Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — Investor Presentation (January 2026)
34 slides from Actuate Therapeutics's investor presentation, January 2026
Slide 1: Corporate Overview
Corporate Overview January 2026
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 overall survival (OS) in global Phase 2 trial in 1L mPDAC Compelling • 40% improvement i
Slide 4: Elraglusib: Multimodal MOA Supported by Clinical Data
Elraglusib: Multimodal MOA Supported by Clinical Data Inhibition of epithelial- T Cells and NK mesenchymal transition (EMT) cells activation ↓ Wnt/β –catenin signaling ↑ MHC-I expression ↓ TGF- β - pathways ↑ IFN-y signaling ↑ TCR signaling ↓ T cell exhaustion markers (PD-1, TIGIT, LAG-3) elraglusib
Slide 5: Strategic Pipeline Growth for IV and Oral Elraglusib
Strategic Pipeline Growth for IV and Oral Elraglusib Pancreatic (PDAC) Program Formulation Phase 1 Phase 2 Phase 3 Milestones - Updated Phase 2 data presented at ASCO GI in January 2026 Actuate-1801 - FDA meeting request: clarity for registration 1L metastatic with GnP IV In Planning** requirements:
Slide 6: Elraglusib in PDAC
ACTUATE THERAPEUTICS Elraglusib in PDAC
Slide 7: mPDAC Represents a High Unmet Need With Significant Commercial Potential
mPDAC Represents a High Unmet Need With Significant Commercial Potential Market Size Metastatic pancreatic cancer is highly aggressive and accounts for approximately 80-85% of all pancreatic cancer diagnoses. Projected market growth to >$5 billion by 20301 Survival Rate and Economic Burden The progn
Slide 8: PDAC: A Disease with Urgent Unmet Needs
7 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 9: 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 Two-Stage trial design - Stage 1 Censored 8 (28%) • Evaluate the combination of elraglusib and GnP Median Survival 15.2
Slide 10: 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: pancreatic adenocarcinoma 1 year OS/mOS 2:1 Elraglusib + GnP Randomization Secondary endpoints: Participants must have Follow Up ORR, DOR, PFS measurable dis
Slide 11: Study 1801 Part 3B RCT Patient Demographics
Study 1801 Part 3B 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.
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 38% Reduction in Risk of Death vs GnP GnP Elraglusib/GnP (n=78) (n=155) Primary Endpoint: mOS (months) 7.2 10.1 HR=0.62; log-rank p=0.02 12-month OS (%) 22.3 44.4 p=0.0004 Events (% events) 74 (94.9%) 128 (82.6%
Slide 13: Durable and Sustained Responses Observed Relative to GnP
Durable and Sustained Responses Observed Relative to GnP GnP + weekly elraglusib: n=155 (3 on treatment, 128 events) GnP : n= 78 (0 on treatment, 74 events) Predefined Safety Population Draft unaudited data as of Nov 22, 2025 12 The final data and results may change as the study continues through co
Slide 14: Elraglusib Arm Demonstrated Strong Improvement in ORR and Depth of Response vs. GnP
Elraglusib Arm Demonstrated Strong Improvement in ORR and Depth of Response vs. GnP GnP Best Overall Response Elraglusib + GnP Best Overall Response • One patient had a partial response on treatment, then was referred for a Whipple procedure and subsequently came off treatment • One patient had a pa
Slide 15: 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 42% Reduction in Risk of Death vs GnP GnP Elraglusib/GnP (n=58) (n=116) Primary Endpoint: mOS (months) 8.5 12.5 HR=0.58; log-rank p=0.035 12-month OS (%) 28.3 52.5 Events (% events) 54 (93
Slide 16: 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 OS and a 35% Reduction in Risk of Death vs GNP GnP Elraglusib/GnP (n=61) (n=114) Primary Endpoint: mOS (months) 6.6 8.3 HR=0.65; log-rank p=0.010 12-month OS (%) 15.2 39.2 p=0.0003* Events (% events) 58 (95.
