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Item 9A. Controls and Procedures

2025-03-13 compared with 2024-03-14 · 429 added, 256 removed, 935 unchanged (42% of the section changed)

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Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”) that 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 (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, 2023, our disclosure controls and procedures were not effective as a result of the material weaknesses 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.

Material Weakness and Remediation Plans

In response to the above identified weakness, we are taking the following remediation measures:

• We are reassessing our accounting procedures and, as part of the financial reporting process, plan to implement the use of supplementary checks and additional reviews and evaluations of transactions to improve the accuracy and reliability of our financial information.

• We are adding appropriate resources to ensure that such procedures are implemented and adequate reviews are performed.

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.

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 have engaged additional technical accounting consultants to provide additional resources for the preparation and review of our quarterly close procedures.

• We will evaluate new accounting software systems to improve system controls, and have already implemented 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, and Principal Accounting Officer will be active participants in these ongoing remediation processes and such processes will be subject to audit committee oversight.

We believe these steps will improve the effectiveness of our internal controls.

While we plan to take the above steps to remediate these weaknesses, we cannot assure you that we will be able to fully remediate them, which could impair our ability to accurately and timely meet our public company reporting requirements.

• 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

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Management’s Annual Report on Internal Control over Financial Reporting

This annual report does not include a report of management's assessment regarding internal control over financial reporting or an attestation report of the company's registered public accounting firm due to a transition period established by rules of the Securities and Exchange Commission for newly public companies.

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.

Changes in Internal Control over Financial Reporting

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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.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The following table sets forth the name, age (as of March 14, 2024) and position of individuals who currently serve as our directors and executive officers.

The following also includes certain information regarding our directors’ and officers’ individual experience, qualifications, attributes and skills, and brief statements of those aspects of our directors’ backgrounds that led us to conclude that they should serve as directors.

The following table sets forth the name, age and position of our directors and executive officers as of March 1, 2025.

Bender 66 President, Chief Executive Officer and Chairman of the Board

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John Wesolowski 65 Principal Accounting Officer and Controller

Ahlers 59 Executive Vice President of Corporate Finance

Emer Leahy 59 Director

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Daniel Donovan 60 Director

Dubin 62 Director

Executive Officers

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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 Account since 1983.

Ahlers has served as our Executive Vice President of Corporate Finance since June 2023 through a consulting agreement with Mr.

Ahlers’ employer, Danforth Advisors LLC, a company that provides strategic and operational finance and accounting services to life science companies.

Previously, Mr.

Ahlers served as our Chief Financial

Officer from January 2022 until June 2023 through the consulting agreement.

From February 2002 to November 2019, Mr.

Ahlers served as Chief Financial Officer of Intarcia Therapeutics, Inc.

Ahlers is an accomplished finance leader with 25 years of experience building life science businesses.

During his career, he has managed capital raising transactions, including initial public offerings, that have raised in excess of $2 billion.

In addition, he has developed and implemented international operations and global tax strategies.

Ahlers holds a B.S.

in accounting from the University of San Francisco.

He is a Certified Public Accountant since 1983.

Non-Employee Directors

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in Neuropharmacology from University College Dublin, Ireland and her MBA from Columbia University.

Since 2000, she has served as CEO of PsychoGenics Inc., a profitable preclinical CNS service company.

She is also CEO of PGI Drug Discovery LLC, a company engaged in psychiatric drug discovery with five partnered clinical programs including one in Phase 3.

Further, she holds an Adjunct Associate Professor of Neuroscience position at Mount Sinai School of Medicine.

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.

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.

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.

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.

Leahy served on the Emerging Companies Section Governing Board for the Board of Directors of the Biotechnology Industry Organization (BIO), the Business Review Board for the Alzheimer’s Drug Discovery Foundation, and the Scientific Advisory Board of the International Rett Syndrome Foundation.

She also currently serves on the Board of Directors of PsychoGenics Inc., Bright Minds Biosciences, and Pasithea Therapeutics.

