the lease commencement date, in determining the present value of future lease payments, if the rate implicit in the lease is not readily determinable. Consideration is given to publicly available data for instruments with similar characteristics when calculating incremental borrowing rates. This incremental borrowing rate estimate is based on a synthetic credit rating derived from the market capitalization of similar companies, the treasury yield curve, and corporate yield spreads.
Basic and dilutive loss per share
Basic net loss per share is determined using the weighted average number of shares of common stock outstanding during each period. Dilutive net loss per share includes the effect, if any, from the potential exercise or conversion of securities, such as convertible preferred stock, convertible notes, stock options, and stock warrants, which would result in the issuance of incremental shares of common stock. The computation of diluted net loss per share does not include the conversion of securities that would have an anti-dilutive effect. Potential shares of common stock issuable upon conversion of preferred stock, exercise of stock options, and exercise of warrants that are excluded from the computation of diluted weighted average shares outstanding listed in the table below because they are anti-dilutive. The basic and diluted computation of net loss per share for the Company are the same because the effects of the Company’s convertible securities would be anti-dilutive. All common and preferred stock participate equally in dividends and the distribution of earnings if and when declared by the Board of Directors, on the Company’s common stock for the year ended December 31, 2024. For purposes of computing earnings per share, all series of preferred stock are considered participating securities. Therefore, the Company must calculate basic and diluted earnings per share using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed earnings. As the preferred stockholders have no obligation to fund losses, no portion of net loss was allocated to the participating securities for the year ended December 31, 2023. There were no preferred shares outstanding during the year ended December 31, 2024.
As of December 31, 2024 and 2023, the following shares of common stock underlying options and warrants were excluded from the computation of diluted weighted average shares outstanding:
December 31,
2024 2023
Options outstanding 2,587,129 1,239,750
Warrants outstanding 2,041,563 801,950
4,628,692 2,041,700
Stock issuance costs
The Company incurred costs related to the sale of its common stock in its IPO and the subsequent sale of common stock in the over-allotment. These costs included underwriter commissions and fees, legal fees, accounting fees, and printing costs. These costs were recorded as a deduction to Additional Paid in Capital.
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Segments
Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance. The Company has one reportable segment, which consists of the application of scientific leadership in the field of localized cancer reduction leading to anti-cancer immune activation. The Company’s chief operating decision maker (“CODM”) is the president and chief executive officer.
The accounting policies of the Company’s segment are the same as those described in the summary of significant accounting policies. To date, the Company has not generated any product revenue and expects to continue to incur significant expenses and operating losses for the foreseeable future as it advances product candidates through all stages of development and clinical trials and, ultimately, seeks regulatory approval. As such, the CODM uses forecast models in deciding how to invest into the segment. Such forecast models are reviewed to assess the Company’s operating results and performance. The CODM is regularly provided with operating expenses and cash balances, which are reported on the statement of operations and balance sheet, respectively .
Recently issued pronouncements
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . ASU 2023-07, which is applicable to entities with a single reportable segment, primarily requires enhanced disclosures about significant segment expenses and enhanced disclosures in interim periods. The Company has adopted the guidance in ASU 2023-07 for the year ended December 31, 2024, and it is being applied retrospectively to its financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures . ASU 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction. The guidance makes several other changes to the income tax disclosure requirements. The guidance in ASU 2023-09 will be effective for annual reporting periods in fiscal years beginning after December 15, 2024. The Company is currently evaluating the impact that the adoption of ASU 2023-09 will have on its financial statement disclosures.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses , as subsequently amended by ASU 2025-01 to clarify the effective date, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented in the statement of operations. The guidance in this ASU is effective for annual reporting periods in fiscal years beginning after December 15, 2026, and interim periods in fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its financial statement disclosures.
Note 4. Cash and Cash Equivalents
Cash and cash equivalents consisted of the following (in thousands):
December 31,
2024 2023
Savings and checking accounts at major U.S. financial institutions $ 428 $ 367
U.S. Treasury securities money market fund 2,162 8,189
Total $ 2,590 $ 8,556
Note 5. Marketable Debt Securities
Marketable debt securities as of December 31, 2023 consisted entirely of U.S. Treasury bills purchased with maturities over three months but less than twelve months. There were no marketable debt securities as of December 31, 2024.
