Theralase Technologies Inc. Roger Dumoulin-White President, Chief - - PowerPoint PPT Presentation

Chapter Title Section

Theralase Technologies Inc. Roger Dumoulin-White President, Chief Executive Officer

1Q2014

CONFIDENTIAL

Company

Anti Cancer Platform Technology

Patented anti-cancer drugs known as Photo Dynamic Compounds (PDCs) localize to the DNA of cancer cells and when light activated destroy the DNA resulting in natural cell death (apoptosis)

Highlights

Up to 100% cancer cell kill at very low concentrations (< 0.8µM) Virtually 0% toxicity at high concentrations (> 100µM) leading to very high safety profile More effective at killing cancer cells than FDA approved drugs (668,000 x ALA, 198 x PHOTOFRIN) No side effects were observed from treatment (quick evacuation of PDC from healthy cells and high light fluence required for activation provides extremely high safety profile) Ultra low toxicity as PDC never enters blood stream (bladder cancer) Water soluble & readily penetrates cellular membrane (DNA localizing) Activated by laser light providing excellent specificity and selectivity Lethal to cancer and bacteria Able to treat solid core hypoxic tumours, such as: breast, prostate and lung Research performed at world renowned Princess Margaret Cancer Centre Activated at long wavelengths (allows deeper tumour destruction) Issued USA Patents: 6,962,910, 7,612,057, 8,148,360, 8,445,475 Pending USA Patent Applications: 61/801,674, 13/863,089, PCT/US13/36595

Opportunity

Complete a FDA Phase 1/2a human bladder cancer clinical study with FDA breakthrough status Execution of a strategic partnering agreement with big pharma for destruction of bladder cancer (i.e.: upfront payments , co-development funds, annual recurring revenue streams)

Strategy

2013 - Milestone 2 (complete): Destruction of cancer in a live animal mouse model. Demonstrated >99% efficacy for a subcutaneous cancerous tumour 2014 - Milestone 3 (in progress): Complete validation in orthotopic rat model, dose toxicity study, GMP drug manufacture and FDA Investigational New Drug (IND) application 2015 - Milestone 4: Complete FDA phase 1/2a human clinical study with FDA breakthrough status 2016 - Milestone 5: Execute strategic partnering agreement with big pharma

Strategy

Bladder Cancer

USA Bladder Cancer Treatment Annual Spending

$3.9 billion (2012)

Statistics

70,000 new cases, > 14,000 deaths in the US each year 386,000 new cases are diagnosed worldwide annually Standard treatment unchanged with no new drugs approved since 1998 5th most common cancer, 4th in men, 8th in women Most expensive cancer to treat with a recurrence rate up to 80% 70% of new bladder cancer cases are early stage disease and 90% of bladder cancers are Transitional Cell Carcinoma (TCC)

Current Standard of Care

Early stage disease (Ta, T1): Trans Urethral Resection of the Bladder Tumour (TURBT) followed by treatment with bacillus Calmette-Guérin (BCG) – 5 year survival rate of 75%. Mid Stage disease (T2, T3a/b): Entire bladder removed along with nearby reproductive organs and lymph nodes in a procedure called a radical cystectomy - 5 year survival rate of 31 to 63% depending on progression

• f disease.

Late stage disease (T4): Disease has spread to distant sites, such as the bones, liver and lungs and is generally regarded as incurable - 5 year survival rate of 21%.

