ACTUATE THERAPEUTICS, INC.
For the period ended Dec 31, 2025. Filed Mar 26, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 26, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Table of Contents
| Page | ||
|---|---|---|
| PART I | ||
| Item 1. | Business | 1 |
| Item 1A. | Risk Factors | 35 |
| Item 1B. | Unresolved Staff Comments | 65 |
| Item 1C. | Cybersecurity | 65 |
| Item 2. | Properties | 66 |
| Item 3. | Legal Proceedings | 66 |
| Item 4. | Mine Safety Disclosures | 66 |
| PART II | ||
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 67 |
| Item 6. | [Reserved] | 68 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 68 |
| Item 7A. | Quantitative and Qualitative Disclosures About Market Risk | 79 |
| Item 8. | Financial Statements and Supplementary Data | 79 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 79 |
| Item 9A. | Controls and Procedures | 79 |
| Item 9B. | Other Information | 80 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 80 |
| PART III | ||
| Item 10. | Directors, Executive Officers and Corporate Governance | 81 |
| Item 11. | Executive Compensation | 81 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 81 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 81 |
| Item 14. | Principal Accountant Fees and Services | 81 |
| PART IV | ||
| Item 15. | Exhibit and Financial Statement Schedules | 82 |
| SIGNATURES | 84 | |
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Unless the context requires otherwise, references in this Annual Report on Form 10-K to “Actuate,” the “Company,” “we,” “us,” and “our” refer to Actuate Therapeutics, Inc.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (“Report” or “Annual Report”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act") about us and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements involve estimates, assumptions and uncertainties which could cause actual results to differ materially from those expressed in them. The forward-looking statements in this Report include, but are not limited to, statements concerning the following:
| · | our expectations for the results of our ongoing Phase 2 clinical trial of elraglusib for the treatment of mPDAC; |
| · | our plans to meet with the U.S. Food and Drug Administration (the “FDA”) or European Medicines Agency (“EMA”) in the first half of 2026 to discuss the design and execution of a Phase 3 global registration study of elraglusib for the treatment of mPDAC; |
| · | our expectations for the results of our pre-clinical studies and clinical trials; |
| · | our ability to enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA; |
| · | our ability to successfully manage our relationships with our licensors and third-party service providers; |
| · | our ability to maintain, protect and further develop our intellectual property rights; |
| · | our ability to fund our current operations with our cash on hand as of the date of this Report and our ability to raise additional capital as and when needed; |
| · | our future financial and operating results; |
| · | our intentions, expectations and beliefs regarding anticipated growth, market penetration and trends in our business; and |
| · | the timing and success of our plan of commercialization. |
These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those summarized under the heading “Risk Factor Summary” and discussed further under the heading “Risk Factors” in this Report.
You should assume that the information appearing in this Report is accurate as of its date only. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. All written or oral forward-looking statements attributable to us or any person acting on our behalf made after the date of this Report are expressly qualified in their entirety by the risk factors and cautionary statements contained in this Report. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this Report or to reflect the occurrence of unanticipated events.
In addition, statements that “we believe” and similarly qualified statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Report, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon them.
The discussion of the Company’s financial condition and results of operations should be read in conjunction with the Company’s consolidated financial statements and the related notes thereto included in this Report.
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RISK FACTOR SUMMARY
The following is a summary of the key risks and uncertainties that make an investment in our securities speculative and risky. The summary below does not contain all of the information that may be important to you, and you should read this summary together with the more detailed description of the risks set forth under "Item 1A. Risk Factors" of this Annual Report.
Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements
| · | We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future. We may never generate revenue or achieve profitability, and if we do achieve profitability, it may not be sustained. |
| · | We will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or our operations. |
| · | Raising additional capital or acquiring or licensing assets by issuing equity or debt securities may cause dilution to our stockholders, and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights. |
Risks Related to the Development and Commercialization of Our Product Candidates
| · | We currently depend entirely on the success of elraglusib, which is our only product candidate. If we are unable to advance elraglusib in clinical development, obtain regulatory approval and ultimately commercialize elraglusib in a timely manner, our business will be materially harmed. |
| · | We do not have and may never have any approved products on the market. Our business is highly dependent upon receiving approvals from various governmental agencies and will be severely harmed if we are not granted approval to manufacture and sell our product candidates. |
| · | Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Elraglusib or any future product candidates may not achieve favorable results or receive regulatory approval on a timely basis, if at all. |
| · | Our product development efforts are at an early stage. We have not yet undertaken any marketing efforts, and there can be no assurance that future anticipated market testing and analyses will validate our marketing strategy. We may need to modify the products, or we may not be successful in either developing or marketing those products. |
| · | The successful commercialization of elraglusib or any future product candidates, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our products could limit our ability to market those products and decrease our ability to generate revenue. |
Risks Related to Our Reliance on Third Parties
| · | The termination of third-party licenses could adversely affect our rights to important technologies. |
| · | Our current drug substance (“DS”) manufacturer of elraglusib is in China, and it is unknown how current or future geopolitical relationships with China may affect our ability to obtain DS, increase our costs, delay clinical trials and potential regulatory approval, and adversely impact our financial condition. |
| · | We depend on a third-party manufacturer for certain drug substances, drug products, raw materials, samples, components, and other materials used in our product candidates. We obtain our supplies on a purchase order basis and do not have any long-term supply agreements in place. If we are unable to source these supplies on a timely basis, or establish longer-term contracts with suppliers, we will not be able to complete our clinical trials or studies on time and the development of our product candidates may be delayed. |
| · | Data provided by collaborators and other parties upon which we rely have not been independently verified and could turn out to be inaccurate, misleading, or incomplete. |
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Risks Related to Our Intellectual Property
| · | We may not be able to enforce our intellectual property rights throughout the world. |
| · | If we and our third-party licensors do not obtain and preserve protection for key intellectual property rights, our competitors may be able to take advantage of our (and our licensors’) development efforts. |
| · | Intellectual property disputes could require us to spend time and money to address such disputes and could limit our intellectual property rights. |
| · | Patent terms may be inadequate to protect the competitive position of elraglusib or any future product candidates for an adequate amount of time. |
| · | We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property. |
| · | Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse impact on the success of our business. |
| · | Intellectual property rights of third parties could adversely affect our ability to commercialize our current or future technologies or drug candidates, and we might be required to litigate or obtain licenses from third parties to develop or market our current or future technologies or drug candidates, which may not be available on commercially reasonable terms, or at all. |
| · | We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property. |
Risks Related to Our Business Operations and Industry
| · | We may be subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability or otherwise adversely affect our business. |
| · | The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business. |
| · | Our information technology systems, or those of any of our service providers, may fail or suffer security incidents and other disruptions, which could result in a material disruption of our development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business. |
| · | Disruptions at the U.S. Food and Drug Administration (the “FDA”) and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, which could negatively impact our business. |
| · | Effective collaboration with the FDA’s Center for Drug Evaluation and Research (“CDER”) for the approval of drug candidates is a highly demanding process which can result in increased time and expense to gain approvals. |
Risks Related to our Common Stock
| · | Concentration of ownership by our principal stockholders limits the ability of others to influence the outcome of director elections and other transactions requiring stockholder approval, creates the potential for conflicts of interest, may negatively impact our stock price and may deter or prevent efforts by others to acquire us, preventing our stockholders from realizing a control premium. |
| · | There was no public market for our common stock prior to the IPO in August 2024. An active, liquid and orderly market for our common stock may not be sustained, or we may in the future fail to satisfy the continued listing requirements of Nasdaq, and you may not be able to resell your shares at or above your purchase price or at all. |
| · | The trading price of the shares of our common stock could be highly volatile regardless of our operating performance, and purchasers of our common stock could incur substantial losses. |
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.