Theralase Technologies Inc. · TSXV:TLT
Theralase Technologies — Investor Presentation (May 2023)
29 slides from Theralase Technologies's investor presentation, May 18, 2023
Slide 1: Destroying Cancer with Light-Activated Compounds
Destroying Cancer with Light-Activated Compounds May 18, 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 Interim clinical data in a Phase II Team Property Non-Muscle Invasive Bladder NMIBC registration clinical study Patented light-activated Cancer (“NMIBC”)2 demonstrating a 65% Complete Extensive preclinical and clin
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 • 75% of bladder cancers are NMIBC1 (5% of bladder cancers are Carcinoma In-Situ (“CIS”) 2) • BCG has a high initial efficacy of up to 75%2,3 (25% failure rate) • BCG is no
Slide 6: Bladder Cancer Addressable Market
Bladder Cancer Addressable Market 6 CIS (with or without resected Ta/T1) Market Annual CIS Initial Failure Recurrence Total New Cases (5%) Rate (25%) Rate (50%) Canada 13,300 665 166 333 499 United States 82,290 4,115 1,029 2,058 3,089 Europe 151,000 7,550 1,888 3,775 5,663 Worldwide 573,000 28,650
Slide 7: Market Opportunity
KEYTRUDA Sales - Market Opportunity Bladder Cancer8 Source: valuate Ltd 7 $1.14 9,251 7 x $200,0001 = Billion Annually $1.85 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 $US
Slide 8: Ruvidar (TLD-1433)
Ruvidar TM (TLD-1433) • Ruthenium based PDC 8 • Designed to destroy solid core tumours, such as bladder, brain, lung and breast when absorbed by the cancer cell and then light activated1 • Preferentially absorbed via transferrin receptor into bladder cancer cells, leaving healthy urothelial cells in
Slide 9: Mechanism of Action
Mechanism of Action Light 9 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 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 • 40% to 50% initial CRR and 30% CRR at 18 to 24 months (US uro- oncologists)1 • 50% initial CRR, 30% CRR at 12 months and 25% CRR at 18 months (International Bladder Cancer Group (“IBCG”))2 • Strong safety and efficacy clinical data on 20 to 25 patients would support a Break-Thro
Slide 12: Proposed Indication and Primary Hypothesis
Proposed Indication 12 RuvidarTM is indicated for the treatment of patients with Bacillus Calmette Guérin (“BCG”)- Unresponsive Non-Muscle Invasive Bladder Cancer (“NMIBC”) with Carcinoma In-Situ (“CIS”), with or without resected Ta / T1 papillary tumors, who are ineligible for cystectomy, have elec
Slide 13: Phase II NMIBC Clinical Study
Phase II NMIBC Clinical Study1 13 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 14: Study Design
Study Design 14 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 15: Phase II NMIBC Interim Clinical Data
Phase II NMIBC Interim Clinical Data1 15 ASSESSMENT 90 DAY 180 DAY 270 DAY 360 DAY 450 DAY Complete Response (“CR”) 60% 51% 41% 31% 30% Indeterminate Response (“IR”) 6% 17% 12% - 3% Total Response (“CR” + IR”) 65% 68% 54% 31% 32% Evaluable Patients 52 47 41 39 37 Note: The data analysis is only a re
Slide 16: Phase II NMIBC Interim Clinical Data – Graphical Representation
Phase II NMIBC Interim Clinical Data – Graphical Representation1 16 Swimmer’s Plot Kaplan -Meier Curve • 34 Evaluable Patients Illustrates the probability of efficacy for the RuvidarTM that achieved CR on at Anti-Cancer Therapy (“ACT”) over the study duration, least one assessment based on the avail
Slide 17: Regulatory Timeline
Regulatory Timeline 17 Milestone 2019 2020 2021 2022 2023 2024 2025 2026 100 to 125 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)
