ACTU 10-K & 10-Q changes, risk factors and insider trading

We have a limited operating history, have incurred incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future. We have a high risk ofmay never generatinggenerate revenue or becomingachieve profitableprofitability, or,and if we do achieve profitability, it may not be sustained.

We have incurred losses since our inception in January 2015 through December 31, 2024 and our accumulated deficit was approximately $132.4$154.6 million at December 31, 2024. 2025. Substantially all of our losses have resulted from expenses incurred in connection with our research and development activities and from general and administrative costs associated with our operations. We expect to continue to incur substantial and increasing operating losses over the next several years as we continue the clinical development of, seek regulatory approval for and potentially commercialize elraglusib and any future product candidates, as well as operate as a public company.

The magnitude of our future losses losses and when, if ever, we will become profitable are uncertain. We do not have any products that have generated any revenues from commercial sales, and do not expect to generate revenues from the commercial sale of products in the near future, if ever. If we are unable to successfully develop, obtain requisite approval for and commercialize elraglusib or any future product candidates, we may never generate revenue. Our ability to generate revenue and achieve profitability will depend on, among other things, successful completion of the development of our product candidates; obtaining necessary regulatory approvals from the FDA and international regulatory agencies; establishing manufacturing, sales, and marketing arrangements with third parties; obtaining adequate reimbursement by third-party payers; and raising sufficient funds to finance our activities. If we are unsuccessful at some or all of these undertakings, our business, financial condition, and results of operations are expected to be materially and adversely affected.things:

We will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or otherour operations.

As of December 31, 2025, we had approximately $13.2 million in cash and cash equivalents and working capital of approximately $7.9 million. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Report will not satisfy the Company’s operational and capital requirements beyond July 2026. Our estimates and assumptions regarding our operating costs may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our operating plans and other demands on our cash resources may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned.

We have incurred and expect to continue to incur significant costs in the development of our sole drug candidate, elraglusib. Accordingly, in the near term, we intend to seek and will need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may may not be available to us on acceptable terms, or at all, including as a result of financial and credit market deterioration or instability, market-wide liquidity shortages, geopolitical events or otherwise. If we are unable to raise capital in the near term or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts, or even curtail or cease operations. Even if we secure necessary financing in the near term, we expect to continue to require substantial funding as the timing for and ability to generate sufficient funds from operations will remain uncertain until such time as we are able to progress elraglusib through development and potential commercialization.

Risks Related to Clinicalthe Development and Potential RegulatoryCommercialization Approvalof Our Product Candidates

If we experience delays or difficulties in the enrollment ofenrolling subjects to our clinical trials, our receipt of necessary regulatory approvals could be delayed or otherwise adversely affected.

Identifying, screening and enrolling enrolling patients to participate in clinical trials of our product candidates is critical to our success, and we may not be able to identify, recruit, recruit, enroll and dose a sufficient number of patients with the required or desired characteristics to complete our clinical trials in a timely manner. We may not be able to initiate or continue certain clinical trials for elraglusib or any future product candidates if we are unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or similar regulatory authorities outside the United States. The timing of our clinical trials depends on our ability to recruit patients to participate as well as to subsequently dose these patients and complete required follow-up periods. Patient enrollment, a significant factor in the timing of clinical trials, is affected by many factors, including the size and characteristics of the patient population, the proximity of patients to clinical sites, the eligibility and exclusion criteria for the trial, the design of the clinical trial, the risk that enrolled patients will not complete a clinical trial, our ability to recruit clinical trial investigators with the appropriate competencies and experience, and competing clinical trials and clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidates being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating as well as any product candidates under development. We will be required to identify and enroll a sufficient number of patients for each of our clinical trials and monitor such patients adequately during and after treatment. Potential patients for any planned clinical trials may not be adequately diagnosed or identified with the diseases which we are targeting, which could adversely impact the outcomes of our trials and could have safety concerns for the potential patients. Potential patients for any planned clinical trials may also not meet the entry criteria for such trials. In particular, because our planned clinical trials of elraglusib are focused on indications with relatively small patient populations, our ability to enroll eligible patients may be limited or may result in slower enrollment than we anticipate.:

As a company, we have not yet initiated nor completed a Phase 2 3 clinical trial and have limited experience in completing regulatory filings, and any delays in regulatory filings could materially affect our financial condition.

