Theralase Technologies Inc. · TSXV:TLT
Theralase Technologies — Investor Presentation (August 2017)
35 slides from Theralase Technologies's investor presentation, August 2017
Slide 1: Corporate Presentation – 3Q2017
CONFIDENTIAL February 17, 2015 Theralase Technologies Inc. Roger Dumoulin-White President, Chief Executive Officer AGM Corporate Presentation Theralase Technologies Inc. Chapter Title Section Corporate Presentation – 3Q2017 TLT: TSXV TLTFF: OTC
Slide 2: Forward Looking Statements
Forward Looking Statements 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: Investor Summary
Investor Summary Investment Considerations: Anti-Cancer Division –Developing a Photo Dynamic Compound (“PDC”) that has an affinity for cancer cells and when light activated has been proven clinically to be safe, tolerable and effective in the treatment of Non-Muscle Invasive Bladder Cancer (“NMIBC”)
Slide 4: PDT Division
PDT Division Anti-Cancer Division: Clinical stage, biotech company that utilizes patented light activated Photo Dynamic Compounds (“PDCs”), in combination with patent pending laser technologies, to destroy various cancers with very high efficacy (> 99%) Nontoxic to healthy tissue with preferential l
Slide 5: NMIBC (in-vitro)
NMIBC (in-vitro) Safety Efficacy 120 45 J cm-2 120 45 J cm-2 90 J cm-2 90 J cm-2 100 100 80 80 Cell Kill (%) Cell Kill (%) 60 60 40 40 20 20 0 0 0.00125 0.0025 0.005 0.01 0.02 0.04 0.00125 0.0025 0.005 0.01 0.02 0.04 Concentration (mM) Concentration (mM) In-vitro study completed at UHN with HT-1376
Slide 6: NMIBC (small animal in-vivo)
NMIBC (small animal in-vivo) (>99% destruction of NMIBC tumors) Left Image indicates elongated bladder removed from orthotopic rat model (in-situ AY-27 rat bladder cancer cells) after intravesical instillation of TLD-1433 PDC demonstrating that TLD-1433 (yellow compound) localizes preferentially to
Slide 7: NMIBC (human)
NMIBC (human) Study Objectives: Primary: Evaluate the safety and tolerability of PDT employing the PDC (TLD-1433), Medical Laser (TLC-3200) and Dosimetry Fibre Optic Cage (“DFOC”) (TLC-3400) Secondary: Evaluate the PharmacoKinetics (“PK”) (movement and exit of drug within tissue) of TLD- 1433 Explor
Slide 8: Overall Study Design
Overall Study Design The Phase Ib NMIBC Clinical Study (“Study”) will consist of 2 phases: 1st phase: 3 subjects to receive PDT employing 0.35 mg/cm2 (Maximum Recommended Starting Dose “MRSD”)) of TLD-1433. MRSD has not raised significant safety concerns; therefore: 2nd phase: 6 additional subjects
Slide 9: NMIBC (human)
NMIBC (human) Preferential accumulation of TLD-1433 in the NMIBC tumour regions of the bladder wall (post rinse) 9
Slide 10: NMIBC (human)
NMIBC (human) Laser Light Delivery with TLC-3200 & TLC-3400 TLC-3200 Medical Laser System combines laser light delivery and dosimetry via the (TLC-3400) Dosimetry Fibre Optic Cage (“DFOC”) to deliver laser light energy of a specific wavelength (“nm”) and energy density (“J/cm2”) to the bladder wall
Slide 11: Dosimetry Screen - Pre Treatment
Dosimetry Screen - Pre Treatment 11
Slide 12: TLC-3200 Treatment Procedure
TLC-3200 Treatment Procedure Bladder illuminated with green laser light (525nm) and treatment discontinued when TLC-3200 confirms delivery of approximately 90 J/cm2. TLC-3200 measures light delivery in real time, ensuring that the final light dose delivery to the bladder remains at approximately 90
Slide 13: Dosimetry Screen - Post Treatment
Dosimetry Screen - Post Treatment 13
Slide 14: Irradiance for First Patients
