Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Investor Presentation (May 2015)
21 slides from Oncosil Medical's investor presentation, May 5, 2015
Slide 1: Developing OncoSil for Pancreatic & Primary Liver cancer
Developing OncoSilTM for Pancreatic & Primary Liver cancer For personal use only Daniel Kenny CEO Investor Update May 2015
Slide 2: Important Notice
Important Notice For personal use only The purpose of the presentation is to provide an update of the business of OncoSil Medical Ltd (ASX:OSL). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. According
Slide 3: OncoSil Medical - Overview
OncoSil Medical - Overview For personal use only • Developing implantable radiotherapy medical device − 30 micron silicon particles contain beta emitting phosphorus – 32 (P32) • Successfully early development – entering into Pivotal Phase for US FDA approval − Four previous Pilot Clinical studies co
Slide 4: Board of Directors
Board of Directors For personal use only • Seasoned biotechnology entrepreneur Dr. Roger Aston • Co-founded pSivida Limited. Former CEO of Hospira Australia and Chairman CEO of Mayne Pharma Group • Experience includes FDA and EU product registration, clinical trials, global licensing agreements, fun
Slide 5: OncoSil - Potential treatment for Pancreatic & Primary Liver Cancer
OncoSil™ - Potential treatment for Pancreatic & Primary Liver Cancer For personal use only Next Generation Radiotherapy • OncoSil Medical has an implantable nuclear medicine ( radiotherapy) device that has been successfully piloted in pancreatic & liver cancer. • Localised radiation therapy is inher
Slide 6: OncoSil Benefits
OncoSilTM Benefits For personal use only • Localised treatment reduces serious side effects associated with standard radiotherapy • Classified as a device therefore shorter time to market than traditional drug development • Synergistic effect with current chemotherapy regime as gemcitabine ‘sensitis
Slide 7: How OncoSil Works
How OncoSilTM Works For personal use only OncoSilTM is suspended in a The physician guides an endoscope down the shielded syringe in the oesophagus, through the stomach and into the first part operating theatre where a of the small intestine. Ultrasound is used to image the physician will make the t
Slide 8: OncoSil - Device Overview
OncoSilTM - Device Overview For personal use only Radiation therapy delivered to the cancer site • Pure “soft beta” radiation source (P32) to avoid systemic side effects • Localised radiation therapy using “sticky” microparticles • Carrier particles are inert silicon • Particles are suspended in flu
Slide 9: Pancreatic Cancer: Unmet Medical need
Pancreatic Cancer For personal use only Unmet Medical need • 338,000 pancreatic cancer incidence yearly world wide (1) • Approximately 45,000 new patients diagnosed with pancreatic cancer in the US each year • Poor prognosis -Median survival ~8 months and 5 year survival less than 7% Target Market •
Slide 10: Primary Liver Cancer: Unmet Medical need
Primary Liver Cancer For personal use only Unmet Medical need • 6th most common cancer in the world • 782,000 new cases diagnosed in 2012 (1) • Due to poor prognosis, 3rd leading cause of cancer mortality, 600,000 deaths annually Target Market Value of HCC market expected to triple in size to $1.4b
Slide 11: Pancreatic Cancer: Patient Pool assumptions - US & EU
Pancreatic Cancer: Patient Pool assumptions – US & EU For personal use only US new cases pa: 46,000 Incidence in Key Markets (US & EU) EU new cases pa: 85,000 131,000 pa. Neuroendocrine (5%) Adenocarcinoma (95%) 6,550 124,450 Ineligible for Surgery (85%) Surgery (15%) 106,000 18,668 pa. Potential Ma
Slide 12: Pancreatic Cancer Treatment Paradigm
Pancreatic Cancer Treatment Paradigm For personal use only = Current standard of care = Emerging standard of care Pancreatic Cancer 15% 35-40% 40-45% Surgical Re-Section Locally Advanced Metastatic Disease First-Line Salvage First-Line Salvage + + Fluorouracil Fluorouracil FOLFIRINOX Chemotherapy (f
Slide 13: Clinical Trials Completed
Clinical Trials Completed For personal use only • BIOSP-201: A single dose, single centre open label phase I/II safety study in hepatocarcinoma, recruitment 31 May 2004 – 09 March 2005, 8 patients enrolled • BIOSP-202: A multi-centre, dose escalating study in hepatocarcinoma, recruitment 17 Oct 2005
Slide 14: Pancreatic cancer: Clinical data to date
Pancreatic cancer: Clinical data to date For personal use only Clinical Trial Results • 17 locally advanced pancreatic cancer patients in single arm study • Significant anti-cancer activity – disease control rate of 82% : 4 Partial Responses, 10 Stable disease and 3 Progressive Disease • Average redu
Slide 15: Target Tumour Response rate: Pancreas
Target Tumour Response rate: Pancreas For personal use only • Target tumour response rate: 81.25% • 13/16 treated patients experienced a reduction in target tumour volume • Of the 13 patients with a reduction in target tumour volume only 2 had less than a 15% reduction • 50% of responders achieved t
Slide 16: Best Response of HCC Target Tumour after Single Fixed Dose of OncoSil
Best Response of HCC Target Tumour after Single Fixed Dose of OncoSilTM For personal use only % Change in target Patient Number Response+ Tumour Volume 001 -44% Stable Disease 002 -80% Partial Response 003 -16% Stable Disease 004 -43% Partial Response 005 -100% Complete Response 006 -100% Complete R
Slide 17: Patents, Trademark & Know How
Patents, Trademark & Know How For personal use only • Multiple granted patents in US, EU, Japan and elsewhere for the therapeutic product and for the manufacturing method (2022 - 2024) • Trademark protection granted for OncoSil™ in Australia, New Zealand, UK, EU, USA, Japan and Singapore Know-How, E
Slide 18: OncoSil Corporate Goals: 2015
OncoSil Corporate Goals: 2015 For personal use only • Finalize design of Pivotal Study for Pancreatic cancer by end of Q2 2015 • Recruit 1st patient in Pivotal Study by end of Q3 2015 • CE Mark approval by end Q3 2015 • IDE approval by Q4 2015 18
Slide 19: Global Regulatory Strategy
Global Regulatory Strategy For personal use only Device Registration Plan for Key Pharmaceutical Markets Calendar Yr H2 2014 H1 2015 H2 2015 H1 2016 H2 2016 H1 2017 H2 2017 OncoSil™ Pivotal study IDE Q4 Approval FDA CE Marking Q3 Approval Sales in EU, Canada & Aus OncoSil’s global registration strat
Slide 20: Capital Structure
Capital Structure For personal use only ASX code OSL Market Cap (April, 2015) $A40m Shares on issue 355m Cash (31 March, 2014) $A7.2m R&D Credits & Pre-payments $A2.55 M Total Cash and Credits $A9.75M Average Burn rate: $A 460K per month Cash reserves to Q1 2017 20
Slide 21: Investment Thesis
Investment Thesis For personal use only 1. OncoSil Medical has strong leadership − New management, energised and focused. 2. High unmet medical need. − Pancreatic cancer has one year survival of 26% and five year survival of 6% − HCC is the 6th most common cancer in the world 3. Current treatments a