Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Investor Presentation (August 2018)
17 slides from Racura Oncology's investor presentation, Aug 3, 2018
Slide 1: Investor Presentation August 2018
For personal use only INVESTOR PRESENTATION August 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 Race Oncology is based in Melbourne Australia Corporate Snapshot For personal use only • Listed on ASX July 2016 (RAC) at A$0.20 Shares on Issue (RAC) Lead Drug Asset: Bisantrene Ordinary 77m • Chemotherapy drug aimed at treating Acute Myeloid Leukemia (AML); valuable drug lost in
Slide 4: The target disease: AML (Acute Myeloid Leukemia)
The target disease: 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 marr
Slide 5: r/r AML: Unmet Medical Need
r/r AML: Unmet Medical Need For personal use only Treatment has not changed Newly diagnosed AML significantly in 30 years • 1st line treatment is ‘7+3’ chemotherapy: 7 days with cytarabine + 3 days with an unfit patients fit patients anthracycline HMAs* 7+3 Intensive • There is no approved 2nd line
Slide 6: Bisantrene
Bisantrene Discovered in the 1970s by Lederle Laboratories (US) For personal use only • Small molecule chemotherapy drug similar to the anthracyclines • Goal: anthracycline performance without the cardiac toxicity Mode of action • Cytotoxic (kills rapidly dividing cancer cells) • Immune-stimulatory
Slide 7: Bisantrene in r/r AML
Bisantrene in r/r AML Average 48% remission rates in five AML Number Complete For personal use only 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 8: Bisantrene – a lost drug asset
Bisantrene – a lost drug asset Big pharma mergers in the 1990s For personal use only • 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 9: Bisantrene's rebirth by Race
Bisantrene’s rebirth by Race Commercial protection obtained For personal use only • Race obtained orphan drug designation (ODD) for Bisantrene in US, conferring 7 years exclusivity after FDA approval • Race also filed two new patents that have now been granted in the US, extending Bisantrene’s exclu
Slide 10: US FDA approval pathway for Bisantrene
US FDA approval pathway for Bisantrene For personal use only Pre-IND meetings with FDA • Target indication is r/r AML in adults • Bisantrene qualifies for FDA review under 505(b)(2) expedited approval pathway – allows Race to use the historical phase II data on Bisantrene • Bisantrene can be conside
Slide 11: Plans to generate revenues under Named Patient Programs outside US
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 Early access schemes allow companies to supply an unlicensed (unapproved) drug if: • Patients have a life-threatening disease with no approved treatment available (r/r AML) • Patients are nominated by a doctor (‘named patient’) • Supply must be unsol
Slide 13: Latest news: Rare Pediatric Disease designation
For personal use only Latest news: Bisantrene granted Rare Pediatric Disease designation: A new value creation pathway
Slide 14: Rare Paediatric Disease (RPD) Designation
Rare Paediatric Disease (RPD) Designation For personal use only 16 July 2018: FDA grants RPD designation for Bisantrene Means Bisantrene can receive a Priority Review Voucher (PRV) at the time of marketing approval for childhood AML • PRV system incentivises companies to pursue rare diseases, such a
Slide 15: Race Oncology Management Team
Race Oncology Management Team Peter Molloy BSc MBA For personal use only 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 Bil
Slide 16: Race Oncology Management Team
Race Oncology Management Team For personal use only Samar Al-Behaisi MD, PhD Chief Medical Officer, Vice President Medical Affairs • Oncologist, medical affairs expert • 20 years industry experience: Takeda, GSK and Novartis • Experience in oncology named patient programs in Europe John Rothman PhD
Slide 17: Summary
Summary Race’s goal is to create value for our investors in three ways: For personal use only 1. Move Bisantrene towards FDA approval for adult AML, making it a valuable asset for potential acquirers 2. Generate revenues through Named Patient Programs outside the US to support Race’s operations 3. S