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ACTUATE THERAPEUTICS, INC.

For the period ended Mar 31, 2025. Filed May 15, 2025.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Mar 31, 2025 · Filed May 15, 2025

ACTU$0.31-4.6%Stored close · as of Nov 9, 2026

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Item 1. Financial Statements

Item 1.Financial Statements

Condensed Consolidated Balance Sheets

March 31, 2025December 31, 2024
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents$3,889,405$8,641,622
Prepaid assets and other current assets359,159566,278
Total current assets4,248,5649,207,900
Deferred offering costs and other assets234,475110,548
Total assets$4,483,039$9,318,448
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable$2,644,349$1,921,189
Other accrued expenses5,200,7625,921,908
Accrued compensation1,237,886888,449
Accrued interest, current70,95770,957
Total current liabilities9,153,9548,802,503
Long term liabilities:
Accrued interest, less current portion11,8316,768
License payable404,991404,991
Total long-term liabilities416,822411,759
Total liabilities9,570,7769,214,262
Commitments and contingencies (Note 5)–
Stockholders’ equity (deficit):
Preferred stock, $0.000001 par value; 10,000,000 shares authorized, no shares issued or outstanding––
Common stock: $0.000001 par value, 200,000,000 shares authorized, 19,531,636 shares issued and outstanding2020
Additional paid-in capital133,609,116132,484,015
Accumulated deficit(138,696,873)(132,379,849)
Total stockholders’ equity (deficit)(5,087,737)104,186
Total liabilities and stockholders’ equity (deficit)$4,483,039$9,318,448

Condensed Consolidated Statements of Operations

(Unaudited)

Three Months Ended March 31,
20252024
Operating expenses:
Research and development$3,220,319$6,860,430
General and administrative3,145,265912,824
Total operating expenses6,365,5847,773,254
Loss from operations(6,365,584)(7,773,254)
Other income (expense):
Change in estimated fair value of warrant liability–(32,515)
Loss on issuance of related party convertible notes payable at fair value–(200,000)
Change in estimated fair value of related party convertible notes payable–(300,000)
Interest expense(5,063)(5,076)
Interest income53,62314,786
Total other income (expense), net48,560(522,805)
Net loss$(6,317,024)$(8,296,059)
Weighted-average shares of common stock outstanding, basic and diluted19,497,7311,535,167
Net loss per share attributable to common stockholders, basic and diluted$(0.32)$(5.40)

Condensed Consolidated Statement of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(Unaudited)

For the Three Months Ended March 31, 2025

Redeemable Convertible · Total
Preferred Stock · Common Stock · Additional · Stockholders’
SharesAmountSharesAmountPaid-in CapitalAccumulated DeficitEquity (Deficit)
Balances, January 1, 2025–$–19,531,636$20$132,484,015$(132,379,849)$104,186
Stock-based compensation expense––––1,125,101–1,125,101
Net loss–––––(6,317,024)(6,317,024)
Balances, March 31, 2025–$–19,531,636$20$133,609,116$(138,696,873)$(5,087,737)

For the Three Months Ended March 31, 2024

Redeemable Convertible · Additional · Total
Preferred Stock · Common Stock · Paid-in · Accumulated · Stockholders’
SharesAmountSharesAmountCapitalDeficitDeficit
Balances, January 1, 202424,678,355$94,178,4041,690,760$2$5,468,006$(105,094,521)$(99,626,513)
Stock-based compensation expense––––148,206–148,206
Net loss–––––(8,296,059)(8,296,059)
Balances, March 31, 202424,678,355$94,178,4041,690,760$2$5,616,212$(113,390,580)$(107,774,366)

Condensed Consolidated Statements of Cash Flows(Unaudited)**

Three Months Ended March 31,
20252024
Operating Activities:
Net loss$(6,317,024)$(8,296,059)
Adjustment to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense1,125,101148,206
Change in estimated fair value of warrant liability–32,515
Loss on issuance of related party convertible notes payable at fair value–200,000
Change in estimated fair value of related party convertible notes payable–300,000
Interest accrued on license payable5,0635,076
Changes in operating assets and liabilities:
Prepaid assets and other current assets207,119(82,867)
Other assets110,548–
Accounts payable622,162483,703
Accrued compensation349,437–
Other accrued expenses(721,146)1,961,844
Net cash used in operating activities(4,618,740)(5,247,582)
Financing Activities:
Proceeds from issuances of related party convertible notes payable–4,500,000
Deferred offering costs(133,477)(142,770)
Net cash provided by (used in) financing activities(133,477)4,357,230
Net change in cash and cash equivalents(4,752,217)(890,352)
Cash and cash equivalents, beginning of period8,641,6222,958,659
Cash and cash equivalents, end of period$3,889,405$2,068,307
Supplemental disclosure of cash flow information:
Cash paid for interest$–$–
Cash paid for income taxes$800$–
Supplemental Schedule of Noncash Financing Activities:
Deferred offering costs, unpaid and accrued$100,998$367,732

