1Q2014 CONFIDENTIAL Theralase Technologies Inc. Roger Dumoulin-White President, Chief Executive Officer Chapter Title Section
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
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 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
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 5 th most common cancer, 4 th in men, 8 th 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 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%.
HT1376 Human Bladder Cancer Cell Line Safety and Efficacy of PDC Efficacy: PDC + Light Safety: PDC + No light 120 120 45 J cm-2 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)
PDC Efficacy vs. ALA (FDA Approved Drug) Safety: PDC + No Light Efficacy: PDC + Light Mouse colon cancer (carcinoma) 100 100 80 80 Cell Kill (%) Cell Kill (%) ALA ALA 60 60 TPDC 14A 40 40 20 20 0 0 0.00016 0.0003 0.0008 0.025 0.00016 0.0003 0.0008 0.025 Concentration (mM) Concentration (mM) Human brain cancer (glioblastoma) 100 100 80 80 Cell Kill (%) Cell Kill (%) 60 60 40 40 20 20 0 0 0.00016 0.0003 0.0008 0.025 0.00016 0.0003 0.0008 0.025 Concentration (mM) Concentration (mM) Rat brain cancer (glioma) 100 100 80 80 Cell Kill (%) Cell Kill (%) 60 60 40 40 20 20 0 0 0.0001 0.0002 0.0005 0.017 0.0001 0.0002 0.0005 0.017 Concentration (mM) Concentration (mM)
Theralase PDC Efficacy vs. 2 FDA Approved Drugs 3 TLD1633 668,000x more 198x more effective than effective than PHOTOFRIN ALA
Destruction of Cancer in Live Animal with PDC 4hr Post PDC Injection PDC injection of 53 mg kg -1 (Pre Light Activation) Tumour induced in animal (BALB/c mice ) with tumour reaching 5.0 0.5 mm in size. 20 Months Post Treatment 24hr Post Light Activation (No recurrence) Mice have survived 20 months cancer free after only 1 PDC treatment
Preclinical Live 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 Survival of mice up to 20 Joint venture with bladder cancer asset placed into an incorporated company with 50/50 ownership split months (50 human years) between Theralase and investment partner after one Theralase PDT treatment
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 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- oncologist and Head of Urology at Princess Margaret Cancer Centre will lead bladder cancer clinical trials
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 + Dec 2010 - Exclusive rights to develop and royalties commercialize targeted covalent drugs for cancer treatment based on Avila’s Avilomics Technology. $912M + Aug 2010 -Worldwide rights to develop and royalties commercialize cancer drug candidates using Seattle Genetics’ antibody -drug conjugate program. $815M + Jan 2012 - Collaboration to discover and develop royalties small molecule drugs against oncology-relevant protein-protein interactions. Note: Deals include up-front, milestone and royalty payments on net sales.
Recent Pharma Deals $700 M + Jan 2012 - Collaboration to discover and develop royalties drugs that target tumor metabolism mechanisms. $540 M + June 2010 - Rights to discover, develop and royalties commercialize novel anti-cancer stem cell therapeutics targeting the Wnt signaling pathway. $508 M + Aug 2010 - Exclusive worldwide rights to develop royalties and commercialize drug candidates arising from its PD-1 program for treatment of cancer. $466 M + Oct 2010, Dec 2011 - Exclusive worldwide rights to royalties 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
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 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
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