Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Shareholder Meeting (November 2023)
31 slides from Oncosil Medical's shareholder meeting presentation, Nov 29, 2023
Slide 1: OncoSil: Intratumoural placement of 32P for locally advanced pancreatic cancer
For personal use only OncoSil™ Intratumoural placement of 32P for locally advanced pancreatic cancer Nigel Lange, 29 November 2023
Slide 2: Disclaimer
Disclaimer 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 Presentation and the informat
Slide 3: Board and Management Team with Experience and Expertise
Board and Management Team with Experience and Expertise Douglas Nigel Gabriel Cubbin Lange Liberatore Non- Managing Non- For personal use only executive Director & CEO executive Chairman Director 30+ years Experienced biopharmaceutical Dr Liberatore is an experienced experience in executive with ove
Slide 4: Corporate Overview
Corporate Overview OncoSil Medical Limited | as at 27 Nov 2023 Major Shareholders (% of listed shares, as at 27 Nov 2023) Health Care – Pharmaceuticals, MRS SARAH CAMERON 6.82% For personal use only GICS: Biotechnology & Life Sciences (Life Sciences Tools & Services) ALUA CAPITAL PTY LTD 2.53% ASX C
Slide 5: Executive Summary
Executive Summary OncoSil™ is a commercial-stage • Implanted device delivers targeted radiation to pancreatic tumours For personal use only breakthrough device delivering targeted radiotherapy for pancreatic cancer • Breakthrough designation received in the EU/UK, US and Singapore • Experienced mana
Slide 6: Introduction
Introduction The prognosis for pancreatic cancer patients has remained almost unchanged for over 40 years1 with a reported five-year survival rate for the disease of 10%2 For personal use only Changes in survival, 1971-72 to 2010-11 0% 25% 50% 75% 100% All Cancers Incidence Testis Malignant Melanoma
Slide 7: Surgical Resection
Surgical Resection The only potentially curative treatment for pancreatic cancer1 RESECTABLE LOCALLY ADVANCED METASTATIC For personal use only % of patients at diagnosis 15% 30% 55% Surgical resection with Palliative therapies Palliative therapies curative intent (CT or ICT/CCRT)1,7,8 (usually CT on
Slide 8: OncoSil Device Overview
OncoSil™ Device Overview For personal use only OncoSil™ is intended OncoSil™ is for the treatment of implanted directly locally advanced into a pancreatic tumour unresectable via injection under pancreatic cancer, endoscopic in combination with ultrasound gemcitabine-based guidance 98% chemotherapy
Slide 9: Significant Accomplishments
Significant Accomplishments Experienced CE Marking Innovation Funding Enabled HDE1 pathway For personal use only team in place obtained (NUB) approved for bile duct cancer3 German funding in US enabled of the OncoSil™ device Application submitted to FDA2 PanCO Study Breakthrough device Current marke
Slide 10: PanCO study demonstrated positive safety and efficacy signals
PanCO study demonstrated positive safety and efficacy signals For personal use only Of the many encouraging outcomes from the PanCO study1, four are particularly important: Established safety profile: No evidence suggesting any additional risk from using OncoSil™ 90.5% of OncoSil™ treated patients h
Slide 11: PanCO results showing compelling evidence of downstaging
PanCO results showing compelling evidence of downstaging OncoSil™ converted patients with unresectable locally advanced pancreatic cancer (LAPC) to surgically resectable, transforming their prognosis and substantially extending survival For personal use only Why is resection What did the PanCO study
Slide 12: OncoSil for metastatic pancreatic adenocarcinoma (mPDAC)
OncoSilTM for metastatic pancreatic adenocarcinoma (mPDAC)* For personal use only Assess clinical outcomes following delivery of novel 32P microparticles via EUS- Objective guided brachytherapy in patients with mPDAC Location Multicentre (5 centres in Australia and UK) retrospective analysis from Se
Slide 13: TRIPP-FFX
TRIPP-FFX An open-label, multi-centre, randomized study of TaRgeted Intratumoural Placement of Phosphorous-32 (OncoSil™) in addition to FOLFIRINOX chemotherapy versus FOLFIRINOX chemotherapy alone in patients with unresectable locally advanced pancreatic For personal use only adenocarcinoma Objectiv
Slide 14: PANCOSIL (Investigator Initiated Study)
PANCOSIL (Investigator Initiated Study) Safety and feasibility of CT-guided percutaneous radionuclide therapy with the OncoSil™ device in patients with non-progressive locally advanced pancreatic cancer (PANCOSIL): an open-label, single-arm phase 1-2 feasibility study For personal use only Objective
Slide 15: PANCOSIL: First patient enrolled on 28 November 2023
