Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Investor Presentation (December 2013)
19 slides from Oncosil Medical's investor presentation, Dec 5, 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: US FDA Registration Study Design for OncoSil
INSTITUTIONAL INVESTOR PRESENTATION For personal use only US FDA REGISTRATION STUDY DESIGN FOR ONCOSIL: Business plan and strategy incorporates US as largest healthcare market Categorised by US FDA as a class III Medical Device has different regulatory hurdles to drugs Planned study design has been
Slide 3: How OncoSil Works
For personal use only HOW ONCOSIL™ WORKS 3
Slide 4: OncoSil Administration
ONCOSIL™ ADMINISTRATION For personal use only Endoscopic ultrasound positions the injection of OncoSil™ in the pancreatic tumour 4
Slide 5: Board and Management
BOARD AND MANAGEMENT For personal use only Board Chairman: Mr. Martin Rogers Non-Executive Director: Dr. Roger Aston Managing Director and CEO: Dr. Neil Frazer Financial Controller & Company Secretary: Mr. Nicholas Falzon Operations management: Head of EU Operations: Dr. Drew Ferguson Chief Scientif
Slide 6: OncoSil Medical: Australian Biotech Company
ONCOSIL MEDICAL : Australian Biotech Company For personal use only ASX OSL Market Cap (Dec 4th ’13) $A38m Shares on issue 346m Cash (approx. after cap. raise) $A13.7m* No. of Shareholders ~600 Substantial holders: Dr Neil Frazer 7.8% Otto Buttula 6.3% New management in place since June 2013. Managem
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 around 8.5 months in locally advanced and metastatic patients treated with gemcitabine and nab- paclitaxel and 5 year survival less than 5% Severe abdominal an
Slide 8: For Pancreatic Cancer Treatments Are Inadequate
FOR PANCREATIC CANCER TREATMENTS ARE INADEQUATE For personal use only Surgery: (20% of tumours) Chemotherapy: (no Kras mutation, 15% of tumours) EB Radiation therapy: Immune therapy: (experimental only) ? Fractionated External Beam Radiation therapy (EB) may be used in combination with chemotherapy
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: 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 10
Slide 11: 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 12: 1st Pilot Study Results
1St PILOT STUDY 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 13: 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 14: US FDA Registration Study: Pancreatic Cancer
US FDA REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY DESIGN: • Randomised Clinical Trial open label (gold standard for medical devices) • Single dose 400Gy radiation • Intratumoural administration using a gastroscope and EUS guided placement • Concomitant gemcitabine or; • Combin
Slide 15: US FDA Registration Study: Interim Analysis
US FDA REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY DESIGN – INTERIM ANALYSIS: • Ultimate in flexibility with a RCT for adjusting patient numbers • Interim analysis once 30-50 patients recruited and at six-twelve months post study commencement • >15% or greater improvement in Pr
Slide 16: US FDA Registration Study: Study Design
US FDA REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY DESIGN: • Concomitant administration of • Gemcitabine 1000mg/m2 standard weekly regimen i.v. alone, or with • Paclitaxel (as Abraxane™) 125mg/m2 weekly per standard regimen • Concomitant medications as standard of care • 20 cen
Slide 17: US FDA Registration Study: Inclusion Criteria
US FDA REGISTRATION STUDY: PANCREATIC CANCER For personal use only STUDY DESIGN - INCLUSION CRITERIA: • Histologically or cytologically proven locally advanced or metastatic adenocarcinoma of the pancreas • Locally advanced pancreatic cancer, not amenable to surgical resection • Measurable disease b
Slide 18: Regulatory Strategy: Plan for Global Device Registration
REGULATORY STRATEGY For personal use only PLAN FOR GLOBAL DEVICE REGISTRATION Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015 Q2 2015 Q3 2015 Q4 2015 GLOBAL REGISTRATION STUDY IDE SUBMISSION WITH FDA CE and TGA submissions OncoSil’s global registration strategy is with CE (Conformité Européenne) mark with t
Slide 19: Value Inflection Points Next 6-12 Months
VALUE INFLECTION POINTS NEXT 6-12 MONTHS For personal use only US FDA gap analysis for IDE process(waiting on major US hospital) European strategy for EMA and CE marking requirements Registration Study design with key opinion leaders and bio-statisticians Commence global Registration Study Australia
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