Leahy also serves on the Board of Trustees of BIONJ, and effective February 2024, began serving in the role of Chair.

She is an Adjunct Associate Professor of Neuroscience position at Mount Sinai School of Medicine since 2017.

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’s extensive experience in the biopharmaceutical industry, including as a CEO of several companies, allows her to make valuable contributions to the Board.

Leahy is qualified to serve as a member of our board of directors due to her extensive pharmaceutical, biotechnology and business background.

Goldberg has served as a member of our board of directors since May 2018.

Since 2019, Dr.

Goldberg has served as Chairman and CEO of Allucent, a global mid-sized clinical research organization.

Goldberg has also served as the Executive Chairman of Thread, a decentralized research and electronic clinical outcome assessment provider, since 2019.

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.

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.

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We believe that Dr.

Goldberg’s medical background and public company board experience allows him to make valuable contributions to our Board.

Donovan joined the Board in January 2023.

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.

Donovan has served as a member of our board of directors since January 2023.

Daniel Donovan is an entrepreneur with extensive experience within the biotech industry.

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We believe that Mr.

Daniel Donovan’s background in cancer and rare disease, finance, drug development, patient advocacy and small company board experience allows him to make valuable contributions to our Board.

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.

Dubin has served on our board of directors since May 2024.

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.

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.

Dubin began his career as a corporate attorney with Cravath, Swaine & Moore in New York City.

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.

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.

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.

Code of Business Conduct

Our board of directors established a Code of Conduct applicable to our directors, officers and employees.

The Code of Conduct is accessible on our website at www.intensitytherapeutics.com .

If we make any substantive amendments to the Code of Conduct or grant any waiver, including any implicit waiver, from a provision of the Code of Conduct to our officers, we will disclose the nature of such amendment or waiver on that website or in a report on Form 8-K.

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

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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 four (4) directors, three (3) of whom qualify as “independent” under Nasdaq listing standards.

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 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.

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 director is Mr.

Daniel Donovan, and his term will expire at the 2024 annual meeting of stockholders;

• the Class I directors are Mr.

Daniel Donovan and Mr.

Dubin, and their terms will expire at the 2027 annual meeting of stockholders;

• the Class II director is Dr.

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Daniel Donovan, Dr.

Emer Leahy and Dr.

Goldberg 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.

Emer Leahy, Dr.

Goldberg and Mr.

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.”

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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.

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 Mr.

Daniel Donovan, Dr.

Emer Leahy and Dr.

Goldberg, with Dr.

Our audit committee consists of Dr.

Emer Leahy, Dr.

Goldberg, and Mr.

Dubin, with Dr.

Emer Leahy serving as Chairperson.

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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.

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:

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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 management and risk mitigation strategies with respect to areas of potential material risk, including operations, finance, legal, regulatory, cybersecurity, strategic and reputational risk.

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

management and risk mitigation strategies with respect to areas of potential material risk, including operations, finance, legal, regulatory, cybersecurity, strategic and reputational risk.

EXECUTIVE COMPENSATION

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Summary Compensation Table

Name and Principal Position Year Salary ($) Bonus ($) Stock Awards ($) Warrant and Option Awards ($) (1)

Non-Equity Incentive Plan Compensation ($) (2)

Name and Principal Position Year Salary ($) Bonus ($) Warrant and Option Awards (1) ($)

All Other Compensation (2) ($)

Bender 2024 544,121 — 1,889,162 52,886 (3)

— — — 261,500 290,317 (5)

President and Chief Executive Officer 2023 553,173 (4)

— 290,317 (6)

Joseph Talamo (7)

2024 370,000 — 1,245,646 46,930 (8)

Chief Financial Officer 2023 14,231 — 442,140 — 456,371

John Wesolowski 2024 251,347 — 308,231 9,551 (9)

Principal Accounting Officer and Controller 2023 186,154 67,015 254,920 19,202 (10)

James Ahlers 2023 — — — — — 75,088 (9)

Executive Vice President of Corporate Finance 2022 — — — 41,226 — 120,800 (9)

(1) In accordance with SEC rules, these columns reflect the aggregate grant date fair value of the option awards and stock awards granted during 2023 and 2022 computed in accordance with Financial Accounting Standard Board ASC Topic 718 for stock-based compensation transactions, or ASC 718.

