ACTUATE THERAPEUTICS, INC.
For the period ended Jun 30, 2026. Filed Aug 14, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2026 · Filed Aug 14, 2026
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Table of Contents
INDEX
| Page | ||
|---|---|---|
| PART I - FINANCIAL INFORMATION | ||
| Item 1. | Financial Statements | 1 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 16 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 25 |
| Item 4. | Controls and Procedures | 25 |
| PART II - OTHER INFORMATION | ||
| Item 1A. | Risk Factors | 26 |
| Item 5. | Other Information | 27 |
| Item 6. | Exhibits | 27 |
| SIGNATURES | 28 | |
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Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Actuate,” the “Company,” “we,” “us,” and “our” refer to Actuate Therapeutics, Inc.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (“Report” or “Quarterly 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 clinical and nonclinical studies of elraglusib and any future product candidates we may choose to pursue, including any modifications to clinical development plans based on feedback that we may receive from regulatory authorities; |
| · | our regulatory plans to seek feedback from the U.S. Food and Drug Administration (the “FDA”) or European Medicines Agency (“EMA”) in 2026 on the design and execution of clinical studies, including the Phase 1/2 clinical study in advanced cancer patients using the oral tablet formulation of elraglusib and the design of a future clinical studies of elraglusib for the treatment of mPDAC and potentially other cancers using the oral tablet formulation of elraglusib; |
| · | 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; |
| · | our ability to maintain the listing of our common stock on the Nasdaq Global Market; 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 risk factors identified in Part II, Item 1A. “Risk Factors” in this Report and under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on March 26, 2026.
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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