Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — Investor Presentation (June 2025)
25 slides from Actuate Therapeutics's investor presentation, Jun 2, 2025
Slide 1: Corporate Overview May 31, 2025
Corporate Overview May 31, 2025
Slide 2: 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,” “believe,” “continue,” “c
Slide 3: Company Highlights
2 IPO: August 2024 HEADQUARTERS: Fort Worth, TX Advancing a potentially class - leading GSK - 3 β inhibitor, elraglusib with a novel, multimodal MOA, in multiple advanced cancer Phase 2 trials Clinical responses (CRs/PRs) and Disease Control observed across cancer histologies Extended survival and i
Slide 4: Elraglusib: Multimodal MOA Supported by Clinical Data
3 Decreased immune evasion T Cells and NK Cells Activation Reduction of fibrosis Accumulation of activated T cells in and through str o m A a Inhibition of epithelial - mesenchymal transition (EMT) Inhibition of cell proliferation and survival Apoptosis GSK - 3 β Elraglusib: Multimodal MOA Supported
Slide 5: Milestones and Strategic Pipeline Growth for GSK-3β Associated Diseases
4 Milestones Phase 3 Phase 2 Phase 1 Preclinical Program Elraglusib Injection (IV) - ASCO presentation of topline data: Q2 2025 - FDA Type B pre - NDA meeting request: 2H 2025* Adult Actuate - 1801 Part 3B Pancreatic Cancer (with GnP) 1st line metastatic In Planning TBD** Adult – Phase 3 or Confirma
Slide 6: Phase 1/2 Study Design for Elraglusib Injection (IV)
5 Phase 1/2 Study Design for Elraglusib Injection (IV) Establishes process for transition from elraglusib (9 - ING - 41) Monotherapy (Part 1) to evaluation of multiple chemotherapy combinations (Part 2) to Phase 2 efficacy studies (Part 3) under one protocol 1 Clinical Study Actuate - 1801 1 Databas
Slide 7: Elraglusib Opportunity in Metastatic Pancreatic Cancer
6 Elraglusib Opportunity Novel GSK - 3 β inhibitor that targets multiple molecular pathways in cancer cells but also impacts the TME and immune response Pancreatic Cancer Metastatic pancreatic cancer is highly aggressive and accounts for approximately 80 - 85% of all pancreatic cancer diagnoses. Pro
Slide 8: Phase 2 Clinical Activity with Extended Median Overall Survival
7 Phase 2 – Clinical Activity with Extended Median Overall Survival • 1801 Part 3A in mPDAC • Simon’s Two - Stage trial design - Stage 1 • Evaluate the combination of elraglusib and gemcitabine/nab - paclitaxel (GnP) • mOS of 15.3 (EE population) • 2 CRs confirmed • 9 PRs confirmed • DCR: 52%, ORR:
Slide 9: 1801 Part 3B: Phase 2 RCT in First-Line Metastatic PDAC
8 2:1 Randomization R ≥ 18 yrs old with metastatic pancreatic adenocarcinoma Participants must have measurable disease as defined by RECIST1.1 No prior therapy Total enrollment: 286 Inclusion Criteria Endpoints Primary endpoints: I year OS/mOS Secondary endpoints: ORR, DOR, PFS Sample size based on
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 wi
Slide 11: Predefined Safety Population Patient Demographics
10 Predefined Safety Population Draft unaudited data as of March 27, 2025 The final data and results may change as the study continues through completion Phase 2 RCT Patient Demographics Elraglusib + GnP (n=155) GnP (n=78) Demographics Sex 75 (48.4%) 35 (44.9%) Female 80 (51.6%) 43 (55.1%) Male Age
Slide 12: Study 1801 Part 3B Meets Primary Endpoint of Improved Survival
11 Study 1801 Part 3B Meets Primary Endpoint of Improved Survival PDAC: pancreatic ductal adenocarcinoma; OS: overall survival; ORR: overall response rate; DCR: disease control rate; PFS: progression - free survival Elraglusib/GnP (155) GnP (78) 10.1 7.2 Primary Endpoint: mOS (months) HR=0.63; log -
Slide 13: Administrative Analysis of 1801 Part 3B OS Swim Plot
12 Administrative Analysis of 1801 Part 3B OS Swim Plot The final data and results may change as the study continues through completion GnP + weekly elraglusib: n=155 (8 on treatment, 114 events) GnP : n= 78 (0 on treatment, 70 events) Predefined Safety Population Draft unaudited data as of March 27
