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Item 9A. Controls and Procedures

2026-03-27 compared with 2025-03-13 · 198 added, 273 removed, 1091 unchanged (30% of the section changed)

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Based upon that evaluation, we have concluded that, as of December 31, 2025, 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 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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Changes in Internal Control over Financial Reporting

Other than the remediations identified above, there have been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2024 covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

There have been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 2025 covered by this report that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

OTHER INFORMATION

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The duration of the trading arrangement is from March 16, 2026 until November 13, 2026 .

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.

On December 5, 2025 , 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

171,936 shares of our Common Stock.

The duration of the trading arrangement is from March 16, 2026 until November 13, 2026 .

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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.

Leahy also serves as Chief Executive Officer of Axelyra Therapeutics, a start up CNS discovery and development company, since 2025.

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.

DRUG), a biotech company, until April 2022, a Board member, Chair of the Compensation committee and a member of the Audit and Governance committees of Pasithea Therapeutics, Inc.

KTTA), a biotech company, since 2021, and a Board member of Prostate Theranostics, a private drug discovery company, since 2025.

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.

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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 currently serves as a Board member of BioNJ since 2020, and served as Chair of the Board of Trustees between 2024 and 2026.

She is a recent finalist in the NJ Chapter of the EY Entrepreneur of the Year.

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

Since January 2026, Dr.

Goldberg has served as Operating Partner of Arsenal Capital Management, a specialized private equity firm in the industrials and healthcare sectors.

Since 2019, Dr.

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Goldberg has served as President and COO of PAREXEL International, one of the world’s largest global biopharmaceutical service providers, with consolidated revenue of approximately $2.4 billion in 2017, over 18,000 employees, and 86 locations in 51 countries.

He was responsible for overseeing all revenue generating business segments including Clinical Research Services, Calyx, and PAREXEL Consulting as well as sales, marketing, corporate quality, and information technology.

He was responsible for overseeing all revenue generating business segments including Clinical Research Services, PAREXEL Informatics, and PAREXEL Consulting as well as sales, marketing, corporate quality, and information technology.

Goldberg helped to pioneer PAREXEL’s strategic partnering approach with some of the world’s leading pharmaceutical companies and to build out the company’s global infrastructure, particularly in the Asia Pacific region, through both organic growth and acquisitions.

Earlier in his PAREXEL career, he founded the company’s Medical Imaging business and helped establish its technology subsidiary, Perceptive Informatics (now PAREXEL Informatics).

Earlier in his PAREXEL career, he founded the company’s Medical Imaging business and helped establish its technology subsidiary, PAREXEL Informatics.

Goldberg holds a BS degree in computer science from MIT and an MD from the University of Massachusetts Medical School.

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We believe that Dr.

Goldberg is qualified to serve as a member of our board of directors because of his medical background and experience as a director of a public company.

Goldberg is qualified to serve as a member of our board of directors because of his medical background, extensive experience in the pharmaceutical services industry, and having served as a named officer of a public company.

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

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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.

Dubin 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.

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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 currently serves as Executive Chair of Cellphire Therapeutics, board member of Nuvance Health, board member of Norwalk Hospital, and member of the Yale School of Public Health Leadership Council.

Dubin was a board member of Notable Laboratories (Nasdaq:

NTBL) in 2024, BioBlast Pharmaceuticals (Nasdaq:

ORPN) from 2015 to 2018, a board member of Connecticut Innovations from 2020 to 2024, an advisory board member of Mythic Pharmaceuticals from 2017 to 2024, and a trustee of American Jewish World Service from 2014 to 2021.

Dubin received his J.D.

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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.

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.

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.

Our directors are divided among the three classes as follows:

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Role of Board of Directors in Risk Oversight Process

Our board of directors has responsibility for the oversight of our risk management processes and, either as a whole or through its committees, regularly discusses with management our major risk exposures, their potential impact on our business and the steps we take to manage them.

The risk oversight process includes receiving regular reports from board committees and members of senior management to enable our board of directors to understand our risk identification, risk

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

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.

EXECUTIVE COMPENSATION

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Summary Compensation Table

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

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

All Other Compensation (2) ($)

Bender 2025 549,150 411,863 (3)

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

340,138 54,331 (4)

President and Chief Executive Officer 2024 544,121 — 1,889,162 52,886 (5)

Joseph Talamo 2025 374,696 152,440 147,728 48,875 (6)

2024 370,000 — 1,245,646 46,930 (8)

Chief Financial Officer 2024 370,000 — 1,245,646 46,930 (7)

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(2) Information includes perquisite and personal benefit received by each Named Executive Officer.

(3) On March 26, 2026, our compensation committee approved payment of 56% of the 2025 bonus to be paid in the Company’s common stock under the 2021 Plan, based on the March 26, 2026 closing stock price of $6.11.

(4) The amounts reported represent $43,831 of Company-paid portion of health and dental insurance and $10,500 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.

(5) The amounts reported represent $42,536 of Company-paid portion of health and dental insurance and $10,350 in matching 401(k) contributions.

(6) The amounts reported represent $38,375 of company-paid portion of health and dental insurance and $10,500 in matching 401(k) contributions.

(7) The amounts reported represent $36,580 of company-paid portion of health and dental insurance and $10,350 in matching 401(k) contributions.

(8) 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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However, if Mr.

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 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.

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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.

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.

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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.

Effective September 1, 2025, Mr.

Wesolowski’s annual salary was reduced to $214,240 to reflect a reduction in his standard work week.

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.

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7,000 21,000 (2)

$ 14.25 5/2/2035

Joseph Talamo 1,600 1,600 (3)

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$ 86.00 10/21/2034

John Wesolowski 14,000 – 4.00 3/27/2027

2,400 9,600 (5)

$ 14.25 5/2/2035

John Wesolowski 560 — $ 100.00 3/27/2027

300 — $ 200.00 2/6/2028

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800 3,200 (10)

(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.