We will need to successfully complete complete clinical trials in order to obtain FDA or comparable foreign regulatory approval to market elraglusib or any future product candidates. Carrying out clinical trials and the submission of a successful NDA or other comparable foreign regulatory submission is a complicated process. As a company, we have not yet initiated nor completed a Phase 23 clinical trialstrial of our product candidates, nor have we demonstrated the ability to obtain marketing approvals, manufacture product candidates at a commercial scale, or conduct sales and marketing activities necessary necessary for the successful commercialization of a product. We may also choose to conduct a number of additional clinical trials of elraglusib in parallel over the next several years, which may be a difficult process to manage with our limited resources and which may divert attention of management. FDA or other regulatory authority could also require us to conduct additional trials which may further delay approval of our product. Consequently, we have no historical basis as a company by which you can evaluate or predict reliably our future success or viability.

Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability, or commercialization of the particular product candidate or product and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate, or our business. If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize elraglusib and any future product candidates may be harmed, which could harm our business, operating results, prospects, or financial condition.

The following discussion and and analysis of the financial condition and results of our operations should be read together with the consolidated financial statements and and related notes of Actuate Therapeutics, Inc. included in Part II Item 8 of this Annual Report on Form 10-K (“Annual Report” or “Report”).

This discussion and analysis containscontain forward-looking statements reflecting our management’s current expectations that involve risks, uncertainties and assumptions. See the section entitled “Cautionary Note Regarding Forward-Looking Statements.” Our actual results and the timing of events may differ materially from those described in or implied by these forward-looking statements due to a number of factors, including those discussed below and elsewhere in this Report, particularly those set forth under “Risk Factors.”

We are a clinical stage biopharmaceutical company focused on developing therapies for the treatment of high impact, difficult to treat cancers through the inhibition of glycogen synthase kinase-3 (“GSK-3”). We are developing elraglusib (formerly 9-ING-41),elraglusib, an ATP-competitive small molecule that is designed to enter cancer cells and block the function of the enzyme glycogen synthase kinase-3 beta (“GSK-3β”), a master regulator of complex biological signaling cascades, including those mediated by oncogenes, that lead to tumor cell survival, growth, migration, and invasion. We believe that the blockade of GSK-3β signaling ultimately results in the death of the cancer cells and the regulation of anti-tumor immunity. There are no approved high-affinity inhibitors of GSK-3β, and we believe elraglusib is one of the most advanced GSK-3β inhibitors in clinical development. Elraglusib was originally known as 9-ING-41 but was granted the elraglusib International Nonproprietary Names (“INN”) and United States Adopted Names (“USAN”) generic name in 2021.

ElraglusibWe believe elraglusib represents a “pipeline in a molecule” with a broad opportunity for us to potentially initiate and advance multiple drug development programs around our lead asset based on its multimodal mechanisms of action, data emerging from completed or ongoing Phase 1/2clinical trials and non-clinical biological, cellular, and animal data. Animal tumor model data, Phaseclinical 1/2 clinicaltrial data and AI-based computational approaches have identified a number of areas of unmet clinical need in cancer treatment where elraglusib may play an interventional role, including pancreatic, metastatic melanoma, lung, colon, breast, renal, and ovarian cancer, leukemias and lymphomas, as well as some pediatric cancers including Ewing sarcoma, neuroblastoma and pediatric leukemias.

We have developed several oral oral dosage forms of elraglusib, which we believe will allow us to expand the number of cancer indications that we are able to target and allow us to further explore more convenient dose delivery options for patients. A clinical candidate tablet, the Elraglusib Oral Tablet, has has been selected for further development andand, subject to future funding, we are planning a Phase 1 study (Actuate-2401) to identify the maximum tolerated dose (“MTD”) and recommended Phase 2 dose (“RP2D”) for Elraglusib Oral Tablet in adult patients with advanced, refractory adultcancers. cancersOnce subject towe futurehave funding.determined Subjecta to additional funding,RP2D, several Phase 2 studies have been identified for further clinical development of Elraglusib Oral TabletTablet, subject to additional funding, based on data from theprevious Actuate-1801 study in indications,studies, including but not limited to, refractory, metastatic melanoma and refractory, metastatic colorectal cancer, and non-small cell lung cancer.

