ACTUATE THERAPEUTICS, INC.

Previous wording

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

Current wording

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

Previous wording

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 study in mPDAC, known as Actuate-1801 Part 3B study, is a randomized, controlled Phase 2 study that enrolled 286 patients with no prior systemic treatment for metastatic disease. The primary endpoint for this 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”) Genitourinary Cancers Symposium (“ASCO GI”) in January 2026 utilizing a data cutoff as of November 22, 2025 showed that the 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:

Current wording

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, is a randomized, controlled Phase 2 clinical study that enrolled 286 patients with no prior systemic 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”) Gastrointestinal Cancers Symposium (“ASCO GI”) in January 2026, utilizing a data cutoff as of November 22, 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:

Previous wording

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 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 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.

Current wording

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 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.

Previous wording

In addition to our development plans for the Elraglusib Oral Tablet, we have advanced the Elraglusib Injection in pediatric cancer patients with recurrent/refractory solid cancers. This 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 this Actuate-1902 study also experienced a number of objective responses in the combination chemotherapy arms, and based on this data, we identified Ewing sarcoma and neuroblastoma as possible new indications for further development of Elraglusib Injection, pending additional funding primarily focused on non-dilutive sources or capital, further expanding the potential use and positive therapeutic impact of elraglusib.

Current wording

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 the Actuate-1902 study also experienced a number of objective responses in the combination chemotherapy arms, and based on these data, we identified neuroblastoma and Ewing sarcoma as possible new indications for further development of Elraglusib Injection, pending additional funding primarily focused on non-dilutive sources of 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.

Previous wording

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 consists of the cost incurred under agreements with hospitals to treat and monitor patients enrolled in our clinical studies, contract research organizations and contract manufacturers, consultants and other third parties to 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.

Current wording

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 consist of the costs incurred under agreements with hospitals that treat and monitor patients enrolled in our clinical studies, contract research organizations and contract manufacturers, consultants, and other third parties 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.

Previous wording

We expense research and development costs as incurred. We currently 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.

Current wording

We expense research and development costs as incurred. We currently have only 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.

Previous wording

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 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 studies. As a result, we expect our research and development expenses to increase substantially in connection with our ongoing and planned clinical and nonclinical 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 nonclinical 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:

Current wording

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 given 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 to increase substantially in connection with our ongoing and planned clinical and nonclinical 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 nonclinical 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:

Previous wording

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 and $6,317,024 for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $160,233,450. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses in 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 potentially seek to discover, acquire and develop additional product candidates, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with being a public company. If we obtain regulatory approval for elraglusib, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing and distribution.

Current wording

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 $10,492,384 and $12,266,429 for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $165,100,085. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and general and administrative costs associated with our operations. We expect to continue to incur significant expenses and operating losses for 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 potentially seek to discover, acquire and develop additional product candidates, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with operating as a public company. If we obtain regulatory approval for elraglusib, we expect to incur significant expenses related to developing our commercialization capability to support product sales, marketing, and distribution.

Previous wording

The decrease in general and administrative expenses of $4,553 for the three months ended March 31, 2026 compared to the same prior year period was primarily due a (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 mostly due to an increase in non-cash stock-based compensation expense of $203,544 related to awards granted to employees, non-employee members of the board of directors, and consultants of the Company.

Current wording

The decrease in general and administrative expenses of $364,309 for the three months ended June 30, 2026 compared to the same prior year period was primarily due to (i) a decrease in personnel-related expenses of $514,875 mostly due to a decrease in non-cash stock-based compensation expense of $345,187 resulting from the timing of amortization of awards granted to employees, non-employee members of the board of directors, and consultants of the 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.

Previous wording

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

Current wording

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

Previous wording

The decrease in research and development expenses of $655,075 for the three months ended March 31, 2026 compared to the same prior year period was primarily due to a decrease in external clinical study expenses of $1,253,182 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 study (Actuate-1801 Part 3B) combined with a decrease of $200,087 in CMC related costs due to the timing of drug product manufacturing to support ongoing and planned clinical studies. These decreases in expenses in the current period were offset by increases in nonclinical and biomarker studies in the amount of $445,676 due to greater nonclinical studies conducted in the current period to support advancing elraglusib combined with an increase in personnel and consulting expenses of $352,518 primarily due to increased headcount combined with an increase in medical and regulatory consulting associated with ongoing regulatory filings.