$ 14.25 5/2/2035

(1) Consists of options granted to Mr.

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(2) Consists of options granted to Mr.

Bender by our compensation committee on May 2, 2025, 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.

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(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.

Talamo by our compensation committee on May 2, 2025, vesting in five equal annual installments beginning on the date of grant.

(6) Consists of options granted to Mr.

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Wesolowski by our compensation committee on October 21, 2024, vesting in five equal annual installments beginning on the date of grant.

(10) Consists of options granted to Mr.

Wesolowski by our compensation committee on May 2, 2025, vesting in five equal annual installments beginning on the date of grant.

2013 Stock and Option Plan

Under our 2013 Stock and Option Plan (the “2013 Plan”), 4,500,000 shares of Common Stock have been reserved for issuance in the form of incentive stock options, non-qualified stock options, restricted stock, unrestricted stock, stock appreciation rights or any combination of the foregoing.

Under our 2013 Stock and Option Plan (the “2013 Plan”), 180,000 shares of Common Stock were 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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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.

Pursuant to the 2021 Plan, we have reserved 120,000 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 share reserve is subject to the following adjustments:

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On January 1, 2024, pursuant to the provisions of the 2021 Plan, authorized shares increased by 19,193 shares.

On January 1, 2025, pursuant to the provisions of the 2021 Plan, authorized shares increased by 21,172 shares.

As of December 31, 2025, options to purchase 38,291 shares of Common Stock were available to be issued under the 2021 Plan.

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As is customary in incentive plans of this nature, each share limit and the number and kind of shares available under the 2021 Plan and any outstanding awards, as well as the exercise price or base price of awards, and performance targets under certain types of performance-based awards, are subject to adjustment in the event of certain reorganizations, mergers, combinations, recapitalizations, stock splits, stock dividends, or other similar events that change the number or kind of shares outstanding, and extraordinary dividends or distributions of property to the stockholders.

The number of shares available under the 2021 Plan was not adjusted as part of the Reverse Split.

Amendment and Termination.

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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.

(2) On May 2, 2025, Dr.

Leahy was granted 2,000 options, vesting in four equal annual installments beginning on the grant date.

(3) On March 6, 2024, Dr.

(3) On May 2, 2025, Dr.

Goldberg was granted 2,000 options, vesting in four equal annual installments beginning on the grant date.

(4) On March 6, 2024, Mr.

(4) On May 2, 2025, Mr.

Donovan was granted 2,000 options, vesting in four equal annual installments beginning on the grant date.

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Applicable percentage ownership in the following table is based on 2,540,518 shares outstanding as of March 1, 2026.

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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152,410 5.8 %

5% Stockholders

Leonard Batterson (9)

2,476,213 16.3 %

Armistice Capital, LLC (10)

1,126,868 7.4 %

Duchossois (11)

1,062,753 7.0 %

5% Stockholders - none

* Less than 1%

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Does not include 61,610 shares of Common Stock underlying options that are not exercisable within sixty days of March 1, 2026.

(9) Consists of (i) 2,023,227 shares of Common Stock held by VCapital Intensity LLC, (ii) 427,986 shares of Common Stock held by BVC — Intensity LLC and (iii) 25,000 shares of Common Stock issuable upon the exercise of warrants exercisable within 60 days after March 1, 2025.

Batterson may be deemed to beneficially own such shares.

The principal business address of VCapital Intensity LLC and BVC — Intensity LLC is 901 W.

Jackson Blvd., Suite 503 Chicago, IL 60607.

(10) This information is based solely on a Schedule 13G filed with the SEC on February 14, 2025.

Consists of 1,126,868 shares of Common Stock directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master Fund”), and may be deemed to be beneficially owned by:

(i) Armistice Capital, LLC (“Armistice Capital”), as the investment manager of the Master Fund;

and (ii) Steven Boyd, as the Managing Member of Armistice Capital.

The address of Armistice Capital Master Fund Ltd.

is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.

Does not include 1,237,113 shares of common stock issuable upon the exercise of warrants held by the Master Fund that are subject to a beneficial ownership limitation of 4.99% and are not exercisable within sixty days of March 1, 2025.

(11) Consists of (i) 1,010,753 shares of Common Stock and (ii) 52,000 shares of Common Stock issuable upon the exercise of warrants exercisable within 60 days after March 1, 2025.

All shares are held by Craig J.

Duchossois Revocable Trust UAD 9/11/1989.

Duchossois may be deemed to beneficially own such shares.

The principal business address of Craig J.

Duchossois is 444 W.

Lake St, Suite 2000, Chicago, Illinois 60606.

The following table summarizes information about our equity compensation plans as of December 31, 2024.

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• any of our directors, executive officers or holders of more than 5% of our capital stock, or any immediate family member of, or person sharing the household with, any of these individuals, had or will have a direct or indirect material interest.

Convertible Note with Shareholder

On September 20, 2021, we entered into a convertible debt agreement (the “2021 Convertible Note”) for aggregate principal of $2,000,000.

On November 29, 2022, and again February 8, 2023, we amended the 2021 Convertible Note to reflect new terms upon the Company’s IPO or equity financing (the “2021 Amended Note”).

Pursuant to the terms of the 2021 Amended Note, the maturity date is October 1, 2025, and has the following conversion terms.

The outstanding principal balance together with the unpaid and accrued interest of the note will be automatically converted upon the earliest of (i) an IPO in excess of $8,000,000 gross proceeds, (ii) a sale event of all or substantially all of the company’s assets or a majority of its equity securities, (iii) non-IPO financing by selling preferred stock in an equity offering other than an IPO or (iv) the maturity date of October 1, 2025.

If an IPO, sale event or non-IPO financing occurs between November 29, 2022 through March 20, 2023 a conversion price discount of 30% would be assessed, if between March 20, 2023 through October 1, 2025 a conversion price discount of 35% would be assessed.