Although research and development activities are central to our business model, the successful development of elraglusib and any future product candidates is highly uncertain. There are numerous factors associated with the successful development of any product candidate such as elraglusib, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased number of patients and duration of later-stage clinical trials. As a result, we expect our research and development expenses willto increase substantially in connection with our ongoing and planned clinical and preclinical development activities in the near term and in the future, provided we are able to raise additional capital. At this time, we cannot accurately estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of elraglusib and any future product candidates. Our future research and development expenses may vary significantly based on a wide variety of factors such as:

General and administrative expenses expenses consist primarily of personnel-related expenses such as employee compensation, benefits, and stock-based compensation, for our personnel personnel in executive and other administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters and professional fees paid for accounting, auditing, consulting and tax services, as well as other costs such as insurance costs, board of director fees, investor and public relations, and travel expenses.

We anticipate our general and and administrative expenses will increase substantially in the future as we expand our operations, including increasing our headcount to support our our continued research and development activities and preparing for later-stage clinical trials and potential commercialization of elraglusib. We also anticipate we will continue to incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance, and investor and public relations expenses associated with operating as a public company.

The decrease in research and development development expenses of $3,032,056$8,383,656 for the year ended December 31, 20242025 compared to the prior year was primarily due to (i) a decrease in preclinical and biomarker studies in the current period of $1,402,916 due to few contracted studies in the current year, (ii) a decrease in external clinical trial expenses of $573,612$8,336,486 mostly related to lower contractpatient researchfees organizationsand (“CRO”) costs inassociated thewith currentfewer yearpatients on study related to the randomized Phase 2 mPDAC trial (Actuate-1801 Part 3B) associatedas withthe fewertrial patientswinds ondown study,and (iiiii) a decrease of $539,148 in Chemistry Manufacturing & Control (“CMC”) related costs due to a decrease in manufacturingCMC related costs of elraglusib$953,419 in the current periodprimarily due to the timing of drug substanceproduct manufacturing toand supportstability thestudies. randomizedThese Phasedecreases 2were mPDACpartially trialoffset by (Actuate-1801i) Partan 3B), increase in preclinical and biomarker studies of $575,238, driven by new studies completed during 2025, and (ivii) aan decrease increase in personnel and consulting expenses of $516,380$331,011, primarily due to ahigher decreasenon-cash instock-based consultingcompensation feesexpense inof the current period as certain consultants transitioned to full-time employment at an overall lower cost to the Company.$314,933.

The increase in general and administrative administrative expenses of $3,218,961$5,718,234 for the year ended December 31, 20242025 compared to the prior year was primarily due to (i) an increase in personnel-related expenses of $1,943,643$3,834,300 primarilymostly due to an increase in non-cash stock-based compensation expense of approximately $1.6 million$3,735,935 related to awards granted to theemployees, president and chief executive officer, the chief financial officer,non-employee members of the board of directorsdirectors, inand connection withconsultants of the IPO, and other administrative award grantsCompany combined with an increase in payroll and bonusrelated expenseexpenses of approximately $0.3 million mostlyprimarily related to the hiring of the Company’s chief financial officer in connectionJune with2024, thean IPOincrease in base salaries for certain administrative employees, offset by a decrease in bonus expense, (ii) an increase in professional and consulting fees of $774,006$1,148,376 primarily relateddue to an increase in search(a) firminvestor relatedand public relation fees, (b) consulting fees toassociated identifywith increased administrative support, and add three new board members to the Company’s Board of Directors to comply with Nasdaq listing requirements, an increase in valuation services to support the estimated fair market value of the Company’s common stock and other financial instruments, including the fair value of the Related Party Convertible Notes Payable, an increase in(c) legal fees related to additionalroutine corporate mattersactivities, which amounts were offset by a decrease in board member search fees and intellectualvaluation propertyservices costs, and an increase in audit and audit related fees associated with the annual and quarterly review of the Company’s financial statements, and (iii) an increase in other expenses of $501,312$735,558 primarily due to an increase in the cost of directors and officerofficers insurance during the current period, combined with an increase ininsurance, board fees, investor relationslisting fees, and other public company expenses.