(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 how we calculate stock-based compensation expense, see the Notes to Financial Statements included in Part II, Item 8 of this Form 10-K.

(2) The 2023 amounts reported represent cash bonuses earned under our 2023 bonus plan based upon the achievement of company objectives for the year ended December 31, 2023, which will be paid in 2024.

(3) Information includes perquisite and personal benefit received by each NEO (excludes perquisites and other personal benefits whose aggregate is less than $10,000).

(4) The amounts reported reflect the deferral and payment of $30,173 in salary from 2022 to 2023.

(5) 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) Plan contributions of up to 3% of eligible earnings up to Federal limits.

(6) The amounts reported represent $53,179 of company-paid portion of health and dental insurance and $9,150 in matching 401(k) Plan contributions of up to 3% of eligible earnings up to Federal limits.

(7) The amounts reported represent $13,406 of accrued vacation payout in cash and $5,796 in matching 401(k) Plan contributions of up to 3% of eligible earnings up to Federal limits.

(8) Consists entirely of matching 401(k) Plan contributions of up to 3% of eligible earnings up to Federal limits.

(9) Consists entirely of consulting fees paid to and accrued to Danforth Advisors LLC.

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.

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.

Narrative Disclosure to Summary Compensation Table

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For fiscal year 2024, the annual base salaries for each of Mr.

Bender and 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 and Mr.

Talamo and Mr.

Wesolowski were $523,000, $370,000 and $215,000 respectively.

Ahlers is an independent consultant whose compensation for 2023 and 2022 was $75,088 and $120,800, respectively, at a current rate of $416 per hour.

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

We have entered into an Amended and Restated Employment Agreement with Mr.

Bender in connection with our IPO (the “Amended and Restated Employment Agreement”), which agreement became effective on November 29, 2021.

The Amended and Restated Employment Agreement provides that Mr.

Bender will receive a base salary of $523,000, which will be reviewed annually and may be increased, but not decreased, without Mr.

Bender’s consent.

The Amended and Restated Employment Agreement also provides that Mr.

Bender is eligible to receive an annual performance-based cash bonus as a percentage (not more than 75%) of base salary, which bonus is earned based on the achievement of performance targets, as determined annually by the Compensation Committee of our board of directors.

Any annual bonus, to the extent earned, is paid in a lump sum.

Under the Amended and Restated Employment Agreement, Mr.

Bender is also eligible to participate in the Company’s equity grant program, which grants shall occur not less than once per year.

The form of equity award agreement and the terms and conditions of such equity awards, including with respect to vesting, will be determined by our board of directors.

Under the Amended and Restated Employment Agreement, Mr.

Bender may terminate his employment at any time and for any reason with prior notice.

We may terminate Mr.

Bender’s employment immediately upon his death, upon a period of disability or immediately upon written notice for “cause” (as defined below).

In the event that Mr.

Bender’s employment is terminated due to his death or disability, for “cause” or upon his resignation without “good reason” (as defined below), we must provide him (or his beneficiaries) with (i) any unpaid base salary through the date of termination, (ii) payment for any accrued but unused paid time off, (iii) reimbursement for expenses properly incurred, and (iv) all other vested entitlements or benefits to which he is entitled (collectively, the “Accrued Benefits”).

If we terminate the executive’s employment without cause or Mr.

Bender terminates his employment for “good reason” (as defined below), then we must provide Mr.

Bender with the Accrued Benefits and subject to his execution and non-revocation of a release of claims, a lump sum payment equal to two times the sum of (i) his annual base salary, plus (ii) his target annual bonus, in each case at the rates and target amounts in effect as of such termination of employment.

If we terminate the executive’s employment without cause or Mr.

