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UNITED STATES
SECURITIES AND
EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities
Exchange Act of 1934
Date of report (Date of earliest event reported):
May 1, 2026
Actuate
Therapeutics, Inc.
(Exact
Name of Registrant as Specified in Charter)
| Delaware |
001-42139 |
47-3044785 |
(State or Other Jurisdiction
of Incorporation) |
(Commission
File Number) |
(IRS Employer
Identification No.) |
1751 River Run, Suite 400
Fort Worth, Texas |
76107 |
| (Address of Principal Executive Offices) |
(Zip Code) |
(817)
887-8455
(Registrant’s Telephone Number, Including Area Code)
N/A
(Former
Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
|
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange
on which registered |
| Common Stock, par value $0.000001 per share |
|
ACTU |
|
The Nasdaq Stock Market LLC |
| |
|
|
|
|
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the
Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
| Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers;
Compensatory Arrangements of Certain Officers. |
On May 1, 2026, the Board
of Directors (“Board”) of Actuate Therapeutics, Inc. (the “Company”), upon the recommendation of the Nominating
and Corporate Governance Committee, appointed Martin H. Huber, MD, to the Board. Dr. Huber was appointed to fill a newly created Board
seat resulting from the expansion of the Board from seven (7) to eight (8) directors, also effective upon his appointment. Dr. Huber will
serve as a Class III director until the Company’s 2027 annual meeting of stockholders, and until his successor is duly elected and
qualified, or until his earlier resignation, death, or removal. Dr. Huber will serve on the Nominating and Corporate Governance Committee
of the Board.
Dr. Huber will receive compensation
in accordance with the Company’s non-employee Director Compensation Program, including an initial grant of non-statutory stock options
to purchase 30,000 shares of common stock, vesting over a three year period, and an annual retainer, paid in equal quarterly installments,
of $44,000. The Company also entered into the Company’s standard form indemnification agreement with Dr. Huber. In connection with
the appointment of Dr. Huber, the Company entered into a separate consulting agreement with Dr. Huber to provide additional research and
development advisory services to the Company upon his appointment, with a quarterly consulting fee of $3,000.
Dr. Huber was the President
and Chief Executive Officer of Mersana Therapeutics, Inc (“Mersana”) from 2023 to January 2026 (and a director from 2020 to
January 2026) until Mersana was acquired by Day One Biopharmaceuticals. Prior to Mersana, he served as the President of R&D, and prior
to that as Chief Medical Officer, of Xilio Therapeutics, Inc. from April 2020 to September 2023. Prior to joining Xilio, Dr. Huber served
as Senior Vice President, Chief Medical Officer at TESARO, Inc. from September 2015 until its January 2019 acquisition by GlaxoSmithKline
plc, and once acquired, as Senior Vice President, Clinical, until April 2020. Prior to TESARO, Dr. Huber served as Vice President, Oncology
Clinical Research at Merck Research Laboratories (“Merck”) from 2012 to 2015. Prior to Merck, he served in roles of increasing
responsibility at Schering-Plough, Hoffmann-La Roche and Rhone-Poulenc Rorer, where he led teams in the areas of oncology clinical development,
drug safety and pharmacovigilance. He was previously an Assistant Professor of Oncology at the University of Texas M.D. Anderson Cancer
Center. Dr. Huber earned his M.D. from Baylor College of Medicine. Dr. Huber currently serves on the board of directors of Syndax Pharmaceuticals
where he is the chair of the Science and Technology Committee.
On
May 6, 2026, the Company issued a press release announcing the appointment of Dr. Huber as a newly appointed director of the Company.
A copy of this press release is furnished hereto as Exhibit 99.1 and is incorporated by reference.