Otherwise at the maturity date a conversion price of $11.50 per share would be assessed.

The 2021 Amended Note accrues interest at 3% per annum, but will increase to 6% per annum after October 1, 2023, and is convertible to shares of our Common Stock.

The occurrence of any of the following shall constitute an event of default:

a) failure to pay when due any principal payment;

b) voluntary bankruptcy or insolvency proceedings;

c) involuntary bankruptcy or insolvency proceedings;

d) judgements in excess of $500,000;

or e) defaults under other indebtedness.

Under these occurrences, the holder may declare all outstanding principal and interest payable to be immediately due and payable.

The 2021 Amended Note automatically converted upon the IPO into 648,109 shares of Common Stock.

On November 29, 2022, we entered into a convertible debt agreement (the “2022 Convertible Note”) for $1,500,000.

On February 8, 2023, we amended the 2022 Convertible Note (the “2022 Convertible Note Amendment”) to reflect new terms upon the Company’s IPO or equity financing.

The outstanding principal balance together with the unpaid and accrued interest of the note will be automatically converted upon the earliest of (i) an IPO of no less than $8,000,000 gross proceeds, (ii) a sale event of all or substantially all of the company’s assets or a majority of its equity securities, (iii) non-IPO financing by selling preferred stock in an equity offering other than an IPO or (iv) the maturity date of October 1, 2025.

If an IPO, sale event or non-IPO financing occurs prior to October 1, 2025, a conversion price discount of 30% would be assessed.

Otherwise at the maturity date a conversion price would be $11.50 per share be assessed.

The 2022 Amended Note automatically converted upon the IPO into 453,463 shares of Common Stock.

On March 30, 2023, we entered into a convertible debt agreement (the “2023 Convertible Note”) for $155,000.

The outstanding principal balance together with the unpaid and accrued interest would be automatically converted upon the earliest of (i) an IPO of no less than $7,000,000 in gross proceeds, (ii) a sale event of all or substantially all of the Company’s assets or a majority of its equity securities, (iii) non-IPO financing by selling preferred stock in an equity offering other than an IPO or (iv) the maturity date of March 30, 2026.

If an IPO, sale event or non-IPO financing occurs prior to March 30, 2026, a conversion price discount of 30% would be assessed;

otherwise at the maturity date a conversion price would be $11.50 per share would be assessed.

This note converted into 45,389 shares of Common Stock at our IPO.

The 2021 Amended Note, the 2022 Convertible Note Amendment and the 2023 Convertible Note were entered into with Leonard Batterson, one of our 10% shareholders.

Indemnification Agreements

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The indemnification agreements also provide for the advancement of expenses in connection with a proceeding prior to a final, non-appealable judgment or other adjudication, provided that the indemnitee provides an undertaking to repay to us any amounts advanced if the indemnitee is ultimately found not to been titled to indemnification by us.

The indemnification agreement set forth procedures for making and responding to a request for indemnification or advancement of expenses, as well as dispute resolution procedures that apply to any dispute between us and an indemnitee arising under the Indemnification Agreements.

indemnification agreement set forth procedures for making and responding to a request for indemnification or advancement of expenses, as well as dispute resolution procedures that apply to any dispute between us and an indemnitee arising under the Indemnification Agreements.

Policies and Procedures for Related Party Transactions

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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The Audit Committee pre-approves all auditing services and any non-audit services that the independent registered public accounting firm is permitted to render under Section10A (h) of the Exchange Act.

The Audit Committee may delegate the pre-approval to one of its members, provided that if such delegation is made, the full Audit Committee must be presented at its next regularly scheduled meeting with any pre-approval decision made by that member.

The Audit Committee

may delegate the pre-approval to one of its members, provided that if such delegation is made, the full Audit Committee must be presented at its next regularly scheduled meeting with any pre-approval decision made by that member.

EXHIBITS, FINANCIAL STATEMENT SCHEDULES

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3.1 Sixth Amended and Restated Certificate of Incorporation of the Registrant, dated June 30, 2023 (incorporated by reference to Exhibit 3.1 of our Form 8-K filed on July 5, 2023).

3.2 Certificate of Amendment of Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of our Form 8-K filed on February 13, 2026)

3.3 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).

3.4 Amendment to Amended and Restated Bylaws, certified as of August 12, 2025 (incorporated by reference to Exhibit 3.1 of our Form 8-K filed on August 12, 2025).

4.1* Description of Securities

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4.4 Form of Common Warrant (incorporated by reference to Exhibit 4.1 of our Form 8-K filed on November 22, 2024).

4.5 Form of Series B-1 Common Warrant (incorporated by reference to Exhibit 4.1 of our Form 8-K filed on April 25, 2025).

4.6 Form of Series B-2 Common Warrant (incorporated by reference to Exhibit 4.2 of our Form 8-K filed on April 25, 2025).

4.7 Form of Representative’s Warrant (incorporated by reference to Exhibit 4.1 of our Form 8-K filed on June 13, 2025).

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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10.8# Employment Agreement, dated June 20, 2023, between Registrant and John Wesolowski (incorporated by reference to Exhibit 10.15 of our Form S-1 filed on June 29, 2023).

10.9 Underwriting Agreement, dated June 29, 2023 (incorporated by reference to Exhibit 10.1 of our Form 8-K filed on July 5, 2023)

10.9# Employment Agreement, dated December 11, 2023 between Registrant and Joseph Talamo (incorporated by reference to Exhibit 10.1 of our Form 8-K filed on December 12, 2023)

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and the purchasers party thereto (incorporated by reference to Exhibit 10.1 of our Form 8-K filed on November 22, 2024).

10.15 Form of Placement Agent Agreement dated October 30, 2025, by and between the Company and A.G.P./Alliance Global Partners (incorporated by reference to Exhibit 1.1 of our Form 8-K filed on October 31, 2025).

10.16 Form of Securities Purchase Agreement, dated as of October 30, 2025, 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 October 31, 2025).