Since our inception, we have not not generated any revenue from product sales and have incurred significant operating losses and negative cash flows from operations. We expect expect to incur significant expenses and operating losses in the foreseeable future as we advance the clinical development of elraglusib and and any future product candidates. As of December 31, 2024, we had cash and cash equivalents of $8,641,622.

As of December 31, 2025, we had cash and cash equivalents of $13,159,423 and working capital of $7,936,503. We expect our expenses to increase substantially substantially in connection with our ongoing activities, particularly as we continue our development of, seek regulatory approval for, and potentially commercialize elraglusib and potentially seek to discover and develop and/or license or acquire additional product candidates, conduct conduct our ongoing and planned clinical trials and preclinical studies, continue our research and development activities, utilize third parties parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated associated with being a public company. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Annual Report will not satisfy the Company’s operational and capital requirements beyond July 2026 without raising additional capital. There can be no assurance that the Company will be able to raise sufficient proceeds in the future under the ATM Facility or Committed Equity Facility or any additional financing will be available to the Company on acceptable terms, if at all.

We have no other committed sources of capital. Until such time, if ever, as we can generate substantial product revenue, we expect to finance our operations through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, and other similar arrangements. As we seek additional financing in the near future, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our ability to raise additional funds may be adversely impacted by business conditions, global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. To the extent we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest in our common stock will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends. If we raise additional funds through collaborations or license agreements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity, debt, or other financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or even cease operations.

Year Ended December 31, 2025 — Net cash used in operating activities for the year ended December 31, 2025 consisted of our net loss of $22,227,852 combined with cash used by a net change in operating assets and liabilities of $3,045,312, which amounts were offset by non-cash stock-based compensation expense of $6,046,661 and an increase in accrued interest on license payable of $20,250 Year Ended December 31, 2024 — Net cash used in operating activities for the year ended December 31, 2024 consisted of our net loss of $27,285,328 combined with the non-cash gain on settlement of the warrant liability of $343,240, which amounts were offset by (i) non-cash stock-based compensation expense of $1,995,793, (ii) a non-cash increase in the fair value of our warrant liability of $78,903, (iii) a loss on issuance of Related Party Convertible Notes Payable at fair value of $400,000, (iv) the change in estimated fair value of Related Party Convertible Notes Payable of $2,192,507, (v) an increase in accrued interest on license payable of $18,641, and (vi) cash provided by a net change in operating assets and liabilities of $1,100,076.

Year Ended December 31, 2023 2025 —During During the year ended December 31, 2023,2025, net cash provided by financing activities consisted of net proceeds received of $4,134,516(i) related$15,573,966 under the September 2025 Public Offering, (ii) $4,592,462 under the June 2025 Private Placement, (iii) $3,826,336 from the sale of common stock to B. Riley under the issuance Committed Equity Facility, and (iv) $34,115 from the exercise of Seriesstock Coptions, Redeemablewhich Convertibleamounts were Preferredoffset Stock.by the payment of deferred offering costs of $302,825.

TheIn April 2015 and August 2024, the Company’s Board of Directors (“Board”) adopted the 2015 Stock Incentive Plan (“2015 Plan”) and the 2024 Stock Incentive Plan (“2024 Plan”), respectively. Under the 2015 Plan and 2024 Plan, the Company periodically grants equity-based equity-based payment awards in the form of restricted common stock awards (“RSAs”), restricted stock units (“RSUs”), and stock options to employees, directors, consultants and non-employees and records stock-based compensation expenses for awards of stock-based payments based on their estimated fair value at the grant date.

The estimated fair value of service-based service-based RSAs and RSAsRSUs are measured at the grant date based on the estimated fair market value of the Company’s common stock on the date of grant and is recognized as expense over the requisite service period, which is generally the awards’ vesting period. The estimated fair value of performance-based RSAs is measured at the grant date based on the estimated fair value of shares expected to be earned at the end of the performance period, and is recognized as expense ratably over the performance period based upon the probable number of shares expected to vest.

