Theralase Technologies Inc. · TSXV:TLT
Theralase Technologies — Investor Presentation (October 2024)
26 slides from Theralase Technologies's investor presentation, Oct 15, 2024
Slide 1: Destroying Cancer at the Speed of Light
Destroying Cancer at the Speed of Light® October 15, 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: Theralase Strategic Objectives
Theralase® Strategic Objectives 3 4Q2024 • Secure $CAN 5 to 10M in equity financing (completion of Phase II registration clinical study) • Receive Ontario Securities Commission receipt for a $CAN 100M base shelf prospectus (raise subsequent funds based on achieving milestones) • Achieve Break Throug
Slide 4: What is Cancer?
What is Cancer? 4 • Cancer occurs when cells sustain DNA damage and become immortal. • Normal cells grow - then die - when given signals to do so. • Cancer cells ignore these signals and continue to multiply, leading to tumours and eventually death, if not destroyed. • Each human has approximately 3
Slide 5: Mechanism of Action
Mechanism of Action Transferrin Light (Visible or Near Infra Red (“NIR”)), 5 Receptor Radiation, Sound and/or Drug (“TfR”)2 TfR 1O 2 RuvidarTM ROS Cancer cell destruction via Rutherrin®1 Cancer Cell Immunogenic Cell Death (“ICD”)3 RuvidarTM Retained Ruvidar TM Healthy Cell Not Taken Up4 Healthy Cell
Slide 6: Company
Company 6 Scientific Research Pipeline Clinical Stage Management Team Intellectual Property Small molecule researched Primary Phase II NMIBC registration clinical Extensive preclinical and clinical 28 issued patents and 17 and developed over the last Non-Muscle Invasive Bladder study interim clinica
Slide 7: Bladder Cancer
Bladder Cancer 7 Non-Muscle Invasive Bladder Cancer 10th Most Common Cancer Worldwide (“NMIBC”) 6th and 17th most common cancer in men and women, respectively 1 Muscle Invasive Bladder Cancer (“MIBC”) 614,298 new cases of bladder cancer per year worldwide in 2022 1 83,190 in US, 15,111 in Canada, 20
Slide 8: Current Treatment Landscape
Current Treatment Landscape 8 • Bacillus Calmette Guérin (“BCG”) - standard of care treatment for NMIBC • 75 to 80% of bladder cancers classified as NMIBC1,2 and 10% of bladder cancers classified as Carcinoma In-Situ (“CIS”)2 • High initial efficacy BCG up to 70%2,3 (30% failure rate) • BCG is not d
Slide 9: Global Market Opportunity
KEYTRUDA Sales - Bladder Cancer7 Global Market Opportunity Source valuate td 9 39,9296 x $200,0001 = $8 Billion Annually • Patients willing to pay between $USD 50k to $USD 150k per Quality Adjusted ife Year (“QALY”) for treatment (2 Years = $USD 100k to $USD 300k (Average = $USD 200k)1 • Bladder can
Slide 10: Ruvidar (TLD-1433)
Ruvidar TM (TLD-1433) 10 • Ruthenium based small molecule • Designed to destroy solid core tumours (i.e.: bladder, brain, lung and breast) when absorbed by the cancer cell • Activity is significantly enhanced when energy activated 1 • Good Manufacturing Practices (“GMP”) manufactured in kilogram bat
Slide 11: Study Treatment
Study Treatment 11 Bladder cancer cells RuvidarTM instilled RuvidarTM localizes Green laser light destroyed by the in bladder via catheter preferentially inside activates RuvidarTM production of singlet demonstrating bladder cancer cells 2,3 through fiber optics oxygen and / or Reactive absorption i
Slide 12: Clinical Target
Clinical Target 12 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 1) Kamat
Slide 13: Phase II NMIBC Clinical Study
Phase II NMIBC Clinical Study1 13 Primary Secondary Objective Tertiary Objective Study design consistent Objective with FDA Guidance: Initial Efficacy Duration of Efficacy Safety “In BCG-Unresponsive (CR achieved at any (12 months duration of CR Incidence and severity of NMIBC, a single-arm clinical
Slide 14: Study Procedure