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Note 6. Prepaid Expenses
Prepaid expenses consisted of the following (in thousands):
December 31,
2024 2023
Prepaid insurance $ 421 $ 647
Prepaid research and development costs 239 —
Prepaid other 113 41
Total $ 773 $ 688
Note 7. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
December 31,
2024 2023
Accrued research and development costs $ 373 $ 439
Accrued employee compensation-related expenses 56 392
Accrued other 79 60
Total $ 508 $ 891
Note 8. Convertible Notes
Prior to the IPO, the Company entered into a series of interest-bearing convertible notes, which bore interest at rates ranging 3 % to 10 %, and were automatically converted upon the IPO at a discount ranging 30 % to 35 % to the conversion price of $ 11.50 per share, in accordance with the respective note agreements. Below is a summary of activity of convertibles notes for the year ended December 31, 2023 (in thousands):
Principal Accrued Interest Total
As of January 1, 2023 4,250 99 4,349
Issuance of Convertible Notes 243 — 243
Interest expense — 145 145
Conversion to common stock upon IPO ( 4,493 ) ( 244 ) ( 4,737 )
Balance as of December 31, 2023 $ — $ — $ —
Upon the IPO, all convertible note principal and accrued interest of $ 4.5 million and $ 0.2 million, respectively, converted into an aggregate of 1,399,716 shares of common stock, pursuant to the conversion terms in each respective note. The Company recorded a non-operating loss on debt extinguishment of $ 2.3 million in the statement of operations, which is equal to the aggregate discounts on the IPO price specified in each convertible note agreement. In addition, upon the IPO, the remaining $ 0.2 million balance of unamortized discount on 2022 Convertible Notes was recognized and recorded in Interest Expense on the Statement of Operations.
Note 9. Stockholders’ Equity
Initial public offering
On July 5, 2023, as described in Note 1, the Company completed IPO, issuing 3,900,000 shares of common stock at the IPO price of $ 5.00 per share. On July 7, 2023, the Company sold the full over-allotment of the IPO shares and issued 585,000 shares of common stock at the IPO price of $ 5.00 per share.
Pursuant to the IPO,
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• all Series A, B and C Preferred Stock was converted into 4,124,851 shares of common stock at conversion prices e qual to $ 4.00 , $ 9.00 and $ 11.50 , respect i v e l y.
• Series B and Series C Preferred Stock received an additional 100,189 and 164,518 shares of common stock, respectively, pursuant to the terms of their security agreements, since the IPO price was less than the original issue price. The additional shares have been recorded as a deemed dividend on the Statement of Operations and Statement of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficiency).
• All voting, dividend, redemption and liquidation preference rights, specific to the Series A, B, and C Preferred Stock were extinguished.
• All Convertible Notes and related accrued interest were converted into 1,399,716 shares of common stock, as described in Note 8.
At The Market Offering Agreement
On July 3, 2024, the Company entered into an At The Market Offering Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may sell and issue, from time to time, up to $ 15.0 million of shares of its common stock (the “Shares”) through Wainwright as the Company’s sales agent (the “ATM Offering”). The Company has no obligation to sell any of the Shares and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement pursuant to its terms.
On November 20, 2024, the Company filed a prospectus supplement to reduce the maximum the Company may sell and issue under the Sales Agreement to $ 7.0 million of its Shares, not including the Shares previously sold under the Sales Agreement.
For the year ended December 31, 2024, the Company issued 51,820 shares of common stock under the Sales Agreement for net proceeds of $ 0.2 million.
Registered direct offering
On November 21, 2024, the Company entered into a Securities Purchase Agreement with a single healthcare focused institutional investor (the “Investor”), pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the Investor, 1,237,113 shares of common stock to the Investor, at a price of $ 2.425 per share, for aggregate gross proceeds of approximately $ 3.0 million before deducting the placement agents’ fees and related offering expenses. In a concurrent private placement, the Company agreed to issue to the Investor common stock warrants to purchase up to 1,237,113 shares (the “Common Warrants”) at an exercise price of $ 2.95 per share, with a relative fair value of $ 1.1 million (see Note 10). Each Common Warrant will be exercisable six months from the issuance date and will expire five and one-half years from the issuance date.
Authorized shares
Pursuant to the sixth amended and restated Certificate of Incorporation, dated June 30, 2023, the total number of shares of all classes of stock which the Company shall have authority to issue is (i) 135,000,000 shares of common stock and (ii) 15,000,000 shares of preferred stock.
Note 10. Stock Based Compensation
The Company has a 2013 Stock Option Plan (the “2013 Plan”), which is administered by our Compensation Committee. Under the 2013 Plan, stock options to purchase shares of common stock could be granted to eligible employees, officers, directors and consultants of the Company.
