Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Bell Potter Emerging Leaders Day 2016
25 slides from Oncosil Medical's conference presentation, Mar 23, 2016
Slide 1: ASX Media Release: OncoSil Medical releases latest Investor Presentation
ASX / Media Release For personal use only 23rd March 2016 OncoSil Medical releases latest Investor Presentation SYDNEY, 23rd March, 2016: OncoSil Medical Limited (ASX: OSL) (OncoSil Medical, the Company) is pleased to release its latest Investor Presentation, delivered at Bell Potter Securities Limi
Slide 2: About OncoSil Medical Ltd
About OncoSil Medical Ltd OncoSil Medical Ltd (OncoSil Medical) is a clinical-stage Australian Lifesciences company with the aim is to provide new For personal use only technologies for safer medical radiation treatments. OncoSil Medical’s lead product is OncoSil™ with the first target indication be
Slide 3: OncoSil: Advancing Pancreatic & Liver Cancer Treatment
Bell Potter Emerging Leaders Day 2016 For personal use only OncoSil: Advancing Pancreatic & Liver Cancer Treatment
Slide 4: 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 5: OncoSil Medical - Overview
OncoSil Medical - Overview For personal use only Developing implantable radiotherapy medical device • 30 micron silicon particles contain beta emitting phosphorus (P32)1 • Safer & stronger medical radiation treatment than external beam radiation Successfully developed – preparing for EU commercialis
Slide 6: OncoSil Medical - Overview
OncoSil Medical - Overview For personal use only CE Mark registration process is ongoing • Company confident of CE Mark being granted in the near term • Company acknowledges that registration process has taken much longer than expected • CE Mark filing is complex & process complicated • Submission d
Slide 7: Board & Management
Board & Management For personal use only Dr. Roger Mr. Daniel Dr. Chris Mr. Martin Aston Kenny Roberts Rogers Chairman CEO & MD Director Non- Executive Director Seasoned biotechnology Former senior Roche & Baxter Former Cochlear CEO Highly A well-recognised Australian entrepreneur. Inventor on paten
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: How OncoSil Works
How OncoSil™ Works For personal use only Pancreatic Cancer Liver Cancer OncoSilTM is suspended in a shielded syringe in the The physician guides an Using CT or real-time imaging, operating theatre where a endoscope down the the physician guides a 20 physician will make the oesophagus, through the ga
Slide 10: US$1bn Pancreatic Cancer
US$1bn Pancreatic Cancer For personal use only Unmet medical need • 338,000 pancreatic cancer incidence yearly world wide1 • Approximately 45,000 new patients diagnosed with pancreatic cancer in the US each year1 • Poor prognosis - median survival ~8 months and 5 year survival less than 5%2 Target m
Slide 11: US$1.4bn Primary Liver Cancer
US$1.4bn Primary Liver Cancer For personal use only Unmet medical need • 6th most common cancer in the world1 • 782,000 new cases diagnosed in 20122 • Due to poor prognosis, 3rd leading cause of cancer mortality, 600,000 deaths annually Target market • Entering the primary liver cancer market repres
Slide 12: 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 13: 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 14: Clinical Success In Pancreatic Cancer
Clinical Success In Pancreatic Cancer For personal use only Clinical Trial Results (Study DB2- 201) • 17 locally advanced pancreatic cancer patients in single arm study1 • Significant anti-cancer activity – disease control rate of 82% : 2 Partial Responses, 12 Stable Disease and 2 Progressive Disease
Slide 15: Target Tumour Response Rate: Pancreas
Target Tumour Response Rate: Pancreas For personal use only Study DB2- 201 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 responde
Slide 16: Results: Pancreatic Cancer
Results: Pancreatic Cancer Study DB2- 201 For personal use only Adapted from Ross PJ et al. 2008 1. Ross PJ et al, 2008,”Novel delivery via endoscopic ultrasound of a 32P brachytherapy device in addition to gemcitabine (G) in advanced pancreatic cancer”, ASCO, Chicago,Illinois. 14
Slide 17: Results: Liver Cancer
Results: Liver Cancer Study BIOSP-201 For personal use only Tumour Volume Response Adapted from Goh MD 2007. Results from tumour volume regression at week 12 and week 24 by CT scan post implantation. Patient 1,3 and 8 withdrew before the scan at week 24 not due to an adverse events 1. Goh AS, 2007,
Slide 18: Results: Liver Cancer
Results: Liver Cancer Study BIOSP-201: For personal use only Best Response of HCC Target Tumour after Single Fixed Dose of OncoSilTM % 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%
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 US FDA Trial US FDA IDE Ongoing CE Marking Ongoing Sales in EU, Singapore Canada & Aus OncoSil’s global registration strategy i
Slide 20: Capital Structure
Capital Structure For personal use only OncoSil Medical Ltd Closing Share Price Analysis $0.27 ASX Code OSL Market Cap A$70m $0.24 Shares on Issue 421m Cash as at Sep 15 $A14.5m $0.21 R & D Credits & Pre-payments A$0.5m $0.18 Total Cash & Credits A$15.0m $0.15 $0.12 Avg Burn Rate/month A$500k $0.09
Slide 21: OncoSil Medical Achievements: 2015
OncoSil Medical Achievements: 2015 For personal use only • ISO 13485 Certification – granted April 2015 • Filed for CE Mark on July 17, 2015 • Successfully completed US FDA Pre-IDE submission process • Filed US FDA IDE submission on December 10, 2015 • Built a strong “world-class” Executive Manageme
Slide 22: OncoSil Corporate Goals: 2016
OncoSil™ Corporate Goals: 2016 For personal use only Image 1 (Top left):Microparticle atomiser • CE Mark approval in near term • First commercial sales in Ex-US (dependent on CE Mark granting) • US FDA IDE approval in near term • Commence Clinical Investigation OncoPac-1 in H2 2016 Image 2 (to the R
Slide 23: Organisational Chart
Organisational Chart For personal use only Daniel Kenny Ainslee Stebbing CEO & Managing Executive Assistant Director Charles Rowland Dr Ash Soman Tom Milicevic President OncoSil Chief Medical Chief Financial Medical USA Officer Officer David James Dr Michelle Peter Casey Nicole Wilson Aurore Mulkens
Slide 24: 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 25% and five year survival of 5%1 • Primary liver cancer is the 6th most common cancer in the world2 3. C
Slide 25: Thank you !!
For personal use only Thank you !! Daniel Kenny CEO & Managing Director OncoSil Medical Ltd www.oncosil.com.au 23
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