Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — Investor Presentation (September 2024)
22 slides from Actuate Therapeutics's investor presentation, September 2024
Slide 1: Corporate Overview
Corporate Overview September 2024
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 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 mPDAC and
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 T Cells and NK Cells - GSK-3β has been shown to potentially contribute to tumor Inhibition of epithelial- mesenchymal transition Activation progression in many treatment naive and refractory/
Slide 5: Strategic Pipeline Growth for GSK-3β Associated Diseases
Strategic Pipeline Growth for GSK-3β Associated Diseases Elraglusib (injection) Program Preclinical Phase 1 Phase 2 Phase 3 Milestones Administrative analysis Pancreatic Cancer (with GnP) of interim data: Q4 2024 Adult Actuate-1801 1st line metastatic Topline Data: Q1 2025 Pediatric Topline Data: 2H
Slide 6: Clinical Study Actuate-1801
Clinical Study Actuate-1801 Phase 1/2 Study Design for Elraglusib Injection 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 1801 - Part 1 1801 - Par
Slide 7: Safety Profile of Elraglusib
Safety Profile of Elraglusib As Monotherapy and in combination with chemotherapy Treatment-Emergent Adverse Events of Any Grade Reported in 20% of Treatment-Emergent Adverse Events of Any Grade Reported in 20% of Patients Patients Treated with elraglusib in Actuate 1801 Part 1 and 2 Treated with e
Slide 8: Part 2: Elraglusib Potential in Metastatic Pancreatic Cancer (mPDAC)
Part 2: 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 marked growth to $4.9 billion by 2026 Survival Rate and Economic Burden The pro
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) • Simon’s two-stage design - Stage 1 Subjects 29 Survival Probability Event 21 (72%) • Evaluate the combination of elraglusib Censored 8 (28%) and gemcitabine/nab-paclitaxel (GnP) Median Survival 1
Slide 10: Phase 2 RCT in First-Line Metastatic PDAC
Phase 2 RCT in First-Line Metastatic PDAC Inclusion Criteria Treatment Endpoints ≥ 18 yrs with metastatic Randomized Primary endpoint: mOS pancreatic adenocarcinoma Participants must have Elraglusib + GnP Secondary endpoints: ORR, measurable disease as defined DOR, PFS Follow Up RECIST1.1 R Survey S
Slide 11: Significant Improvements in mOS vs GnP
Significant Improvements in mOS vs GnP Administrative Analysis of Interim Data from April 30th, 2024, Demonstrates a mOS of 12.2 months The administrative analysis of interim data indicates that >50% of the GnP Elraglusib/GnP (78) (155) patients in the GnP control group progressed and were no longer
Slide 12: Administrative Analysis Swim Plot
Administrative Analysis Swim Plot 1801 Part 3B OS Swim Plot GnP + weekly elra: n=155 (47 on treatment, 53 events) GnP: n=78 (20 on treatment, 42 events) 11 The final data and results may change as the study continues through completion Months Predefined Safety Population Draft unaudited data as of A
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 140% 140% 120% ■ Partial Response 120% ■ Partial Response 100% ■ Stable Disease 100% ■ Stable Disease % Change from Baseline ■ Progressive D
Slide 14: 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 15: Elraglusib Potential in High Unmet Need-Pediatric Oncology
Elraglusib Potential in High Unmet Need-Pediatric Oncology
Slide 16: Developing Elraglusib for the Treatment of Refractory Ewing Sarcoma
Developing Elraglusib for the Treatment of Refractory Ewing Sarcoma Ewing sarcoma is the second most common malignant bone tumor in children, adolescents, and young adults, with >200 cases diagnosed in the US each year Patients that have metastasis There are currently no Phase 1/2 study (Actuate-190
Slide 17: Objective Responses and Prolonged Survival in Ewing Sarcoma
Objective Responses and Prolonged Survival in Ewing Sarcoma 8 patients with EWS and EWS- related sarcomas with disease 1 patient has a progression prior to joining the 1 patient has CR which durable ongoing CMR* study received the combination of continues for with no detectable elraglusib+cyclophosp
Slide 18: Elraglusib Oral Formulations Provide Similar Drug Exposures to IV
Elraglusib Oral Formulations Provide Similar Drug Exposures to IV Elraglusib Arithmetic Mean Concentration-Time Profiles • 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 v
Slide 19: Key Near Term Anticipated Development Plans and Milestones
Key Near Term Anticipated Development Plans and Milestones 2024 2025 Request Type B Meeting mPDAC Part 3A to discuss EWS AA/BTD publication Topline data Phase 2 FDA Type D mPDAC EMA advice meeting mPDAC Sept Oct Nov Dec Jan Mar Jun Initiate planning of confirmatory Phase 3 Submit PFS in >80% / OS in
Slide 20: 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 21: 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 22: The Passion to Pursue More
ACTUATE THERAPEUTICS The Passion to Pursue More
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