Notes to the Condensed Consolidated Financial Statements

For The Three Months Ended March 31, 2025 (unaudited)

1.DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION

Actuate Therapeutics, Inc. (the “Company”) was incorporated in the State of Delaware on January 16, 2015 and is headquartered in Fort Worth, Texas. The Company is a clinical-stage biopharmaceutical company focused on developing novel therapies for the treatment of cancers through the inhibition of glycogen synthase kinase-3 (“GSK-3”). The Company’s lead investigational product, elraglusib (formerly 9-ING-41), is a small molecule that is designed to enter cancer cells and block the function of the enzyme GSK-3β, thereby causing the death of the cancer cells and the regulation of anti-tumor immunity.

The Company has a 100%-owned Irish subsidiary, Actuate Therapeutics Limited, that is currently dormant.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and notes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements include only normal and recurring adjustments that the Company believes are necessary to fairly state the Company’s financial position and the results of its operations and cash flows. Operating results for the three months ended March 31, 2025 are not necessarily indicative of the results expected for the full fiscal year or any subsequent interim period. The condensed consolidated balance sheet at December 31, 2024 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP for complete financial statements. Because all of the disclosures required by U.S. GAAP for complete financial statements are not included herein, these unaudited condensed consolidated financial statements and the notes accompanying them should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2025.

Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

Going Concern and Management’s Plans

The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. As of March 31, 2025, the Company had cash and cash equivalents of $3,889,405 and a working capital deficit of $4,905,390. The Company has not generated any revenue and has incurred recurring operating losses since inception. The Company expects to continue to incur losses for the foreseeable future and therefore, the Company’s ability to continue its operations is highly dependent on its ability to raise additional capital in the near term to fund its future operations.

Management anticipates, based on currently proposed plans and assumptions, that our cash and cash equivalents on hand will not satisfy the Company’s operational and capital requirements beyond the second quarter of fiscal year 2025. As the Company continues to pursue its business plan, it expects to finance its operations through equity offerings, debt financings, or other capital sources.

On March 27, 2025, the Company entered into a common stock purchase agreement (the “Committed Equity Facility”) with B. Riley Principal Capital II (“B. Riley”) giving the Company the right, but not the obligation, to sell to B. Riley over a 36-month period up to the lesser of (i)$50 million of newly issued shares of our common stock and (ii) 3,904,374 shares of the Company’s common stock (see Note 7). The price per share of common stock sold to B. Riley is determined by reference to the volume weighted average price of the Company’s common stock as defined within the Committed Equity Facility less a 3% discount, subject to certain limitations and conditions. The total net proceeds that the Company will receive under the Committed Equity Facility will depend on the frequency and prices at which the Company sells common stock to B. Riley. However, there can be no assurance that the Company will be able to raise sufficient proceeds under the Committed Equity Facility or any additional financing will be available to the Company on acceptable terms, if at all. In addition, our ability to raise additional capital may be adversely impacted by global economic conditions, disruptions to, and volatility in, the financial markets in the United States and worldwide. If events or circumstances occur such that the Company does not obtain additional funding, it may be necessary to significantly reduce its scope of operations to reduce the current rate of spending through actions such as the need to delay, limit, reduce, grant rights to develop or terminate its product development or even cease operations, which could have a material adverse effect on the Company’s business, results of operations or financial condition. Based on the above matters, we have concluded that there is substantial doubt regarding the Company’s ability to continue as a going concern for a year from the date these unaudited condensed consolidated financial statements were issued.

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The Company’s significant accounting policies are disclosed in the audited financial statements and the notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2025. Since the date of such audited consolidated financial statements, there have been no changes to the Company’s significant accounting policies, except as noted below.