Bender terminates his employment for good reason and such termination is concurrent with or within six months after a change of control of the Company, then in addition to

receiving the Accrued Benefits, but in lieu of other severance payments, Mr.

Bender shall receive as a lump sum severance payment, at the time of such termination, an amount equal to (i) two and one-half (2.5) times the sum of (A) his base salary and (B) target annual bonus, each as in effect at the time of such termination, plus (ii) a payment equal to his target annual bonus for the calendar year in which the termination date occurred pro-rated for the period for which Mr.

Bender was employed by us during such year.

For purposes of the Amended and Restated Employment Agreement, “cause” generally means the executive’s (i) the failure by the executive to cure a breach of a material duty imposed on the executive under the Amended and Restated Employment Agreement or any other written agreement between executive and the Company, or any policy of the Company, after written notice thereof by the Company, if curable in the reasonable discretion of the Board, (ii) acts by executive of fraud, embezzlement, theft, willful misconduct, gross negligence, or other material dishonesty directed against the Company, (iii) the failure or refusal by executive to perform any material duties under the Amended and Restated Employment Agreement or to follow any lawful and reasonable direction of the Company;

or (vi) the executive’s being charged with a felony (other than a traffic offense), or a crime involving moral turpitude.

For purposes of the Amended and Restated Employment Agreement, “good reason” generally means a resignation by the executive on account of:

(i) a material reduction in the executive’s duties, authority or responsibilities;

(ii) relocation of executive’s place of employment without executive’s 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 Amended and Restated Employment Agreement.

Good reason will not exist unless the executive notifies the Company in writing of such action not later than a set time after its initial occurrence and the Company has not remediated the action within a set time after such notice.

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.

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.

Bender’s base salary may not be decreased without his consent.

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.

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.

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”).

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

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.

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.

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:

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 Employment Agreement”), pursuant to which he will serve as Interim Chief Financial Officer, Principal Accounting Officer and Controller of the Company.

Under the Wesolowski Employment Agreement, Mr.

Wesolowski is entitled to a base salary of $165,000.

The Wesolowski Employment Agreement provides for at-will employment.

Under the Wesolowski Employment Agreement, Mr.

Wesolowski is also eligible to participate in the Company’s equity grant program.

The form of equity award agreement and the terms and conditions of such equity awards, including with respect to vesting, will be determined by our board of directors.

Effective July 22, 2023, Mr.

Wesolowski’s base salary is $215,000.

The Wesolowski Employment Agreement also includes customary confidentiality and non-disparagement provisions, as well as provisions relating to assignment of inventions.

The Wesolowski Employment Agreement also includes non-competition and non-solicitation of employees and customers provision that applies during the executive’s employment with the Company and for a period of one year after termination of employment.

Consulting Agreement with James Ahlers

On August 10, 2021, we entered into a Consulting Agreement (the “Consulting Agreement”) with Danforth Advisors, LLC, a company that provides strategic and operational finance and accounting services to life science companies, through which we retained the services of James Ahlers to initially serve as our Chief Financial Officer, and then eventually as our Vice President of Corporate Finance.

Pursuant to the Consulting Agreement, Mr.

Ahlers performs services for the Company on a part-time basis and is compensated at an hourly rate.

Ahler’s current hourly rate is $416 per hour.

The term of the Consulting Agreement is to continue until either party shall give notice of termination, subject to the terms in the Agreement.

The Consulting Agreement also includes customary confidentiality and non-solicitation provisions, as well as provisions relating to assignment of inventions.

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.

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.

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

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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, 2023, as adjusted for the Reverse Split:

The following table presents the outstanding equity awards held by each of our named executive officers as of December 31, 2024:

Option Awards

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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

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11.50 9/5/2031

Warrant Awards

Number of securities underlying unexercised warrants exercisable (#) Number of securities underlying unexercised warrants

unexercisable (#) Warrant exercise price ($) Warrant expiration date

6,250 6,250 (7)

9.00 12/13/2032

25,000 25,000 (8)

6.43 7/19/2033

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.

