ACTUATE THERAPEUTICS, INC. 10-K

Item 9A. Controls and Procedures. Attestation Report of the Independent Registered Public Accounting Firm This Annual Report does not include an attestation report of our independent registered public accounting firm due to an exemption provided by the JOBS Act for “emerging growth companies.” Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Our management, with the participation of our principal executive officer and our principal financial officer, has evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act as of December 31, 2025. Based on such evaluation, our principal executive officer and our principal financial officer have concluded that as of such date, our disclosure controls and procedures were effective at the reasonable assurance level. Management’s Annual Report on Internal Control Over Financial Reporting Management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rules 13a-15(f) and 15d-15(f). We maintain internal control over financial reporting designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with GAAP. 79 The effectiveness of any system of internal control over financial reporting, including ours, is subject to inherent limitations, including the exercise of judgment in designing, implementing, operating, and evaluating the controls and procedures, and the inability to eliminate misconduct completely. Accordingly, in designing and evaluating the disclosure controls and procedures, management recognizes that any system of internal control over financial reporting, including ours, no matter how well designed and operated, can only provide reasonable, not absolute assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible controls and procedures relative to their costs. Moreover, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. We intend to continue to monitor and upgrade our internal controls as necessary or appropriate for our business, but cannot assure you that such improvements will be sufficient to provide us with effective internal control over financial reporting. As of December 31, 2025, our management conducted an evaluation of the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework (2013). Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of our internal control over financial reporting. Based on management’s assessment, management has concluded that, as of December 31, 2025, our internal control over financial reporting was effective. Changes in Internal Control over Financial Reporting There have been no changes in our internal control over financial reporting during the quarter ended December 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information. Rule 10b5-1 Trading Plans During the quarter ended December 31, 2025, no director or officer of the Company adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in Item 408(a) of Regulation S-K. Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. 80 PART III The information required by Part III is omitted from this Report because we will file a definitive proxy statement within 120 days after the end of our 2025 fiscal year pursuant to Regulation 14A for our 2026 Annual Meeting of Stockholders, or the 2026 Proxy Statement, and the information to be included in the 2026 Proxy Statement is incorporated herein by reference. Item 10. Directors, Executive Officers and Corporate Governance. The information required by this item will be contained in our 2026 Proxy Statement and is incorporated herein by reference. Item 11. Executive Compensation. The information required by this item will be contained in our 2026 Proxy Statement and is incorporated herein by reference. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this item will be contained in our 2026 Proxy Statement and is incorporated herein by reference. Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this item will be contained in our 2026 Proxy Statement and is incorporated herein by reference. Item 14. Principal Accountant Fees and Services. The information required by this item will be contained in our 2026 Proxy Statement and is incorporated herein by reference. 81 PART IV Item 15. Exhibits and Financial Statement Schedules (1) Financial Statements. The consolidated financial statements of Actuate Therapeutics, Inc. filed as part of this Report are listed on the Index to Financial Statements on page F-1. (2) Finance Statement Schedules. All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto. (3) Exhibits. The exhibits filed or furnished as part of this Report are set forth below. Exhibit Number Description of Document 3.1 Sixth Amended and Restated Certificate of Incorporation (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on August 14, 2024) 3.2 Amended and Restated Bylaws of Actuate Therapeutics, Inc. (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on August 14, 2024) 4.1 Form of Common Stock Certificate of Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) 4.2 Fourth Amended and Restated Investors’ Rights Agreement, by and between the Registrant and certain of its stockholders, dated November 30, 2022 (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on May 24, 2024) 4.3 Form of Representative Warrant issued to Underwriter under IPO (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) 4.4 Form of Second Amended and Restated Warrant issued to holders of Convertible Redeemable Preferred Stock (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) 4.5 Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Registrant’s Annual Report on Form 10-K, filed with the SEC on March 13, 2025) 4.8 Form of Warrant, dated June 25, 2025, by and among Registrant and each of the purchasers party thereto under the Securities Purchase Agreement (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on June 26, 2025) 10.1± Exclusive License Agreement with Equity, dated April 6, 2015, as amended, between The Board of Trustees of the University of Illinois and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on July 16, 2024) 10.2± License Agreement, dated March 31, 2015, as amended, between Northwestern University and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) 10.3+ Actuate Therapeutics, Inc. 2015 Equity Incentive Plan, as amended, and form of grant agreements thereunder (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) 10.4+ Actuate Therapeutics, Inc. 2024 Equity Incentive Plan (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) 10.5+ Form of Stock Option Agreement under the Actuate Therapeutics, Inc. 2024 Stock Incentive Plan (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) 10.6+ Form of Restricted Stock Unit Agreement under the Actuate Therapeutics, Inc. 2024 Stock Incentive Plan (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) 10.7+ Non-Employee Director Compensation Policy (incorporated by reference to Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 21, 2024) 82 Exhibit Number Description of Document 10.8+ Employment Agreement, effective April 15, 2015 and as amended on each of February 5, 2016, September 28, 2017, September 23, 2018, January 29, 2019, August 1, 2022, January 27, 2023 December 12, 2023 and May 9, 2024, between Daniel Schmitt, and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) 10.9+ Employment Agreement, effective June 1, 2022, between Andrew P. Mazar, Ph.D., and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) 10.10+ Employment Agreement, effective June 1, 2024, between Paul Lytle, and the Registrant (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) 10.11 Form of Indemnification Agreement for Directors and Officers (incorporated by reference to Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) 10.12+ Tenth Amendment to Employment Agreement by and between Daniel Schmitt and the Registrant dated March 11, 2025 (incorporated by reference to Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025) 10.13+ First Amendment to Employment Agreement by and between Andrew P. Mazar, Ph.D. and the Registrant dated March 11, 2025 (incorporated by reference to Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025) 10.14+ First Amendment to Employment Agreement by and between Paul Lytle and the Registrant dated March 11, 2025 (incorporated by reference to Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025) 10.15 Securities Purchase Agreement, dated March 27, 2025, by and between Registrant and B. Riley Principal Capital II, LLC (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on March 28, 2025) 10.16 Registration Rights Agreement, dated March 27, 2025, by and between Registrant and B. Riley Principal Capital II, LLC (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on March 28, 2025) 10.17 Form of Securities Purchase Agreement, dated June 25, 2025, by and among Registrant and each of the purchasers party thereto (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on June 26, 2025) 10.18 Form of Registration Rights Agreement, dated June 25, 2025, by and among Registrant and each of the purchasers party thereto (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on June 26, 2025) 10.19 At the Market Issuance Sales Agreement dated as of November 28, 2025 between Registrant, on the one hand, and B. Riley Securities, Inc. and Craig-Hallum Capital Group LLC, on the other (incorporated by reference to Registrant’s Current Report on Form 8-K as filed on November 28, 2025) 19.1 Insider Trading Policy (incorporated by reference to Registrant’s Annual Report on Form 10-K, filed with the SEC on March 13, 2025) 21.1* Subsidiaries of the Registrant 23.1* Consent of Crowe LLP, Independent Registered Public Accounting Firm 31.1* Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended 31.2* Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as amended 32* Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 97.1 Clawback Policy of Actuate Therapeutics, Inc. (incorporated by reference to Registrant’s Annual Report on Form 10-K, filed with the SEC on March 13, 2025) 101.INS* XBRL Instance Document 101.SCH* XBRL Schema Document 101.CAL* XBRL Calculation Linkbase Document 101.DEF* XBRL Definition Linkbase Document 101.LAB* XBRL Label Linkbase Document 101.PRE* XBRL Presentation Linkbase Document _____________________ * Filed herewith + Indicates management contract or compensatory plan. ± Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10) of Regulation S-K on the basis that they are not material and would likely cause competitive harm to the registrant if disclosed. Item 16. Form 10-K Summary. None. 83 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized. Dated: March 26, 2026 ACTUATE THERAPEUTICS, INC. /s/ Daniel M. Schmitt Daniel M. Schmitt. President and Chief Executive Officer, Director (Principal Executive Officer) Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Name Position Date /s/ Daniel M. Schmitt President, Chief Executive Officer and Director (principal executive officer) March 26, 2026 Daniel M. Schmitt /s/ Paul Lytle Chief Financial Officer (principal financial and accounting officer) March 26, 2026 Paul Lytle /s/ Aaron G. L. Fletcher Director and Chairperson March 26, 2026 Aaron G.L. Fletcher, Ph.D. /s/ Jason Keyes Director March 26, 2026 Jason Keyes /s/ Amy Ronneberg Director March 26, 2026 Amy Ronneberg /s/ Roger Sawhney Director March 26, 2026 Roger Sawhney /s/ Todd Thomson Director March 26, 2026 Todd Thomson /s/ Daniel Zabrowski Director March 26, 2026 Daniel Zabrowski, Ph.D. 84 ACTUATE THERAPEUTICS, INC. INDEX TO FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID 173 ) F-2 Consolidated Balance Sheets as of December 31, 2025 and 2024 F-3 Consolidated Statements of Operations for the years ended December 31, 2025 and 2024 F-4 Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the years ended December 31, 2025 and 2024 F-5 Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024 F-6 Notes to the Consolidated Financial Statements F-7 F- 1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM Stockholders and the Board of Directors of Actuate Therapeutics, Inc. Fort Worth, Texas Opinion on the Financial Statements We have audited the accompanying consolidated balance sheet of Actuate Therapeutics Inc. (the "Company") as of December 31, 2025 and 2024, the related consolidated statements of operations, redeemable convertible preferred stock and stockholders’ equity (deficit), and cash flows for