In 2022, the Company replaced the 2013 Plan with the 2021 Stock Incentive Plan (the “2021 Plan”), authorizing the granting of equity awards for the issuance of up to 3,000,000 shares of common stock. Upon adoption of the 2021 Plan, no more shares would be issued under the 2013 Plan. Starting on January 1, 2022, the shares authorized under the 2021 Plan shall have an annual increase of the lessor of (a) 3.5 % of the aggregate number of shares of Common Stock outstanding on the final day of the preceding calendar year, or (b) such smaller amount as determined by the Board. On January 1, 2023 and January 1, 2024, an additional 238,700 and 479,828 shares, respectively, were authorized under the 2021 Plan. As of December 31, 2024, 1,881,649 shares were available for issuance under the 2021 Plan.
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The Company recorded total stock-based compensation in its Statements of Operations as follows (in thousands):
Years Ended December 31,
2024 2023
Research and development $ 1,240 $ 714
General and administrative 1,833 684
Total stock-based compensation expense $ 3,073 $ 1,398
Stock options
The following table summarizes the range of assumptions used to estimate the fair value of stock options issued in 2024 and 2023:
2024 2023
Stock price $ 3.44 to $ 5.19
$ 2.82 to $ 6.88
Exercise price $ 3.44 to $ 5.19
$ 2.82 to $ 6.88
Expected volatility 97.06 to 102.16 %
97.06 % to 99.74 %
Risk free interest rates 4.07 to 4.46 %
3.87 % to 4.97 %
Expected term (years) 5 to 7
5.75 to 6.25
For the years ended December 31, 2024 and 2023 , a dividend yield of 0 % was used because the Company has not historically paid and does not intend to pay a dividend on Common Stock in the foreseeable future. The expected stock price volatility assumption was estimated based on the historical volatilities for industry peers, as the Company had no active market for its stock prior to the IPO and limited history for issuance price of its stock. The risk-free rate assumption is determined using the yield currently available on U.S. Treasury zero coupon issues with a remaining term commensurate with the expected term of the award. The expected term of the option represents the period the options are expected to be outstanding.
The following table summarizes the activity for stock options for the year ended December 31, 2024:
Options Weighted-
Average
Exercise Price Weighted Average
Remaining
Contractual Term
(in years) Aggregate
Intrinsic
Value (in
thousands)
Outstanding at December 31, 2023 1,239,750 $ 8.00 6.4 $ 1,865
Issued 1,435,879 $ 4.34
Exercised ( 88,500 ) $ 3.01
Forfeited and cancelled — $ —
Outstanding at December 31, 2024 2,587,129 $ 6.14 7.9 $ —
Exercisable at December 31, 2024 1,268,778 $ 7.68 6.3 $ —
All options expire 10 years from date of grant. Options outstanding begin to expire in September 2025. Options that were granted to employees and consultants have vesting periods that vary by award to recipient and range from immediate vesting to a period of up to 4 years.
The weighted average grant date fair value of stock options issued was $ 3.51 and $ 4.21 for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2024 , total unrecognized compensation cost related to options was approximately $ 4.1 million and is expected to be recognized over the remaining weighted average service period of 2.8 years.
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Warrants
The following table summarizes the range of assumptions used to estimate the fair value of warrants issued in 2024 and 2023:
2024 2023
Stock price $ 2.95 to $ 5.19
$ 3.10 to $ 5.00
Exercise price $ 2.95 to $ 5.19
$ 6.00 to $ 6.25
Expected volatility 97.06 % to 100.64 %
97.06 % to 103.85 %
Risk free interest rates 4.12 % to 4.39 %
3.59 % to 4.85 %
Expected term (years) 5.5 to 7
3 to 5
For the years ended December 31, 2024 and 2023 , a dividend yield of 0 % was used because the Company has not historically paid and does not intend to pay a dividend on Common Stock in the foreseeable future. The expected stock price volatility assumption was estimated based on the historical volatilities for industry peers, as the Company had no active market for its stock prior to the IPO and limited history for issuance price of its stock. The risk-free rate assumption is determined using the yield currently available on U.S. Treasury zero coupon issues with a remaining term commensurate with the expected term of the award. The expected term of the option represents the period the options are expected to be outstanding.