Principles of Consolidation

The consolidated financial statements include the accounts of Actuate Therapeutics, Inc. and its wholly owned subsidiary, Actuate Therapeutics Limited. All material intercompany accounts and transactions have been eliminated in the consolidated financial statements.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions, and judgements that affect the reported amounts of assets, liabilities, expenses, and related disclosures in the accompanying notes. The Company bases its estimates, assumptions and judgements on historical experience when available and on various factors that it believes to be reasonable under the circumstances as of the date of the accompanying unaudited condensed consolidated financial statements including stock-based compensation expense and accrued expenses (including accrued expenses related to research and development (“R&D”) as described below), and the recoverability of the Company’s net deferred tax assets and related valuation allowance. In addition, other factors may affect estimates, including the expected business and operational changes, the sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Actual results could differ materially from the estimates and assumptions used in the preparation of the accompanying unaudited condensed consolidated financial statements under different assumptions or conditions.

Accrued Expenses Related to R&D Expenses

As part of the process of preparing our unaudited condensed consolidated financial statements, we are required to estimate our R&D expenses as of each balance sheet date. This process involves reviewing open contracts, including clinical site contracts, and communicating with our personnel to identify services that have been performed on our behalf, and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of the actual cost. We make estimates of our R&D expenses as of each balance sheet date based on facts and circumstances known to us at that time. The significant estimates in our R&D expenses include the costs incurred for services performed by our vendors in connection with services for which we have not yet been invoiced. We base our expenses related to R&D activities on our estimates of the services received and efforts expended pursuant to quotes and contracts with contractors and vendors that conduct R&D on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. Advance payments for goods and services that will be used in future R&D activities are expensed when the activity has been performed or when the goods have been received rather than when the payment is made.

Although we do not expect our estimates to be materially different from amounts actually incurred, if our estimates of the status and timing of services performed differ from the actual status and timing of services performed, it could result in us reporting amounts that are too high or too low in any particular period. To date, there have been no material differences between our estimates of such expenses and the amounts actually incurred.

Fair Value of Financial Instruments

Authoritative guidance requires disclosure of the fair value of financial instruments. The Company applies fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The carrying amount of certain of the Company’s financial instruments, including cash and cash equivalents, accounts payable and accrued liabilities, approximate their estimated fair values primarily due to the short-term nature of the instruments or based on information obtained from market sources and management estimates. A fair value hierarchy is used to rank the quality and reliability of the information used to determine fair values. Financial assets and liabilities carried at fair value which is not equivalent to cost will be classified and disclosed in one of the following three categories:

·Level 1 — Quoted prices (unadjusted) in active markets for identical assets and liabilities;
·Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as unadjusted quoted prices for similar assets and liabilities, unadjusted quoted prices in the markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
·Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation.

The Company reviews the fair value hierarchy classification at each reporting date. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the periods presented.

Deferred Offering Costs

The Company capitalized as deferred offering costs all direct and incremental legal, professional, accounting and other third-party fees incurred in connection with the Company’s equity offerings. Deferred offering costs will be offset against offering proceeds upon the completion of an offering or during the offering period as proceeds are received on a pro rata basis. In the event that an offering is abandoned, deferred offering costs will be expensed in the period of abandonment in the unaudited condensed consolidated statement of operations.

Comprehensive Loss

There were no differences between net loss and comprehensive loss presented in the unaudited condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024.

Net Loss Per Share Attributable to Common Stockholders

Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration of potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, Redeemable Convertible Preferred Stock, convertible notes payable, warrants to purchase Redeemable Convertible Preferred Stock, outstanding warrants, unvested RSAs, and outstanding stock options and RSUs are considered to be potentially dilutive securities when outstanding (see Note 10). As of August 14, 2024, Redeemable Convertible Preferred Stock, convertible notes payable, warrants to purchase Redeemable Convertible Preferred Stock were no longer outstanding, and therefore were no longer considered to be potentially dilutive securities during the quarter ended March 31, 2025.

Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities as the Redeemable Convertible Preferred Stock and common stock subject to repurchase are considered participating securities. The Redeemable Convertible Preferred Stock did not have a contractual obligation to share in the Company’s losses, and unvested RSAs subject to repurchase is considered an unvested stock-based compensation award for accounting purposes. As such, the net loss is attributed entirely to common stockholders. Because the Company has reported a net loss for the reporting periods presented, the diluted net loss per common share is the same as basic net loss per common share for those periods.

Recently Issued Accounting Standards Not Yet Adopted

Accounting standards not listed below were assessed and determined not to be applicable or are expected to have minimal impact on the Company’s unaudited condensed consolidated financial statements.

