Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Investor Presentation (March 2017)
20 slides from Racura Oncology's investor presentation, Mar 9, 2017
Slide 1: Specialty Pharmaceutical Business Focused on Fast-to-Market Opportunities
For personal use only Specialty Pharmaceutical Business Focused on Fast-to-Market Opportunities ASX: RAC Investor Presentation March 2017
Slide 2: Disclaimer
Disclaimer For personal use only 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 necessar
Slide 3: Race Oncology Overview
Race Oncology Overview For personal use only • Business Model - Specialty Pharma Corporate Snapshot – Rescuing, rediscovering or repurposing overlooked drugs that can deliver early Shares on Issue commercial milestones Ordinary 52.8m – ASX Listing July 2016 (ASX: RAC), raised $4.3m Performance Share
Slide 4: Race Business Model
Race Business Model For personal use only Pursuing Late Stage Drug Assets Drug Development Specialty Pharma Big Biotech Companies Race Oncology Pharma Patent Investigational New Drug Application New Drug (IND) Application s Filed Application (NDA) Marketing & Pre- Early Phase Regulatory post Clinica
Slide 5: Initial Drug Asset: Bisantrene
Initial Drug Asset: Bisantrene For personal use only • Near Term – European Named Patient Program (NPP) – A NPP provides patients with access to life-saving drugs that are not yet approved – In certain EU countries, the drug can be sold under the NPP to hospitals and patients Dual value – Race expec
Slide 6: Bisantrene Overview
Bisantrene Overview For personal use only • Related to the anthracyclines – Most frequently prescribed cancer drugs, 1st line treatment for many cancers – But anthracyclines cause cardiac toxicity, limiting their usefulness – Also, cancers can become resistant to anthracyclines • Bisantrene advantag
Slide 7: Bisantrene History
Bisantrene History For personal use only • Developed by US pharma company Lederle in the 1980s – Tested in >40 phase II clinical studies by Lederle and US NCI Rescued late stage (National Cancer Institute) drug asset – Est. US$100-200m spent on Bisantrene development (based on 2017 costs for the sam
Slide 8: AML (Acute Myeloid Leukemia)
AML (Acute Myeloid Leukemia) For personal use only • Progenitor white blood cells (myeloblasts) AML is a blood cancer caused by fail to differentiate into functional white proliferation of myeloblasts and a blood cells shortage of white blood cells – Myeloblasts proliferate and build up in bone marr
Slide 9: r/r AML: Unmet Medical Need
r/r AML: Unmet Medical Need For personal use only Newly diagnosed • 1st line treatment is Intensive Chemotherapy AML (IC) Elderly and – 7 days of treatment with cytarabine + unfit AML unfit patients fit patients 3 days with an anthracycline – Known as ‘7+3’ chemotherapy HMAs* or 7+3 Intensive 1st li
Slide 10: Bisantrene in r/r AML
Bisantrene in r/r AML For personal use only • Average 48% remission rates in five AML Number of Complete studies (1987-1994) Study Phase AML Response* Patients Rate – Patients were mostly heavily pretreated with up Study 1, to 8 cycles of chemotherapy and were relapsed 1987 II 40 50% or refractory S
Slide 11: US Approval Pathway: 505(b)(2)
US Approval Pathway: 505(b)(2) For personal use only • Pre-IND meeting with FDA 14 Feb 2017 – Bisantrene qualifies for 505(b)(2) expedited approval pathway – Significantly risk-mitigating for Race 505(b)(2) • 505(b)(2) accelerated – Expedited development pathway approval pathway – Can be used where
Slide 12: US Pivotal Clinical Trial
US Pivotal Clinical Trial For personal use only • FDA confirmed r/r AML is target indication in US • Protocol for pivotal (registration) study now being developed Bisantrene could – Target is r/r AML be approved in – IND to be filed in 2017 the US after a – Likely a multi-site study: US, France and
Slide 13: Commercial Protection
Commercial Protection For personal use only • Race owns two filed patents on Bisantrene – “Compositions to Improve the Therapeutic Benefit of Bisantrene Bisantrene has and Analogs and Derivatives Thereof” – “Combinatorial Methods to Improve the Therapeutic Benefit of filed patents and Bisantrene and
Slide 14: European Named Patient Sales
European Named Patient Sales For personal use only • Race expects first sales of Bisantrene in 2017 – Under a Named Patient Program (NPP) in Europe Early sales opportunity • Named patient sales are legal in France, Italy, Turkey delivers profitable sales – France will the first NPP market for Bisant
Slide 15: NPP Pathway in France
NPP Pathway in France For personal use only 2016 2017 2018 Appoint NPP Pre-launch planning Pre-launch sales agent and market research Marketing Final product GMP API GMP production production & release (Sai Life Sci) (IriSys) NPP launch NPP Launch in other in France markets ODD (EU) application and
Slide 16: Race value-added since listing
Race value-added since listing For personal use only Key goal At listing: Jul 2016 +9 months (Mar 2017) No API available GMP manufacturing of API completed with API Manufacturing Manufacturers still to be identified enough drug for NPP and clinical trials Finished product IriSys appointed, manufactu
Slide 17: Milestones 2017-2018
Milestones 2017-2018 For personal use only • 2017 – Complete manufacturing of finished product ready for named patient sales and start of pivotal clinical study – Secure EU Orphan Drug Designation in Europe – Apply for NPP authorisation in France and generate first Major value sales inflexion points
Slide 18: Management
Management For personal use only CEO: Peter Molloy CSO: John Rothman PhD • Experienced biotech CEO with • Co-inventor on Bisantrene success on ASX (Biota) patents • 17 years big pharma • Director/Sr Dir at Roche; Exec marketing: Int’l Marketing VP, VP for Science & Operations, Pharmacia Advaxis Man
Slide 19: Investment Summary
Investment Summary For personal use only • Specialty pharma company with low risk business model • Low base operating cost and expedited path to market • World-class team with deep oncology and commercial experience • Bisantrene: late-stage clinical asset that could be approved in the US after a sin
Slide 20: ASX code: RAC
For personal use only ASX code: RAC Registered Office: Level 2, 50 Kings Park Rd West Perth WA 6008 Contact: investors@raceoncology.com www.raceoncology.com