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ACTUATE THERAPEUTICS, INC.

ACTU
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Business Summary

Actuate Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for difficult-to-treat cancers by inhibiting glycogen synthase kinase-3 (GSK-3) . The company's lead investigational product, elraglusib (formerly 9-ING-41), is an ATP-competitive small molecule designed to block the function of GSK-3β, a master regulator in cancer cell survival, growth, migration, and invasion, ultimately leading to cancer cell death and regulation of anti-tumor immunity . There are no approved high-affinity inhibitors of GSK-3β, and elraglusib is believed to be one of the most advanced GSK-3β inhibitors in clinical development .

The company operates under a core business model centered on the development and potential commercialization of elraglusib, which it refers to as a "pipeline in a molecule" due to its broad therapeutic potential across various cancer types . Revenue generation is currently non-existent, as the company has not generated any revenue from product sales since its inception in 2015 . Its primary customer segments, upon potential approval, would be patients with high-impact, difficult-to-treat cancers, initially focusing on metastatic pancreatic ductal adenocarcinoma (mPDAC), pediatric cancers like Ewing sarcoma and neuroblastoma, and metastatic melanoma . The company relies on third-party manufacturers for drug substance and product, and on contract research organizations (CROs) and academic collaborators for research and development activities .

Elraglusib is being developed in two primary forms: Elraglusib Injection and Elraglusib Oral Tablet. Elraglusib Injection is the most advanced, having treated over 500 patients in Phase 1 and Phase 2 studies . Its lead clinical program is for first-line mPDAC, where the Actuate-1801 Part 3B study, a randomized, controlled Phase 2 trial, enrolled 286 patients . Updated data as of November 22, 2025, showed the trial met its primary endpoint, demonstrating a statistically significant improvement in median overall survival (mOS) with elraglusib plus gemcitabine/nab-paclitaxel (GnP) versus GnP alone (mOS 10.1 months vs. 7.2 months, p=0.02, HR=0.62) . The 12-month survival rate nearly doubled from 22.3% in the GnP arm to 44.4% in the elraglusib/GnP arm, and the 24-month survival rate increased almost fivefold from 2.6% to 12.9% . Elraglusib Injection is also being evaluated in pediatric cancer patients with recurrent/refractory solid cancers in the Actuate-1902 Phase 1/2 study, which identified Ewing sarcoma and neuroblastoma as new indications for further development based on objective responses in combination chemotherapy arms . The Elraglusib Oral Tablet is a clinical candidate selected for further development, with plans for a Phase 1 study to identify the maximum tolerated dose and recommended Phase 2 dose (RP2D) in adult patients with advanced, refractory cancers, subject to future funding . This oral form is intended to expand target cancer indications and offer more convenient dose delivery .

For the fiscal year ended December 31, 2025, Actuate Therapeutics reported a net loss of $(22,227,852) , an improvement from a net loss of $(27,285,328) in the prior year . Total operating expenses decreased to $22,495,312 from $25,160,734 in 2024 . Research and development expenses were $10,292,620 , while general and administrative expenses were $12,202,692 . The basic and diluted net loss per share attributable to common stockholders was $(1.06) for 2025, compared to $(3.26) for 2024. As of December 31, 2025, the company had cash and cash equivalents of $13,159,423 and working capital of $7,936,503 . Total liabilities were $6,111,907 , and total stockholders' equity was $7,924,003 .

Year-over-year, research and development expenses decreased by $8,383,656 , primarily due to an $8,336,486 decrease in external clinical trial expenses as the randomized Phase 2 mPDAC trial (Actuate-1801 Part 3B) winds down, and a $953,419 decrease in CMC related costs due to the timing of drug product manufacturing and stability studies . These decreases were partially offset by a $575,238 increase in preclinical and biomarker studies and a $331,011 increase in personnel and consulting expenses . General and administrative expenses increased by $5,718,234 , driven by a $3,834,300 increase in personnel-related expenses, largely due to higher non-cash stock-based compensation expense of $3,735,935 , and increases in professional and consulting fees ($1,148,376) and other expenses ($735,558) related to public company operations. Interest income increased by $65,417 to $287,710 in 2025, mainly due to a higher average cash balance .