In December 2023, the FASB issued ASU 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The guidance includes the requirement that public business entities, on an annual basis, disclose specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold (if the effect of those reconciling items is equal to or greater than 5% of the amount computed by multiplying pretax income (or loss) by the applicable statutory income tax rate). It also requires that all entities disclose, on an annual basis, the amount of income taxes paid (net of refunds received) disaggregated by federal (national), state, and foreign taxes and the amount of income taxes paid (net of refunds received) disaggregated by individual jurisdictions in which income taxes paid (net of refunds received) is equal to or greater than 5% of total income taxes paid (net of refunds received) and requires that all entities disclose income (or loss) from continuing operations before income tax expense (or benefit) disaggregated between domestic and foreign and income tax expense (or benefit) from continuing operations disaggregated by federal (national), state, and foreign. Lastly, the guidance eliminates the requirement for all entities to disclose the nature and estimate of the range of the reasonably possible change in the unrecognized tax benefits balance in the next 12 months or make a statement that an estimate of the range cannot be made. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The guidance should be applied on a prospective basis. Retrospective application is permitted. The Company is currently evaluating the impact that this guidance may have on its consolidated financial statements for the year ended December 31, 2025.

3. FAIR VALUE MEASUREMENTS

As of March 31, 2025 and December 31, 2024, there were no financial assets or liabilities carried at fair value which were not equivalent to cost.

**4. OTHER ACCRUED EXPENSES **

Other accrued expenses as of March 31, 2025 and December 31, 2024 consisted of the following:

Schedule of other accrued expenses
March 31, 2025December 31, 2024
Accrued clinical trial costs$4,796,265$5,483,846
Other accrued expenses404,497438,062
Total other accrued expenses$5,200,762$5,921,908

5. COMMITMENTS AND CONTINGENCIES

Operating Lease

On December 1, 2024, the Company rented office space on a month-to-month basis with no long-term commitment, representing a short-term lease. As a result, the Company has elected to apply the short-term lease exemption to its office lease and therefore has not recorded a right of use (“ROU”) asset and related lease liability in accordance with ASC 842, “Leases” (“ASC 842”). Rent expense recorded during the three months ended March 31, 2025 was $12,600, which amount is included in general and administrative expenses in the accompanying unaudited condensed consolidated statement of operations.

Legal

The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of its business. Such matters are subject to many uncertainties and outcomes and are not predictable with assurance. While management believes that such matters are currently insignificant, matters arising in the ordinary course of business for which the Company is or could become involved in litigation may have a material adverse effect on its business and financial condition. To the Company’s knowledge, the Company is not subject to any pending legal proceedings.

Indemnities and Guarantees

We have made certain indemnities and guarantees, under which we may be required to make payments to a guaranteed or indemnified party, in relation to certain transactions. We indemnify our officers and directors to the maximum extent permitted under the laws of the State of Delaware. The duration of these indemnities and guarantees varies and, in certain cases, is indefinite. These indemnities and guarantees do not provide for any limitation of the maximum potential future payments we could be obligated to make. Historically, we have not been obligated to make any payments for these obligations and no liabilities have been recorded for these indemnities and guarantees in the accompanying unaudited condensed consolidated balance sheets.

6. LICENSES AND AGREEMENTS

UIC License Agreement

On April 6, 2015, the Company entered into an Exclusive License Agreement with Equity (the “UIC License Agreement”) with The Board of Trustees of the University of Illinois (“UIC”), whereby, UIC granted the Company (a) an exclusive, nontransferable license, with the right to sublicense under UIC’s rights in the Patent Rights (as defined in the UIC License Agreement), and (b) a non-exclusive, non-transferable license, with the right to sublicense, to use UIC’s rights in the Technical Information (as defined in the UIC License Agreement) within the Territory and the Field as each such term is defined in the UIC License Agreement. In consideration of the license granted under the UIC License Agreement, the Company agreed to pay UIC (i) development milestones of up to $1.25 million, of which, up to $0.25 million is due upon the progress of clinical trials and $1.0 million is due upon the initiation of commercial sales, (ii) annual minimum royalty payments of $5,000 beginning on the third anniversary year of the UIC License Agreement and increasing to $15,000 in year four, $35,000 in year five, and $50,000 in year six and each year thereafter, (iii) royalty on net sales for product covered under the Patent Rights in the low single digits with a 50% reduction in royalties for products solely utilizing Technical Information, (iv) a declining percentage of sublicensing revenue based on the escalating stage of development upon a sublicensing event, and (v) the reimbursement of all patent and related expenses incurred by UIC covering the Patent Rights. For the three months ended March 31, 2025 and 2024, the Company incurred minimum royalties and other reimbursable expenses to UIC in the aggregate amount of $8,103 and $0, respectively, which amounts were included in general and administrative expenses in the accompanying unaudited condensed consolidated statements of operations.

