Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Investor Presentation (March 2018)
40 slides from Oncosil Medical's investor presentation, Mar 21, 2018
Slide 1: Investor Presentation: Surgical Resection Data Update & Capital Raise
Investor Presentation ASX.OSL Surgical Resection Data Update & Capital Raise March 2018
Slide 2: Important notice
Important notice 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 Presentation and the informati
Slide 3: Summary
Summary • Oncosil Medical Limited (“OSL” or the “Company”) is pleased to announce that two study participants have undergone surgical resection with curative intent (Whipple procedure), both achieving R0 (clear margins) outcomes Surgical • In addition, three other study participants are currently be
Slide 4: Sources and uses of funds
Sources and uses of funds Source of funds (A$m) Use of Funds (A$m) Placement proceeds 12.7 EU Commercialisation 2.0 - 3.0 SPP proceeds 0.0 – 4.0 PMCF study, and US and PanCo studies 9.5 - 11.0 Working capital including specific initiatives (manufacturing optimisation and other project and 1.2 – 2.7
Slide 5: Key catalysts in CY 2018
Key catalysts in CY 2018 Revamped leadership team Target submission of 16 week 20 patient supplemental data to BSI by 31-May-18 CE Mark Target CE Mark certification Target EU first sales Continued recruitment into the Global Pancreatic Cancer clinical study Global Pancreatic program, (PanCO
Slide 6: Surgical resection outcomes & positive clinical data
1. Surgical resection outcomes & positive clinical data OncoSil Medical 6
Slide 7: Tumours successfully resected
Tumours successfully resected Recap of study context Study population drawn To date, 2 out of 20 implanted patients have undergone from patients with surgical resection with curative intent (undergoing the unresectable locally Whipple procedure) advanced pancreatic cancer Both patients have ac
Slide 8: PanCO study – positive results to date
PanCO study – positive results to date Positive clinical data on 20 patients (at Week 8) and 14 patients (at Week 16) Study progress overview 40 patients enrolled1 28 patients implanted1 Disease Control Rate (DCR) of 100% Partial Response – a reduction (Week 8) and 87% (Week 16) in tumour longest
Slide 9: Substantial tumour volumetric reduction
Substantial tumour volumetric reduction Revamped leadership team Best tumour volumetric change in first 20 implanted patients: Preliminary data 18 of 20 patients (90%) demonstrated reduction in 60% tumour volume of at least 20% 40% from baseline % change from baseline 20% (20%) * (40%) * (60%) † * *
Slide 10: Commercialisation Pathway
2. Commercialisation Pathway OncoSil Medical 10
Slide 11: Clinical pathway overview
Clinical pathway overview PanCO and OncoPaC-1 to inform future studies Future focus Phases: Current focus Studies to drive clinical adoption (EU & global) 2 concurrent trials, targeting 65 patients total and secure US FDA approval Trials: PanCO – 45 patients Company exploring clinical study options
Slide 12: Significant opportunity for OncoSil
Significant opportunity for OncoSil Current available treatment for pancreatic cancer The opportunity for OncoSil Surgery (resection), if diagnosed early enough Only two drugs to have made Chemotherapy (Gemcitabine and Abraxane) significant improvements in pancreatic cancer in over 20 years: ⎼
Slide 13: Positive reception at key conferences
Positive reception at key conferences Early study data presented at European Association of Nuclear Medicine (EANM) Annual Congress and European Society of Medical Oncology (ESMO) The EANM is the largest organisation dedicated to Nuclear Medicine in Europe ESMO is Europe’s leading non-profit med
Slide 14: Partnering with leading cancer centres
Partnering with leading cancer centres 15 leading cancer centres participating in Global Pancreatic Cancer clinical programme Region Centre MD Anderson, Texas Johns Hopkins, Maryland Moffit Cancer Centre Florida Cedars Sinai Hospital, LA Guy’s & St Thomas’, London University of Leicester Hammersmith
Slide 15: Clear pathway to commercialisation
Clear pathway to commercialisation Strategic partners provide multiple paths to market to optimise value Well positioned for commercialisation Potential paths to market Broad technology platform Treatment for multiple solid tumours Strategic licensing partners in all key geographies Excellent clinic
Slide 16: Target markets
UK(Launch market) 1,2 Pancreatic cancer 8,747 Liver cancer 4,186 European Union1,2 Pancreatic cancer 79,331 Liver cancer 51,785 Target markets Annual incidence China1,2 Global opportunity United States 1,2 Pancreatic cancer 65,727 Liver cancer 351,000 Pancreatic cancer US>$2.0bn Pancreatic cancer 42
Slide 17: Global Commercial opportunity in excess of $2bn
Global Commercial opportunity in excess of $2bn 130,000 cases per year in US+EU alone: more than 70,000 of these could benefit from OncoSil More than 70,000 relevant Locally OncoSil™ provides a suitable treatment to patients in EU and US alone advanced control the growth of the primary tumour and pr
Slide 18: OncoSil's commercial path has precedent
OncoSil’s commercial path has precedent Sirtex provides a useful case study to demonstrate the potential commercial journey for OncoSil due to similarities in addressable market 24-Aug-00 5-Mar-02 Listed on the ASX with Phase II FDA approval for SIR-spheres achieved and Phase III clinical trials com
Slide 19: Sector M&A trends
Sector M&A trends Over A$2bn of acquisitions in February 2018 highlights attraction of early-stage Australian biotech to global pharmaceutical players Acquiree Acquirer Consideration A$1.6 billion1 A$502 million1 A$120 million1 Date 30 Jan 2018 22 Feb 2018 6 Feb 2018 Premium 60% (1 month VWAP)2 160%
Slide 20: Capital raise details