During 2025, Actuate Therapeutics engaged in several significant operational and financing developments. The company received net proceeds of $3,800,465 from the sale of 539,967 shares of common stock under a Committed Equity Facility with B. Riley Principal Capital II. It also completed a private placement in June 2025, raising aggregate net proceeds of $4,592,462 from the issuance of 666,497 shares of common stock and warrants . In September 2025, an underwritten public offering generated net proceeds of $15,573,966 from the issuance of 2,464,286 shares of common stock, including an over-allotment option . Furthermore, the company entered into an At Market Issuance Sales Agreement (ATM Facility) in November 2025, allowing it to sell up to $100 million of common stock through sales agents , though no shares were sold under this facility in 2025 . The company also supported the commencement of a Phase 1b investigator-initiated trial (IIT) with UPMC Hillman Cancer Center in August 2025, evaluating elraglusib in combination with retifanlimab and mFOLFIRINOX for advanced pancreatic adenocarcinoma .

Business Outlook

Management anticipates that the company's existing cash and cash equivalents as of the date of the Annual Report will not satisfy operational and capital requirements beyond July 2026 without raising additional capital . The company expects to continue incurring substantial and increasing operating losses for the foreseeable future as it advances clinical development, seeks regulatory approval, and potentially commercializes elraglusib and any future product candidates .

Actuate Therapeutics plans to meet with the FDA and EMA in the first half of 2026 to discuss the design and execution of a Phase 3 global registration study for elraglusib in mPDAC to support potential product registration . The company believes elraglusib has broad therapeutic potential across various cancer types, including pancreatic, metastatic melanoma, lung, colon, breast, renal, ovarian cancer, leukemias, lymphomas, Ewing sarcoma, and neuroblastoma . Based on promising data from the Phase 1 portion of the Actuate-1902 study, the company is considering advancing the development of elraglusib in pediatric cancers, including Ewing sarcoma and neuroblastoma, pending additional internal or external funding support . The Elraglusib Oral Tablet is slated for a Phase 1 study to identify the maximum tolerated dose and RP2D in adult patients with advanced, refractory cancers, subject to future funding . Following this, several Phase 2 studies have been identified for the oral tablet in indications such as refractory, metastatic melanoma, refractory, metastatic colorectal cancer, and non-small cell lung cancer . The company also intends to explore strategically identified investigator-initiated trials (IITs) to identify additional indications and standard of care products to combine with elraglusib, aiming to leverage non-dilutive funding for these IITs .

The company expects its research and development expenses to increase substantially in connection with ongoing and planned clinical and preclinical development activities in the near term and future, provided additional capital is raised . General and administrative expenses are also anticipated to increase as operations expand, including increased headcount to support R&D and preparations for later-stage clinical trials and potential commercialization . The company will also incur increased accounting, audit, legal, regulatory, compliance, director and officer insurance, and investor and public relations expenses associated with operating as a public company .

Actuate Therapeutics plans to finance its cash needs through equity offerings, debt financings, or other capital sources, including current or potential future collaborations, licenses, and other similar arrangements . As of December 31, 2025, the company had $100 million in remaining capacity under its ATM Facility and 3,364,407 shares of common stock in remaining capacity under its Committed Equity Facility . 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 .

Management has concluded that there is substantial doubt regarding the company's ability to continue as a going concern . The company's 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, and diminished liquidity and credit availability . If unable to raise additional funds, the company may be required to delay, limit, reduce, grant rights to develop, or terminate product development or future commercialization efforts, or even cease operations . The company's current drug substance (DS) manufacturer for elraglusib is in China, and geopolitical relationships with China could affect the ability to obtain DS, increase costs, and delay clinical trials and regulatory approval .

Risk Factors

Actuate Therapeutics faces substantial risks, including its limited operating history and recurring operating losses, with an accumulated deficit of approximately $154.6 million as of December 31, 2025 , raising substantial doubt about its ability to continue as a going concern beyond July 2026 without additional capital . The company's entire business depends on the success of its sole product candidate, elraglusib, and failure to advance it through clinical development, obtain regulatory approval, or commercialize it in a timely manner would materially harm the business . Clinical and preclinical drug development is lengthy, expensive, and uncertain, with high failure rates, and early results are not necessarily predictive of future outcomes . The company relies heavily on third-party manufacturers for drug substance (located in China) and drug product, and on contract research organizations for clinical trials, posing risks of supply chain disruptions, increased costs, delays, and potential data inaccuracies . Intellectual property protection is critical, but patents may be challenged, invalidated, circumvented, or have inadequate terms, and trade secrets could be disclosed . The company is subject to extensive and evolving U.S. and foreign healthcare laws and regulations, including anti-kickback statutes, false claims acts, and data privacy laws like GDPR, with non-compliance potentially leading to significant fines, liability, and reputational harm (e.g., fines up to the greater of 4% of global annual revenues or €20.0 million under EU GDPR) . Changes in U.S. fiscal, tax, and healthcare policies, such as those under the Inflation Reduction Act of 2022, could reduce product profitability and demand . Cybersecurity threats to information technology systems, or those of service providers, could disrupt development programs, compromise sensitive information, and expose the company to liability . Unstable market and economic conditions, including geopolitical conflicts, could hinder the ability to raise funds, forcing delays or termination of operations .