10.17 Underwriting Agreement, dated June 11, 2025, by and between Intensity Therapeutics, Inc.

and ThinkEquity LLC (incorporated by reference Exhibit 1.1 of our Form 8-K filed on June 13, 2025).

10.18 Form of Placement Agent Agreement dated April 24, 2025, by and between the Company and A.G.P./Alliance Global Partners and Brookline Capital Markets, a division of Arcadia Securities, LLC (incorporated by reference to Exhibit 1.1 of our Form 8-K filed on April 25, 2025).

10.19 Form of Securities Purchase Agreement, dated as of April 24, 2025, by and between Intensity Therapeutics, Inc.

and the purchasers party thereto (incorporated by reference to Exhibit 10.1 from our Form 8-K filed on April 25, 2025).

19.1* Insider Trading Policy.

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

97.1 Clawback Polic y (in corporated by reference to Exhibit 97.1 of our Form 10-K filed on March 14, 2024)

97.1 Clawback Policy (incorporated 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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Statements of operations for the years ended December 31, 202 5 and 202 4

Statements of changes in redeemable convertible preferred stock and stockholders’ equity (deficiency) for the years ended December 31, 202 4 and 202 3

Statements of changes in stockholders’ equity for the years ended December 31, 202 5 and 202 4

Statements of cash flows for the years ended December 31, 202 5 and 202 4

Notes to December 31, 202 4 and 202 3 financial statements

Notes to financial statements

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

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We have audited the accompanying balance sheets of Intensity Therapeutics, Inc.

(the “Company”) as of December 31, 2024 and 2023, and the related statements of operations, changes in redeemable convertible preferred stock and stockholders’ equity (deficiency), and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”).

(the “Company”) as of December 31, 2025 and 2024, and the related statements of operations, changes in stockholders’ equity, and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.

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The accompanying financial statements have been prepared assuming that the Company will continue as a going concern.

As discussed in Note 2 to the financial statements, the Company has incurred losses from operations and negative cash flows that raise substantial doubt about its ability to continue as a going concern.

As discussed in Note 2 to the financial statements, the Company has incurred losses from operations and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern.

Management’s plans in regard to these matters are also described in Note 2.

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Cash and cash equivalents $ 11,921 $ 2,590

Marketable debt securities — 6,220

Prepaid expenses and other current assets 788 773

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Total current liabilities 2,146 1,755

Other long-term liabilities — 36

Lease liability, net of long-term portion 79 110

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Authorized shares of 15,000,000 as of both December 31, 2025 and 2024, respectively.

None issued and outstanding as of both December 31, 2024 and 2023, respectively.

None issued and outstanding as of both December 31, 2025 and 2024.

Common stock, par value $ .0001 .

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Interest income 180 314

Interest expense - ( 305 )

Loss on debt extinguishment - ( 2,262 )

Other income, net 186 3

Net loss $ ( 11,606 ) $ ( 16,268 )

Preferred stock deemed dividend - ( 1,324 )

Net loss attributable to common stockholders $ ( 16,268 ) $ ( 11,862 )

Loss per share, basic and diluted $ ( 8.56 ) $ ( 29.24 )

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INTENSITY THERAPEUTICS, INC.

STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIENCY)

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(in thousands, except share amounts)

Series A Redeemable Convertible Preferred Stock Series B Convertible Preferred Series C Convertible Preferred Common Stock Additional Paid in Capital Accumulated Deficit Stockholders’ Equity (Deficiency)

Shares Amount Shares Amount Shares Amount Shares Amount

Common Stock Additional Paid in Capital Accumulated Deficit Stockholders’ Equity

Shares Amount

Balances at December 31, 2023 548,375 $ - $ 63,677 $ ( 50,515 ) $ 13,162

Issuance of common stock in public offering for cash, net of $ 3,403 issuance costs

Issuance of common stock in registered direct offering, net of $ 321 issuance costs

49,484 - 1,361 - 1,361

Issuance of warrants underwriters in connection with public offering - - - - - - - - 1,170 - 1,170

Conversion of preferred stock into common stock ( 5,000,000 ) ( 10,000 ) ( 1,449,113 ) - ( 1,800,606 ) - 4,124,851 - 10,000 - 10,000

Conversion of convertible notes into common stock - - - - - - 1,399,716 - 6,998 - 6,998

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

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

2,073 - 150 - 150

Issuance of common stock in exchange for services 470 - 51 - 51

Exercise of options 3,540 - 266 - 266

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

Exercise of warrants 973 55 55

Stock-based compensation expense - - 3,073 - 3,073

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Balances at December 31, 2024 604,915 $ - $ 69,701 $ ( 66,783 ) $ 2,918

Issuance of common stock in registered direct offering, net of $ 321 issuance costs

Issuance of common stock in public offerings, net of $ 698 issuance costs

432,383 - 2,678 - 2,678

Issuance of warrants in registered direct offering, net of $ 252 issuance costs

Issuance of warrants in public offering, net of $ 235 issuance costs

- - 1,041 - 1,041

Issuance of common stock in registered direct offering, net of $ 412 issuance costs

200,000 - 3,588 - 3,588

Issuance of common stock in employee stock purchase plan 5,109 - 33 - 33

Issuance of common stock in ATM offering, net of $ 471 issuance costs

1,279,428 - 11,168 - 11,168

Issuance of common stock in exchange for services - - - - - - 11,750 - 51 - 51

Exercise of options - - - - - - 88,500 - 266 - 266

Exercise of warrants 2,640 - 56 - 56

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Adjustments to reconcile net loss to net cash used in operating activities:

Amortization of discount on convertible notes - 159

Change in carrying value of right-of-use asset 26 25

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Stock issued in exchange for services - 51

Loss on debt extinguishment - 2,262

Changes in operating assets and liabilities, net:

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Redemption of marketable debt securities - 9,410

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

Net cash provided by investing activities - 6,354

Cash flows from financing activities:

Proceeds from Public Offerings 4,652 -

Issuance costs related to Public Offerings ( 933 ) -

Proceeds from Registered Direct Offering 4,000 3,000

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Issuance costs related to ATM offering ( 471 ) ( 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 common stock issuances 33 -

Proceeds from exercise of options and warrants 56 321

Net cash provided by financing activities 18,564 2,900

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

Net increase (decrease) in cash and cash equivalents 9,331 ( 5,966 )

Cash and cash equivalents at beginning of period 2,590 8,556

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Supplemental disclosure of non-cash financing activities:

Right-of-use lease asset and operating lease liability $ - $ 155

Convertible notes issued in exchange for services $ - 13

Conversion of convertible notes and accrued interest into common stock $ - $ 4,737

Warrants issued in relation to issuance of convertible notes $ - $ 159

Common stock issued in exchange for services $ - $ 51

Warrants issued to underwriter in connection with stock issuance $ 1,041 $ 1,068

Preferred stock deemed dividend $ - $ 1,324

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

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The Company is based in Connecticut and was incorporated in Delaware in December 2012.

As a result of its initial public offering (the “IPO”) that priced on June 29, 2023, the Company began trading on the Nasdaq Capital Market under the symbol “INTS” on June 30, 2023.

The IPO closed on July 5, 2023 at the IPO price of $ 5.00 per share, at which time the Company issued 3,900,000 shares of our common stock for gross proceeds of $ 19.5 million.

After deducting offering expenses of $ 2.0 million, the Company received net proceeds received of $ 17.5 million.

On July 7, 2023, the Company sold the full over-allotment shares at the IPO price of $ 5.00 per share, resulting in the issuance of 585,000 shares of our common stock for gross proceeds of $ 2.9 million.

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

The Company has used the net proceeds from the IPO to initiate clinical studies, conduct manufacturing suitable for phase 3 studies, submit regulatory filings to the United States Food & Drug Administration (“FDA”) and for general and corporate purposes.

On February 19, 2026, the Company effected a 1-for-25 reverse stock split (the “Reverse Stock Split”).

Every 25 shares of the Company’s issued and outstanding shares of the Company’s common stock were automatically converted into one share of the Company’s common stock.

All fractional shares created by the Reverse Stock Split were paid in cash.

The Reverse Stock Split has no impact on the par value per share of the Company’s common stock which remain at $ .0001 .

All holders of options and warrants had the exercise price multiplied by 25 and the number of shares issuable upon exercise divided by 25.

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.

Liquidity and Plan of Operation

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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 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.

Based on the cash and cash equivalents as of December 31, 2025, the Company believes that it has sufficient cash into the second quarter of 2027 for its current operations.

Notwithstanding the projected cash runway, the Company's ability to continue its operations thereafter is dependent on obtaining additional capital, which is not within the Company's control.

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’s financial instruments that are exposed to concentrations of credit risk consist entirely of cash and investments in U.S.

Treasury bills.

Treasury securities.

These financial instruments are held at two U.S.

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The investments in the U.S.

Treasury securities and U.S.

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

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

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

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The Company considers all liquid investments acquired with a maturity of three months or less to be cash equivalents.

Marketable debt securities

Investments in U.S.

Treasury bills purchased with a maturity over three months but less than twelve months are classified separately from cash and cash equivalents in current assets.

Investments in U.S.

Treasury bills are classified as available for sale.

Under the classification of available for sale, securities are reported at fair value.

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

At December 31, 2024, there were no marketable securities or unrealized gains or losses, and all accrued interest was recognized as interest income in the Statement of Operations.

Fair value measurement

The Company reports its investments at fair value.

The Company reports its investments, if any, at fair value.

Fair value is an estimate of the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants (i.e., the exit price at the measurement date).

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The Company uses judgment in determining fair value of assets and liabilities and Level 3 assets and liabilities involve greater judgment than Level 1 or Level 2 assets or liabilities.

As of December 31, 2023, the Company invested $ 6.2 million in U.S.

Treasury Bills, included in marketable debt securities.

Treasury bills are valued at market prices obtained from independent vendor services, which we believe to be reliable.

In some cases, the pricing vendor may provide prices quoted by a single broker or market maker.

Treasury Bills are categorized in Level 2 of the fair value hierarchy.

As of December 31, 2024, there were no investments in U.S.

Treasury Bills.

The Company’s financial instruments, including cash equivalents and current liabilities are carried at cost, which approximates fair value due to the short-term nature of these instruments.

The Company did not have any assets or liabilities measured at fair value on a recurring or nonrecurring basis as of December 31, 2025 or 2024.

Stock-based compensation

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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.

As of both December 31, 2025 and 2024, the advance payment balances were $ 1.2 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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ROU assets are initially measured at the present value of the future minimum lease payments adjusted for any prior lease prepayments, lease incentives and initial direct costs.

Certain leases contain escalation, renewal and/or termination options that are factored into the ROU asset as appropriate.

Certain leases contain escalation, renewal and/or

termination options that are factored into the ROU asset as appropriate.

Operating leases result in a straight-line rent expense over the expected lease term.

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The computation of diluted net loss per share does not include the conversion of securities that would have an anti-dilutive effect.

Potential shares of common stock issuable upon conversion of preferred stock, exercise of stock options, and exercise of warrants that are excluded from the computation of diluted weighted average shares outstanding listed in the table below because they are anti-dilutive.

The basic and diluted computation of net loss per share for the Company are the same because the effects of the Company’s convertible securities would be anti-dilutive.

All common and preferred stock participate equally in dividends and the distribution of earnings if and when declared by the Board of Directors, on the Company’s common stock for the year ended December 31, 2024.

For purposes of computing earnings per share, all series of preferred stock are considered participating securities.

Therefore, the Company must calculate basic and diluted earnings per share using the two-class method.

Under the two-class method, net income for the period is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed earnings.

