Theralase Technologies Inc. · TSXV:TLT
Theralase Technologies — Investor Presentation (October 2023)
21 slides from Theralase Technologies's investor presentation, Oct 23, 2023
Slide 1: Destroying Cancer with Light-Activated Compounds
Destroying Cancer with Light-Activated Compounds October 23, 2023 TSXV:TLT | OTCQB:TLTFF
Slide 2: Forward-Looking Statements
Forward-Looking Statements 2 Forward-Looking Statements (“FLS”) contained in this presentation deal with the future revenue potential, business opportunities and/or strategic initiatives of Theralase® Technologies Inc. (“Theralase®” or the “Company”); including, information, analyses and/or projecti
Slide 3: Company
Company 3 Scientific Pipeline Clinical Stage Management Intellectual Research Primary Phase II NMIBC registration clinical Team Property Non-Muscle Invasive Bladder study interim clinical data Patented light-activated Cancer (“NMIBC”)2 demonstrates: Extensive preclinical and clinical 28 issued paten
Slide 4: Bladder Cancer
Bladder Cancer 4 Non-Muscle Invasive 10th Most Common Cancer Bladder Cancer Worldwide (“NMIBC”) Muscle Invasive 6th and 17th most common cancer Bladder Cancer in men and women, respectively1 (“MIBC”) Annually 573,000 new cases of bladder cancer internationally in 20201 Annually 82,290 in US, 13,300
Slide 5: Current Treatment Landscape
Current Treatment Landscape 5 • Intravesical Bacillus Calmette Guérin (“BCG”) is the current standard of care treatment for NMIBC with 75% of bladder cancers classified as NMIBC1 and 5% of bladder cancers classified as Carcinoma In-Situ (“CIS”)2 • High initial efficacy BCG up to 75%2,3 (25% failure
Slide 6: Market Opportunity
KEYTRUDA Sales - Market Opportunity Bladder Cancer8 Source: valuate Ltd 6 $1.15 7,7067 x $200,0001 = Billion Annually $1.54 Billion Annually Social Demand Patients willing to pay between $USD 50,000 to $USD 150,000 per Quality Adjusted Life Year (“QALY”) for treatment (2 Years = $USD 100,000 to $USD
Slide 7: Ruvidar (TLD-1433)
Ruvidar TM (TLD-1433) 7 • Ruthenium based PDC • Designed to destroy solid core tumours, such as bladder, brain, lung and breast when absorbed by the cancer cell and then light activated1 • High yield and high purity drug (98%) • GMP manufactured in kilogram batches • < 0.5 grams used for NMIBC Study
Slide 8: Mechanism of Action
Mechanism of Action Light 8 Transferrin (Visible or Near Infra Red (“NIR”)) Receptor (“TfR”)2 TfR 1O 2 ROS RuvidarTM Cancer cell destruction via Rutherrin®1 Cancer Cell Immunogenic Cell Death (“ICD”)3 RuvidarTM Retained Ruvidar TM Healthy Cell Not Taken Up4 Healthy Cell Unaffected Transferrin (Tf) 1
Slide 9: Study Treatment
Study Treatment 9 RuvidarTM instilled Bladder cancer cells in bladder via RuvidarTM localizes Green laser light destroyed by the catheter preferentially activates production of singlet demonstrating inside bladder cancer RuvidarTM through oxygen and / or absorption cells2,3 fiber optics Reactive Oxy
Slide 10: Clinical Target
Clinical Target 10 • 50% initial CRR, 30% CRR at 12 months and 25% CRR at 18 months (International Bladder Cancer Group (“IBCG”))1 1) Kamat AM et al. J Clin Oncol. 2016; 34: 1935-1944
Slide 11: Phase II NMIBC Clinical Study
Phase II NMIBC Clinical Study1 11 Primary Tertiary Study design consistent Secondary Objective Objective Objective with FDA Guidance: Initial Efficacy Duration of Safety “In BCG-Unresponsive NMIBC, a single-arm (CR achieved at any Efficacy Incidence and severity of point in time) (12 months duration
Slide 12: Study Design
Study Design 12 Complete Complete Complete Complete Complete Response? Response? Response? Response? Response? Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Visit 10 Visit 11 Visit 12 End of Study Days -45 to -1 Day 0 Day 7 + 1 Day 30 + 7 Day 60 + 7 Day 90 + 14 Day 180 + 14
Slide 13: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 13 1) Press Release - Theralase® Provides Update on Bladder Cancer Clinical Study – October 16, 2023
Slide 14: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 14 Achieved Primary Achieved Secondary Achieved Secondary Achieved Tertiary Achieved Tertiary Achieved Primary Objective (n) Objective (%) Objective (n) Objective (%) Objective (n) Objective (%) Complete Response ("CR") 37 65% 14 33% 57 100% Indeterminate Respon
Slide 15: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 15 On August 1, 2020, the Company optimized the Study II Treatment. For patients that received the optimized Study II Treatment the CR, IR and Total Responders are detailed below by assessment visit. Study II Clinical Data (Evaluable Patients) Optimized Treatmen
Slide 16: FDA Approved Drugs Versus Ruvidar
FDA Approved Drugs Versus RuvidarTM 16 Initial Complete Number of Response Rate Durable CRR Durable CRR FDA Approved Drug Patients (“CRR”) (12 months) (15 months) Safety Limitations Cost Not a BCG-Unresponsive Study treatment $USD 43,950 to Valrubicin1, 2 90 21.1% 7.7% Not Reported population. Not r
Slide 17: Regulatory Timeline
Regulatory Timeline 17 Milestone 2019 2020 2021 2022 2023 2024 2025 2026 100 Patients Enrolled and Provided Primary Study Treatment (Projected) FDA Fast Track Designation (Actual) Breakthrough Designation (Projected) Patient Follow Up (Projected) Premarket Approval (Study Device) (Projected) Data Lo
Slide 18: Capital Structure
Capital Structure 18 TSXV:TLT 10/23/2023 Common share price $CAN 0.26 Warrants 82,458,050 Market Capital $CAN 58.0 M Options 18,510,000 Insider Shares Outstanding 223,142,675 ~ 12.8% Fully Diluted Ownership Analyst Coverage
Slide 19: Investment Highlights
Investment Highlights 19 • Theralase® is focused on providing the next standard of care treatment for bladder cancer. The 10th most common cancer in the world (6th in men). • Theralase® provides a unique value proposition combining a patented light-sensitive drug and proprietary laser system that ha
Slide 20: Statutory Rights of Action
Statutory Rights of Action 20 In certain circumstances, purchasers resident in certain provinces of Canada, are provided with a remedy for rescission or damages, or both, in addition to any other right they may have at law, where an offering memorandum (such as this Presentation) and any amendment t
Slide 21: Contact Information
Contact Information Roger DuMoulin-White, BSc, P.Eng, Pro.Dir President and Chief Executive Officer rwhite@theralase.com, 416.699.5273 x 225 Arkady Mandel, MD, PhD, DSc Toll Free: 1.866.THE.LASE (843.5273) Work: 416.699.LASE (5273) Chief Scientific Officer www.theralase.com amandel@theralase.com, 41
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