Actuate Therapeutics is like an early-stage **Genentech** focused on pioneering novel targeted cancer therapies.

Think of Actuate Therapeutics as an emerging **Bristol Myers Squibb** or **Merck**, but with a unique approach to cancer that enhances anti-tumor immunity.

• Elraglusib (formerly 9-ING-41): An ATP competitive small molecule drug candidate in clinical development as an intravenous solution (Elraglusib Injection) for the treatment of various cancers, with its lead program targeting metastatic pancreatic ductal adenocarcinoma.

Actuate Therapeutics (ACTU) is a clinical-stage biopharmaceutical company focused on the development of new drug therapies. As of the provided description, the company is still in the research and development phase, with its lead product candidate, elraglusib, currently undergoing Phase 2 clinical trials. The company does not yet have any approved products on the market generating commercial sales.

Therefore, Actuate Therapeutics does not have major commercial customers (either other companies or individual consumers) from the sale of its products at this time. Its activities are focused on drug discovery, clinical development, and seeking regulatory approvals.

Daniel M. Schmitt, President, Chief Executive Officer and Director

Mr. Schmitt has served as CEO since March 2015 and as a director since April 2015. He is also a co-founder of Actuate Therapeutics. He brings over 30 years of industry experience in operations management, new product development, and business development, having held senior executive positions in both large pharmaceutical and small biotechnology companies, including Fujisawa, Searle/Pharmacia, and Ilex Oncology. Mr. Schmitt has led and contributed to the successful development and launch of multiple pharmaceutical products and has executed numerous high-value licensing, acquisition, and development deals totaling nearly $1 billion in upfront and potential milestone payments. His past roles include Chief Operating Officer of Genus Oncology, LLC and SVP, Licensing & Commercial Development at Immtech Pharmaceuticals, Inc.. He also served as an Entrepreneur-in-Residence at Northwestern University and as an external expert consultant for the University of Chicago and the University of Illinois-Chicago.

Paul J. Lytle, Chief Financial Officer and Principal Accounting Officer

Mr. Lytle brings three decades of finance and accounting experience, with over 25 years in public companies listed on NASDAQ. His journey into biotech leadership began in 1997 when he became a controller and later CFO for a biotechnology company. He has served as co-founder, CFO, and director for multiple biotech companies and has raised over $500 million in net proceeds from various equity and debt offerings. He previously helped build a manufacturing business to approximately $60 million in revenue, which later sold for $1 billion in 2024.

Dr. Andrew P. Mazar, PhD, Chief Operating Officer and Scientific Co-Founder

Dr. Mazar is a co-founder of Actuate Therapeutics. He is an internationally recognized expert in cancer metastasis and translational oncology. His experience includes co-founding, serving as Chief Scientific Officer, and acting as a Director for Monopar Therapeutics, Inc. He has also been an Entrepreneur-in-Residence, Professor of Pharmacology, and Founding Director of the Center for Developmental Therapeutics at Northwestern University. Dr. Mazar has been involved in the development of eleven drugs from discovery through Phase 2, is an inventor on over 70 patents, and has authored more than 250 peer-reviewed publications and book chapters. He is also a serial entrepreneur, having founded seven start-ups.

Key risks to Actuate Therapeutics (ACTU) include:

• Clinical Trial Outcomes and Regulatory Approval Risk: The company's future prospects are heavily dependent on the successful completion of its ongoing randomized Phase 2 trial (Actuate-1801 Part 3B) for its lead product candidate, elraglusib, in metastatic pancreatic cancer, and its ability to obtain subsequent regulatory approvals. The preliminary analysis, while positive with a median overall survival of 12.2 months in the elraglusib combination therapy arm versus 7.3 months in the control group, is explicitly stated as interim data that "should not be relied upon as a final analysis and is subject to change once full data analysis is complete." There is no guarantee that the final results will be positive or that elraglusib will demonstrate sufficient efficacy and safety to gain regulatory approval.
• Reliance on a Single Lead Product Candidate: Actuate Therapeutics' business is substantially dependent on the successful development and commercialization of its lead drug, elraglusib. The company's description heavily emphasizes elraglusib as its primary focus and most advanced clinical indication. A failure of elraglusib in clinical trials, or an inability to secure regulatory approval or successfully commercialize it, would have a severe adverse impact on the company's business, financial condition, and results of operations, given the lack of other advanced pipeline candidates detailed in the provided information.

Actuate Therapeutics' primary product, elraglusib, a glycogen synthase kinase-3 (GSK-3) inhibitor, is being developed for the treatment of high-impact cancers, with its most advanced clinical indication being metastatic pancreatic ductal adenocarcinoma (mPDAC). The addressable markets for elraglusib, particularly in pancreatic cancer, are substantial and projected to grow.

Global Market for Pancreatic Cancer Treatment

The global pancreatic cancer treatment market was valued at USD 6.4 billion in 2024 and is projected to reach USD 12.4 billion by 2030, growing at a compound annual growth rate (CAGR) of 11.8% from 2024 to 2030. Other estimates indicate the market was valued at USD 3.82 billion in 2025, with a projection to reach USD 14.43 billion by 2034, exhibiting a CAGR of 15.95% from 2026 to 2034. Another report shows the global market size at USD 3.28 billion in 2025, expected to exceed USD 12.05 billion by 2035, with a CAGR of more than 13.9% during the 2026-2035 period, with the 2026 market size assessed at USD 3.69 billion.

U.S. Market for Pancreatic Cancer Treatment

In the United States, the pancreatic cancer treatment market was estimated at USD 1.02 billion in 2024 and is projected to grow at a CAGR of 12.02% from 2025 to 2030. Another source indicates the U.S. market size was USD 1.75 billion in 2025 and is projected to reach approximately USD 5.46 billion by 2035, with a CAGR of 12.05% during the forecast period of 2026 to 2035. The U.S. market is also estimated at USD 1.98 billion by 2026 and is projected to grow to an estimated value of USD 5.25 billion by 2032.

Patient Population for Pancreatic Cancer

Pancreatic ductal adenocarcinoma (PDAC) accounts for approximately 90% of all pancreatic cancers. In the United States, the annual incidence of pancreatic cancer is expected to exceed 66,000 patients, with roughly 70% of these individuals presenting with metastatic disease. In 2023, approximately 64,050 new cases of pancreatic cancer were reported in the U.S. Across the seven major markets (the U.S., EU4, the UK, and Japan), the total number of incident cases of pancreatic ductal adenocarcinoma was around 165,000 in 2023.

Expected Revenue Growth Drivers for Actuate Therapeutics (ACTU)

• Successful Commercialization of Elraglusib for Metastatic Pancreatic Cancer (mPDAC): The company anticipates top-line results for its randomized Phase 2 trial (Actuate-1801 Part 3B) in mPDAC during the first quarter of 2025. Positive results and subsequent regulatory approval would lead to the commercial launch of Elraglusib Injection, establishing a primary revenue stream from this advanced clinical indication. Preliminary interim data has shown promising median overall survival rates, suggesting a strong potential for market entry.

• Expansion of Elraglusib into Additional Adult Cancer Indications: Beyond mPDAC, Actuate Therapeutics views elraglusib as a broad opportunity for multiple drug development programs. The company has identified its potential role in treating various adult cancers, including colon, lung, breast, renal, ovarian, leukemias, lymphomas, and melanoma. Successful advancement and eventual approval in these additional indications would significantly expand the addressable market and contribute to future revenue growth.

• Development and Commercialization of Elraglusib for Pediatric Cancers: Actuate Therapeutics is also exploring elraglusib's efficacy in pediatric cancers such as Ewing sarcoma, neuroblastoma, and pediatric leukemias. Successful clinical development and market penetration in these specialized areas would represent a distinct revenue driver.

• Leveraging Elraglusib's Ability to Overcome Chemoresistance and Enhance Combination Therapies: The company believes that elraglusib's mechanism of inhibiting GSK-3ß may overcome and reverse NF-kB-mediated cancer cell survival and chemoresistance to conventional chemotherapeutic drugs. This potential to improve the efficacy of existing chemotherapy regimens could increase its adoption as a combination therapy across a range of human cancers, thereby driving revenue.

Share Repurchases

• Actuate Therapeutics has not engaged in share repurchases over the last five years, with its trailing twelve months (TTM) Buyback Yield standing at -17.58% and an average of -16.15% over the past five years, indicating dilution rather than repurchases.

Share Issuance

• In September 2025, Actuate Therapeutics completed a public offering, raising $17.25 million by issuing 2,464,286 shares of common stock at $7.00 per share. The net proceeds of $15.62 million from this offering were designated for working capital and general corporate purposes.
• The company's shares outstanding increased by 12.0% from the prior quarter to 23 million in Q3 2025.
• In September 2025, Actuate Therapeutics filed a $250 million mixed securities shelf.

Inbound Investments

• Actuate Therapeutics has raised a total of $72.2 million over 10 funding rounds, which include 4 early-stage, 3 late-stage, 2 debt, and 1 post-IPO round.
• A Post IPO funding round secured $4.67 million on June 27, 2025.
• In October 2022, the company reported raising approximately $11.2 million in equity from 30 investors as part of a $50 million offering.

Outbound Investments

• Actuate Therapeutics has not made any investments or acquisitions.

Capital Expenditures

• Specific dollar values for Actuate Therapeutics' capital expenditures are not consistently reported as separate figures in available financial summaries.
• The company anticipates operating expenses and capital expenditures over the upcoming year, which are based on management's estimates of future events.