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As filed with the Securities and Exchange Commission
on July 25, 2025
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
Actuate Therapeutics,
Inc.
(Exact name of registrant as specified in its charter)
Delaware |
|
8731 |
|
47-3044785 |
(State or other jurisdiction of
incorporation or organization) |
|
(Primary Standard Industrial
Classification Code Number) |
|
(I.R.S. Employer
Identification Number) |
1751 River Run, Suite 400
Fort Worth, Texas 76107
(817) 887-8455
(Address, including zip code, and telephone number,
including area code, of registrant’s principal executive offices)
Daniel Schmitt
President and Chief Executive Officer
1751 River Run, Suite 400
Fort Worth, Texas 76107
(817) 887-8455
(Name, address, including zip code, and telephone
number, including area code, of agent for service)
Copies to:
Janet Spreen, Esq.
Baker & Hostetler LLP
127 Public Square, Suite 2000
Cleveland, Ohio 44114
Telephone: (216) 621-0200
Approximate date of commencement
of proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.
If any of the securities being
registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check
the following box: ☒
If this Form is filed to register
additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities
Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective
amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective
amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement
number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark whether
the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ |
|
|
Accelerated filer ☐ |
Non-accelerated filer ☒ |
|
|
Smaller reporting company ☒ |
|
|
|
Emerging growth company ☒ |
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 7(a)(2)(B) of the Securities Act.
The registrant hereby amends
this Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further
amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a)
of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant
to said Section 8(a), may determine.
The information in this preliminary
prospectus is not complete and may be changed. The selling stockholders may not sell these securities until the registration statement
filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and
is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED JULY
25, 2025
PRELIMINARY PROSPECTUS

ACTUATE THERAPEUTICS, INC.
1,332,994 Shares of Common Stock
This prospectus relates to
the resale from time to time by the selling stockholders identified herein (each, a “Selling Stockholder” and, together, the
“Selling Stockholders”) of up to an aggregate of 1,332,994 shares (the “Shares”) of common stock, par value $0.000001
per share (the “Common Stock”), of Actuate Therapeutics, Inc., a Delaware corporation (the “Company”), which consists
of (i) 666,497 shares of Common Stock, and (ii) 666,497 shares of Common Stock issuable upon the exercise of warrants (the “Warrants”
and the shares of Common Stock issuable upon the exercise of the Warrants, the “Warrant Shares”).
We will not receive any of
the proceeds from the sale of the Shares by the Selling Stockholders. However, upon any exercise of the Warrants, we will receive the
exercise price of such Warrants.
The Selling Stockholders
may sell or otherwise dispose of the Shares covered by this prospectus in a number of different ways and at varying prices. We provide
more information about how the Selling Stockholders may sell or otherwise dispose of the Shares covered by this prospectus in the section
entitled “Plan of Distribution.” For information on the Selling Stockholders, see the section entitled “Selling Stockholders.”
Discounts, concessions, commissions and similar selling expenses attributable to the sale of Shares covered by this prospectus will be
borne by the Selling Stockholders. We will pay all expenses (other than discounts, concessions, commissions and similar selling expenses)
relating to the registration of the Shares with the Securities and Exchange Commission (the “SEC”).
Our Common Stock is currently
listed on The Nasdaq Global Market (“Nasdaq”) under the symbol “ACTU.” On July 24, 2025, the last reported sales
price of our Common Stock, as reported on Nasdaq, was $6.99 per share.
We are an “emerging
growth company” and a “smaller reporting company” as defined under the federal securities laws and have elected to comply
with certain reduced public company reporting requirements in this prospectus and may elect to do so in future filings. See “Prospectus Summary-Emerging Growth Company and Smaller Reporting Company.”
Investing in our
securities involves a high degree of risk. You should review carefully the risks and uncertainties described in the section titled
“Risk Factors” beginning on page 8 of this prospectus, and under similar headings in any amendments
or supplements to this prospectus.
Neither the Securities
and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or passed upon the accuracy
or adequacy of this prospectus. Any representation to the contrary is a criminal offense.
The date
of this prospectus is , 2025.
TABLE OF CONTENTS
|
Page |
ABOUT THIS PROSPECTUS |
ii |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS |
iii |
INDUSTRY AND MARKET DATA |
iv |
PROSPECTUS SUMMARY |
1 |
THE OFFERING |
7 |
RISK FACTORS |
8 |
USE OF PROCEEDS |
10 |
MARKET INFORMATION FOR SECURITIES AND DIVIDEND POLICY |
11 |
SELLING STOCKHOLDER |
12 |
DESCRIPTION OF CAPITAL STOCK |
14 |
SECURITIES ACT RESTRICTIONS ON RESALE OF SECURITIES |
19 |
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS |
20 |
PLAN OF DISTRIBUTION |
24 |
LEGAL MATTERS |
26 |
EXPERTS |
26 |
WHERE YOU CAN FIND MORE INFORMATION |
26 |
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE |
27 |
ABOUT THIS PROSPECTUS
This prospectus is part of
a registration statement on Form S-1 that we filed with the SEC to register the securities described in this prospectus for resale by
the Selling Stockholders who may, from time to time, sell the securities described in this prospectus. We will not receive any of the
proceeds from the sale of the Shares by the Selling Stockholders. However, upon any exercise of the Warrants, we will receive the exercise
price of such Warrants.
We may also file a prospectus
supplement or post-effective amendment to the registration statement of which this prospectus forms a part that may contain material information
relating to these offerings. The prospectus supplement or post-effective amendment may also add, update or change information contained
in this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus and the applicable
prospectus supplement or post-effective amendment, you should rely on the prospectus supplement or post-effective amendment, as applicable.
Before purchasing any securities, you should carefully read this prospectus, any post-effective amendment, and any applicable prospectus
supplement, together with the additional information described under the heading “Where You Can Find More Information”
and “Incorporation of Certain Information by Reference.”
Neither we nor any of the
Selling Stockholders have authorized anyone to provide any information or to make any representations other than those contained in this
prospectus, any accompanying prospectus supplement or any free writing prospectus we have prepared. We and the Selling Stockholders take
no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus
is an offer to sell only the securities offered hereby and only under circumstances and in jurisdictions where it is lawful to do so.
No dealer, salesperson or other person is authorized to give any information or to represent anything not contained in this prospectus,
any applicable prospectus supplement or any related free writing prospectus. This prospectus is not an offer to sell securities, and it
is not soliciting an offer to buy securities, in any jurisdiction where the offer or sale is not permitted. You should assume that the
information appearing in this prospectus or any prospectus supplement is accurate only as of the date on the front of those documents
only, regardless of the time of delivery of this prospectus or any applicable prospectus supplement, or any sale of a security. Our business,
financial condition, results of operations and prospects may have changed since those dates.
This prospectus contains summaries
of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete
information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to
herein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectus
is a part, and you may obtain copies of those documents as described below under “Where You Can Find More Information”
and “Incorporation of Certain Information by Reference.”
This prospectus includes our
trademarks, and trade names, including but not limited to Actuate and Actuate Therapeutics, which are protected under applicable intellectual
property laws. This prospectus also may contain trademarks, service marks, trade names, and copyrights of other companies, which are the
property of their respective owners. Solely for convenience, the trademarks, service marks, trade names, and copyrights referred to in
this prospectus are listed without the TM, SM, ©, and ® symbols, but we will assert, to the fullest extent under applicable law,
our rights or the rights of the applicable licensors, if any, to these trademarks, service marks, trade names, and copyrights.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including
any prospectus supplement or document incorporated by reference herein, contains forward-looking statements about us and our industry.
In addition, from time to time, we or our representatives have made or will make forward-looking
statements. The forward-looking statements involve substantial risks and uncertainties. All statements, other than statements related
to present facts or current conditions or of historical facts, contained in this prospectus, including statements regarding our strategy,
future operations, future financial position, future financing, future revenues, and projected costs, prospects, plans and objectives
of management, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned clinical trials
and preclinical studies for elraglusib and any future product candidates, the timing and likelihood of regulatory filings and approvals
for elraglusib and any future product candidates, our ability to commercialize elraglusib and any future product candidates, if approved,
the pricing and reimbursement of elraglusib and any future product candidates, if approved, the potential to develop future product candidates,
the potential benefits of strategic collaborations and potential to enter into any future strategic arrangements, the timing and likelihood
of success, plans and objectives of management for future operations, future results of anticipated product development efforts, and 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 will require substantial additional capital to finance our operations,
are forward-looking statements. 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. In addition, any forward-looking statements are qualified
in their entirety by reference to the factors discussed further under the heading “Risk Factors” in this prospectus
or in any prospectus supplement or document incorporated by reference.
You should assume that the
information appearing in this prospectus or any prospectus supplement 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 prospectus are expressly
qualified in their entirety by the risk factors and cautionary statements contained in this prospectus. 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 prospectus 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 prospectus, 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.
INDUSTRY AND MARKET DATA
Certain market, industry and
competitive data included in this prospectus were obtained from our own internal estimates and research, as well as from publicly available
information, reports of governmental agencies and industry publications and surveys in addition to research, surveys and studies conducted
by third parties. The content of these third-party sources, except to the extent specifically set forth in this prospectus, does not constitute
a portion of this prospectus and is not incorporated herein. Internal estimates are derived from publicly available information released
by industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made by
us based on such data and our knowledge of our industry and market, which we believe to be reasonable. In some cases, we do not expressly
refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any
paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise
expressly stated or the context otherwise requires.
In addition, while we are
responsible for all of the disclosure contained in this prospectus and we believe the industry, market and competitive position data included
in this prospectus is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change
based on various factors, including those discussed in the sections titled “Risk Factors” and “Special Note
Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed
in the estimates made by the independent parties and by us.
PROSPECTUS SUMMARY
This summary highlights
information contained in greater detail elsewhere in or incorporated by reference into this prospectus. This summary does not contain
all of the information that is important to your investment decision, and is qualified in its entirety by the more detailed information
and consolidated financial statements included elsewhere in or incorporated by reference into this prospectus. You should carefully read
this summary together with the more detailed information contained elsewhere in this prospectus before making an investment decision.
Investors should carefully consider the information set forth under the caption “Risk Factors” appearing elsewhere in this
prospectus and in documents incorporated by reference. Unless the context requires otherwise, references in this prospectus to “Actuate,”
the “Company,” “we,” “us,” and “our” refer to Actuate Therapeutics, Inc.
Overview
We are a clinical stage biopharmaceutical
company focused on developing therapies for the treatment of high impact, difficult to treat cancers through the inhibition of glycogen
synthase kinase-3 (“GSK-3”). We are developing elraglusib (formerly 9-ING-41), an ATP-competitive small molecule that is designed
to enter cancer cells and block the function of the enzyme glycogen synthase kinase-3 beta (“GSK-3β”), a master regulator
of complex biological signaling cascades, including those mediated by oncogenes, that lead to tumor cell survival, growth, migration,
and invasion. We believe that the blockade of GSK-3β signaling ultimately results in the death of the cancer cells and the regulation
of anti-tumor immunity.
