Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — Investor Presentation (August 2025)
25 slides from Actuate Therapeutics's investor presentation, August 2025
Slide 1: Corporate Overview
Corporate Overview August 2025
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements about us, including our clinical trials and development plans, and our industry, that are based on management’s beliefs and assumptions and on information currently available to our management. The words “anticipate,” “
Slide 3: Company Highlights
Company Highlights Class-Leading • Highly specific small molecule kinase-inhibitor with excellent drug-like properties GSK-3β Inhibitor • >500 patients treated to date • Statistically significant improvements in OS in global phase 2 trial in 1L mPDAC Compelling • 40% improvement in mOS Survival Data
Slide 4: Elraglusib: Multimodal MOA Supported by Clinical Data
Elraglusib: Multimodal MOA Supported by Clinical Data • Elraglusib is an ATP-competitive inhibitor of GSK-3β • GSK-3β has been shown to potentially contribute to tumor T Cells and NK Cells Inhibition of epithelial- progression in many treatment naive and mesenchymal transition Activation (EMT) refra
Slide 5: Strategic Pipeline Growth for GSK-3β Associated Diseases
Strategic Pipeline Growth for GSK-3β Associated Diseases Elraglusib Injection (IV) Program Preclinical Phase 1 Phase 2 Phase 3 Milestones - BTD Submission & Response: Q4 Pancreatic Cancer (with Adult Actuate-1801 2025 GnP) 1st line metastatic Part 3B - FDA Type B pre-NDA meeting request: 2H 2025* Pa
Slide 6: Clinical Study Actuate-1801
Clinical Study Actuate-1801 Phase 1/2 Study Design for Elraglusib Injection (IV) Establishes process for transition from elraglusib monotherapy (Part 1) to evaluation of multiple chemotherapy combinations (Part 2) to Phase 2 efficacy studies (Part 3) under one protocol1 1801 - Part 1 1801 - Part 2 1
Slide 7: Elraglusib Potential in Metastatic Pancreatic Cancer (mPDAC)
Elraglusib Potential in Metastatic Pancreatic Cancer (mPDAC) Pancreatic Cancer Metastatic pancreatic cancer is highly aggressive and accounts for approximately 80-85% of all pancreatic cancer diagnoses. Projected market growth to >$5 billion by 2030 Survival Rate and Economic Burden The prognosis re
Slide 8: Phase 2 Clinical Activity with Extended Median Overall Survival
Phase 2 – Clinical Activity with Extended Median Overall Survival Kaplan Meier – Overall Survival (EE) • 1801 Part 3A in mPDAC Subjects 29 Survival Probability Event 21 (72%) • Simon’s Two-Stage trial design - Stage 1 Censored 8 (28%) Median Survival 15.26 • Evaluate the combination of elraglusib an
Slide 9: 1801-Part 3B: Phase 2 RCT in First-Line Metastatic PDAC
1801-Part 3B: Phase 2 RCT in First-Line Metastatic PDAC Inclusion Criteria Treatment Endpoints ≥ 18 yrs old with metastatic Primary endpoints: Randomized I year OS/mOS pancreatic adenocarcinoma Elraglusib + GnP Secondary endpoints: Participants must have Follow Up ORR, DOR, PFS measurable disease as
Slide 10: PDAC: A Disease with Urgent Unmet Needs
9 PDAC: A Disease with Urgent Unmet Needs • Most patients with PDAC present with advanced or metastatic disease with poor survival • Median survival remains < 1 year, with real world data for mOS ranging from 6-9 months • Apart from PARP inhibitors as maintenance therapy in a subset of patients with
Slide 11: Phase 2 RCT Patient Demographics
Phase 2 RCT Patient Demographics Demographics GnP (n=78) Elraglusib + GnP (n=155) Demographics GnP (n=78) Elraglusib + GnP (n=155) Sex Eastern Cooperative Oncology Group Performance Status Female 35 (44.9%) 75 (48.4%) 0 31 (39.7%) 64 (41.3%) Male 43 (55.1%) 80 (51.6%) 1 45 (57.7%) 89 (57.4%) Age (ye
Slide 12: Study 1801 Part 3B Meets Primary Endpoint of Improved Survival
Study 1801 Part 3B Meets Primary Endpoint of Improved Survival Doubling of 1 year OS and 37% Reduction in Risk of Death vs GnP GnP Elraglusib/GnP (78) (155) Elraglusib + GnP Primary Endpoint: mOS (months) 7.2 10.1 HR=0.63; log-rank p=0.01 12 month OS (%) 22.3 44.1 p=0.0005 Events (% events) 70 (89.7
Slide 13: Administrative Analysis of 1801 Part 3B OS Swim Plot