Irradiance for First 3 Patients Average PDT Irradiance Achieved for the first 3 patients Average Irradiance (sensors 1 to 6) Target Dose: 140 90 J/cm2 (+/- 20%) Irradiance (J/cm2) 120 100 Achieved Dose: 80 90 J/cm2 (+ 10% /- 0%) 60 40 20 0 001 002 003 Patient 14
Slide 15: Adverse Events
Adverse Events Subject 001-001 001-002 001-003 1 – Mild (ongoing @ 2 – Moderate Pelvic Pain nil day 30) (resolved @ day 6) 2 – Moderate 2 – Moderate Bladder Spasms nil (resolved @ day 6) (resolved@ day 21) 1 – Mild (resolved @ 1 – Mild (resolved @ Constipation nil day 5) day 6) 2 – Moderate Urge Inc
Slide 16: PK Analysis (TLD-1433)
PK Analysis (TLD-1433) Concentrations of Ruthenium Complex Concentrations of Ruthenium Complex in Human Urine in Clinical Samples in Human Plasma in Clinical Samples 1,400 2.5 Concentration [ng/ml] Concentration [ng/ml] 1,200 2.0 1,000 800 1.5 600 1.0 400 0.5 200 0 0.0 0 8 16 24 32 40 48 56 64 72 0
Slide 17: GBM (in-vitro)
GBM (in-vitro) Human brain cancer Safety (Glioblastoma Multiforme) Efficacy 100 100 ALA Rat brain cancer Cell Kill (%) Cell Kill (%) TPDC 50 (glioma) 50 0 0 0.0001 0.0002 0.0005 0.017 0.0001 0.0002 0.0005 0.017 U87 (Human Glioblastoma Multiforme (“GBM”) brain cancer cell line) and F98 (rat brain gli
Slide 18: GBM (small animal in-vivo)
GBM (small animal in-vivo) Sept. 9, 2016: Tumour diameter 1.44 mm (Volume 1.56 mm3) (202% daily growth rate) Sept. 10, 2016: Rutherrin® (TLD-1433 PDC (5 mg/kg) + transferrin) is injected intravenously via the rat’s saphenous tail vein Sept 11, 2016: 24 hours post injection, Rutherrin® infused animal
Slide 19: Immune Response
Immune Response First slide – 350,000 colon cancer cells injected into mouse subcutaneously (below skin surface). Tumor allowed to grow to approximately 5 mm in diameter and then 53 mg/kg of TLD-1433 injected intra-tumorly Second slide – TLD-1433 allowed to absorb into colon cancer cells for 4 hours
Slide 20: Mechanisms of Action
Mechanisms of Action Transferrin + PDC targets cancer cells and destroys them Transferrin is a naturally occurring glyco-protein that transports iron to every cell in our body. Iron is a transitional VIII metal, as is Ruthenium and Osmium (main centers of Theralase PDCs) that are indistinguishable b
Slide 21: TLT Division
TLT Division Therapeutic Laser Technology (“TLT”) Division Commercial operating division that designs, develops and sells therapeutic lasers to healthcare practitioners to eliminate pain, reduce inflammation and accelerate tissue healing generating approximately $2 M in revenue annually, minimizing
Slide 22: Next Generation Therapeutic Laser
Next Generation Therapeutic Laser “Cell Sensing®” technology uses patented algorithms to determine the depth of injury and automatically delivers the precise amount of laser light required to heal the condition (Uses set powers and time for chronic knee pain) Dramatically increases efficacy over exi
Slide 23: Pain Market
Pain Market US pain market exceeds $100B annually and growing rapidly6 45% of this population remain in significant pain post surgery or prescribed pain medicine7 Patients are seeking alternative treatment methods as their pain is still present. Doctors are not prescribing pain medication due to hig
Slide 24: Business Model
Business Model Healthcare practitioners charge between $20 to $150 per 15 minute treatment (Average: $50 per treatment session) Healthcare practitioners perform between 100 and 500 treatment sessions per month (Average: 200 treatment sessions per month) Healthcare practitioners generate on average $
Slide 25: Next Steps