Slide 18: Capital Structure
Capital Structure 18 TSXV:TLT 05/18/2023 Common share price $CAN 0.275 Warrants 75,812,650 Market Capital $CAN 59.5 M Options 18,150,000 Insider Shares Outstanding 216,502,675 ~ 10% Ownership Analyst Coverage
Slide 19: Investment Highlights
Investment Highlights 19 • Clinical stage pharmaceutical company advancing innovative light activated compounds to treat cancer • Lead candidate, Ruvidar TM, targeting significant unmet need in treating BCG-Unresponsive NMIBC CIS • ½ way through Phase 2 registration clinical study with enrollment an
Slide 20: Contact Information
Contact Information Arkady Mandel, MD, PhD, DSc Interim Chief Executive Officer / Chief Scientific Officer amandel@theralase.com 416.699.5273 x 260 Kristina Hachey, CPA Chief Financial Officer khachey@theralase.com 416.699.5273 x 224 Toll Free: 1.866.THE.LASE (843.5273) Work: 416.699.LASE (5273) TSX
Slide 21: Appendix
Appendix
Slide 22: FDA Approved Drugs Versus TLD-1433
FDA Approved Drugs Versus TLD-1433 22 Initial Complete Number of Response Rate Durable CRR Durable CRR Drug Patients (“CRR”) (12 months) (15 months) Safety Limitations Monthly Cost Not a BCG-Unresponsive 18% Study treatment Valrubicin1 78 10 to 13% Not Reported population. Not Unknown related SAEs r
Slide 23: Cost of Cancer Therapy Drugs (Breakthrough Designation)
Cost of Cancer Therapy Drugs (Breakthrough Designation) 23 Drug Name BLA/NDA Monoclonal Anti-Body (“MAB”) Indication Cost Per Month ($USD) Metastatic Non-Small Cell Alecensa NDA No 12,500 Lung Cancer Non-Muscle Invasive Bladder Keytruda BLA Yes 12,500 Cancer Multiple Myeloma Cancer (in combination w
Slide 24: Non-Small Cell Lung Cancer (NSCLC)
Non-Small Cell Lung Cancer (“NSCLC”)1 24 NSCLC - Rutherrin® + X-Ray Activation A549 – Human NSCLC Cells Rutherrin® + X-Ray Activation leads to a 3 log 1) Kaspler, P, Roufaiel, M, Mandel, A. Theralase Research Paper June 20, 2021 kill of human NSCLC cells in-vitro
Slide 25: GlioBlastoma Multiforme (GBM)
GlioBlastoma Multiforme (“GBM”) 25 Effect of Rutherrin® in Glioblastoma Orthotopic Rat Model RG2 Tumour Volume Kaplan-Meier Survival Curve Radiation + Radiation only Rutherrin®
Slide 26: Virus Vaccine Research and Development
Virus Vaccine Research and Development 26 Primary: RuvidarTM has the ability to inactivate enveloped viruses by up to 6 log kill in-vitro using nanomolar concentrations, thus allowing the manufacture of a wholly-inactivated vaccine for H1N1 Influenza, Zika, Herpes Simplex and Corona viruses - Biolog
Slide 27: Management / Board of Directors
Management / Board of Directors 27 Arkady Mandel Kristina Hachey Guy Anderson Matthew Perraton, Randy Bruder MD, PhD, DSc CPA MDA, CFP®, CIM® PFP, FMA, FCSI Independent Director Interim Chief Executive Officer Chief Financial Officer Independent Director Independent Director & Chief Scientific Offic
Slide 28: Medical and Scientific Advisory Board
Medical and Scientific Advisory Board 28 Ashish Kamat, MD MD Anderson • Internationally recognized expert in urologic oncology and authority in the management of urologic cancers • Expertise in bladder cancer, organ sparing and minimally invasive techniques. Maintains an active research portfolio wi
Slide 29: Past Events - 2023
Past Events - 2023 29 American Society of Clinical Oncology’s Annual Genitourinary Cancers Symposium (ASCO-GU) February 16 to 18, 2023 San Francisco, California Abstract Presented American Urological Association Annual Meeting April 28 to May 1, 2023 Chicago, Illinois Abstract Presented
Theralase Technologies — Investor Presentation (May 2023) on 6ix