As the preferred stockholders have no obligation to fund losses, no portion of net loss was allocated to the participating securities for the year ended December 31, 2023.

There were no preferred shares outstanding during the year ended December 31, 2024.

Accordingly, the basic and diluted computation of net loss per share for the Company are the same for all periods presented.

The Company had no preferred stock outstanding during the years ended December 31, 2025 and 2024, and therefore, no participating securities were included in the computation of earnings (loss) per share for those periods.

Accordingly, the Company did not apply the two-class method.

As of December 31, 2025 and 2024, the following shares of common stock underlying options and warrants were excluded from the computation of diluted weighted average shares outstanding:

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Recently issued pronouncements

In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures .

ASU 2023-07, which is applicable to entities with a single reportable segment, primarily requires enhanced disclosures about significant segment expenses and enhanced disclosures in interim periods.

The Company has adopted the guidance in ASU 2023-07 for the year ended December 31, 2024, and it is being applied retrospectively to its financial statement disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures .

ASU 2023-09 is intended to improve income tax disclosure requirements by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) the disaggregation of income taxes paid by jurisdiction.

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.

The Company adopted the guidance in ASU 2023-09 retrospectively for the year ended December 31, 2025.

The adoption of this guidance did not impact the Company’s accounting for income taxes, effective tax rate, or deferred tax balances.

The standard resulted in expanded income tax disclosures included in the notes to the financial statements..

In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40):

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Total $ 11,921 $ 2,590

Marketable Debt Securities

Marketable debt securities as of December 31, 2023 consisted entirely of U.S.

Treasury bills purchased with maturities over three months but less than twelve months.

There were no marketable debt securities as of December 31, 2024.

Prepaid Expenses

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Total $ 1,532 $ 508

Convertible Notes

Prior to the IPO, the Company entered into a series of interest-bearing convertible notes, which bore interest at rates ranging 3 % to 10 %, and were automatically converted upon the IPO at a discount ranging 30 % to 35 % to the conversion price of $ 11.50 per share, in accordance with the respective note agreements.

Below is a summary of activity of convertibles notes for the year ended December 31, 2023 (in thousands):

Principal Accrued Interest Total

As of January 1, 2023 4,250 99 4,349

Issuance of Convertible Notes 243 — 243

Interest expense — 145 145

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

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

Upon the IPO, all convertible note principal and accrued interest of $ 4.5 million and $ 0.2 million, respectively, converted into an aggregate of 1,399,716 shares of common stock, pursuant to the conversion terms in each respective note.

The Company recorded a non-operating loss on debt extinguishment of $ 2.3 million in the statement of operations, which is equal to the aggregate discounts on the IPO price specified in each convertible note agreement.

In addition, upon the IPO, the remaining $ 0.2 million balance of unamortized discount on 2022 Convertible Notes was recognized and recorded in Interest Expense on the Statement of Operations.

Stockholders’ Equity

Initial public offering

On July 5, 2023, as described in Note 1, the Company completed IPO, issuing 3,900,000 shares of common stock at the IPO price of $ 5.00 per share.

On July 7, 2023, the Company sold the full over-allotment of the IPO shares and issued 585,000 shares of common stock at the IPO price of $ 5.00 per share.

Pursuant to the IPO,

• all Series A, B and C Preferred Stock was converted into 4,124,851 shares of common stock at conversion prices e qual to $ 4.00 , $ 9.00 and $ 11.50 , respect i v e l y.

• Series B and Series C Preferred Stock received an additional 100,189 and 164,518 shares of common stock, respectively, pursuant to the terms of their security agreements, since the IPO price was less than the original issue price.

The additional shares have been recorded as a deemed dividend on the Statement of Operations and Statement of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficiency).

• All voting, dividend, redemption and liquidation preference rights, specific to the Series A, B, and C Preferred Stock were extinguished.

• All Convertible Notes and related accrued interest were converted into 1,399,716 shares of common stock, as described in Note 8.

Authorized shares

Pursuant to the sixth amended and restated Certificate of Incorporation, dated June 30, 2023, the total number of shares of all classes of stock which the Company shall have authority to issue is (i) 135,000,000 shares of common stock and (ii) 15,000,000 shares of preferred stock.

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

On December 4, 2025, the Company filed a prospectus supplement to adjust the maximum the Company may sell and issue under the Sales Agreement to $ 30.0 million of its Shares (the “ATM Adjustment”), not including the Shares previously sold under the Sales Agreement.

Since inception through December 31, 2025, the Company has issued 1,281,501 Shares under the Sales Agreement for net proceeds of $ 11.3 million, including 120,447 Shares issued subsequent to the ATM Adjustment date for net proceeds of $ 1.6 million.

As of December 31, 2025, the Company may issue and sell up to $ 28.4 million of Shares remaining under the Sales Agreement.

November 2024 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, 49,484 shares of common stock to the Investor, at a price of $ 60.625 per share (the “November 2024 Offering”), 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 49,484 shares (the “Common Warrants”) at an exercise price of $ 73.75 per share, with a relative fair value of $ 1.1 million.

Each Common Warrant is exercisable six months from the issuance date and will expire five and one-half years from the issuance date.

April 2025 Public Offering

On April 24, 2025, the Company commenced a best efforts public offering (the “April 2025 Offering”) of an aggregate of (i) 125,333 shares (the “Shares”) of the Company’s common stock, (ii) 125,333 Series B-1 Common Warrants (the “Series B-1 Common Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-1 Common Warrant Shares”), (iii) 125,333 Series B-2 Common Warrants (the “Series B-2 Common Warrants” and together with the Series B-1 Warrants, the “Warrants”) to purchase up to 125,333 shares of common stock (the “Series B-2 Common Warrant Shares” and together with the Series B-1 Common Warrant Shares, the “Warrant Shares”).

In connection with the April 2025 Offering, the Company entered into a Securities Purchase Agreement on April 24, 2025 with certain institutional investors participating in the April 2025 Offering.

