Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Investor Presentation (July 2013)
26 slides from Oncosil Medical's investor presentation, Jul 18, 2013
Slide 1: Dr. Neil Frazer, Chief Executive Officer & Managing Director
For personal use only DR.NEIL FRAZER CHIEF EXECUTIVE OFFICER & MANAGING DIRECTOR @Dr_Neil_Frazer 1
Slide 2: Important Notice
IMPORTANT NOTICE For personal use only The purpose of the presentation is to provide an update of the business of OncoSil Medical Ltd (ASX:OSL). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification. According
Slide 3: How OncoSil Works
For personal use only HOW ONCOSIL™ WORKS 3
Slide 4: Board and Management
BOARD AND MANAGEMENT For personal use only Board Chairman: Mr. Martin Rogers Executive Director: Mr. David McAuliffe Non-Executive Director: Dr. Roger Aston Managing Director and CEO: Dr. Neil Frazer General Counsel & Company Secretary: Ms. Jillian McGregor Management: Dr. Neil Frazer Head of EU Ope
Slide 5: OncoSil Medical: Australian Biotech Company
ONCOSIL MEDICAL : Australian Biotech Company For personal use only ASX OSL Market Cap (18th July, 13) $A21m Shares on issue 242m Cash June 30th, 2013 $A3.4m No. of Shareholders ~550 Major holders: TISIA NOMINEES PTY LTD 6.47% JK NOMINEES PTY LTD 6.47% DENLIN NOMINEES PTY LTD 6.25% WEBINVEST PTY LTD
Slide 6: OncoSil Medical Offers Potential Treatment for Pancreatic Cancer, a Major Unmet Need
ONCOSIL MEDICAL OFFERS POTENTIAL TREATMENT FOR PANCREATIC CANCER, A MAJOR UNMET NEED For personal use only • OncoSil Medical has a medical device in development that is ready for a registration study • Registration will be sought in all major markets as a medical device • Medical devices have a frac
Slide 7: Pancreatic Cancer: Major Unmet Clinical Need
PANCREATIC CANCER For personal use only MAJOR UNMET CLINICAL NEED 280,000+ pancreatic cancer incidence yearly world wide (1) Median survival 4-6 months and 5 year survival less than 5% Severe abdominal and back pain is a significant complication in patients who develop pancreatic cancer Approximatel
Slide 8: Pancreatic Cancer
PANCREATIC CANCER For personal use only Gemicitabine (Roche) is the standard treatment with median survival < 6 months Side effects include: Fever, Fatigue, Vomiting, Hair Loss, Mouth Sores and Diarrhea Erlotinib (Roche) is currently the last line therapy “Whipple” surgery is applicable in only 10-2
Slide 9: Market for OncoSil
MARKET FOR ONCOSIL™ For personal use only Pancreatic cancer overall Global incidence 280,000 per annum US, Japan, Australia Developing world and Europe 88,000 p.a.(est) 192,000 p.a. Surgery, refuse the Suitable for Oncosil™ treatment, or decline for other reason 28,800 - 47,000 * p.a 163,200 p.a. •
Slide 10: Treatment Choices for Most Human Cancers
TREATMENT CHOICES FOR MOST HUMAN CANCERS For personal use only Surgery: Cut out the tumour Chemotherapy: Poison tumour growth Radiation therapy: Irradiate the body (external beam radiation shown) Disrupt growth pathways in the immune Immune therapy: system 10
Slide 11: For Pancreatic Cancer These Are Less Effective
FOR PANCREATIC CANCER THESE ARE LESS EFFECTIVE For personal use only Surgery: (20% of tumours) Chemotherapy: (no K-ras mutation) EB Radiation therapy: Immune therapy: (experimental only) Fractionated External Beam Radiation therapy (EB) may be used in combination with chemotherapy but evidence of ef
Slide 12: OncoSil Micro Particles
ONCOSIL™ Micro Particles For personal use only OncoSil™ particles compared with a human hair and red blood cells ONCOSIL ™ 30 MICRON PARTICLES STERILE FILL FINISH (GERMANY) Red Cells HUMAN HAIR (SAME SCALE) REACTOR (NETHERLANDS) OncoSil ™ 0 100 200 u I________I________I 12
Slide 13: OncoSil Manufacture
ONCOSIL™ MANUFACTURE For personal use only • Mix Silicon and Phosphorus at 1480oC Starting • Atomise with water to create Si‐P micro particles material • Grade particles to 30 microns • Etch with acid to create porosity Create 32P Micro particles • Place in a high neutron reactor • Package and ship
Slide 14: OncoSil Injection
ONCOSIL ™ INJECTION For personal use only PHARMACY RECONSTITUTES ONCOSIL ™ ENDOSCOPIC ULTRASOUND GUIDED TUMOUR INJECTION 14
Slide 15: OncoSil Administration
ONCOSIL™ ADMINISTRATION For personal use only Endoscopic ultrasound positions the injection of OncoSil™ in the pancreatic tumour 15
Slide 16: OncoSil
ONCOSIL ™ For personal use only Technology has approximately US$25 million already invested Technology is ready for a registration trial in pancreatic cancer A management team highly experienced in oncology and commercialisation Two key patent families covering manufacture and composition of matter
Slide 17: OncoSil Convenience and Cost Effectiveness
ONCOSIL™ For personal use only CONVENIENCE The treatment is an outpatient visit or overnight stay Hospital radio-pharmacies prepare the device prior to use 30 minute endoscopic procedure by skilled gastrointestinal endoscopists, radiologists, radiation oncologists or surgeons Only 1 or 2 treatments
Slide 18: OncoSil
ONCOSIL™ For personal use only OncoSil™ uses a micro particle radioactive technology OncoSil™ is targeting pancreatic cancer OncoSil™ has P-32 as a source of beta particle radiation with much longer duration of radiation, killing more dividing cells and potentially cancer stem cells as well OncoSil™
Slide 19: Medical Device Development Requires Four Key Ingredients
MEDICAL DEVICE DEVELOPMENT REQUIRES FOUR KEY INGREDIENTS For personal use only Key steps in getting a drug or device to commercialization Level 1 Regulatory Reimbursement by Clinical effectiveness Approval Payers Development (demonstrates (permits (Physicians accept (product discovery) efficacy) com
Slide 20: Pilot Trial Undertaken in Pancreatic Cancer
PILOT TRIAL UNDERTAKEN IN PANCREATIC CANCER (1) For personal use only STUDY DESIGN: A fixed dose study in 17 patients with pancreatic cancer A single intra-tumoural implantation of OncoSil™ (100 Gy) Gemcitabine commenced within 2 weeks prior to implantation, or within three days following implantati
Slide 21: Pilot Study (2)
PILOT STUDY (2) For personal use only RESULTS: Analysis of patients demonstrated significant tumouricidal activity with a disease control rate of 82% Over the 24 week period of the trial, patients experienced an average reduction in pain of 35%, with a maximum reduction of 69% between weeks 8 and 11
Slide 22: 2nd Pilot Study
2nd PILOT STUDY For personal use only STUDY DESIGN: A dose escalating study in 6 patients with pancreatic cancer Ascending doses; a single intra-tumoural implantation of Oncosil™ (up to 400 Gy) Gemcitabine commenced within two weeks prior to implantation, or within three days following implantation.
Slide 23: Planned Registration Study: Pancreatic Cancer
PLANNED REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY DESIGN Randomised open label clinical trial (Gold Standard) Combination with standard of care (gemcitabine) versus gemcitabine alone Gemcitabine commenced within two weeks prior to implantation, or within three days following
Slide 24: Regulatory Strategy: Plan for Global Device Registration
REGULATORY STRATEGY For personal use only PLAN FOR GLOBAL DEVICE REGISTRATION Q3 2013 Q4 2013 Q1 2014 Q2 2014 Q3 2014 CE MARKING WITH EMA GLOBAL REGISTRATION STUDY PRE-IDE MEETING WITH FDA TGA ARTG and PBS OncoSil’s global registration strategy is with CE (Conformité Européenne) mark with the EMA (E
Slide 25: Patents, Trademarks and Know How
PATENTS, TRADEMARKS AND KNOW HOW For personal use only Multi-layered protection from multiple granted patents in US, EU, Japan and elsewhere on therapeutic product and on manufacturing method Trademark protection granted for OncoSil™ in Australia, New Zealand, UK, EU, USA, Japan and Singapore Know-H
Slide 26: Value Inflection Points Next 6-12 Months
VALUE INFLECTION POINTS NEXT 6-12 MONTHS For personal use only OncoSil Medical establishing a global strategic manufacturing alliance US FDA gap analysis for IDE process Pre-IDE meeting with FDA European strategy of EMA and CE marking requirements Registration Study design with key opinion leaders a