The Company accounts for the grant grant of stock options based on the estimated fair value of the underlying option using the Black-Scholes valuation model on the date of grant and are recognized as expense in the consolidated statement of operations on a straight-line basis over the requisite service period, period, which is the vesting period. The Black-Scholes valuation model requires the input of subjective assumptions, including expected volatility, volatility, expected dividend yield, expected term, risk-free rate of return and the estimated fair value of the underlying common stock on the date of grant. Prior to the IPO, the Company regularly engaged a third-party valuation specialist to assist with estimates related to the valuation of the Company’s common stock. PostSince the Company’s IPO, the fair value of our common stock iswas determined based on the closing price of our common stock as reported on the date of grant on the primary stock exchange on which our common stock is traded.

Other than as set forth below and in Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” there have been no material changes to our risk factors disclosed in Part I, Item 1A, of our Annual Report.

This discussion and analysis contains forward-looking statements reflecting our management’s current expectations that involve risks, uncertaintiesuncertainties, and assumptions. See the section entitled “Cautionary Note Regarding Forward-Looking Statements.” Our actual results and the timing of events may differ materially from those described in or implied by these forward-looking statements due to a number of factors, including those discussed below and elsewhere in this Report, particularly those set forth under “Risk Factors.”

We have exclusively licensed elraglusib, elraglusib, a proprietary and patent protected GSK-3 inhibitor developed inthrough a collaboration between The Board of Trustees of the University of Illinois-Chicago (“UIC”) and Northwestern University (“NU”).

To date, we have treated over 500 patients with elraglusib as an IV injection (“Elraglusib Injection”) in Phase 1 and Phase 2 studies. We have also developed an oral formulation of elraglusib (“Elraglusib Oral Tablet”), which we believe will allow us to pursue a number of cancer indications with a more convenient dose delivery option for patients with the ability to dose patients on a daily basis. We filed an Investigational New Drug (“IND”) application with the FDA in April 2026 to advance the Elraglusib Oral Tablet into a Phase 1/2 clinical study to identify the maximum tolerated dose and Recommended Phase 2 Dose (“RP2D”) in adult patients with advanced, refractory cancerscancers, and we recently received FDA clearance to proceed with the Phase 1/2 clinical study. Once we have determined a RP2D, several Phase 2 or registrational studies have been identified for further clinical development of Elraglusib Oral Tablet, subject to additional funding, based on data from previous studies, including but not limited to, first-line metastatic pancreatic ductal adenocarcinoma (“mPDAC”), refractory, metastatic melanoma, refractory, metastatic colorectal cancer, and non-small cell lung cancer.

In addition, we have generated promising results with a once weekly IV infusion of elraglusib in first-line treatment of patients with mPDAC. Our Phase 2 clinical study in mPDAC, known as Actuate-1801 Part 3B study,3B, is a randomized, controlled Phase 2 clinical study that enrolled 286 patients with no prior systemic treatment treatment for metastatic disease. The primary endpoint for this clinical study was median overall survival (“mOS”), with overall survival (“OS”) summarized throughout the study by estimates of 1-year survival. Updated data results presented at the American Society of Clinical Oncology (“ASCO”) GenitourinaryGastrointestinal Cancers Symposium (“ASCO GI”) in January 20262026, utilizing a data cutoff as of November 22, 2025 2025, showed that the clinical study met its primary endpoint, demonstrating a statistically significant improvement in mOS with elraglusib plus gemcitabine/nab-paclitaxel (“GnP”) versus GnP alone. Data presented at ASCO GI included:

While these data are impressive with once weekly dosing, we believe we can further improve the outcome of patients using the Elraglusib Oral Tablet at the RP2D, including a more frequent dosing regimen to be identified in the Phase 1/2 clinical study. We believe this strategy will further align with other new approaches to treating mPDAC with investigational products that are delivered orally to patients. In addition, the safety profile of elraglusib in over 500 patients to date shows the product is well tolerated as a monotherapy and in combination with chemotherapy. We believe this will may allow the Elraglusib Oral Tablet to be combined with other investigational products, including but not limited to RAS and MEK inhibitors, where possible additive or synergistic mechanisms of action may potentiate better outcomes for patients treated with combination therapy including elraglusib.

