Theralase Technologies Inc. Roger Dumoulin-White President ...€¦ · Late stage disease (T4):...
Transcript of Theralase Technologies Inc. Roger Dumoulin-White President ...€¦ · Late stage disease (T4):...
Chapter Title Section
Theralase Technologies Inc. Roger Dumoulin-White President, Chief Executive Officer
2Q2014CONFIDENTIAL
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)
Highlights100% cancer cell kill at very low concentrations (< 0.8µM)
No 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)
Statistics70,000 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 CareEarly 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 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%.
Safety: PDC + No light Efficacy: PDC + Light
HT1376 Human Bladder Cancer Cell LineSafety and Efficacy of PDC
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0.00125 0.0025 0.005 0.01 0.02 0.04
Cel
l Kill
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Concentration (mM)
45 J cm-290 J cm-2
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0.00125 0.0025 0.005 0.01 0.02 0.04C
ell K
ill (
%)
Concentration (mM)
45 J cm-290 J cm-2
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0.0001 0.0002 0.0005 0.017
Ce
ll K
ill (
%)
Concentration (mM)
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0.00016 0.0003 0.0008 0.025C
ell
Kill
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)Concentration (mM)
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0.00016 0.0003 0.0008 0.025
Ce
ll K
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%)
Concentration (mM)
ALA
14A
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0.0001 0.0002 0.0005 0.017
Cell
Kill
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Concentration (mM)
0
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0.00016 0.0003 0.0008 0.025
Cell
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Concentration (mM)
Safety: PDC + No Light Efficacy: PDC + Light Mouse colon cancer (carcinoma)
PDC Efficacy vs. ALA (FDA Approved Drug)
ALATPDC
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0.00016 0.0003 0.0008 0.025
Cell
Kill
(%
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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 Activation20 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 only 1 PDC treatment
Preclinical
2013: $0 M2014: $0 M2015: $0 M2016: $250 M
Investment $10 M
ROI2500% in 3 yrs
Investment vehicleJoint 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 injectedIrradiation: λ=530 nm, 192 J
Survival of mice up to 20 months (50 human years) after one Theralase PDT treatment
Scientific Riskin-vitro and small animal in-vivo results show virtually zero toxicity and up to 100% cancer kill across a wide range of cancers
Manufacturing RiskDrug 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 RiskVery 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 RiskCompany currently trades on the TSXV under ticker TLT and is a fully reporting issuer
Execution RiskOutsourced 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 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 AvilomicsTechnology.
$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 TechnologyDesigner 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)
HighlightsUsed 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
OpportunityExpand sales and marketing in 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
StrategyExpand sales and marketing team in Toronto (complete), Calgary (complete), 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 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 PainHand and Wrist Pain
Neck and Shoulder
PainHeat 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 mW100 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 ResultsPractitioners 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)
SummaryOn 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 FeePractitioners 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 revenuePractitioner Cost: $500 per monthPractitioner is generating 20X return on investment
2014 ObjectiveInstalled 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 RiskZero. Alpha prototype is already designed and patented.
Manufacturing RiskZero. Laser manufacturing will be completed by Theralase which is ISO-13485 certified and has designed and manufactured laser systems for over 20 years.
Regulatory RiskZero. Current therapeutic laser technology is already FDA, Health Canada and CE approved. The next generation will use these approvals for regulatory approval.
Financing RiskZero. $3.15 M financing completed in November 2013 to commercialize next generation therapeutic laser and commence Phase 1 / 2a anti-cancer clinical trial.
Liquidity RiskVirtually zero. Company currently trades on the TSXV under ticker TLT and is a fully reporting issuer.
Execution RiskExtremely 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 TeamRoger Dumoulin-White, P. Eng, President & CEOFounded 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 medicineKristina Hachey, CGA, CFO17+ years of experience in finance and financings in public and private companiesWayne Embree, VP Engineering38+ years of experience in designing and managing design teams in the production of electronics devices
Derek Small, Director of Sales & Marketing15+ years of professional sales and sales management in medical capital equipment sales in Canada and the US
Ontario Cancer Institute, Princess Margaret Cancer Centre - University Health Network
Ontario Centers of Excellence – Photonics
Acadia University / Virginia Tech
Buffalo Niagara Medical Campus
Scripps Research Institute
Management and Advisors
Board of DirectorsS. 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
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
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 TechnologyPatented 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 TeamExperienced management team with ability to execute on strategic initiatives
Contact Information
Theralase Technologies Inc.1945 Queen Street EastToronto, Ontario, M4L 1H7Canada
TLT:TSXVRoger Dumoulin-WhiteFounder, President & CEO1-866-THE-LASE (843-5273) [email protected]
Common shares: 65,726,309
Stock price: $0.34
Market capitalization: $22.6 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 conditionand operating results, include information, analyses and projections as to future corporate developments which arecurrently in the planning stage, and on the projected operating financial performance of the Company, whichconstitute forward-looking statements. Such forward-looking statements, made with special reference to theCompany’s ongoing technologically complex healthcare and medical device research and development efforts, whichmay include in-house and independent clinical trials, testing new medical technologies and their applications, involveknown and unknown risks and uncertainties that could cause actual events and results to differ materially from thoseestimated or anticipated and which may have been implied or expressed in such forward-looking statements. Noconclusions as to the successful outcome of the ongoing and planned research and development projects in which theCompany is involved are intended or implied nor can they be foreseen or predicted prior to definitive corporateannouncements 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 suchexpressions, although not all forward looking statements contain these identifying words, any statements that refer toexpectations, projections or other characterizations of future events or circumstances are forward lookingstatements. Although Theralase believes that the expectations reflected in any forward looking statements made inthis presentation are reasonable, such statement are based on a number of assumptions which may prove to beincorrect, including, but not limited to assumptions relating to the risks and factors set out below. Accordingly, noassurances can be given that any of the events or circumstances contemplated by any such forward lookingstatements will transpire or occur or, if any of them transpire or occur or, if any of them transpire or occur, whatimpact they will have on Theralase’s results of operations or financial condition. A more complete list of risks anduncertainties 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 theCompany does not undertake any obligations to update publicly or to revise any of the included forward-lookingstatements, whether as a result of new information, future events, or otherwise. The forward-looking statementscontained 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