Form 8-K

8-K — ACTUATE THERAPEUTICS, INC.

Accession: 0001683168-26-003515

Filed: 2026-05-06

Period: 2026-05-01

CIK: 0001652935

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Other Events

Item: Financial Statements and Exhibits

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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.

Item 8.01. Other Events.

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

EX-99.1 — PRESS RELEASE

EX-99.1

Filename: actuate_ex9901.htm · Sequence: 2

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

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

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