Theralase Technologies Inc. · TSXV:TLT
Theralase Technologies — Investor Presentation (March 2024)
24 slides from Theralase Technologies's investor presentation, Mar 18, 2024
Slide 1: Destroying Cancer at the Speed of Light
Destroying Cancer at the Speed of Light® March 18, 2024 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: What is Cancer?
What is Cancer? 3 • Cancer occurs when cells have DNA damage and become immortal. • Normal cells grow—and then die—when they are given signals to do so. • Cancer cells ignore these signals and continue to multiply, leading to tumours and eventually death if not destroyed. • We have approximately 30
Slide 4: Mechanism of Action
Mechanism of Action Light 4 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 5: Company
Company 5 Scientific Pipeline Clinical Stage Management Intellectual Research Team Property Patented light-activated Primary Phase II NMIBC registration clinical Extensive preclinical and clinical 28 issued patents and 17 Photo Dynamic Compounds Non-Muscle Invasive Bladder study interim clinical dat
Slide 6: Bladder Cancer
Bladder Cancer 6 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 7: Current Treatment Landscape
Current Treatment Landscape 7 • Bacillus Calmette Guérin (“BCG”) is the standard of care treatment for NMIBC • 75% of bladder cancers classified as NMIBC1 and 5 to 10% of bladder cancers classified as Carcinoma In-Situ (“CIS”)2 • High initial efficacy BCG up to 75%2,3 (25% failure rate) • BCG is not
Slide 8: Market Opportunity
KEYTRUDA Sales - Market Opportunity Bladder Cancer8 Source: valuate Ltd 8 $1.15 7,7067 x $200,0001 = Billion Annually $1.54 Billion Annually Social Demand Patients willing to pay between $USD 50k to $USD 150k per Quality Adjusted Life Year (“QALY”) for treatment (2 Years = $USD 100k to $USD 300k (Av
Slide 9: Ruvidar (TLD-1433)
Ruvidar TM (TLD-1433) 9 • Ruthenium based PDC • Designed to destroy solid core tumours (i.e.: bladder, brain, lung and breast) when absorbed by the cancer cell and light activated1 • GMP manufactured in kilogram batches with high yield and high purity (98%) • < 0.5 grams used for NMIBC Study Treatme
Slide 10: Study Treatment
Study Treatment 10 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 Ox
Slide 11: Clinical Target
Clinical Target 11 A clinically meaningful initial Complete Response Rate (“CRR”) for Carcinoma In-Situ (“CIS”) or recurrence-free rate (for papillary tumors) of at least: • 50% at 6 months • 30% at 12 months • 25% at 18 months is recommended. (International Bladder Cancer Group (“IBCG”))1 Theralase
Slide 12: Phase II NMIBC Clinical Study
Phase II NMIBC Clinical Study1 12 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 13: Study Design
Study Design 13 • Approximately 100 patients with BCG-Unresponsive NMIBC CIS • 10 clinical study sites currently enrolling patients in Canada and the United States (Up to 15 in 2024) • Patient provided primary Study Procedure on Day 0 (1 hour of drug instillation, 1 to 1.5 hours of light activation)
Slide 14: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 14 Ruvidar has been demonstrated to achieve complete responses in patients, previously treated with and who failed therapy with: BCG, systemic PD-L1 immunotherapies and chemotherapies, intravesical oncolytic viruses and intravesical chemotherapies (gemcitabine w
Slide 15: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 15 Primary Objective Secondary Objective Tertiary Objective Assessment Performance Performance Performance # % # % # % Study II Clinical Data Complete Response ("CR") 38 64% 17 36% 59 100% (Evaluable Patients) Indeterminate Response Complete Response ("CR") Inde
Slide 16: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 16 On August 1, 2020, the Company optimized the Study II Treatment. For patients that received the optimized Study II Study II Clinical Data Treatment the CR, IR and Total Responders are detailed below by assessment visit. (Evaluable Patients) Optimized Treatmen
Slide 17: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 17 Swimmer’s Plot: Kaplan-Meier Curve • > 80% of patients remained in Study II after 90 days, following the initial Study II Treatment. • For all evaluable patients, 41% of Total Response (“TR”) have a duration of response ≥ 450 days, while 37% of Complete Respo
Slide 18: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 18 Serious Adverse Events For 63 patients treated in Study II, there have been 13 Serious Adverse vents (“SAEs”) reported: • 2 – Grade 2 (resolved within 1 and 1 days, respectively) • 7 – Grade 3 (resolved within 1,2, 3, 4, 4, 82 and unknown days, respectively)
Slide 19: FDA Approved Drugs Versus Ruvidar
FDA Approved Drugs Versus RuvidarTM 19 Company/ FDA Initial Complete Approved Drug (Date of Number of Response Durable CR Annual Cost Approval) Patients (“CR”) (15 months) Pros Cons ($USD 000s) Not a Anthra Pharmaceuticals First intravesical drug BCG-Unresponsive population. Not $44 to $66 Valrubici
Slide 20: Competitive (Non-FDA Approved) Drugs Versus Ruvidar
Competitive (Non-FDA Approved) Drugs Versus RuvidarTM 20 Initial Complete Competitive Drug Number of Response Durable CR Annual Cost (Non-FDA Approved) Patients (“CR”) (15 months) Pros Cons ($USD 000s) Combinational product, combined with standard of care BCG. Unknown contribution of BCG in $Unknown
Slide 21: Regulatory Timeline
Regulatory Timeline 21 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 22: Capital Structure
Capital Structure 22 TSXV:TLT 03/15/2024 Common share price $CAN 0.21 Warrants 87,194,853 Market Capital $CAN 49.4 M Options 18,500,000 Shares Outstanding 235,127,528 Finder Units 2,041,941 Insider Fully Diluted 344,906,263 12.75% Fully Diluted Ownership
Slide 23: Investment Highlights
Investment Highlights 23 • Potential next standard of care treatment for bladder cancer (10th most common cancer in the world (6th in men)) • Unique value proposition combining a patented light-sensitive drug and proprietary laser system • Able to directly destroy bladder cancer, leaving healthy bla
Slide 24: Contact Information
Contact Information Roger DuMoulin-White, B.Sc., P.Eng., Pro.Dir. President and Chief Executive Officer rwhite@theralase.com, 416.699.5273 x 225 Arkady Mandel, M.D., Ph.D., D.Sc. Toll Free: 1.866.THE.LASE (843.5273) Work: 416.699.LASE (5273) Chief Scientific Officer www.theralase.com amandel@therala
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