Racura Oncology Ltd · ASX:RAC
Racura Oncology — Investor Presentation (January 2017)
18 slides from Racura Oncology's investor presentation, Jan 11, 2017
Slide 1: Race Oncology Update: Investor Presentation, JP Morgan Conference, Pre-IND Meeting with FDA
ASX RELEASE Race Oncology Update: Investor Presentation, JP Morgan Conference, Pre-IND Meeting with FDA 11 January 2016, San Francisco CA: Race Oncology Ltd (ASX: RAC) announced today that it had released an updated investor presentation that was shared with investors at a function this week in San
Slide 2: Specialty Pharma – Fast to Market Drugs
Specialty Pharma – Fast to Market Drugs 1
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 the date of this presentation. The information in this presentation is provided in summary form and does not contain all information necessary to make an investmen
Slide 4: Overview
Overview • Race Oncology (RAC) listed on the ASX in July 2016 • Our first drug is a cancer chemotherapy drug called “Bisantrene” • We expect to see first sales of Bisantrene by end 2017 under a European Named Patient Program (NPP) • Low valuation (~A$11m) with significant upside from anticipated mil
Slide 5: Bisantrene
Bisantrene • Chemotherapy with reduced cardiotoxicity • Developed by Lederle in the 1980s, because of its reduced cardiac toxicity compared with the anthracyclines • Tested in >40 phase II clinical studies by Lederle and NCI (National Cancer Institute) Bisantrene Phase 2 and 3 Clinical Studies 1982-
Slide 6: Bisantrene – lost and rediscovered
Bisantrene – lost and rediscovered • Impressive activity in relapsed/refractory AML • Average 48% CR in r/r AML in studies (1987-94) • In 1990, approved in France for treating AML • Then the drug disappeared after a string of big pharma mergers during the 1990s: • Am. Cyanamid/Lederle AHP/Wyeth
Slide 7: Acute Myeloid Leukaemia (AML)
Acute Myeloid Leukaemia (AML) • AML is a blood cancer (leukaemia) • Caused by proliferation of immature immune cells from bone marrow (‘blasts’) • Orphan disease • Around 20,000 new patients a year in the US • Disease mainly of the elderly • Incidence growing as pop. ages • AML progresses rapidly an
Slide 8: Treatment of AML
Treatment of AML • Standard of Care (SOC) • For younger/fitter patients: ‘7+3’ chemotherapy → cytarabine x 7 days, daunorubicin (or epirubicin) x 3 days • 1st line SOC has not changed in 30 years • No effective 2nd line when SOC fails • Unmet medical need • Most respond to SOC and then relapse • Rel
Slide 9: Bisantrene clinical studies in r/r AML
Bisantrene clinical studies in r/r AML Number of AML Complete Study Phase Patients Response Rate Study 1, 1987 II 40 50% Study 2, 1989 II 10 40% Study 3, 1989 II 15 47% Study 4, 1993 II 7 72% Study 5, 1994 II 13 38% Total/Average 85 48% 8
Slide 10: Short term strategy: AML/NPP
Short term strategy: AML/NPP • During 2017, Race will apply to sell Bisantrene in France and some other EU countries where drugs can be sold under a Named Patient Program (NPP) • We will also seek licensees for countries outside Europe, where profitable NPP sales can be made • The product will be ai
Slide 11: Long term market opportunity
Long term market opportunity • The longer term opportunity is FDA approval of Bisantrene for general marketing • Pathway to FDA approval • pre-IND meeting with FDA (Feb 2017) • IND filed • Complete clinical studies to meet FDA requirements • File for marketing approval in US • File for marketing app
Slide 12: Two value creation pathways
Two value creation pathways Yr 1 Yr 2 Yr 3 Yr 4 Yr 5 Yr 6 Principal medium term value chain NPP program: Launch in Europe for r/rAML and unfit elderly under NPP Manufacturing Licensing in other markets Secondary longer term value chain FDA US Phase II bridging IND US Phase III study in AML (2-3 yrs)
Slide 13: Year Targets: Initiate NPP Sales
Year 1 Targets: Initiate NPP Sales • Completed or in-process • GMP manufacturing of Bisantrene API underway (Sai Life Sciences, India) • GMP drug product manufacturer appointed (IriSys, US) • Clinical protocol for US bridging study being developed (Camargo, US) • Pre-IND meeting with FDA set • NPP m
Slide 14: Years 2-5
Years 2-5 • Expand NPP sales • Grow EU NPP sales • Continue licensing Bisantrene to marketing partners for all countries outside EU NPP markets • FDA program • Conduct registration studies in US • Gain FDA and EMA approval • Launch under general marketing approval in all countries • Expand clinical
Slide 15: Key management & board
Key management & board • CEO: Peter Molloy • CSO: John Rothman PhD • CEO, Biota (antiviral drugs) • Co-inventor on Bisantrene patents • CEO, SLIL Biomedical (oncology) • Director/Senior Director at Roche; • VP Strategic Marketing, Pharmacia Exec VP for Science & Operations, Advaxis • Managing Direct
Slide 16: US Scientific Advisory Board
US Scientific Advisory Board • US Key Opinion • SAB members are Leaders: advising Race on: • Martin Tallman MD • Clinical positioning of • Memorial Sloan Kettering Bisantrene Cancer Center • Clinical trial protocols for • Roland Walter MD ongoing development • Fred Hutchinson Cancer Research Center
Slide 17: Share Price
Share Price Jul 15, 2016 - Jan 06, 2017 @RAC Jul Aug Sep Oct Nov Dec @Volume 4.00 mil 3.00 2.00 ———————a MC ANINGSTAR 16 RACES ONCOLOBY
Slide 18: ASX code: RAC
ASX code: RAC Reg. Office: L2, 50 Kings Park Rd West Perth WA 6008 Contact: investors@raceoncology.com 17
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