Oncosil Medical Ltd · ASX:OSL
Oncosil Medical — Shareholder Meeting (October 2019)
39 slides from Oncosil Medical's shareholder meeting presentation, Oct 29, 2019
Slide 1: OncoSil AGM CEO Presentation
ASX Announcement 29 October 2019 OncoSil AGM CEO Presentation Sydney, Australia – 29 October 2019: OncoSil Medical Ltd (ASX: OSL) (OncoSil or the Company), a medical device company focused on localised treatments for patients with pancreatic and liver cancer, has released its CEO presentation for th
Slide 2: Forward Looking Statements
exceeds $1b. Hepatocellular carcinoma (HCC) or liver cancer, is the 6th most common cancer in the world with 782,000 new cases diagnosed in 2012. While hepatocellular carcinoma can be treated by surgery or transplantation, the majority of patients with HCC have disease which is too advanced for surg
Slide 3: Advancing Pancreatic cancer treatment – changing the prognosis
ASX.OSL Advancing Pancreatic cancer treatment – changing the prognosis CEO AGM Presentation 29 October 2019
Slide 4: Investment Highlights
Investment Highlights 1 Clear Commercialising a breakthrough implantable radiotherapy mission treatment for solid tumours 2 Current and previous clinical studies demonstrate: ▪ Excellent Local Disease Control Sound ▪ Prolonged Overall Survival science ▪ Encouraging resection rates ▪ Superior outcome
Slide 5: Significant opportunity for OncoSil in pancreatic cancer
Significant opportunity for OncoSil in pancreatic cancer Current available treatment for pancreatic cancer The Oncosil Opportunity ▪ Surgery (resection), if diagnosed early enough ▪ Chemotherapy (Gemcitabine & Abraxane, FOLFIRINOX) Only two drugs to have made significant improvements in pancreatic c
Slide 6: Disease Prognosis & Treatment Options
Disease Prognosis & Treatment Options Patients eligible for Overall Survival: curative surgery. 15% Resectable (Surgical Resection with • 50% at 3 years (Gemenetzis)1 • median 35.3 months (Gemenetzis)1 Curative Intent) Unresectable and eligible Locally for palliative therapies. Median Overall Surviv
Slide 7: Disease Prognosis & Treatment Options
Disease Prognosis & Treatment Options 15% European Society of Medical Oncology (ESMO) Clinical Practice Guidelines – LAPC • Standard of care is 6 months of gemcitabine [I, A] • A minor role of chemoradiation in this subgroup of patients has been observed [I, A] • It is impossible to recommend any ch
Slide 8: 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 9: Classification of Cholangiocarcinoma (bile duct cancer)
Classification of Cholangiocarcinoma (bile duct cancer) CCA can be classified as intrahepatic (ICC), perihilar (pCCA) or distal (dCCA). pCCA and dCCA can be grouped as extrahepatic cholangiocarcinoma (ECC) Morphological classification1,2 Intrahepatic Morphology Description (5-10%)3-9 Mass-forming •
Slide 10: OncoSil™ In Cholangiocarcinoma
FDA Meeting – 11th April 2018 OncoSil™ In Cholangiocarcinoma Intrahepatic and Distal CCA Patients with Intrahepatic and Distal CCA would be eligible for OncoSil™. These variants of CCA can be accessed, either percutaneously under CT guidance and/or via endoscopic ultrasonography. The OncoSil™ device
Slide 11: The OncoSil™ Device
1 The OncoSil™ Device
Slide 12: Device Overview
Device Overview Radioactive Microparticles that contain a pure beta emitting isotope (32P). Microparticles are suspended in Diluent to allow direct injection into the tumour. Microparticles are implanted directly into a tumour via EUS, and are designed to deliver an absorbed dose of 100Gy. Single us
Slide 13: Device Procedure
Device Procedure Oncosil™ Microparticles are suspended ina rheological Diluent Endoscope guided (ultrasound) into the upper intestine OncoSil™ injected directly into the tumor. Implanted Microparticle localization shown on Bremsstrahlung imaging Using ultrasound imaging the needle is guided into the
Slide 14: Manufacturing & Supply Chain
Manufacturing & Supply Chain 12 Manufacturing capacity Manufacturing Management Supply chain in Logistics of capacity to meet Dangerous Goods Expertise to meet needs place and validated needs Logistics for all radioactive goods shipments have Ultra Pure Base Material DG handling & been verified. In-
Slide 15: PanCO Study