The following table summarizes the activity for warrants for the year ended December 31, 2024:
Warrants Weighted-
Average
Exercise Price Weighted Average
Remaining Contractual Term
(in years) Aggregate
Intrinsic
Value (in
thousands)
Outstanding at December 31, 2023 801,950 $ 6.30 3.9 $ 2,096
Issued 1,287,113 $ 3.02
Exercised ( 24,313 ) $ 2.26
Forfeited and cancelled ( 23,187 ) $ 2.86
Outstanding at December 31, 2024 2,041,563 $ 4.32 4.7 $ —
Exercisable at December 31, 2024 747,200 $ 6.51 3.2 $ —
All warrants outstanding are exercisable for purchase of common stock. In connection with the IPO, 313,950 warrants were issued to the Company’s underwriters during the year ended December 31, 2023. In connection with the registered direct offering, 1,237,113 warrants were issued to the Investor during the year ended December 31, 2024.
At December 31, 2024, total unrecognized compensation cost related to warrants was approximately $ 0.2 million and is expected to be recognized over the remaining weighted average service period of 2.6 years.
Note 11. Leases
In January 2017, the Company entered into a lease for approximately 2,500 square feet of office space in Westport, Connecticut, (the “Westport Lease”), which was subsequently extended and increased to approximately 4,000 square feet. In June 2023, the Westport Lease was terminated.
In July 2023, the Company signed a 5.5 -year lease for approximately 2,700 square feet of office space in Shelton, Connecticut, (the “Shelton Lease”). The Company has a one-time option to cancel the Shelton Lease after 36 months if it provides written notice before the end of month 30 . A payment of approximately $ 47,000 would be due at the end of month 36 if the Company exercises this option. This option is not reasonably certain to occur.
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Rent expense for the years ended December 31, 2024 and 2023 was $ 34,000 and $ 55,000 , respectively. Cash paid for operating leases for the years ended December 31, 2024 and 2023 was approximately $ 38,000 and $ 49,000 , respectively, all of which pertained to the Shelton Lease.
The following table summarizes the balance sheet classification of the operating lease asset and related lease liabilities as of December 31, 2024 for the Shelton Lease and as of December 31, 2023 for the Westport Lease (in thousands):
December 31,
2024 December 31,
2023
Right-of-use asset, net $ 122 $ 147
Lease liability, current portion 28 20
Lease liability, net of current portion 110 138
$ 138 $ 158
The following variables were used to determine the right-of-use asset and the operating lease liabilities at December 31, 2024 and 2023:
December 31,
2024 December 31,
2023
Weighted average remaining lease term 4.2 years 0.75 years
Weighted average operating lease discount rate 6.4 % 3.9 %
Future minimum lease payments under the lease agreement as of December 31, 2024 were as follows (in thousands):
Year ended
2025 $ 36
2026 37
2027 39
2028 39
2029 7
Total lease payments $ 158
Less: Amounts representing interest ( 20 )
Present value of lease liabilities $ 138
Note 12. Other Uncertainties
The Company holds patents in Russia and Israel, both of which are currently involved in military action. The outcomes of these military actions could impact our ability to maintain and protect these patents.
Note 13. Related Parties
In 2023, a minority stockholder was engaged as a consultant to serve as the Company’s chief medical officer. Under the consulting agreement, the Company recorded approximately $ 6,200 of research and development expense for the year ended December 31, 2023.
The Company sublet a portion of its lease in Westport Lease to a minority stockholder, and recognized sublease income of approximately $ 23,000 for the year ended December 31, 2023. Sublease income is recorded as a reduction of general and administrative expenses in the Statement of Operations. The sublease ended in April 2023.
As of December 31, 2023, the Company held a $ 36,000 deposit related to a service agreement with a minority stockholder, and is recorded in other long-term liabilities on the balance sheet. The deposit was returned to the minority stockholder during 2024.
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In October 2023, the Company issued 80,000 warrants for consulting services to be rendered by two shareholders, which vested over the subsequent twelve months. These warrants were valued at $ 198,000 , of which $ 149,000 and $ 49,000 were expensed during the years ended December 31, 2024 and 2023, respectively, and were expensed to general and administrative expense.
In April 2024, the Company entered into a non-material agreement with a service organization controlled by a board member. For the year ended December 31, 2024, the Company expensed $ 42,110 and paid $ 40,310 to the service organization for services performed, which is recognized in research and development expenses on the statement of operations. As of December 31, 2024, the Company recognized $ 1,800 in accrued expenses.