each of the two years in the period ended December 31, 2025, 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 two years ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America. Going Concern The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred recurring operating losses, has had negative operating cash flows and has not recognized any revenues since its inception. In addition, the Company has an accumulated deficit of $154,607,701 as of December 31, 2025 and is dependent on its ability to raise capital. These matters raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. Management has concluded there is substantial doubt regarding the Company’s ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion. /s/ Crowe LLP We have served as the Company’s auditor since 2024. Costa Mesa, California March 26, 2026 F- 2 Actuate Therapeutics, Inc. Consolidated Balance Sheets December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 13,159,423 $ 8,641,622 Prepaid assets and other current assets 483,996 566,278 Total current assets 13,643,419 9,207,900 Deferred offering costs and other assets 392,491 110,548 Total assets $ 14,035,910 $ 9,318,448 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable $ 1,524,190 $ 1,921,189 Other accrued expenses 3,567,404 5,921,908 Accrued compensation 588,304 888,449 Accrued interest, current 27,018 70,957 Total current liabilities 5,706,916 8,802,503 Long term liabilities: Accrued interest, less current portion – 6,768 License payable 404,991 404,991 Total long-term liabilities 404,991 411,759 Total liabilities 6,111,907 9,214,262 Commitments and contingencies (Note 6) – – Stockholders’ equity: Preferred stock, $ 0.000001 par value, 10,000,000 shares authorized, no shares issued or outstanding – – Common stock, $ 0.000001 par value, 200,000,000 shares authorized, 23,245,203 and 19,531,636 shares issued and outstanding at December 31, 2025 and 2024, respectively 23 20 Additional paid-in capital 162,531,681 132,484,015 Accumulated deficit ( 154,607,701 ) ( 132,379,849 ) Total stockholders’ equity 7,924,003 104,186 Total liabilities and stockholders’ equity $ 14,035,910 $ 9,318,448 See accompanying notes to consolidated financial statements. F- 3 Actuate Therapeutics, Inc. Consolidated Statements of Operations Year Ended December 31, 2025 2024 Operating expenses: Research and development $ 10,292,620 $ 18,676,276 General and administrative 12,202,692 6,484,458 Total operating expenses 22,495,312 25,160,734 Loss from operations ( 22,495,312 ) ( 25,160,734 ) Other income (expense): Change in estimated fair value of warrant liability – ( 78,903 ) Gain on settlement of warrants – 343,240 Loss on issuance of related party convertible notes payable at fair value – ( 400,000 ) Change in estimated fair value of related party convertible notes payable – ( 2,192,507 ) Interest expense ( 20,250 ) ( 18,717 ) Interest income 287,710 222,293 Total other income (expense), net 267,460 ( 2,124,594 ) Net loss $ ( 22,227,852 ) $ ( 27,285,328 ) Weighted-average shares of common stock outstanding, basic and diluted 21,021,817 8,372,741 Net loss per share attributable to common stockholders, basic and diluted $ ( 1.06 ) $ ( 3.26 ) See accompanying notes consolidated financial statements. F- 4 Actuate Therapeutics, Inc. Consolidated Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) Redeemable Convertible Additional Total Preferred Stock Common Stock Paid-in Accumulated Stockholders’ Shares Amount Shares Amount Capital Deficit Equity (Deficit) Balances, December 31, 2023 24,678,355 $ 94,178,404 1,690,760 $ 2 $ 5,468,006 $ ( 105,094,521 ) $ ( 99,626,513 ) Issuance of common stock in initial public offering, net of underwriting discounts, commissions and offering costs of $ 3,734,389 – – 3,220,000 3 22,025,608 – 22,025,611 Conversion of redeemable convertible preferred stock into common stock upon closing of initial public offering ( 24,678,355 ) ( 94,178,404 ) 13,710,379 14 94,178,390 – 94,178,404 Conversion of related party convertible notes payable into common stock upon closing of initial public offering – – 884,427 1 8,092,506 – 8,092,507 Reclassification of warrant liability to equity upon exchange of warrants to purchase redeemable convertible preferred stock for warrants to purchase common stock upon closing of initial public offering – – – – 485,172 – 485,172 Exercise of in-the-money warrants to purchase redeemable convertible preferred stock and conversion into common stock upon closing of initial public offering – – 26,070 – 238,540 – 238,540 Stock-based compensation expense – – – – 1,995,793 – 1,995,793 Net loss – – – – – ( 27,285,328 ) ( 27,285,328 ) Balances, December 31, 2024 – – 19,531,636 20 132,484,015 ( 132,379,849 ) 104,186 Issuance of shares under underwritten public offering, net of underwriter discounts and issuance costs of $ 1,676,036 – – 2,464,286 3 15,573,963 – 15,573,966 Issuance of shares under June 2025 Private Placement, net of issuance costs of $ 73,017 – – 666,497 – 4,592,462 – 4,592,462 Issuance of shares under Committed Equity Facility, net of issuance costs of $ 603,655 – – 539,967 – 3,800,465 – 3,800,465 Exercise of stock option awards – – 15,942 34,115 – 34,115 Issuance of vested and settled restricted stock units – – 26,875 – – – – Stock-based compensation expense – – – – 6,046,661 – 6,046,661 Net loss – – – – – ( 22,227,852 ) ( 22,227,852 ) Balances, December 31, 2025 – $ – 23,245,203 $ 23 $ 162,531,681 $ ( 154,607,701 ) $ 7,924,003 See accompanying notes to consolidated financial statements. F- 5 Actuate Therapeutics, Inc. Consolidated Statements of Cash Flows Year Ended December 31, 2025 2024 Operating Activities: Net loss $ ( 22,227,852 ) $ ( 27,285,328 ) Adjustment to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 6,046,661 1,995,793 Change in estimated fair value of warrant liability – 78,903 Gain on settlement of warrant liability – ( 343,240 ) Loss on issuance of related party convertible notes payable at fair value – 400,000 Change in estimated fair value of related party convertible notes payable – 2,192,507 Interest accrued on license payable 20,250 18,641 Changes in operating assets and liabilities: Prepaid assets and other current assets 82,282 ( 529,371 ) Other assets 110,548 ( 110,548 ) Accounts payable ( 512,536 ) ( 1,500,651 ) Accrued compensation ( 300,145 ) 610,949 Accrued interest ( 70,957 ) ( 70,957 ) Other accrued expenses ( 2,354,504 ) 2,700,654 Net cash used in operating activities ( 19,206,253 ) ( 21,842,648 ) Financing Activities: Proceeds from issuance of shares of common stock under underwritten public offering, net of underwriting discounts and offering costs 15,573,966 – Proceeds from issuance of shares of common stock under June 2025 Private Placement, net 4,592,462 – Proceeds from issuance of shares of common stock under the Committed Equity Facility, net 3,826,336 – Proceeds from the exercise of stock options 34,115 – Proceeds from initial public offering, net of underwriting discounts and commissions – 23,956,800 Payment of offering costs related to initial public offering – ( 1,931,189 ) Proceeds from issuance of related party short-term loan – 200,000 Payment of related party short-term loan – ( 200,000 ) Proceeds from issuances of related party convertible notes payable – 5,500,000 Deferred offering costs ( 302,825 ) – Net cash provided by financing activities 23,724,054 27,525,611 Net change in cash and cash equivalents 4,517,801 5,682,963 Cash and cash equivalents, beginning of period 8,641,622 2,958,659 Cash and cash equivalents, end of period $ 13,159,423 $ 8,641,622 Supplemental disclosure of cash flow information: Cash paid for interest $ 70,957 $ 71,033 Cash paid for income taxes $ 800 $ 800 Supplemental Schedule of Noncash Financing Activities: Conversion of redeemable convertible preferred stock into common stock upon initial public offering $ – $ 94,178,404 Reclassification of warrant liability to equity upon exchange of not in-the-money Series B and Series C Redeemable Convertible Preferred Stock Warrants for warrants to purchase common stock $ – $ 485,172 Exercise of in-the-money warrants to purchase redeemable convertible preferred stock and conversion into common stock upon initial public offering $ – $ 238,540 Conversion of related party convertible notes payable into common stock upon initial public offering $ – $ 8,092,507 Deferred offering costs, unpaid and accrued $ 115,537 $ – Deferred offering costs charged against Committed Equity Facility $ 25,871 $ – See accompanying notes consolidated financial statements. F- 6 Actuate Therapeutics, Inc. Notes to the Consolidated Financial Statements For The Years Ended December 31, 2025 and 2024 1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION Actuate Therapeutics, Inc. (the “Company”) was incorporated in the State of Delaware on January 16, 2015 and is headquartered in Fort Worth, Texas. The Company is a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of cancers through the inhibition of glycogen synthase kinase-3 (“GSK-3”). The Company’s lead investigational product, elraglusib (formerly 9-ING-41), is a small molecule that is designed to enter cancer cells and block the function of the enzyme GSK-3β, thereby causing the death of the cancer cells and the regulation of anti-tumor immunity. The Company has a 100 %-owned Irish subsidiary, Actuate Therapeutics Limited, that is currently dormant. Initial Public Offering On August 14, 2024, the Company completed the closing of its IPO of 2,800,000 shares of common stock at an initial offering price to the public of $8.00 per share, before the underwriters’ discount of $0.56 per share. Additionally, the underwriters exercised their option (“Overallotment Option”) to purchase an additional 420,000 shares at the same price of $8.00 per share less the underwriters’ discount on September 12, 2024. The Company’s common shares began trading on the Nasdaq Global Market on August 13, 2024, under the symbol “ACTU”. The Company received net proceeds of approximately $ 22 million, after deducting discounts and commissions of approximately $1.8 million and other offering expenses of approximately $1.9 million (or approximately $ 3.7 million in aggregate) for the issuance of 3,220,000 shares of common stock of the Company, including shares issued under the Overallotment Option. Upon the closing of the Company’s IPO and Overallotment Option, the Company issued the underwriters warrants to purchase up to 161,000 shares of common stock, representing 5% of the shares of common stock issued under the IPO and Overallotment Option, at an exercise price of $ 10.00 per share (see Note 8). In addition, the Company’s Redeemable Convertible Preferred Stock (see Note 7), Related Party Convertible Notes Payable (see Note 4) and in-the-money warrants to purchase the Company’s Redeemable Convertible Preferred Stock (see Note 8) converted into or were automatically exercised for, as applicable, common stock immediately prior to the closing of the IPO. Basis of Presentation The Company’s consolidated financial statements are presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and reflect the financial position, results of operations and cash flows for all periods presented. Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”). Going Concern and Management’s Plans The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As of December 31, 2025, the Company had cash and cash equivalents of $ 13,159,423 and working capital of $ 7,936,503 . The Company has not generated any revenue and has incurred recurring operating losses since inception. The Company expects to continue to incur losses for the foreseeable future and therefore, the Company’s ability to continue its operations is highly dependent on its ability to raise additional capital to fund its future operations. F- 7 On March 27, 2025, the Company entered into a common stock purchase agreement (the “Committed Equity Facility”) with B. Riley Principal Capital II (“B. Riley”) giving the Company the right, but not the obligation, to sell to B. Riley over a 36-month period up to the lesser of (i) $50 million of newly issued shares of our common stock and (ii) 3,904,374 shares of the Company’s common stock. During the year ended December 31, 2025, we received net proceeds of $ 3,800,465 in exchange for 539,967 shares of common stock sold under the Committed Equity Facility. As of December 31, 2025, there were 3,364,407 shares of common stock in remaining capacity under the Committed Equity Facility (see Note 7). On June 25, 2025, the Company entered into a securities purchase agreement for a private placement of common stock and warrants with certain institutional and accredited investors, which closed on June 27, 2025 (the “June 2025 Private Placement”). Under the June 2025 Private Placement, the Company received aggregate net proceeds of $ 4,592,462 (see Note 7). On September 10, 2025, the Company entered into an underwriting agreement (the “Underwriter Agreement”) with Lucid Capital Markets, LLC (“Underwriter”) relating to an underwritten public offering of 2,142,858 shares of common stock plus an over-allotment option to purchase up to an additional 321,428 shares of common stock at the public offering price of $ 7.00 per share, less underwriting discounts and commissions and other offering expenses (“September 2025 Public Offering”). The offering closed on September 11, 2025 and the Company issued 2,464,286 shares of common stock to the Underwriter, including shares issued under the over-allotment option, in exchange for net proceeds of $ 15,573,966 (see Note 7). On November 28, 2025, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley Securities, Inc. and Craig-Hallum Capital Group LLC (each a “Sales Agent” and collectively the “Sales Agents”) with respect to an “at the market” offering program (the “ATM Facility”), under which the Company may, from time to time, at its sole discretion, issue and sell through the Sales Agents, up to $100 million of shares of common stock. Pursuant to the ATM Agreement, the Company may sell the shares through the Sales Agents by any method permitted that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act. The Sales Agents will use commercially reasonable efforts consistent with their normal trading and sales practices to sell the shares from time to time, based upon instructions from us, including any price or size limits or other customary parameters or conditions we may impose. The Company will pay the Sales Agents a commission of up to 3.0% of the gross sales proceeds of any common stock sold through the Sales Agents under the ATM Agreement and also has provided the Sales Agents with customary indemnification rights. During the year ended December 31, 2025, the Company did not sell any shares of common stock under the ATM Facility. As of December 31, 2025, the Company had $ 100 million in remaining capacity under its ATM Facility (see Note 7). There can be no assurance that the Company will be able to raise sufficient proceeds in the future under the Committed Equity Facility, the ATM Facility, or any additional financing will be available to the Company on acceptable terms, if at all. Management anticipates, based on currently proposed plans and assumptions, that our cash and cash equivalents on hand will not satisfy the Company’s operational and capital requirements beyond July 2026 without raising additional capital. As the Company continues to execute its business plan, it plans to seek financing for its operations through equity offerings, debt financings, or other capital sources. The Company’s ability to raise additional capital may be adversely impacted by business conditions, global economic conditions, disruptions to, and volatility in, the financial markets in the United States and worldwide, among other matters, and it may not obtain this necessary capital when needed on acceptable terms, or at all. If events or circumstances occur such that the Company does not obtain additional funding, it may be necessary to significantly reduce our scope of operations to reduce the current rate of spending through actions such as the need to delay, limit, reduce, grant rights to develop or terminate its product development or even cease operations, which could have a material adverse effect on the Company’s business, results of operations or financial condition. Based on the above matters, we have concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern. F- 8 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The consolidated financial statements include the accounts of Actuate Therapeutics, Inc. and its wholly owned subsidiary, Actuate Therapeutics Limited. All material intercompany accounts and transactions have been eliminated in the consolidated financial statements. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions, and judgements that affect the reported amounts of assets, liabilities, expenses, and related disclosures in the accompanying notes. The Company bases its estimates, assumptions and judgements on historical experience when available and on various factors that it believes to be reasonable under the circumstances as of the date of the accompanying consolidated financial statements including stock-based compensation expense, accrued expenses (including accrued expenses related to research and development (“R&D”) as described below), and the recoverability of the Company’s net deferred tax assets and related valuation allowance. In addition, other factors may affect estimates, including the expected business and operational changes, the sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from the estimates and assumptions used in the preparation of the accompanying consolidated financial statements under different assumptions or conditions. Accrued Expenses Related to R&D Expenses As part of the process of preparing our consolidated financial statements, we are required to estimate our R&D expenses as of each balance sheet date. This process involves reviewing open contracts, including clinical site contracts, and communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our R&D expenses as of each balance sheet date based on facts and circumstances known to us at that time. The significant estimates in our R&D expenses include the costs incurred for services performed by our vendors in connection with services for which we have not yet been invoiced. We base our expenses related to R&D activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with contractors and vendors that conduct R&D on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. Advance payments for goods and services that will be used in future R&D activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred. Segment Reporting and Geographic Concentrations The Company manages its operations as a single operating segment in the U.S. (see Note 13). Cash and Cash Equivalents The Company considers all highly liquid investments acquired with a maturity of three months or less from the purchase date that can be liquidated without prior notice or penalty to be cash equivalents. Cash and cash equivalents includes bank demand deposits, U.S. treasury bills and money market funds that invest primarily in U.S. government treasuries. F- 9 Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. The Company deposits cash and cash equivalents with high credit quality financial institutions in the U.S. Deposits held in checking and money market accounts may, from time to time, exceed the federally insured amounts. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant risk in its cash and cash equivalents. The primary objectives of the Company’s investment portfolio are the preservation of capital and maintenance of liquidity. The Company is subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, risks related to the successful development and commercialization of product candidates, fluctuations in operating results and financial risks, the ability to successfully raise additional funds when needed, protection of proprietary rights and patent risks, patent litigation, compliance with government regulations, dependence on key personnel and collaboration partners, and competition from competing products in the marketplace. Deferred Offering Costs The Company capitalized as deferred offering costs all direct and incremental legal, professional, accounting and other third-party fees incurred in connection with the Company’s equity offerings. Deferred offering costs will be offset against offering proceeds upon the completion of an offering or during the offering period as proceeds are received on a pro rata basis. In the event that an offering is abandoned, deferred offering costs will be expensed in the period of abandonment in the consolidated statement of operations. Fair Value of Financial Instruments Authoritative guidance requires disclosure of the fair value of financial instruments. The Company applies fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The carrying amount of certain of the Company’s financial instruments, including cash and cash equivalents, accounts payable and accrued liabilities, approximate their estimated fair values primarily due to the short-term nature of the instruments or based on information obtained from market sources and management estimates. The Related Party Convertible Notes Payable (see Note 4) and the Redeemable Convertible Preferred Stock Warrant Liability (see Note 8) were carried at fair value until the closing of the IPO based on unobservable market inputs. The Company measures the fair value of certain of its financial liabilities on a recurring basis. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value which is not equivalent to cost will be classified and disclosed in one of the following three categories: · Level 1 — Quoted prices (unadjusted) in active markets for identical assets and liabilities; · Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. F- 10 The Company reviews the fair value hierarchy classification at each reporting date. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented. As of December 31, 2025 and 2024, there were no financial assets or liabilities carried at fair value which were not equivalent to cost. Comprehensive Loss There were no differences between net loss and comprehensive loss presented in the consolidated statements of operations for the years ended December 31, 2025 and 2024. R&D Expenses In accordance with authoritative guidance, the Company charges research and development costs to operations as incurred. Research and development expenses consist primarily of personnel and related costs, external costs of outside vendors engaged clinical trials, contract manufacturers, consultants and other third parties to conduct and support our clinical trials and preclinical studies. Patent Costs Patent fees and patent related costs in connection with filing and prosecuting patent applications are expensed as incurred and are classified as general and administrative expenses in the accompanying consolidated statements of operations. Fair Value Option of Accounting for Related Party Convertible Notes Payable When financial instruments contain various embedded derivatives which may require bifurcation and separate accounting of those derivatives apart from the entire host instrument, if eligible, ASC 825, Financial Instruments (“ASC 825”) allows issuers to elect the fair value option (“FVO”) of accounting for those instruments. The FVO may be elected on an instrument-by-instrument basis and is irrevocable unless a new election date occurs. The FVO allows the issuer to account for the entire financial instrument at fair value with subsequent remeasurements of that fair value recorded through the statements of operations at each reporting period until the conversion or payment of the Related Party Convertible Notes Payable balance. A financial instrument is generally eligible for the FVO if, amongst other factors, no part of the convertible, or contingently convertible, instrument is classified in stockholders’ equity. Based on the eligibility assessment discussed above, the Company concluded that its Related Party Convertible Notes Payable were eligible for the FVO and accordingly elected to apply the FVO to its Related Party Convertible Notes Payable in accordance with ASC 825. Accordingly, the Related Party Convertible Notes Payable were measured at fair value on their issuance dates and remeasured at estimated fair value at the end of each reporting period with changes in fair value recognized as a component of other income (expense) in the consolidated statements of operations. The primary reason for electing the fair value option was to address simplification and cost-benefit