Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Investor Presentation (August 2016)
26 slides from Oncosil Medical's investor presentation, Aug 22, 2016
Slide 1: Advancing Pancreatic & Liver Cancer Treatment
For personal use only ASX.OSL Advancing Pancreatic & Liver Cancer Treatment Company Presentation 22 August 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: Overview
Developing an implantable Global Pivotal Study underway- radiotherapy medical device FDA approved IDE - July, 2016 For personal use only ‘OncoSilTM ’ for pancreatic Trial sites being engaged and liver cancer New leadership team CE Mark targeted in the near – Daniel Kenny CEO term followed by commerc
Slide 4: 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 5: OncoSil procedure
OncoSil™ procedure* For personal use only OncoSilTM is OncoSil™ injected suspended in a directly into the shielded syringe in tumour the operating theatre Endoscope Using CT or real-time guided into the imaging, needle guided upper intestine into the target lesion * Above procedure is for treating p
Slide 6: Target markets and global opportunity
UK (Launch market) 1 For personal use only Pancreatic cancer 8,747 Liver cancer 4,186 Target European Union1 markets Pancreatic cancer 79,331 Liver cancer 51,785 Annual incidence Global opportunity2 United States1 Pancreatic cancer 42,885 Pancreatic cancer US$1.0bn Liver cancer 30,449 Chemo regime U
Slide 7: Pancreatic cancer unmet need
Symptoms Treatments For personal use only Weight loss, malaise, jaundice Surgery (resection) if diagnosed early Cancer metastases around the Chemotherapy (Gemcitabine) Pancreatic body into lymph nodes, lungs etc. in combination with Paclitaxel External Radiation (ablation) therapy cancer Causes Issu
Slide 8: 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 9: Competitive landscape
Competitive landscape For personal use only Device Provider Cancers treated Delivery Product Approvals Notes Liver (HCC) Pancreas Other FDA CE Needle injection Small glass microspheres Limited approval TheraSphere® BTG International (LSE:BTG) X X into liver artery – into tumour via bloodflow contain
Slide 10: OncoSil results in pancreatic cancer
OncoSil™ results in pancreatic cancer For personal use only Four clinical studies completed Average reduction 2 x Primary Liver/HCC & 2 x Pancreatic Cancer in pain of 35% 69% max. pain reduction Study DB2-201 – weeks 8 and 11 following implant – Open label, Phase IIa safety study 17 patients with lo
Slide 11: Tumour reduction and increased survival
Tumour reduction and Increased survival For personal use only Tumour Reduction in target tumour volume response rate of for 13 of 16 treated patients 81.25 % 15% 11 of the 13 patients 50% 7 of the 13 patients Survival Probability -0.75 -0.75 Overall survival median 309 days -0.5 Progression free sur
Slide 12: 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 Trial sponsored studies entry Programme Patient registry 4 Pillar Commercial s
Slide 13: US market entry – IDE Study approved
US market entry – IDE Study approved For personal use only Regulatory Pivotal Trial Randomised High profile strategy underway Trial 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 14: 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 15: Dosing and Endpoints
Dosing and Endpoints For personal use only Primary Efficacy Endpoint • Local Progression Free Survival (LPFS) within the pancreas ‒ improvement in median LPFS from 6 months to 8.5 months A single dose is ‒ powered with significance level set at 0.05 implanted into the tumour using the final suspensi
Slide 16: OncoPac-1 Study Milestones & Timing
IDE Approval – July 2016 For personal use only Trial 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 17: Manufacturing and 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 18: 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 19: 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 20: Corporate snapshot – ASX.OSL
Corporate details – ASX.OSL* Share Price A$0.147 Corporate snapshot For personal use only 52 week range A$0.091-0.270 Daily Liquidity – 3 months ~$0.10m Shares on Issue 468.5m $0.30 25m Options – expiring 30 June 2017 19.0m $0.25 Market Cap A$68.9m 20m Free float 100.0% Share $0.20 price Reported Ca
Slide 21: 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 22: Appendices
For personal use only ASX.OSL Appendices
Slide 23: Clinical advisory board
Clinical advisory board For personal use only Dr. Joseph Michael Herman, M.D., M.Sc. Professor Pierce Chow Johns Hopkins University, Baltimore USA Singapore General Hospital Co-Director, Pancreatic Cancer Multidisciplinary Clinic, Associate Professor Chow was recently appointed as Chairman of the Pr
Slide 24: Intellectual property
Intellectual property For personal use only Region Granted Latest Expiry Date Exclusive licence from pSiMedica for 8% net sales royalty USA 3 Sep-2028 28 patents granted and 6 filed Canada 1 Feb-2022 Patents protect OncoSilTM technology Europe (ex. UK) 14 Dec-2024 • Devices & methods for treating ca
Slide 25: Pancreatic cancer patient pool assumptions – US & EU
Pancreatic cancer Patient Pool Assumptions – US & EU For personal use only Incidence in Key Markets (US & EU) 131,000 pa. US new cases pa: 46,000 EU new cases pa: 85,000 Neuroendocrine (5%) Adenocarcinoma (95%) 6,550 124,450 Ineligible for Surgery (85%) Surgery (15%) 106,000 18,668 pa. Locally Advan
Slide 26: 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
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