(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, or 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.

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.

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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.

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Approval by our stockholders of amendments to the 2013 Plan must be obtained if required by law.

As of December 31, 2023, our board of directors has determined not to make any further awards under the 2013 Plan.

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, or the 2021 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.

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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 the immediately preceding calendar year or (B) such smaller number of shares as is determined by our board.

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:

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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.

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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

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”).

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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.

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.

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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.

Other than as set forth in the table and described more fully below, we did not make equity awards or pay any other compensation to any non-employee members of our board of directors in 2023.

During fiscal year 2023, Lewis H.

Bender, our President and Chief Executive Officer, served as a member of our board of directors and received no additional compensation for his services as a member of our board of directors.

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 fiscal year 2023.

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.

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Daniel Donovan 62,500 203,220 (4)

Dubin 31,250 183,700 (5)

(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

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

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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 60 days of March 1, 2024 are counted as outstanding.

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

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).

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2,567,227 16.3 %

Joseph Talamo (2)

John Wesolowski (3)

James Ahlers (3)

Emer Leahy (4)

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2,476,213 16.3 %

Larry Levy (9)

Armistice Capital, LLC (10)

1,126,868 7.4 %

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Does not include 401,903 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2025.

(3) Includes 1,250 shares of common stock issuable upon the exercise of warrants that are exercisable within sixty days of March 1, 2024.

Does not include 3,750 shares of common stock underlying warrants that are not exercisable within sixth days of March 1, 2024.

(3) Includes 91,131 shares of Common Stock issuable upon the exercise of options that are exercisable within sixty days of March 1, 2025.

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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.

(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.

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Jackson Blvd., Suite 503 Chicago, IL 60607.

(9) Consists of (i) 387,500 shares of Common Stock held by LFP River West Investors, LLC — Series 21, (ii) 370,531 shares of Common Stock held by LFP River West Investors, LLC — Series 38 and (iii) 75,733 shares of Common Stock held by Levy Family Investors LLC and (iv) 52,000 shares of Common Stock issuable upon the exercise of warrants exercisable within 60 days after March 1, 2024.

Does not include 24,000 shares of common stock underlying options that are not exercisable within sixty days of March 1, 2024.

Levy may be deemed to beneficially own such shares.

The registered address for LFP River West Investors, LLC is 251 Little Falls Drive, Wilmington, DE 19808.

(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.

Does not include 24,000 shares of common stock underlying options that are not exercisable within sixty days of March 1, 2024.

All shares are held by Craig J.

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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 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.

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

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.

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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 includes fees for consents and comfort letters of $195,000 in 2023 and $167,000 in 2022.

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.

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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).

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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).

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)

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32.2** Certification of CFO Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

97.1* Clawback Policy

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

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* Filed herewith.

** Furnished herewith.

FORM 10-K SUMMARY

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Goldberg Director March 13, 2025

/s/ Thomas I.

Dubin Director March 13, 2025

INTENSITY THERAPEUTICS, INC.

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Marketable debt securities — 6,220

Prepaid expenses 682 63

Other current assets 6 76

Prepaid expenses and other current assets 773 688

Total current assets 3,363 15,464

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Total assets $ 4,783 $ 17,295

LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIENCY)

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

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Lease liability, current portion 28 20

Convertible note and accrued interest - 4,349

Total current liabilities 1,755 3,959

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Total liabilities $ 1,865 $ 4,133

Series A redeemable convertible preferred stock, par value $ .0001 .

Authorized, issued, and outstanding shares of none and 5,000,000 as of December 31, 2023 and 2022, respectively.

Commitments and contingencies

STOCKHOLDERS’ EQUITY (DEFICIENCY)

STOCKHOLDERS’ EQUITY

Preferred stock, par value $ .0001 .

Authorized shares of 15,000,000 and 20,000,000 as of December 31, 2023 and 2022, respectively.

Series B convertible preferred stock, par value $ .0001 .

Designated, issued, and outstanding shares of none and 1,449,113 as of December 31, 2023 and 2022, respectively.

