Theralase(Technologies(Inc.( Roger(Dumoulin5White...
Transcript of Theralase(Technologies(Inc.( Roger(Dumoulin5White...
Chapter Title Section
Theralase Technologies Inc. Roger Dumoulin-‐White President, Chief Executive OfficerAGM Corporate Presentation
February 17, 2015CONFIDENTIAL
Theralase Technologies Inc.Corporate Presentation 1Q2016
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 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 statements are based on a number of assumptionswhich may prove to be incorrect.
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 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 the Company’s regulatory and financial filings.
Furthermore, the forward-‐looking statements contained in this presentation are made as of the date hereof. The Company does not undertake any obligation to update publicly or to revise any of the included forward-‐looking statements, whether as a result of new information, future events, or otherwise, unless required by applicable laws. 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
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Therapeutic Laser Technology (“TLT”) Division: Cold laser technology using laser light to penetrate into tissue up to 4” to heal nerve, muscle, and joint conditions at the source of injury
Effective in eliminating pain, reducing inflammation and healing tissue
TLC-‐1000 series, Legacy business that generates $2 M revenue per year (70% effective)
TLC-‐2000 series,Next generation patented biofeedback cloud based therapeutic laser system launched in Canada and the US in 1Q2016 and in Europe in 2Q2016 (90% effective)
Photo Dynamic Therapy (“PDT”) Division: Laser light activated Photo Dynamic Compounds (“PDCs”) able to destroy cancer
TLC-‐3000, Laser light activated PDCs proven to destroy numerous cancers pre-‐clinically. Clinical evaluation commences with Non Muscle Invasive Bladder Cancer (“NMIBC”) in a Phase Ib clinical trial in 1Q2016
Theralase (TLT: TSXV) (TLTFF: OTC) develops and commercializes medical laser technology , which heals patients safer, faster, and more effectively than any competitive product.
Corporate Overview
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Manufacture medical laser technology that is clinically proven to:• Eliminate pain• Reduce inflammation • Accelerate tissue healing
70% success in healing nerve, muscle and joint conditions • Low back pain• Knee pain• Hundreds of other pain conditions
Legacy business generates $2 M annually
Therapeutic Laser Division
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US pain market exceeds $100 B annually and growing rapidly 1
45% of this population remain in significant pain post surgery or during prescribed pain medicine2
TLC-‐2000 expected to be eligible for a unique reimbursable Current Procedural Terminology (“CPT”) code in the U.S. for national reimbursement due to Cell Sensing® technology
Pain Market
1 Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC.
2 Peter D. Hart Research Associates. Page 3. KEY FINDINGS. Americans in Pain.
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• Dramatically increase efficacy over existing technologies by targeting injured tissue with patented “Cell Sensing®” technology
• Canada, U.S. and European patents
• 90% success in healing nerve, muscle and joint conditions
• 2000% ROI for healthcare practitioners
• Targeted to generate $50 M annually within 5 years of launch
• Recurring revenue model
Next Generation Technology -‐ TLC-‐2000
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Business Model
Business Model Overview
Up Front / Recurring Revenue
• 60 month lease = $400 to $800 per month depending on number of laser probes (Higher investment equals less treatment time)
• Lease includes: product, training, warranty, marketing, patient referrals and software updates for term of lease
• At end of lease, practitioner has the following options:• Return equipment to Theralase and discontinue use• Pay 10% residual to Theralase, keep technology and discontinue support• Pay $200 to $400 per month ad infinitum to maintain warranty and marketing support• Purchase latest Theralase technology and recommence lease process
Illustrative Example: (Average Sale Price: $25,000)
§ 400 units sold equates to $10 M in revenue.
§ 800 units sold equates to $20 M in revenue.
