Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Broker Meets Biotech Conference 2018
16 slides from Racura Oncology's conference presentation, Sep 13, 2018
Slide 1: ASX Announcement: Race Investor Presentation at Broker Meets Biotech Conference
13 September 2018 For personal use only ASX Announcement / Media Release Race Investor Presentation at Broker Meets Biotech Conference 13 September 2018: Race Oncology Limited (“RAC”) announced today that the Company is presenting at the ‘Broker Meets Biotech’ investor conference in Adelaide today.
Slide 2: Investor Presentation September 2018
For personal use only INVESTOR PRESENTATION September 2018
Slide 3: 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 4: Bisantrene
Bisantrene Mode of action For personal use only • DNA intercalator – kills proliferating cancer cells, like acute myeloid leukemia (AML) • Has immune-stimulatory effects – activates macrophages to attack cancer cells • Binds to DNA displacing telomerase binding proteins, leading to programmed cell d
Slide 5: Bisantrene and Race Oncology
Bisantrene and Race Oncology Race owns: For personal use only • Two issued patents on Bisantrene in the US (exp. 2034) • Orphan Drug Designation in US (7 years’ exclusivity) • Rare paediatric disease designation in US – potential for Priority Review Voucher Race has successfully manufactured Bisantr
Slide 6: The target disease: AML
The target disease: AML 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 blood • Shortage o
Slide 7: Relapsed/refractory (r/r) AML: Unmet Medical Need
Relapsed/refractory (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
Slide 8: Bisantrene Phase activity in r/r AML
Bisantrene Phase 2 activity in r/r AML For personal use only Number Complete of AML* Response Study Phase Patients Rate Study 1, 1987 II 40 50% Study 2, 1989 II 10 40% Study 3, 1989 II 15 47% Bisantrene 250mg in vials Study 4, 1993 II 7 72% Bisantrene Study 5, 1994 II 13 38% lyophilised Total/Averag
Slide 9: 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 10: Bisantrene granted Rare Paediatric Disease designation: A new value creation pathway
For personal use only July 2018: Bisantrene granted Rare Paediatric Disease designation: A new value creation pathway
Slide 11: Rare Paediatric Disease Designation by FDA
Rare Paediatric Disease Designation by FDA For personal use only July 2016: FDA grants Bisantrene Rare Paediatric Disease designation: Means Bisantrene can receive a Priority Review Voucher (PRV) at the time of marketing approval for rare childhood AML About PRV • PRV system incentivises companies t
Slide 12: Named Patient Program Outside US
For personal use only Named Patient Program Outside US
Slide 13: Named Patient Program (NPP)
Named Patient Program (NPP) For personal use only Early access schemes allow supply of 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 unsolicited (no
Slide 14: 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 15: 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 16: 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. Secure a saleable Priority Review Voucher through a targeted paediatric development program 3. Ge