considerations that result from accounting for hybrid financial instruments at fair value in their entirety versus bifurcation of the embedded derivatives from the debt hosts. The estimated fair values of the Related Party Convertible Notes Payable were determined using valuation models that incorporated assumptions and estimates. The Company assessed these assumptions and estimates at each financial reporting period as additional information impacting the assumptions was obtained. Assumptions in the models included but were not limited to equity value, volatility, time to a conversion event, risk-free rate and scenario weightings. The fair value measurements of the Related Party Convertible Notes Payable were based on significant inputs that were not observable in the market and represented a Level 3 measurement (see Note 5). The change in fair value related to accrued interest was also included within the single line of change in fair value of Related Party Convertible Notes Payable in the consolidated statements of operations. F- 11 In addition, in certain circumstances, the estimated fair value at issuance may be greater than the face value at issuance. The loss on issuance of the Related Party Convertible Notes Payable of $ 400,000 recorded during year ended December 31, 2024 represented the difference between the estimated fair value of the Related Party Convertible Notes Payable and the gross proceeds received on the issuance date based on the assumptions, including the proximity in time to the anticipated IPO, the discount on conversion of the Related Party Convertible Notes Payable, and the increased probability-weighted IPO scenario. In connection with the closing of the Company’s IPO, the Related Party Convertible Notes Payable were converted into common stock and no amounts are outstanding as of December 31, 2024 (see Note 4). Redeemable Convertible Preferred Stock The Company recorded all shares of Redeemable Convertible Preferred Stock at their respective fair values on the dates of issuance, net of issuance costs. Redeemable Convertible Preferred Stock was recorded outside of permanent equity because while it was not mandatorily redeemable, in certain events considered not solely within the Company’s control, such as a merger, acquisition, or sale of all or substantially all of the Company’s assets, each referred to as a “deemed liquidation event,” the Redeemable Convertible Preferred Stock could become redeemable at the option of the holders of at least a majority of the then outstanding preferred shares. The Company did not adjust the carrying value of the Redeemable Convertible Preferred Stock to its liquidation preference because a deemed liquidation event obligating the Company to pay the liquidation preference to holders of shares of Redeemable Convertible Preferred Stock did not occur prior to conversion and was subsequently not triggered upon the closing of the Company’s IPO when all shares of Redeemable Convertible Preferred Stock converted into shares of common stock (see Note 7). Redeemable Convertible Preferred Stock Warrants The Company’s Redeemable Convertible Preferred Stock Warrants (see Note 8) required liability classification and accounting as the underlying Redeemable Convertible Preferred Stock was considered contingently redeemable and could have obligated the Company to transfer assets to the holders at a future date upon occurrence of a deemed liquidation event. The warrants were recorded at their estimated fair value upon issuance and were subject to remeasurement to estimated fair value at each balance sheet date, with changes in the estimated fair value recognized as a component of other income (expense) in the accompanying consolidated statements of operations. The Company adjusted the warrant liability for changes in estimated fair value until the earlier of the exercise, conversion, or expiration of the Redeemable Convertible Preferred Stock Warrants. In July 2024, the Redeemable Convertible Preferred Stock Warrants were amended to provide that if underlying Redeemable Convertible Preferred Stock Warrants were out-of-the-money based on the initial public offering price in the IPO, the out-of-the-money Redeemable Convertible Preferred Stock Warrants would convert into warrants to purchase common stock with an exercise price per share that reflected the Conversion Ratio (see Note 7) then in effect for the underlying Redeemable Convertible Preferred Stock. Accordingly, the Redeemable Convertible Preferred Stock Warrants were remeasured upon the closing of the IPO and marked to market to their fair value before being reclassified to equity. Stock-Based Compensation In April 2015 and August 2024, the Company’s Board of Directors (“Board”) adopted the 2015 Stock Incentive Plan (“2015 Plan”) and the 2024 Stock Incentive Plan (“2024 Plan”), respectively, which are more fully described in Note 9. The Company periodically grants equity-based payment awards in the form of restricted common stock awards (“RSAs”), restricted stock units (“RSUs”), and stock options to employees, directors and non-employees and records stock-based compensation expenses for awards of stock-based payments based on their estimated fair value at the grant date. The estimated fair value of service-based RSAs is measured at the grant date based on the estimated fair market value of the Company’s common stock on the date of grant and is recognized as expense over the requisite service period, which is generally the awards’ vesting period. The estimated fair value of performance-based RSAs is measured at the grant date based on the estimated fair value of shares expected to be earned at the end of the performance period, and is recognized as expense ratably over the performance period based upon the probable number of shares expected to vest. F- 12 The Company accounts for the grant of stock options based on the estimated fair value of the underlying option using the Black-Scholes valuation model on the date of grant and are recognized as expense in the consolidated statement of operations on a straight-line basis over the requisite service period, which is the vesting period. The Black-Scholes valuation model requires the input of subjective assumptions, including expected volatility, expected dividend yield, expected term, risk-free rate of return and the estimated fair value of the underlying common stock on the date of grant. Prior to the IPO, the Company regularly engaged a third-party valuation specialist to assist with estimates related to the valuation of the Company’s common stock. The Company classifies stock-based compensation expense in the consolidated statements of operations in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. The Company recognizes forfeitures related to stock-based compensation awards as they occur. Net Loss Per Share Attributable to Common Stockholders Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, Redeemable Convertible Preferred Stock, convertible notes payable, warrants to purchase Redeemable Convertible Preferred Stock, unvested RSAs, and outstanding stock options and RSUs are considered to be potentially dilutive securities when outstanding (see Note 10). As of August 14, 2024, Redeemable Convertible Preferred Stock, convertible notes payable, warrants to purchase Redeemable Convertible Preferred Stock were no longer outstanding, and therefore were no longer considered to be potentially dilutive securities during the year ended December 31, 2025. In addition, included in the basic and diluted net loss per share calculation were RSUs awarded to an executive officer that had vested in August 2025, but the issuance and delivery of the shares were deferred. The number of shares underlying vested and unsettled RSUs at December 31, 2025 was 272,055 . Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities as the Redeemable Convertible Preferred Stock and common stock subject to repurchase are considered participating securities. The Redeemable Convertible Preferred Stock did not have a contractual obligation to share in the Company’s losses, and unvested RSAs subject to repurchase is considered an unvested stock-based compensation award for accounting purposes. As such, the net loss is attributed entirely to common stockholders. Because the Company has reported a net loss for the reporting periods presented, the diluted net loss per common share is the same as basic net loss per common share for those periods. Income Taxes The Company accounts for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”). In accordance with authoritative guidance, deferred tax assets and liabilities are recorded for temporary differences between the financial reporting and tax bases of assets and liabilities using the current enacted tax rate expected to be in effect when the differences are expected to reverse. A valuation allowance is recorded on deferred tax assets unless realization is considered more likely than not. The Company evaluates its tax positions taken or expected to be taken in the course of preparing the Company’s tax returns to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet the “more-likely-than-not” threshold are not recorded as a tax benefit or expense in the current year. The Company recognizes interest and penalties, if any, related to uncertain tax positions in interest expense. No interest and penalties related to uncertain tax positions were accrued at either December 31, 2025 or 2024. F- 13 The Company follows authoritative guidance which requires the evaluation of existing tax positions. The Company files in the federal and various state jurisdictions. Management has analyzed all open tax years, as defined by the statute of limitations, for all major jurisdictions. Open tax years are those that are open for examination by taxing authorities. Tax years covering the years from 2020 to 2024 are the only open years for the Company as of the issuance date of these consolidated financial statements. The Company also has elected to utilize research credits against the employer portion of payroll tax as it is considered a qualified small business under the Internal Revenue code. Due to the uncertainty of utilizing the research credits, the Company accounts for the credits against research and development expenses in the accompanying consolidated financial statements when the related expense is incurred. Recently Adopted Accounting Standards In December 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. The guidance includes the requirement that public business entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). It also requires that all entities disclose, on an annual basis, the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes and the amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5% of total income taxes paid (net of refunds received) and requires that all entities disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. Lastly, the guidance eliminates the requirement for all entities to disclose the nature and estimate of the range of the reasonably possible change in the unrecognized tax benefits balance in the next 12 months or make a statement that an estimate of the range cannot be made. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The guidance should be applied on a prospective basis. Retrospective application is permitted. The Company adopted the guidance as of December 31, 2025 with no material impact on the Company’s consolidated financial statements upon adoption. On July 4, 2025, the U.S. H.R.1, an act to provide for reconciliation pursuant to title II of H.Con.Res.14. (the One Big Beautiful Bill Act or “OBBA”) was enacted. The OBBA introduces multiple tax law and other legislative changes, including modifications to income tax provisions such as domestic research and development expenses, capital expenditures, and U.S. taxation of international earnings; the repeal or acceleration of the sunset of certain tax credits under the 2022 Inflation Reduction Act and elimination of certain penalties for violations of certain regulatory credit programs. We have recognized the effects of the OBBA provisions in our financial results to the extent they are applicable to the year ended December 31, 2025. Recently Issued Accounting Standards Not Yet Adopted Accounting standards not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s consolidated financial statements. 