The
information furnished pursuant to Item 8.01 of this Current Report on Form 8-K, including the information contained in Exhibit 99.1 of
this Current Report on Form 8-K, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in
such a filing.
| Item 9.01. | Financial Statements and
Exhibits. |
(d) Exhibits
The following exhibits are furnished with this report:
| Exhibit No. |
|
Description |
| |
|
| 99.1 |
|
Press release issued by Actuate Therapeutics, Inc. on May 6, 2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 hereunto
duly authorized.
| |
Actuate Therapeutics, Inc. |
| |
|
| Date: May 6, 2026 |
By: |
/s/ Daniel M. Schmitt |
| |
|
Name: Daniel M. Schmitt |
| |
| Title: President and Chief Executive Officer |
Exhibit 99.1

Actuate Therapeutics
Announces Key Appointment
of Industry Veteran to Board of Directors
Martin Huber, MD brings deep expertise
in oncology drug development, regulatory strategy, and commercialization of novel therapies
CHICAGO, IL and FORT WORTH, Texas, May 6, 2026
(GLOBE NEWSWIRE) — Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage
biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers, today announced
the appointment of Martin Huber, MD, as an Independent Director, effective
immediately. This appointment strengthens Actuate’s leadership team as it advances elraglusib across multiple difficult-to-treat
cancer indications toward registration studies and commercialization.
“We are pleased to welcome Marty to our
Board of Directors. His dedication and expertise are going to prove invaluable to our mission, and we are excited to have him join us
in advancing our programs toward key goals,” said Daniel Schmitt, President & Chief Executive Officer of Actuate Therapeutics.
“Dr. Huber’s decades of experience and drug development expertise will be instrumental as we advance elraglusib for the treatment
of cancers with high unmet medical need, where elraglusib has the potential to positively affect outcomes for patients.”
Dr. Huber recently served as President and Chief
Executive Officer of Mersana Therapeutics until its acquisition by Day One Pharmaceuticals in January 2026. Previously, he held senior
R&D leadership roles at Xilio Therapeutics and TESARO, including Chief Medical Officer, and contributed to the approval of multiple
oncology medicines such as pembrolizumab, niraparib, dostarlimab, trastuzumab, and docetaxel. Dr. Huber began his career at the University
of Texas M.D. Anderson Cancer Center and earned his medical degree from Baylor College of Medicine.
“Having spent my career developing new cancer
therapies, I've seen firsthand how challenging it is to find new approaches that can truly impact patient outcomes in difficult-to-treat
malignancies,” said Dr. Huber. “Actuate's focus on GSK-3β inhibition targets a well-validated and important pathway that
has historically been difficult to target. The team has made significant progress in advancing the science, most recently with its impressive
results demonstrated in metastatic pancreatic cancer. I look forward to contributing to help Actuate bring these innovative therapies
to more patients across additional histologies.”
About Actuate Therapeutics, Inc.
Actuate is a clinical-stage biopharmaceutical
company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational
drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and
resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated
B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune
checkpoints and immune cell function.
For additional information, please visit the Company’s
website at www.actuatetherapeutics.com or
follow us on LinkedIn, X, and Facebook.

Forward-Looking Statements
This press release contains forward-looking statements
about us, including our and other parties’ clinical trials and development plans, 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. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this
press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties
which could cause actual results to differ materially from those expressed in them, including but not limited to that preliminary and
unpublished data may be subject to change and further interpretation following the availability of more data or following a more comprehensive
review of the data and should not be relied upon as a final analysis; clinical and preclinical drug development involves a lengthy and
expensive process with uncertain timelines and outcomes, results of prior preclinical studies, early clinical trials and sub-group studies
are not necessarily predictive of future results and may not correlate with improved responses, and elraglusib may not achieve positive
clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully
enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA
and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or
other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials
or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our
reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition
from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition
raises substantial doubt as to our ability to continue as a going concern and we require additional capital to finance our operations
beyond the second quarter of fiscal year 2026, and a failure to obtain this necessary capital in the near term on acceptable terms, or
at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In
addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Item
1A. 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,
and our Quarterly Reports on Form 10-Q, and other filings with the SEC. 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. 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 press release
or to reflect the occurrence of unanticipated events.
Investor
Contact
Mike Moyer
Managing Director
LifeSci Advisors, LLC
mmoyer@lifesciadvisors.com
Media
Contact
Ignacio Guerrero-Ros, Ph.D.
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
(858) 717-2310