Management Priorities

Management's message to shareholders conveys a vision of building a leading oncology company centered around elraglusib, a patented, active product candidate with a novel, multimodal mechanism of action profile, capable of being delivered in different ways to treat a wide variety of cancers . They emphasize rapid advancement of currently active clinical trials and preparing additional indications for future expansion of elraglusib development . Key strategic priorities include advancing elraglusib through clinical trials, obtaining regulatory development incentives such as Orphan Drug Designation and Fast Track Designation, exploring strategic partnerships to accelerate and maximize the potential of GSK-3 inhibitors, and leveraging academic and research partnerships, including a collaboration with Lantern Pharma Inc. to utilize their AI platform for biomarker-derived signatures . The company plans to meet with the FDA and EMA in the first half of 2026 to discuss the design and execution of a Phase 3 global registration study for elraglusib in mPDAC . Despite these plans, management explicitly states that existing cash and cash equivalents are estimated to not satisfy operational and capital requirements beyond July 2026 without raising additional capital , leading to a conclusion of substantial doubt regarding the company's ability to continue as a going concern .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 1, Business — Overview
  2. [2] Item 1, Business — Overview
  3. [3] Item 1, Business — Overview
  4. [4] Item 1, Business — Broad Therapeutic Potential
  5. [5] Item 7, MD&A — Components of Our Results of Operations
  6. [6] Item 1, Business — Our Strategy and Strengths
  7. [7] Item 1, Business — Manufacturing
  8. [8] Item 1, Business — Significant Clinical Experience and Promising Phase 2 Data in mPDAC
  9. [9] Item 1, Business — Significant Clinical Experience and Promising Phase 2 Data in mPDAC
  10. [10] Item 1, Business — Significant Clinical Experience and Promising Phase 2 Data in mPDAC
  11. [11] Item 1, Business — Significant Clinical Experience and Promising Phase 2 Data in mPDAC
  12. [12] Item 1, Business — Elraglusib Injection Shows Promise in the Treatment of Pediatric Cancers
  13. [13] Item 1, Business — Elraglusib Oral Dose Tablet Allows Us to Expand into New Indications
  14. [14] Item 1, Business — Elraglusib Oral Dose Tablet Allows Us to Expand into New Indications
  15. [15] Item 7, MD&A — Results of Operations
  16. [16] Item 7, MD&A — Results of Operations
  17. [17] Item 7, MD&A — Results of Operations
  18. [18] Item 7, MD&A — Results of Operations
  19. [19] Item 7, MD&A — Results of Operations
  20. [20] Item 7, MD&A — Results of Operations
  21. [21] Item 7, MD&A — Results of Operations
  22. [22] Item 7, MD&A — Results of Operations
  23. [23] Item 7, MD&A — Liquidity and Capital Resources
  24. [24] Item 7, MD&A — Liquidity and Capital Resources
  25. [25] Item 8, Consolidated Balance Sheets
  26. [26] Item 8, Consolidated Balance Sheets
  27. [27] Item 7, MD&A — Research and Development Expenses
  28. [28] Item 7, MD&A — Research and Development Expenses
  29. [29] Item 7, MD&A — Research and Development Expenses
  30. [30] Item 7, MD&A — General and Administrative Expenses
  31. [31] Item 7, MD&A — General and Administrative Expenses
  32. [32] Item 7, MD&A — General and Administrative Expenses
  33. [33] Item 7, MD&A — General and Administrative Expenses
  34. [34] Item 7, MD&A — Other Income (Expense)
  35. [35] Item 7, MD&A — Results of Operations
  36. [36] Item 7, MD&A — Other Income (Expense)
  37. [37] Item 7, MD&A — Cash Flows From Financing Activities
  38. [38] Item 7, MD&A — Cash Flows From Financing Activities
  39. [39] Item 7, MD&A — Cash Flows From Financing Activities
  40. [40] Item 7, MD&A — Cash Flows From Financing Activities
  41. [41] Item 7, MD&A — Cash Flows From Financing Activities
  42. [42] Item 7, MD&A — Cash Flows From Financing Activities
  43. [43] Item 7, MD&A — Liquidity and Capital Resources
  44. [44] Item 7, MD&A — Liquidity and Capital Resources