Safety: PDC + No light Efficacy: PDC + Light HT1376 Human Bladder Cancer Cell Line Safety and Efficacy of PDC

20 40 60 80 100 120 0.00125 0.0025 0.005 0.01 0.02 0.04 Cell Kill (%) Concentration (mM) 45 J cm-2 90 J cm-2 20 40 60 80 100 120 0.00125 0.0025 0.005 0.01 0.02 0.04 Cell Kill (%) Concentration (mM) 45 J cm-2 90 J cm-2

20 40 60 80 100 0.0001 0.0002 0.0005 0.017 Cell Kill (%) Concentration (mM) 20 40 60 80 100 0.00016 0.0003 0.0008 0.025 Cell Kill (%) Concentration (mM) 20 40 60 80 100 0.00016 0.0003 0.0008 0.025 Cell Kill (%) Concentration (mM)

ALA 14A

20 40 60 80 100 0.0001 0.0002 0.0005 0.017 Cell Kill (%) Concentration (mM) 20 40 60 80 100 0.00016 0.0003 0.0008 0.025 Cell Kill (%) Concentration (mM)

Safety: PDC + No Light Efficacy: PDC + Light Mouse colon cancer (carcinoma)

PDC Efficacy vs. ALA (FDA Approved Drug)

ALA TPDC

20 40 60 80 100 0.00016 0.0003 0.0008 0.025 Cell Kill (%) Concentration (mM)

Rat brain cancer (glioma) Human brain cancer (glioblastoma)

Theralase PDC Efficacy vs. 2 FDA Approved Drugs

3

668,000x more effective than ALA 198x more effective than PHOTOFRIN TLD1633

PDC injection of 53 mg kg-1 4hr Post PDC Injection (Pre Light Activation)

Destruction of Cancer in Live Animal with PDC

24hr Post Light Activation 20 Months Post Treatment (No recurrence)

Tumour induced in animal (BALB/c mice ) with tumour reaching 5.0  0.5 mm in size. Mice have survived 20 months cancer free after

• nly 1 PDC treatment

Preclinical

2013: $0 M 2014: $0 M 2015: $0 M 2016: $250 M

Investment

$10 M

ROI

2500% in 3 yrs

Investment vehicle

Joint venture with bladder cancer asset placed into an incorporated company with 50/50 ownership split between Theralase and investment partner

Live Animal Survival

Colon Cancer cells injected Irradiation: λ=530 nm, 192 J

Survival of mice up to 20 months (50 human years) after one Theralase PDT treatment

Scientific Risk

in-vitro and small animal in-vivo results show virtually zero toxicity and up to 100% cancer kill across a wide range of cancers

Manufacturing Risk

Drug manufacturing will be outsourced to a GMP facility. Laser design will be completed by Theralase which is ISO- 13485 certified and has designed and manufactured laser systems for over 20 years. Manufacturing of sub components will occur at ISO-9001 manufacturing facilities

Regulatory Risk

Very low as anti-cancer technology has demonstrated up to 100% effectiveness in bladder cancer cells with virtually zero toxicity as it never enters the blood stream. FDA is very supportive of approving new cancer drugs

Financing Risk

$3.15 M financing completed in November 2013 to commercialize next generation therapeutic laser and commence Phase 1/2a anti-cancer clinical trial

Liquidity Risk

Company currently trades on the TSXV under ticker TLT and is a fully reporting issuer

Execution Risk

Outsourced to Princess Margaret Cancer Centre, one of the top 5 cancer institutes in the world. Canada’s top uro-

• ncologist and Head of Urology at Princess Margaret Cancer Centre will lead bladder cancer clinical trials

Anti-Cancer Technology Risk

Recent Pharma Deals

Note: Deals include up-front, milestone and royalty payments on net sales.

$1B + royalties July 2011 - Worldwide rights to develop and commercialize Bi-specific T cell engager antibodies against 2 solid tumour targets. $964M + royalties Dec 2010 - Exclusive rights to develop and commercialize targeted covalent drugs for cancer treatment based on Avila’s Avilomics Technology. $912M + royalties Aug 2010 -Worldwide rights to develop and commercialize cancer drug candidates using Seattle Genetics’ antibody-drug conjugate program. $815M + royalties Jan 2012 - Collaboration to discover and develop small molecule drugs against oncology-relevant protein-protein interactions.