ASX.OSL PanCO Study Results & Naïve Indirect Treatment Analysis
Slide 16: PanCO Study Design and Objective
PanCO Study Design and Objective Screening OncoSil™ Implantation (1 – 14 days) Enrol to: Oncosil™ + FOLFIRINOX Continuation of Overall or PD FOLFIRINOX gemcitabine + nab-paclitaxel chemotherapy survival or gemcitabine + Week 1 Week 2 Week 3 Week 4 Week 5 onwards nab-paclitaxel • 8 weekly CT – RECIST
Slide 17: PanCO Patient Population And Study Criteria
PanCO Patient Population And Study Criteria • Histologically or cytologically proven adenocarcinoma of the pancreas • Unresectable locally advanced pancreatic carcinoma • Target tumour diameter 2−6 cm Key eligibility criteria • ECOG Performance Status 0 to 1 • No distant metastases • No prior radiot
Slide 18: PanCO Study: Results and Comparator Analysis
PanCO Study: Results and Comparator Analysis LDCR16 weeks – Local Disease Control Rates at 16 weeks (LDCR16 weeks) of 82% in the Intention-to-Treat (ITT) (p=0.0001) cohort of met primary enrolled patients and 90.5% in the Per Protocol (PP) (p<0.0001) population that received OncoSil™ plus CT, demons
Slide 19: PanCO Study: Results and Comparator Analysis (2/2)
PanCO Study: Results and Comparator Analysis (2/2) Low chemo – These encouraging results were achieved despite relatively low chemotherapy intensity due to poor tolerability to the intensity chemotherapy agents, and consequently dose delays ≥one week, dose reductions and/or termination of CT were se
Slide 20: Median Overall Survival Results: PanCO vs. Naïve Indirect Treatment Comparison
Median Overall Survival Results: PanCO vs. Naïve Indirect Treatment Comparison Median overall survival OS remains the gold-standard outcome for benchmarking the clinical benefit in patients with pancreatic cancer, as it does for many other cancers 18
Slide 21: PanCO Overall Survival (OS)
PanCO Overall Survival (OS) at a Median Follow-Up of 16.1 Months PanCO ITT cohort PanCO PP cohort • Median OS: 15.5 months (95% CI: 11.3, nc) • Median OS: 16.0 months (95% CI: 11.1, nc) • 1-year survival: 63.4% (95% CI: 47.8%, 75.4%) • 1-year survival: 64.0% (95% CI: 47.5%, 76.5%) Abbreviations: C.I
Slide 22: Systematic Literature Review: Overall Survival Analyses
Systematic Literature Review: Overall Survival Analyses (All Identified Treatment Arms) Abbreviations: 5FU, Fluorouracil; ADM, Adriamycin (doxorubicin); Abr, abraxane (nab-paclitaxel); Cap, capecitabine; CCRT, induction chemotherapy with consolidation chemoradiotherapy; cet, cetuximab; C.I., confide
Slide 23: Overall Survival Summary of the Evidence on Clinical Benefit Meta-Analysis of Medians
Overall Survival Summary of the Evidence on Clinical Benefit Meta- Analysis of Medians: PanCO Against ‘State-of-the-Art’ Therapies Median OS (months; 95% C.I.) PanCO (ITT) 15.5 (11.3, NC) PanCO (PP) 16.0 (11.1, NC) All Treatments 12.7 (12.2, 13.6) CT Only 12.7 (11.9, 13.6) CCRT Only 12.6 (12.2, 14.0
Slide 24: Overall Survival: Statistical Comparison of Median OS
Overall Survival: Statistical Comparison of Median OS, from PanCO Against ‘State-of-the-Art’ Therapies Parameter of PanCO N p- CT Type ITT/PP n>PanCO Interest Median Trials value CT + ICT + ITT 15.5 54 10 <0.001 CCRT CT + ICT + PP 16.0 54 6 <0.001 CCRT OS CT only ITT 15.5 34 7 <0.001 CT only PP 16.0
Slide 25: Secondary Outcome Results: PanCO vs. Naïve Indirect Treatment Comparison
Secondary Outcome Results: PanCO vs. Naïve Indirect Treatment Comparison Median PFS, LPFS (PanCO only), one-year survival, LDCR (PanCO only), DCR, ORR and resection rate 23
Slide 26: PanCO Progression-Free Survival (PFS)
PanCO Progression-Free Survival (PFS) at a Median Follow-Up of 16.1 Months PanCO ITT cohort PanCO PP cohort • Median PFS: 9.3 months (95% CI: 5.9, 12.2) • Median PFS: 9.3 months (95% CI: 7.2, 12.2) • 1-year survival: 32.8% (95% CI: 21.3%, 50.6%) • 1-year survival: 32.3% (95% CI: 20.4%, 51.3%) Abbrev
Slide 27: Systematic Literature Review: Progression-Free Survival Analyses
Systematic Literature Review: Progression-Free Survival Analyses (All Identified Treatment Arms) Abbreviations: 5FU, Fluorouracil; ADM, Adriamycin (doxorubicin); Abr, abraxane (nab-paclitaxel); Cap, capecitabine; CCRT, induction chemotherapy with consolidation chemoradiotherapy; cet, cetuximab; C.I.
