Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — Investor Presentation (July 2024)
24 slides from Actuate Therapeutics's investor presentation, July 2024
Slide 1: Corporate Overview
CORPORATE OVERVIEW July 2024 0
Slide 2: Legal Disclaimer
Legal Disclaimer Actuate Therapeutics, Inc. (the "Company," "Actuate," "we," "our" and "us") has filed a registration statement (including a preliminary prospectus) on Form S-1 (File No. 333-279734) related to this proposed initial public offering with the Securities and Exchange Commission (the "SE
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements. Forward-looking statements are not historical facts but are based on certain assumptions of our management, which we believe to be reasonable but are inherently uncertain, and describe our future plans, strategies and
Slide 4: Company Highlights
Company Highlights 1 Developing elraglusib, a leading GSK-3β inhibitor with novel, multimodal MOA, in multiple advanced cancer Phase 2 trials 2 Clinical responses (CRs/PRs) and Disease Control observed across cancer histologies with elraglusib IV as single agent and in combination with chemotherapy
Slide 5: Multimodal MOA Supported by Clinical Data
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 progression in many treatment naive and refractory/resistant tumors • Pleiotropic effects as signaling adaptor • Elraglusib downregulates well-c
Slide 6: Multimodal MOA Supported by Clinical Data
Multimodal MOA Supported by Clinical Data Drug Study Phase 1 Phase 2 Phase 3 Anticipated Milestones Part 1 and 2: Dose Escalation Published Carneiro et al. 2024 Refractory Cancers Fully Enrolled Part 3A: Pancreatic Cancer (combined with GnP) Completed Adult 1st line metastatic (single arm) Submitted
Slide 7: 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 Elraglusib
Slide 8: 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 9: 1st Line Treatment of mPDAC
1st Line Treatment of mPDAC Phase 2 – Actuate 1801 Part 3A • Simon’s two-stage design - Stage 1 • 1st line metastatic pancreatic cancer (mPDAC) • Evaluate combination of elraglusib and gemcitabine/nab-paclitaxel (GnP) • First 23 consecutively evaluable patients defined as analysis set n= 29 after re
Slide 10: Phase 2 RCT in First-Line Metastatic PDAC
Phase 2 RCT in First-Line Metastatic PDAC Phase 2 RCT • Primary endpoint: OS Analysis of the interim data from Actuate-1801 3B is based on the study statistical analysis plan for informal interim data analysis when >50% of the • Secondary endpoints: ORR, DOR, PFS patients in the GnP control group pr
Slide 11: Phase 2 RCT in First-Line Metastatic PDAC
Phase 2 RCT in First-Line Metastatic PDAC Survival Swim Plots The final data and results may change as the study continues through completion Predefined Safety Population Draft unaudited data as of April 30, 2024 10
Slide 12: Phase 2 RCT in First-Line Metastatic PDAC
Phase 2 RCT in First-Line Metastatic PDAC Best Overall Response Waterfall Plots The final data and results may change as the study continues through completion Predefined Safety Population Draft unaudited data as of April 30, 2024 11
Slide 13: Phase 2 RCT in First-Line Metastatic PDAC
Phase 2 RCT in First-Line Metastatic PDAC Time on Treatment Swim Plots GnP | n=78 (12 PRs) GnP + weekly elra | n=155 (32 PRs) The final data and results may change as the study continues through completion Predefined Safety Population Draft unaudited data as of April 30, 2024 12
Slide 14: Patient Demographics
Patient Demographics as of May 1, 2024 Demographics – 1801 3B GnP (N = 78) GnP + Weekly Elra (N=155) General Classification of Pancreatic Cancer GnP (N = 78) GnP + Weekly Elra (N=155) (at initial diagnosis) Sex Female 35 (44.9%) 75 (48.4%) Borderline resectable pancreatic carcinoma 0 9 (5.8%) Male 4
Slide 15: 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 • Extraordinary results for two melanoma patients in the study • First objective response reported in patient treated with 5 mg/kg elraglusib monotherapy • Metastatic melan
Slide 16: Clinical Responses in Areas of High Unmet Need-Pediatric Oncology
Clinical Responses in Areas of High Unmet Need-Pediatric Oncology Objective responses and durable survival highlight development opportunity in Ewing sarcoma • Seven patients were enrolled in Actuate-1902 and appear to have Phase 1/2 study (Actuate-1902) in pediatric metastatic, refractory Ewing and
Slide 17: Higher Doses of Elraglusib Appear Associated with Better Overall Survival
Higher Doses of Elraglusib Appear Associated with Better Overall Survival • Single agent dose escalation (Actuate-1801 Part 1) was evaluated in 67 patients in 15 different cancer types1 • 35/67 subjects were enrolled at the three highest doses (9.4, 12.4 and 15 mg/kg) • Patients were advanced, refra
Slide 18: Elraglusib Clinical Pharmacology
Elraglusib Clinical Pharmacology Supports Additional Dose Exploration Plasma Pharmacokinetics (PK) after a Single IV Dose in Actuate-1801 Part 1 Dose Cmax Tmax AUC24 AUC72 AUC∞ λz t1/2 CL Vz n • Range of clinical benefit for mg/kg ng/mL H ng•h/mL ng•h/mL ng•h/mL 1/h h L/h/kg L/kg elraglusib injectio
Slide 19: Elraglusib Oral Formulations
Elraglusib Oral Formulations Oral elraglusib formulations have been developed that provide similar drug exposures to current IV • Several possible oral dosage forms may allow potential expansion into pediatric cancer indications and adult indications where standard of care is oral • May improve comp
Slide 20: Elraglusib Oral Tablet
Elraglusib Oral Tablet Exceeds Plasma Exposures of Elraglusib Injection Elraglusib Oral Tablet Plasma Exposure (AUC) at MTD is similar to the Highest Dose of elraglusib Injection tested to date Target Dose Actual Dose Half-life Tmax Cmax AUClast Dose-limiting Route Potency Dose Number (mg/kg) (mg/kg
Slide 21: Key Near Term Anticipated Development Plans and Milestones
Key Near Term Anticipated Development Plans and Milestones IV Program Part 3A paper EMA advice PFS in >80% FDA Type D Topline data 1801 meeting Phase 2 mPDAC (PDAC) OS in 70% of mPDAC control patients PDAC ODD PDAC EMA / COMP 2024 July August September October November December 2025 1H 2025 2H 2025
Slide 22: Actuate Patent Portfolio
Actuate Patent Portfolio United States World-Wide: National Stage Applications Pending in US 8,207,216-licensed from UIC North America, Asia, Europe, South America, Israel, Africa and Australia Claims directed to compounds, pharmaceutical compositions, and methods of use International Patent Applica
Slide 23: Investment Highlights
Investment Highlights Leading Therapeutic Profile Extensive data on activity from leading research institutions and promising clinical data in multiple cancer histologies Significant Unmet Needs Developing elraglusib to address therapeutic shortcomings in key difficult-to-treat and refractory tumors
Slide 24: Actuate Therapeutics
ACTUATE HERAPEUTICS
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