Slide 14: Phase 2 RCT Best Overall Response
13 Predefined Safety Population Data as of March 27, 2025 Phase 2 RCT in First - Line Metastatic PDAC - Best Overall Response The final data and results may change as the study continues through completion. 1801 Part 3B: GnP + Weekly Elra Best Overall Response 1801 Part 3B: GnP Best Overall Response
Slide 15: Elraglusib + GnP Data Show OS Benefit Across Key Subgroups
14 Elraglusib + GnP Data Show OS Benefit Across Key Subgroups The final data and results may change as the study continues through completion Predefined Safety Population Data as of April 27, 2025 Draft unaudited data Elraglusib + GnP Better Elraglusib + GnP,
Slide 16: Subgroup Treated for One Cycle - Significant Benefit in OS
15 The final data and results may change as the study continues through completion Subgroup of Patients Treated for One Cycle (4 weeks) - Significant Benefit in OS PDAC: pancreatic ductal adenocarcinoma; OS: overall survival; ORR: overall response rate; DCR: disease control rate; PFS: progression -
Slide 17: Patients with Liver Metastases - Significant Benefit in mOS and mPFS
16 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 Elraglusib/GnP (114) GnP (61) 8.3 6.6 Primary Endpoint: mOS (months) HR=0.62; log - rank p=0.008 39.2 15.2 12 month OS (%) p=0.0003 92 (80.7%) 56 (91.8%) Even
Slide 18: Subsequent Anti-Cancer Therapy
17 Subsequent Anti - Cancer Therapy Predefined Safety Population Draft unaudited data as of March 27, 2025 LV - leucovorin * this patient also received anti - neoplastic therapy with radiation ** Other primarily represents various other chemotherapy regimens The final data and results may change as
Slide 19: Safety Profile of Elraglusib in Combination with GnP
18 Actuate 1801 Part 3B (ongoing) TEAEs of Any Grade Reported in 20% of Patients Treated with elraglusib Safety Profile of Elraglusib in Combination with GnP • Overall rate of a TEAE and/or an SAE observed were similar in the elraglusib + GnP - treated patients as compared to GnP - treated patients
Slide 20: Clinical Activity in Areas of High Unmet Need in 1801 Part 1 and 2
19 mOS (1801) Key Histologies Combination 9.1 months CPI Refractory, Metastatic Melanoma Elraglusib Monotherapy 6.9 months Refractory, metastatic Colorectal Elraglusib/Irinotecan ND CPI/Platinum refractory, metastatic NSCLC Elraglusib/Carboplatin 12 weeks on elraglusib leads to Complete Response by
Slide 21: Elraglusib Oral Formulations Provide Similar Drug Exposures to IV
20 Elraglusib Oral Formulations Provide Similar Drug Exposures to IV • Decreased cost of manufacturing at commercial scale compared to IV formulations • Phase 1 Study of Oral Solution in Normal Healthy Volunteers (NHV) showed > 50 % bioavailability vs IV after a single dose • Exposure and pharmacody
Slide 22: Key Near Term Anticipated Development Plans and Milestones
21 Key Near Term Anticipated Development Plans and Milestones For Accelerating Registration in mPDAC 2026 2025 Jan Mar Jun mPDAC: Initiate planning of Phase 3 or Confirmatory Trial mPDAC: Phase 2 Topline data mPDAC: Part 3A publication mPDAC: ASCO Presentation Sep Dec mPDAC: FDA Type B pre - NDA Mee
Slide 23: Seasoned and Successful Leadership
22 Steven D. Reich, MD – Sr VP, Clinical Development and Acting Chief Medical Officer • Oncology drug development executive leader for commercial clinical development and strategy • Directed multi - national medical research groups within pharmaceutical/biotechnology companies and CRO • Lead investi
Slide 24: Investment Highlights
23 Extensive data on activity from leading research institutions and promising clinical data in multiple cancer histologies Developing elraglusib to address therapeutic shortcomings in key difficult - to - treat and refractory tumors Focus on mediating cancer cell survival and chemoresistance throug
Slide 25: The Passion to Pursue More
The Passion to Pursue More
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