Slide 28: Systematic Literature Review: Progression-Free Survival Analyses (CT Treatment Arms Only)
Systematic Literature Review: Progression-Free Survival Analyses (CT Treatment Arms Only) Abbreviations: 5FU, Fluorouracil; ADM, Adriamycin (doxorubicin); Abr, abraxane (nab-paclitaxel); Cap, capecitabine; CCRT, induction chemotherapy with consolidation chemoradiotherapy; cet, cetuximab; C.I., confi
Slide 29: PanCO Local Disease Control Rate at 16 weeks
PanCO Local Disease Control Rate at 16 weeks (LCDR16 weeks) PanCO Local Disease Control Rate at 16 weeks Maintenance of local tumour control: (LCDR16 weeks) per RECIST 1.1 Week 24 LCDR 30/42 implanted study participants had SD, PR or ITT PP had undergone surgical resection with curative (N=50) (N=42
Slide 30: PanCO Local Progression Free Survival and Overall Survival Correlation
PanCO Local Progression Free Survival and Overall Survival Correlation – Line of Best Fit 95% CI Scatter Plot Scatterplot ofofOv Overall Survival erall Surv iv al Vs Local PFS v ersus Local PFS Line of Line of Best best Fit f it 95% with CI95% CI 21 R2= 0.77 18 15 Overall Survival (month) 12 9 Both
Slide 31: PanCO Best Response Per RECIST 1.1
PanCO Best Response Per RECIST 1.1 Overall Response Rate (ORR) • 13 implanted study participants (31.0%; 95% CI: 17.6%, 47.1%) achieved a Best Response of Partial Response (PR) based on RECIST 1.1 assessment. ⁻ Defined as a ≥30% decrease in the longest diameter of the local target tumour (compared t
Slide 32: Systematic Literature Review: Disease Control Rate Analyses
Systematic Literature Review: Disease Control Rate Analyses Subgroups Based On Treatment Abbreviations: 5FU, Fluorouracil; ADM, Adriamycin (doxorubicin); Abr, abraxane (nab-paclitaxel); Cap, capecitabine; CRT, consolidation chemoradiotherapy; C.I., confidence interval; cis, cisplatin; CT, chemothera
Slide 33: Systematic Literature Review: Resection Rate Analyses
Systematic Literature Review: Resection Rate Analyses Subgroups Based On Treatment Abbreviations: 5FU, Fluorouracil; Abr, abraxane (nab-paclitaxel); Cap, capecitabine; CRT, consolidation chemoradiotherapy; C.I., confidence interval; CT, chemotherapy; Dip, docetaxel/ifosfamide/cisplatin; FOLFIRINOX,
Slide 34: PanCO Surgical Resection with Curative Intent
PanCO Surgical Resection with Curative Intent 10 implanted study participants were restaged and subsequently had surgical resection with curative intent (PP: 23.8%; 95% CI: 12.1%, 39.5%; ITT: 20.0%; 95% CI: 10.0%, 33.7%). 8 of these had R0 (microscopically negative) surgical margins. Mode of action
Slide 35: Prognostic Significance of Resected LAPC
Prognostic Significance of Resected LAPC Retrospective analysis of 415 patients with unresectable LAPC presenting to Johns Hopkins Hospital pancreatic multidisciplinary clinic between Jan 2013 and Sept 2017. 116 (28.0% of the LAPC cohort) deemed eligible for surgical exploration either due to respon
Slide 36: PanCO Tumour Volumetric Assessment
PanCO Tumour Volumetric Assessment Maximum percentage change in tumour volume from baseline (prior to surgical resection) for each patient by 25 11* outcome 7* 5* 0 % Change from baseline -6^ -9* -25 -17† -20‡ -31* -31^ -33^ -34* -35^ -37† -38* -40^ -41^ -50 -45‡ -46† -51‡ -52‡ -52‡ -52^ -56* -57* -
Slide 37: Summary of Key PanCO Efficacy Outcomes
Summary of Key PanCO Efficacy Outcomes Performance (efficacy) data for the 42 study participants implanted with the OncoSil™ device demonstrate clinically relevant benefits for patients with unresectable locally advanced pancreatic cancer (LAPC). ORR: Median OS: LDCR16 weeks Median PFS: Median LPFS:
Slide 38: Conclusion
1 Conclusion
Slide 39: OncoSil at a potential value inflection point
OncoSil at a potential value inflection point ReThe Company is well positioned to realise value of OncoSil™ device team ▪ CER submission following positive COC meeting CE Mark ▪ Target CE Mark certification ▪ Target EU first sales ▪ Secured US FDA IDE approval US Market Entry ▪ HUD Cholangiocarcinom