Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Investor Presentation (February 2018)
19 slides from Racura Oncology's investor presentation, Feb 9, 2018
Slide 1: Investor Presentation February 2018
For personal use only INVESTOR PRESENTATION February 2018
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by Race Oncology Ltd (“Race” or the “Company”) based on information available to it as at For personal use only the date of this presentation. The information in this presentation is provided in summary form and does not contain all information necessar
Slide 3: Corporate Overview
Corporate Overview For personal use only Race Oncology is based in Melbourne Australia Corporate Snapshot • Listed on ASX July 2016 (RAC) at A$0.20 Shares on Issue (RAC) Lead Drug Asset: Bisantrene Ordinary 65m • Chemotherapy that meets vital need in AML Performance Shares 10m • Was tested in >40 cl
Slide 4: Overview of AML (Acute Myeloid Leukemia)
Overview of AML (Acute Myeloid Leukemia) For personal use only Progenitor white blood cells (myeloblasts) AML is a blood cancer caused fail to differentiate into white blood cells by proliferation of myeloblasts and a shortage of white blood cells • They proliferate and build up in bone marrow and b
Slide 5: r/r AML: Unmet Medical Need
r/r AML: Unmet Medical Need For personal use only Treatment has not changed in 30 years Newly diagnosed AML • 1st line treatment is 7+3 chemotherapy: 7 days with cytarabine + 3 days with an anthracycline unfit patients fit patients There is no approved 2nd line treatment, HMAs* 7+3 Intensive 1st lin
Slide 6: Bisantrene
Bisantrene For personal use only Bisantrene Dihydrochloride 250mg lyophilised powder for reconstitution & infusion via central venous line
Slide 7: Bisantrene Overview
Bisantrene Overview For personal use only Small molecule drug related to anthracyclines Bisantrene is a small molecule drug for • Discovered in the 1970s by Lederle Laboratories (US) treating AML – Goal: anthracycline performance without cardiac toxicity Mode of action • In addition to its cytotoxic
Slide 8: Bisantrene in r/r AML
Bisantrene in r/r AML For personal use only Average 48% remission rates in five AML Number Complete studies (1987-1994) of AML Response* Study Phase Patients Rate • Patients were heavily pre-treated with up to 8 cycles of chemotherapy, i.e., Study 1, 1987 II 40 50% relapsed/refractory Study 2, 1989
Slide 9: Bisantrene – a lost drug asset
Bisantrene – a lost drug asset For personal use only Big pharma mergers in the 1990s • Around the time of the French AML approval, Lederle’s parent company (American Cyanamid) ran into financial problems • American Cyanamid sold Lederle to Wyeth, which had no oncology franchise • Wyeth was later sol
Slide 10: Bisantrene's rebirth by Race
Bisantrene’s rebirth by Race For personal use only Commercial protection obtained • Race owns two recent (2014) patent applications (Notice of Allowance on one already in US) and orphan drug designation (ODD) in US – confers 7 years in-market exclusivity GMP drug product manufactured • June 2017: GM
Slide 11: Named Patient Programs outside US revenue plan
For personal use only While completing steps for FDA marketing approval of Bisantrene, Race Oncology plans to generate revenues under Named Patient Programs outside US
Slide 12: Named Patient Program (NPP)
Named Patient Program (NPP) For personal use only In several countries, early access schemes allow companies to supply and earn revenues for an unapproved drug if: • Patients have no other treatment recourse (r/r AML) • Patients are nominated by a doctor (‘named patient’) • No promotion allowed NPP
Slide 13: AML physician response to Bisantrene
AML physician response to Bisantrene For personal use only Pre-NPP physician research in France (Jun/Jul ‘17) • Depth interviews with 14 leading French haem-oncologists with significant AML case-loads • All confirmed that despite new drugs available, r/r AML is important unmet need • Majority had sp
Slide 14: Race Oncology Management Team
Race Oncology Management Team For personal use only Peter Molloy Managing Director & CEO • ASX CEO who has delivered 10x market cap growth (Biota) • 17 years big pharma marketing: Managing Director, Pharmacia • Launched 23 products • 40 licensing deals • Built profitable pharma businesses Bill Garne
Slide 15: Race Oncology Management Team
Race Oncology Management Team For personal use only John Rothman PhD Chief Scientific Officer • Co-inventor on Bisantrene patents • Director/Sr Dir at Roche; Exec VP for Science & Operations, Advaxis • Multiple drug approvals at Roche; outstanding pharmaceutical scientist Gordon Beck Sr VP Business
Slide 16: The year ahead 2018
For personal use only The year ahead 2018
Slide 17: Anticipated milestones in 2018
Anticipated milestones in 2018 For personal use only Commercial • ATU approval in France, first NPP revenues • NPP commences in Italy, Turkey, Korea • Preparations for entry into other NPP countries Regulatory & Clinical • IND filed for registration trial, protocol finalised • CRO appointed to manag
Slide 18: Summary
Summary • Race’s mission is to rescue overlooked drugs, like Bisantrene, that can For personal use only meet medical needs and save patients’ lives • Our goal is to create value for our investors by moving Bisantrene towards approval, while generating early revenues under NPP • We have made great pr
Slide 19: Contact
For personal use only CONTACT Registered office: L2, 710 Collins St, Melbourne VIC 3008 (03) 9097 1656 plmolloy@raceoncology.com
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