In addition to our development plans for the Elraglusib Oral Tablet, we have advanced the development of Elraglusib Injection in pediatric cancer patients with recurrent/refractory solid cancers. This clinical study, Actuate-1902, is a Phase 1/2 study that evaluated escalating doses of elraglusib as a single agent as well as in combination with irinotecan or cyclophosphamide/topotecan in the Phase 1 portion of the study. Patients in thisthe Actuate-1902 study also experienced a number of objective responses in the combination chemotherapy arms, and based on thisthese data, we identified neuroblastoma and Ewing sarcoma and neuroblastoma as possible new indications for further development of Elraglusib Injection, pending additional funding primarily focused on non-dilutive sources orof capital, further expanding the potential use and positive therapeutic impact of elraglusib. In June 2026, we entered into an initial agreement with the University of Birmingham to evaluate elraglusib in the BEACON2 clinical study, an international, multi-arm, multi-stage platform clinical study designed to identify and advance promising treatment approaches for children with relapsed and refractory neuroblastoma. The planned clinical study is expected to enroll up to 20 patients with relapsed and refractory neuroblastoma in a dose confirmation cohort to evaluate safety and to determine the maximum tolerated dose (“MTD”), RP2D, and pharmacokinetics (“PK”) profile of the combination of elraglusib with dinutuximab beta plus chemotherapy. Following completion of the dose confirmation stage, the regimen may advance into a randomized portion of the study, where approximately 75 patients will be enrolled with a planned interim analysis.

Research and development expenses consist primarily of external and internal costs incurred in performing clinical and nonclinical development activities. Our external research and development costs primarily consistsconsist of the costcosts incurred under agreements with hospitals tothat treat and monitor patients enrolled enrolled in our clinical studies, contract research organizations and contract manufacturers, consultantsconsultants, and other third parties to that conduct and support our clinical studies and nonclinical studies. Our internal research and development costs primarily include research and development personnel-related expenses such as employee compensation, benefits, employer taxes, insurance, and stock-based compensation.

We expense research and development costs as incurred. We currently have only have one product candidate, elraglusib. Therefore, since our inception, substantially all of our research and development costs were related to the development of elraglusib. We track research and development expenses on an aggregate basis and not on an indication-by-indication or treatment setting-by-treatment setting basis.

Although research and development activities are central to our business model, the successful development of elraglusib and any future product candidates is highly uncertain. There are numerous factors associated with the successful development of any product candidate such as elraglusib, including future study design and various regulatory requirements, many of which cannot be determined with accuracy at this time based ongiven our stage of development. In addition, future regulatory factors beyond our control may impact our clinical development programs. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased number of patients and longer duration of later-stage clinical studies. As a result, we expect our research and development expenses expenses to increase substantially in connection with our ongoing and planned clinical and nonclinical development activities in the near term term and in the future, provided we are able to raise additional capital. At this time, we cannot accurately estimate or know the nature, timing, timing and costs of the efforts that will be necessary to complete the nonclinical and clinical development of elraglusib and any future product product candidates. Our future research and development expenses may vary significantly based on a wide variety of factors such as:

General and administrative expenses expenses consist primarily of personnel-related expensesexpenses, such as employee compensation, benefits, and stock-based compensation, for our personnel personnel in executive and other administrative functions. General and administrative expenses also include legal fees relating to patent and corporate matters and professional fees paid for accounting, auditing, consultingconsulting, and tax services, as well as other costs such as insurance costs, board of director fees, investor and public relations, and travel expenses.

Interest income represents interest interest earned on our cash and cash equivalents at the then prevailingthen-prevailing market rates.

We have incurred significant operating losses and negative cash flows from operations since our inception. Our net losses were $22,227,852 and $27,285,328 for the years ended December 31, 2025 and 2024, respectively, and $5,625,749$10,492,384 and $6,317,024$12,266,429 for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. As of MarchJune 31,30, 2026, we had an accumulated deficit of $160,233,450.$165,100,085. Substantially all of our net losses have resulted from from costs incurred in connection with our research and development programs and general and administrative costs associated with our operations. operations. We expect to continue to incur significant expenses and operating losses infor the foreseeable future, and we anticipate these losses will increase substantially as we continue our development of, seek regulatory approval for, and potentially commercialize elraglusib, and and potentially seek to discover, acquire and develop additional product candidates, utilize third parties to manufacture elraglusib, hire hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with beingoperating as a public company. If we obtain regulatory approval for elraglusib, we expect to incur significant expenses related to developing our commercialization capability capability to support product sales, marketingmarketing, and distribution.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025:

The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025:

The following table summarizes our research and development development expenses for the three months ended MarchJune 31,30, 2026 and 2025:

The decrease in research and development development expenses of $655,075$697,980 for the three months ended MarchJune 31,30, 2026 compared to the same prior year period was primarily due to (i) a decrease in external clinical study expenses of $1,253,182$749,598 mostly related to lower patient fees and CRO costs associated with fewer patients on study during the current period related to the randomized Phase 2 mPDAC clinical study (Actuate-1801 Part 3B), combined with(ii) a decrease of $200,087 $68,095 in CMC related costs primarily due to the timing of drugour productstability manufacturing to support ongoingstudies, and planned(iii) clinicala studies.decrease Theseof decreases in expenses in the current period were offset by increases$53,488 in nonclinical and biomarker studiesresearch incosts theprimarily amount of $445,676 duerelated to greater nonclinicallower studiesbioanalytical conductedcosts. inThese thedecreases currentwere periodpartially tooffset support advancing elraglusib combined withby an increase in personnel and consulting expenses of $352,518$173,201 primarily due to increased headcount combined with an increase in medicalnon-cash stock-based compensation expense of $106,685 related to awards granted to employees and regulatoryconsultants consultingof associatedthe with ongoing regulatory filings.Company.

The following following table summarizes our general and administrative expenses for the three months ended MarchJune 31,30, 2026 and 2025:

The decrease decrease in general and administrative expenses of $4,553$364,309 for the three months ended MarchJune 31,30, 2026 compared to the same prior year period was was primarily due ato (i) decrease in professional and consulting fees of $167,917 mostly due to lower legal fees in the current period which was partially offset by an increase in investor and public relation fees and a (ii) decrease in other expenses of $3,962 primarily due to lower insurance costs. These amounts were offset by an increase in personnel-related expenses of $167,326$514,875 mostly due to ana increase decrease in non-cash stock-based compensation expense of $203,544$345,187 relatedresulting tofrom the timing of amortization of awards granted to employees, non-employee members of the board of directors, directors, and consultants of the Company.Company and (ii) a decrease in other expenses of $68,626 primarily related to lower insurance costs and travel costs. These decreases were partially offset by a current period increase in professional and consulting fees of $219,192 mostly due to an increase in investor and public relations fees.

Other income (expense), net, for for the three months ended MarchJune 31,30, 2026 and 2025 iswas comprised of the following:

On November 28, 2025, the Company Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley Securities, Inc. and Craig-Hallum Capital Capital Group LLC (each a “Sales Agent” and collectively the “Sales Agents”) with respect to an “at the market” offering program (the “ATM Facility”), under which the Company may, from time to time, at its sole discretion, issue and sell through the Sales Agents, up to $100 million of shares of common stock. Pursuant to the ATM Agreement, the Company may sell the shares through the Sales Agents by any method permitted that is deemed an “at the market” offering as defined in Rule 415 under the Securities Act. The Sales Agents will use commercially reasonable efforts consistent with their normal trading and sales practices to sell the shares from time to time, based upon instructions from us, including any price or size limits or other customary parameters or conditions we may impose. The Company will pay the Sales Agents a commission of up to 3.0% of the gross sales proceeds of any common stock sold through the Sales Agents under the ATM Agreement and also has provided the Sales Agents with customary indemnification rights. During the threesix months ended MarchJune 31,30, 2026, the Company sold 198,793498,193 shares of common stock at a weighted-average price of $2.68 $2.66 per share for net proceeds of $519,624$1,249,591 under the ATM Facility. As of MarchJune 31,30, 2026, the Company had approximately $99.5$98.7 million in remaining capacity capacity under its ATM Facility.

On March 27, 2025, we 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. During the threesix months ended MarchJune 31,30, 2026, the Company did not issue any shares of common stock under the Committed Equity Facility. As of MarchJune 31,30, 2026, we had 3,364,407 shares of common stock in remaining capacity under our Committed Equity Facility.