In addition, the Company entered into a sublicense and collaboration agreement dated August 28, 2017 with an unrelated entity that was covered under the UIC License Agreement, which sublicense agreement was later terminated on January 31, 2018. Under the UIC License Agreement, the Company owed UIC a certain percentage of amounts received under the sublicense agreement in the amount of $449,990. The Company paid UIC 10% of the sublicense fees in the amount of $44,999 and the remaining unpaid balance of $404,991 (“Deferred Amount”) was originally due and payable to UIC in two installments: 50% due and payable on the one-year anniversary from the first commercial sale and 50% due on the second-year anniversary from the first commercial sale. The Deferred Amount is treated as debt and continues to accrue interest at a rate of five percent (5%) per annum, representing the prime rate as of the date of the agreement plus 1%. On July 16, 2024, the Company and UIC entered an amendment to the UIC License Agreement (“UIC Amendment”). Pursuant to the UIC Amendment, accrued interest is due and payable in two installments: (i) 50% was due within 30 days following the closing of the Company’s initial public offering (“IPO”) on August 14, 2024; and (ii) 50% is due within 30 days following the first anniversary of the closing of the IPO. Thereafter, interest will be paid annually within 30 days following the second anniversary of the closing of the IPO and annually thereafter. In addition, the UIC Amendment provides for payment of the Deferred Amount and any accrued interest thereon upon the sooner of (i) termination of the UIC License Agreement by the Company, (ii) the Company ceases development of the licensed UIC technology, (iii) the Company consummates a Change in Control (as defined in the UIC License Agreement), (iv) the Company sublicenses the licensed technology or the developed product, (v) the one-year anniversary following approval of a NDA of a licensed product, or (vii) the Company executes a partnership agreement with any entity resulting in the payment to us above a specified milestone amount or the Company secures cumulative financing equal to or exceeding $200 million. In addition, the UIC Amendment provides that to the extent the Company secures equity financing equal to or exceeding $85 million through its IPO or otherwise, 50% of the Deferred Amount is due and payable within 30 days. The remaining 50% of the Deferred Amount shall be due and payable upon the first to occur of any of the events noted above in clauses (i) through (vii). Finally, the UIC Amendment provides that for as long as the Company or a sublicensee is selling the licensed product, the Company will pay all consideration provided for in the original UIC License Agreement and described above until the last to expire market exclusivity date, the period of which for all products in a jurisdiction will not exceed a total of seven (7) years beginning with the date regulatory approval is granted for the first licensed product in the jurisdiction, and such obligation will survive termination of the UIC License Agreement.

As of March 31, 2025, interest payable to UIC was $82,788, of which, $70,957 is classified as current and $11,831 is classified as non-current. As of December 31, 2024, interest payable to UIC was $77,725, of which, $70,957 was classified as current and $6,768 is classified as non-current, which amounts are included in the accompanying unaudited condensed consolidated balance sheets.

7. STOCKHOLDERS’ EQUITY (DEFICIT)

Authorized and Issued Capital

The Company’s authorized capital consists of 200,000,000 shares of common stock, $0.000001 par value per share, and 10,000,000 shares of preferred stock, $0.000001 par value per share. As of March 31, 2025 and December 31, 2024, there were 19,531,636 shares of common stock issued and outstanding. There wereno shares of preferred stock outstanding as of March 31, 2025 and December 31, 2024.

Committed Equity Facility

On March 27, 2025, the Company entered into a Committed Equity Facility with B. Riley giving the Company the right, but not the obligation, to sell to B. Riley over a 36-month period up to the lesser of (i) $50 million of newly issued shares of our common stock and (ii) 3,904,374 shares of the Company’s common stock. The price per share of common stock sold to B. Riley is determined by reference to the volume weighted-average price of the Company’s common stock as defined within the Committed Equity Facility less a 3% discount, subject to certain limitations and conditions. The total net proceeds that the Company will receive under the Committed Equity Facility will depend on the frequency and prices at which the Company sells common stock to B. Riley.