Series C convertible preferred stock, par value $ .0001 .

Designated, issued, and outstanding shares of none and 1,800,606 as of December 31, 2023 and 2022, respectively.

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 and 50,000,000 as of December 31, 2023 and 2022, respectively.

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.

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Accumulated deficit ( 66,783 ) ( 50,515 )

Total stockholders’ equity (deficiency) $ 13,162 $ ( 15,098 )

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficiency) $ 17,295 $ 1,757

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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Loss on debt extinguishment - ( 2,262 )

Other income, net 3 24

Net loss $ ( 16,268 ) $ ( 10,538 )

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Weighted average number of shares of common stock, basic and diluted 13,906,973 8,616,324

8,616,324 3,410,103

The accompanying notes are an integral part of these financial statements.

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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 )

Stock-based compensation expense - - - - - - - - 1,169 - 1,169

Net loss - - - - - - - - - ( 7,582 ) ( 7,582 )

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

Warrants issued to underwriters in connection with public offering - - - - - - - - 1,170 - 1,170

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

Warrants issued to convertible note holders - - - - - - - - 159 - 159

Exercise of options and warrants - - - - - - 25,000 - 50 - 50

Issuance of warrants to convertible note holders - - - - - - - - 159 - 159

Exercise of options - - - - - - 25,000 - 50 - 50

Deemed dividend - - - - - - 264,707 - 1,324 ( 1,324 ) -

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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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Stock-based compensation expense 3,073 1,398

Stock issued in exchange for services 51 -

Loss on debt extinguishment - 2,262

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Redemption of marketable debt securities 9,410 9,030

Net cash used in investing activities ( 6,023 ) -

Net cash provided by (used in) investing activities 6,354 ( 6,023 )

Cash flows from financing activities:

Proceeds from issuance of convertible note 230 2,250

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 increase (decrease) in cash and cash equivalents 7,244 ( 3,227 )

Net (decrease) increase in cash and cash equivalents ( 5,966 ) 7,244

Cash and cash equivalents at beginning of period 8,556 1,312

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After deducting offering expenses of $ 0.2 million, the Company received an additional $ 2.7 million in net cash proceeds.

The Company has begun to use and will continue to use 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.

In April 2023, the Company effected a two-for-one reverse stock split (the “Reverse Stock Split”).

All owners received one issued and outstanding share of the Company’s common stock in exchange for two outstanding shares of the Company’s common stock.

All fractional shares created by the two-for-one exchange were paid in cash.

The conversion price of Series A redeemable convertible preferred stock, Series B convertible preferred stock, and Series C convertible preferred stock were adjusted to reflect the Reverse Stock Split by doubling the original conversion price.

The Reverse Stock Split has no impact on the par value per share of the Company’s common stock, Series A redeemable convertible preferred stock, Series B convertible preferred stock, and Series C convertible preferred stock, all of which remain at $ .0001 .

All holders of options and warrants had the exercise price doubled and the number of shares issuable upon exercise reduced by half.

All current and prior period amounts related to shares, share prices and loss per share, presented in the Company’s financial statements and the accompanying notes have been restated for the Reverse Stock Split.

All preferred stock and convertible notes were converted into common stock on the IPO date.

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.

Liquidity and Plan of Operation

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The Company, therefore, expects to continue to incur substantial losses for the foreseeable future.

Cash, cash equivalents and marketable debt securities totaled $ 14.8 million as of December 31, 2023.

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.

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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, cash equivalents, and marketable debt securities as of December 31, 2023, the Company believes that it has cash through the end of the first quarter of 2025 for its current operations.

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.

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The Company neither owns nor controls any subsidiary companies.

Financial impact of events beyond our control

Our financial condition and results of operations may be impacted by factors we may not be able to control, such as the COVID-19 or other pandemic, global supply chain disruptions, global trade disputes and/or political instability.

Increases in interest rates, especially if coupled with reduced government spending and volatility in financial markets, may have the effect of further increasing economic uncertainty and heightening these risks.

