Actuate Therapeutics

What Actuate Therapeutics does

Actuate Therapeutics is a clinical-stage biopharmaceutical company headquartered in Fort Worth, Texas (with a secondary communications presence in Chicago), founded in 2015 as Apotheca Therapeutics, Inc. and listed on NASDAQ (ACTU) since August 13, 2024. The company is developing elraglusib (formerly 9-ING-41), a first-in-class, highly selective small-molecule inhibitor of glycogen synthase kinase-3β (GSK-3β), delivered in both an established once-weekly IV formulation and a newly IND-cleared oral tablet formulation. Elraglusib's mechanism combines tumor-intrinsic pathway inhibition (NF-κB, DNA damage response) with immune-microenvironment modulation (regulation of PD-1, LAG-3, PD-L1; expansion of CD8+ T cells and NK cells), positioning it as a combination-ready backbone for difficult-to-treat cancers. Its lead clinical program targets first-line metastatic pancreatic ductal adenocarcinoma (mPDAC) — supported by Phase 2 Actuate 1801 data showing a 38% reduction in death risk and a doubling of 1-year survival when added to gemcitabine/nab-paclitaxel — with parallel development in Ewing sarcoma, CPI-refractory and BRAFV600E metastatic melanoma, pediatric neuroblastoma (via the BEACON2 platform), and preclinical RAS-inhibitor combinations.

The company's pipeline is structured around four FDA designations (Fast Track in pancreatic cancer; Orphan Drug in glioblastoma, neuroblastoma, and pancreatic cancer; Rare Pediatric Disease in neuroblastoma) and supported by collaborations with Incyte (retifanlimab combinations), Cancer Research UK's CRCTU (BEACON2), and academic centers (Northwestern, Mass General Brigham, University of Pittsburgh). Actuate is pre-revenue: elraglusib is investigational, drug access is restricted to clinical trial participation, and no pricing or commercial product is in market. Capital is raised through equity — a $17.25M public offering closed in September 2025, a $100M ATM facility announced in January 2026, and prior Series B/B-3 rounds totaling approximately $28.2M (2019). The company carries a going-concern qualification and requires additional capital beyond July 2026. With a 11-50 person team, a small cap (~$53-59M) public listing, and a single-asset platform, Actuate is a binary clinical-stage biotech whose near-term value drivers are pivotal data in mPDAC, oral formulation Phase 1/2 initiation, and PRV-eligible pediatric readouts.

Name

Actuate Therapeutics

Legal name

Actuate Therapeutics, Inc.

Website

https://actuatetherapeutics.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Actuate Therapeutics is a clinical-stage, NASDAQ-listed biopharmaceutical company (ACTU) developing elraglusib, a first-in-class selective GSK-3β inhibitor in IV and oral formulations, targeting hard-to-treat cancers with lead development in metastatic pancreatic ductal adenocarcinoma and expansion into Ewing sarcoma, melanoma, and pediatric neuroblastoma.

Ownership category

akta.pro rank

Product category

Oncology Pharmaceuticals

NAICS

Pharmaceutical and Medicine Manufacturing (3254), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Medical Oncology (HLAKAFAB)

akta.pro secondary industries

Gastrointestinal Oncology (HLAKAFAK), Neuro-Oncology (HLAKAFAH), Neuro-oncology (HLAKAIAL), Oncology Pathways & Precision Medicine Decision Support (HLACAGAH), Molecular Tumor Boards & Clinical Interpretation Services (HLAAANAD)

Keywords

• Clinical-stage biopharmaceutical
• Oncology drug development
• Small molecule therapeutics
• GSK-3 inhibitor research
• Cancer immunotherapy pipeline

Headquarters

HQ city

Fort Worth

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Others, Marketing or Sales

Revenue model

1. None - clinical-stage, pre-revenue: Actuate is a clinical-stage biopharmaceutical company with no approved commercial products. Elraglusib is investigational and not commercially available; access is limited to clinical trial participation. No product revenue is currently generated.
2. Capital raising via equity offerings and ATM agreements: Capital is raised through public common stock offerings (e.g., $17.25 million offering closed September 11, 2025 at $7.00/share, managed by Lucid Capital Markets) and at-the-market (ATM) sales agreements (up to $100 million ATM sales agreement with B. Riley Securities and Craig-Hallum Capital Group announced January 2026; additional market issuance sales agreement with B. Riley and Craig-Hallum announced November 2025).

Go-to-market motion3 records

Distribution channels3 records

Marketing channels8 records

Core offering

Actuate Therapeutics is developing elraglusib (formerly 9-ING-41), a first-in-class selective small-molecule GSK-3β inhibitor delivered in both intravenous and oral tablet formulations. The drug targets multiple molecular pathways driving tumor progression, chemoresistance, and immune evasion (NF-κB, DDR, PD-1/LAG-3/PD-L1 modulation, T-cell and NK-cell expansion) and is being advanced as a combination-ready backbone therapy for hard-to-treat cancers, with lead programs in metastatic pancreatic ductal adenocarcinoma, Ewing sarcoma, melanoma, and pediatric neuroblastoma.