As of MarchJune 31,30, 2026, we had cash cash and cash equivalents of $8,134,004$4,425,841 and working capital of $3,797,551.$942,745. We expect our expenses to increase substantially in connection with with our ongoing activities, particularly as we continue our development of, seek regulatory approval for, and potentially commercialize elraglusib elraglusib and potentially seek to discover and develop and/or license or acquire additional product candidates, conduct our ongoing and planned clinical studies and nonclinical studies, continue our research and development activities, utilize third parties to manufacture elraglusib, elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with beingoperating as a public company. Based on our current operating plan, we estimate that our existing cash and cash equivalents as of the date of this Report will not satisfy the Company’s operational and capital requirements beyond JulySeptember 2026 without raising additional capital. There can be no assurance that the Company will be able to raise sufficient proceeds in the future under the ATM Facility or Committed Equity Facility or any additional financing will be available to the Company on acceptable terms, if at all.

Until such time, if ever, that that we can generate substantial product revenue, we expect to finance our operations through equity offerings, debt financings, or other capital capital sources, including current or potential future collaborations, licenses, and other similar arrangements. As we seek additional financing financing in the near future, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our ability to raise additional funds may be adversely impacted by business conditions, global economic conditions, disruptions to, and volatility in, the credit and financial markets in the United States and worldwide, and diminished liquidity and credit availability. To the extent we raise additional capital through the sale of equity or convertible debt securities, stockholders’ ownership interest in our common stock will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions, engaging in acquisition, merger or collaboration transactions, selling or licensing our assets, making capital expenditures, redeeming our stock, making certain investments or declaring dividends. If we raise additional funds through collaborations or license agreements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity, debt, or other financings when needed, we may be required to delay, limit, reducereduce, or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves, or even cease operations.

We are continuing to invest in in our elraglusib clinical studies and have entered into contractual obligations with each clinical study site. Each contract shall continue until the completion of the clinical study at that site. Our clinical study costs are dependent on, among other things, the size, number and length duration of each clinical study.

The following table provides a summary of our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025:

ThreeSix Months Ended MarchJune 31,30, 2026 — Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2026 consisted of our net loss of $5,625,749$10,492,384 combined with cash used by a net change in operating assets and liabilities of $891,529,$1,775,849, which amounts were partially offset by (i) non-cash stock-based compensation expense of $1,356,389,$2,697,158, (ii) non-cash stock issued for services of $138,500, and (iii) an increase in accrued interest on license payable of $5,062.$10,125.

ThreeSix Months Ended MarchJune 31,30, 2025 — Net cash used in operating activities for the threesix months ended MarchJune 31,30, 2025 consisted of our net loss of $6,317,024,$12,266,429, which amount was partially offset by (i) non-cash stock-based compensation expense of $1,125,101,$2,704,372, (ii) an increase in accrued interest on license payable of $5,063, and (iii) cash provided by a net change in operating assets and liabilities of $568,120.$759,431, and (iii) an increase in accrued interest on license payable of $10,125.

ThreeSix Months Ended MarchJune 31,30, 2026 — During the threesix months ended MarchJune 31,30, 2026, net cash usedprovided inby financing activities consisted of net proceeds received of $1,251,213 from the sale of shares of common stock under the ATM Facility, before the amortization of deferred offering costs of $1,622, which amount was partially offset by the payment of taxes from withholding of common stock on settlement of restricted stock units of $527,716,$527,716 whichand amountthe was partially offset by net proceeds receivedpayment of $519,624deferred fromoffering the salecosts of shares of common stock under the At-the-Market Facility.$34,629.

ThreeSix Months Ended MarchJune 31,30, 2025 — During the threesix months ended MarchJune 31,30, 2025, net cash usedprovided inby financing activities consisted of deferrednet proceeds offeringreceived costsof paid(i) during$4,621,546 under the currentJune period2025 relatedPrivate Placement, (ii), $2,163,100 from the sale of common stock to B. Riley under the Company’s Committed Equity Facility enteredand into(iii) on$34,115 Marchfrom 27,the 2025.exercise of stock options, which amounts were partially offset by the payment of deferred offering costs of $175,226.