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”. This amended guidance requires disaggregation of specific expense categories in the notes to the financial statements and a qualitative description of the remaining expense amounts not separately disaggregated. This standard becomes effective for reporting companies with annual reporting periods beginning after December 15, 2026, and requires prospective application with an option to apply it retrospectively. The Company anticipates adopting this standard in its Annual Report on Form 10-K for the year ending December 31, 2027. The Company is currently evaluating the impact that the adoption of this standard will have on its consolidated financial statements. F- 14 3. OTHER ACCRUED EXPENSES Other accrued expenses as of December 31, 2025 and 2024 consisted of the following: Schedule of other accrued expenses December 31, 2025 December 31, 2024 Accrued clinical trial costs $ 3,169,433 $ 5,483,846 Other accrued expenses 397,971 438,062 Total other accrued expenses $ 3,567,404 $ 5,921,908 4. RELATED PARTY CONVERTIBLE NOTES PAYABLE On February 20, 2024, March 27, 2024, and May 8, 2024, the Company issued convertible promissory notes in the amount of $ 3,000,000 , $ 1,500,000 , and $ 1,000,000 , respectively, to Bios Clinical Opportunity Fund, LP, a fund affiliated with a current member and a former member of the board of directors of the Company and a majority shareholder, which notes accrued interest at a rate of 7 % per annum and would mature on August 16, 2024 , as amended (“Maturity Date”). Principal and accrued interest were due and payable on the Maturity Date, subject to an automatic conversion upon a Qualified Financing (as defined below) or the Company’s first firm commitment underwritten initial public offering of its common stock or at the option of the holder, convertible into shares of Series C Redeemable Convertible Preferred Stock. In the event the Company either completed a financing of at least $5,000,000 in gross proceeds (“Qualified Financing”) or closed the Company’s first firm commitment underwritten initial public offering of its common stock before the Maturity Date, the Related Party Convertible Notes Payable were to automatically convert into (i) in the case of a Qualified Financing, that number of shares of capital stock issued in such Qualified Financing (the “Qualified Financing Securities”) equal to the quotient obtained by dividing the outstanding principal amount of the Related Party Convertible Notes Payable plus all accrued and unpaid interest thereon by eighty percent (80%) of the per share price at which shares are to be sold in such Qualified Financing or (ii) in the case of an initial public offering, such number of shares of common stock equal to the outstanding principal amount of the Related Party Convertible Notes Payable plus all accrued and unpaid interest thereon, divided by eighty percent (80%) of the initial public offering price. Transaction fees of the related party in the amount of $ 50,000 that were withheld by the related party were expensed as incurred in accordance with ASC 825. Prior to the closing of the Company’s IPO, the fair value of the Related Party Convertible Notes Payable was estimated at each reporting period using a scenario-weighted binomial lattice model to calculate equity values at different points in time leading up to a conversion event. Assumptions in the model include but are not limited to the following: equity value, conversion price, accrued interest, volatility, risk-free interest rate, dividend yield, time to a conversion event, and scenario weightings. Accrued interest on the Related Party Convertible Notes Payable was included in the determination of the estimated fair value. In connection with the closing of the Company’s IPO, the Company issued Bios Clinical Opportunity Fund, LP 884,427 shares of its common stock upon the conversion of the Related Party Convertible Notes Payable, including accrued interest thereon, at a conversion price of $ 6.40 per share, representing 80% of the IPO price of $8.00 per share. The Related Party Convertible Notes Payable was marked to market to its fair value on the conversion date before being reclassified to equity. The aggregate fair value at the time of conversion was calculated by multiplying the number of shares of common stock issued upon conversion by the fair value per share on the conversion date, which was the closing price of the Company’s common stock on the Nasdaq Global Market on the closing date of the IPO. F- 15 The following table sets forth the changes in the estimated fair value of the Company’s Related Party Convertible Notes Payable for the year ended December 31, 2024: Schedule of estimated fair value of related party convertible notes payable Balance as of January 1, 2024 $ – Principal amount of Related Party Convertible Notes Payable issued 5,500,000 Loss recorded at issuance (see Note 2) 400,000 Change in fair value 2,192,507 Conversion into common stock ( 8,092,507 ) Balance as of December 31, 2024 $ – 5. COMMITMENTS AND CONTINGENCIES Operating Lease On December 1, 2024, the Company rented office space on a month-to-month basis with no long-term commitment, representing a short-term lease. As a result, the Company has elected to apply the short-term lease exemption to its office lease and therefore has not recorded a right of use (“ROU”) asset and related lease liability in accordance with ASC 842, “Leases” (“ASC 842”). Rent expense recorded during the years ended December 31, 2025 and 2024 was $ 51,200 and $ 4,200 , respectively, which amount is included in general and administrative expenses in the accompanying consolidated statements of operations. Legal The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes and are not predictable with assurance. While management believes that such matters are currently insignificant, matters arising in the ordinary course of business for which the Company is or could become involved in litigation may have a material adverse effect on its business and financial condition. To the Company’s knowledge, the Company is not subject to any ongoing or pending legal proceedings. Indemnities and Guarantees We have made certain indemnities and guarantees, under which we may be required to make payments to a guaranteed or indemnified party, in relation to certain transactions. We indemnify our officers and directors to the maximum extent permitted under the laws of the State of Delaware. The duration of these indemnities and guarantees varies and, in certain cases, is indefinite. These indemnities and guarantees do not provide for any limitation of the maximum potential future payments we could be obligated to make. Historically, we have not been obligated to make any payments for these obligations and no liabilities have been recorded for these indemnities and guarantees in the accompanying consolidated balance sheets. 6. LICENSES AND AGREEMENTS UIC License Agreement On April 6, 2015, the Company entered into an Exclusive License Agreement with Equity (the “UIC License Agreement”) with The Board of Trustees of the University of Illinois (“UIC”), whereby, UIC granted the Company (a) an exclusive, nontransferable license, with the right to sublicense under UIC’s rights in the Patent Rights (as defined in the UIC License Agreement), and (b) a non-exclusive, non-transferable worldwide license, with the right to sublicense, to use UIC’s rights in the Technical Information (as defined in the UIC License Agreement) for all uses. In consideration of the license granted under the UIC License Agreement, the Company agreed to pay UIC (i) development milestones of up to $1.25 million, of which, up to $0.25 million is due upon the progress of clinical trials and $1.0 million is due upon the initiation of commercial sales, (ii) annual minimum royalty payments, increasing to $50,000 in year six and each year thereafter, (iii) royalty on net sales for product covered under the Patent Rights in the low single digits with a 50% reduction in royalties for products solely utilizing Technical Information, (iv) a declining percentage of sublicensing revenue based on the escalating stage of development upon a sublicensing event, and (v) the reimbursement of all patent and related expenses incurred by UIC covering the Patent Rights. For the years ended December 31, 2025 and 2024, the Company incurred minimum royalties and other reimbursable expenses to UIC in the aggregate amount of $ 62,008 and $ 75,000 , respectively, which amounts were included in general and administrative expenses in the accompanying consolidated statements of operations. F- 16 In addition, the Company entered into a sublicense and collaboration agreement dated August 28, 2017 with an unrelated entity that was covered under the UIC License Agreement, which sublicense agreement was later terminated on January 31, 2018. Under the UIC License Agreement, the Company owed UIC a certain percentage of amounts received under the sublicense agreement in the amount of $ 449,990 . The Company paid UIC 10% of the sublicense fees in the amount of $44,999 and the remaining unpaid balance of $ 404,991 (“Deferred Amount”) was originally due and payable to UIC in two installments: 50% due and payable on the one-year anniversary from the first commercial sale and 50% due on the second-year anniversary from the first commercial sale. The Deferred Amount is treated as debt and continues to accrue interest at a rate of five percent (5%) per annum, representing the prime rate as of the date of the agreement plus 1%. On July 16, 2024, the Company and UIC entered into an amendment to the UIC License Agreement (“UIC Amendment”). Interest is due and payable annually within 30 days following the second anniversary of the closing of the IPO and annually thereafter. In addition, the UIC Amendment provides for payment of the Deferred Amount and any accrued interest thereon upon the sooner of (i) termination of the UIC License Agreement by the Company, (ii) the Company ceases development of the licensed UIC technology, (iii) the Company consummates a Change in Control (as defined in the UIC License Agreement), (iv) the Company sublicenses the licensed technology or the developed product, (v) the one-year anniversary following approval of a NDA of a licensed product, or (vii) the Company executes a partnership agreement with any entity resulting in the payment to us above a specified milestone amount or the Company secures cumulative financing equal to or exceeding $200 million. In addition, the UIC Amendment provides that to the extent the Company secures equity financing equal to or exceeding $85 million through its IPO or otherwise, 50% of the Deferred Amount is due and payable within 30 days. The remaining 50% of the Deferred Amount shall be due and payable upon the first to occur of any of the events noted above in clauses (i) through (vii). Finally, the UIC Amendment provides that for as long as the Company or a sublicensee is selling the licensed product, the Company will pay all consideration provided for in the original UIC License Agreement and described above until the last to expire market exclusivity date, the period of which for all products in a jurisdiction will not exceed a total of seven (7) years beginning with the date regulatory approval is granted for the first licensed product in the jurisdiction, and such obligation will survive termination of the UIC License Agreement. As of December 31, 2025, interest payable to UIC was $ 27,018 included in the accompanying consolidated balance sheet. As of December 31, 2024, interest payable to UIC was $ 77,725 , of which, $ 70,957 was classified as current and $ 6,768 was classified as non-current, which amounts are included in the accompanying consolidated balance sheet. 