Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — Investor Presentation (January 2025)
21 slides from Actuate Therapeutics's investor presentation, January 2025
Slide 1: Corporate Overview
Corporate Overview January 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 Advancing a potentially class-leading GSK-3β 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 increased responses are observed in
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 Pancreatic Cancer (with Adult Actuate-1801 Topline Data: Q1 2025* GnP) 1st line metastatic Part 3B Pancreatic Cancer (with Adult – Phase 3 RCT In Planning TBD** G
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 (9-ING-41) 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
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 >$7 billion by 2030 Survival Rate and Economic Burden The prognosis re
Slide 8: 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 pancreatic adenocarcinoma I year OS/mOS Elraglusib + GnP Secondary endpoints: Participants must have Follow Up ORR, DOR, PFS measurable disease as
Slide 10: 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
Slide 11: Doubling of 1 year OS and 37% Reduction in Risk of Death vs GnP
Doubling of 1 year OS and 37% Reduction in Risk of Death vs GnP Administrative Analysis of Interim Data from Nov 15th, 2024, Demonstrates a Hazard Ratio of 0.63 GnP Elraglusib/GnP The administrative analysis of interim data indicates that >80% of the patients in the GnP (78) (155) control group prog
Slide 12: Administrative Analysis of 1801 Part 3B OS Swim Plot
Administrative Analysis of 1801 Part 3B OS Swim Plot 11 Predefined Safety Population The final data and results may change as the study continues through completion Draft unaudited data as of November 15th, 2024
Slide 13: 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 reported as 100% tumor reduction as of November 22, 2024 Predefined Safety Population 12 The final data and results may change a
Slide 14: Nearly 3-Fold Increase in 1 year OS and 40% Reduction in Risk of Death
Nearly 3-Fold Increase in 1 year OS and 40% Reduction in Risk of Death Analysis of Patients with Liver Metastases Demonstrates a Hazard Ratio of 0.60 GnP Elraglusib/GnP (61) (114) mPDAC Patients with Liver Metastases at Study Entry Primary Endpoint: 1 Year OS (%) Elraglusib + GnP 14.1 39.3 P<0.0003*
Slide 15: 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 (%) Key Takeaways Elraglusib + GnP GnP (N=155) (N=78) • Overall rate of a TEAE and/or a SAE observed were similar in Adverse event A
Slide 16: 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 17: 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 18: Key Near Term Anticipated Development Plans and Milestones
Key Near Term Anticipated Development Plans and Milestones 2024 2025 Initiate Phase I in solid tumors with Oral Tablet* mPDAC: ASCO 2025 mPDAC: mPDAC: Initiate planning of Phase 2 topline data mPDAC: confirmatory Phase 3 trial FDA Type B Meeting request to discuss development planning Dec Jan Mar Ju
Slide 19: 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 20: Investment Highlights
Investment Highlights Extensive data on activity from leading research institutions and promising clinical Leading Therapeutic Profile data in multiple cancer histologies Developing elraglusib to address therapeutic shortcomings in key difficult-to-treat Significant Unmet Needs and refractory tumors
Slide 21: The Passion to Pursue More
ACTUATE THERAPEUTICS The Passion to Pursue More
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