Theralase Corporate Presentation


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Theralase Corporate Presentation

  1. 1. 1Q2014CONFIDENTIAL Theralase Technologies Inc.  Roger Dumoulin‐White   Chapter Title Section g President, Chief Executive Officer Chapter  Title Section
  2. 2. Company Anti Cancer Platform TechnologyAnti 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)  HighlightsHighlights 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) Ult l t i it PDC t bl d t (bl dd )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
  3. 3. O i Strategy 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 cancerExecution 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
  4. 4. Bladder Cancer USA Bladder Cancer Treatment Annual SpendingUSA 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 y g ( , ) ( ) y 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  of 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%.
  5. 5. HT1376 Human Bladder Cancer Cell Line Safety and Efficacy of PDC Safety: PDC + No light Efficacy: PDC + LightSafety: PDC + No light Efficacy: PDC + Light  100 120 45 J cm‐2 90 J cm‐2 100 120 45 J cm‐2 90 J cm‐2 40 60 80 Cell Kill (%) 40 60 80 Cell Kill (%) 0 20 0.00125 0.0025 0.005 0.01 0.02 0.04 Concentration (mM) 0 20 0.00125 0.0025 0.005 0.01 0.02 0.04 Concentration (mM)Concentration (mM)
  6. 6. Safety: PDC + No Light Efficacy: PDC + Light Mouse colon cancer (carcinoma) PDC Efficacy vs. ALA (FDA Approved Drug) 40 60 80 100 llKill(%) ALA 14A 40 60 80 100 llKill(%) ALA TPDC 0 20 0.00016 0.0003 0.0008 0.025 Cel Concentration (mM) 0 20 0.00016 0.0003 0.0008 0.025 Ce Concentration (mM) Human brain cancer (glioblastoma) 40 60 80 100 llKill(%) 40 60 80 100 Kill(%) 0 20 0.00016 0.0003 0.0008 0.025 Cel Concentration (mM) 0 20 40 0.00016 0.0003 0.0008 0.025 Cell Concentration (mM) Rat brain cancer (glioma) 40 60 80 100 Kill(%) 40 60 80 100 Kill(%) 0 20 40 0.0001 0.0002 0.0005 0.017 Cell Concentration (mM) 0 20 40 0.0001 0.0002 0.0005 0.017 Cell Concentration (mM)
  7. 7. Theralase PDC Efficacy vs. 2 FDA Approved Drugs 33 TLD1633 668 000 198668,000x more effective than ALA 198x more effective than PHOTOFRIN
  8. 8. Destruction of Cancer in Live Animal with PDC PDC injection of 53 mg kg‐1 4hr Post PDC Injection  (Pre Light Activation) T i d d iTumour induced in  animal (BALB/c mice )  with tumour reaching 5.0   0.5 mm in size. 20 Months Post Treatment 24hr Post Light Activation 20 Months Post Treatment  (No recurrence) Mice have survived 20Mice have survived 20  months cancer free after  only 1 PDC treatment
  9. 9. Preclinical Live Animal SurvivalLive Animal Survival Colon Cancer cells injected Irradiation: λ=530 nm, 192 J  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  Survival of mice up to 20  months (50 human years)between Theralase and investment partner months (50 human years)  after one Theralase PDT  treatment 
  10. 10. Scientific Risk Anti‐Cancer Technology Risk 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 Riskg 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 RiskRegulatory 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 Riskg $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 l d h d k d f llCompany 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‐ oncologist and Head of Urology at Princess Margaret Cancer Centre will lead bladder cancer clinical trialsoncologist and Head of Urology at Princess Margaret Cancer Centre will lead bladder cancer clinical trials
  11. 11. Recent Pharma Deals $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  t t t b d A il ’ A il icancer treatment based on Avila’s Avilomics Technology.  $912M + Aug 2010 ‐Worldwide rights to develop and$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  t i t i i t ti Note: Deals include up‐front, milestone and royalty payments on net sales.  protein‐protein interactions. 
  12. 12. 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. p g g g g p y $508 M +  royalties  Aug 2010 ‐ Exclusive worldwide rights to develop  and commercialize drug candidates arising from y g g f its PD‐1 program for treatment of cancer.  $466 M + Oct 2010, Dec 2011 ‐ Exclusive worldwide rights to$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. 
  13. 13. Company Therapeutic Laser Platform TechnologyTherapeutic 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)  HighlightsHighlights 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 H lth C d d CE d f l i t 180 t iFDA, 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
  14. 14. Opportunity Strategy 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 h h l h h h l dLaunch 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
  15. 15. Theralase Therapeutic Laser Comparison TLC‐1000 p p 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  Heat Heat Heat /  Rotator Cuff  Wrist Pain Pain 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  ( W) 50,000 mW 30 mW 10 mW 5 mW 5 mW 15 mW (mW) , Total Actual  Tested Power 850 90 10 20 72 150 Photon Density  Per Laser Diode 5000 3 1 0.5 0.5 1.5Per 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  $17 $112 $1 400 $600 $112 $200 per mW (USD) $17 $112 $1,400 $600 $112 $200
  16. 16. TLC‐2000 Next Generation Therapeutic Laser Launch 2014Next Generation Therapeutic Laser – Launch 2014 Dramatically improves efficacy over existing Key Benefits 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 USA Patent: 6,413,267, Canadian Patent: 2,315,521,  l i l i d i d iBelgium, Italy, United Kingdom, Germany, France, Spain  Patent: 1075854
  17. 17. 2013 PRACTITIONER SURVEY Company 2013 PRACTITIONER SURVEY  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%700%
  18. 18. Business Model TLC‐2000 Business Model 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  i d 2 h k i d f 2 h i i hequipment 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 in10 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 C l iConclusions  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
  19. 19. U S Healthcare Demographics US Demographics U.S. Healthcare Demographics Healthcare Practitioners* 2008 2017 % increase Veterinarians 59,700 79,400 33.0%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% * All statistics from the U.S. Bureau of Labor Statistics, Washington, DC, Occupational Outlook Handbook, 2010 – 2011 edition
  20. 20. Scientific Risk Therapeutic Laser Technology Risk 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 andZero. 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 willZero. 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.
  21. 21. Management Team Management and Advisors Board of DirectorsManagement 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 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. 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 Randy Bruder ‐ Owner and operator of a wholesale / retail  operation for the last 25 years Matt Perraton ‐ 13+ years of financial experience for TD  Waterhouse 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 Guy Anderson ‐ 16+ years of financial experience with the  Investment Planning Counsel Dr. James Andrews, American Sports Medicine Institute  Scientific & Medical Advisors design teams in the production of electronics devices Princess Margaret Cancer Centre ‐ University Health  Network 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,  Strong Strategic Partnerships Ontario Centers of Excellence – Photonics National Research Council ‐ IRAP Virginia Tech 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  Virginia Tech  Buffalo Niagara Medical Campus Scripps Research Institute Cancer Institute, Princess Margaret Cancer Centre
  22. 22. Investors Why Invest?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
  23. 23. Contact Information h l h lTheralase Technologies Inc. 1945 Queen Street East Toronto, Ontario, M4L 1H7 Canada TLT:TSXV Roger Dumoulin‐White Founder President & CEOFounder, President & CEO 1‐866‐THE‐LASE (843‐5273) x225 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
  24. 24. Forward Looking Statements Forward Looking Statements 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 theconstitute 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 C i i l d i d d i li d h b f di d i d fi i iCompany 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 ing p y g 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 sedarcomuncertainties inherent to the Company s industry can be found in our MD&A reports listed on 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.p p y q y y All references to dollars herein are to Canadian dollars except as otherwise indicated.