7. STOCKHOLDERS’ EQUITY Authorized and Issued Capital The Company’s authorized capital consists of 200,000,000 shares of common stock, $ 0.000001 par value per share, and 10,000,000 shares of preferred stock, $ 0.000001 par value per share. As of December 31, 2025 and 2024, there were 23,245,203 and 19,531,636 shares of common stock issued and outstanding, respectively. There were no shares of preferred stock outstanding as of December 31, 2025 and 2024. Reverse Stock Split On May 31, 2024, the Company’s board of directors approved a 1-for-1.8 reverse stock split of its issued and outstanding shares of common stock and stock option awards, which was effected on June 7, 2024. All issued and outstanding shares of common stock (including outstanding RSAs), stock option awards and per share data have been adjusted in these consolidated financial statements, on a retrospective basis, to reflect the reverse stock split for all periods presented. The par value of the common stock and preferred stock was not adjusted as a result of the reverse stock split. The shares of common stock underlying outstanding stock options and other equity instruments were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased in accordance with the terms of the agreements governing such securities. In addition, the conversion price for each series of the Company’s Redeemable Convertible Preferred Stock, which automatically converted into shares of common stock upon the closing of the IPO, were proportionally adjusted. Fractional shares resulting from the reverse stock split were rounded up to the nearest whole share. F- 17 Funding Agreements November 2025 ATM Facility On November 28, 2025, the Company entered into an ATM Agreement, under which the Company may, from time to time, at its sole discretion, issue and sell through the Sales Agents, up to $ 100 million of shares of common stock. Pursuant to the ATM Agreement, the Company may sell the shares through the Sales Agents by any method permitted that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act. The Sales Agents will use commercially reasonable efforts consistent with their normal trading and sales practices to sell the shares from time to time, based upon instructions from the Company, including any price or size limits or other customary parameters or conditions we may impose. The Company will pay the Sales Agents a commission of up to 3.0 % of the gross sales proceeds of any common stock sold through the Sales Agents under the ATM Agreement and also has provided the Sales Agents with customary indemnification rights. During the year ended December 31, 2025, the Company did not sell any shares of common stock under the ATM Facility. As of December 31, 2025, the Company had $ 100 million in remaining capacity under its ATM Facility (see Note 14). September 2025 Public Offering On September 10, 2025, the Company entered into an underwritten public offering of 2,142,858 shares of common stock plus an over-allotment option to purchase up to an additional 321,428 shares of common stock at the public offering price of $ 7.00 per share, less underwriting discounts and commissions and other offering expenses. Upon closing the September 2025 Public Offering on September 11, 2025 (“Closing Date”), the Company issued 2,464,286 shares of common stock to the Underwriter, including shares issued under the over-allotment option, in exchange for net proceeds of $ 15,573,966 , after deducting underwriter discounts and commissions and other offering expenses of approximately $ 1,676,036 . In addition, the Company agreed, subject to certain exceptions, not to sell any shares of its capital stock or any securities convertible into or exercisable or exchangeable for shares of capital stock for a period of seventy-five (75) days from the Closing Date. June 2025 Private Placement On June 25, 2025, the Company entered into a securities purchase agreement for a private placement of common stock and warrants with certain institutional and accredited investors, including Bios 2024 Co-Invest, LP. Dr. Aaron G.L. Fletcher, the Chairman of the Company’s Board of Directors, is a Managing Partner and co-founder of Bios Partners, of which Bios 2024 Co-Invest, LP is an affiliate entity. Upon closing of the June 2025 Private Placement on June 27, 2025, the Company issued and sold an aggregate of (i) 666,497 shares of common stock of the Company at a purchase price of $ 7.00 per share, and (ii) issued warrants to purchase up to an aggregate of 666,497 shares of common stock at an exercise price of $ 7.00 per share (see Note 8). The Company received aggregate gross proceeds of $ 4,665,479 from the June 2025 Private Placement, before deducting fees and offering expenses of $ 73,017 , of which the Company received gross proceeds of $ 499,996 from Bios 2024 Co-Invest, LP in exchange for 71,428 shares of common stock and warrants to purchase 71,428 shares of common stock. Pursuant to the securities purchase agreement, the Company entered into a registration rights agreement (“Registration Rights Agreement”) with the investors, pursuant to which the Company agreed to register for resale the shares of common stock and shares of common stock underlying the warrants (“Registrable Securities”). Under the Registration Rights Agreement, the Company agreed to file a registration statement with the U.S. Securities and Exchange Commission (the “SEC”), covering the resale of the shares of common stock, which was filed on July 25, 2025 prior to the filing deadline. The registration statement was declared effective by the SEC on August 4, 2025. The Company also agreed to use reasonable efforts to keep such registration statement effective until the earlier of (i) the date on which the Purchasers have resold all the Registrable Securities covered thereby or (ii) the date on which the Registrable Securities may be resold by the investors without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144 (“Rule 144”) of the Securities Act, without the requirement for the Company to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect. In addition, certain liquidated damages provisions will apply to the Company in the event that the registration is not effective or its use has been suspended beyond specified grace periods, as described in the Registration Rights Agreement. F- 18 Committed Equity Facility On March 27, 2025, the Company entered into a Committed Equity Facility with B. Riley giving the Company the right, but not the obligation, to sell to B. Riley over a 36-month period up to the lesser of (i) $50 million of newly issued shares of our common stock and (ii) 3,904,374 shares of the Company’s common stock. The price per share of common stock sold to B. Riley is determined by reference to the daily volume weighted-average price of the Company’s common stock as defined within the Committed Equity Facility less a 3% discount, subject to certain limitations and conditions, as calculated on each day the Company sells shares of its common stock under the Committed Equity Facility. The total net proceeds that the Company will receive under the Committed Equity Facility will depend on the quantity, frequency and prices at which the Company sells common stock to B. Riley. Upon the initial satisfaction of the conditions to B. Riley’s obligation to purchase shares under the Committed Equity Facility, including that a registration statement registering the resale by B. Riley of the shares of common stock under the Securities Act is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC (which occurred on April 16, 2025), we have the right, but not the obligation, from time to time at our sole discretion, to deliver one or more notices to direct B. Riley to purchase a specified number of shares of common stock on any trading day, not to exceed the lesser of: (i) 1,000,000 shares of common stock and (ii) up to 50.0% of the total aggregate number (or volume) of shares of our common stock traded on Nasdaq during the applicable trading day, provided the closing sale price of our common stock on Nasdaq on the trading day immediately prior to such purchase date is not less than $1.00. In addition, we will not sell, and B. Riley will not purchase any shares pursuant to the Committed Equity Facility, which, when aggregated with all other shares of common stock then beneficially owned by B. Riley and its affiliates, would result in the beneficial ownership by B. Riley and its affiliates of more than 4.99% of our outstanding voting power or shares of common stock. Moreover, under the applicable Nasdaq rules, in no event may we issue to B. Riley more than 3,904,374 shares of common stock (representing 19.99% of the shares of common stock outstanding immediately prior to the execution of the Committed Equity Facility) unless (i) we obtain stockholder approval in accordance with applicable Nasdaq rules, or (ii) the average price per share paid by B. Riley for all of the shares of common stock that we direct B. Riley to purchase from us pursuant to the Committed Equity Facility equals or exceeds $7.56 per share (representing the lower of (a) the official closing price of our common stock on Nasdaq immediately preceding the execution of the Committed Equity Facility and (b) the average official closing price of our common stock on Nasdaq for the five consecutive trading days immediately preceding the execution of the Committed Equity Facility, as adjusted to take into account the payment of the Cash Commitment Fee (as defined below) to B. Riley). As consideration for B. Riley’s commitment to purchase shares of common stock at the Company’s direction, the Company agreed to pay B. Riley a cash commitment fee in the amount of up to $ 500,000 (the “Cash Commitment Fee”), which represents 1.0% of B. Riley’s $50,000,000 total aggregate purchase commitment under the Committed Equity Facility. The Cash Commitment Fee will be earned and paid by withholding cash amounts equal to 10% of the total aggregate purchase price payable by B. Riley to the Company in connection with each purchase effected under the Committed Equity Facility, until such time as B. Riley shall have earned and received from such cash withholdings a total aggregate amount in cash equal to $500,000. As of December 31, 2025, the Company has paid to B. Riley an aggregate Cash Commitment Fee of $ 440,412 . In addition, the Company reimbursed B. Riley for the reasonable legal fees and disbursements of B. Riley’s legal counsel and other expenses in the amount of $ 125,000 and agreed to future quarterly reimbursements of $5,000 during the term of the Committed Equity Facility. We have the right to terminate the Committed Equity Facility at any time, at no cost or penalty, upon ten (10) trading days’ prior written notice to B. Riley. In addition, there are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages under the Committed Equity Facility, other than a prohibition (with certain limited exceptions) on entering into specified variable rate transactions, as defined. F- 19 During the year ended December 31, 2025, B. Riley purchased 539,967 and shares of common stock under the Committed Equity Facility in exchange for net proceeds to the Company of $ 3,800,465 , after deducting the 3% discount, the earned Cash Commitment Fee, and other offering expenses in the aggregate amount of $ 603,655 . Redeemable Convertible Preferred Stock On August 14, 2024, the closing date of the Company’s IPO, all shares of Redeemable Convertible Preferred Stock were automatically converted into 13,710,379 shares of common stock. Reserved Shares As of December 31, 2025, the Company reserved the following shares of common stock for issuance upon the (i) exercise of outstanding warrants, (ii) issuance of shares reserved under the Committed Equity Facility, (iii) exercise of issued and outstanding stock option awards and restricted stock unit awards, and (v) to reserve the remaining shares available for grant under the 2024 Stock Incentive Plan (“2024 Plan”): Schedule of reserved shares of common stock for issuance December 31, 2025 Shares of common stock reserved under the Committed Equity Facility 3,364,407 Shares reserved for issuance under the 2024 Plan 2,184,341 Stock option awards issued and outstanding 1,841,977 Warrants issued and outstanding to purchase common stock 922,096 Restricted stock unit awards issued and outstanding 617,236 Total 8,930,057 8. WARRANTS As of December 31, 2025, the following warrants to purchase shares of common stock were outstanding: Schedule of warrant outstanding Warrants Outstanding Exercise Price per Share Expiry Date June 2025 Private Placement Warrants 666,497 $ 7.00 Warrant Expiry Date (defined below) Underwriter warrants issued under IPO 161,000 $ 10.00 August 12, 2027 Warrants originally issued in conjunction with Series B Redeemable Convertible Preferred Stock 76,376 $ 10.55 August 13, 2026 Warrants