Study Procedure 14 • Approximately 75 to 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 hour of light activation
Slide 15: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 15 PREVIOUS BCG CIS + Ta THERAPY TREATMENTS AGE SEX Non- RACE 7% STAGE <7 Female ≤ 65 White 5% 16% 16% CIS + T1 21% 15% Male CIS ≥7 > 65 White 84% 78% 95% 79% 84% Ruvidar has been demonstrated to achieve complete responses in patients, previously treated with an
Slide 16: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 16 Primary Objective Performance Secondary Objective Performance Tertiary Objective Performance Confidence Confidence Confidence # % # % # % Interval (95%) Interval (95%) Interval (95%) Complete Response ("CR") 41 60.3% 18.5% 18 26.5% 12.23% 68 100.0% Indetermin
Slide 17: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 17 In response to the FDA request, there is a demonstrated duration of CR of 13.2% (9/68) at 540 days, 8.8% (6/68) at 630 days, 7.4% (5/68) at 720 days, 7.4% (5/68) at 900 days and 5.9% (4/68) at 1080 days, with significant clinical data still pending. 90 Days 1
Slide 18: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 18 The Swimmer’s plot below is a graphical representation of the interim clinical results (n=41) for patients who achieved a CR at any point in time and their response over 1080 days, graphically demonstrating a patient's response to a treatment over time. As ca
Slide 19: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 19 In summary, the interim clinical data demonstrates that patients consenting to participate in Study II have a 60.3% chance of achieving CR. If CR is obtained, then the patient is estimated to have a 47.8%, 42.6% and 35.6% chance of remaining cancer free for 1
Slide 20: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 20 Serious Adverse Events For 75 patients treated in Study II, there have been 15 Serious Adverse vents (“SAEs”) reported • 1 – Grade 1 (resolved in 9 days) • 3 – Grade 2 (resolved within 1, 1 and 33 days, respectively) • 7 – Grade 3 (resolved within 1, 2, 3, 4,
Slide 21: FDA Approved Drugs
FDA Approved Drugs 21 Initial Company/ FDA Complete Duration of Market Approved Drug Number of Response Response Annual Cost Capitalization (Date of Approval) Patients (“CR”) (12 months) (24 months) (36 months) Pros Cons ($USD 000s) ($USD Billion) Endo Pharmaceuticals First intravesical drug Not a $
Slide 22: Competitive (Non-FDA Approved) Drugs Versus Ruvidar
Competitive (Non-FDA Approved) Drugs Versus RuvidarTM 22 Initial Number Complete Duration of Market Competitive Drug of Response Response Annual Cost Capitalization (Non-FDA Approved) Patients (“CR”) (12 months) (24 months) (36 months) Pros Cons ($USD 000s) ($USD Billion) Johnson and Johnson Gemcita
Slide 23: Regulatory Timeline
Regulatory Timeline 23 Milestone 2019 2020 2021 2022 2023 2024 2025 2026 75 to 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) D
Slide 24: Capital Structure
Capital Structure 24 TSXV:TLT 10/09/2024 Common share price $CAN 0.185 Warrants 37,386,360 Market Capital $CAN 45.4 M Options 8,500,000 Shares Outstanding 242,818,035 Finder Units 18,864 Insider Fully Diluted 288,723,259 12.75% Fully Diluted Ownership
Slide 25: Investment Highlights
Investment Highlights 25 • Next standard of care treatment for bladder cancer (10th most common cancer in the world (6th in men)) • Unique value proposition, combining a patented small molecule and proprietary laser system • Able to directly destroy bladder cancer, leaving healthy bladder cells inta
Slide 26: 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. Chief Scientific Officer Toll Free: 1.866.THE.LASE (843.5273) amandel@theralase.com, 416.699.5273 x 260 Work: 416.699.LAS
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