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As filed with the Securities and Exchange Commissionon 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 telephonenumber, 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 commencementof proposed sale to the public: As soon as practicable after this Registration Statement is declared effective.

If any of the securities beingregistered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 checkthe following box: ☒

If this Form is filed to registeradditional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the SecuritiesAct registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effectiveamendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effectiveamendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whetherthe registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerginggrowth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reportingcompany” 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 financialaccounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

 

The registrant hereby amendsthis Registration Statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a furtheramendment 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 pursuantto said Section 8(a), may determine.

 

 

 

   

 

 

The information in this preliminaryprospectus is not complete and may be changed. The selling stockholders may not sell these securities until the registration statementfiled with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities andis not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

SUBJECT TO COMPLETION, DATED JULY25, 2025

 

PRELIMINARY PROSPECTUS

 

 

ACTUATE THERAPEUTICS, INC.

 

1,332,994 Shares of Common Stock

 

This prospectus relates tothe 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 $0.000001per share (the “Common Stock”), of Actuate Therapeutics, Inc., a Delaware corporation (the “Company”), which consistsof (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 ofthe proceeds from the sale of the Shares by the Selling Stockholders. However, upon any exercise of the Warrants, we will receive theexercise price of such Warrants.

 

 The Selling Stockholdersmay sell or otherwise dispose of the Shares covered by this prospectus in a number of different ways and at varying prices. We providemore information about how the Selling Stockholders may sell or otherwise dispose of the Shares covered by this prospectus in the sectionentitled “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 beborne 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 currentlylisted on The Nasdaq Global Market (“Nasdaq”) under the symbol “ACTU.” On July 24, 2025, the last reported salesprice of our Common Stock, as reported on Nasdaq, was $6.99 per share.

 

We are an “emerginggrowth company” and a “smaller reporting company” as defined under the federal securities laws and have elected to complywith 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 oursecurities 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 amendmentsor supplements to this prospectus.

 

Neither the Securitiesand Exchange Commission nor any state securities commission has approved or disapproved of these securities, or passed upon the accuracyor adequacy of this prospectus. Any representation to the contrary is a criminal offense.

 

The dateof 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

 

 

 

 

 

 

 

 

 

 

 

 

 i 

 

 

ABOUT THIS PROSPECTUS

 

This prospectus is part ofa registration statement on Form S-1 that we filed with the SEC to register the securities described in this prospectus for resale bythe Selling Stockholders who may, from time to time, sell the securities described in this prospectus. We will not receive any of theproceeds from the sale of the Shares by the Selling Stockholders. However, upon any exercise of the Warrants, we will receive the exerciseprice of such Warrants.

 

We may also file a prospectussupplement or post-effective amendment to the registration statement of which this prospectus forms a part that may contain material informationrelating to these offerings. The prospectus supplement or post-effective amendment may also add, update or change information containedin this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus and the applicableprospectus 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 prospectussupplement, 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 theSelling Stockholders have authorized anyone to provide any information or to make any representations other than those contained in thisprospectus, any accompanying prospectus supplement or any free writing prospectus we have prepared. We and the Selling Stockholders takeno responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectusis 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 itis not soliciting an offer to buy securities, in any jurisdiction where the offer or sale is not permitted. You should assume that theinformation appearing in this prospectus or any prospectus supplement is accurate only as of the date on the front of those documentsonly, 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 summariesof certain provisions contained in some of the documents described herein, but reference is made to the actual documents for completeinformation. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred toherein have been filed, will be filed or will be incorporated by reference as exhibits to the registration statement of which this prospectusis 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 ourtrademarks, and trade names, including but not limited to Actuate and Actuate Therapeutics, which are protected under applicable intellectualproperty laws. This prospectus also may contain trademarks, service marks, trade names, and copyrights of other companies, which are theproperty of their respective owners. Solely for convenience, the trademarks, service marks, trade names, and copyrights referred to inthis 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.

 

 

 

 

 

 ii 

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus, includingany 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-lookingstatements. The forward-looking statements involve substantial risks and uncertainties. All statements, other than statements relatedto 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 objectivesof management, research and development plans, the anticipated timing, costs, design and conduct of our ongoing and planned clinical trialsand preclinical studies for elraglusib and any future product candidates, the timing and likelihood of regulatory filings and approvalsfor 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 likelihoodof success, plans and objectives of management for future operations, future results of anticipated product development efforts, and ourability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continueas 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 uncertaintieswhich could cause actual results to differ materially from those expressed in them. In addition, any forward-looking statements are qualifiedin their entirety by reference to the factors discussed further under the heading “Risk Factors” in this prospectusor in any prospectus supplement or document incorporated by reference.

 

You should assume that theinformation appearing in this prospectus or any prospectus supplement is accurate as of its date only. Because the risk factors referredto above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by usor on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaksonly 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 factorswill arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combinationof factors, may cause actual results to differ materially from those contained in any forward-looking statements. All written or oralforward-looking statements attributable to us or any person acting on our behalf made after the date of this prospectus are expresslyqualified in their entirety by the risk factors and cautionary statements contained in this prospectus. Unless legally required, we donot undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances afterthe 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 statementsare based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonablebasis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we haveconducted 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.

 

 

 

 

 iii 

 

 

INDUSTRY AND MARKET DATA

 

Certain market, industry andcompetitive data included in this prospectus were obtained from our own internal estimates and research, as well as from publicly availableinformation, reports of governmental agencies and industry publications and surveys in addition to research, surveys and studies conductedby third parties. The content of these third-party sources, except to the extent specifically set forth in this prospectus, does not constitutea portion of this prospectus and is not incorporated herein. Internal estimates are derived from publicly available information releasedby industry analysts and third-party sources, our internal research and our industry experience, and are based on assumptions made byus based on such data and our knowledge of our industry and market, which we believe to be reasonable. In some cases, we do not expresslyrefer 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 anyparagraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwiseexpressly stated or the context otherwise requires.

 

In addition, while we areresponsible for all of the disclosure contained in this prospectus and we believe the industry, market and competitive position data includedin this prospectus is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to changebased on various factors, including those discussed in the sections titled “Risk Factors” and “Special NoteRegarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressedin the estimates made by the independent parties and by us.

 

 

 

 

 

 

 

 

 

 iv 

 

 

 

PROSPECTUS SUMMARY

 

This summary highlightsinformation contained in greater detail elsewhere in or incorporated by reference into this prospectus. This summary does not containall of the information that is important to your investment decision, and is qualified in its entirety by the more detailed informationand consolidated financial statements included elsewhere in or incorporated by reference into this prospectus. You should carefully readthis 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 thisprospectus 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 biopharmaceuticalcompany focused on developing therapies for the treatment of high impact, difficult to treat cancers through the inhibition of glycogensynthase kinase-3 (“GSK-3”). We are developing elraglusib (formerly 9-ING-41), an ATP-competitive small molecule that is designedto enter cancer cells and block the function of the enzyme glycogen synthase kinase-3 beta (“GSK-3β”), a master regulatorof 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 regulationof anti-tumor immunity.

 

We have exclusively licenseda 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 evaluatedin a Phase 2 trial in patients with metastatic pancreatic ductal adenocarcinoma (“mPDAC”), our most advanced clinical indicationto 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 broadopportunity for us to potentially initiate and advance multiple drug development programs around our lead asset based on data emergingfrom completed or ongoing Phase 1/2 trials and non-clinical biological, cellular, and animal data. Animal tumor model data, Phase 1/2clinical data and AI-based computational approaches have identified a number of areas of unmet clinical need in cancer where elraglusibmay play an interventional role, including pancreatic, metastatic melanoma, lung, colon, breast, renal, and ovarian cancer, leukemiasand lymphomas, as well as some pediatric cancers including Ewing sarcoma, neuroblastoma and pediatric leukemias.

 

Corporate Information

 

Our principal executive officesare 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, thisprospectus or the registration statement of which it forms a part.

 

 

 

 

 

 1 

 

 

 

Recent Developments

 

On June 25, 2025, we enteredinto 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 issuedand 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 areexercisable 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 “MilestoneDate” is the earliest to occur of (i) the U.S. Food and Drug Administration (“FDA”) issuing Breakthrough Therapy designationfor elraglusib and (ii) the date that the FDA provides written communication available to the Company of its determination as to whetherthe 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, acurrent stockholder of the Company purchased 71,428 shares and Warrants to purchase 71,428 shares in the Private Placement for an aggregatepurchase price of $499,996, and, together with its affiliates following the closing of the Private Placement is deemed to beneficiallyown approximately 49.9% of the Common Stock. Dr. Aaron G.L. Fletcher, who is the Managing Partner and co-founder of Bios Partners, isthe Chairman of the Company’s Board of Directors.

 

The Private Placement closedon June 27, 2025 (the “Closing Date”). The Company received gross proceeds from the Private Placement of approximately $4.7million, before deducting fees and offering expenses. The Company intends to use the net proceeds from the Private Placement for workingcapital and general corporate purposes.

 

In connection with the PrivatePlacement, on June 25, 2025, we entered into a registration rights agreement (the “Registration Rights Agreement”) with theSelling Stockholders, pursuant to which we agreed to file a registration statement with the SEC covering the resale of the Shares soldin the Private Placement. We agreed to file such registration statement within 45 days following the Closing Date. The Registration RightsAgreement 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 descriptionsof the Securities Purchase Agreement and the Registration Rights Agreement do not purport to be complete and are qualified in their entiretyby reference to the full text of such documents, which are filed as exhibits to the registration statement of which this prospectus formsa part and are incorporated by reference herein.

 

Risk Factor Summary

 

Our business is subject tomany 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 Form10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, and the other documents incorporated by reference in thisprospectus. If any of the risks summarized below actually occurs, our business, prospects, financial condition or operating results couldbe materially and adversely affected. In particular, our risks include, but are not limited to, the following:

 

 

 

 

 

 2 

 

 

 

Risks Related to the Offering

 

·Our financial condition raises substantial doubt as to our ability to continue asa 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 existingstockholders 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 pursuantto 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 Conditionand Capital Requirements

 

·We have a limited operating history, have incurred significant operating lossesand expect to incur significant operating losses for the foreseeable future. We have a high risk of never generating revenue or becomingprofitable 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 terminateour development programs, commercialization efforts or other operations.
   
·Raising additional capital may cause dilution to our stockholders, restrict ouroperations or require us to relinquish rights to our technologies or product candidates. In addition, any capital obtained by us may beobtained on terms that are unfavorable to us, our investors, or both.
   
·Under the common stock purchase agreement, dated March 27, 2025 (the “CommittedEquity Facility”) with B. Riley Principal Capital II (“B. Riley”), it is not possible to predict the actual number ofshares we will sell to B. Riley, or the actual gross proceeds resulting from those sales.

 

Risks Related to Clinical Development and Potential RegulatoryApproval

 

·We do not have, and may never have, any approved products on the market. Our businessis highly dependent upon receiving approvals from various governmental agencies and will be severely harmed if we are not granted approvalto manufacture and sell our product candidates.
   
·We currently depend entirely on the success of elraglusib, which is our only productcandidate. If we are unable to advance elraglusib in clinical development, obtain regulatory approval and ultimately commercialize elraglusibin a timely manner, our business will be materially harmed.

 

 

 

 

 

 3 

 

 

 

·Even if we complete all planned clinical trials including a Phase 3 trial in thefuture, 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 processwith uncertain timelines and outcomes, and results of prior preclinical studies and early clinical trials are not necessarily predictiveof future results. Elraglusib or any future product candidates may not achieve favorable results or receive regulatory approval on a timelybasis, 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 capitalizeon more profitable or successful alternatives.
   
·Use of elraglusib or any future product candidates could be associated with sideeffects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend ordiscontinue clinical trials, abandon elraglusib or any future product candidate, limit the commercial profile of an approved label orresult in other significant negative consequences that could severely harm our business, financial condition, results of operations andprospects.
   
·If we experience delays or difficulties in the enrollment of subjects to our clinicaltrials, our receipt of necessary regulatory approvals could be delayed or otherwise adversely affected.
   
·Interim, topline, and preliminary data from our clinical trials that we announceor publish from time to time may change as more patient data become available and are subject to audit and verification procedures thatcould 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 importanttechnologies.
   
·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 usedin clinical trials and potential commercialization, if approved, which could adversely affect our business, financial condition or resultsof 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 commercializeour product candidates and adversely affect our financial condition.
   
·Data provided by collaborators and other parties upon which we rely have not beenindependently verified and could turn out to be inaccurate, misleading, or incomplete.

 

 

 

 

 

 4 

 

 

 

Risks Related to Commercialization of Elraglusib and anyFuture 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 developmentbefore 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 keyintellectual 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-relatedagreements, we may incur damages and could lose rights that may be necessary for developing, commercializing and protecting our currentor 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 cannotrecruit qualified employees or other significant personnel, we may experience program delays and increased compensation costs, and ourbusiness may be materially disrupted.
   
·Competition and technological change may make our product candidates less competitiveor obsolete. We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will sufferif we fail to compete effectively.
   
·Our anticipated operating expenses and capital expenditures are based upon our management’sestimates 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 othersto influence the outcome of director elections and other transactions requiring stockholder approval, creates the potential for conflictsof interest, may negatively impact our stock price and may deter or prevent efforts by others to acquire us, preventing our stockholdersfrom realizing a control premium.
   
·Current and new investors will experience dilution due to future sales or issuancesof our Common Stock.
   
·The trading price of the shares of our Common Stock could be highly volatile regardlessof our operating performance, and purchasers of our Common Stock could incur substantial losses.

 

 

 

 

 5 

 

 

 

·Numerous shares may now be sold into the open market upon expiry of the IPO lock-upin 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 existingstockholders under this offering or the Committed Equity Facility with B. Riley could cause the price of our shares of Common Stock tofall.

 

Implications of Being an Emerging Growth Company and a SmallerReporting Company

 

We are an “emerginggrowth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act). As an emerging growth company, wemay take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are notemerging growth companies. These include, but are not limited to:

 

·being permitted to provide only two years of audited financial statements, in additionto any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysisof Financial Condition and Results of Operations” disclosure;
   
·not being required to comply with the auditor attestation requirements in the assessmentof our internal control over financial reporting;
   
·not being required to comply with any requirement that may be adopted by the PublicCompany Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditors’ report providing additionalinformation 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 executivecompensation and stockholder approval of any golden parachute payments not previously approved.

 

Additionally, under the JOBSAct, an emerging growth company can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBSAct until such time as those standards apply to private companies. We irrevocably elected to avail ourselves of this exemption from newor revised accounting standards, and, therefore, are not subject to the same new or revised accounting standards as public companies whoare not emerging growth companies. As a result, our consolidated financial statements may not be comparable to companies that comply withnew or revised accounting pronouncements as of public company effective dates. We intend to rely on other exemptions provided by the JOBSAct, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-OxleyAct.

 

We will remain an emerginggrowth 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 bynon-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 totalannual gross revenue of $1.235 billion or more during such fiscal year (as indexed for inflation), (iii) the date on which we have issuedmore than $1 billion in non-convertible debt in the prior three-year period, and (iv) the last day of the fiscal year following the fifthanniversary 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 “smallerreporting company” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longeran emerging growth company. We may take advantage of certain of the scaled disclosures available to smaller reporting companies and willbe able to take advantage of these scaled disclosures for so long as our voting and non-voting Common Stock held by non-affiliates isless than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 millionduring the most recently completed fiscal year and our voting and non-voting Common Stock held by non-affiliates is less than $700.0 millionmeasured on the last business day of our second fiscal quarter.

 

 

 

 

 

 6 

 

 

 

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 “RiskFactors” on page 8 of this prospectus and the section titled “Risk Factors” in the documents incorporatedby 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 outstandingprior to and to be outstanding immediately after this offering, as set forth in the table above, is based on 20,470,504 shares outstandingas of June 30, 2025, and excludes:

 

·1,774,477 shares of our Common Stock issuable upon the exercise of stock options outstanding as of June30, 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 June30, 2025;
   
·3,647,945 shares of Common Stock that remain reserved for issuance under the Committed Equity Facilitywith 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 exerciseprice of $7.87 per share, however, of such shares subject to warrants, the 666,497 shares of Common Stock issuable upon exercise of theWarrants at an exercise price of $7.00 per share are included in the number of shares of Common Stock outstanding immediately after givingeffect 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”).

 

 

 

 

 

 

 7 

 

 

RISK FACTORS

 

Investing in our CommonStock is speculative and involves a high degree of risk. You should consider carefully the risks described below and in the “RiskFactors” section of our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025, ourQuarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 15, 2025, each as updated or supersededby the risks and uncertainties described under similar headings in other documents that are filed after the date hereof and incorporatedby reference into this prospectus together with all of the other information contained in this prospectus and incorporated by referenceherein, and any free writing prospectus that we may authorize for use in connection with this offering. If any of these risks occur, ourbusiness, 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 presentlyknown to us or that we currently deem immaterial also may impair our business operations. In these circumstances, the market price ofour Common Stock could decline, and you may lose all or part of your investment. This prospectus also contains forward-looking statementsthat involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statementsas a result of a number of factors, including the risks described below and in the “Risk Factors” section of our Annual Reporton 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 substantialdoubt 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 thePrivate Placement and the Committed Equity Facility, based on our current operating plan, we estimate that our existing cash and cashequivalents as of the date hereof will not satisfy the Company’s operational and capital requirements for fiscal year 2025.

 

We have incurred and expectto continue to incur significant costs in the development of our sole drug candidate, elraglusib. Our unaudited condensed consolidatedfinancial statements have been prepared assuming that we will continue to operate as a going concern, which contemplates the realizationof assets and the satisfaction of liabilities in the normal course of business; however, our current liabilities exceeded our assets asof 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 completedevelopment and potentially receive approval of our product candidate. We expect to continue to fund our operations primarily throughutilization of our current financial resources and we will require additional funding of capital in the near term.

 

These conditions raise substantialdoubt about our ability to continue as a going concern. Additionally, our independent registered public accounting firm included in itsaudit opinion for the year ended December 31, 2024 an explanatory paragraph that there is substantial doubt as to our ability to continueas a going concern. We plan to address these conditions by raising funds from public or private offerings of equity or debt securitiesand other funding sources, which may include our Committed Equity Facility. However, there can be no assurance that such funding willbe available to us, or will be obtained on terms favorable to us or will provide us with sufficient funds to meet our objectives. Newlyissued securities may include preferences, superior voting rights, and the issuance of warrants or other convertible securities thatwill have additional dilutive effects. Further, the sale of or the perception of the sale of a substantial number of our common stockby selling securityholders pursuant to a registration statement filed with the SEC will adversely affect the price of our Common Stockdue to our limited trading volume. In addition, the sale of a substantial number of our Common Stock by such selling securityholderswill adversely affect the share price that we may obtain in future financings and may adversely affect our ability to conduct and completefuture financings.

 

 

 

 8 

 

 

We may incur substantial costs in pursuing futurecapital and/or financing, including investment banking fees, legal fees, accounting fees, printing and distribution expenses and othercosts. We may also be required to recognize non-cash expenses in connection with certain securities we may issue, such as convertiblenotes and warrants, which will adversely impact our financial condition and results of operations. Our ability to obtain needed financingmay be impacted by such factors as the weakness of capital markets, and the fact that we have not been profitable, which could impactthe 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 evencurtail or cease operations.

 

In addition, the reactionof investors to the inclusion of a going concern statement by our auditors and our potential inability to continue as a going concernmay materially adversely affect our ability to raise new capital or enter into partnerships. The perception that we may not be able tocontinue as a going concern may also make it more difficult to operate our business due to concerns about our ability to meet our contractualobligations. If we become unable to continue as a going concern, we may have to liquidate our assets and the value we receive for ourassets in liquidation or dissolution could be significantly lower than the value reflected in our unaudited condensed consolidated financialstatements, and it is likely that investors would lose all or a part of their investment.

 

Investors who buy shares at different timeswill likely pay different prices.

 

The Selling Stockholders mayresell 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, investorswho 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 investmentresults. Investors may experience a decline in the value of the shares they purchase from the Selling Stockholders in this offering asa 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 securitiesin the public market by our existing stockholders could cause the price of our shares of Common Stock to fall.

 

The Selling Stockholders canresell, 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 Stockin 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 additionalequity securities.

 

Our management team has broad discretionover the use of any proceeds received pursuant to the exercise of the Warrants and you may not agree with how we use the proceeds andthe proceeds may not be invested successfully.

 

We will not receive any ofthe proceeds from the sale of the Warrant Shares, if any, by the Selling Stockholders pursuant to this prospectus. We may receive up toapproximately $4.7 million if all Warrants are exercised in full, based on the per share exercise price of $7.00 for the Warrants. Ourmanagement team will have broad discretion as to the use of the net proceeds from the exercise of the Warrants, if any, and we could usesuch proceeds for purposes other than those contemplated at the time of this prospectus. Accordingly, you will be relying on the judgmentof our management team with regard to the use of those net proceeds, and you will not have the opportunity, as part of your investmentdecision, to assess whether the proceeds are being used appropriately. It is possible that, pending their use, we may invest those netproceeds in a way that does not yield a favorable, or any, return for us. The failure of our management team to use such funds effectivelycould have a material adverse effect on our business, financial condition, operating results, and cash flows.

 

 

 

 9 

 

 

USE OF PROCEEDS

 

We will not receive any ofthe proceeds from the sale or other disposition of the Shares by the Selling Stockholders pursuant to this prospectus. However, we mayreceive proceeds in the aggregate of up to approximately $4.7 million if all of the Warrants in this offering are exercised. We cannotpredict 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 proceedsfrom the exercise of the Warrants for working capital and general corporate purposes. As of the date of this prospectus, we cannot specifywith 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.

 

 

 

 

 

 

 

 

 

 

 10 

 

 

MARKET INFORMATION FOR SECURITIES AND DIVIDENDPOLICY

 

Market Information

 

Our Common Stock is currentlylisted on the Nasdaq Global Market under the symbol “ACTU.”

 

As of June 30, 2025, therewere 20,470,504 shares of our Common Stock outstanding, held of record by 103 stockholders. Because many of our shares of common stockare held by brokers and other institutions on behalf of stockholders, this number is not indicative of the total number of stockholdersrepresented by these stockholders of record.

 

Dividend Policy

 

We have not declared or paidany cash dividends on our Common Stock to date. We may retain future earnings, if any, for future operations, expansion and debt repaymentand have no current plans to pay cash dividends for the foreseeable future. Any decision to declare and pay dividends in the future willbe 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 therestrictions contained in any future financing instruments. We do not anticipate declaring any cash dividends to holders of the CommonStock in the foreseeable future.

 

 

 

 

 

 

 

 

 

 

 

 11 

 

 

SELLING STOCKHOLDER

 

This prospectus relates tothe resale from time to time of: (i) 666,497 shares of Common Stock, and (ii) 666,497 shares of Common Stock issuable upon the exerciseof the Warrants pursuant to this prospectus and any accompanying prospectus supplement. We are registering the shares of our Common Stockincluded in this prospectus pursuant to the provisions of the Registration Rights Agreement we entered into with the Selling Stockholderson 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 “SellingStockholders” 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 thanthrough a public sale. The following table sets forth, as of June 30, 2025, the names of the Selling Stockholders, and other informationregarding the beneficial ownership (as determined under Section 13(d) of the Exchange Act of 1934, as amended, and the rules and regulationsthereunder) of the shares of Common Stock held by each of the Selling Stockholders, as of the date of this prospectus, assuming exerciseof all Warrants held by each such Selling Stockholder on that date. The third column lists the aggregate number of shares of Common Stockthat 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 ownershipof 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 June30, 2025.
   
(3)Assumes the sale of all shares of our Common Stock being offered for resale pursuant to this prospectus.

 

 

 

 12 

 

 

 (4)The business address of GROW Small Cap Equity Long Short L.P. is 4275 Executive Square, Suite 335, LaJolla, CA 92037. Includes 428,571 shares of Common Stock issuable upon the exercise of Warrants held by GROW Small Cap Equity Long ShortL.P. Carl Wiese is the Manager of Grow Small Cap Equity Long Short L.P.
   
(5)The business address of 3i, LP is2 Wooster Street, 2nd Floor, New York, NY 10013. Includes 71,428 shares of Common Stock issuable upon the exercise of Warrants held by3i, 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 ManagementLLC. Mr. Tarlow disclaims beneficial ownership of the securities beneficially owned directly by 3i, LP and indirectly by 3i ManagementLLC.
   
(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. MatthewTiampo is the portfolio manager of the Off-Piste Fund LP. Matthew Tiampo exercises voting and investment discretion over securitiesheld 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.

 

 

 

 13 

 

 

DESCRIPTION OF CAPITAL STOCK

 

General

 

The following descriptionsummarizes some of the terms of our amended and restated certificate of incorporation and our amended and restated bylaws, and of theDelaware 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, copiesof which have been filed as exhibits to the registration statement of which this prospectus is part.

 

Our authorized capital stockconsists 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 Stockare 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 tovote in any election of directors can elect all of the directors standing for election, if they so choose, other than any directors thatholders of any preferred stock we may issue may be entitled to elect. Subject to the supermajority votes for some matters, other mattersshall be decided by the affirmative vote of our stockholders having a majority in voting power of the votes cast by the stockholders presentor represented and voting on such matter. Our amended and restated certificate of incorporation also provides that our directors may beremoved only for cause and only by the affirmative vote of the holders of at least two-thirds in voting power of the outstanding sharesof capital stock entitled to vote thereon. In addition, the affirmative vote of the holders of at least two-thirds in voting power ofthe outstanding shares of capital stock entitled to vote thereon is required to amend or repeal, or to adopt any provision inconsistentwith, several of the provisions of our amended and restated certificate of incorporation. See the subsection titled “-CertainAnti-Takeover Effects of Delaware Law” and “-Amendment of Charter Provisions” below.

 

Dividends

 

Subject to preferences thatmay apply to any outstanding preferred stock, the holders of our Common Stock are entitled to receive dividends, if and when declaredby 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 themafter 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 Stockhave no conversion, preemptive or other subscription rights, and there are no sinking fund or redemption provisions applicable to ourCommon Stock. The rights, preferences and privileges of the holders of our Common Stock are subject to, and may be adversely affectedby, the rights of the holders of shares of any series of our preferred stock that we may designate and issue in the future.

 

 

 

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Fully Paid and Nonassessable

 

All of our outstanding sharesof Common Stock are fully paid and nonassessable.

 

Preferred Stock

 

Our amended and restated certificategrants our board of directors the authority, without further stockholder authorization, to issue from time to time up to 10,000,000 sharesof preferred stock in one or more series and to fix the terms, limitations, voting rights, relative rights and preferences and variationsof each series. Although we have no present plans to issue any shares of preferred stock, the issuance of shares of preferred stock, orthe issuance of rights to purchase such shares, could decrease the amount of earnings and assets available for distribution to the holdersof our Common Stock, could adversely affect the rights and powers, including voting rights, of the Common Stock and could have the effectof delaying, deterring or preventing a change of control of our company or an unsolicited acquisition proposal.

 

Warrants

 

As of June 30, 2025, therewere outstanding warrants to purchase an aggregate of 922,096 shares of our Common Stock at a weighted average exercise price of $7.87per share, including the Warrants issued in the Private Placement.

 

Private Placement Warrants

 

The Warrants to purchase ofup to 666,497 shares of Common Stock were issued pursuant to the Securities Purchase Agreement, at an exercise price of $7.00 per shareof Common Stock, subject to adjustment as forth in the Warrants. The Warrants will be exercisable on a cash only basis at any time afterthe date of issuance and expire 20 days following the Milestone Date for additional proceeds to the Company of up to approximately $4.7million if all Warrants are exercised in full. The registration statement of which this prospectus forms a part registers the WarrantShares issuable upon exercise of the Warrants.

 

Equity Awards

 

As of June 30, 2025, therewere 1,774,477 stock options outstanding, which have a weighted average exercise price of approximately $6.49 per share, and 584,111 unvestedRSUs outstanding under the 2024 Plan.

 

Registration Rights

 

Certain holders of sharesof our Common Stock are entitled to certain rights with respect to registration of such shares under the Securities Act under the investorrights agreement entered into in connection with the purchase of our preferred stock that converted into Common Stock upon our IPO.

 

The Company entered into aregistration 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 enteredinto the Registration Rights Agreement, providing for the registration of their Shares as set forth in this registration statement.

 

Copies of the Investor RightsAgreement, the B. Riley Registration Rights Agreement and the Registration Rights Agreement are incorporated by reference as exhibitsto the registration statement of which this prospectus forms a part.

 

 

 

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Certain Anti-Takeover Provisions of DelawareLaw

 

Some provisions of Delawarelaw, our amended and restated certificate of incorporation and our amended and restated bylaws contain provisions that could make thefollowing transactions more difficult: an acquisition of us by means of a tender offer; an acquisition of us by means of a proxy contestor otherwise; or the removal of our incumbent officers and directors. It is possible that these provisions could make it more difficultto 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, summarizedbelow, are intended to discourage coercive takeover practices and inadequate takeover bids. These provisions are also designed to encouragepersons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of the increasedprotection of our potential ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructureus outweigh the disadvantages of discouraging these proposals because negotiation of these proposals could result in an improvement oftheir terms.

 

Undesignated Preferred Stock

 

The ability of our board ofdirectors, without action by the stockholders, to issue up to 10,000,000 shares of undesignated preferred stock with voting or other rightsor preferences as designated by our board of directors could impede the success of any attempt to change control of us. These and otherprovisions may have the effect of deferring hostile takeovers or delaying changes in control or management of our company.

 

Stockholder Meetings

 

Our amended and restated certificateof incorporation and our amended and restated bylaws provide that a special meeting of stockholders may be called only by our board ofdirectors, chairman of the board of directors, chief executive officer or president, or by a resolution adopted by a majority of our boardof directors.

 

Requirements for Advance Notification ofStockholder Nominations and Proposals

 

Our amended and restated bylawsestablish advance notice procedures with respect to stockholder proposals to be brought before a stockholder meeting and the nominationof candidates for election as directors, other than nominations made by or at the direction of the board of directors or a committee ofthe board of directors.

 

Elimination of Stockholder Action by WrittenConsent

 

Our amended and restated certificateof incorporation eliminates the right of stockholders to act by written consent without a meeting.

 

Staggered Board of Directors

 

Our amended and restated certificateof incorporation provides that our board of directors will be divided into three classes. The directors in each class serve for a three-yearterm, with one class being elected each year by our stockholders. This system of electing directors may tend to discourage a third partyfrom attempting to obtain control of us, because it generally makes it more difficult for stockholders to replace a majority of the directors.

 

 

 

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Removal of Directors

 

Our amended and restated certificateof incorporation provides that no member of our board of directors may be removed from office except for cause and, in addition to anyother vote required by law, upon the approval of not less than two thirds of the total voting power of all of our outstanding voting stockthen entitled to vote in the election of directors.

 

Stockholders Not Entitled to CumulativeVoting

 

Our amended and restated certificateof incorporation does not permit stockholders to cumulate their votes in the election of directors. Accordingly, the holders of a majorityof the outstanding shares of our Common Stock entitled to vote in any election of directors can elect all of the directors standing forelection, 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 Section203 of the Delaware General Corporation Law, which prohibits persons deemed to be “interested stockholders” from engagingin a “business combination” with a publicly held Delaware corporation for three years following the date these persons becomeinterested 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 personwho, together with affiliates and associates, owns, or within three years prior to the determination of interested stockholder statusdid own, 15% or more of a corporation’s voting stock. Generally, a “business combination” includes a merger, asset orstock sale, or other transaction resulting in a financial benefit to the interested stockholder. The existence of this provision may havean anti-takeover effect with respect to transactions not approved in advance by the board of directors.

 

Choice of Forum

 

Our amended and restated certificateof incorporation provides that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the Stateof Delaware (the Court of Chancery) (or, in the event the Court of Chancery does not have jurisdiction, the federal district court forthe District of Delaware or other state courts of the State of Delaware) will be the sole and exclusive forum for the following typesof 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 amendedand restated certificate of incorporation or amended and restated bylaws; or (iv) any action asserting a claim governed by the internalaffairs doctrine, in all cases to the fullest extent permitted by law. The provision would not apply to suits brought to enforce a dutyor liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Furthermore, ouramended 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 ofaction arising under the Securities Act, including all causes of action asserted against any defendant to such complaint. For the avoidanceof doubt, this provision is intended to benefit and may be enforced by us, our officers and directors, the underwriters to any offeringgiving rise to such complaint, and any other professional entity whose profession gives authority to a statement made by that person orentity and who has prepared or certified any part of the documents underlying the offering. In any case, stockholders will not be deemedto have waived our compliance with the federal securities laws and the rules and regulations thereunder. The enforceability of similarchoice of forum provisions in other companies’ certificates of incorporation has been challenged in legal proceedings, and it ispossible that a court could find these types of provisions to be inapplicable or unenforceable. Our amended and restated certificate ofincorporation also provides that any person or entity purchasing or otherwise acquiring any interest in shares of our capital stock willbe deemed to have notice of and to have consented to this choice of forum provision.

 

 

 

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Amendment of Charter Provisions

 

The amendment of any of theabove provisions, except for the provision making it possible for our board of directors to issue preferred stock, would require approvalby holders of at least two thirds of the total voting power of all of our outstanding voting stock.

 

The provisions of Delawarelaw, our amended and restated certificate of incorporation and our amended and restated bylaws could have the effect of discouraging othersfrom attempting hostile takeovers and, as a consequence, they may also inhibit temporary fluctuations in the market price of our CommonStock that often result from actual or rumored hostile takeover attempts. These provisions may also have the effect of preventing changesin the composition of our board of directors and management. It is possible that these provisions could make it more difficult to accomplishtransactions that stockholders may otherwise deem to be in their best interests.

 

Transfer Agent

 

The transfer agent and registrarfor our Common Stock is Broadridge Corporate Issuer Solutions, LLC. The transfer agent’s address is 51 Mercedes Way, Edgewood, NY11717.

 

Listing

Our Common Stock is listedon the Nasdaq Global Market under the trading symbol “ACTU.”

 

 

 

 

 

 18 

 

 

SECURITIES ACT RESTRICTIONS ON RESALE OF SECURITIES

 

Rule 144

 

A person who has beneficiallyowned restricted Common Stock for at least six months would be entitled to sell such securities, provided that (i) such person is notdeemed 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 subjectto the Exchange Act periodic reporting requirements for at least three months before the sale and have filed all required reports underSection 13 or 15(d) of the Exchange Act during the 12 months (or such shorter period as we have been required to file reports) precedingthe sale.

 

Persons who have beneficiallyowned 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 onlya 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 noticeof the sale is filed with the SEC.

 

Sales by our affiliates underRule 144 are also subject to certain requirements relating to manner of sale, notice and the availability of current public informationabout us.

 

 

 

 

 

 

 

 

 

 

 

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MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCESTO NON-U.S. HOLDERS

 

The following is a summaryof the material U.S. federal income tax consequences to non-U.S. holders (as defined below) of the acquisition, ownership and dispositionof 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 estateor 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 promulgatedthereunder, judicial decisions and published rulings and administrative pronouncements of the Internal Revenue Service (IRS), all as ineffect as of the date hereof. These authorities are subject to differing interpretations and may change, possibly retroactively, resultingin U.S. federal income tax consequences different from those discussed below. We have not requested a ruling from the IRS with respectto the statements made and the conclusions reached in the following summary, and there can be no assurance that the IRS or a court willagree with such statements and conclusions.

 

This discussion is limitedto non-U.S. holders who purchase our Common Stock and who hold our Common Stock as a “capital asset” within the meaning ofSection 1221 of the Code (generally, property held for investment). This discussion does not address all of the U.S. federal income taxconsequences that may be relevant to a particular holder in light of such holder’s circumstances. This discussion also does notconsider any specific facts or circumstances that may be relevant to holders subject to special rules under the U.S. federal income taxlaws, 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 entitiesall 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.

 

 

 

 20 

 

 

If an entity or arrangementthat is classified as a partnership for U.S. federal income tax purposes holds our Common Stock, the U.S. federal income tax treatmentof a partner in the partnership will generally depend on the status of the partner, the activities of the partnership and certain determinationsmade at the partner level. Partnerships holding our Common Stock and the partners in such partnerships are urged to consult their taxadvisors about the particular U.S. federal income tax consequences to them of holding and disposing of our Common Stock.

 

THIS DISCUSSION IS FOR INFORMATIONALPURPOSES ONLY AND IS NOT TAX ADVICE. PROSPECTIVE INVESTORS SHOULD CONSULT THEIR TAX ADVISORS REGARDING THE PARTICULAR U.S. FEDERAL INCOMETAX 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 anyentity or arrangement treated as a partnership) for U.S. federal income tax purposes. A U.S. person is any person that, for U.S. federalincome 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 organizedin 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 oneor more U.S. persons who have the authority to control all substantial decisions of the trust or (ii) that has a valid election in effectunder applicable Treasury Regulations to be treated as a U.S. person.

 

Distributions on Common Stock

 

We have never declared orpaid any cash dividends on our capital stock and we do not currently intend to pay any cash dividends on our capital stock in the foreseeablefuture. However, if we do make cash or other property distributions on our Common Stock, such distributions will constitute dividendsfor 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 capitaland will first be applied against and reduce a holder’s tax basis in our Common Stock, but not below zero. Any excess will be treatedas gain realized on the sale or other disposition of our Common Stock and will be treated as described under the section titled “Gainon Disposition of Our Common Stock” below.

 

Subject to the discussionsbelow regarding effectively connected income, backup withholding and 1471 through 1474 of the Code (commonly referred to as FATCA), dividendspaid 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 grossamount 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 thepayment of dividends and must be updated periodically. If the non-U.S. holder holds the stock through a financial institution or otheragent 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. Prospectiveinvestors should consult their tax advisors concerning whether they may benefit from an applicable income tax treaty.

 

 

 

 21 

 

 

Non-U.S. holders that do notprovide the required certification on a timely basis, but that qualify for a reduced treaty rate, may obtain a refund of any excess amountswithheld by timely filing an appropriate claim for refund with the IRS.

 

If a non-U.S. holder holdsour Common Stock in connection with the conduct of a trade or business in the United States, and dividends paid on our Common Stock areeffectively connected with such holder’s U.S. trade or business (and are attributable to such holder’s permanent establishmentin the United States if required by an applicable tax treaty), the non-U.S. holder will be exempt from U.S. federal withholding tax. Toclaim the exemption, the non-U.S. holder must generally furnish a valid IRS Form W-8ECI (or applicable successor form) to the applicablewithholding agent.

 

However, any such effectivelyconnected dividends paid on our Common Stock generally will be subject to U.S. federal income tax on a net income basis at the regularU.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 foreigncorporation also may be subject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable incometax treaty) of its effectively connected earnings and profits for the taxable year, as adjusted for certain items. Non-U.S. holders shouldconsult 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 discussionsbelow regarding backup withholding and FATCA, a non-U.S. holder generally will not be subject to U.S. federal income tax on any gain realizedon 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 theUnited 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 moreduring 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 statusas a United States real property holding corporation (USRPHC) for U.S. federal income tax purposes at any time within the shorter of thefive-year period preceding the disposition or the non-U.S. holder’s holding period for our Common Stock, and our Common Stock isnot “regularly traded” on an established securities market (as defined by applicable Treasury Regulations).

 

Determining whether we area USRPHC depends on the fair market value of our U.S. real property interests relative to the fair market value of our other trade orbusiness assets and our foreign real property interests. We believe that we are not currently and do not anticipate becoming a USRPHCfor 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 becomea USRPHC and the “regularly traded” exception noted above does not apply to the disposition, a non-U.S. holder will generallybe 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 thatthe branch profits tax generally will not apply. Prospective investors are encouraged to consult their own tax advisors regarding thepossible consequences to them if we are, or were to become, a USRPHC.

 

Gain described in the firstbullet 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 ratesin 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 besubject to an additional branch profits tax equal to 30% (or such lower rate specified by an applicable income tax treaty) of its effectivelyconnected earnings and profits for the taxable year, as adjusted for certain items. A non-U.S. holder described in the second bullet pointabove 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 incometax treaties that may provide for different rules.

 

 

 

 22 

 

 

Information Reporting and Backup Withholding

 

Annual reports are requiredto be filed with the IRS and provided to each non-U.S. holder indicating the amount of distributions on our Common Stock paid to suchholder and the amount of any tax withheld with respect to those distributions. These information reporting requirements apply even ifno 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 specifictreaty 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 dispositionof our Common Stock provided the non-U.S. holder furnishes the required certification for its non-U.S. status, such as by providing avalid IRS Form W-8BEN, W-8BEN-E or W-8ECI, or certain other requirements are met. Backup withholding may apply if the payor has actualknowledge, or reason to know, that the holder is a U.S. person.

 

Backup withholding is notan additional tax. If any amount is withheld under the backup withholding rules, the non-U.S. holder should consult with a U.S. tax advisorregarding the possibility of and procedure for obtaining a refund or a credit against the non-U.S. holder’s U.S. federal incometax liability, if any.

 

Withholding on Foreign Entities

 

FATCA imposes a U.S. federalwithholding 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 tothe U.S. tax authorities certain information regarding certain U.S. account holders of such institution (which includes certain equityand 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 suchentity provides the withholding agent a certification identifying certain direct and indirect U.S. owners of the entity or an exemptionapplies. An intergovernmental agreement between the United States and an applicable foreign country may modify these requirements. FATCAcurrently applies to dividends paid on our Common Stock. Under certain circumstances, a non-U.S. holder might be eligible for refundsor credits of such taxes.

 

Prospective investors areencouraged to consult with their own tax advisors regarding the potential implications of FATCA on their investment in our Common Stock.

 

The preceding discussionof U.S. federal tax considerations is for general information only. It is not tax advice. Each prospective investor should consult itstax advisor regarding the particular U.S. federal, state and local and non-U.S. tax consequences of purchasing, holding and disposingof our Common Stock, including the consequences of any proposed change in applicable laws.

 

 

 

 

 23 

 

 

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 interestsin shares of Common Stock received after the date of this prospectus from a Selling Stockholder as a gift, pledge, partnership distributionor other transfer, may, from time to time, sell, transfer or otherwise dispose of any or all of their shares of Common Stock or interestsin 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 marketprice, at varying prices determined at the time of sale, or at negotiated prices.

 

The Selling Stockholders mayuse 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 blockas 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 prospectusis 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 defaultin the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of Common Stock, from timeto time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the SecuritiesAct, amending the list of Selling Stockholders to include the pledgee, transferee or other successors in interest as Selling Stockholdersunder this prospectus. The Selling Stockholders also may transfer the shares of Common Stock in other circumstances, in which case thetransferees, pledgees or other successors in interest will be the Selling Stockholders for purposes of this prospectus.

 

 

 

 24 

 

 

In connection with the saleof our Common Stock or interests therein, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financialinstitutions, which may in turn engage in short sales of the Common Stock in the course of hedging the positions they assume. The SellingStockholders may also sell shares of our Common Stock short and deliver these securities to close out their short positions, or loan orpledge the Common Stock to broker-dealers that in turn may sell these securities. The Selling Stockholders may also enter into optionor other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which requirethe delivery to such broker-dealer or other financial institution of shares offered by this prospectus, which shares such broker-dealeror other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

The aggregate proceeds tothe Selling Stockholders from the sale of the Common Stock offered by them will be the purchase price of the Common Stock less discountsor 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 ofthe proceeds from this offering. Upon any exercise of the Warrants, however, we will receive the exercise price of the Warrants.

 

The Selling Stockholders alsomay resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, provided thatthey meet the criteria and conform to the requirements of that rule, or another available exemption from the registration requirementsunder the Securities Act.

 

The Selling Stockholders andany 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 tobe underwriters solely as a result of their participation in this offering). Any discounts, commissions, concessions or profit they earnon 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 SecuritiesAct.

 

To the extent required, theshares 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 beset forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includesthis prospectus.

 

In order to comply with thesecurities laws of some states, if applicable, the Common Stock may be sold in these jurisdictions only through registered or licensedbrokers or dealers. In addition, in some states the Common Stock may not be sold unless it has been registered or qualified for sale oran exemption from registration or qualification requirements is available and is complied with.

 

We have advised the SellingStockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and tothe 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 prospectusdelivery requirements of the Securities Act. The Selling Stockholders may indemnify any broker-dealer that participates in transactionsinvolving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act.

 

We have agreed to indemnifythe Selling Stockholders against liabilities, including liabilities under the Securities Act and state securities laws, relating to theregistration of the shares offered by this prospectus.

 

We have agreed with the SellingStockholders to use commercially reasonable efforts to cause the registration statement of which this prospectus constitutes a part tobecome effective and to remain continuously effective until the earlier of: (i) the date on which the Selling Stockholders shall haveresold or otherwise disposed of all the shares covered by this prospectus and (ii) the date on which the shares covered by this prospectusno longer constitute “Registrable Securities” as such term is defined in the Registration Rights Agreement, such that theymay be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations and withoutcurrent public information pursuant to Rule 144 under the Securities Act or any other rule of similar effect.

 

 

 

 25 

 

 

LEGAL MATTERS

 

The validity of the securitiesoffered by this prospectus will be passed upon for us by Baker & Hostetler LLP, Cleveland, Ohio.

 

 

EXPERTS

 

The consolidated financialstatements of Actuate Therapeutics, Inc. as of December 31, 2024 and for the year then ended incorporated in this Prospectus by referenceto 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 financialstatements of Actuate Therapeutics, Inc. as of December 31, 2023 and for the year ended December 31, 2023 incorporated in this Prospectusby reference to the Annual Report on Form 10-K for the year ended December 31, 2024 have been so incorporated in reliance on the reportof KMJ Corbin & Company LLP, independent registered public accounting firm, given on the authority of said firm as experts in auditingand accounting.

 

 

WHERE YOU CAN FIND MORE INFORMATION

 

We have filed with the SECa registration statement on Form S-1, including exhibits and schedules, under the Securities Act, with respect to the shares of CommonStock being offered by this prospectus. This prospectus, which constitutes part of the registration statement, does not contain all ofthe information in the registration statement and its exhibits. For further information with respect to us and the Common Stock offeredby this prospectus, we refer you to the registration statement and its exhibits. Statements contained in this prospectus as to the contentsof any contract or any other document referred to are not necessarily complete, and in each instance, we refer you to the copy of thecontract or other document filed as an exhibit to the registration statement. Each of these statements is qualified in all respects bythis 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 otherinformation with the SEC. These reports, proxy statements and other information will be available for review on the web site of the SECreferred to above. We also maintain a website at www.actuatetherapeutics.com, at which, following the completion of this offering, youmay 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 ofwhich it forms a part, and the inclusion of our website address in this prospectus is an inactive textual reference only.

 

 

 

 26 

 

 

INCORPORATION OF CERTAIN INFORMATION BY REFERENCE

 

The SEC allows us to “incorporateby reference” certain of the information that we file with it after the date of the filing of the registration statement of whichthis prospectus forms a part, which means that we can disclose important information to you by referring you to the documents containingthat information. The information incorporated by reference is considered to be part of this prospectus, and later information that wefile with the SEC will automatically update and supersede this information.

 

The documents listed belowand 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 informationfurnished 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 suchitems unless such Form 8-K expressly provides to the contrary), including all such documents we may file with the SEC after the date onwhich the registration statement that includes this prospectus was initially filed with the SEC and prior to the effectiveness of theregistration statement and all such documents we may file with the SEC after the effectiveness of the registration statement, are incorporatedby reference in this prospectus until the termination of the offering under this registration statement:

 

·our Annual Report on Form10-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 February7, 2025, March28, 2025, May 6, 2025, May 23, 2025, June 2, 2025 and June 26, 2025; and
   
·the description of our capital stock set forth in Exhibit4.5 of our Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 13, 2025, together with any amendmentsor reports filed for the purpose of updating such description.

 

All documents we file withthe 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 isnot deemed filed under such provisions, (i) on or after the date of filing of the registration statement containing this prospectus andprior to the effectiveness of the registration statement and (ii) on or after the date of this prospectus until the earlier of the dateon which all of the securities registered hereunder have been sold or this prospectus has been withdrawn, shall be deemed incorporatedby reference in this prospectus and to be a part of this prospectus from the date of filing of those documents. The information in documentsthat 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 ofthese filings (including certain exhibits that are specifically incorporated by reference therein) to each person, including any beneficialowner, 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 informationfiled 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 websiteat https://actuatetherapeutics.com/. Information contained on our website or accessible through our website is not incorporated by referenceherein.

 

You should read the informationrelating to us in this prospectus together with the information in the documents incorporated by reference. Nothing contained herein shallbe deemed to incorporate information furnished, but not filed, with the SEC.

 

 

 

 27 

 

 

 

 

 

 

 

 

 

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 inconnection 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 Section145 of the General Corporation Law of the State of Delaware (the DGCL) empowers a corporation to indemnify any person who was or is aparty 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 isor 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 (includingattorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by the person in connection withsuch action, suit or proceeding if the person acted in good faith and in a manner the person reasonably believed to be in or not opposedto the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe theperson’s conduct was unlawful.

 

Subsection (b) of Section145 empowers a corporation to indemnify any person who was or is a party or is threatened to be made a party to any threatened, pendingor 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 personacted in any of the capacities set forth above, against expenses (including attorneys’ fees) actually and reasonably incurred bythe 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 personreasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification shall be made inrespect of any claim, issue or matter as to which such person shall have been adjudged to be liable to the corporation unless and onlyto 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 entitledto indemnity for such expenses which the Court of Chancery or such other court shall deem proper.

 

 

 

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Section 145 further providesthat 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 personshall be indemnified against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connectiontherewith; that indemnification provided for by Section 145 shall not be deemed exclusive of any other rights to which the indemnifiedparty 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’sheirs, executors and administrators. Section 145 also empowers the corporation to purchase and maintain insurance on behalf of any personwho 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 assertedagainst such person and incurred by such person in any such capacity, or arising out of his status as such, whether or not the corporationwould have the power to indemnify such person against such liabilities under Section 145.

 

Section 102(b)(7) of the DGCLprovides that a corporation’s certificate of incorporation may contain a provision eliminating or limiting the personal liabilityof 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’sor officer’s duty of loyalty to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involveintentional misconduct or a knowing violation of law, (iii) under Section 174 of the DGCL or (iv) for any transaction from which the directoror officer derived an improper personal benefit.

 

Our amended and restated certificateof incorporation and our amended and restated bylaws provide that we shall indemnify our directors and officers, and may indemnify ouremployees 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 enteredinto indemnification agreements with each of our directors and officers. These agreements require us to indemnify these individuals tothe fullest extent permitted under Delaware law against liabilities that may arise by reason of their service to us, and to advance expensesincurred as a result of any proceeding against them as to which they could be indemnified. We also intend to enter into indemnificationagreements with our future directors and officers.

 

Insofar as indemnificationfor liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling persons pursuant to theforegoing provisions, or otherwise, we have been advised that, in the opinion of the SEC, such indemnification is against public policyas 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, wewill, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to the court of appropriate jurisdictionthe question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by thefinal adjudication of such issue.

 

Item 15. Recent Sales of Unregistered Securities.

 

Since January 1, 2022, we have made the followingsales of unregistered securities:

 

(1) In multiple closings fromAugust 2022 to June 2023, we issued and sold to certain investors an aggregate of 5,570,200 shares of our Series C redeemable convertiblepreferred stock at a purchase price of $4.36 per share, and received aggregate net proceeds of approximately $23.4 million.

 

 

 

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(2) In June 2023, in connectionwith our Series C financing, we issued to the placement agent warrants to purchase an aggregate of 32,796 shares of our Series C redeemableconvertible preferred stock at an exercise price of $5.23 per share (without giving effect to the conversion into Common Stock or thereverse 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 Warrantsare exercisable for Common Stock through August 13, 2026.

 

(3) In February, March andMay 2024, we issued and sold to a certain accredited investor convertible promissory notes, with principal amounts of $3.0 million, $1.5million and $1.0 million, respectively, subject to an automatic conversion upon a Qualified Financing (as defined below) or an InitialPublic Offering (as defined below) or at the option of the holder, convertible into shares of Series C redeemable convertible preferredstock. In the event we either completed a financing of at least $5 million in gross proceeds (“Qualified Financing”) or closeda firm commitment underwritten initial public offering of our Common Stock before July 31, 2024 (the “Maturity Date”), asamended, the note will automatically convert into (i) in the case of a Qualified Financing, that number of shares of capital stock issuedin such Qualified Financing (the Qualified Financing Securities) equal to the quotient obtained by dividing the outstanding principalamount of the note plus all accrued and unpaid interest thereon by eighty percent (80%) of the per share price at which shares were tobe sold in such Qualified Financing or (ii) in the case of an initial public offering, such number of shares of Common Stock equal tothe outstanding principal amount of the note plus all accrued and unpaid interest thereon, divided by eighty percent (80%) of the initialpublic offering price. In the event a Qualified Financing or initial public offering did not occur prior to the Maturity Date, then onor after the Maturity Date, the holder could elect to either (i) convert the note into such number of shares of Series C redeemable convertiblepreferred stock equal to the principal amount plus the accrued but unpaid interest thereon divided by $7.848 or (ii) elect that the notebecome fully due and payable in cash. In connection with the closing of the Company’s IPO on August 14, 2024, the Company issuedthe 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 connectionwith the IPO, we issued to the underwriters, Titan Partners Group LLC, a division of American Capital Partners, LLC, and Newbridge SecuritiesCorporation, warrants to purchase up to 161,000 shares of Common Stock, representing 5% of the shares of Common Stock issued under theIPO and overallotment option, at an exercise price of $10.00 per share, representing 125% of the initial offering price. The warrantsbecame exercisable on February 8, 2025 and expire on August 12, 2027. The warrants can only be exercised on a cash basis through November11, 2025 and only on a cashless basis on November 12, 2025 and thereafter.

 

(5) From January 1, 2021 untilthe 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 $2.142to $4.68.

 

(6) From January 1, 2021 untilthe IPO, we granted to certain of our directors, employees and consultants restricted stock awards under our 2015 Plan covering an aggregateof 1,186,204 shares of our Common Stock.

 

(7) In March 2025, we enteredinto a common stock purchase agreement with B. Riley (the “Common Stock Purchase Agreement”), pursuant to which we have theright to sell to B. Riley up to 3,904,374 shares of Common Stock, subject to certain limitations and the satisfaction of specified conditionsin the Common Stock Purchase Agreement, from time to time over the 36-month period beginning on the Commencement Date (as defined in theCommon 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 enteredinto the Securities Purchase Agreement for the private placement of an aggregate (i) 666,947 shares of Common Stock, at a purchase priceof $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 $4.7million if all Warrants are exercised in full.

 

 

 

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The offers, sales and issuancesof the securities described in paragraphs (1) through (4) and (7) through (8) were deemed to be exempt from registration under the SecuritiesAct in reliance on Section 4(a)(2) (or Regulation D promulgated thereunder) in that the issuance of securities to the accredited investorsdid not involve a public offering. The recipients of securities in each of these transactions acquired the securities for investment onlyand not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the securitiesissued in these transactions. Each of the recipients of securities in these transactions was an accredited investor under Rule 501 ofRegulation D. Except as described in paragraph (4), no underwriters were involved in these transactions.

 

The offers, sales and issuancesof the securities described in paragraphs (5) and (6) were deemed to be exempt from registration under the Securities Act in relianceon either Rule 701 in that the transactions were under compensatory benefit plans and contracts relating to compensation as provided underRule 701 or Section 4(a)(2) in that the issuance of securities to the accredited investors did not involve a public offering. The recipientsof such securities were our employees, directors or bona fide consultants and received the securities under the 2015 Plan. Such equityawards were subsequently registered pursuant to the registration statement on Form S-8 (File No. 333-281557) filed with the SEC on August14, 2024.

 

Appropriate legends were affixedto the securities issued in these transactions. Each of the recipients of securities in these transactions had adequate access, throughemployment, business or other relationships, to information about us.

 

Item 16. Exhibits

 

(a) Exhibits

 

The exhibits listed below are filed as part ofthis 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)

 

 

 

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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.

 

 

 

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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 thoseparagraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of theSecurities 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.

 

 

 

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  (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 undertakesthat, for purposes of determining any liability under the Securities Act, each filing of the registrant’s annual report pursuantto section 13(a) or section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual reportpursuant to section 15(d) of the Exchange Act) that is incorporated by reference in the registration statement shall be deemed to be anew registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemedto be the initial bona fide offering thereof.

 

(c)    Insofar as indemnification for liabilitiesarising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoingprovisions, or otherwise, the registrant has been advised that in the opinion of the SEC such indemnification is against public policyas 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 registrantin the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connectionwith the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controllingprecedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressedin the Securities Act and will be governed by the final adjudication of such issue.

 

 

 

 

 

 

 

 

 

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SIGNATURES

 

Pursuant to the requirementsof 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 THESEPRESENTS, that each person whose signature appears below hereby constitutes and appoints Daniel M. Schmitt and Paul Lytle, and each ofthem, his or her true and lawful attorneys-in-fact and agents, each with full power of substitution and resubstitution, for him or herand 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 filedpursuant to Rule 462(b) under the Securities Act of 1933, and to file the same, with exhibits thereto and other documents in connectiontherewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full powerand authority to do and perform each and every act and thing requisite and necessary to be done, as fully for all intents and purposesas 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 orher substitute or substitutes may lawfully do or cause to be done by virtue hereof.

 

Pursuant to the requirementsof the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the datesindicated.

 

Name   Position   Date

 

/s/ Daniel M. Schmitt

 

 

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.

 

 

 

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Exhibit 5.1

 

 

 

 

July 25, 2025

 

Actuate Therapeutics, Inc.

1751 River Run, Suite 400

Fort Worth, Texas 76107

 

Re: Registration Statement on Form S-1 filed by Actuate Therapeutics,Inc.

 

Ladies and Gentlemen:

 

We have acted as counselto Actuate Therapeutics, Inc., a Delaware corporation (the “Company”), in connection with the filing of a registrationstatement on Form S-1 (the “Registration Statement”) with the Securities and Exchange Commission (the “Commission”)under the Securities Act of 1933, as amended (the “Securities Act”). The Registration Statement relates to theoffer and resale from time to time by the selling stockholders named in the Registration Statement (the “Selling Stockholders”)of up to 1,332,994 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 (the “Shares”),and (ii) 666,497 shares of Common Stock issuable upon the exercise of warrants (the “Warrants” and the sharesof Common Stock issuable upon the exercise of the Warrants, the “Warrant Shares”).

 

In connection with this opinion,we have examined and relied upon such documents and such matters of fact and law as we deem necessary to render the opinions containedherein. We have assumed the genuineness of all signatures, the legal capacity of all natural persons to execute and deliver documents,the authenticity of all documents submitted to us as originals, the conformity to originals of all documents submitted to us as copies,the accuracy, completeness and authenticity of certificates of public officials, the due authorization, execution and delivery of alldocuments by all persons other than the Company where execution and delivery are prerequisites to the effectiveness thereof. As to certainfactual matters, we have relied upon a certificate of an officer of the Company and have not independently verified such matters. Forpurposes of this opinion, we have assumed that at the time of the issuance of the Warrant Shares, a sufficient number of shares of CommonStock will remain authorized and available for issuance pursuant to the Company’s Sixth Amended and Restated Certificate of Incorporation,as it then may be amended (the “Certificate of Incorporation”) and that the Company will comply with all applicable noticerequirements regarding uncertificated shares provided in the Delaware General Corporation Law.

 

Subjectto the foregoing and the other matters set forth herein, we are of the opinion that:

 

(a)the Shares have been duly authorized by all necessary corporateaction of the Company and are validly issued, fully paid and nonassessable; and

 

(b)when the Warrant Shares shall have been duly registered on the books of the transfer agent and registrartherefor in the name of or on behalf of the Warrant holders and have been issued by the Company against payment therefor in the circumstancescontemplated by the Warrants, the Warrant Shares will be duly authorized by all necessary corporate action of the Company and will bevalidly issued, fully paid and nonassessable.

 

Our opinion is expressedonly with respect to the General Corporation Law of the State of Delaware. We express no opinion to the extent that any other laws areapplicable to the subject matter hereof. We are not rendering any opinion as to compliance with any federal or state antifraud law, ruleor regulation relating to securities, or to the sale or issuance thereof. The opinion expressed above is as of the date hereof only, andwe express no opinion as to, and assume no responsibility for, the effect of any fact or circumstance occurring, or of which we learn,subsequent to the date of this opinion letter.

 

We hereby consent to thereference to our firm under the caption “Legal Matters” in the prospectus included in the Registration Statement and to thefiling of this opinion as an exhibit to the Registration Statement. In giving such consent, we do not hereby admit that we are in thecategory of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations of the Commission.

 

 

Very truly yours,

 

 

/s/ Baker & Hostetler LLP

 

Exhibit 23.1

 

 

 

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTINGFIRM

 

 

 

We consent to the incorporation by reference inthis Registration Statement of Actuate Therapeutics, Inc. on Form S-1 of our report dated March 13, 2025 on the consolidated balance sheetof Actuate Therapeutics, Inc. as of December 31, 2024 and the consolidated statements of operations, redeemable convertible preferredstock and stockholders’ equity (deficit), and cash flows for the year ended December 31, 2024 appearing in the 2024 Form 10-K ofActuate Therapeutics, Inc., and to the reference to us under the heading "Experts" in the prospectus.

 

 

 

 

/s/ Crowe LLP

 

Costa Mesa, California

July 25, 2025

 

 

Exhibit 23.2

 

 

 

 

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTINGFIRM

 

We consent to the incorporation by reference inthis Registration Statement on Form S-1 of Actuate Therapeutics, Inc. of our report dated February 29, 2024 (except for the retroactiveeffect of the 1-for-1.8 reverse stock split as described in the “Reverse Stock Split” section of Note 1, as to which the dateis June 7, 2024, and except for Note 14, as to which the date is March 13, 2025), relating to the consolidated financial statements ofActuate Therapeutics, Inc. and subsidiary as of December 31, 2023 and for the year then ended, appearing in the Annual Report on Form10-K of Actuate Therapeutics, Inc. for the year ended December 31, 2024.

 

We also consent to the references to us underthe headings “Experts” in the prospectus, which is part of such Registration Statement.

 

 

/s/ KMJ Corbin & Company LLP

 

Glendora, California
July 25, 2025