We have exclusively licensed
a portfolio of GSK-3 inhibitors developed in a collaboration between The Board of Trustees of the University of Illinois-Chicago (“UIC”)
and Northwestern University (“NU”). Elraglusib is the lead investigational product in our portfolio and is being evaluated
in a Phase 2 trial in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”), our most advanced clinical indication
to date. We have also advanced a Phase 1/2 clinical trial in refractory pediatric malignancies, including Ewing sarcoma (“EWS”),
which we recently completed in July 2025.
Elraglusib represents a broad
opportunity for us to potentially initiate and advance multiple drug development programs around our lead asset based on data emerging
from completed or ongoing Phase 1/2 trials and non-clinical biological, cellular, and animal data. Animal tumor model data, Phase 1/2
clinical data and AI-based computational approaches have identified a number of areas of unmet clinical need in cancer where elraglusib
may play an interventional role, including pancreatic, metastatic melanoma, lung, colon, breast, renal, and ovarian cancer, leukemias
and lymphomas, as well as some pediatric cancers including Ewing sarcoma, neuroblastoma and pediatric leukemias.
Corporate Information
Our principal executive offices
are located at 1751 River Run, Suite 400, Fort Worth, Texas 76107. Our telephone number is (817) 887-8455. Our website address is www.actuatetherapeutics.com.
Information contained on our website or connected thereto does not constitute part of, and is not incorporated by reference into, this
prospectus or the registration statement of which it forms a part.
Recent Developments
On June 25, 2025, we entered
into a securities purchase agreement (the “Securities Purchase Agreement”) for a private placement (the “Private Placement”)
with certain institutional and accredited investors, or the Selling Stockholders. Pursuant to the Securities Purchase Agreement, we issued
and sold to the Selling Stockholders an aggregate of (i) 666,497 shares of Common Stock, at a purchase price of $7.00 per share, and (ii)
Warrants to purchase up to an aggregate of 666,497 shares of Common Stock with an exercise price of $7.00 per Warrant. The Warrants are
exercisable on a cash only basis at any time after the date of issuance and expire 20 days following the Milestone Date (as defined below)
for additional proceeds to the Company of up to approximately $4.7 million if all Warrants are exercised in full. The “Milestone
Date” is the earliest to occur of (i) the U.S. Food and Drug Administration (“FDA”) issuing Breakthrough Therapy designation
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 existing Phase 2 clinical data or data from a future Phase 3 clinical trial.
Bios 2024 Co-Invest, LP, a
current stockholder of the Company purchased 71,428 shares and Warrants to purchase 71,428 shares in the Private Placement for an aggregate
purchase price of $499,996, and, together with its affiliates following the closing of the Private Placement is deemed to beneficially
own approximately 49.9% of the Common Stock. Dr. Aaron G.L. Fletcher, who is the Managing Partner and co-founder of Bios Partners, is
the Chairman of the Company’s Board of Directors.
The Private Placement closed
on June 27, 2025 (the “Closing Date”). The Company received gross proceeds from the Private Placement of approximately $4.7
million, before deducting fees and offering expenses. The Company intends to use the net proceeds from the Private Placement for working
capital and general corporate purposes.
In connection with the Private
Placement, on June 25, 2025, we entered into a registration rights agreement (the “Registration Rights Agreement”) with the
Selling Stockholders, pursuant to which we agreed to file a registration statement with the SEC covering the resale of the Shares sold
in the Private Placement. We agreed to file such registration statement within 45 days following the Closing Date. The Registration Rights
Agreement includes customary indemnification rights in connection with the registration statement providing for the resale of the Shares.
The registration statement of which this prospectus forms a part has been filed in accordance with the Registration Rights Agreement.
The foregoing summary descriptions
of the Securities Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entirety
by reference to the full text of such documents, which are filed as exhibits to the registration statement of which this prospectus forms
a part and are incorporated by reference herein.
Risk Factor Summary
Our business is subject to
many significant risks. You should read and carefully consider the risks summarized below. These risks are discussed more fully in the
“Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 13, 2025, our Quarterly Report on Form
10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, and the other documents incorporated by reference in this
prospectus. If any of the risks summarized below actually occurs, our business, prospects, financial condition or operating results could
be materially and adversely affected. In particular, our risks include, but are not limited to, the following:
Risks Related to the Offering
| · | Our financial condition raises substantial doubt as to our ability to continue as
a going concern. |
| | |
| · | Investors who buy shares at different times will likely pay different prices. |
| | |
| · | Sales of a substantial number of our securities in the public market by our existing
stockholders could cause the price of our shares of Common Stock to fall. |
| | |
| · | Our management team has broad discretion over the use of any proceeds received pursuant
to the exercise of the Warrants, and you may not agree with how we use the proceeds, and the proceeds may not be invested successfully. |
Risks Related to Our Limited Operating History, Financial Condition
and Capital Requirements
| · | We have a limited operating history, have incurred significant operating losses
and expect to incur significant operating losses for the foreseeable future. We have a high risk of never generating revenue or becoming
profitable or, if we achieve profitability, it may not be sustained. |
| | |
| · | We require substantial additional capital in the near term 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 other operations. |
| | |
| · | Raising additional capital may cause dilution to our stockholders, restrict our
operations or require us to relinquish rights to our technologies or product candidates. In addition, any capital obtained by us may be
obtained on terms that are unfavorable to us, our investors, or both. |
| | |
| · | Under the common stock purchase agreement, dated March 27, 2025 (the “Committed
Equity Facility”) with B. Riley Principal Capital II (“B. Riley”), it is not possible to predict the actual number of
shares we will sell to B. Riley, or the actual gross proceeds resulting from those sales. |
Risks Related to Clinical Development and Potential Regulatory
Approval
| · | 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. |
| | |
| · | 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. |
| · | Even if we complete all planned clinical trials including a Phase 3 trial in the
future, there is no guarantee that at the time of submission the FDA will accept our NDA. |
| | |
| · | Clinical and preclinical drug development involves a lengthy and expensive process
with uncertain timelines and outcomes, and results of prior 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. |
| | |
| · | We may not be successful in our efforts to advance elraglusib in additional indications.
We may expend our limited resources to pursue a new product candidate or a particular indication for elraglusib and fail to capitalize
on more profitable or successful alternatives. |
| | |
| · | Use of elraglusib or any future product candidates 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, abandon elraglusib or any future product candidate, limit the commercial profile of an approved label or
result in other significant negative consequences that could severely harm our business, financial condition, results of operations and
prospects. |
| | |
| · | If we experience delays or difficulties in the enrollment of subjects to our clinical
trials, our receipt of necessary regulatory approvals could be delayed or otherwise adversely affected. |
| | |
| · | Interim, topline, and preliminary data from our clinical trials that we announce
or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that
could result in material changes in the final data. |
Risks Related to Our Reliance on Third Parties
| · | The termination of third-party licenses could adversely affect our rights to important
technologies. |
| | |
| · | Our current elraglusib drug substance (“DS”) manufacturer 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. |
| | |
| · | Unfavorable tariffs could increase the cost of drug substance of elraglusib used
in clinical trials and potential commercialization, if approved, which could adversely affect our business, financial condition or results
of operations. |
| | |
| · | We rely on third parties to conduct our non-clinical studies and clinical trials.
If these parties do not successfully carry out their duties or meet deadlines, we may be unable to obtain regulatory approval for or commercialize
our product candidates and adversely affect our financial condition. |
| | |
| · | 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. |
Risks Related to Commercialization of Elraglusib and any
Future Product Candidates
| · | We have a limited operating history and no products approved for commercial sale,
which may make it difficult to evaluate our prospects and likelihood of success. |
| | |
| · | Our business is highly dependent on the success of our sole product candidate, elraglusib,
and any other future product candidates that we advance into clinical development, all of which will require significant additional development
before we can seek regulatory approval for and launch a product commercially. |
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 development efforts. |
| | |
| · | If we fail to comply with our license, collaboration or other intellectual property-related
agreements, we may incur damages and could lose rights that may be necessary for developing, commercializing and protecting our current
or future technologies or drug candidates or granting sublicenses. |
Risks Related to Our Business Operations and Industry
| · | If we lose key management leadership, and/or scientific personnel, and if we cannot
recruit qualified employees or other significant personnel, we may experience program delays and increased compensation costs, and our
business may be materially disrupted. |
| | |
| · | Competition and technological change may make our product candidates less competitive
or obsolete. We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer
if we fail to compete effectively. |
| | |
| · | Our anticipated operating expenses and capital expenditures are based upon our management’s
estimates of possible future events. Actual amounts could differ materially from those estimated. |
Risks Associated 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. |
| | |
| · | Current and new investors will experience dilution due to future sales or issuances
of our Common Stock. |
| | |
| · | 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. |
| · | Numerous shares may now be sold into the open market upon expiry of the IPO lock-up
in February 2025. Substantial sales of shares could cause the price of our Common Stock to decline. |
| | |
| · | Sales of a substantial number of our securities in the public market by our existing
stockholders under this offering or the Committed Equity Facility with B. Riley could cause the price of our shares of Common Stock to
fall. |
Implications of Being an Emerging Growth Company and a Smaller
Reporting Company
We are an “emerging
growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). As an emerging growth company, we
may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not
emerging growth companies. These include, but are not limited to:
| · | being permitted to provide only two years of audited financial statements, in addition
to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis
of Financial Condition and Results of Operations” disclosure; |
| | |
| · | not being required to comply with the auditor attestation requirements in the assessment
of our internal control over financial reporting; |
| | |
| · | not being required to comply with any requirement that may be adopted by the Public
Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditors’ report providing additional
information about the audit and the financial statements; |
| | |
| · | reduced disclosure obligations regarding executive compensation; and |
| | |
| · | exemptions from the requirements of holding a nonbinding advisory vote on executive
compensation and stockholder approval of any golden parachute payments not previously approved. |
Additionally, under the JOBS
Act, an emerging growth company can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS
Act until such time as those standards apply to private companies. We irrevocably elected to avail ourselves of this exemption from new
or revised accounting standards, and, therefore, are not subject to the same new or revised accounting standards as public companies who
are not emerging growth companies. As a result, our consolidated financial statements may not be comparable to companies that comply with
new or revised accounting pronouncements as of public company effective dates. We intend to rely on other exemptions provided by the JOBS
Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley
Act.
We will remain an emerging
growth company until the earliest of (i) the last day of the fiscal year in which the market value of our Common Stock that is held by
non-affiliates exceeds $700.0 million as of June 30th of that fiscal year, (ii) the last day of the fiscal year in which we have total
annual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have issued
more than $1 billion in non-convertible debt in the prior three-year period, and (iv) the last day of the fiscal year following the fifth
anniversary of the date of the first sale of equity securities in our initial public offering (the “IPO”), or December 31,
2029.
We are also a “smaller
reporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer
an emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will
be able to take advantage of these scaled disclosures for so long as our voting and non-voting Common Stock held by non-affiliates is
less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million
during the most recently completed fiscal year and our voting and non-voting Common Stock held by non-affiliates is less than $700.0 million
measured on the last business day of our second fiscal quarter.
