Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Investor Presentation (May 2020)
37 slides from Oncosil Medical's investor presentation, May 4, 2020
Slide 1: Investor Presentation: Advancing Pancreatic cancer treatment
For personal use only ASX.OSL Investor Presentation Advancing Pancreatic cancer treatment Transforming the prognosis May 2020
Slide 2: Commercialising a breakthrough implantable radiotherapy treatment for pancreatic cancer
For personal use only Commercialising a breakthrough implantable radiotherapy treatment for pancreatic cancer 2
Slide 3: Executive Summary
Executive Summary OncoSil Medical is a commercial-stage • Implanted device (brachytherapy) delivers targeted radiation to pancreatic tumour For personal use only medical device company pursuing • In combination with chemotherapy it has clinically proven to double survival times and reduce targeted r
Slide 4: Treating pancreatic cancer is challenging and difficult
Treating Pancreatic cancer is challenging and difficult For personal use only Existing treatments for pancreatic cancer are ineffective... ...resulting in very poor survival rates1 Late diagnosis • Symptoms often unnoticed until cancer has metastasised Sub-optimal current standard of care ~8.5 month
Slide 5: The OncoSil device provides a unique and effective solution
The OncoSil™ device provides a unique and effective solution Radiation therapy delivered directly into the tumour For personal use only The Approvals The Trials • CE Mark approval • 6 clinical studies completed to date • Breakthrough designation in EU, UK and US • All yielding positive results on to
Slide 6: Technology backed by a body of strong clinical evidence
Technology backed by a body of strong clinical evidence For personal use only OncoSil™ has clinically proven to prolong median overall survival in LAPC patients Effectively doubled ~16 months Reduction in the risk of death compared to length of survival 20% CT-only and ICT + CCRT studies 2 Majority
Slide 7: Compelling PanCO results showing clear evidence of downstaging
Compelling PanCO results showing clear evidence of downstaging OncoSil™ converts inoperable patients to operable, extending survival and quality of life significantly For personal use only What is downstaging? Why is it important? What did PanCO trial show? The event of Typical survival lengths Trip
Slide 8: Significant market opportunity for OncoSil to become standard of care
Significant market opportunity for OncoSil to become standard of care There are more than 50k locally advanced pancreatic cancer (LAPC) cases p.a. in EU & UK 1 For personal use only Disease prognosis Current treatment OncoSil solution Future OncoSil™ could be used to downstage tumours focus 15% Rese
Slide 9: Highly attractive and scalable operating model for commercialisation
Highly attractive and scalable operating model for commercialisation For personal use only • Patented technology that is difficult to reverse engineer No competitors1 • There are no similar, competing products commercially available or in development, as supported by the breakthrough designation • H
Slide 10: OncoSil's commercialisation strategy currently in full swing
OncoSil‘s commercialisation strategy currently in full swing Clear focus on first sales in Europe and entry into other markets For personal use only • CE Mark Granted (Apr-20) • Many jurisdictions recognise CE Marking and do not necessarily require • Scalable manufacturing capabilities separate clin
Slide 11: Targeting a >US$3bn global unmet need in pancreatic cancer treatment
Targeting a >US$3bn, global unmet need in pancreatic cancer treatment For personal use only OncoSil’s market opportunity for LAPC: Target market Commercialisation status Pancreatic cancer Locally advanced pancreatic cancer Market opportunity incidences p.a 1 2 (USD)3 UK (launch market) Approved to s
Slide 12: Europe – clear path to first revenues
Europe – clear path to first revenues For personal use only Step by step plan to achieving first revenues ✓ Conducted PanCO clinical trial which underpinned CE Mark Clinical trials and ✓ Increased awareness and buy-in through results and ongoing publications evidence development ✓ Support of key opi
Slide 13: Europe – repeatable sales model to increase penetration
Europe – repeatable sales model to increase penetration For personal use only A B 5 activated hospitals – used in OncoSil clinical studies and now trained and ready to buy with Receive CE Mark more to come online1 Network Increase utilisation within effect C hospital and add more F creating Drive St
Slide 14: US – Primary focus on Pancreatic but scope to expand into new indications
US – Primary focus on Pancreatic but scope to expand into new indications Potential to expand into new indications driving greater economies of scale For personal use only Pancreatic Cancer Bile Duct Cancer Market opportunity US$500mn p.a1,2 US$80mn p.a3 August 2016: December 2018: Investigation
Slide 15: Experienced Board of Directors with commercialisation experience
Experienced Board of Directors with commercialisation experience For personal use only Dr Chris Roberts AO Dr Roger Aston Chairman Non Executive Director • 40+ years experience in medical innovation • Seasoned biotechnology entrepreneur with extensive • Served for 11 years as CEO of Cochlear Limited
Slide 16: Strong clinical and commercial pedigree in leadership team
Strong clinical and commercial pedigree in leadership team For personal use only Daniel Kenny Karl Pechmann David James CEO & MD CFO Global Head, Manufacturing Ops • Joined in January 2015 • Accredited Chartered Accountant • Pharmaceutical manufacturing • Proven biopharmeceutical and Chartered Secre
Slide 17: Several upcoming catalysts from different commercialisation paths
Several upcoming catalysts from different commercialisation paths For personal use only News flow and catalysts • Announcement of the appointment of Nigel Lange – Now • Humanitarian Device Exemption (HDE) filing with FDA for Bile Duct Cancer – Q2 2020 • Regulatory clearance in Hong Kong – anticipate
Slide 18: Capital Raising Details
For personal use only ASX.OSL Capital Raising Details
Slide 19: Offer details and timetable
Offer details and timetable Capital raising of up to ~A$19.0m via $14.0m Placement and $5.0m Underwritten For personal use only Entitlement Offer Event Timing Event Timing Private Placement to institutions, sophisticated and professions investors to raise up to A$14 million via the Placement issue o
Slide 20: Use of funds
Use of funds • Funds primarily used to support commercialisation activities across UK / Europe and For personal use only ASEAN regions Key Category Description Amount (A$m) Additional sales resources to support new Support UK / EU Commercialisation commercialisation activities for the OncoSilTM A$7.