Upon the initial satisfaction of the conditions to B. Riley’s obligation to purchase shares under the Committed Equity Facility, including that a registration statement registering the resale by B. Riley of the shares of common stock under the Securities Act of 1933, as amended (the “Securities Act”) is declared effective by the SEC and a final prospectus relating thereto is filed with the SEC, we will have the right, but not the obligation, from time to time at our sole discretion, to deliver one or more notices to direct B. Riley to purchase a specified number of shares of common stock on any trading day, not to exceed the lesser of: (i) 1,000,000 shares of common stock and (ii) up to 50.0% of the total aggregate number (or volume) of shares of our common stock traded on Nasdaq during the applicable trading day, provided the closing sale price of our common stock on Nasdaq on the trading day immediately prior to such purchase date is not less than $1.00.

In addition, we will not sell, and B. Riley will not purchase any shares pursuant to the Committed Equity Facility, which, when aggregated with all other shares of common stock then beneficially owned by B. Riley and its affiliates, would result in the beneficial ownership by B. Riley and its affiliates of more than 4.99% of our outstanding voting power or shares of common stock.

Moreover, under the applicable Nasdaq rules, in no event may we issue to B. Riley more than 3,904,374 shares of common stock (representing 19.99% of the shares of common stock outstanding immediately prior to the execution of the Committed Equity Facility) unless (i) we obtain stockholder approval in accordance with applicable Nasdaq rules, or (ii) the average price per share paid by B. Riley for all of the shares of common stock that we direct B. Riley to purchase from us pursuant to the Committed Equity Facility equals or exceeds $7.56 per share (representing the lower of (a) the official closing price of our common stock on Nasdaq immediately preceding the execution of the Committed Equity Facility and (b) the average official closing price of our Common Stock on Nasdaq for the five consecutive trading days immediately preceding the execution of the Committed Equity Facility, as adjusted to take into account the payment of the Cash Commitment Fee (as defined below) to B. Riley).

As consideration for B. Riley’s commitment to purchase shares of common stock at the Company’s direction, the Company agreed to pay B. Riley a cash commitment fee in the amount of up to $500,000 (the “Cash Commitment Fee”), which represents 1.0% of B. Riley’s $50,000,000 total aggregate purchase commitment under the Committed Equity Facility. The Cash Commitment Fee will be earned and paid by withholding cash amounts equal to 10% of the total aggregate purchase price payable by B. Riley to the Company in connection with each purchase effected under the Committed Equity Facility, until such time as B. Riley shall have earned and received from such cash withholdings a total aggregate amount in cash equal to $500,000.

In addition, the Company has agreed to reimburse B. Riley for the reasonable legal fees and disbursements of B. Riley’s legal counsel and other expenses in an amount not to exceed $125,000 in addition to $5,000 per fiscal quarter during the term of the Committed Equity Facility.

We have the right to terminate the Committed Equity Facility at any time, at no cost or penalty, upon ten (10) trading days’ prior written notice to B. Riley. In addition, there are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages under the Committed Equity Facility, other than a prohibition (with certain limited exceptions) on entering into specified variable rate transactions, as defined.

As of March 31, 2025, there have been no sales to B. Riley under the Committed Equity Facility (see Note 13).

Reserved Shares

As of March 31, 2025, the Company reserved the following shares of common stock for issuance upon the (i) exercise of outstanding warrants, (ii) issuance of shares reserved under the Committed Equity Facility, (iii) exercise of issued and outstanding stock option awards and restricted stock unit awards, and (v) to reserve the remaining shares available for grant under the 2024 Stock Incentive Plan (“2024 Plan”):

Schedule of reserved shares of common stock for issuance
Warrants issued and outstanding to purchase common stock255,599
Shares of common stock reserved under the Committed Equity Facility3,904,374
Stock option awards issued and outstanding860,539
Restricted stock unit awards issued and outstanding584,111
Shares reserved for issuance under the 2024 Plan3,241,721
Total8,846,344

8. WARRANTS

As of March 31, 2025, the following warrants to purchase up to 255,599 shares of common stock were outstanding:

Schedule of warrant outstanding
Warrants OutstandingExercise Price per ShareExpiry Date
Warrants issued under IPO161,000$10.00August 12, 2027
Warrants originally issued in conjunction with Series B Redeemable Convertible Preferred Stock76,376$10.55August 13, 2026
Warrants originally issued in conjunction with Series C Redeemable Convertible Preferred Stock18,223$9.42August 13, 2026
Total255,599