originally issued in conjunction with Series C Redeemable Convertible Preferred Stock 18,223 $ 9.42 August 13, 2026 Total 922,096 F- 20 June 2025 Private Placement Warrant Upon closing of the June 2025 Private Placement on June 27, 2025 (see Note 7), the Company issued warrants to purchase up to an aggregate of 666,497 shares of common stock at an exercise price of $ 7.00 per share. The warrants are exercisable on a cash only basis at any time after the date of issuance and expire 20 days following the earliest to occur of (i) the U.S. Food and Drug Administration (“FDA”) issuing Breakthrough Therapy Designation (“BTD”) for elraglusib and (ii) the date that the FDA provides written communication available to the Company of its determination as to whether the Company may pursue registration for elraglusib using its currently available Phase 2 data or data from a Phase 3 clinical trial (“Warrant Expiry Date”). The warrants issued under the June 2025 Private Placement were classified as a component of permanent stockholders’ equity within additional paid-in-capital and were recorded at the issuance date. The warrants are equity classified because they are freestanding financial instruments that are legally detachable and separately exercisable from the equity instruments, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, permit the holders to receive a fixed number of shares of common stock upon exercise, are indexed to the Company’s common stock and meet the equity classification criteria. In addition, the warrants do not provide any guarantee of value or return. Warrants Issued Under IPO Upon the closing of the Company’s IPO and Overallotment Option, we issued the underwriters warrants to purchase up to 161,000 shares of common stock, representing 5% of the shares of common stock issued under the IPO and Overallotment Option, at an exercise price of $ 10.00 per share (“Underwriter Warrants”), representing 125% of the initial offering price. The Underwriter Warrants were not exercisable prior to February 8, 2025 (or 180-days from the effective date of the registration statement) and expire on August 12, 2027 . The Underwriter Warrants can only be exercised on a cashless basis. The Underwriter Warrants met the criteria for equity classification and were recorded as a component of additional paid-in capital at the time of issuance. Redeemable Convertible Preferred Stock Warrants and Warrant Liability On June 30, 2023, in connection with issuance of the Series C Redeemable Convertible Preferred Stock, the Company issued the placement agent warrants to purchase 18,223 shares of Series C Redeemable Convertible Preferred Stock at an exercise price of $ 9.42 per share (“Series C Redeemable Convertible Preferred Stock Warrants” or “Series C Warrants”). On September 7, 2018, in connection with convertible promissory note payable agreements, the Company agreed to issue the noteholders warrants to purchase shares of Series B-1 Redeemable Convertible Preferred Stock (“Series B Redeemable Convertible Preferred Stock Warrants” or “Series B Warrants”). Warrants to purchase 76,376 shares of Series B-1 Redeemable Convertible Preferred Stock were issued at an exercise price of $ 5.27 per share and warrants to purchase 76,376 shares of Series B-1 Redeemable Convertible Preferred Stock were issued at an exercise price of $ 10.55 per share. The Company remeasured the fair value of the Series B Warrants and Series C Warrants at the end of each reporting period, with any adjustments being recorded as a component of other income (expense) in the accompanying consolidated statements of operations. Upon the closing of the IPO on August 14, 2024, the Series B Warrants issued at an exercise price of $ 5.27 per share (in-the-money warrants) were automatically exercised and settled on a cashless basis for shares of our Series B Redeemable Convertible Preferred Stock, and such shares of Series B Redeemable Convertible Preferred Stock were subsequently converted into 26,070 shares of our common stock. The fair value at the time of settlement of $ 238,540 was calculated by multiplying the number of shares of common stock issued upon settlement by the fair value per share on the settlement date, which was the closing price of the Company’s common stock on the Nasdaq Global Market on the closing date of the IPO. Upon the settlement of the in-the-money warrants, the Company recorded a gain on settlement of $ 343,240 on August 14, 2024. In addition, upon the closing of the IPO, the remaining out-of-the money Series B Warrants and Series C Warrants were amended in July 2024 to become exercisable for the same number of shares of common stock with an exercise price of $ 10.55 and $ 9.42 per share, respectively, and exercisable for a period of two years after the closing date of the IPO or through August 13, 2026. F- 21 The estimated fair value of the warrant liability for the Series B Warrants and Series C Warrants was $ 0 as of December 31, 2024. The following table sets forth the changes in the estimated fair value of the warrant liability in connection with the Company’s Series B Warrants and Series C Warrants for the year ended December 31, 2024: Schedule of estimated fair value of the warrant liability Estimated fair value as of December 31, 2023 $ 988,049 Change in fair value 78,903 Exercise of in-the-money warrants to purchase redeemable convertible preferred stock and conversion into common stock upon closing of IPO ( 238,540 ) Gain on settlement of in-the-money warrants upon conversion into common stock upon closing of IPO ( 343,240 ) Reclassification of warrant liability to equity upon exchange of warrants to purchase redeemable convertible preferred stock for warrants to purchase common stock upon closing of IPO ( 485,172 ) Balance as of December 31, 2024 $ – During the year ended December 31, 2024, the aggregate increase in the fair value of the Series B Warrants and Series C Warrants was $ 78,903 . During the year ended December 31, 2024, the increase in fair value of the in-the-money Series B Warrants was $ 96,050 . Prior to settlement, the fair value of the in-the-money Series B Warrants was determined using the Black-Scholes valuation model with the following assumptions: Schedule of assumptions In-the-Money Series B Warrants Prior to Settlement Expected term (in years) 4.04 Expected volatility 127.26 % Weighted average risk-free interest rate 5.25 % Expected dividend yield 0.00 % Fair value of convertible preferred stock $ 8.82 The out-of-the money Series B Warrants and Series C Warrants were remeasured upon the closing of the IPO and marked to market to its aggregate fair value of $ 485,172 before being reclassified to equity. During the year ended December 31, 2024, the decrease in fair value of the out-of-the-money Series B Warrants and Series C Warrants was $ 17,147 . The fair value of the out-of-the money Series B Warrants and Series C Warrants as of August 14, 2024, the closing date of the Company’s IPO, was determined using the Black-Scholes valuation model with the following assumptions: Schedule of assumptions Out-of-the Money Series B Warrants Out-of-the Money Series C Warrants Expected term (in years) 2.0 2.0 Expected volatility 111.47 % 111.47 % Weighted average risk-free interest rate 3.97 % 3.97 % Expected dividend yield 0.00 % 0.00 % Fair value of convertible preferred stock - - Fair value of common stock per share $ 9.15 $ 9.15 F- 22 9. EQUITY COMPENSATION PLANS Stock Incentive Plans In connection with the Company’s IPO, our board of directors adopted and our stockholders approved our 2024 Plan, which became effective on August 12, 2024, the effective date of the registration statement for the Company’s IPO. The purpose of the 2024 Plan is to enhance the Company’s ability to attract, retain and motivate individuals by providing these individuals with equity ownership and incentive opportunities. All of the Company’s employees, as well as all of the Company’s non-employee directors and other consultants, advisors and other persons who provide services to the Company are eligible to receive incentive awards under the 2024 Plan, including stock options grants, stock appreciation rights (“SARs”), restricted stock awards (“RSAs”), restricted stock units (“RSUs”), and other awards. Up to 3,316,444 shares of common stock were originally reserved for future issuance under the 2024 Plan, which number included 496,801 shares of common stock reserved for issuance under the 2015 Plan as of the closing date of the IPO. In addition, the number of shares of common stock available for issuance under the 2024 Plan is subject to an annual increase on the first day of each calendar year beginning on January 1, 2025 and ending on and including January 1, 2034 equal to the lesser of (i) 5% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Board. As of December 31, 2025, there were 2,184,341 shares available for grant under the 2024 Plan. In addition, the Company had previously adopted the 2015 Stock Incentive Plan (the “2015 Plan”). As of December 31, 2025, there were 349,626 stock options outstanding and 17,617 unvested RSAs outstanding under the 2015 Plan. On August 12, 2024, the effective date of the 2024 Plan, there were no remaining shares available for grant under the 2015 Plan. Restricted Stock Awards There were no RSAs granted during the years ended December 31, 2025 and 2024. At December 31, 2025, the total estimated unrecognized compensation cost related to unvested service-based RSAs and unvested performance based RSAs was approximately $ 11,000 and $ 42,000 , respectively. The unrecognized cost related to service-based RSAs is expected to be recognized over the remaining weighted average vesting period of 0.30 years. The unrecognized cost related to performance-based RSAs will be recognized ratably over the performance period based upon the probable number of shares expected to vest. During the years ended December 31, 2025 and 2024, there was no expense recorded for the outstanding performance-based RSAs. The following summarizes our RSAs transaction activity for years ended December 31, 2025 and 2024: Schedule of RSAs transaction activity Restricted Common Stock Award Shares (#) Weighted Average Grant Date Fair Value ($) Unvested balance at December 31, 2023 169,030 2.21 Granted – – Vested ( 122,567 ) 2.11 Forfeited – – Unvested balance at December 31, 2024 46,463 2.48 Granted – – Vested ( 28,846 ) 2.11 Forfeited – – Unvested balance at December 31, 2025 17,617 3.10 F- 23 Restricted Stock Units At December 31, 2025, the total estimated unrecognized compensation cost related to unvested RSUs was approximately $ 1,653,000 . This cost is expected to be recognized over the remaining weighted average vesting period of 0.60 years. The following summarizes our RSUs transaction activity for the years ended December 31, 2025 and 2024: Schedule of RSUs transaction activity Restricted Common Stock Unit Shares (#) Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2023 – – Granted 544,111 9.15 Vested and settled – – Forfeited – – Outstanding at December 31, 2024 544,111 9.15 Granted 300,000 8.43 Vested and settled ( 26,875 ) 8.34 Forfeited ( 200,000 ) 8.23 Outstanding at December 31, 2025 617,236 9.13 Awards vested at December 31, 2025 272,055 9.15 Awards nonvested at December 31, 2025 345,181 9.12 Stock Options The following summarizes our stock option transaction activity for the years ended December 31, 2025 and 2024: Schedule of stock option transaction activity Number of Shares Weighted- Average Exercise Price (per share)($) Weighted- Average Remaining Contractual Term (in years) Aggregate Intrinsic Value ($) Outstanding at December 31, 2023 265,566 2.14 Options granted 542,751 7.13 Options exercised – – Options canceled and forfeited ( 27,778 ) 4.68 Outstanding at December 31, 2024 780,539 5.52 Options granted 1,077,380 7.16 Options exercised ( 15,942 ) 2.14 Options canceled and forfeited – – Outstanding at December 31, 2025 1,841,977 6.51 8.85 1,137,506 Vested and expected to vest as of December 31, 2025 1,841,977 6.51 8.85 1,137,506 Exercisable as of December 31, 2025 589,821 5.57 8.44 820,334 F- 24 The aggregate intrinsic value in the table above represents the total pretax intrinsic value (the difference between the Company’s closing stock price on the last trading day of 2025 and the exercise price, multiplied by the number of in-the-money options) that would have been received by the option holders had all option holders exercised their options on the last trading day of 2025. This amount changes based on the fair market value of the Company’s common stock. The aggregate intrinsic value of stock options exercised during the year ended December 31, 2025 was $ 131,362 . As of December 31, 2025, total unrecognized stock-based compensation cost related to stock options was approximately $ 5,539,000 . This cost is expected to be recognized over the weighted average remaining period of 1.42 years. The following table provides the assumptions used in determining the estimated fair value of stock option awards granted during the years ended December 31, 2025 and 2024: Schedule of stock option assumptions Year Ended December 31, 2025 2024 Weighted average expected volatility 99.27 % 92.54 % Weighted average risk-free interest rate 4.00 % 3.75 % Expected dividend yield 0.00 % 0.00 % Weighted average expected term (in years) 5.72 5.72 The following table summarizes the stock-based compensation expense recorded in the accompanying consolidated statements of operations during the years ended December 31, 2025 and 2024: Schedule of stock-based compensation expense Year Ended December 31, 2025 2024 Research and development $ 462,466 $ 147,533 General and administrative 5,584,195 1,848,260 Total $ 6,046,661 $ 1,995,793 The Company has not recognized and does not expect to recognize in the near future, any tax benefit related to employee stock-based compensation expense as a result of the full valuation allowance related to its net deferred tax assets. 