Product overview

Actuate Therapeutics is a clinical-stage biopharmaceutical company offering a single therapeutic platform centered on its lead investigational drug, elraglusib — a first-in-class small-molecule GSK-3β inhibitor delivered in two formulations: an established IV formulation (Elraglusib IV) and an oral tablet formulation (Elraglusib Oral Tablet) currently advancing into Phase 1/2 development. The elraglusib IV formulation anchors the lead Pancreatic Cancer Clinical Program (elraglusib + gemcitabine/nab-paclitaxel and elraglusib + FOLFIRINOX/losartan) and the Ewing Sarcoma Clinical Program, while the elraglusib oral tablet drives a broader pipeline that includes the Melanoma Clinical Program, the Pediatric Neuroblastoma Program (BEACON2 trial), and the Elraglusib + RAS Inhibitor Combination Program. Together, these indication-specific programs and research initiatives form Actuate's modular development strategy: a single GSK-3β-targeting molecule deployed across multiple oncology indications and combination regimens to position elraglusib as a differentiated backbone therapy for difficult-to-treat cancers.

Differentiator

Problem solved

Functional benefit

Products and services

• Elraglusib (formerly 9-ING-41) IV Formulation First-in-class, highly selective small-molecule GSK-3β inhibitor administered intravenously (once weekly). It targets multiple molecular pathways driving tumor progression, chemoresistance, and immune evasion (NF-κB, DDR, PD-1/LAG-3/PD-L1 modulation, T-cell and NK-cell activation) across multiple cancer histologies, with lead development in metastatic pancreatic ductal adenocarcinoma and Ewing sarcoma.
• Elraglusib Oral Tablet Formulation Oral tablet formulation of the GSK-3β inhibitor elraglusib designed to enable broader clinical use, improved patient convenience, and higher drug exposure than the IV formulation. FDA IND clearance supports a planned Phase 1/2 study in advanced solid tumors including melanoma, NSCLC, colorectal, and pancreatic cancers, with Phase 1 initiation planned for 2H 2026 and expansion into refractory melanoma and select hematologic malignancies.
• Pancreatic Cancer Clinical Program (Elraglusib + Chemotherapy) Lead clinical development program combining elraglusib with gemcitabine/nab-paclitaxel (GnP) and with FOLFIRINOX (+/- losartan) in previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC), based on the Phase 2 Actuate 1801 study (NCT03678883) showing 38% reduction in death risk and doubling of 1-year survival versus chemotherapy alone.
• Ewing Sarcoma Clinical Program (Elraglusib + Chemotherapy) Clinical development program for elraglusib in Ewing sarcoma, a rare pediatric/adolescent bone cancer, combining elraglusib with cyclophosphamide/topotecan chemotherapy and showing complete and partial responses in heavily pretreated patients.
• Melanoma Clinical Program (Elraglusib monotherapy and combinations)
• Pediatric Neuroblastoma Clinical Program (BEACON2 Trial) Elraglusib in combination with dinutuximab beta plus chemotherapy will be evaluated in the BEACON2 platform trial (EudraCT 2024-516115-24) conducted by the Cancer Research UK Clinical Trials Unit at the University of Birmingham for children with relapsed and refractory neuroblastoma; supported by FDA Rare Pediatric Disease designation for elraglusib in neuroblastoma.
• Elraglusib + RAS Inhibitor Combination Program Strategic research initiative combining the GSK-3β inhibitor elraglusib with emerging RAS-targeted therapies to address adaptive resistance in RAS-driven cancers. Includes in-vitro studies of elraglusib with select RAS inhibitors, in-vivo tumor regression and survival studies, and translational biomarker analysis; initial data expected in 2H 2026.

Quantifiable outcome

• Elraglusib + GnP reduced risk of death by 38% (HR 0.62; p=0.01) in previously untreated mPDAC Phase 2
• +7 more outcomes

Segments6 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature5 records

Partnerships

Ten partnerships are on record, tiered core, flagship and minor.