  45. [45] Item 1, Business — Investigator-Initiated Trials
  46. [46] Item 7, MD&A — Liquidity and Capital Resources
  47. [47] Item 1A, Risk Factors — We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future.
  48. [48] Item 1, Business — Developing Elraglusib Injection for the Treatment of mPDAC
  49. [49] Item 1, Business — Broad Therapeutic Potential
  50. [50] Item 1, Business — Advance Our Lead Product Candidate, Elraglusib, Through Clinical Trials.
  51. [51] Item 1, Business — Elraglusib Oral Tablet for the Treatment of Solid Tumors
  52. [52] Item 1, Business — Elraglusib Oral Tablet for the Treatment of Solid Tumors
  53. [53] Item 1, Business — Advance Our Lead Product Candidate, Elraglusib, Through Clinical Trials.
  54. [54] Item 7, MD&A — Research and Development Expenses
  55. [55] Item 7, MD&A — General and Administrative Expenses
  56. [56] Item 7, MD&A — General and Administrative Expenses
  57. [57] Item 7, MD&A — Liquidity and Capital Resources
  58. [58] Item 7, MD&A — Liquidity and Capital Resources
  59. [59] Item 7, MD&A — Liquidity and Capital Resources
  60. [60] Item 7, MD&A — Liquidity and Capital Resources
  61. [61] Item 7, MD&A — Liquidity and Capital Resources
  62. [62] Item 7, MD&A — Liquidity and Capital Resources
  63. [63] Item 7, MD&A — Liquidity and Capital Resources
  64. [64] Item 1A, Risk Factors — Our current drug substance ("DS") manufacturer of elraglusib is in China, and it is unknown how current or future geopolitical relationships with China may affect our ability to obtain DS, increase our costs, delay clinical trials and potential regulatory approval, and adversely impact our financial condition.
  65. [65] Item 1A, Risk Factors — We have a limited operating history, have incurred significant operating losses since our inception and expect to incur significant operating losses for the foreseeable future.
  66. [66] Item 1A, Risk Factors — 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 our operations.
  67. [67] Item 1A, Risk Factors — We currently depend entirely on the success of elraglusib, which is our only product candidate.
  68. [68] Item 1A, Risk Factors — Clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results.
  69. [69] Item 1A, Risk Factors — Our current drug substance ("DS") manufacturer of elraglusib is in China, and it is unknown how current or future geopolitical relationships with China may affect our ability to obtain DS, increase our costs, delay clinical trials and potential regulatory approval, and adversely impact our financial condition.
  70. [70] Item 1A, Risk Factors — If we and our third-party licensors do not obtain and preserve protection for key intellectual property rights, our competitors may be able to take advantage of our (and our licensors') development efforts.
  71. [71] Item 1A, Risk Factors — Failure to comply with health privacy and other data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity and could negatively affect our operating results and business.
  72. [72] Item 1A, Risk Factors — The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.
  73. [73] Item 1A, Risk Factors — Our information technology systems, or those of any of our service providers, may fail or suffer security incidents and other disruptions, which could result in a material disruption of our development programs, compromise sensitive information related to our business or prevent us from accessing critical information, potentially exposing us to liability or otherwise adversely affecting our business.
  74. [74] Item 1A, Risk Factors — Unstable market and economic conditions may have serious adverse consequences on our ability to raise funds, which may cause us to cease or delay our operations.
  75. [75] Item 1, Business — Our Strategy and Strengths
  76. [76] Item 1, Business — Our Strategy and Strengths
  77. [77] Item 1, Business — Our Strategy and Strengths
  78. [78] Item 1, Business — Developing Elraglusib Injection for the Treatment of mPDAC
  79. [79] Item 7, MD&A — Liquidity and Capital Resources
  80. [80] Item 7, MD&A — Liquidity and Capital Resources

Analysis on 5/19/2026