9. EQUITY COMPENSATION PLANS

Stock Incentive Plans

In connection with the Company’s IPO, our board of directors adopted and our stockholders approved our 2024 Stock Incentive Plan (the “2024 Plan”), which became effective on August 12, 2024, the effective date of the registration statement for the Company’s IPO. The purpose of the 2024 Plan is to enhance the Company’s ability to attract, retain and motivate individuals by providing these individuals with equity ownership and incentive opportunities. All of the Company’s employees, as well as all of the Company’s non-employee directors and other consultants, advisors and other persons who provide services to the Company are eligible to receive incentive awards under the 2024 Plan, including stock options grants, stock appreciation rights (“SARs”), restricted stock awards (“RSAs”), restricted stock units (“RSUs”), and other awards. Up to 3,316,444 shares of common stock were originally reserved for future issuance under the 2024 Plan. In addition, the number of shares of common stock available for issuance under the 2024 Plan is subject to an automatic annual increase on the first day of each calendar year beginning on January 1, 2025 and ending on and including January 1, 2034 equal to the lesser of (i) 5% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as may be determined by the Board. Effective January 1, 2025, the number of shares of common stock reserved for issuance under the 2024 Plan increased by 976,581 under clause (i). As of March 31, 2025, there were 3,241,721 shares available for grant under the 2024 Plan.

In addition, the Company had previously adopted the 2015 Stock Incentive Plan (the “2015 Plan”). As of March 31, 2025, there were 365,568 stock options outstanding and 25,192 unvested RSAs outstanding under the 2015 Plan. On the effective date of the 2024 Plan, there were no remaining shares available for grant under the 2015 Plan.

Restricted Stock Awards

There were no RSAs granted during the three months ended March 31, 2025. At March 31, 2025, the total estimated unrecognized compensation cost related to unvested service-based RSAs and unvested performance based RSAs was approximately $27,000 and $42,000, respectively. The unrecognized cost related to service-based RSAs is expected to be recognized over the remaining weighted average vesting period of 0.68 years. The unrecognized cost related to performance-based RSAs will be recognized ratably over the performance period based upon the probable number of shares expected to vest. As of March 31, 2025, there was no expense recorded for the outstanding performance-based RSAs.

The following summarizes our RSAs transaction activity for three months ended March 31, 2025:

Schedule of RSAs transaction activity
Restricted Common Stock Award SharesWeighted Average Grant Date Fair Value
Unvested balance at December 31, 202446,463$2.48
Granted–$–
Vested(21,271)$2.11
Forfeited–$–
Unvested balance at March 31, 202525,192$2.80

Restricted Stock Units

At March 31, 2025, the total estimated unrecognized compensation cost related to unvested RSUs was approximately $3,724,000. This cost is expected to be recognized over the remaining weighted average vesting period of 1.07 years.

The following summarizes our RSUs transaction activity for the three months ended March 31, 2025:

Schedule of RSUs transaction activity
Restricted Common Stock Unit SharesWeighted Average Grant Date Fair Value
Unvested balance at December 31, 2024544,111$9.15
Granted40,000$9.68
Vested–$–
Forfeited–$–
Unvested balance at March 31, 2025584,111$9.19

Stock Options

The following summarizes our stock option transaction activity for the three months ended March 31, 2025:

Schedule of stock option transaction activity
Number of Stock OptionsGrant Date Weighted Average Exercise Price
Outstanding at December 31, 2024780,539$5.52
Options granted80,000$8.87
Options exercised–$–
Options canceled and forfeited–$–
Outstanding at March 31, 2025860,539$5.83

As of March 31, 2025, total unrecognized stock-based compensation cost related to stock options was approximately $2,594,000. This cost is expected to be recognized over the weighted average remaining period of 1.54 years.

The following table provides the assumptions used in determining the estimated fair value of stock option awards granted during the three months ended March 31, 2025:

Schedule of stock option assumptions
Expected volatility100.98%
Risk-free interest rate4.39%
Expected dividend yield0.00%
Expected term (in years)5.69

The following table summarizes the stock-based compensation expense recorded in the accompanying unaudited condensed consolidated statements of operations during the three months ended March 31, 2025 and 2024:

Schedule of stock-based compensation expense
Three Months Ended March 31,
20252024
Research and development$128,926$72,948
General and administrative996,17575,258
Total$1,125,101$148,206

The Company has not recognized and does not expect to recognize in the near future, any tax benefit related to employee stock-based compensation expense as a result of the full valuation allowance related to its net deferred tax assets.