• Cancer Research UK Clinical Trials Unit (CRCTU), University of BirminghamcoreStrategic or Co-development Partner · 9 June 2026Elraglusib selected for evaluation in the BEACON2 trial (EudraCT 2024-516115-24), an international, multi-arm, multi-stage Phase 1/2 platform trial in pediatric neuroblastoma. Actuate combines elraglusib with dinutuximab beta plus chemotherapy; trial sponsored by CRCTU at up to 60 sites across 16 countries. Capital-efficient approach to generating pediatric clinical data.
• Mass General Brigham Cancer InstitutecoreStrategic or Co-development Partner · 30 May 2026Conducted the Phase 2 study of elraglusib in combination with FOLFIRINOX and the TGF-β inhibitor losartan in patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Lead author Priyadarshini Pathak presented data at ASCO 2026.
• Crowe LLPcoreImplementation/ SI/ Consulting Partner · 23 May 2026Ratified at the May 23, 2026 annual meeting as Actuate's independent registered public accounting firm for the fiscal year ending December 31, 2026; ratification passed by 18,571,817 votes in favor vs 50,023 against.
• Northwestern University / Northwestern MedicinecoreStrategic or Co-development Partner · 14 April 2026Funded and partnered with Northwestern researchers (lead author Dr. Devalingam Mahalingam) for the Phase 2 clinical trial of elraglusib + GnP in mPDAC; results published in Nature Medicine (April 2026). Northwestern investigators are key KOLs and collaborators on ASCO presentations.
• Incyte Corporation and University of PittsburghflagshipStrategic or Co-development Partner · 6 August 2025Collaboration on a clinical trial evaluating elraglusib in combination with Incyte's retifanlimab (PD-1 inhibitor) and mFOLFIRINOX in patients with advanced pancreatic cancer. Combines elraglusib's GSK-3β inhibition with a checkpoint inhibitor and chemotherapy backbone.
• LifeSci AdvisorscoreGTM or Marketing Partner · 1 January 2025Investor relations firm of record for Actuate Therapeutics; Mike Moyer serves as primary IR contact ([email protected], 617-308-4306). Manages investor outreach, conference participation, and analyst engagement.
• Russo Partners, LLCcoreGTM or Marketing Partner · 1 January 2025Media relations partner; contacts Ignacio Guerrero-Ros, Ph.D. and David Schull (858-717-2310 / 646-942-5604). Handles press releases, media inquiries, and external communications strategy.
• Baker & Hostetler LLPcoreImplementation/ SI/ Consulting Partner · 1 January 2024Actuate's corporate counsel providing legal services for SEC filings, corporate governance, and transactional matters.
• KMJ Corbin & Company LLPcoreImplementation/ SI/ Consulting Partner · 1 January 2024Independent registered public accounting firm of record for Actuate (note: at the May 2026 annual meeting shareholders also ratified Crowe LLP as the auditor for fiscal year ending December 31, 2026).
• Broadridge Corporate Issuer Solutions, LLCminorImplementation/ SI/ Consulting Partner · 1 January 2024Transfer agent for Actuate Therapeutics common stock, located at 51 Mercedes Way, Edgewood, NY 11717.

Scale indicators11 records

Recent moves7 records

Expansion highlights7 records

Direct peers

• NuCana plc: Clinical-stage biopharmaceutical company developing chemotherapy-based treatments for pancreatic cancer and other hard-to-treat solid tumors. Directly comparable to Actuate on lead indication (mPDAC), clinical-stage status, and small-cap public profile, and competes for the same investigator and KOL network.
• Tyme Technologies (now Lavie Bio legacy / SMMT): Clinical-stage oncology company historically focused on novel cancer metabolism approaches including for pancreatic cancer. Comparable to Actuate as a small-cap, clinical-stage biotech targeting mPDAC and similar hard-to-treat cancers via differentiated mechanisms.
• Syndax Pharmaceuticals: Clinical-stage oncology company developing small-molecule therapies for solid tumors and hematologic malignancies. Comparable in clinical-stage focus on difficult-to-treat cancers, combination-ready mechanism, small-cap public profile, and use of FDA expedited pathways (Fast Track, Orphan).
• Cogent Biosciences: Clinical-stage precision oncology company developing kinase inhibitors for genomically defined cancers. Comparable to Actuate on small-molecule mechanism, clinical-stage development, public-company infrastructure, and use of biomarker-defined patient selection.
• Theseus Pharmaceuticals: Clinical-stage oncology company developing small-molecule kinase inhibitors (including pan-RAF and other targeted therapies) for solid tumors. Comparable to Actuate as a small-cap clinical biotech pursuing combination- and indication-broad oncology strategies.
• BioAtla: Clinical-stage biopharmaceutical company developing Conditionally Active Biologics (CABs) and small molecules for solid tumors. Comparable to Actuate in clinical-stage status, oncology focus on hard-to-treat cancers, public small-cap profile, and emphasis on tumor-selective targeting.
• Compass Therapeutics: Clinical-stage oncology company developing antibody-based therapies for solid tumors, including pancreatic cancer. Comparable to Actuate in clinical-stage focus on mPDAC, combination strategy, and public-company development profile.

Broad incumbents

• Incyte Corporation: Established mid-cap biopharmaceutical company with marketed oncology and hematology products. Direct partner on Actuate's elraglusib + retifanlimab + mFOLFIRINOX combination trial; comparable as the developer of the PD-1 inhibitor backbone that elraglusib is being combined with, and a potential acquirer of clinical-stage assets.
• Merck & Co. Global biopharmaceutical company and leader in immuno-oncology (Keytruda) and pancreatic cancer clinical research. Comparable as the dominant checkpoint-inhibitor franchise with which elraglusib could be combined in future trials, and a likely strategic acquirer of small-molecule oncology assets.
• Bristol-Myers Squibb: Global biopharmaceutical company with a major immuno-oncology franchise (Opdivo, Yervoy) and multiple pancreatic cancer combination programs. Comparable as a strategic combination partner and potential acquirer of clinical-stage oncology assets like elraglusib.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/ActuateThera
• Facebookfacebook.com/profile.php?id=61572431561095
• LinkedInlinkedin.com/company/actuate-therapeutics-inc.

Compliance7 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds8 records

Investors6 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Actuate Therapeutics