Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Shareholder Meeting (November 2018)
15 slides from Racura Oncology's shareholder meeting presentation, Nov 27, 2018
Slide 1: AGM Presentation 2018
For personal use only AGM PRESENTATION 2018 Managing Director, Peter Molloy
Slide 2: Corporate Snapshot
Corporate Snapshot For personal use only Shares on Issue (RAC) Ordinary 77m Performance Shares 10m Options 26m Shareholders (22/11/18) 876 Market Capitalization (AUD) Share price (23/11/18) $0.13 Market Capitalisation $10 m Cash (30/9/18) $2.8 m Major Shareholders Update Pharma, Inc. 12 m 16.0% Pete
Slide 3: Overview
Overview Bisantrene is a chemotherapy drug that was tested against a range of cancers in the For personal use only • 1980s • Race is rediscovering and repurposing bisantrene for the treatment of Acute Myeloid Leukaemia (AML) • Race owns new patents, Orphan Drug designation and a Rare Paediatric Dise
Slide 4: What is Bisantrene?
What is Bisantrene? A small molecule chemotherapy drug with promise For personal use only • Originally developed by Lederle in the 1980s with the goal of creating a non-cardiotoxic anthracycline • Numerous clinical studies confirmed its lack of cardiotoxicity and higher tolerability than anthracycli
Slide 5: Bisantrene's performance in previous Phase AML studies
Bisantrene’s performance in previous Phase 2 AML studies For personal use only Impressive activity in AML Adult or AML pts Study treated with CR CR rate • 136 r/r AML patients Pediatric bisantrene treated in nine Phase 2 Marty et al., 1984 Adult 10 8 80% studies Isnard et al., 1987 Adult 37 25 68% •
Slide 6: Race is rediscovering and repurposing Bisantrene
Race is rediscovering and repurposing Bisantrene Race now effectively owns Bisantrene For personal use only • Race owns new patents that are granted in US and expire 2034 • Race owns the original trademark (Zantrene®) • Race owns a US Orphan Drug Designation in AML (7 years exclusivity after approva
Slide 7: Race's goals
Race’s goals 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 2. Develop Bisantrene for paediatric AML and secure a Priority Review Voucher that can be sold 3. Generate usage and revenues through Named Patient
Slide 8: 2018 Review: Operations
For personal use only 2018 Review: Operations
Slide 9: Named Patient Program
Named Patient Program For personal use only Initiatives and achievements • Completed manufacturing of 1st batch of Bisantrene for NPP supply • Completed market research studies with haem-oncologists in France, Italy and UK • Conducted three group meetings with doctors (two in France, one UK) to disc
Slide 10: FDA approval pathway: adult r/r AML
FDA approval pathway: adult r/r AML For personal use only Initiatives and achievements • Bisantrene patents were granted in US • Secured NCI collaboration giving RAC right to all NCI Bisantrene data • FDA confirmed Bisantrene qualifies for 505(b)(2) • Appointed CRO (Novotech) to run the internationa
Slide 11: Paediatric program
Paediatric program For personal use only Initiatives and achievements • Bisantrene was awarded a ‘Rare Paediatric Disease’ designation by FDA, which opens the door to a ‘Priority Review Voucher’ (PRV) • Published case reports on the use of Bisantrene in two French girls, who are still alive today be
Slide 12: Licensing program: Biosynergy
Licensing program: Biosynergy For personal use only Initiatives and achievements • Agreement with Biosynergy (Dr John Cullity, RAC director) to undertake partnering of Bisantrene Plan • Active outreach to prospective licensing partners for Bisantrene (focus on US rights), including meetings at vario
Slide 13: 2019 prospects
For personal use only 2019 prospects
Slide 14: Cash position and expenses
Cash position and expenses • At 30 Sept 2018, RAC had $2.845 m in cash reserves For personal use only • Based on projected operating expenses, this is expected to more than cover operational costs through 30 June 2019 • Expenses management for remainder of FY19 – Payroll expenses (management and boa
Slide 15: Objectives for remainder of FY19
Objectives for remainder of FY19 • See Bisantrene used in treating AML patients under NPP For personal use only • Complete manufacturing of Bisantrene stock for the clinical trial(s) • Finalise the clinical protocol and file IND for the adult AML trial • Gain FDA acceptance of the protocol • Finalis