The April 2025 Offering closed on April 28, 2025.

Each Share was sold together with one Series B-1 Common Warrant to purchase one share of common stock and one Series B-2 Common Warrant to purchase one share of common stock.

The combined offering price for each Share and accompanying Warrants was $ 18.75 .

Each Warrant has an exercise price of $ 21.25 and was immediately exercisable upon issuance.

The Series B-1 Common Warrants will expire on the five-year anniversary of the date of issuance, and the Series B-2 Common Warrants will expire on the eighteen-month anniversary of the date of issuance.

The Company raised an aggregate of $ 2.35 million in the April 2025 Offering, and net proceeds of the April 2025 Offering, after deducting the fees and expenses were approximately $ 1.9 million.

June 2025 Public Offering

On June 11, 2025, the Company entered into an underwriting agreement (the “Underwriting Agreement”) by and between ThinkEquity LLC (the “Underwriter”) relating to the issuance and sale of an aggregate of 267,000 shares (the “Firm Shares”) of the Company’s common stock, to the Underwriter at a price to the public of $ 7.50 per share (the “June 2025 Offering”).

Pursuant to the terms of the Underwriting Agreement, the Company granted to the Underwriter a 45-day option to purchase up to an additional 40,050 shares of common stock in the June 2025 Offering (the “Option Shares” and together with the Firm Shares, the “Shares”).

The Underwriter exercised its option in full to purchase the 40,050 Option Shares at the public offering price on June 12, 2025.

The June 2025 Offering, including the exercise of the Underwriter’s over-allotment option, closed on June 13, 2025.

All of the Shares were sold by the Company.

Pursuant to the Underwriting Agreement, the Company also agreed to issue to the Underwriter and/or its designees warrants to purchase up to 15,352 shares of common stock (the “Representative’s Warrants”), which equals 5 % of the Shares purchased in the June 2025 Offering, such warrants to be exercisable as set forth in the Representative’s Warrant Agreement.

The net proceeds to the Company from the June 2025 Offering, including the exercise of the Underwriter’s over-allotment option, were

approximately $ 1.8 million after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company.

October 2025 Registered Direct Offering

On October 30, 2025, the Company entered into a Securities Purchase Agreement with an institutional investor (the “Institutional Investor”), pursuant to which the Company agreed to issue and sell, in a registered direct offering by the Company directly to the Institutional Investor, 200,000 shares of common stock to the Investor, at a price of $ 20.00 per share, for aggregate gross proceeds of approximately $ 4.0 million (the “October 2025 Offering”).

The net proceeds from the October 2025 Offering, after deducting the placement agent’s fees and related offering expenses, were approximately $ 3.6 million.

Stock Based Compensation

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Upon adoption of the 2021 Plan, no more shares would be issued under the 2013 Plan.

Starting on January 1, 2022, the shares authorized under the 2021 Plan shall have an annual increase of the lessor of (a) 3.5 % of the aggregate number of shares of Common Stock outstanding on the final day of the preceding calendar year, or (b) such smaller amount as determined by the Board.

On January 1, 2023 and January 1, 2024, an additional 238,700 and 479,828 shares, respectively, were authorized under the 2021 Plan.

Starting on January 1, 2022, the shares authorized under the 2021 Plan shall have an annual increase of the lesser 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, January 1, 2024, and January 1, 2025, an additional 9,548 , 19,193 , and 21,172 shares, respectively, were authorized under the 2021 Plan.

As of December 31, 2025, 38,291 shares were available for issuance under the 2021 Plan.

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Stock options

The following table summarizes the range of assumptions used to estimate the fair value of stock options issued in 2024 and 2023:

Stock price $ 3.44 to $ 5.19

The following table summarizes the range of assumptions used to estimate the fair value of stock options issued using the Black-Scholes-Merton option pricing model:

Stock price $ 14.25

$ 86.00 to $ 129.75

Exercise price $ 3.44 to $ 5.19

Exercise price $ 14.25

$ 86.00 to $ 129.75

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The expected term of the option represents the period the options are expected to be outstanding.

The following table summarizes the activity for stock options for the year ended December 31, 2024:

The following table summarizes the activity for stock options under the 2013 and 2021 Plans for the year ended December 31, 2025:

Options Weighted-

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All options expire 10 years from date of grant.

Options outstanding begin to expire in September 2025.

Options outstanding begin to expire in June 2026.

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.

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As of December 31, 2025 , total unrecognized compensation cost related to options was approximately $ 2.8 million and is expected to be recognized over the remaining weighted average service period of 2.2 years.

The following table summarizes the range of assumptions used to estimate the fair value of warrants issued in 2024 and 2023:

The following table summarizes the range of assumptions used to estimate the fair value of warrants issued using the Black-Scholes-Merton option pricing model:

Stock price $ 7.50 to $ 18.75

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All warrants outstanding are exercisable for purchase of common stock.

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

In connection with the registered direct offering, 1,237,113 warrants were issued to the Investor during the year ended December 31, 2024.

At December 31, 2024, total unrecognized compensation cost related to warrants was approximately $ 0.2 million and is expected to be recognized over the remaining weighted average service period of 2.6 years.

In January 2017, the Company entered into a lease for approximately 2,500 square feet of office space in Westport, Connecticut, (the “Westport Lease”), which was subsequently extended and increased to approximately 4,000 square feet.

In June 2023, the Westport Lease was terminated.

The Company concluded the warrants described in Note 7 are accounted for under ASC 718 and were determined to be equity-classified.

As of December 31, 2025, total unrecognized compensation cost related to warrants was approximately $ 0.1 million and is expected to be recognized over the remaining weighted average service period of 1.8 years.

In July 2023, the Company signed a 5.5 -year lease for approximately 2,700 square feet of office space in Shelton, Connecticut, (the “Shelton Lease”).