Note 14. Income Taxes
The components of the Company’s provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate were as follows (in thousands):
2024 2023
Statutory federal income tax rate $ ( 3,414 ) $ ( 2,213 )
State taxes, net of federal tax benefit ( 949 ) ( 350 )
Change in valuation allowance 4,216 1,888
Loss on debt extinguishment — 475
Federal return to provision 14 87
Other permanent items 133 113
Provision for income taxes $ — $ —
The components of the net deferred tax assets are as follows (in thousands):
2024 2023
Deferred tax assets:
Net operating loss carryforwards $ 10,235 $ 8,612
Capitalized research expense 3,774 1,782
Share based compensation 1,713 1,011
Research and development credits 495 596
Lease liability 37 43
Gross deferred tax assets 16,254 12,044
Less valuation allowance ( 16,221 ) ( 12,005 )
Total deferred tax assets 33 39
Deferred tax liabilities:
Right of use assets ( 33 ) ( 39 )
Total deferred tax liabilities ( 33 ) ( 39 )
Deferred income taxes, net $ — $ —
As of December 31, 2024, the Company has U.S. federal and state net operating loss carryforwards of $ 38.0 million and $ 38.0 million, respectively, which may be used to offset future taxable income, if any. As of December 31, 2023 , the Company had U.S. federal and state net operating loss carryforwards of $ 32.0 million and $ 31.9 million, respectively, which may be used to offset future taxable income, if any. The Company’s U.S. federal and state net operating loss carryforwards begin to expire in 2033 and the U.S. federal net operating losses generated between 2018 and 2024 can be carried forward indefinitely. Federal loss carryforwards of $ 7.0 million expire between the years 2033 and 2037, and the remainder have no expiration date.
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As of December 31, 2024 and 2023, the Company has U.S. federal and state credit carryforwards of $ 0.3 million and $ 0.2 million, respectively, which may be used to offset future taxable income, if any. The Company’s U.S. federal and state credit carryforwards begin to expire in 2033. The Company’s ability to utilize these net operating loss carryforwards and tax credit carryforwards may be limited if the Company experiences an ownership change pursuant to Internal Revenue Code Section 382 and 383. An ownership change occurs when the ownership percentages of 5% or greater stockholders change by more than 50% over a three-year period. The Company has not completed an analysis under Section 382 of the Code.
A valuation allowance for deferred tax assets is recorded when it is more likely than not that some or all of the benefit from the deferred tax asset will not be realized. The Company provides a valuation allowance to offset deferred tax assets for net operating losses incurred during the year and for other deferred tax assets where, in the Company’s opinion, it is more likely than not that the financial statement benefit of these losses will not be realized. The increase in valuation allowance for the years ended December 31, 2024 and 2023 totaled $ 4.2 million and $ 1.9 million, respectively.
The Company’s policy is to classify interest and penalties, if any, as components of the income tax provision in the statement of operations. The Company has no t recorded any unrecognized tax benefit, interest or penalty in the years ended December 31, 2024 and 2023.
The Company is subject to income tax in the U.S. Federal and Connecticut jurisdictions.
Note 15. Segments
The Company has a single segment and allocates resources based on cash resources and operating expense projections. The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended December 31, 2024 and 2023:
F-18
Table of Contents
Years Ended December 31,
2024 2023
Research and development expenses:
Clinical trial expenses:
IT-01 Study (Phase 1/2 Metastatic Cancers) $ ( 128 ) $ 984
INVINCIBLE-2 Study (Phase 2 Breast) 233 402
INVINCIBLE-3 Study (Phase 3 Sarcoma) 6,225 578
INVINCIBLE-4 Study (Phase 2 Breast) 524 19
Other clinical trial expenses (a)
223 4
Clinical trial expenses 7,077 1,987
Contract manufacturing 657 922
Salaries and benefits related 1,379 896
Consulting & Other (b)
143 267
Stock-based compensation 1,240 714
Research and development expenses 10,496 4,786
General and administrative expenses:
Salaries and benefits related 884 559
Legal fees 728 423
Audit fees 349 404
Consulting 768 430
Insurance 874 608
Other (c)
653 425
Stock-based compensation 1,833 684
General and administrative expenses 6,089 3,533
Loss from operations ( 16,585 ) ( 8,319 )
Other segment items, net (d)
317 43
Loss on debt extinguishment — ( 2,262 )
Net loss $ ( 16,268 ) $ ( 10,538 )
(a) Represents ancillary clinical and clinical-related costs associated with clinical studies.
(b) Consulting & Other includes research and development consulting costs and travel-related costs.
(c) Other includes facility expenses, office supplies, computer and software related costs, public relations costs, and travel-related costs.
(d) Other segment items include interest income, interest expense, and foreign exchange gains and losses.
F-19
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.