Slide 21: Appendix
For personal use only Appendix ASX.OSL
Slide 22: Corporate Summary
Corporate Summary For personal use only OncoSil Medical Limited (ASX:OSL) Share price performance (1 year) • Proprietary brachytherapy (internal radiation) medical device A$/share • Developing and commercialising its proprietary paltform technology, 0.30 OncoSil™ ; anticipating first revenues in Eur
Slide 23: The OncoSil Device
For personal use only 1 The OncoSil™ Device
Slide 24: The technology provides a commercially successful treatment for hard to reach cancers
The technology provides a commercially successful treatment for hard to reach cancers For personal use only What is brachytherapy? Four key brachytherapy market segments • Internal radiotherapy designed to treat cancer by bringing the radioactive particles physically closer to the tumour Market segm
Slide 25: OncoSil radiation therapy is delivered directly into the tumour
OncosilTM radiation therapy is delivered directly into the tumour For personal use only OncoSilTM is a single-use brachytherapy device to be used in conjunction with chemotherapy Delivered through microspheres: 30-micron silicon particles contain beta-emitting Phosphorus32 (P32) OncoSilTM microspher
Slide 26: Minimally invasive procedure and allows for targeted radiation
Minimally invasive procedure and allows for targeted radiation For personal use only 26
Slide 27: Significant patent coverage in all geographies
Significant patent coverage in all geographies OncoSil is actively exploring patent extension For personal use only Existing Patent Coverage: EU, UK, US - 2028 APAC and - 2024 If OncoSil receives US approval, ASEAN OncoSil will get a 5-year period of markets exclusivity rights commencing from when t
Slide 28: PanCO Trial Results
For personal use only 2 PanCO Trial Results
Slide 29: Summary of the PanCO results
Summary of the Pan-Co results Performance (efficacy) data for the 42 study participants implanted with the OncoSil™device For personal use only demonstrate clear benefits for patients with unresectable locally advanced pancreatic cancer ORR: Median OS: LDCR16 weeks Median PFS: Median LPFS: 31% 16 mo
Slide 30: PanCO Study Design and Objective
PanCO Study Design and Objective OncoSil™ Implantation For personal use only Screening (1 – 14 days) Enrol to: Oncosil™ + FOLFIRINOX Overall or Continuation of chemotherapy PD FOLFIRINOX gemcitabine + nab-paclitaxel survival or gemcitabine + Week 1 Week 2 Week 3 Week 4 Week 5 onwards nab-paclitaxel
Slide 31: Systematic Literature Review: Overall Survival Analyses
Systematic Literature Review: Overall Survival Analyses For personal use only All Identifiable Treatment Arms Summary of Analysis Regimen Median OS (95% CI) CT-only and ICT + 12.7 months (12.2, 13.6) CCRT PanCO (ITT) 15.5 months (11.3, NC) PanCO (PP) 16.0 months (11.1, NC) 31
Slide 32: PanCO Local Disease Control Rate at weeks (LCDR16 weeks)
PanCO Local Disease Control Rate at 16 weeks (LCDR16 weeks) For personal use only Maintenance of local tumour control: Week 24 LCDR 30/42 implanted study participants had SD, PR or had undergone surgical resection with curative intent at Week 24: LDCR24 weeks = 71.4% (95% CI: 55.4%, 84.3%) PanCO Loc
Slide 33: PanCO Tumour Volumetric Assessment
PanCO Tumour Volumetric Assessment For personal use only Maximum % change in tumour volume from baseline (prior to surgical resection) for each patient by outcome 25 11* 7* 5* % Change from baseline 0 -6^ -9* -25 -17† -20‡ -31* -31^ -33^ -34* -35^ -37† -38* -50 -40^ -41^ -45‡ -46† * Week 8 -51‡ -52‡
Slide 34: Systematic Literature Review: Disease Control Rate
Systematic Literature Review: Disease Control Rate For personal use only Subgroups Based on Treatment Summary of Analysis Regimen DCR (95% CI) CT-only and ICT + 80.1% (72.9, 86.4) CCRT CT-only 71.3% (73.6, 85.9) ICT + CCRT 88.5% (80.4, 94.9) PanCO (ITT) 95.7% (85.5, 99.5) PanCO (PP) 100.0% (91.6, 10
Slide 35: Systematic Literature Review: Resection Rate Analyses
Systematic Literature Review: Resection Rate Analyses For personal use only Subgroups Based on Treatment Summary of Analysis Resection Regimen (95% CI) Rate CT-only and ICT + 9.9% (6.7, 13.5) CCRT CT-only 7.7% (3.1, 13.5) ICT + CCRT 11.5% (7.4, 16.2) PanCO (ITT) 20.0% (10.0, 33.7) PanCO (PP) 23.8% (
Slide 36: 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 a general overview of the Company. This Presentation and the information contained may require further explanation and/or clarification. Accordingly, this P
Slide 37: 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 OncoSil Medical 37