The Company has a one-time option to cancel the Shelton Lease after 36 months if it provides written notice before the end of month 30 .

A payment of approximately $ 47,000 would be due at the end of month 36 if the Company exercises this option.

This option is not reasonably certain to occur.

Rent expense for the years ended December 31, 2024 and 2023 was $ 34,000 and $ 55,000 , respectively.

Cash paid for operating leases for the years ended December 31, 2024 and 2023 was approximately $ 38,000 and $ 49,000 , respectively, all of which pertained to the Shelton Lease.

The following table summarizes the balance sheet classification of the operating lease asset and related lease liabilities as of December 31, 2024 for the Shelton Lease and as of December 31, 2023 for the Westport Lease (in thousands):

The Company had a one-time option to cancel the Shelton Lease after 36 months if it provided written notice before the end of month 30 .

A payment of approximately $ 47,000 would have been due at the end of month 36 if the Company exercised this option.

This option was not exercised.

Rent expense for both the years ended December 31, 2025 and 2024 were $ 34,000 .

Cash paid for operating leases for the years ended December 31, 2025 and 2024 was approximately $ 68,000 and $ 38,000 , respectively.

The following table summarizes the balance sheet classification of the operating lease asset and related lease liabilities as of December 31, 2025 and December 31, 2024 (in thousands):

2025 December 31,

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Related Parties

In 2023, a minority stockholder was engaged as a consultant to serve as the Company’s chief medical officer.

Under the consulting agreement, the Company recorded approximately $ 6,200 of research and development expense for the year ended December 31, 2023.

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

Sublease income is recorded as a reduction of general and administrative expenses in the Statement of Operations.

The sublease ended in April 2023.

As of December 31, 2023, the Company held a $ 36,000 deposit related to a service agreement with a minority stockholder, and is recorded in other long-term liabilities on the balance sheet.

The deposit was returned to the minority stockholder during 2024.

In October 2023, the Company issued 3,200 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.

These warrants were valued at $ 198,000 , of which the remaining $ 149,000 was expensed to general and administrative expense during the year ended December 31, 2024 .

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.

For the years ended December 31, 2025 and 2024, the Company expensed $ 49,910 and $ 42,110 , and paid $ 49,910 and $ 40,310 to the service organization for services performed, which is recognized in research and development expenses on the statement of operations.

As of both December 31, 2025 and 2024, the Company recognized $ 1,800 in accrued expenses.

On July 4, 2025, the U.S.

government enacted the One Big Beautiful Bill Act (“OBBBA”) which includes, among other provisions, changes to the U.S.

corporate income tax system, including the allowance of 100% expensing of qualified asset expenditures, immediate expensing of qualifying domestic research and development expenses and permanent extensions of certain other provisions within the Tax Cuts and Jobs Act.

Certain provisions are effective for 2025, beginning January 19, 2025.

Under ASC 740, Income Taxes, the Company is required to recognize the effects of changes in tax laws in the period in which the legislation is enacted.

The enactment did not impact our effective tax rate for the year ended December 31, 2025.

The Company does not currently expect OBBBA to have a material impact on its long-term effective tax rate.

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

federal statutory corporate tax rate were as follows (in thousands):

Percent Amount Percent Amount

Statutory federal income tax rate 21.0 % $ ( 2,437 ) 21.0 % $ ( 3,414 )

State taxes, net of federal tax benefit ( 949 ) ( 350 )

State income taxes, net of federal income tax benefit* — % — — % —

Change in valuation allowance ( 20.5 )% 2,388 ( 20.1 )% 3,267

Loss on debt extinguishment — 475

Federal return to provision 14 87

Other adjustments — % 3 ( 0.2 )% 38

Other permanent items ( 0.5 )% 46 ( 0.7 )% 109

Provision for income taxes — % $ — — % $ —

*The Company files state income taxes in Connecticut

The components of the net deferred tax assets are as follows (in thousands):

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Research and development credits 488 495

Compensation accrual 215 —

Lease liability 30 37

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Federal and Connecticut jurisdictions.

The Company did not make any income tax payments during the years ended December 31, 2025 and 2024.

As no income taxes were paid, disaggregation by federal or state jurisdiction was not applicable for the periods presented.

The Company has a single segment and allocates resources based on cash resources and operating expense projections.

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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)

IT-01 Study (Phase 1/2 Metastatic Cancers) (a)

$ — $ ( 128 )

INVINCIBLE-2 Study (Phase 2 Breast) (a)

INVINCIBLE-3 Study (Phase 3 Sarcoma) (b)

INVINCIBLE-4 Study (Phase 2 Breast) (c)

Other clinical trial expenses 18 223

Clinical trial expenses 4,285 7,077

1 unchanged sentence

Salaries and benefits related 1,521 1,379

Consulting & Other (b)

Consulting & Other (d)

Stock-based compensation 773 1,240

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Loss from operations ( 11,972 ) ( 16,585 )

Other segment items, net (d)

Loss on debt extinguishment — ( 2,262 )

Other segment items, net (f)

Net loss $ ( 11,606 ) $ ( 16,268 )

(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.

(a) Completed study.

(b) In March 2025, the Company paused new site activations and patient enrollments due to funding constraints.

(c) In September 2025, the Company paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6.

(d) Consulting & Other includes research and development consulting costs and travel-related costs.

(e) Other includes facility expenses, office supplies, computer and software related costs, public relations costs, and travel-related costs.

(f) Other segment items include interest income, interest expense, and foreign exchange gains and losses.

Subsequent Events

ATM Sales Agreement Issuances

Subsequent to December 31, 2025 through March 22, 2026, the Company issued 16,154 shares of common stock under the ATM Sales Agreement for net proceeds of $ 0.2 million.

ATM Sales Agreement

On March 23, 2026, the Company filed a prospectus supplement to adjust the maximum the Company may sell and issue under the Sales Agreement to $ 60.0 million of its Shares, not including the Shares previously sold under the Sales Agreement.

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