THE OFFERING
Common stock offered by the Selling Stockholders |
|
Up to 1,332,994 shares of Common Stock, which consists of (i) 666,497 shares of Common Stock, and (ii) 666,497 shares of Common Stock issuable upon the exercise of the Warrants. |
|
|
|
Shares of Common Stock outstanding prior to this offering |
|
20,470,504 shares of Common Stock. |
|
|
|
Shares of Common Stock outstanding immediately after giving effect to the issuance of the shares registered hereunder |
|
21,137,001 shares of Common Stock. |
|
|
|
Use of Proceeds |
|
We will not receive any of the proceeds from the sale of the Shares by the Selling Stockholders. However, upon any exercise of the Warrants, we will receive the exercise price of such Warrants. See the section titled “Use of Proceeds.” |
|
|
|
Risk Factors |
|
Investing in our Common Stock involves a high degree of risk. See the section titled “Risk
Factors” on page 8 of this prospectus and the section titled “Risk Factors” in the documents incorporated
by reference herein for a discussion of factors you should carefully consider before investing in our Common Stock. |
|
|
|
Nasdaq symbol for our Common Stock |
|
“ACTU” |
The number of shares of our Common Stock outstanding
prior to and to be outstanding immediately after this offering, as set forth in the table above, is based on 20,470,504 shares outstanding
as of June 30, 2025, and excludes:
| · | 1,774,477 shares of our Common Stock issuable upon the exercise of stock options outstanding as of June
30, 2025, at a weighted average exercise price of $6.49 per share; |
| | |
| · | 584,111 shares of our Common Stock issuable upon vesting of restricted stock units outstanding as of June
30, 2025; |
| | |
| · | 3,647,945 shares of Common Stock that remain reserved for issuance under the Committed Equity Facility
with B. Riley Principal Capital II; |
| | |
| · | 922,096 shares of Common Stock issuable upon the exercise of warrants outstanding as of June 30, 2025, at a weighted average exercise
price of $7.87 per share, however, of such shares subject to warrants, the 666,497 shares of Common Stock issuable upon exercise of the
Warrants at an exercise price of $7.00 per share are included in the number of shares of Common Stock outstanding immediately after giving
effect to the issuance of the shares registered hereunder; and |
| | |
| · | 2,311,841 shares of Common Stock reserved for future issuance under our 2024 Stock Incentive Plan (the
“2024 Plan”). |
RISK FACTORS
Investing in our Common
Stock is speculative and involves a high degree of risk. You should consider carefully the risks described below and in the “Risk
Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025, our
Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, each as updated or superseded
by the risks and uncertainties described under similar headings in other documents that are filed after the date hereof and incorporated
by reference into this prospectus together with all of the other information contained in this prospectus and incorporated by reference
herein, and any free writing prospectus that we may authorize for use in connection with this offering. If any of these risks occur, our
business, financial condition, results of operations and future growth prospects could be materially and adversely affected. Additionally,
these risks and uncertainties are not the only risks and uncertainties that we face. Additional risks and uncertainties not presently
known to us or that we currently deem immaterial also may impair our business operations. In these circumstances, the market price of
our Common Stock could decline, and you may lose all or part of your investment. This prospectus also contains forward-looking statements
that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements
as a result of a number of factors, including the risks described below and in the “Risk Factors” section of our Annual Report
on Form 10-K, our Quarterly Report on Form 10-Q and other documents incorporated by reference. See the section titled “Special Note Regarding Forward-Looking Statements.”
Risks Related to the Offering
Our financial condition raises substantial
doubt as to our ability to continue as a going concern.
As of March 31, 2025, we had
$3,889,405 in cash and cash equivalents and working capital deficit of $4,905,390. While we have received additional funding through the
Private Placement and the Committed Equity Facility, based on our current operating plan, we estimate that our existing cash and cash
equivalents as of the date hereof will not satisfy the Company’s operational and capital requirements for fiscal year 2025.
We have incurred and expect
to continue to incur significant costs in the development of our sole drug candidate, elraglusib. Our unaudited condensed consolidated
financial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business; however, our current liabilities exceeded our assets as
of March 31, 2025. To date, we have not generated product revenues from our activities and have incurred substantial operating losses.
We expect that we will continue to generate substantial operating losses for the foreseeable future, if and until, we are able to complete
development and potentially receive approval of our product candidate. We expect to continue to fund our operations primarily through
utilization of our current financial resources and we will require additional funding of capital in the near term.
These conditions raise substantial
doubt about our ability to continue as a going concern. Additionally, our independent registered public accounting firm included in its
audit opinion for the year ended December 31, 2024 an explanatory paragraph that there is substantial doubt as to our ability to continue
as a going concern. We plan to address these conditions by raising funds from public or private offerings of equity or debt securities
and other funding sources, which may include our Committed Equity Facility. However, there can be no assurance that such funding will
be available to us, or will be obtained on terms favorable to us or will provide us with sufficient funds to meet our objectives. Newly
issued securities may include preferences, superior voting rights, and the issuance of warrants or other convertible securities that
will have additional dilutive effects. Further, the sale of or the perception of the sale of a substantial number of our common stock
by selling securityholders pursuant to a registration statement filed with the SEC will adversely affect the price of our Common Stock
due to our limited trading volume. In addition, the sale of a substantial number of our Common Stock by such selling securityholders
will adversely affect the share price that we may obtain in future financings and may adversely affect our ability to conduct and complete
future financings.
We may incur substantial costs in pursuing future
capital and/or financing, including investment banking fees, legal fees, accounting fees, printing and distribution expenses and other
costs. We may also be required to recognize non-cash expenses in connection with certain securities we may issue, such as convertible
notes and warrants, which will adversely impact our financial condition and results of operations. Our ability to obtain needed financing
may be impacted by such factors as the weakness of capital markets, and the fact that we have not been profitable, which could impact
the availability and cost of future financings. If we are unable to raise capital in the near term or on commercially acceptable terms,
we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, or even
curtail or cease operations.
In addition, the reaction
of investors to the inclusion of a going concern statement by our auditors and our potential inability to continue as a going concern
may materially adversely affect our ability to raise new capital or enter into partnerships. The perception that we may not be able to
continue as a going concern may also make it more difficult to operate our business due to concerns about our ability to meet our contractual
obligations. If we become unable to continue as a going concern, we may have to liquidate our assets and the value we receive for our
assets in liquidation or dissolution could be significantly lower than the value reflected in our unaudited condensed consolidated financial
statements, and it is likely that investors would lose all or a part of their investment.
Investors who buy shares at different times
will likely pay different prices.
The Selling Stockholders may
resell all, some or none of the Shares at any time or from time to time in their discretion and at different prices. As a result, investors
who purchase shares from the Selling Stockholders in this offering at different times will likely pay different prices for those shares,
and so may experience different levels of dilution, and in some cases substantial dilution, and different outcomes in their investment
results. Investors may experience a decline in the value of the shares they purchase from the Selling Stockholders in this offering as
a result of future sales made by us at prices lower than the prices such investors paid for their shares in this offering.
Sales of a substantial number of our securities
in the public market by our existing stockholders could cause the price of our shares of Common Stock to fall.
The Selling Stockholders can
resell, under this prospectus, up to 1,332,994 shares of Common Stock, which consists of (i) 666,497 shares of Common Stock, and (ii)
666,497 shares of Common Stock issuable upon the exercise of the Warrants. Sales of a substantial number of our shares of Common Stock
in the public market by the Selling Stockholders and/or by our other existing stockholders, or the perception that those sales might occur,
could depress the market price of our shares of Common Stock and could impair our ability to raise capital through the sale of additional
equity securities.
Our management team has broad discretion
over the use of any proceeds received pursuant to the exercise of the Warrants and you may not agree with how we use the proceeds and
the proceeds may not be invested successfully.
We will not receive any of
the proceeds from the sale of the Warrant Shares, if any, by the Selling Stockholders pursuant to this prospectus. We may receive up to
approximately $4.7 million if all Warrants are exercised in full, based on the per share exercise price of $7.00 for the Warrants. Our
management team will have broad discretion as to the use of the net proceeds from the exercise of the Warrants, if any, and we could use
such proceeds for purposes other than those contemplated at the time of this prospectus. Accordingly, you will be relying on the judgment
of our management team with regard to the use of those net proceeds, and you will not have the opportunity, as part of your investment
decision, to assess whether the proceeds are being used appropriately. It is possible that, pending their use, we may invest those net
proceeds in a way that does not yield a favorable, or any, return for us. The failure of our management team to use such funds effectively
could have a material adverse effect on our business, financial condition, operating results, and cash flows.
USE OF PROCEEDS
We will not receive any of
the proceeds from the sale or other disposition of the Shares by the Selling Stockholders pursuant to this prospectus. However, we may
receive proceeds in the aggregate of up to approximately $4.7 million if all of the Warrants in this offering are exercised. We cannot
predict when, or if, the Warrants will be exercised. It is possible that the Warrants may expire and may never be exercised.
We intend to use any proceeds
from the exercise of the Warrants for working capital and general corporate purposes. As of the date of this prospectus, we cannot specify
with certainty all of the particular uses, and the respective amounts we may allocate to those uses, for any net proceeds we receive.
Accordingly, we will retain broad discretion over the use of these proceeds.
MARKET INFORMATION FOR SECURITIES AND DIVIDEND
POLICY
Market Information
Our Common Stock is currently
listed on the Nasdaq Global Market under the symbol “ACTU.”
As of June 30, 2025, there
were 20,470,504 shares of our Common Stock outstanding, held of record by 103 stockholders. Because many of our shares of common stock
are held by brokers and other institutions on behalf of stockholders, this number is not indicative of the total number of stockholders
represented by these stockholders of record.
Dividend Policy
We have not declared or paid
any cash dividends on our Common Stock to date. We may retain future earnings, if any, for future operations, expansion and debt repayment
and have no current plans to pay cash dividends for the foreseeable future. Any decision to declare and pay dividends in the future will
be made at the discretion of our board of directors and will depend on, among other things, our results of operations, financial condition,
cash requirements, contractual restrictions and other factors that the board may deem relevant and subject to applicable laws and the
restrictions contained in any future financing instruments. We do not anticipate declaring any cash dividends to holders of the Common
Stock in the foreseeable future.
SELLING STOCKHOLDER
This prospectus relates to
the resale from time to time of: (i) 666,497 shares of Common Stock, and (ii) 666,497 shares of Common Stock issuable upon the exercise
of the Warrants pursuant to this prospectus and any accompanying prospectus supplement. We are registering the shares of our Common Stock
included in this prospectus pursuant to the provisions of the Registration Rights Agreement we entered into with the Selling Stockholders
on June 25, 2025 in order to permit the Selling Stockholders to offer the shares included in this prospectus for resale from time to time.
When we refer to the “Selling
Stockholders” in this prospectus, we mean the persons listed in the table below, and the pledgees, donees, transferees, assignees,
successors, designees and others who later come to hold any of the Selling Stockholders’ interest in the Common Stock other than
through a public sale. The following table sets forth, as of June 30, 2025, the names of the Selling Stockholders, and other information
regarding the beneficial ownership (as determined under Section 13(d) of the Exchange Act of 1934, as amended, and the rules and regulations
thereunder) of the shares of Common Stock held by each of the Selling Stockholders, as of the date of this prospectus, assuming exercise
of all Warrants held by each such Selling Stockholder on that date. The third column lists the aggregate number of shares of Common Stock
that the Selling Stockholders may offer pursuant to this prospectus.
Name of Selling Stockholder(1) | |
Number of securities Owned Prior to Offering | | |
Maximum Number of shares of Common Stock to be Sold Pursuant to this Prospectus (3) | | |
Number of shares of Common Stock Owned After Offering | |
| |
Number | | |
Percent (2) | | |
| | |
Number | | |
Percent | |
GROW Small Cap Equity Long Short L.P. (4) | |
| 857,142 | | |
| 4.10% | | |
| 857,142 | | |
| 0 | | |
| – | |
3i, LP (5) | |
| 142,856 | | |
| * | | |
| 142,856 | | |
| 0 | | |
| – | |
Bios Equity Affiliated Funds (6) | |
| 10,191,259 | | |
| 49.62% | | |
| 142,856 | | |
| 10,048,403 | | |
| 48.92% | |
Laurence Lytton (7) | |
| 73,428 | | |
| * | | |
| 71,428 | | |
| 2,000 | | |
| * | |
Matthew Tiampo (8)(9) | |
| 85,712 | | |
| * | | |
| 85,712 | | |
| 0 | | |
| – | |
Off-Piste Fund LP (9) | |
| 28,570 | | |
| * | | |
| 28,570 | | |
| 0 | | |
| – | |
Thomas O’Halloran (10) | |
| 48,267 | | |
| * | | |
| 29,000 | | |
| 19,267 | | |
| * | |
Victor O’Halloran (11) | |
| 4,000 | | |
| * | | |
| 4,000 | | |
| 0 | | |
| – | |
________________
| * Represents beneficial ownership
of less than 1.0% of the outstanding shares of our Common Stock. |
| | |
| (1) | Unless otherwise specified below, the business address of each person is: c/o Actuate Therapeutics, Inc.,
1751 River Run, Suite 400, Fort Worth, Texas 76107. |
| | |
| (2) | Applicable percentage ownership is based on 20,470,504 shares of our Common Stock outstanding as of June
30, 2025. |
| | |
| (3) | Assumes the sale of all shares of our Common Stock being offered for resale pursuant to this prospectus. |
| (4) | The business address of GROW Small Cap Equity Long Short L.P. is 4275 Executive Square, Suite 335, La
Jolla, CA 92037. Includes 428,571 shares of Common Stock issuable upon the exercise of Warrants held by GROW Small Cap Equity Long Short
L.P. Carl Wiese is the Manager of Grow Small Cap Equity Long Short L.P. |
| | |
| (5) | The business address of 3i, LP is
2 Wooster Street, 2nd Floor, New York, NY 10013. Includes 71,428 shares of Common Stock issuable upon the exercise of Warrants held by
3i, LP. 3i Management LLC is the general partner of 3i, LP, and Maier Joshua Tarlow is the manager of 3i Management LLC. As such, Mr.
Tarlow exercises sole voting and investment discretion over securities beneficially owned directly or indirectly by 3i, LP and 3i Management
LLC. Mr. Tarlow disclaims beneficial ownership of the securities beneficially owned directly by 3i, LP and indirectly by 3i Management
LLC. |
| | |
| (6) | The business address of Bios Equity Affiliated Funds (as defined below) is 1751 River Run, Suite
400, Fort Worth, Texas 76107. Includes (i) 300,749 shares of common stock held by Bios Actuate Co-Invest I, LP, (ii) 2,094,650
shares of common stock held by Bios Actuate Co-Invest II, LP, (iii) 573,394 shares of common stock held by Bios Actuate Co-Invest
III, LP, (iv) 307,538 shares of common stock held by Bios Fund I QP, LP, (v) 525,797 shares of common stock held by Bios Fund I, LP,
(vi) 131,248 shares of common stock and 3,528 shares of common stock issuable upon the exercise of warrants held by Bios Fund II NT,
LP, (vii) 980,433 shares of common stock and 26,355 shares of common stock issuable upon the exercise of warrants held by Bios Fund
II QP, LP, (viii) 300,143 shares of common stock and 8,068 shares of common stock issuable upon the exercise of warrants held by
Bios Fund II, LP, (ix) 404,814 shares of common stock held by Bios Fund III NT, LP, (x) 2,506,667 shares of common stock held by
Bios Fund III QP, LP, (xi) 383,791 shares of common stock held by Bios Fund III, LP, (xii) 84,917 shares of common stock and 31,884
shares of common stock underlying options that are or will be exercisable within 60 days held by BP Directors, LP, (xiii) 1,259,427
shares of common stock held by Bios Clinical Opportunity Fund, LP, and (xiv) 196,428 shares of common stock and 71,428 shares of
common stock issuable upon the exercise of warrants held by Bios 2024 Co-Invest, LP. Bios Equity Partners, LP is the general partner
of Bios Actuate Co-Invest I, LP; Bios Equity Partners III, LP is the general partner of Bios Actuate Co-Invest II, LP, Bios Actuate
Co-Invest III, LP, Bios Fund III NT, LP, Bios Fund III QP, LP, Bios Fund III, LP; Bios Equity Partners, LP is the general partner of
Bios Fund I QP, LP and Bios Fund I, LP; Bios Equity Partners II, LP is the general partner of Bios Fund II NT, LP, Bios Fund II QP,
LP and Bios Fund II, LP; Dr. Fletcher and Leslie W. Kreis, Jr. are the general partners of BP Directors, LP; and Bios Equity COF, LP
is the general partner of Bios Clinical Opportunity Fund, LP (collectively, the “Bios Equity Affiliated Funds”). Cavu
Management, LP, an entity managed and controlled by Mr. Kreis, Jr., and Bios Capital Management, LP, an entity managed and
controlled by Dr. Fletcher (“Bios Capital Management, LP”), are the general partners of Bios Equity Partners, LP, Bios
Equity Partners II, LP and Bios Equity Partners III, LP. Bios Capital Management, LP is the general partner of Bios Equity COF, LP.
Cavu Advisors LLC, an entity that is managed and controlled by Mr. Kreis, Jr., is the general partner of Cavu Management LP. Bios
Advisors GP, LLC, an entity that is managed and controlled by Dr. Fletcher, is the general partner of Bios Capital Management, LP.
The shares owned by Bios Equity Affiliated Funds are aggregated for purposes of reporting share ownership information. Mr. Kreis,
Jr. and Dr. Fletcher share voting and investment control with respect to shares held by the Bios Equity Affiliated Funds. Dr.
Fletcher is the Chairman of the Company’s Board of Directors. |
| | |
| (7) | Includes 35,714 shares of Common Stock issuable upon the exercise of Warrants held by Laurence Lytton. |
| | |
| (8) | Includes 28,571 shares of Common Stock issuable upon the exercise of Warrants held by Matthew Tiampo. |
| | |
| (9) | The business address for the Off-Piste Fund LP is 200 S. Virginia Street, 8th Floor,
Reno, Nevada 89501. Includes 14,285 shares of Common Stock issuable upon the exercise of Warrants held by Off-Piste Fund LP. Matthew
Tiampo is the portfolio manager of the Off-Piste Fund LP. Matthew Tiampo exercises voting and investment discretion over securities
held by Off-Piste Fund LP. |
| | |
| (10) | Includes 14,500 shares of Common Stock issuable upon the exercise of Warrants held by Thomas O’Halloran. |
| | |
| (11) | Includes 2,000 shares of Common Stock issuable upon the exercise of Warrants held by Victor O’Halloran. |
DESCRIPTION OF CAPITAL STOCK
General
The following description
summarizes some of the terms of our amended and restated certificate of incorporation and our amended and restated bylaws, and of the
Delaware General Corporation Law. Because it is only a summary, it does not contain all the information that may be important to you.
For a complete description, you should refer to our amended and restated certificate of incorporation, amended and restated bylaws, copies
of which have been filed as exhibits to the registration statement of which this prospectus is part.
Our authorized capital stock
consists of 200,000,000 shares of Common Stock, par value of $0.000001 per share, and 10,000,000 shares of preferred stock, par value
$0.000001 per share.
Common Stock
Voting Rights
Holders of our Common Stock
are entitled to one vote for each share held on all matters submitted to a vote of stockholders, including the election of directors,
and do not have cumulative voting rights. Accordingly, the holders of a majority of the outstanding shares of Common Stock entitled to
vote in any election of directors can elect all of the directors standing for election, if they so choose, other than any directors that
holders of any preferred stock we may issue may be entitled to elect. Subject to the supermajority votes for some matters, other matters
shall be decided by the affirmative vote of our stockholders having a majority in voting power of the votes cast by the stockholders present
or represented and voting on such matter. Our amended and restated certificate of incorporation also provides that our directors may be
removed only for cause and only by the affirmative vote of the holders of at least two-thirds in voting power of the outstanding shares
of capital stock entitled to vote thereon. In addition, the affirmative vote of the holders of at least two-thirds in voting power of
the outstanding shares of capital stock entitled to vote thereon is required to amend or repeal, or to adopt any provision inconsistent
with, several of the provisions of our amended and restated certificate of incorporation. See the subsection titled “-Certain
Anti-Takeover Effects of Delaware Law” and “-Amendment of Charter Provisions” below.
Dividends
Subject to preferences that
may apply to any outstanding preferred stock, the holders of our Common Stock are entitled to receive dividends, if and when declared
by our board of directors, out of funds legally available therefor.
Liquidation
In the event of a liquidation,
dissolution or winding up, our stockholders will be entitled to share ratably in all assets remaining available for distribution to them
after payment of liabilities and after provision is made for each class of stock, if any, having preference over the Common Stock.
Rights, Preferences and Privileges
Holders of our Common Stock
have no conversion, preemptive or other subscription rights, and there are no sinking fund or redemption provisions applicable to our
Common Stock. The rights, preferences and privileges of the holders of our Common Stock are subject to, and may be adversely affected
by, the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future.
Fully Paid and Nonassessable
All of our outstanding shares
of Common Stock are fully paid and nonassessable.
Preferred Stock
Our amended and restated certificate
grants our board of directors the authority, without further stockholder authorization, to issue from time to time up to 10,000,000 shares
of preferred stock in one or more series and to fix the terms, limitations, voting rights, relative rights and preferences and variations
of each series. Although we have no present plans to issue any shares of preferred stock, the issuance of shares of preferred stock, or
the issuance of rights to purchase such shares, could decrease the amount of earnings and assets available for distribution to the holders
of our Common Stock, could adversely affect the rights and powers, including voting rights, of the Common Stock and could have the effect
of delaying, deterring or preventing a change of control of our company or an unsolicited acquisition proposal.
Warrants
As of June 30, 2025, there
were outstanding warrants to purchase an aggregate of 922,096 shares of our Common Stock at a weighted average exercise price of $7.87
per share, including the Warrants issued in the Private Placement.
Private Placement Warrants
The Warrants to purchase of
up to 666,497 shares of Common Stock were issued pursuant to the Securities Purchase Agreement, at an exercise price of $7.00 per share
of Common Stock, subject to adjustment as forth in the Warrants. The Warrants will be exercisable on a cash only basis at any time after
the date of issuance and expire 20 days following the Milestone Date for additional proceeds to the Company of up to approximately $4.7
million if all Warrants are exercised in full. The registration statement of which this prospectus forms a part registers the Warrant
Shares issuable upon exercise of the Warrants.
Equity Awards
As of June 30, 2025, there
were 1,774,477 stock options outstanding, which have a weighted average exercise price of approximately $6.49 per share, and 584,111 unvested
RSUs outstanding under the 2024 Plan.
Registration Rights
Certain holders of shares
of our Common Stock are entitled to certain rights with respect to registration of such shares under the Securities Act under the investor
rights agreement entered into in connection with the purchase of our preferred stock that converted into Common Stock upon our IPO.
The Company entered into a
registration rights agreement with B. Riley with respect to the resale of any shares sold under the Committed Equity Facility (the “B.
Riley Registration Rights Agreement”).
The Selling Stockholders entered
into the Registration Rights Agreement, providing for the registration of their Shares as set forth in this registration statement.
Copies of the Investor Rights
Agreement, the B. Riley Registration Rights Agreement and the Registration Rights Agreement are incorporated by reference as exhibits
to the registration statement of which this prospectus forms a part.
Certain Anti-Takeover Provisions of Delaware
Law
Some provisions of Delaware
law, our amended and restated certificate of incorporation and our amended and restated bylaws contain provisions that could make the
following transactions more difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contest
or otherwise; or the removal of our incumbent officers and directors. It is possible that these provisions could make it more difficult
to accomplish or could deter transactions that stockholders may otherwise consider to be in their best interest or in our best interests,
including transactions that provide for payment of a premium over the market price for our shares.
These provisions, summarized
below, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encourage
persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of the increased
protection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure
us outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement of
their terms.
Undesignated Preferred Stock
The ability of our board of
directors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock with voting or other rights
or preferences as designated by our board of directors could impede the success of any attempt to change control of us. These and other
provisions may have the effect of deferring hostile takeovers or delaying changes in control or management of our company.
Stockholder Meetings
Our amended and restated certificate
of incorporation and our amended and restated bylaws provide that a special meeting of stockholders may be called only by our board of
directors, chairman of the board of directors, chief executive officer or president, or by a resolution adopted by a majority of our board
of directors.
Requirements for Advance Notification of
Stockholder Nominations and Proposals
Our amended and restated bylaws
establish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nomination
of candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee of
the board of directors.
Elimination of Stockholder Action by Written
Consent
Our amended and restated certificate
of incorporation eliminates the right of stockholders to act by written consent without a meeting.
Staggered Board of Directors
Our amended and restated certificate
of incorporation provides that our board of directors will be divided into three classes. The directors in each class serve for a three-year
term, with one class being elected each year by our stockholders. This system of electing directors may tend to discourage a third party
from attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.
Removal of Directors
Our amended and restated certificate
of incorporation provides that no member of our board of directors may be removed from office except for cause and, in addition to any
other vote required by law, upon the approval of not less than two thirds of the total voting power of all of our outstanding voting stock
then entitled to vote in the election of directors.
Stockholders Not Entitled to Cumulative
Voting
Our amended and restated certificate
of incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, the holders of a majority
of the outstanding shares of our Common Stock entitled to vote in any election of directors can elect all of the directors standing for
election, if they choose, other than any directors that holders of our preferred stock may be entitled to elect.
Delaware Anti-Takeover Statute
We are subject to Section
203 of the Delaware General Corporation Law, which prohibits persons deemed to be “interested stockholders” from engaging
in a “business combination” with a publicly held Delaware corporation for three years following the date these persons become
interested stockholders unless the business combination is, or the transaction in which the person became an interested stockholder was,
approved in a prescribed manner or another prescribed exception applies. Generally, an “interested stockholder” is a person
who, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder status
did own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset or
stock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may have
an anti-takeover effect with respect to transactions not approved in advance by the board of directors.
Choice of Forum
Our amended and restated certificate
of incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State
of Delaware (the Court of Chancery) (or, in the event the Court of Chancery does not have jurisdiction, the federal district court for
the District of Delaware or other state courts of the State of Delaware) will be the sole and exclusive forum for the following types
of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii)
any action asserting a claim of breach of a fiduciary duty by any of our directors, officers or stockholders to us or our stockholders;
(iii) any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law or our amended
and restated certificate of incorporation or amended and restated bylaws; or (iv) any action asserting a claim governed by the internal
affairs doctrine, in all cases to the fullest extent permitted by law. The provision would not apply to suits brought to enforce a duty
or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Furthermore, our
amended and restated certificate of incorporation also provides that unless we consent in writing to the selection of an alternative forum,
the federal district courts of the United States shall be the exclusive forum for the resolution of any complaint asserting a cause of
action arising under the Securities Act, including all causes of action asserted against any defendant to such complaint. For the avoidance
of doubt, this provision is intended to benefit and may be enforced by us, our officers and directors, the underwriters to any offering
giving rise to such complaint, and any other professional entity whose profession gives authority to a statement made by that person or
entity and who has prepared or certified any part of the documents underlying the offering. In any case, stockholders will not be deemed
to have waived our compliance with the federal securities laws and the rules and regulations thereunder. The enforceability of similar
choice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it is
possible that a court could find these types of provisions to be inapplicable or unenforceable. Our amended and restated certificate of
incorporation also provides that any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock will
be deemed to have notice of and to have consented to this choice of forum provision.
Amendment of Charter Provisions
The amendment of any of the
above provisions, except for the provision making it possible for our board of directors to issue preferred stock, would require approval
by holders of at least two thirds of the total voting power of all of our outstanding voting stock.
The provisions of Delaware
law, our amended and restated certificate of incorporation and our amended and restated bylaws could have the effect of discouraging others
from attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our Common
Stock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changes
in the composition of our board of directors and management. It is possible that these provisions could make it more difficult to accomplish
transactions that stockholders may otherwise deem to be in their best interests.
Transfer Agent
The transfer agent and registrar
for our Common Stock is Broadridge Corporate Issuer Solutions, LLC. The transfer agent’s address is 51 Mercedes Way, Edgewood, NY
11717.
Listing
Our Common Stock is listed
on the Nasdaq Global Market under the trading symbol “ACTU.”
SECURITIES ACT RESTRICTIONS ON RESALE OF SECURITIES
Rule 144
A person who has beneficially
owned restricted Common Stock for at least six months would be entitled to sell such securities, provided that (i) such person is not
deemed to have been one of our affiliates at the time of, or at any time during the three months preceding, a sale and (ii) we are subject
to the Exchange Act periodic reporting requirements for at least three months before the sale and have filed all required reports under
Section 13 or 15(d) of the Exchange Act during the 12 months (or such shorter period as we have been required to file reports) preceding
the sale.
Persons who have beneficially
owned restricted Common Stock for at least six months but who are our affiliates at the time of, or any time during the three months preceding,
a sale, would be subject to additional restrictions, by which such person would be entitled to sell within any three month period only
a number of securities that does not exceed the greater of either of the following:
| · | 1% of the then outstanding shares of Common Stock; or |
| | |
| · | the average weekly trading volume of Common Stock, as applicable, during the four calendar weeks preceding the date on which notice
of the sale is filed with the SEC. |
Sales by our affiliates under
Rule 144 are also subject to certain requirements relating to manner of sale, notice and the availability of current public information
about us.
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES
TO NON-U.S. HOLDERS
The following is a summary
of the material U.S. federal income tax consequences to non-U.S. holders (as defined below) of the acquisition, ownership and disposition
of our Common Stock. This discussion is not a complete analysis of all potential U.S. federal income tax consequences relating thereto,
does not address the potential application of the Medicare contribution tax on net investment income, and does not address any estate
or gift tax consequences or any tax consequences arising under any state, local or foreign tax laws, or any other U.S. federal tax laws.
This discussion is based on the Internal Revenue Code of 1986, as amended (the Code), and applicable Treasury Regulations promulgated
thereunder, judicial decisions and published rulings and administrative pronouncements of the Internal Revenue Service (IRS), all as in
effect as of the date hereof. These authorities are subject to differing interpretations and may change, possibly retroactively, resulting
in U.S. federal income tax consequences different from those discussed below. We have not requested a ruling from the IRS with respect
to the statements made and the conclusions reached in the following summary, and there can be no assurance that the IRS or a court will
agree with such statements and conclusions.
This discussion is limited
to non-U.S. holders who purchase our Common Stock and who hold our Common Stock as a “capital asset” within the meaning of
Section 1221 of the Code (generally, property held for investment). This discussion does not address all of the U.S. federal income tax
consequences that may be relevant to a particular holder in light of such holder’s circumstances. This discussion also does not
consider any specific facts or circumstances that may be relevant to holders subject to special rules under the U.S. federal income tax
laws, including:
| · | certain former citizens or long-term residents of the United States; |
| | |
| · | partnerships or other pass-through entities (and investors therein); |
| | |
| · | “controlled foreign corporations;” |
| | |
| · | “passive foreign investment companies;” |
| | |
| · | corporations that accumulate earnings to avoid U.S. federal income tax; |
| | |
| · | banks, financial institutions, investment funds, insurance companies, brokers, dealers or traders in securities; |
| | |
| · | tax-exempt organizations and governmental organizations; |
| | |
| · | tax-qualified retirement plans; |
| | |
| · | “qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities
all of the interests of which are held by qualified foreign pension funds; |
| | |
| · | persons subject to the alternative minimum tax; |
| | |
| · | persons that own, or have owned, actually or constructively, more than 5% of our Common Stock at any time; |
| | |
| · | accrual-method taxpayers subject to special tax accounting rules under Section 451(b) of the Code; and |
| | |
| · | persons holding our Common Stock as part of a hedging or conversion transaction, straddle, synthetic security,
constructive sale, or other risk reduction strategy or integrated investment. |
If an entity or arrangement
that is classified as a partnership for U.S. federal income tax purposes holds our Common Stock, the U.S. federal income tax treatment
of a partner in the partnership will generally depend on the status of the partner, the activities of the partnership and certain determinations
made at the partner level. Partnerships holding our Common Stock and the partners in such partnerships are urged to consult their tax
advisors about the particular U.S. federal income tax consequences to them of holding and disposing of our Common Stock.
THIS DISCUSSION IS FOR INFORMATIONAL
PURPOSES ONLY AND IS NOT TAX ADVICE. PROSPECTIVE INVESTORS SHOULD CONSULT THEIR TAX ADVISORS REGARDING THE PARTICULAR U.S. FEDERAL INCOME
TAX CONSEQUENCES TO THEM OF ACQUIRING, OWNING AND DISPOSING OF OUR COMMON STOCK, AS WELL AS ANY TAX CONSEQUENCES ARISING UNDER ANY STATE,
LOCAL OR FOREIGN TAX LAWS AND ANY OTHER U.S. FEDERAL TAX LAWS.
Definition of Non-U.S. Holder
For purposes of this discussion,
a non-U.S. holder is any beneficial owner of our Common Stock that is not a “U.S. person” or a partnership (including any
entity or arrangement treated as a partnership) for U.S. federal income tax purposes. A U.S. person is any person that, for U.S. federal
income tax purposes, is or is treated as any of the following:
| · | an individual who is a citizen or resident of the United States; |
| | |
| · | a corporation (or entity treated as a corporation for U.S. federal income tax purposes) created or organized
in or under the laws of the United States, any state thereof or the District of Columbia; |
| | |
| · | an estate, the income of which is subject to U.S. federal income tax regardless of its source; or |
| | |
| · | a trust (i) whose administration is subject to the primary supervision of a U.S. court and which has one
or more U.S. persons who have the authority to control all substantial decisions of the trust or (ii) that has a valid election in effect
under applicable Treasury Regulations to be treated as a U.S. person. |
Distributions on Common Stock
We have never declared or
paid any cash dividends on our capital stock and we do not currently intend to pay any cash dividends on our capital stock in the foreseeable
future. However, if we do make cash or other property distributions on our Common Stock, such distributions will constitute dividends
for U.S. federal income tax purposes to the extent paid from our current or accumulated earnings and profits, as determined under U.S.
federal income tax principles. Amounts not treated as dividends for U.S. federal income tax purposes will constitute a return of capital
and will first be applied against and reduce a holder’s tax basis in our Common Stock, but not below zero. Any excess will be treated
as gain realized on the sale or other disposition of our Common Stock and will be treated as described under the section titled “Gain
on Disposition of Our Common Stock” below.
Subject to the discussions
below regarding effectively connected income, backup withholding and 1471 through 1474 of the Code (commonly referred to as FATCA), dividends
paid to a non-U.S. holder of our Common Stock generally will be subject to U.S. federal withholding tax at a rate of 30% of the gross
amount of the dividends or such lower rate specified by an applicable income tax treaty. To receive the benefit of a reduced treaty rate,
a non-U.S. holder must furnish us or our paying agent with a valid IRS Form W-8BEN or IRS Form W-8BEN-E (or applicable successor form)
and satisfy applicable certification and other requirements. This certification must be provided to us or our paying agent before the
payment of dividends and must be updated periodically. If the non-U.S. holder holds the stock through a financial institution or other
agent acting on the non-U.S. holder’s behalf, the non-U.S. holder will be required to provide appropriate documentation to the agent,
which then will be required to provide certification to us or our paying agent, either directly or through other intermediaries. Prospective
investors should consult their tax advisors concerning whether they may benefit from an applicable income tax treaty.
Non-U.S. holders that do not
provide the required certification on a timely basis, but that qualify for a reduced treaty rate, may obtain a refund of any excess amounts
withheld by timely filing an appropriate claim for refund with the IRS.
If a non-U.S. holder holds
our Common Stock in connection with the conduct of a trade or business in the United States, and dividends paid on our Common Stock are
effectively connected with such holder’s U.S. trade or business (and are attributable to such holder’s permanent establishment
in the United States if required by an applicable tax treaty), the non-U.S. holder will be exempt from U.S. federal withholding tax. To
claim the exemption, the non-U.S. holder must generally furnish a valid IRS Form W-8ECI (or applicable successor form) to the applicable
withholding agent.
However, any such effectively
connected dividends paid on our Common Stock generally will be subject to U.S. federal income tax on a net income basis at the regular
U.S. federal income tax rates in the same manner as if such holder were a resident of the United States. A non-U.S. holder that is a foreign
corporation also may be subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income
tax treaty) of its effectively connected earnings and profits for the taxable year, as adjusted for certain items. Non-U.S. holders should
consult their tax advisors regarding any applicable income tax treaties that may provide for different rules.
Gain on Disposition of Our Common Stock
Subject to the discussions
below regarding backup withholding and FATCA, a non-U.S. holder generally will not be subject to U.S. federal income tax on any gain realized
on the sale or other disposition of our Common Stock, unless:
| · | the gain is effectively connected with the non-U.S. holder’s conduct of a trade or business in the
United States, and if required by an applicable income tax treaty, is attributable to a permanent establishment maintained by the non-U.S.
holder in the United States; |
| | |
| · | the non-U.S. holder is a nonresident alien individual present in the United States for 183 days or more
during the taxable year of the disposition, and certain other requirements are met; or |
| | |
| · | our Common Stock constitutes a “United States real property interest” by reason of our status
as a United States real property holding corporation (USRPHC) for U.S. federal income tax purposes at any time within the shorter of the
five-year period preceding the disposition or the non-U.S. holder’s holding period for our Common Stock, and our Common Stock is
not “regularly traded” on an established securities market (as defined by applicable Treasury Regulations). |
Determining whether we are
a USRPHC depends on the fair market value of our U.S. real property interests relative to the fair market value of our other trade or
business assets and our foreign real property interests. We believe that we are not currently and do not anticipate becoming a USRPHC
for U.S. federal income tax purposes, although there can be no assurance we will not in the future become a USRPHC. If we are or become
a USRPHC and the “regularly traded” exception noted above does not apply to the disposition, a non-U.S. holder will generally
be taxed on any gain in the same manner as gain that is effectively connected with the conduct of a U.S. trade or business, except that
the branch profits tax generally will not apply. Prospective investors are encouraged to consult their own tax advisors regarding the
possible consequences to them if we are, or were to become, a USRPHC.
Gain described in the first
bullet point above generally will be subject to U.S. federal income tax on a net income basis at the regular U.S. federal income tax rates
in the same manner as if such holder were a resident of the United States. A non-U.S. holder that is a foreign corporation also may be
subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of its effectively
connected earnings and profits for the taxable year, as adjusted for certain items. A non-U.S. holder described in the second bullet point
above will be subject to U.S. federal income tax at a flat 30% rate (or such lower rate specified by an applicable income tax treaty)
on gain realized upon the sale or other taxable disposition of our Common Stock, but may be offset by certain U.S.-source capital losses
(even though the individual is not considered a resident of the United States), provided that the non-U.S. holder has timely filed U.S.
federal income tax returns with respect to such losses. Non-U.S. holders should consult their tax advisors regarding any applicable income
tax treaties that may provide for different rules.
Information Reporting and Backup Withholding
Annual reports are required
to be filed with the IRS and provided to each non-U.S. holder indicating the amount of distributions on our Common Stock paid to such
holder and the amount of any tax withheld with respect to those distributions. These information reporting requirements apply even if
no withholding was required because the distributions were effectively connected with the holder’s conduct of a U.S. trade or business,
or withholding was reduced or eliminated by an applicable income tax treaty. This information also may be made available under a specific
treaty or agreement with the tax authorities in the country in which the non-U.S. holder resides or is established. Backup withholding,
currently at a 24% rate, generally will not apply to payments to a non-U.S. holder of dividends on or the gross proceeds of a disposition
of our Common Stock provided the non-U.S. holder furnishes the required certification for its non-U.S. status, such as by providing a
valid IRS Form W-8BEN, W-8BEN-E or W-8ECI, or certain other requirements are met. Backup withholding may apply if the payor has actual
knowledge, or reason to know, that the holder is a U.S. person.
Backup withholding is not
an additional tax. If any amount is withheld under the backup withholding rules, the non-U.S. holder should consult with a U.S. tax advisor
regarding the possibility of and procedure for obtaining a refund or a credit against the non-U.S. holder’s U.S. federal income
tax liability, if any.
Withholding on Foreign Entities
FATCA imposes a U.S. federal
withholding tax of 30% on certain payments made to a “foreign financial institution” (as specially defined under these rules)
unless such institution enters into an agreement with the U.S. government to withhold on certain payments and to collect and provide to
the U.S. tax authorities certain information regarding certain U.S. account holders of such institution (which includes certain equity
and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners) or an exemption applies.
FATCA also generally imposes a U.S. federal withholding tax of 30% on certain payments made to a non-financial foreign entity unless such
entity provides the withholding agent a certification identifying certain direct and indirect U.S. owners of the entity or an exemption
applies. An intergovernmental agreement between the United States and an applicable foreign country may modify these requirements. FATCA
currently applies to dividends paid on our Common Stock. Under certain circumstances, a non-U.S. holder might be eligible for refunds
or credits of such taxes.
Prospective investors are
encouraged to consult with their own tax advisors regarding the potential implications of FATCA on their investment in our Common Stock.
The preceding discussion
of U.S. federal tax considerations is for general information only. It is not tax advice. Each prospective investor should consult its
tax advisor regarding the particular U.S. federal, state and local and non-U.S. tax consequences of purchasing, holding and disposing
of our Common Stock, including the consequences of any proposed change in applicable laws.
PLAN OF DISTRIBUTION
The Selling Stockholders,
which as used herein includes donees, pledgees, transferees or other successors-in-interest selling shares of Common Stock or interests
in shares of Common Stock received after the date of this prospectus from a Selling Stockholder as a gift, pledge, partnership distribution
or other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of Common Stock or interests
in shares of Common Stock on any stock exchange, market or trading facility on which the shares are traded or in private transactions.
These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market
price, at varying prices determined at the time of sale, or at negotiated prices.
The Selling Stockholders may
use any one or more of the following methods when disposing of shares or interests therein:
| · | distributions to members, partners, stockholders or other equity holders of the Selling Stockholders; |
| | |
| · | ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
| | |
| · | block trades in which the broker-dealer will attempt to sell the shares as agent, but may position and resell a portion of the block
as principal to facilitate the transaction; |
| | |
| · | purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
| | |
| · | an exchange distribution in accordance with the rules of the applicable exchange; |
| | |
| · | privately negotiated transactions; |
| | |
| · | short sales and settlement of short sales entered into after the effective date of the registration statement of which this prospectus
is a part; |
| | |
| · | through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise; |
| | |
| · | broker-dealers may agree with the Selling Stockholders to sell a specified number of such shares at a stipulated price per share; |
| | |
| · | a combination of any such methods of sale; and |
| | |
| · | any other method permitted pursuant to applicable law. |
The Selling Stockholders may,
from time to time, pledge or grant a security interest in some or all of the shares of Common Stock owned by them and, if they default
in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of Common Stock, from time
to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities
Act, amending the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as Selling Stockholders
under this prospectus. The Selling Stockholders also may transfer the shares of Common Stock in other circumstances, in which case the
transferees, pledgees or other successors in interest will be the Selling Stockholders for purposes of this prospectus.
In connection with the sale
of our Common Stock or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial
institutions, which may in turn engage in short sales of the Common Stock in the course of hedging the positions they assume. The Selling
Stockholders may also sell shares of our Common Stock short and deliver these securities to close out their short positions, or loan or
pledge the Common Stock to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into option
or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require
the delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The aggregate proceeds to
the Selling Stockholders from the sale of the Common Stock offered by them will be the purchase price of the Common Stock less discounts
or commissions, if any. Each of the Selling Stockholders reserves the right to accept and, together with their agents from time to time,
to reject, in whole or in part, any proposed purchase of Common Stock to be made directly or through agents. We will not receive any of
the proceeds from this offering. Upon any exercise of the Warrants, however, we will receive the exercise price of the Warrants.
The Selling Stockholders also
may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided that
they meet the criteria and conform to the requirements of that rule, or another available exemption from the registration requirements
under the Securities Act.
The Selling Stockholders and
any underwriters, broker-dealers or agents that participate in the sale of the Common Stock or interests therein may be “underwriters”
within the meaning of Section 2(a)(11) of the Securities Act (it being understood that the Selling Stockholders shall not be deemed to
be underwriters solely as a result of their participation in this offering). Any discounts, commissions, concessions or profit they earn
on any resale of the shares may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters”
within the meaning of Section 2(a)(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities
Act.
To the extent required, the
shares of our Common Stock to be sold, the names of the Selling Stockholders, the respective purchase prices and public offering prices,
the names of any agent, dealer or underwriter, and any applicable commissions or discounts with respect to a particular offer will be
set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes
this prospectus.
In order to comply with the
securities laws of some states, if applicable, the Common Stock may be sold in these jurisdictions only through registered or licensed
brokers or dealers. In addition, in some states the Common Stock may not be sold unless it has been registered or qualified for sale or
an exemption from registration or qualification requirements is available and is complied with.
We have advised the Selling
Stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to
the activities of the Selling Stockholders and their affiliates. In addition, to the extent applicable, we will make copies of this prospectus
(as it may be supplemented or amended from time to time) available to the Selling Stockholders for the purpose of satisfying the prospectus
delivery requirements of the Securities Act. The Selling Stockholders may indemnify any broker-dealer that participates in transactions
involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.
We have agreed to indemnify
the Selling Stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to the
registration of the shares offered by this prospectus.
We have agreed with the Selling
Stockholders to use commercially reasonable efforts to cause the registration statement of which this prospectus constitutes a part to
become effective and to remain continuously effective until the earlier of: (i) the date on which the Selling Stockholders shall have
resold or otherwise disposed of all the shares covered by this prospectus and (ii) the date on which the shares covered by this prospectus
no longer constitute “Registrable Securities” as such term is defined in the Registration Rights Agreement, such that they
may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations and without
current public information pursuant to Rule 144 under the Securities Act or any other rule of similar effect.
LEGAL MATTERS
The validity of the securities
offered by this prospectus will be passed upon for us by Baker & Hostetler LLP, Cleveland, Ohio.
EXPERTS
The consolidated financial
statements of Actuate Therapeutics, Inc. as of December 31, 2024 and for the year then ended incorporated in this Prospectus by reference
to the Annual Report on Form 10-K for the year ended December 31, 2024 have been so incorporated in reliance on the report of Crowe LLP,
independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
The consolidated financial
statements of Actuate Therapeutics, Inc. as of December 31, 2023 and for the year ended December 31, 2023 incorporated in this Prospectus
by reference to the Annual Report on Form 10-K for the year ended December 31, 2024 have been so incorporated in reliance on the report
of KMJ Corbin & Company LLP, independent registered public accounting firm, given on the authority of said firm as experts in auditing
and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC
a registration statement on Form S-1, including exhibits and schedules, under the Securities Act, with respect to the shares of Common
Stock being offered by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all of
the information in the registration statement and its exhibits. For further information with respect to us and the Common Stock offered
by this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus as to the contents
of any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of the
contract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects by
this reference.
You may read our SEC filings,
including this registration statement, over the Internet at the SEC’s website at www.sec.gov. Upon the closing of this offering,
we will be subject to the information reporting requirements of the Exchange Act and we will file reports, proxy statements and other
information with the SEC. These reports, proxy statements and other information will be available for review on the web site of the SEC
referred to above. We also maintain a website at www.actuatetherapeutics.com, at which, following the completion of this offering, you
may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to,
the SEC. Information contained on or accessible through our website is not a part of this prospectus or the registration statement of
which it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to “incorporate
by reference” certain of the information that we file with it after the date of the filing of the registration statement of which
this prospectus forms a part, which means that we can disclose important information to you by referring you to the documents containing
that information. The information incorporated by reference is considered to be part of this prospectus, and later information that we
file with the SEC will automatically update and supersede this information.
The documents listed below
and any future filings made by us with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act (excluding any information
furnished pursuant to Item 2.02 or Item 7.01 on any Current Report on Form 8-K and exhibits filed on such form that are related to such
items unless such Form 8-K expressly provides to the contrary), including all such documents we may file with the SEC after the date on
which the registration statement that includes this prospectus was initially filed with the SEC and prior to the effectiveness of the
registration statement and all such documents we may file with the SEC after the effectiveness of the registration statement, are incorporated
by reference in this prospectus until the termination of the offering under this registration statement:
| · | our Annual Report on Form
10-K for the year ended December 31, 2024, filed on March 13, 2025; |
| | |
| · | our Quarterly Report on Form 10-Q for the three months ended March 31, 2025, filed on May 15, 2025; |
| | |
| · | our Current Reports on Form 8-K filed (except for items 2.02 and 7.01) on February
7, 2025, March
28, 2025, May 6, 2025, May 23, 2025, June 2, 2025 and June 26, 2025; and |
| | |
| · | the description of our capital stock set forth in Exhibit
4.5 of our Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 13, 2025, together with any amendments
or reports filed for the purpose of updating such description. |
All documents we file with
the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act, except as to any portion of any report or document that is
not deemed filed under such provisions, (i) on or after the date of filing of the registration statement containing this prospectus and
prior to the effectiveness of the registration statement and (ii) on or after the date of this prospectus until the earlier of the date
on which all of the securities registered hereunder have been sold or this prospectus has been withdrawn, shall be deemed incorporated
by reference in this prospectus and to be a part of this prospectus from the date of filing of those documents. The information in documents
that we file in the future will update and supersede the information currently included and incorporated by reference in this prospectus.
We will provide a copy of
these filings (including certain exhibits that are specifically incorporated by reference therein) to each person, including any beneficial
owner, to whom a prospectus is delivered. You may request a copy of any or all of these filings at no cost, by writing or calling us at:
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, Texas 76107
(817) 887-8455
Copies of certain information
filed by us with the SEC, including our Annual Report on Form 10-K and Current Reports on Form 8-K, are also available on our website
at https://actuatetherapeutics.com/. Information contained on our website or accessible through our website is not incorporated by reference
herein.
You should read the information
relating to us in this prospectus together with the information in the documents incorporated by reference. Nothing contained herein shall
be deemed to incorporate information furnished, but not filed, with the SEC.
1,332,994 Shares of Common Stock
PRELIMINARY PROSPECTUS
, 2025
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution.
The estimated expenses in
connection with the sale of the securities being registered hereby, are as follows:
SEC registration fee | |
$ | 1,169.39 | |
Legal fees and expenses | |
| 30,000.00 | * |
Accounting fees and expenses | |
| 10,000.00 | * |
Printing expenses | |
| 500.00 | * |
Miscellaneous | |
| 1,330.61 | * |
Total | |
$ | 43,000.00 | |
*These fees are estimates and accordingly are subject to change.
Item 14. Indemnification of Directors and Officers.
Subsection (a) of Section
145 of the General Corporation Law of the State of Delaware (the DGCL) empowers a corporation to indemnify any person who was or is a
party or who is threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal,
administrative or investigative (other than an action by or in the right of the corporation) by reason of the fact that the person is
or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director,
officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including
attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection with
such action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposed
to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe the
person’s conduct was unlawful.
Subsection (b) of Section
145 empowers a corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending
or completed action or suit by or in the right of the corporation to procure a judgment in its favor by reason of the fact that the person
acted in any of the capacities set forth above, against expenses (including attorneys’ fees) actually and reasonably incurred by
the person in connection with the defense or settlement of such action or suit if the person acted in good faith and in a manner the person
reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be made in
respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and only
to the extent that the Court of Chancery or the court in which such action or suit was brought shall determine upon application that,
despite the adjudication of liability but in view of all the circumstances of the case, such person is fairly and reasonably entitled
to indemnity for such expenses which the Court of Chancery or such other court shall deem proper.
Section 145 further provides
that to the extent a director or officer of a corporation has been successful on the merits or otherwise in the defense of any action,
suit or proceeding referred to in subsections (a) and (b) of Section 145, or in defense of any claim, issue or matter therein, such person
shall be indemnified against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection
therewith; that indemnification provided for by Section 145 shall not be deemed exclusive of any other rights to which the indemnified
party may be entitled; and the indemnification provided for by Section 145 shall, unless otherwise provided when authorized or ratified,
continue as to a person who has ceased to be a director, officer, employee or agent and shall inure to the benefit of such person’s
heirs, executors and administrators. Section 145 also empowers the corporation to purchase and maintain insurance on behalf of any person
who is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director,
officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise against any liability asserted
against such person and incurred by such person in any such capacity, or arising out of his status as such, whether or not the corporation
would have the power to indemnify such person against such liabilities under Section 145.
Section 102(b)(7) of the DGCL
provides that a corporation’s certificate of incorporation may contain a provision eliminating or limiting the personal liability
of a director or officer to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director or officer,
provided that such provision shall not eliminate or limit the liability of a director or officer (i) for any breach of the director’s
or officer’s duty of loyalty to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL or (iv) for any transaction from which the director
or officer derived an improper personal benefit.
Our amended and restated certificate
of incorporation and our amended and restated bylaws provide that we shall indemnify our directors and officers, and may indemnify our
employees and other agents, to the maximum extent permitted by the DGCL, and our bylaws provide that we shall indemnify directors, officers,
employees and other agents to the maximum extent permitted by the DGCL.
In addition, we have entered
into indemnification agreements with each of our directors and officers. These agreements require us to indemnify these individuals to
the fullest extent permitted under Delaware law against liabilities that may arise by reason of their service to us, and to advance expenses
incurred as a result of any proceeding against them as to which they could be indemnified. We also intend to enter into indemnification
agreements with our future directors and officers.
Insofar as indemnification
for liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling persons pursuant to the
foregoing provisions, or otherwise, we have been advised that, in the opinion of the SEC, such indemnification is against public policy
as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities
(other than the payment of expenses incurred or paid by a director, officer or controlling person in a successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, we
will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to the court of appropriate jurisdiction
the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the
final adjudication of such issue.
Item 15. Recent Sales of Unregistered Securities.
Since January 1, 2022, we have made the following
sales of unregistered securities:
(1) In multiple closings from
August 2022 to June 2023, we issued and sold to certain investors an aggregate of 5,570,200 shares of our Series C redeemable convertible
preferred stock at a purchase price of $4.36 per share, and received aggregate net proceeds of approximately $23.4 million.
(2) In June 2023, in connection
with our Series C financing, we issued to the placement agent warrants to purchase an aggregate of 32,796 shares of our Series C redeemable
convertible preferred stock at an exercise price of $5.23 per share (without giving effect to the conversion into Common Stock or the
reverse stock split), which warrant converted into a warrant to purchase 18,223 shares of Common Stock at an exercise price of $9.42,
or the Series C Warrants, at the closing of our initial public offering (the “IPO” on August 14, 2024. The Series C Warrants
are exercisable for Common Stock through August 13, 2026.
(3) In February, March and
May 2024, we issued and sold to a certain accredited investor convertible promissory notes, with principal amounts of $3.0 million, $1.5
million and $1.0 million, respectively, subject to an automatic conversion upon a Qualified Financing (as defined below) or an Initial
Public Offering (as defined below) or at the option of the holder, convertible into shares of Series C redeemable convertible preferred
stock. In the event we either completed a financing of at least $5 million in gross proceeds (“Qualified Financing”) or closed
a firm commitment underwritten initial public offering of our Common Stock before July 31, 2024 (the “Maturity Date”), as
amended, the note will 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 note plus all accrued and unpaid interest thereon by eighty percent (80%) of the per share price at which shares were 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 note plus all accrued and unpaid interest thereon, divided by eighty percent (80%) of the initial
public offering price. In the event a Qualified Financing or initial public offering did not occur prior to the Maturity Date, then on
or after the Maturity Date, the holder could elect to either (i) convert the note into such number of shares of Series C redeemable convertible
preferred stock equal to the principal amount plus the accrued but unpaid interest thereon divided by $7.848 or (ii) elect that the note
become fully due and payable in cash. In connection with the closing of the Company’s IPO on August 14, 2024, the Company issued
the holder 884,427 shares of its Common Stock upon the conversion of the convertible promissory notes, including accrued interest thereon,
at a conversion price of $6.40 per share, representing 80% of the IPO price of $8.00 per share.
(4) In August 2024, in connection
with the IPO, we issued to the underwriters, Titan Partners Group LLC, a division of American Capital Partners, LLC, and Newbridge Securities
Corporation, 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, representing 125% of the initial offering price. The warrants
became exercisable on February 8, 2025 and expire on August 12, 2027. The warrants can only be exercised on a cash basis through November
11, 2025 and only on a cashless basis on November 12, 2025 and thereafter.
(5) From January 1, 2021 until
the IPO, we granted to certain of our directors, employees and consultants under our 2015 Stock Incentive Plan, as amended (the 2015 Plan),
options to purchase 393,346 shares of our Common Stock, all of which remain outstanding, with per share exercise prices ranging from $2.142
to $4.68.
(6) From January 1, 2021 until
the IPO, we granted to certain of our directors, employees and consultants restricted stock awards under our 2015 Plan covering an aggregate
of 1,186,204 shares of our Common Stock.
(7) In March 2025, we entered
into a common stock purchase agreement with B. Riley (the “Common Stock Purchase Agreement”), pursuant to which we have the
right to sell to B. Riley up to 3,904,374 shares of Common Stock, subject to certain limitations and the satisfaction of specified conditions
in the Common Stock Purchase Agreement, from time to time over the 36-month period beginning on the Commencement Date (as defined in the
Common Stock Purchase Agreement). As of June 30, 2025, we sold 256,429 shares of our Common Stock to B. Riley for proceeds of $2,148,506,
net of discounts and offering costs.
(8) In June 2025, we entered
into the Securities Purchase Agreement for the private placement of an aggregate (i) 666,947 shares of Common Stock, at a purchase price
of $7.00 per share, and (ii) the Warrants to purchase up to an aggregate of 666,497 shares of Common Stock, with an exercise price of
$7.00 per Warrant, for aggregate gross proceeds of approximately $4.7 million, and additional gross proceeds of up to approximately $4.7
million if all Warrants are exercised in full.
The offers, sales and issuances
of the securities described in paragraphs (1) through (4) and (7) through (8) were deemed to be exempt from registration under the Securities
Act in reliance on Section 4(a)(2) (or Regulation D promulgated thereunder) in that the issuance of securities to the accredited investors
did not involve a public offering. The recipients of securities in each of these transactions acquired the securities for investment only
and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securities
issued in these transactions. Each of the recipients of securities in these transactions was an accredited investor under Rule 501 of
Regulation D. Except as described in paragraph (4), no underwriters were involved in these transactions.
The offers, sales and issuances
of the securities described in paragraphs (5) and (6) were deemed to be exempt from registration under the Securities Act in reliance
on either Rule 701 in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided under
Rule 701 or Section 4(a)(2) in that the issuance of securities to the accredited investors did not involve a public offering. The recipients
of such securities were our employees, directors or bona fide consultants and received the securities under the 2015 Plan. Such equity
awards were subsequently registered pursuant to the registration statement on Form S-8 (File No. 333-281557) filed with the SEC on August
14, 2024.
Appropriate legends were affixed
to the securities issued in these transactions. Each of the recipients of securities in these transactions had adequate access, through
employment, business or other relationships, to information about us.
Item 16. Exhibits
(a) Exhibits
The exhibits listed below are filed as part of
this registration statement.
Exhibit
Number |
|
Description of Document |
3.1 |
|
Sixth
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report
on Form 8-K, filed with the SEC on August 14, 2024) |
3.2 |
|
Amended
and Restated Bylaws of Actuate Therapeutics, Inc. (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report
on Form 8-K, filed with the SEC on August 14, 2024) |
4.1 |
|
Form
of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 to the 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 Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1/A, filed with the
SEC on May 24, 2024) |
4.3 |
|
Form
of Representative Warrant (incorporated by reference to Exhibit 4.3 to the 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
Exhibit 4.4 to the Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) |
4.5 |
|
Form
of Warrant (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC
on June 26, 2025) |
5.1* |
|
Opinion of Baker & Hostetler LLP |
10.1+ |
|
Actuate
Therapeutics, Inc. 2015 Equity Incentive Plan, as amended, and form of grant agreements thereunder (incorporated by reference to
Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) |
10.2+ |
|
Actuate
Therapeutics, Inc. 2024 Equity Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement
on Form S-1, filed with the SEC on May 24, 2024) |
10.3+ |
|
Form
of Stock Option Agreement under the Actuate Therapeutics, Inc. 2024 Stock Incentive Plan (incorporated by reference to Exhibit 10.13
to the Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) |
10.4+ |
|
Form
of Restricted Stock Unit Agreement under the Actuate Therapeutics, Inc. 2024 Stock Incentive Plan (incorporated by reference to Exhibit
10.14 to the Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) |
10.5+ |
|
Non-Employee
Director Compensation Policy (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q,
filed with the SEC on September 24, 2024) |
10.6† |
|
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 Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1/A, filed with
the SEC on July 16, 2024) |
10.7† |
|
License
Agreement, dated March 31, 2015, as amended, between Northwestern University and the Registrant (incorporated by reference to Exhibit
10.5 to the Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) |
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 Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1/A, filed with the SEC on June 11, 2024) |
10.9+ |
|
Tenth
Amendment to Employment Agreement by and between Daniel Schmitt and the Registrant dated March 11, 2025 (incorporated by reference
to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025) |
10.10+ |
|
Employment
Agreement, effective June 1, 2022, between Andrew P. Mazar, Ph.D., and the Registrant (incorporated by reference to Exhibit 10.7
to the Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) |
10.11+ |
|
First
Amendment to Employment Agreement by and between Andrew P. Mazar, Ph.D. and the Registrant dated March 11, 2025 (incorporated
by reference to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025) |
10.12+ |
|
Employment
Agreement, effective June 1, 2024, between Paul Lytle, and the Registrant (incorporated by reference to the Exhibit 10.9 to Registrant’s
Registration Statement on Form S-1, filed with the SEC on May 24, 2024) |
10.13+ |
|
First Amendment to Employment Agreement by and between Paul Lytle and the Registrant dated March 11, 2025 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q, filed with the SEC on May 15, 2025) |
10.14+ |
|
Form of Indemnification Agreement for Directors and Officers (incorporated by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1, filed with the SEC on May 24, 2024) |
10.15 |
|
Common Stock Purchase Agreement, dated March 27, 2025, between the Registrant and B. Riley Principal Capital II, LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 28, 2025) |
10.16 |
|
Registration Rights Agreement, dated March 27, 2025, between the Registrant and B. Riley Principal Capital II, LLC (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on March 28, 2025) |
10.17 |
|
Form of Securities Purchase Agreement, dated June 25, 2025, by and among the Registrant and each of the purchasers party thereto (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 26, 2025) |
10.18 |
|
Form of Registration Rights Agreement, dated June 25, 2025, by and among the Registrant and each of the purchasers party thereto (incorporated by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K, filed with the SEC on June 26, 2025) |
21.1 |
|
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K, filed with the SEC on March 13, 2025) |
23.1* |
|
Consent of Crowe LLP, Independent Registered Public Accounting Firm |
23.2* |
|
Consent of KMJ Corbin & Company LLP, Independent Registered Public Accounting Firm |
23.3* |
|
Consent of Baker & Hostetler LLP (included in Exhibit 5.1) |
24.1* |
|
Power of Attorney (included on signature page) |
107* |
|
Filing Fee Table |
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 17. Undertakings
(a) The undersigned registrant hereby undertakes:
|
(1) |
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement: |
|
(i) |
to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended (the “Securities Act”); |
|
|
|
|
(ii) |
to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the SEC pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee Tables” or “Calculation of Registration Fee” table, as applicable, in the effective registration statement; and |
|
|
|
|
(iii) |
to include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement; |
|
|
|
|
provided, however, that: paragraphs
(a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are incorporated by reference in the registration statement,
or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement. |
|
(2) |
That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
|
|
|
|
(3) |
To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. |
|
|
|
|
(4) |
That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use. |
|
(5) |
That, for the purpose of determining liability of the registrant under the Securities Act to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser: |
|
(i) |
Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424; |
|
|
|
|
(ii) |
Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant; |
|
|
|
|
(iii) |
The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and |
|
|
|
|
(iv) |
Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser |
(b) The undersigned registrant hereby undertakes
that, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuant
to section 13(a) or section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report
pursuant to section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be a
new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities
arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing
provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policy
as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant
in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection
with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed
in the Securities Act and will be governed by the final adjudication of such issue.
SIGNATURES
Pursuant to the requirements
of the Securities Act of 1933, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized in the City of Fort Worth, State of Texas, on July 25, 2025.
Actuate Therapeutics, Inc.
By: /s/ Daniel M. Schmitt
Name: Daniel M. Schmitt
Title: President and Chief Executive Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE
PRESENTS, that each person whose signature appears below hereby constitutes and appoints Daniel M. Schmitt and Paul Lytle, and each of
them, his or her true and lawful attorneys-in-fact and agents, each with full power of substitution and resubstitution, for him or her
and in his or her name, place and stead, in any and all capacities, to sign any and all amendments, including post-effective amendments,
to this Registration Statement, and any registration statement relating to the offering covered by this Registration Statement and filed
pursuant to Rule 462(b) under the Securities Act of 1933, and to file the same, with exhibits thereto and other documents in connection
therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power
and authority to do and perform each and every act and thing requisite and necessary to be done, as fully for all intents and purposes
as he or she might or could do in person, hereby ratifying and confirming all that each of said attorneys-in-fact and agents, or his or
her substitute or substitutes may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements
of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates
indicated.
Name |
|
Position |
|
Date |
|
|
President, Chief Executive Officer and Director
(Principal Executive Officer) |
|
July 25, 2025 |
Daniel M. Schmitt |
|
|
|
/s/ Paul Lytle |
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
July 25, 2025 |
Paul Lytle |
|
|
|
/s/ Aaron G.L.
Fletcher, |
|
Director and Chairperson |
|
July 25, 2025 |
Aaron G.L. Fletcher, Ph.D. |
|
|
|
/s/ Jason Keyes |
|
Director |
|
July 25, 2025 |
Jason Keyes |
|
|
|
/s/ Amy
Ronneberg |
|
Director |
|
July 25, 2025 |
Amy Ronneberg |
|
|
|
/s/ Roger Sawhney |
|
Director |
|
July 25, 2025 |
Roger Sawhney |
|
|
|
/s/ Todd Thomson |
|
Director |
|
July 25, 2025 |
Todd Thomson |
|
|
|
/s/ Daniel Zabrowski |
|
Director |
|
July 25, 2025 |
Daniel Zabrowski, Ph.D. |