Administrative Analysis of 1801 Part 3B OS Swim Plot GnP + weekly elraglusib: n=155 (8 on treatment, 114 events) GnP : n= 78 (0 on treatment, 70 events) Predefined Safety Population 12 The final data and results may change as the study continues through completion Draft unaudited data as of March 27
Slide 14: Phase 2 RCT in First-Line Metastatic PDAC - Best Overall Response
Phase 2 RCT in First-Line Metastatic PDAC - Best Overall Response 1801 Part 3B: GnP Best Overall Response 1801 Part 3B: GnP + Weekly Elra Best Overall Response * ** *Patient had a partial response on treatment, then was referred for a Whipple procedure and subsequently came off treatment **Patient h
Slide 15: Elraglusib + GnP Data Show OS Benefit Across Key Subgroups
Elraglusib + GnP Data Show OS Benefit Across Key Subgroups Elraglusib + GnP, Elraglusib + GnP Better Predefined Safety Population 14 The final data and results may change as the study continues through completion Data as of April 27, 2025 Draft unaudited data
Slide 16: Subgroup of Patients Treated for One Cycle - Significant Benefit in OS
Subgroup of Patients Treated for One Cycle (4 weeks) - Significant Benefit in OS Near Doubling of 1 year OS and 43% Reduction in Risk of Death vs GnP GnP Elraglusib/GnP (58) (116) Primary Endpoint: mOS (months) 8.5 12.5 HR=0.57; log-rank p=0.018 12-month OS (%) 28.3 52.5 mOS, p=0.018 Events (% event
Slide 17: Patients with Liver Metastases - Significant Benefit in mOS and mPFS
Patients with Liver Metastases - Significant Benefit in mOS and mPFS 2.5X Increase in 1 Year Survival and a 38% Reduction in Risk of Death GnP Elraglusib/GnP (61) (114) Primary Endpoint: mOS (months) 6.6 8.3 HR=0.62; log-rank p=0.008 12 month OS (%) 15.2 39.2 p=0.0003 Events (% events) 56 (91.8%) 92
Slide 18: Subsequent Anti-Cancer Therapy Is Balanced Between Both Arms
17 Subsequent Anti-Cancer Therapy Is Balanced Between Both Arms GnP Elraglusib/ GnP (78) (155) Subsequent ant i-cancer t herapy (%) 37 (47.4%) 78 (50%) Syst emic ant i-neoplast ic t herapy 36 (46%) 78 (50%) FOLFIRINOX 13 (35%) 23 (28%) FOLFOX 1(3%) 0 (0%) FOLFIRI 3 (8%) 7 (9%) GnP 3 (8%) 10 (13%) 5-
Slide 19: Safety Profile of Elraglusib in Combination with GnP
Safety Profile of Elraglusib in Combination with GnP Actuate 1801 Part 3B (ongoing) TEAEs of Any Grade Reported in ³20% of Patients Treated with elraglusib Key Takeaways • Overall rate of a TEAE and/or an SAE observed were similar in the elraglusib + GnP-treated patients as compared to GnP- treated
Slide 20: Clinical Activity in Areas of High Unmet Need in 1801 Part 1 and 2
Clinical Activity in Areas of High Unmet Need in 1801 Part 1 and 2 Actuate 1801 Part 1 evaluated elraglusib as a single agent • First objective response reported in patient treated with 5 mg/kg elraglusib monotherapy • Metastatic melanoma diagnosed in 2018; widely metastasized to the brain, lungs, b
Slide 21: Elraglusib Oral Formulations Provide Similar Drug Exposures to IV
Elraglusib Oral Formulations Provide Similar Drug Exposures to IV • Decreased cost of manufacturing at Elraglusib Arithmetic Mean Concentration-Time Profiles commercial scale compared to IV formulations • Phase 1 Study of Oral Solution in Normal Healthy Volunteers (NHV) showed >50% bioavailability v
Slide 22: Key Near Term Anticipated Development Plans and Milestones
Key Near Term Anticipated Development Plans and Milestones For Accelerating Registration in mPDAC 2025 2026 mPDAC: mPDAC: ASCO Presentation BTD Submission & mPDAC: mPDAC: Response Initiate planning of Phase FDA Type B pre-NDA mPDAC: mPDAC: mPDAC: 3 or Confirmatory Trial Phase 2 Topline data Meeting
Slide 23: Seasoned and Successful Leadership
Seasoned and Successful Leadership Experienced leadership team with demonstrated ability to develop and commercialize cancer drugs Daniel M. Schmitt – Chief Executive Officer and Founder • 30+ years of biotechnology and pharmaceutical experience across senior executive roles • Led and contributed to
Slide 24: Investment Highlights
Investment Highlights Compelling Survival Data in mPDAC Potential For Accelerated Registration in Major Markets Broad Therapeutic Potential in Multiple Oncology Indications Extended IP Protection Seasoned Leadership Team 23
Slide 25: Ticker: ACTU
ACTUATE THERAPEUTICS Ticker: ACTU
Actuate Therapeutics — Investor Presentation (August 2025) on 6ix