Theralase Technologies Inc. · TSXV:TLT
Theralase Technologies — Investor Presentation (June 2019)
24 slides from Theralase Technologies's investor presentation, Jun 26, 2019
Slide 1: Corporate Presentation: Next Generation Treatment for Non-Muscle Invasive Bladder Cancer
The material contained in this document is strictly confidential and the sole property of Theralase Technologies Inc. This presentation does not, and shall not, in any circumstances, constitute an offer to sell or solicitation of an offer to buy any securities of Theralase Technologies Inc. Cautiona
Slide 2: Forward Looking Statement
FORWARD LOOKING STATEMENT Certain statements contained or incorporated in this presentation, which deal with the financial condition and operating results of Theralase Technologies Inc. (“Theralase” or the “Company”), include information, analyses and projections as to future corporate developments
Slide 3: Introduction
INTRODUCTION • Clinical stage pharmaceutical company • Lead asset is light activated Photo Dynamic Compounds (“PDCs”) intended to safely and effectively treat cancer • Lead cancer indication is Non-Muscle Invasive Bladder Cancer (“NMIBC”). • Medical Laser Technologies (“MLT”) develops, designs, manu
Slide 4: History
HISTORY 2019 – 2021 2011 – 2015 2015 – 2018 (Planned) Photo Dynamic Clinical Clinical Therapy Phase 1 Phase 2 • In licensed TLD-1433(1) • Completed Phase Ib • Phase II NMIBC clinical NMIBC clinical study(3) study commenced(5) • Began preclinical - 66% Complete Response research with TLD- (“CR”) at 3
Slide 5: Investment Highlights
INVESTMENT HIGHLIGHTS LARGE Unmet medical need and multi-billion dollar international market(9) OPPORTUNITY STRONG MANAGEMENT Seasoned management with pharmaceutical and medical device experience(6) TEAM SIGNIFICANT Successfully completed Phase Ib NMIBC clinical study with strong safety, TRACTION ph
Slide 6: Experienced Leadership Team
EXPERIENCED LEADERSHIP TEAM Kipton Lade Shawn Shirazi Arkady Mandel Kristina Hachey BSc, MSc, MBA PhD MD, PhD, DSc CPA CEO - Device Division CEO - Drug Division Chief Scientific Officer Chief Financial Officer 25+ years in Medical Device 20+ years in Drug Development, 25+ years in Technology 20+ yea
Slide 7: Medical and Scientific Advisors
MEDICAL AND SCIENTIFIC ADVISORS Michael Jewett Ashish M. Kamat Michael O’Donnell Lothar Lilge Brian Wilson MD MD MD PhD PhD UHN, Chair of MSAB MD Anderson University of Iowa UHN UHN • Professor of surgery • Internationally • Long history of focusing • Professor in the • Senior Scientist and Head (ur
Slide 8: Non-Muscle Invasive Bladder Cancer (NMIBC)
NON-MUSCLE INVASIVE BLADDER CANCER (“NMIBC”) 240,000 Stages of Bladder Cancer new cases of bladder cancer each year in the U.S., Canada and Europe(11) Theralase’s lead cancer indication is 70% Non-Muscle Invasive of all new cases are classified as NMIBC(12) Bladder Cancer Once papillary cancer 30% h
Slide 9: Large Market Opportunity
LARGE MARKET OPPORTUNITY (all figures in $U.S.) Willingness to pay(16) $50K - $150K Estimated Target Market(9) $1.1 billion (16) Willingness to pay per quality adjusted life year (QALY) for competitor drug, Pembrolizumab. Source: Cost-effectiveness of Pembrolizumab in Second-line Advanced Bladder Ca
Slide 10: Theralase's Photo Dynamic Therapy Solution
THERALASE’S PHOTO DYNAMIC THERAPY SOLUTION Patented drug is TLD-1433, (laser light activated PDC for the treatment of NMIBC) • Laser light activated (Theralase TLC-3200 System) • NMIBC cells destroyed through the production of Reactive Oxygen Species and singlet oxygen • Performed as an outpatient d
Slide 11: TLD-1433 Mechanism of Action
TLD-1433 MECHANISM OF ACTION(18) TLD-1433 + Transferrin = Rutherrin® TfR = Transferrin receptor • Transferrin transports molecular Iron to every cell in the body • Ruthenium is a transition metal having similar properties to Iron. TLD-1433 is a Ruthenium based compound binding to transferrin to form
Slide 12: Phase Ib Clinical Study