3. Capital raise details OncoSil Medical 20
Slide 21: Offer overview
Offer overview • OSL is raising approximately $12.7 million via a Placement plus a SPP of $15,000 per eligible shareholder, which is capped at a total of $4 million Offer size and • The Placement will be conducted across two tranches: structure ‒ Tranche 1 – OSL will issue approximately 72.7 million
Slide 22: Offer timetable
Offer timetable Placement Date • Trading Halt (pre-market open) Wednesday, 21 March 2018 • Bookbuild opens • ASX Announcement of Offer completion Friday, 23 March 2018 • Trading Halt lifted (pre-market open) • Expected settlement of new shares issued under Tranche 1 of the Placement Tuesday, 27 Marc
Slide 23: Company Overview
4. Company Overview OncoSil Medical 23
Slide 24: OncoSil Medical | Investment Highlights
OncoSil Medical | Investment Highlights 1 Clear Commercialising a breakthrough implantation radiation mission treatment for Pancreatic cancer 2 Current and previous clinical studies demonstrate: Excellent Local Disease Control Sound Significant reduction in tumour size and volume science Excel
Slide 25: OncoSil Medical
OncoSil Medical OncoSilTM is a first in class medical device for the treatment of unresectable locally advanced pancreatic cancer First in class technology Share price performance (1 year) Proprietary brachytherapy (internal radiation) medical Share price (acps) Volume (m) device $0.20 12 Cancer
Slide 26: About the OncoSil device
About the OncoSilTM device An implantable radiotherapy medical device targeting pancreatic cancer OncoSilTM is a single-use brachytherapy device Delivered through microparticles: 30-micron silicon particles contain beta-emitting Phosphorus-32 (32P) OncoSilTM Microparticles are inserted directly into
Slide 27: Implantation procedure
Implantation procedure Studies continue to show the device implantation is technically straightforward Endoscope guided into the OncoSil™ injected OncoSilTM dose is upper intestine directly into the suspended in a tumour Using CT or real-time imaging, specially formulated the needle is guided into t
Slide 28: Real-Time Visualisation
Real-Time Visualisation Needle Positioning in Pancreatic Mass via Endoscopic Ultrasound (EUS) Needle positioning OncoSil™ deposition BSI Meeting XXXX 28
Slide 29: OncoSil at a potential value inflection point
OncoSil at a potential value inflection point The Company is well positioned to realise value of OncoSil™ device Current focus Before 2015: 2016 to 2018: 2018 onwards: Demonstrate Satisfy regulatory Path to potential obligations commercialisation 4 studies show Secure US FDA IDE approval Secur
Slide 30: Board of Directors
Board of Directors • Board and management are experienced leaders in the pharmaceutical and medical device space, having held senior positions at Cochlear (ASX:COH), Sirtex Medical (ASX:SRX), ABIVAX, Baxter International, Roche and more • Extensive leadership experience guiding products from clinica
Slide 31: Highly experienced management team
Highly experienced management team Revamped Medical (ASX:SRX) leadership • Management team experienced leaders team in the medical device space having held senior positions at Sirtex • Extensive leadership experience in clinical studies, commercialisation and manufacturing & operations Mr Daniel Ken
Slide 32: Key risks
4. Key risks OncoSil Medical 32
Slide 33: Key risks
Key risks This section outlines some of the key risks associated with an investment in Oncosil. Oncosil’s business is subject to a number of risk factors both specific to its business and of a general nature which may impact on its future performance and forecasts. This is not an exhaustive list of
Slide 34: Key Risks – Business Risks (cont)
Key Risks – Business Risks (cont) Oncosil operates within a highly regulated industry, relating to the manufacture, distribution and supply of medical devices. There is no guarantee that Oncosil will maintain the required approvals, licenses and registrations from all relevant regulatory authorities
Slide 35: Key Risks – Business Risks (cont)
Key Risks – Business Risks (cont) The Oncosil business model requires ongoing re-investment into clinical trials with no revenues currently contracted. As such, Oncosil will continue to rely upon its cash to Access to Capital fund the business as an on-going concern. Any unforeseen events which rest
Slide 36: Key Risks – Business Risks (cont)
Key Risks – Business Risks (cont) Joint Venture Oncosil is unable to predict the risk of financial failure or default by a participant in any joint venture to which Oncosil is or may become a party or the insolvency or Parties, Agents, managerial failure by any of the contractors used by Oncosil in
Slide 37: Key Risks – Offer and General risks
Key Risks – Offer and General risks Offer and General Risks The market price of Oncosil shares will fluctuate due to various factors, many of which are non-specific to Oncosil, including recommendations by brokers and analysts, Share Price Australian and international general economic conditions, in
Slide 38: Key Risks – Offer and General risks (cont)
Key Risks – Offer and General risks (cont) Oncosil prepares its general purpose financial statements in accordance with Australian International Financial Reporting Standards (AIFRS) and the Corporations Act 2001 Accounting (Cth). Australian Accounting Standards are subject to amendment from time to
Slide 39: Foreign selling / Offer jurisdictions
Foreign selling / Offer jurisdictions International Offer Restrictions This document does not constitute an offer of new ordinary shares ("New Shares") of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New Sha
Slide 40: Daniel Kenny CEO & Managing Director
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 40