Recent Pharma Deals

$700 M + royalties Jan 2012 - Collaboration to discover and develop drugs that target tumor metabolism mechanisms. $540 M + royalties June 2010 - Rights to discover, develop and commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. $508 M + royalties Aug 2010 - Exclusive worldwide rights to develop and commercialize drug candidates arising from its PD-1 program for treatment of cancer. $466 M + royalties Oct 2010, Dec 2011 - Exclusive worldwide rights to discover, develop, manufacture and market TAP compounds for the treatment of cancer.

Note: Deals include up-front, milestone and royalty payments on net sales.

Company

Therapeutic Laser Platform Technology

Designer and manufacturer of cold laser technology used to heal a wide range of nerve, muscle and joint conditions (i.e.: Low Back Pain, Knee Osteoarthritis, Shoulder Tendonitis)

Highlights

Used daily by thousands of practitioners worldwide Millions of patients successfully treated Superpulsed technology able to penetrate up to 4” into tissue (best in class) Proven via clinical studies to eliminate pain, reduce inflammation and accelerate tissue healing through 3 independent cellular pathways (>90% efficacy) FDA, Health Canada and CE approved for sale into 180 countries Large installed base of over 800 systems in Canada and 400 systems in the US and Internationally Patented next generation therapeutic laser technology completed and launching 4Q 2014

Opportunity

Expand sales and marketing into Western Canada and the 5 largest US States (30% of US GDP) Commercialize next generation therapeutic laser (TLC-2000) US pain market exceeds $100 Billion annually and is growing rapidly with aging population and rising healthcare costs

Strategy

Launch Canadian sales and marketing offices in Toronto (complete), Calgary, Manhattan, Los Angeles, Tampa, Houston and Chicago in 2014 and 2015 Expand manufacturing representatives and distributors across Canada and the US in non-key territories Launch next generation TLC-2000 therapeutic laser system through 800 existing Theralase customers in Canada and 400 existing Theralase customers in US in 4Q2014 Displace competitive products through new sales and marketing offices in Canada and the US with next generation TLC-2000 therapeutic laser system in 2015

Strategy

Theralase Therapeutic Laser Comparison

TLC-1000

Theralase TLC -1007H Microlight ML-830 Erchonia Quantum MEDX Meditech Wavelength (nm) 905 and 660 830 635 635 785 840 Drive Platform / FDA Approval Super Pulse / NHN Continuous Wave / NHN Continuous Wave / NHN Continuous Wave / ILY Continuous Wave / ILY Continuous Wave / ILY / NHN Indicated Use Knee Pain Hand and Wrist Pain Neck and Shoulder Pain Heat Heat Heat / Rotator Cuff Tendonitis Average Power (mW) 7 X 100 mW 6 x 25 mW 3 X 30 mW 2 X 5 mW 4 X 5 mW 16 X 5 mW 100 X 15 mW Peak Power (mW) 50,000 mW 30 mW 10 mW 5 mW 5 mW 15 mW Total Actual Tested Power 850 90 10 20 72 150 Photon Density Per Laser Diode (W/cm2) 5000 3 1 0.5 0.5 1.5 Approximate List Price (USD) $15,000 $10,000 $14,000 $12,000 $8,000 $30,000 Approximate cost per mW (USD) $17 $112 $1,400 $600 $112 $200

TLC-2000

Next Generation Therapeutic Laser – Launch 2014

Dramatically improves efficacy over existing technology by targeting tissue based on a patient’s physical characteristics (patient specific) Allows migration from capital equipment model to recurring revenue model No up front fee, with $1,000 trade up allowance to replace existing technology 2014 Objective: Installed base of 400 units at $16,500 each, equates to $6.6 M in annual revenue

Key Benefits

USA Patent: 6,413,267, Canadian Patent: 2,315,521, Belgium, Italy, United Kingdom, Germany, France, Spain Patent: 1075854