Slide 17: Clinical Benefit Observed For Elraglusib + GnP Across All Subgroups Evaluated
Clinical Benefit Observed For Elraglusib + GnP Across All Subgroups Evaluated Predefined Safety Population Draft unaudited data as of Nov 22, 2025 16 The final data and results may change as the study continues through completion
Slide 18: Subsequent Anti-Cancer Therapy Is Balanced Between Both Arms
17 Subsequent Anti-Cancer Therapy Is Balanced Between Both Arms GnP Elraglusib/GnP (N = 78) (N = 155) Subsequent anti-cancer therapy, n (%) 30 (38%) 79 (51%) Systemic anti-cancer therapy, n (%) 29 (37%) 79 (51%) FOLFIRINOX 10 (13%) 18 (12%) FOLFOX 4 (5%) 3 (2%) FOLFOXIRI 2 (3%) 6 (4%) FOLFIRI 3 (4%)
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 20% of Patients Treated with elraglusib Patients, n (%) Elraglusib + GnP GnP Key Takeaways Adverse event (N=155) (N=78) Any Grade Grade ≥3 Any Grade Grade ≥3 • Overall rate of a TEAE a
Slide 20: mPDAC Future Development and Registration Plans
mPDAC Future Development and Registration Plans • Regulatory discussions planned with FDA and EMA on registration pathway • Registration trial design to be harmonized to support approval in both the US and EU Inclusion Criteria Treatment Endpoints ≥ 18 yrs old with mPDAC Primary endpoints: mOS Parti
Slide 21: Elraglusib in Pediatric Cancers
Elraglusib in Pediatric Cancers
Slide 22: Elraglusib Shows Promise in Difficult to Treat Pediatric Cancers
Elraglusib Shows Promise in Difficult to Treat Pediatric Cancers GSK-3β represents a credentialed target in pediatric Key Elraglusib Pediatric Regulatory Designations: cancers • US Orphan Drug Designations • Ewing’s (EWS) and related small round cell sarcomas with EWSR1 • Pediatric neuroblastoma tra
Slide 23: Phase 1 Elraglusib Trial Demonstrated Clinical Responses in Pediatric Cancers
Phase 1 Elraglusib Trial Demonstrated Clinical Responses in Pediatric Cancers 1902 Trial Update Clinical responses and disease control observed in 15 of 40 patients with difficult-to-treat refractory pediatric cancers • 10 of 19 patients treated with elraglusib plus cyclophosphamide/topotecan showed
Slide 24: Elraglusib Pediatric Development Plans
Elraglusib Pediatric Development Plans • Actuate has been engaging with KOLs and patient advocacy groups in US, EU, UK, and Japan on Phase 2 study designs • Pre-IND meeting with FDA planned to discuss registration pathway in EWS • Discussions initiated and ongoing with US, EU, UK, and Japan KOLs reg
Slide 25: Elraglusib in Metastatic Melanoma and Other Cancer Indications
Elraglusib in Metastatic Melanoma and Other Cancer Indications
Slide 26: Elraglusib Tablet to be Utilized in New Indications
Elraglusib Tablet to be Utilized in New Indications Elraglusib Blood Concentration – Oral Formulations IV (10 mg/kg) Elra:CAP ASD Capsule (20 mg/kg) Elra: PVAP ASD Capsule (20 mg/kg) Oral Suspension (10 mg/kg) Oral Soln (20 mg/kg) Tablet has excellent drug-like properties 8,000 • Two tablets could r
Slide 27: Elraglusib Tablet Clinical Development Plan
Elraglusib Tablet Clinical Development Plan Phase 1 Study Design Phase 2 Study Design Daily dose at RP2D Inclusion Treatment Endpoints Criteria BOIN 3+3 Design CPI refractory metastatic melanoma and other • CPI refractory 1000 mg advanced refractory cancers DL 5 QD metastatic melanoma and Planned st
Slide 28: Metastatic Melanoma is a High Unmet Need With Significant Commercial Potential
Metastatic Melanoma is a High Unmet Need With Significant Commercial Potential Market Size Metastatic melanoma is the deadliest form of skin cancer and accounts for the majority of melanoma deaths (~57,000 deaths per year worldwide).1 U.S. new cases are ~105k per year,2 and global new cases are ~330
Slide 29: Elraglusib Has Potential in Multiple Indications with High Unmet Need
Elraglusib Has Potential in Multiple Indications with High Unmet Need MRI on prior MRI during MRI after 2 MRI after 4 therapy washout (growth) cycles (PR) cycles (CR) Actuate 1801 Part 1 evaluated elraglusib as a single agent • First objective response reported in patient treated with 5 mg/kg elragl
Slide 30: GSK-3β is a Therapeutic Target Across Numerous Cancer Histologies
GSK-3β is a Therapeutic Target Across Numerous Cancer Histologies Elraglusib Evaluated Across Elra Preclinical Elra Clinical Multiple Cancers Activity Activity Bladder ✓ • Extensive preclinical and clinical evidence Breast ✓ supports GSK-3β as a therapeutic target in > 20 Colorectal ✓ ✓ different ca
Slide 31: Key Near Term Anticipated Development Plans and Milestones
Key Near Term Anticipated Development Plans and Milestones 2026 mPDAC: mPDAC: mPDAC: mPDAC: mPDAC: Presentation of FDA Meeting on FDA and EMA Meeting Initiate Global Global Registration Updated 1801-3B Data Clinical & Registration Minutes Available Registration Trial Trial - FPFD at ASCO GI Pathway
Slide 32: 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 33: Investment Highlights
Investment Highlights Compelling Survival Data in mPDAC Broad Therapeutic Potential in Multiple Oncology Indications Significant Commercial Potential in Major Markets Extended IP Protection Seasoned Leadership Team 32
Slide 34: Nasdaq Global Market: ACTU
ACTUATE THERAPEUTICS Nasdaq Global Market: ACTU
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