PANCOSIL (Investigator Initiated Study) First patient enrolled on 28 November 2023 " For personal use only I am very excited that today we have been able to treat the first patient with OncoSil™ through a CT-guided percutaneous implantation procedure. This novel means of implantation of the OncoSil™
Slide 16: Innovation Funding (NUB) in Germany
Innovation Funding (NUB) in Germany Funding for the use of the OncoSil™ device in Europe’s largest market For personal use only In February 2022, the Institute for the Hospitals who have submitted NUB applications Hospital Remuneration System (InEK) can now negotiate with Statutory Health Insurance
Slide 17: G-BA Fully Funded trial in Germany
G-BA Fully Funded trial in Germany Fully-funded trial leading to public insurance reimbursement For personal use only In March 2022, the Federal Joint Committee (G-BA) recommended a fully- OncoSil will receive revenue payments for the funded trial take place in Germany provision of the OncoSilTM dev
Slide 18: Site Training Update
Site Training Update Training New Sites to start OncoSilTM treatments For personal use only
Slide 19: FY23 Highlights
FY23 Highlights Continuous investment in commercialization An agreement was reached with University Hospital Sankt Pölten OncoSil signs For personal use only Bupa UK & Axa Hospital, Austria to approves distribution agreement commence treating First patient Gabriel Liberatore appointed to reimburseme
Slide 20: Regulatory Updates
Regulatory Updates For personal use only UKCA Renewal – In progress (deadline 26 May 2024) EU MDR Submission – In progress (deadline 26 May 2024) Additional questions from FDA – In progress (deadline 26 July 2024) TGA Pre-submission Request – Q1 2024
Slide 21: FY24 Marketing Activities
FY24 MARKETING ACTIVITIES Reached over 10,000 HCPs For personal use only
Slide 22: Transformation Overview
Transformation Overview • New State of the Art Facility at the Macquarie Medical Centre in the Sydney, NSW area. Proudly Australian site serving the global market. For personal use only • Transformational technology being applied to the new facility: • High tech Opening and laminar dispensing system
Slide 23: Cyclotek Site, Macquarie University Hospital
Cyclotek Site, MacQuarie University Hospital • Partnership with Australian based Molecular Imaging company, Cyclotek, a proven supplier of Positron Emission For personal use only Tomography (PET) radiopharmaceuticals. • Cyclotek will be a key supplier of our medical device to our global markets. • S
Slide 24: Innovation
Innovation • Expanded Technology Development Team to provide: For personal use only • Clinical and site design support • Package engineering • Process and Product Development • Commercial logistics and supply-chain • New innovative designs & solutions : • Target quartz ampoule • Isolator technologie
Slide 25: Key Inflection Points
Key Inflection Points For personal use only • US HDE approval in distal cholangiocarcinoma (dCCA) • GBA German fully funded clinical trial approval • PancoSil clinical trial - (percutaneous application under CT guidance administered by Interventional Radiology)
Slide 26: The OncoSil device is now in early stage commercialisation
The OncosilTM device is now in early stage commercialisation The OncoSil™ device, an effective treatment for locally advanced pancreatic cancer, is now penetrating its already large and continually growing target addressable markets For personal use only Many key components of commercialisation st
Slide 27: OncoSil: Intratumoural placement of 32P for locally advanced pancreatic cancer
For personal use only OncoSil™ Intratumoural placement of 32P for locally advanced pancreatic cancer Nigel Lange, November 2023
Slide 28: Transformation Overview
Transformation Overview • New State of the Art Facility at the Macquarie Medical Centre in the Sydney, NSW area. Proudly Australian site serving the global market. For personal use only • Transformational technology being applied to the new facility: • High tech Opening and laminar dispensing system
Slide 29: Cyclotek Site, Macquarie University Hospital
Cyclotek Site, MacQuarie University Hospital • Partnership with Australian based Molecular Imaging company, Cyclotek, a proven supplier of Positron For personal use only Emission Tomography (PET) radiopharmaceuticals. • Cylcotek will be a key supplier of our medical device to our global markets. • S
Slide 30: Innovation
Innovation Expanded Technology Development Team to provide: • Clinical and site design support For personal use only • Package engineering • Process and Product Development • Commercial logistics and supply-chain New innovative designs & solutions : • Target quartz ampoule • Isolator technologies •
Slide 31: Nigel Lange, CEO & Managing Director
For personal use only Nigel Lange CEO & Managing Director E: nigel.lange@oncosil.com OncoSil Medical Ltd www.oncosil.com
OncoSil Medical — Shareholder Meeting (November 2023) on 6ix