Additionally, rising inflation rates may affect us by increasing operating expenses, such as employee-related costs and clinical trial expenses, negatively impacting our results of operations.

The Company’s financial results for the year ended December 31, 2023 were not significantly impacted by COVID-19 or other factors beyond our control, such as those described above.

However, the Company cannot predict the impact of any of these factors on future results or the Company’s ability to raise capital due to a variety of factors, including but not limited to the continued good health of Company employees, the ability of service providers and suppliers to continue to operate and deliver, the ability of the Company to maintain operations, and any government and/or public actions taken in response to these factors.

Use of estimates

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The investments in the U.S.

Securities money market fund and U.S.

Treasury securities and U.S.

Treasury bills are not FDIC insured but are backed by the U.S.

Treasury bills are subject to market risk if they are sold prior to maturity.

Treasury securities are subject to market risk if they are sold prior to maturity.

The Company has not experienced any losses in such accounts.

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Unrealized gains or losses would be included in accumulated other comprehensive income within the equity section of the Balance Sheet.

At December 31, 2023, there were no unrealized gains or losses and all accrued interest was recognized as Interest income in the Statement of Operations.

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

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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 initiative, including preclinical, individual clinical study, and manufacturing activities.

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 costs by program because these costs are deployed across multiple programs and, as such, are not separately classified.

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.

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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 mid-2024, the Company intends on initiating a Phase 3 open-label, randomized study for certain soft tissue sarcoma subtypes.

In connection with this study, the Company recorded an advance payment of $ 1.7 million, which will be applied to invoices at the end of the study and is included in Other Assets in the Balance Sheet as of December 31, 2023, as the Phase 3 study is expected to span several years.

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.

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.

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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, 2023, the Company does not have any significant uncertain tax positions.

As of December 31, 2024, the Company does not have any uncertain tax positions.

There are no estimated interest costs and penalties provided for in the Company’s financial statements for the year ended December 31, 2024.

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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 at December 31, 2023.

As of December 31, 2023 and 2022, the following shares of common stock underlying preferred stock, options, and warrants were excluded from the computation of diluted weighted average shares outstanding.

In accordance with the Reverse Stock Split in April 2023 (see Note 1), the number of shares of common stock underlying the preferred stock, options and warrants are now half, and the below information gives effect to this Reverse Stock Split:

Preferred stock Series A outstanding - 2,499,999

Preferred stock Series B outstanding - 724,552

Preferred stock Series C outstanding - 900,300

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:

Options outstanding 2,587,129 1,239,750

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4,628,692 2,041,700

As of December 31, 2022, the shares that would be issued from the convertible notes outstanding are also excluded from diluted weighted average shares outstanding, since the conversion rate is dependent upon qualified liquidity events.

All convertible notes were converted into shares of common stock on June 29, 2023.

Stock issuance costs

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These costs were recorded as a deduction to Additional Paid in Capital.

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

The Company does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material impact on its financial statements.

Reclassifications

Certain prior year amounts have been reclassified to conform to current year presentation.

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.

Cash and Cash Equivalents

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Prepaid insurance $ 421 $ 647

Prepaid research and development costs 239 —

Prepaid other 113 41

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Accrued expenses consisted of the following (in thousands):

Clinical study patient costs incurred but not yet invoiced $ 439 $ 1,393

Accrued vacation, wages, bonuses, and related payroll taxes 392 329

Accrued research and development costs $ 373 $ 439

Accrued employee compensation-related expenses 56 392

Accrued other 79 60

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Convertible Notes

Prior to the IPO, the Company entered into a series of interest-bearing convertible notes as described below.

In September 2021, the Company entered into a convertible note agreement with a shareholder for aggregate principal of $ 2.0 million, as amended in November 2022 (the “2021 Convertible Note”).

The outstanding principal balance and accrued interest on the note automatically converted upon the IPO at a discount of 35 % to the conversion price of $ 11.50 per share in accordance with the note agreement.