Moving away from a capital equipment model to a recurring revenue model
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Practitioner’s Incentive
• 8 to 16 treatments /month @ $50 per treatment covers cost of lease• Clinic retains all revenue in excess of $400 to $800 per month (average $500 per month)• Clinics generate > $10,000 / month (200 patient treatments @ $50)• 2000% Return on Investment
• Effective – Patented3 anti-‐cancer drugs able to destroy cancer cells > 99% when light activated
• Safe -‐ 0% toxicity to healthy tissue
• Targeted –Targets only cancer cells
• Immune Response -‐ Proven ability to prevent recurrence of cancer even after repeated exposures
• Diagnostic -‐ Proven ability to detect cancer cells
• Versatile – Able to be activated at a various tissue depths
• Highly Accredited – Research performed at the number 3 cancer research institute in the world
Photo Dynamic Therapy Division (Anti-‐Cancer)
83 Issued U.S. Patents: 6,962,910, 7,612,057, 8,148,360, 8,445,475, Pending U.S. Patent Applications: PCT/US14/30194, 13/863,089, PCT/US13/36595
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Bladder Cancer PDT Treatment
• Insert catheter into urethra• 60 minute installation of PDC to
localize drug inside bladder cancer cells
• Flush bladder three times to remove loose PDC
• Insert fibre optic bundle• Activate PDC for 30 minutes• Void bladder to remove
destroyed bladder cancer cells
Safety Efficacy
0
20
40
60
80
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120
0.001250.0025 0.005 0.01 0.02 0.04
Cell Kill (%)
Concentration (mM)
45 J cm-‐290 J cm-‐2
0
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-‐290 J cm-‐2
Safety and Efficacy Profile
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4 Research performed at Princess Margaret Cancer Centre, University Health Network by Theralase research scientists under the direction of Dr. Lothar Lilge Ph.D., UHN and Dr. Arkady Mandel Ph.D., M.D., D. Sc., Chief Scientific Officer of Theralase, HT1376 Human Bladder Cancer Line Safety and Efficacy of PDC
020406080100
0.0001 0.0002 0.0005 0.017
Cell Kill (%)
Concentration (mM)
020406080100
0.00016 0.0003 0.0008 0.025
Cell Kill (%)
Concentration (mM)
020406080100
0.0001 0.0002 0.0005 0.017
Cell Kill (%)
Concentration (mM)
020406080100
0.00016 0.0003 0.0008 0.025
Cell Kill (%)
Concentration (mM)
Safety EfficacyMouse colon cancer (carcinoma)
ALATPDC
Rat brain cancer(glioma)
Human brain cancer (glioblastoma)
Dramatically Better Than Two FDA Approved Drugs 5
ALATPDC
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5 Research performed at Princess Margaret Cancer Centre, University Health Network by Theralase research scientists under the direction of Dr. Lothar Lilge Ph.D. and Dr. Arkady Mandel Ph.D., M.D., D. Sc., Chief Scientific Officer of Theralase
Mechanism of Action
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Transferrin combines with PDC to target cancer cells and destroy them
PDC injection of 53 mg kg-‐1 4hr Post PDC Injection (Pre Light Activation)
24hr Post Light Activation20 Months Post Treatment (No
recurrence)
Tumour induced in mice
Mice survive 20 months cancer free after only 1 Anti-‐Cancer treatment
Immune Response 6
136 Research performed at Princess Margaret Cancer Centre, University Health Network by Theralase research scientists under the direction of Dr. Lothar Lilge Ph.D. and Dr. Arkady Mandel Ph.D., M.D., D. Sc., Chief Scientific Officer of Theralase
Rat Orthotopic Model
Anti-‐Cancer drug preferentially accumulates in bladder tumour and pre-‐tumourous tissue versus healthy urothelium (180 times higher)
>99% destruction of bladder cancer tumours
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Therapeutic Laser Divisionü Health Canada Approval of TLC-‐2000 Therapeutic Laserü FDA Approval of TLC-‐2000 Therapeutic Laser§ CE Approval of TLC-‐2000 Therapeutic Laser (1Q2016)
Anti-‐Cancer Divisionü Health Canada Clinical Trial Application (“CTA”) approvalü University Health Network Research Ethics Board (“UHN REB”) approval§ Health Canada Investigational Trial Application (“ITA”) approval§ FDA pre-‐Investigational New Drug Application (“IND”) Approval (1Q2016)§ FDA IND Application Approval (1Q2016)§ Commence enrolling subjects into Health Canada Phase Ib clinical study for
NMIBC (1Q2016)
Next Steps
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Ownership / Capitalization Table
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OWNERSHIP TABLE as Jan 4, 2016
Holder Name # of Common Shares% of Common
Shares # of Fully Diluted
Shares% of Fully Diluted
Shares
Officers & DirectorsRoger Dumoulin-‐White (CEO) 5,343,306 5.0% 10,495,806 7.6%
Kristina Hachey (CFO) 913,410 0.9% 1,413,410 1.0%Randy Bruder (Director) 1,410,324 1.3% 1,980,324 1.4%
Matthew Perraton (Director) 42,699 0.0% 552,065 0.4%Guy Anderson (Director) 20,000 0.0% 540,000 0.4%
Total Officers & Directors 7,729,739 7.2% 14,981,605 10.9%
Public Float 99,317,621 92.8% 122,697,695 89.1%
TOTAL Shares 107,047,360 100.00% 137,679,300 100.0%
CAPITALIZATION TABLE
Description# of Common Shares
Equivalent
Common Shares Outstanding 107,047,360
Options (Weighted Average Price $0.50) 10,105,000
Warrants (Weighted Average Price $0.53) 20,526,940
Total Fully Diluted Shares Outstanding 137,679,300
1945 Queen Street EastToronto, Ontario, M4L 1H7, CANADA
Michael BorovecDirector, Investor Relations647-‐230-‐[email protected]
Roger Dumoulin-‐WhitePresident & CEO1-‐866-‐THE-‐LASE (843-‐5273) [email protected]
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