2013 PRACTITIONER SURVEY

Company

20 Canadian and US Theralase customers (MDs, DCs, NPs PTs) Survey Results

Practitioners charge between $25 to $75 per treatment (Average: $50) Practitioners treat a single location 8 to 12 minutes per location (Average: 10 minutes) Practitioners treat 100 to 400 patient treatments per month (Average: 200 treatments per month)

Summary

On average, Canadian and US medical practitioner utilize the Theralase therapeutic medical laser for 2000 minutes per month charging patients $5 per minute, generating $10,000 in monthly revenue for their practice At an average purchase price of $16,500 for the Theralase TLC-2000 therapeutic medical laser system, the ROI is > 700%

Business Model

TLC-2000

No Up Front Fee

Practitioners sign a 42 month lease (6 payments @ $99 per month, followed by 36 payments at $500 + tax per month) for the Professional Model, which allows for a $1,000 trade up allowance. Program includes: 42 month equipment warranty and 42 month marketing program. At end of 42 month term, customer must continue with monthly payments into perpetuity or system ceases to operate.

Unlimited Use (Tracked through Internet)

10 treatments per month @ $50 per treatment covers cost of lease. Medical practitioner retains all revenue in excess of $500 per month (typically $10,000 per month generated from use of product) Monthly report of usage per condition e-mailed to customer with marketing support to increase usage per condition

Conclusions

Practitioner Revenue: 200 patient treatments @ $50 per treatment = $10,000 monthly revenue Practitioner Cost: $500 per month Practitioner is generating 20X return on investment

2014 Objective

Installed base of 400 units financed initially through 42 month leases at $16,500 each equating to $6.6 M in annual revenue

U.S. Healthcare Demographics

Healthcare Practitioners* 2008 2017 % increase Veterinarians 59,700 79,400 33.0% Physical Therapists 185,500 241,700 30.3% Medical Doctors 661,000 805,500 21.9% Chiropractors 49,100 58,700 19.6% Dentists 141,900 164,000 15.6% Podiatrists 12,200 13,300 9.0% Hospitals 5,795 5,795 0.0% Total 1,115,195 1,368,395 18.5% 3,500 unit installed base (target 2016) 0.31% 0.25%

US Demographics

* All statistics from the U.S. Bureau of Labor Statistics, Washington, DC, Occupational Outlook Handbook, 2010 – 2011 edition

Scientific Risk

• Zero. Alpha prototype is already designed and patented.

Manufacturing Risk

• Zero. Laser manufacturing will be completed by Theralase which is ISO-13485 certified and has designed and

manufactured laser systems for over 20 years.

Regulatory Risk

• Zero. Current therapeutic laser technology is already FDA, Health Canada and CE approved. The next generation will

use these approvals for regulatory approval.

Financing Risk

• Zero. $3.15 M financing completed in November 2013 to commercialize next generation therapeutic laser and

commence Phase 1 / 2a anti-cancer clinical trial.

Liquidity Risk

Virtually zero. Company currently trades on the TSXV under ticker TLT and is a fully reporting issuer.

Execution Risk

Extremely Low. Theralase will displace its own technology in 2014 to achieve sales objectives. Theralase will displace a small portion of competitive products to achieve 2015 and 2016 objectives.

Therapeutic Laser Technology Risk

Management Team

Roger Dumoulin-White, P. Eng, President & CEO Founded Theralase in 1995, 27+ years as a senior manager with private and public companies Arkady Mandel, MD, PhD., DSc, Chief Scientific Officer 21+ years experience as a key founder of therapeutic uses of lasers in dermatology and other areas of clinical medicine Kristina Hachey, CGA, CFO 17+ years of experience in finance and financings in public and private companies Wayne Embree, VP Engineering 38+ years of experience in designing and managing design teams in the production of electronics devices Princess Margaret Cancer Centre - University Health Network Ontario Centers of Excellence – Photonics National Research Council - IRAP Virginia Tech Buffalo Niagara Medical Campus Scripps Research Institute

Management and Advisors

Board of Directors

• S. Donald Moore –Director & senior officer to several public

companies Roger Dumoulin-White - Company’s founder, President & CEO with previous senior management experience with Ford Motor Co. Randy Bruder - Owner and operator of a wholesale / retail

• peration for the last 25 years

Matt Perraton - 13+ years of financial experience for TD Waterhouse Guy Anderson - 16+ years of financial experience with the Investment Planning Counsel

• Dr. James Andrews, American Sports Medicine Institute
• Dr. Jeffrey Dugas, American Academy of Orthopedic Surgeons,

ASMI, International Cartilage Repair Society Kevin Wilk DPT, American Physical Therapy Association, ASMI

• Dr. Lyle Cain, American Orthopedic Society for Sports Medicine,

Michael Jewett MD, Professor of Surgery (Urology) at Univ. of Toronto, Surgical Oncology at Princess Margaret Cancer Centre Lothar Lilge PhD, Professor in the Department of Medical Biophysics at the University of Toronto, Senior Scientist Ontario Cancer Institute, Princess Margaret Cancer Centre

Scientific & Medical Advisors Strong Strategic Partnerships

Investors

Why Invest? Patented Technology

Patented anti-cancer technology for bladder cancer Patented next generation TLC-2000 therapeutic laser technology

Large Market Opportunity

$3.9 Billion bladder cancer treatment market in US, with no new drugs approved since 1998 $100 Billion pain market in US

Experienced Management Team

Experienced management team with ability to execute on strategic initiatives

Contact Information

Theralase Technologies Inc.

1945 Queen Street East Toronto, Ontario, M4L 1H7 Canada

TLT:TSXV

Roger Dumoulin-White Founder, President & CEO 1-866-THE-LASE (843-5273) x225 rwhite@theralase.com Common shares: 65,726,309 Stock price: $0.50 Market capitalization: $32.8 M Auditors: Collins Barrows Legal Counsel: Blaney McMurtry Transfer Agent: TMX Equity

Forward Looking Statements

Certain statements contained or incorporated in this presentation, which deal with the Company’s financial condition and operating results, include information, analyses and projections as to future corporate developments which are currently in the planning stage, and on the projected operating financial performance of the Company, which constitute forward-looking statements. Such forward-looking statements, made with special reference to the Company’s ongoing technologically complex healthcare and medical device research and development efforts, which may include in-house and independent clinical trials, testing new medical technologies and their applications, involve known and unknown risks and uncertainties that could cause actual events and results to differ materially from those estimated or anticipated and which may have been implied or expressed in such forward-looking statements. No conclusions as to the successful outcome of the ongoing and planned research and development projects in which the Company is involved are intended or implied nor can they be foreseen or predicted prior to definitive corporate announcements as to their outcome. Certain forward looking statements are identified by words such as “believe”, “anticipate”, “estimate”, “expect”, “intend”, “plan”, “expect”, “project”, “may”, and “will” and the negative of such expressions, although not all forward looking statements contain these identifying words, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward looking

• statements. Although Theralase believes that the expectations reflected in any forward looking statements made in

this presentation are reasonable, such statement are based on a number of assumptions which may prove to be incorrect, including, but not limited to assumptions relating to the risks and factors set out below. Accordingly, no assurances can be given that any of the events or circumstances contemplated by any such forward looking statements will transpire or occur or, if any of them transpire or occur or, if any of them transpire or occur, what impact they will have on Theralase’s results of operations or financial condition. A more complete list of risks and uncertainties inherent to the Company’s industry can be found in our MD&A reports listed on www.sedar.com. Furthermore, the forward-looking statements contained in this presentation are made as of the date hereof and the Company does not undertake any obligations to update publicly or to revise any of the included forward-looking statements, whether as a result of new information, future events, or otherwise. The forward-looking statements contained in this presentation are expressly qualified by this cautionary statement. All references to dollars herein are to Canadian dollars except as otherwise indicated.

Forward Looking Statements