Current wording

The decrease in research and development expenses of $1,353,055 for the six months ended June 30, 2026 compared to the same prior year period was primarily due to a decrease in external clinical study expenses of $2,002,780 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 a decrease in CMC related costs of $268,182 in the current period primarily due to the timing of drug product manufacturing and stability studies to support ongoing and planned clinical studies. These decreases in expenses in the current period were partially offset by (i) an increase in personnel and consulting expenses of $525,719 primarily due to increased headcount, an increase in medical and regulatory consulting associated with ongoing regulatory filings, and an increase in non-cash stock-based compensation expense of $134,429 and (ii) an increase in nonclinical and biomarker research studies in the amount of $392,188 due to greater nonclinical studies and bioanalytical studies conducted in the current period to support advancing elraglusib and the oral tablet formulation.

Previous wording

On November 28, 2025, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley Securities, Inc. and Craig-Hallum 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 three months ended March 31, 2026, the Company sold 198,793 shares of common stock at a weighted-average price of $2.68 per share for net proceeds of $519,624 under the ATM Facility. As of March 31, 2026, the Company had approximately $99.5 million in remaining capacity under its ATM Facility.

Current wording

On November 28, 2025, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley Securities, Inc. and Craig-Hallum 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 six months ended June 30, 2026, the Company sold 498,193 shares of common stock at a weighted-average price of $2.66 per share for net proceeds of $1,249,591 under the ATM Facility. As of June 30, 2026, the Company had approximately $98.7 million in remaining capacity under its ATM Facility.

Previous wording

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 three months ended March 31, 2026, the Company did not issue any shares of common stock under the Committed Equity Facility. As of March 31, 2026, we had 3,364,407 shares of common stock in remaining capacity under our Committed Equity Facility.

Current wording

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 six months ended June 30, 2026, the Company did not issue any shares of common stock under the Committed Equity Facility. As of June 30, 2026, we had 3,364,407 shares of common stock in remaining capacity under our Committed Equity Facility.

Previous wording

As of March 31, 2026, we had cash and cash equivalents of $8,134,004 and working capital of $3,797,551. We expect our expenses to increase 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 our ongoing and planned clinical studies and nonclinical studies, continue our research and development activities, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs 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 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.

Current wording

As of June 30, 2026, we had cash and cash equivalents of $4,425,841 and working capital of $942,745. We expect our expenses to increase 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 our ongoing and planned clinical studies and nonclinical studies, continue our research and development activities, utilize third parties to manufacture elraglusib, hire additional personnel, expand and protect our intellectual property, and incur additional costs associated with operating 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 September 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.

Previous wording

We are continuing to invest 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 study at that site. Our clinical study costs are dependent on, among other things, the size, number and length of each clinical study.

Current wording

We are continuing to invest 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 duration of each clinical study.

Previous wording

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

Current wording

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

Previous wording

Three Months Ended March 31, 2026 — Net cash used in operating activities for the three months ended March 31, 2026 consisted of our net loss of $5,625,749 combined with cash used by a net change in operating assets and liabilities of $891,529, which amounts were offset by non-cash stock-based compensation expense of $1,356,389, non-cash stock issued for services of $138,500, and an increase in accrued interest on license payable of $5,062.

Current wording

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

Previous wording

Three Months Ended March 31, 2025 — Net cash used in operating activities for the three months ended March 31, 2025 consisted of our net loss of $6,317,024, which amount was offset by (i) non-cash stock-based compensation expense of $1,125,101, (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.

Current wording

Six Months Ended June 30, 2025 — Net cash used in operating activities for the six months ended June 30, 2025 consisted of our net loss of $12,266,429, which amount was partially offset by (i) non-cash stock-based compensation expense of $2,704,372, (ii) cash provided by a net change in operating assets and liabilities of $759,431, and (iii) an increase in accrued interest on license payable of $10,125.

Previous wording

Three Months Ended March 31, 2026 — During the three months ended March 31, 2026, net cash used in financing activities consisted of the payment of taxes from withholding of common stock on settlement of restricted stock units of $527,716, which amount was partially offset by net proceeds received of $519,624 from the sale of shares of common stock under the At-the-Market Facility.

Current wording

Six Months Ended June 30, 2026 — During the six months ended June 30, 2026, net cash provided by 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 and the payment of deferred offering costs of $34,629.