Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Shareholder Meeting (October 2016)
15 slides from Oncosil Medical's shareholder meeting presentation, Oct 18, 2016
Slide 1: Advancing Pancreatic & Liver Cancer Treatment
For personal use only ASX.OSL Advancing Pancreatic & Liver Cancer Treatment CEO Presentation 18 October 2016
Slide 2: Important notice
Important notice For personal use only This Presentation has been prepared by OncoSil Medical Ltd (ASX:OSL) (OncoSil or the Company) to provide an overview of the Company. This Presentation and the information contained may require further explanation and/or clarification. Accordingly, this Presenta
Slide 3: Revamped leadership team
Revamped leadership team For personal use only Dr Chris Roberts Mr Daniel Kenny Director & Chairman Elect CEO & MD Former Cochlear CEO Former senior Roche Highly experienced director & Baxter executive. Accomplished and senior executive with 40 and proven business leader years experience in the with
Slide 4: FY2016 Achievements Delivered
September 2015 •Submission of CE Mark application for OncoSil™ For personal use only October 2015 •OncoSil™ CE Mark application granted Fast Track review status December 2015 •Investigational Device Exemption submitted to the FDA for OncoPac-1 FY2016 clinical study January 2016 •Chris Roberts appoin
Slide 5: Device overview
Pure “soft beta” radiation source For personal use only (P32) to avoid systemic side effects Localised radiation therapy using “sticky” microparticles Device Carrier particles are inert silicon overview Particles are suspended in Radiation therapy fluid to allow direct injection into the tumour deli
Slide 6: Target markets
UK (Launch market) 1 Pancreatic cancer 8,747 Liver cancer 4,186 European Union1 For personal use only Pancreatic cancer 79,331 Liver cancer 51,785 Target markets Annual incidence China1 Global opportunity2 United States1 Pancreatic cancer 65,727 Liver cancer 351,000 Pancreatic cancer 42,885 Pancreat
Slide 7: Current treatments are limited
First-line Salvage For personal use only Surgical re-section 15% FOLFIRINOX Chemotherapy (folinic acid, fluorouracil, irinotecan, oxaliplatin) Current Chemoradiotherapy Fluorouracil treatments are Locally (chemotherapy + limited external beam radiation) advanced Pancreatic 35-40% cancer Metastic dis
Slide 8: 4 Pillar Commercial strategy
Dedicated Clinical Training team Trained IDE study sites expand into For personal use only Direct+Contract Sales commercial centres Outlicensing/ Targeted non- Leverage Investigator JV where appropriate US market Clinical Study sponsored studies entry Programme Patient registry 4 Pillar Commercial s
Slide 9: US market entry – IDE Study approved
US market entry – IDE Study approved For personal use only Regulatory Pivotal Study Randomised High profile strategy underway Study structure U.S. Trial Focus on pancreatic Investigational Device Pivotal Study of 300 centres and cancer indication – Exemption (IDE) with patients, 1:1 randomised PIs a
Slide 10: OncoPac-1 Global Pivotal Study - Overview
OncoPac-1 Global Pivotal Study - Overview For personal use only • Randomised, safety and efficacy study, OncoSil™ microparticles in unresectable locally advanced pancreatic cancer • N = 300 subjects (150 per arm) treated at ~30 Centres • Stage 1: 20 patient safety assessment • After Stage 1 patients
Slide 11: OncoPac-1 Study Milestones & Timing
IDE Approval – July 2016 For personal use only Study preparation securing sites, and IRB approvals – ongoing OncoPac-1 Enrolment of subjects – 2017 - 2018 Study Milestones & Follow up and data collection - 2019 Timing PMA submission to FDA ~2020 FDA approval and U.S. launch * These dates are estimat
Slide 12: Manufacturing & supply chain
Supply For personal use only chain in Expertise place and to manage Manufacturing capacity to validated execution risk meet needs Storage, handling & distribution by partner, Manufacturing In-house expertise Base Material is ultra Eckhert & Ziegler in & supply chain – over 20 years with nuclear medi
Slide 13: Targeted milestones
Targeted milestones For personal use only Calendar Years H1 2016 H2 2016 H1 2017 H2 2017 H1 2018 H2 2018 US FDA IDE - approved CE Marking Sales in EU Global Clinical Trial Sales in NZ, Singapore, Canada & Australia *These Milestones are based on the Company’s estimates and may change at any time. On
Slide 14: Value proposition
For personal use only Value proposition US market entry underway Pancreatic cancer is 6th most common – IDE granted by FDA in July 2016 cancer – poor treatment options Poised for commercial launch Median overall survival ↑ by 2 months to 8.5 months over the past 20 years – pending CE Mark in near te
Slide 15: Daniel Kenny, CEO & Managing Director
For personal use only Daniel Kenny CEO & Managing Director E: daniel.kenny@oncosil.com.au OncoSil Medical Ltd www.oncosil.com.au T: +61 2 9223 3344 F: +61 2 9252 3988