10. NET LOSS PER SHARE ATTRIBUTABLE TO COMMON STOCKHOLDERS The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders: Schedule of computation of basic and diluted net loss per share attributable to common stockholders Year Ended December 31, 2025 2024 Numerator: Net loss $ ( 22,227,852 ) $ ( 27,285,328 ) Denominator: Weighted-average shares of common stock outstanding, basic and diluted 21,021,817 8,372,741 Net loss per share attributable to common stockholders, basic and diluted $ ( 1.06 ) $ ( 3.26 ) F- 25 The potential dilutive effect of Redeemable Convertible Preferred Stock and Related Party Convertible Notes outstanding during the periods prior to their exercise were calculated using the if-converted method assuming the conversion of underlying instruments as of the earliest period reported or at the date of issuance, if later, but are excluded if their effect is anti-dilutive. The potential dilutive effect of outstanding stock options, outstanding warrants, outstanding RSUs, and unvested RSAs during the period are calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. The number of whole shares of common stock that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect were as follows: Schedule of anti-dilutive shares As of December 31, 2025 2024 Options issued and outstanding 1,841,977 780,539 Warrants issued and outstanding 922,096 255,599 Unvested restricted stock unit awards issued and outstanding 345,181 544,111 Unvested RSAs 17,617 46,463 Total 3,126,871 1,626,712 11. INCOME TAXES The Company accounts for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”), which requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of the future tax benefits is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. Because of the Company’s recent history of operating losses, management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a full valuation allowance. The provision (benefit) for income taxes for the years ended December 31, 2025 and 2024 is as follows: Schedule of provision (benefit) for income taxes December 31, 2025 2024 Current Federal $ – $ – State 800 800 Foreign – – Total current 800 800 Deferred Federal ( 4,076,182 ) ( 5,918,525 ) State ( 68,960 ) ( 35,752 ) Foreign – – Change in valuation allowance 4,145,142 5,954,277 Total deferred – – Income tax provision $ 800 $ 800 F- 26 The income tax provision is included in general and administrative expenses in the accompanying consolidated statements of operations. Deferred tax assets and liabilities reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts used for income tax purposes. Significant components of our deferred tax assets as of December 31, 2025 and 2024 are as follows: Schedule of components of deferred tax assets December 31, 2025 2024 Deferred tax assets (liabilities): Capitalized R&D, net of amortization $ 8,771,836 $ 8,914,944 Other 1,667,435 590,030 Net operating loss carryforwards 18,249,620 14,295,945 Research and development tax credits 13,277,728 13,908,401 Total deferred tax assets 41,966,619 37,709,320 Valuation allowance ( 41,966,619 ) ( 37,709,320 ) Net deferred tax assets $ – $ – Upon adoption of ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, the reconciliation of the effective income tax rate at the Federal statutory rate for the year ended December 31, 2025 is as follows: Schedule of effective income tax rate December 31, 2025 Amount Percentage Statutory federal income tax rate $ ( 4,667,681 ) 21.00 % State income tax rate, net of federal income tax effect 632 0.00 % Tax credits: Research and development tax credits ( 440,198 ) 1.98 % Change in valuation allowance 5,008,947 ( 22.54 %) Nontaxable and nondeductible items: Other 99,100 ( 0.44 %) Effective income tax 800 0.00 % The reconciliation of taxes at the federal statutory rate to our provision for (benefit from) income taxes for the year ended December 31, 2024 in accordance with the guidance prior to the adoption of ASU 2023-09 was as follows: December 31, 2024 Statutory federal income tax rate 21.00 % Research and development tax credits 6.23 % Other ( 2.00 %) Change in valuation allowance ( 25.23 %) Effective income tax rate 0.00 % F- 27 Upon adoption of ASU 2023-09, cash paid for income taxes, net of refunds, during the years ended December 31, 2025 and 2024 was as follows: Schedule of cash paid for income taxes December 31, 2025 2024 Federal $ – $ – State (California) 800 800 Total cash paid for income taxes, net of refunds $ 800 $ 800 As of December 31, 2025 and 2024, the Company had gross federal income tax net operating loss (“NOL”) carryforwards of $ 86,521,657 and $ 67,858,056 , respectively, and federal research tax credits of $ 13,277,728 and $ 13,908,401 , respectively. Of the federal NOL carryforwards, $ 3,010,902 will expire beginning in 2035 and $ 83,510,755 has an indefinite life while the federal research tax credits will expire by 2044. In addition, the Company has state NOL carryovers of $ 696,277 that will carry forward indefinitely. Utilization of U.S. net operating losses and tax credit carryforwards may be limited by “ownership change” rules, as defined in Sections 382 and 383 of the Code. Similar rules may apply under state tax laws. The Company has not conducted a study to date to assess whether a limitation would apply under Sections 382 and 383 of the Code as and when it starts utilizing its net operating losses and tax credits. The Company will continue to monitor activities in the future. In the event the Company previously experienced an ownership change, or should experience an ownership change in the future, the amount of net operating losses and research and development credit carryovers available in any taxable year could be limited and may expire unutilized. Federal net operating losses incurred in tax years beginning before December 31, 2017, are subject to a 20 year carry forward period and net operating losses incurred after December 31, 2017, can be carried forward indefinitely but will be subjected to the 80% taxable income limitation. In assessing the realization of deferred tax assets, management considers whether it is more likely than not that some portion, or all, of the deferred tax asset will be realized. The ultimate realization of deferred tax assets is dependent upon the Company attaining future taxable income during periods in which those temporary differences become deductible. Due to the uncertainty surrounding the realization of the benefits of its deferred assets, including NOL carryforwards, the Company has provided a 100% valuation allowance on its deferred tax assets at December 31, 2025 and 2024. 12. RELATED PARTY TRANSACTIONS On June 25, 2025, the Company entered into a securities purchase agreement for a private placement of common stock and warrants with certain institutional and accredited investors, including Bios 2024 Co-Invest, LP. Dr. Aaron G.L. Fletcher, the Chairman of the Company’s Board of Directors, is a Managing Partner and co-founder of Bios Partners, with which Bios 2024 Co-Invest, LP is affiliated. The Company received $ 499,996 from Bios 2024 Co-Invest, LP in exchange for 71,428 shares of common stock and warrants to purchase 71,428 shares of common stock (see Note 7). On August 12, 2024, we issued to Bios Clinical Opportunity Fund, LP, a fund affiliated with a current member and a former member of the board of directors of the Company and a majority shareholder, a promissory note in the principal amount of $ 200,000 (“August Note”) in exchange for net proceeds of $ 200,000 . The August Note accrued interest at a rate of 7 % per annum and was due and payable on the earlier of (i) the closing of the IPO or (ii) August 16, 2024, as amended. The August Note was paid in full on August 14, 2024, including accrued interest thereon. On February 20, 2024, March 27, 2024, and May 8, 2024, the Company issued convertible promissory notes in the amount of $ 3,000,000 , $ 1,500,000 , and $ 1,000,000 , respectively, to Bios Clinical Opportunity Fund, LP (see Note 4). F- 28 13. SEGMENT REPORTING The Company manages its operations as a single operating segment. which includes all activities related to the development and potential commercialization of novel therapies for the treatment of cancer, for the purposes of assessing performance and making operating decisions. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”). The Company’s CODM is its President and Chief Executive Officer, who reviews and evaluates consolidated net income (loss) for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods. In addition to the significant expense categories included within consolidated net income (loss) presented on the Company’s Consolidated Statements of Operations, see below for disaggregated amounts that comprise research and development expenses for the years ended December 31, 2025 and 2024: Schedule of research and development expenses Year Ended December 31, 2025 2024 External clinical trial expenses $ 5,051,488 $ 13,387,974 Personnel and consulting expenses 3,514,773 3,183,762 Preclinical and biomarker research 972,646 397,408 Chemistry, Manufacturing & Control (“CMC”) related costs 753,713 1,707,132 Total research and development expenses $ 10,292,620 $ 18,676,276 In addition, the Company has a wholly-owned subsidiary, Actuate Therapeutics Limited, which is a dormant entity with no assets, liabilities or operations in any foreign countries. 14. SUBSEQUENT EVENTS The Company has evaluated all subsequent events and transactions through the date these consolidated financial statements were issued, to ensure these financial statements include appropriate disclosure of events both recognized in the financial statements and events which occurred but were not recognized in the financial statements. The Company has concluded that no subsequent event has occurred that requires disclosure, except as described herein. Sales under November 2025 ATM Facility After the year ended December 31, 2025 through March 25, 2026, we sold 197,059 shares of common stock under the ATM Facility at a weighted-average price of $2.68 per share for net proceeds of approximately $516,000 (see Note 7). Annual Stock Option Grants On February 9, 2026, the Company approved the annual grant of 775,000 stock options to employees and other service providers to be granted on April 1, 2026, including the following amounts to be granted to the Company’s executive officers: Mr. Schmitt, 237,000 stock options; Mr. Lytle, 105,000 stock options; and Dr. Mazar, 105,000 stock options (the “Annual Option Grants”). The Annual Option Grants will vest as to 25% on the first anniversary of the grant date with the remaining 75% vesting in equal monthly installments during the 36 months following the first anniversary of the grant date. F- 29