The 2021 Convertible Note had accrued interest at 3 % per annum.

In November 2022, the Company entered into convertible note agreements with shareholders for an aggregate $ 2.3 million with three holders (the “2022 Convertible Notes”).

The outstanding principal balance and accrued interest on these notes automatically converted upon the IPO at a discount of 30 % to the conversion price of $ 11.50 per share in accordance with the note agreement.

The 2022 Convertible Notes had accrued interest at 10 % per annum.

In March through May 2023, the Company entered into convertible note agreements for an aggregate $ 0.2 million with four holders (the “2023 Convertible Notes”).

The outstanding principal balances and accrued interest on these notes

automatically converted upon the IPO at a discount of 30 % to the conversion price of $ 11.50 per share in accordance with the note agreement.

The 2023 Convertible Notes had accrued interest at 10 % per annum.

Convertible notes consisted of the following as of December 31, 2023 and 2022 (in thousands):

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

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Interest expense — 145 145

Balance as of December 31, 2022 4,250 99 4,349

Issuance of 2023 Convertible Notes 243 — 243

Interest expense - 2023 — 145 145

Conversion to common stock upon IPO ( 4,493 ) ( 244 ) ( 4,737 )

Balance as of December 31, 2023 $ — $ — $ —

As of December 31, 2022, the Company classified the convertible notes as a current liability since the Company anticipated that these notes would automatically convert into shares of common stock within one year.

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.

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Initial public offering

On June 29, 2023, as described in Note 1, the Company priced its IPO, issuing 3,900,000 shares of common stock at the IPO price of $ 5.00 per share.

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.

On June 29, 2023, pursuant to the IPO,

Pursuant to the IPO,

• 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.

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• 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

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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, an additional 238,700 shares were authorized under the 2021 Plan.

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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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

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All options expire 10 years from date of grant.

Options outstanding begin to expire in August 2024.

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, 2023 , total unrecognized compensation cost related to options was approximately $ 1,848,000 and is expected to be recognized over the remaining weighted average service period of 2.2 years.

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.

The following table summarizes the range of assumptions used to estimate the fair value of warrants issued in 2024 and 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

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In connection with the IPO, 313,950 warrants were issued to the Company’s underwriters during the year ended December 31, 2023.

At December 31, 2023, total unrecognized compensation cost related to warrants was approximately $ 282,000 and is expected to be recognized over the remaining weighted average service period of 1.4 years.

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.

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.

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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.

Cash paid for the Westport Lease will commence in 2024.

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):

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Future minimum lease payments under the lease agreement as of December 31, 2024 were as follows (in thousands):

2028 and thereafter 46

Total lease payments $ 158

2 unchanged sentences

Other Uncertainties

The Company holds one of its patents in Russia.

The payment for this patent is paid until September 15, 2024.

If subsequent payments to Russia are restricted, the Company may lose this patent in Russia.

The Company has no other significant business activities in Belarus, Russia or the Ukraine.

The Company also holds a patent in Israel which is currently involved in military action.

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.

Related Parties

Beginning in February 2022, 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 and $ 96,000 of research and development expense for the years ended December 31, 2023 and 2022, respectively.

The Company sublet a portion of its Westport Lease to a minority stockholder, and recognized sublease income of approximately $ 23,000 and $ 68,000 for the years ended December 31, 2023 and 2022.

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 and 2022, 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 will be returned to the minority stockholder at the completion of the service agreement.

In October 2023, the Company issued 80,000 warrants for consulting services to be rendered by the two shareholders, which will vest over the subsequent twelve months.

These warrants are valued at $ 198,000 and will be expensed to general and administrative expense over the subsequent twelve month period.

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.

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.

The components of the Company’s provision for income taxes and income taxes computed using the U.S.

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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.

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Federal and Connecticut jurisdictions.

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:

Years Ended December 31,

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)

Clinical trial expenses 7,077 1,987

Contract manufacturing 657 922

Salaries and benefits related 1,379 896

Consulting & Other (b)

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

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)

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures