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United States securities and exchange commission logo
April 1, 2024
Daniel Schmitt
President and Chief Executive Officer
Actuate Therapeutics, Inc.
1751 River Run, Suite 400
Fort Worth, TX 76107
Re:Actuate Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted March 4, 2024
CIK No. 0001652935
Dear Daniel Schmitt:
            We have reviewed your draft registration statement and have the following comments.
            Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe a comment applies to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
            After reviewing the information you provide in response to this letter and your amended
draft registration statement or filed registration statement, we may have additional comments.
Draft Registration Statement on Form S-1 Submitted March 4, 2024
Prospectus Summary
Our Lead Product Candidate, page 1
1.We note your disclosure in the last paragraph on page 1 that "[o]bjective responses and
durable disease control were observed in both the single agent and combination treatment
arms of the study" and that you observed a "median overall survival (mOS) of 15.3
months in the efficacy evaluable (n=29) patient population." Please clarify if these results
were based on studies powered for statistical significance.
Pipeline and Development Timeline, page 2
2.We note that your pipeline table includes the investigator-initiated studies with elraglusib.
We further note your disclosure on page 90 that “[t]hese studies are exploratory and not
considered critical path for [you] at this stage and will not be discussed further beyond the

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summary in Figure 14.” Please provide us with your analysis as to whether these
investigator-initiated studies are material and should be included in your pipeline table.
3.For clarity, please revise your pipeline table to identify the study names (e.g., Actuate-
1801) covered by each row. Please also shorten the length of the arrow in the first row of
the pipeline table, or tell us why you do not believe the revision is appropriate. In this
regard, the arrow appears to indicate that you are further along in your phase 2 trials,
nearing phase 3, than indicated in your disclosures throughout the registration statement.
For example, we note your disclosure on page 90 that a randomized, controlled phase 2
trial has finished accrual.
4.We note your disclosure on page 2 that you are also evaluating the potential for additional
exploratory development of Elraglusib Injection in other pediatric cancer indications,
including neuroblastoma. Please tell us why your pipeline table shows you may be
pursuing Elraglusib Oral Tablet for neuroblastoma or revise your disclosure as
appropriate.
5.We note your disclosure on page 2 that "[s]everal Phase 2 indications, including
refractory, metastatic melanoma and refractory, metastatic colorectal cancer have been
identified for further clinical development of Elraglusib Oral Tablet based on data from
the Actuate-1801 study once the RP2D has been identified." If the RP2D for these
indications has not been established, please tell us why your pipeline table shows
Elraglusib Oral Tablet for melanoma and colorectal cancer as being part way through
Phase 2 or revise your disclosure as appropriate.
Our Strategy, page 4
6.We note your disclosure in the third bullet point that "[o]ne of [y]our strategic objectives
is to obtain development incentives in the United States and in other countries that could
accelerate [y]our path to drug approval: Orphan Drug Designation, Fast-Track designation
and Breakthrough Therapy Designation (BTD) in the United States; Orphan and priority
medicines (PRIME) designations in the EU; and Orphan designations in Japan and
Australia." Please balance this disclosure with a statement similar to the one on page 22
that such designations may not lead to a faster development or regulatory review or
approval process, and does not increase the likelihood that a product candidate will
receive FDA approval.
The Offering
Assumed offering price, page 8
7.We note that the assumed offering price is based on the purchase of "one-half of a share"
of your common stock. Please revise this disclosure to reconcile to the remainder of your
disclosure or advise.

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April 1, 2024
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Risks Related to Clinical Development and Regulatory Approval
We rely on third parties for the manufacture and shipping of elraglusib . . . , page 26
8.We note your disclosure in this risk factor regarding the risk of your suppliers’ inability to
manufacture your products in sufficient quantities or at defined quality specifications.
Please also address the risk, to the extent applicable, that your suppliers are under no
obligation to supply products to you. In this regard, we note your disclosure on page 110
that you currently obtain your supplies on a purchase order basis and do not have any
long-term supply agreements in place.
Use of Proceeds, page 67
9.We note your disclosure in the third paragraph that you currently intend to use proceeds
from this offering, together with your existing cash and cash equivalents, to fund clinical
trials and product development, research and development, clinical manufacturing, as well
as for working capital and other general corporate purposes, including pre-commercial
activity. We further note your disclosure in the penultimate paragraph that these funds will
not be sufficient to complete development in all potential indications of elraglusib. Please
revise your disclosure to identify how you intend to allocate the proceeds among these
different purposes. Please also clarify which elraglusib trials you currently intend to fund
with the proceeds from this offering, how the proceeds will be allocated among these trials
and indications, and how far into the development process you anticipate such proceeds to
enable you to reach.
10.We note your disclosure on page 8 that some shares of your common stock are subject to a
right of repurchase by you. If a portion of the proceeds from this offering will be used to
repurchase shares, please make that clear or otherwise disclose how the repurchase rights
will be impacted by your offering.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 83
11.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the initial public offering and the estimated offering price. This information will help
facilitate our review of your accounting for equity issuances including stock
compensation. Please discuss with the staff how to submit your response.
Business
Our Pipeline and Development Timeline, page 89
12.When discussing your clinical studies, we note several references to your pursuit of
certain studies if “adequate funding” or “requisite funding” is secured. Please clarify

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whether the proceeds from this offering will provide “adequate funding” or the “requisite
funding” for these studies or parts thereof.
Elraglusib Clinical Development, page 94
13.We note your disclosure that a "safe" dose was identified. Please revise to remove any
statements regarding safety or efficacy determinations as such determinations are solely
within the authority of the FDA.
Northwestern University License Agreement, page 108
14.Please revise your disclosure to specify when the last to expire of the patent rights
licensed under the NU License Agreement is scheduled to expire.
University of Illinois-Chicago Exclusive License Agreement with Equity, page 108
15.Please revise your disclosure to briefly describe the "Patent Rights" licensed to you under
the UIC License Agreement and specify when the last of those patent rights is scheduled
to expire.
Intellectual Property, page 109
16.We note your disclosure that you “own or have licensed 76 issued patents and pending
patent applications worldwide.” Please disclose the specific product candidates or product
candidate groups to which these patents and patent applications relate. Please also disclose
the expected expiration of any issued patents that are material to your business, including
the original composition of matter patents covering elraglusib in-licensed from The
University of Illinois-Chicago and the new composition of matter patent applications that
cover elraglusib polymorphs.
Management
Background of Directors and Executive Officers, page 128
17.Please revise your disclosure regarding Andrew P. Mazar, Ph.D., to identify his business
experience between April 2019 through June 2022. Refer to Item 401(e)(1) of Regulation
S-K.
Executive Compensation, page 136
18.We note that you have identified Daniel M. Schmitt, your President and Chief Executive
Officer, and Andrew P. Mazar, Ph.D., your Chief Operating Officer, as your named
executive officers for the year ended December 31, 2023. We further note that you have
excluded Paul Lytle, your Interim Chief Financial Officer, from your list of named
executive officers given that he was not appointed to his position until February 2024.
Please confirm to us that no other person served as an executive officer (e.g., a
predecessor Chief Financial Officer) for the Company in 2023. Alternatively, please

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revise your disclosure to include such other executive officer(s) in your list of named
executive officers. Refer to Item 402(m)(2)(ii) and (iii) of Regulation S-K.
Summary Compensation Table, page 136
19.We note from footnote 3 to your Summary Compensation Table that Andrew P. Mazar,
Ph.D., assumed the role of Chief Operating Officer on April 1, 2022 as a consultant and
that he became your employee on June 1, 2022. However, it does not appear that Dr.
Mazar’s consulting fees are included in the table. Please revise the table to include all
compensation awarded to, earned by, or paid to Dr. Mazar for all services rendered to the
Company in all capacities, including as a consultant, during the periods presented in the
table. Refer to Item 402(m)(1) of Regulation S-K. Please also revise footnote 3 to provide
context for the option awards granted to Dr. Mazar in 2023 and to include the information
required by Instruction 1 to Item 402(n)(2)(vi) of Regulation S-K.
Employment Agreements
Interim Chief Financial Officer, page 138
20.Please disclose the material terms upon which the consulting agreement with Paul Lytle,
your Interim Chief Financial Officer, may be terminated.
Outstanding Equity Awards at Year End, page 138
21.Please revise footnote 3 to the table to clarify which, if any, of the vesting conditions
described in the footnote have been satisfied, and clarify how you arrived at the
corresponding number of remaining unearned shares presented in the table.
Director Compensation, page 139
22.For each director, please disclose by footnote to the appropriate column of the Director
Compensation Table the aggregate number of stock awards, if any, and the aggregate
number of option awards outstanding at December 31, 2023. Refer to Instruction to Item
402(r)(2)(iii) and (iv) of Regulation S-K.
Certain Relationships and Related Party Transactions, page 146
23.If appropriate, in accordance with Item 404 of Regulation S-K, please disclose in this
section the transactions described in Note 12 (Related Party) to the financial statements on
page F-21, or tell us why such disclosure would not be appropriate. Please also provide us
with your analysis as to whether Richard Kenley, your Vice President of Manufacturing,
should be disclosed in the "Management" section pursuant to Item 401(b) of Regulation S-
K.
Principal Securityholders, page 150
24.We note your disclosure on page 150 that the applicable percentage ownership presented
in the beneficial ownership table gives effect to a number of actions, including the

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conversion of all outstanding shares of your redeemable convertible preferred stock into
shares of your common stock immediately prior to the closing of this offering.
Accordingly, the beneficial ownership table appears to present the percentage ownership
of your common stock only. However, your disclosures in footnotes 4 and 5 to the table
indicate that the corresponding rows in the table include shares of preferred stock. Please
revise the table and/or these footnotes as appropriate, including, if applicable, to clarify
whether the numbers presented in the footnotes actually reflect the shares of common
stock underlying the outstanding shares of preferred stock and, if so, how such numbers
were calculated. Alternatively, please tell us why you do not believe such presentation is
appropriate.
25.In footnote 5, we note your disclosure that Mr. Thomson shares voting and investment
control with respect to shares held by the Kairos Venture Affiliated Funds. Please revise
your disclosure to identify any other natural persons with whom Mr. Thomson shares
voting and investment control of such shares.
26.In footnote 7, we note your disclosure that certain shares of common stock are held by the
Catharine A. Zabrowski Irrevocable Trust, of which Catherine A. Zabrowski is the trustee.
Although we also note your disclosure on page 150 that, unless otherwise indicated, you
believe that all persons named in the table have sole voting and investment power with
respect to all the common stock beneficially owned by them, please revise footnote 7 to
clarify whether Daniel Zabrowski, as listed in the table, has sole voting and investment
power over the shares held in the Catherine A. Zabrowski Irrevocable Trust or whether
Catherine A. Zabrowski, in her capacity as trustee of such trust or otherwise, shares or has
sole voting and investment power of such shares.
Description of Capital Stock
Choice of Forum, page 158
27.We note your disclosure that your amended and restated certificate of incorporation will
provide that the federal district courts of the United States shall be the exclusive forum for
resolving any complaint asserting a cause of action arising under the Securities Act.
Please include a risk factor regarding the potential risks to investors from this forum
provision, including, as examples only, increased costs to bring a claim and the possibility
that such provision may discourage the filing of claims or limit investors’ ability to bring a
claim in a judicial forum that they find favorable.
Note 8 - Warrants, page F-17
28.Please revise to disclose the exercise price of all the warrants to purchase shares of your
Series B-1 redeemable convertible preferred stock.
Item 16. Exhibits, page II-3
29.Please include the form of representative’s warrants, as discussed on page 168, as an
exhibit to the registration statement.

 FirstName LastNameDaniel Schmitt
 Comapa