10. Net Loss Per Share Attributable to Common Stockholders

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders:

Schedule of computation of basic and diluted net loss per share attributable to common stockholders
Three Months Ended March 31,
20252024
Numerator:
Net loss$(6,317,024)$(8,296,059)
Denominator:
Weighted-average shares of common stock outstanding, basic and diluted19,497,7311,535,167
Net loss per share attributable to common stockholders, basic and diluted$(0.32)$(5.40)

The potential dilutive effect of Redeemable Convertible Preferred Stock and Related Party Convertible Notes Payable outstanding during the three months ended March 31, 2024 was calculated using the if-converted method assuming the conversion of underlying instruments as of the earliest period reported or at the date of issuance, if later, but are excluded if their effect is anti-dilutive. The potential dilutive effect of outstanding stock options, unvested RSAs, unvested RSUs, and outstanding warrants during the period are calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive.

The number of whole shares of common stock that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect were as follows:

Schedule of anti-dilutive shares
March 31,
20252024
Redeemable Convertible Preferred Stock–13,710,379
Related Party Convertible Notes Payable to purchase redeemable convertible preferred stock–576,475
Options issued and outstanding860,539393,346
Unvested RSAs25,192138,385
Unvested RSUs584,111–
Warrants issued and outstanding255,599170,975
Total1,725,44114,989,560

11. RELATED PARTY TRANSACTIONS

During 2018, the Company entered into a master service agreement with Pacific BioPharma Logistics, Inc. (“PBL”) to provide clinical support related to the packaging, labeling, kitting, storage, distribution and inventory of the Company’s investigational products. Mr. Richard Kenley, Vice President of Manufacturing for the Company (but not an “executive officer” of the Company, as defined under Rule 3b-7 of the Securities Exchange Act of 1934, as amended), is an unpaid advisor for PBL and his spouse is a shareholder in PBL. During the three months ended March 31, 2025 and 2024, we incurred $168,271 and $371,423, respectively, in services provided by PBL, which amounts are included in research and development expense in the accompanying unaudited condensed consolidated statements of operations. As of March 31, 2025 and December 31, 2024, we had an outstanding balance owed to PBL of $81,973 and $51,540, respectively, which amounts are included in accounts payable in the accompanying unaudited condensed consolidated balance sheets.

12. SEGMENT REPORTING

The Company manages its operations as a single operating segment, which includes all activities related to the development and potential commercialization of novel therapies for the treatment of cancer, for the purposes of assessing performance and making operating decisions. The determination of a single business segment is consistent with the consolidated financial information regularly provided to the Company’s chief operating decision maker (“CODM”). The Company’s CODM is its President and Chief Executive Officer, who reviews and evaluates consolidated net income (loss) for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods.

In addition to the significant expense categories included within consolidated net income (loss) presented on the Company’s unaudited condensed consolidated statements of operations, see below for disaggregated amounts that comprise research and development expenses for the three months ended March 31, 2025 and 2024:

Schedule of research and development expenses
Three Months Ended March 31,
20252024
External clinical trial expenses$1,834,371$5,098,162
Personnel and consulting expenses856,693868,974
Chemistry Manufacturing & Control (“CMC”) related costs436,854588,506
Preclinical and biomarker research92,401304,788
Total research and development expenses$3,220,319$6,860,430

In addition, the Company has a wholly-owned subsidiary, Actuate Therapeutics Limited, which is a dormant entity with no assets, liabilities or operations in any foreign countries.

13. SUBSEQUENT EVENTS

The Company has evaluated all subsequent events and transactions through the date these unaudited condensed financial statements were issued, to ensure these financial statements include appropriate disclosure of events both recognized in the financial statements and events which occurred but were not recognized in the financial statements. The Company has concluded that no subsequent event has occurred that requires disclosure, except as described below.

Awards Granted under the 2024 Plan

During April 2025, the Company granted to certain of its employees and consultants stock options to purchase an aggregate of 839,880 shares of our common stock at an exercise price of $6.70 per share and awarded to certain consultants 200,000 RSUs under the Company’s 2024 Plan.

Committed Equity Facility

Subsequent to March 31, 2025 and through May 14, 2025, the Company issued 72,082 shares of common stock to B. Riley under the Committed Equity Facility (see Note 7) in exchange for net proceeds of approximately $597,000.

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