PHASE IB CLINICAL STUDY Successfully completed a Phase Ib NMIBC clinical study(3) • 3 patients at Maximum Recommended Starting Dose (0.35 mg/cm2) • 3 patients at Therapeutic Dose (0.70 mg/cm2) Secondary Exploratory Primary Pharmacokinetics Efficacy (evaluated Safety and tolerability (movement and ex
Slide 13: Results
RESULTS(3) Primary - Safety - Strong safety profile - 95% of AEs completely resolved within 180 days - 5% of AEs not completely resolved were not related to study drug Secondary – Pharmacokinetics(21) Concentration of TLD-1433 in Urine Versus Time Concentration of TLD-1433 in Plasma Versus Time TLD-
Slide 14: Phase II Clinical Study
PHASE II CLINICAL STUDY ACT (Anti-Cancer Treatment) – NMIBC Approximately 100 patients to be Multi-site (Approximately 20 sites) evaluated at Therapeutic Dose (0.70 single-arm, open-label study mg/cm2) All patients to receive two treatment procedure (Day 0 and Day 180)(22) Key Inclusion Criteria • H
Slide 15: ACT-NMIBC Outcome Measures
ACT-NMIBC OUTCOME MEASURES Primary Outcome Measure(23) Evaluated by Complete Response (“CR”) at 90 days post-treatment and duration of CR evaluated at 360 days post-treatment. CR defined as being at least one of the following: • Negative cystoscopy and negative urine cytology; or • Positive cystosco
Slide 16: Capitalization and Use of Proceeds
CAPITALIZATION AND USE OF PROCEEDS ($CDN Millions, except per share figures) Capitalization(24) Use of Proceeds Share Price(25) $0.485 Minimum Maximum Basic Shares Outstanding 146.3 Phase II NMIBC Clinical Study $6.00 $12.00 Dilutive Securities(26) 8.2 Working Capital $0.80 $1.85 F.D. Shares Outstan
Slide 17: Investment Highlights
INVESTMENT HIGHLIGHTS TWO AND DONE Two outpatient day surgery procedures(22) EFFICACY Strong efficacy signal(3) REGULATORY FAST TRACK Potential for fast track designation Successful Phase II results could support COMMERCIALIZATION marketing application 17
Slide 18: Appendix
APPENDIX
Slide 19: Intellectual Property & Publications
INTELLECTUAL PROPERTY & PUBLICATIONS • U.S. composition of matter patent expires in June 20344 • 12 issued patents(10) • 34 patents filed in various stages of approval (pending, published & allowed) in U.S., Canada and International(10) TLD-1433 Chemical Structure 19
Slide 20: Promising Clinical Results
PROMISING CLINICAL RESULTS(27) 001-001 001-002 001-003 001-004 001-005 001-006 Subject (Patient 1) (Patient 2) (Patient 3) (Patient 4) (Patient 5) (Patient 6) Treatment MSRD MSRD MSRD Therapeutic Dose Therapeutic Dose Therapeutic Dose Dose (0.35mg/cm2) (0.35mg/cm2) (0.35mg/cm2) (0.70mg/cm2) (0.70mg/
Slide 21: Competition
COMPETITION Year Clinical Safety (Adverse Efficacy Study Drug Events (AEs)) > Status (CR >=30% at 12 months) Completed Grade 2 Current Studies Ongoing TLD-1433 (Theralase)(3) CR = 66% at 12 months No Phase II to commence Q2 2019 (phase II) Ongoing Oncolytic adenovirus (CG0070 CR = 27% at 12 months Y
Slide 22: PDT Treatment Procedure
PDT TREATMENT PROCEDURE(22) 1. Study Drug (TLD-1433) reconstituted in pharmacy up to 24 Human Bladder Post Rinse Showing TLD-1433 hours prior to treatment procedure Localized to Bladder Cancer Tumours 2. Catheter inserted through urethra and Study Drug instilled intravesically into bladder for appro
Slide 23: Peer Reviewed Publications
PEER REVIEWED PUBLICATIONS Kalinina, Sviatlana; Breymayer, Jasmin; Reess, Kirsten; et al. Correlation of intracellular oxygen and cell metabolism by simultaneous PLIM of phosphorescent TLD1433 and FLIM of NAD(P)H Journal of biophotonics Pages: e201800085: 2018 Kaspler, Pavel; Lazic, Savo; Forward, S
Slide 24: Peer Reviewed Publications (Continued)
PEER REVIEWED PUBLICATIONS (CONTINUED) Monro S; Colon KL; Roque J; et al. Transition Metal Complexes and Photodynamic Therapy from a Tumor-Centered Approach: Challenges, Opportunities, and Highlights from the Development of TDL1433 Chem Rev, 2018 Oct 8. doi: 10.1021/acs.chemrev.8b00211 Yassine AA; L
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