Next Steps Anti-Cancer Division Approximate Timing: 2Q2018 - Complete a Health Canada Phase Ib clinical study for NMIBC 1Q2019 - Complete a Health Canada Phase Ib clinical study for additional cancer indication 2Q2020 – Complete a pivotal Health Canada / FDA Phase II clinical study for NMIBC 1Q2021
Slide 26: Key Metrics
Key Metrics Market Data (As of August 22, 2017) Stock Price C$0.475 52 Week High / Low C$0.54/$0.175 Market Capitalization C$59.5 M Basic Shares Outstanding 125,231,526 Warrants 31,343,075 Options 9,585,000 Fully Diluted Shares Outstanding 166,159,601 Insider Ownership 6.9% (10.9% fully diluted) 26
Slide 27: Appendix - Management Team
Appendix - Management Team Roger Dumoulin-White – President & Chief Executive Officer President and CEO of Theralase Technologies Inc. since 2004 (Theralase Inc. since 1994) Before founding Theralase Inc., served as a Product Team Manager with Ford Electronics Manufacturing Corporation, a division o
Slide 28: Appendix - TLT Division Advisors
Appendix - TLT Division Advisors James Andrews, MD World renowned orthopaedic sports surgeon. Founder of the American Sports Medicine Institute (“ASMI”) President and Chairman of the Andrews Research and Education Foundation dedicated to prevention, education and research at the Andrews Institute. M
Slide 29: Appendix - PDT Division Advisors
Appendix - PDT Division Advisors Michael Jewett, MD: (UHN) Professor of Surgery (Urology) at the University of Toronto, Surgical Oncology at Princess Margaret Cancer Centre, University Health Network (“UHN”). Clinical practice is in urologic oncology with research interests in testicular cancer and
Slide 30: Appendix - TLT Division Research
Appendix - TLT Division Research 1.Action of a Diode Laser in Orthopaedics and Traumatology: http://theralase.com/wp-content/uploads/2014/09/Action-of-Diode-Laser-in-Orthopaedic-and- Traumatology.pdf 2. A Renaissance in Low-Level Laser Therapy: http://theralase.com/wp-content/uploads/2014/05/A-Renai
Slide 31: Appendix - PDT Division Research
Appendix - PDT Division Research 1. Arenas, Yaxal, Susan Monro, Ge Shi, Arkady Mandel, Sherri McFarland, and Lothar Lilge. 2013. “Photodynamic Inactivation of Staphylococcus Aureus and Methicillin-Resistant Staphylococcus Aureus with Ru(II)-Based Type I/type II Photosensitizers.” Photodiagnosis and
Slide 32: Appendix - PDT Division Research
Appendix - PDT Division Research 6. Reichardt, Christian, Mitch Pinto, Maria Wächtler, Mat Stephenson, Stephan Kupfer, Tariq Sainuddin, Julien Guthmuller, Sherri A. McFarland, and Benjamin Dietzek. 2015. “Photophysics of Ru(II) Dyads Derived from Pyrenyl-Substitued Imidazo[4,5-f][1,10]phenanthroline
Slide 33: Appendix - Key Customers
Appendix - Key Customers Business relationships with world-class organizations: Research Institutions Sports Teams and Organizations 33
Slide 34: Appendix - Bladder Cancer
Appendix - Bladder Cancer Bladder Cancer by the Numbers:8, 9,10 $3.9 Billion (2016), 76,960 new cases, 16,390 deaths in the US each year Bladder cancer starts from the inside of the organ and grows into the organ, making it a prime target for intravesical PDT 5th most common cancer, 4th in men, 8th
Slide 35: Appendix - NMIBC Clinical Trial
Appendix - NMIBC Clinical Trial Title: A Phase Ib Trial of Intravesical Photodynamic Therapy in Patients with Non-Muscle Invasive Bladder Cancer at High Risk of Progression Who are Refractory to Therapy with Bacillus Calmette-Guerin (“BCG”) and Who are Medically Unfit for or Refuse a Cystectomy Obje
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