Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Shareholder Meeting (November 2020)
29 slides from Racura Oncology's shareholder meeting presentation, Nov 30, 2020
Slide 1: Annual general meeting presentation, 30 November 2020
annual general meeting presentation, 30 November 2020
Slide 2: Introducing the new Race: Precision Oncology
INTRODUCING THE NEW RACE PRECISION ONCOLOGY 2
Slide 3: 2019-2020 A pivotal period for bisantrene
2019-2020 A pivotal period for bisantrene July 2019 Nov 2019 May 2020 June 2020 Sept 2020 Nov 2020 Nov 2020 First patient 5 Path Strategy Race starts Bisantrene high- CCSA appointed Bisantrene data Breast cancer treated in Phase II released for preclinical breast lighted as potent clinical + FDA pub
Slide 4: Strategic update: Activities that led us here
Strategic update Activities that led us here Which means Key decision Evolved strategy to pursue outsized rewards for Race Informed by Race positioning Bisantrene as Oncology and its shareholders a precision oncology agent, Regulatory assessment with differentiated chemotherapeutic potential M&A eva
Slide 5: Three heroes
Three heroes 1 The drug 2 The team 3 The three pillars strategy 5
Slide 6: 1. The drug. Bisantrene
1. The drug. bisantrene Bisantrene is an anti-cancer agent developed in the 1980s by Lederle Pharmaceuticals It was tested in >40 human trials; showed excellent activity in AML (acute myeloid leukemia), breast and ovarian cancer and was approved in France for AML. Since acquiring Bisantrene, Race ha
Slide 7: 2. The team. Seasoned board and executive, key opinion leaders
2. The team. Seasoned board and executive, key opinion leaders BOARD Dr John Cullity, Mr Phil Lynch, Dr Daniel Tillett, Prof Borje Andersson, MD Non-Executive Chairman CEO and Managing Director CSO and Executive Director CMO and Executive Director MANAGEMENT Mr Phil Lynch, Dr Daniel Tillett, PhD Pro
Slide 8: 2. The team. Extended Race team
2. The team. extended race team Business Advisors & Consultants Clinical Advisors Industry Partners and Scientific Collaborators Accountants Onyx Corporate Pty Ltd Clinical Advisory Prof. Borje Andersson, MD, PhD, Clinical Manufacturing Drug IrySys LLC Board MD Andersson Cancer Centre, Product Contr
Slide 9: 3. The three pillar strategy
3. the three pillar strategy Plan and progress clinical programs which prove efficacy and utility in targeted indications for GOAL Bisantrene, so that its potential is realised through license or sale to a scaled pharma Pillar 1 Pillar 2 Pillar 3 FTO Breast Cancer AML STRATEGIES Extramedullary Melan
Slide 10: Pillar 1: FTO new focus
Pillar 1 fto new focus Rationale Pillar 1 City of Hope identifies Bisantrene as highly potential FTO targeted agent at low dose FTO Melanoma Next Steps Clear Cell Renal Cell Carcinoma Pre clinical evaluation in Melanoma and Clear Cell Renal Cell Carcinoma Seek to run clinical trials to confirm FTO i
Slide 11: FTO central role in cancer
FTO Central ROLE In Cancer ● Scientific discoveries over the last decade have identified dysregulation (loss of control) of RNA methylation as a key driver of cancer development1 ● Changes in m6A RNA methylation control the expression of key genes in cancer development and growth2 ● Fat mass- and ob
Slide 12: The targeted agent challenge
The TargetED agent challenge ● To run a clinical trial using a cancer gene target (i.e. FTO) you need clinical data showing that the cancer target is predicative Gene target of a clinical response. ● Problem. Need clinical data to run a targeted agent trial, but you can only gather clinical data by
Slide 13: Melanoma opportunity
Melanoma opportunity ● One of the most dangerous cancers: 7000 deaths (USA), 1500 (Aust)1 ● Major improvements in treatment (BRAF/MEK inhibitors, immune checkpoint), but the 5-year survival rate for advanced melanoma is still as low as ~25%1 ● Major problem - treatment resistance ● FTO ● FTO was fou
Slide 14: Clear cell renal cell carcinoma
Clear Cell Renal cell carcinoma ● 10th most common cancer; often only diagnosed after metastasis1 ● New treatments. TKI, checkpoint inhibitors1 ● 5-year survival rate still very low (~12%)1 ● 90% of ccRCC are caused by mutations in the von Hippel-Lindau (VHL) tumour suppressor gene2 ● FTO ● FTO was
Slide 15: FTO next steps
FTO next steps Melanoma and clear cell renal cell carcinoma have the right properties to overcome the targeted agent “chicken and the egg” problem ● FTO target: 50% melanoma; 90% ccRCC ● Past clinical evidence of bisantrene working in these cancers (Phase I/II)1,2 ● Good modern pre-clinical data ● T
Slide 16: Pillar 2: Breast cancer progressing
Pillar 2 breast CANCER progressing Rationale Pillar 2 Large indication and clear patient need Safety and efficacy for Bisantrene from historical trials Breast cancer Move to proof of Next Steps concept human clinical trials Positive pre clinical data to be assessed by Advisory Board Anthracycline Tr
Slide 17: Breast cancer recent preclinical results
Breast Cancer Recent Preclinical Results1 ● Bisantrene as a single drug shows similar efficacy to doxorubicin and epirubicin in a range of different breast cancer types ● Bisantrene shown in both historical clinical and recent preclinical studies to kill breast cancer cells resistant to doxorubicin
Slide 18: Breast cancer combination trial
Breast cancer combination trial Phase I/II proof-of-concept (POC) trial in breast cancer Use drug combinations where preclinical data show an additive effect with Bisantrene Use optimal drug dosing, administration and combinations Historical breast cancer trials used sub-optimal dosing and administr
Slide 19: Pillar 3: Extramedullary AML assessing
Pillar 3 extramedullary AML assessing Rationale Pillar 3 Unmet patient need Bisantrene EMD history and recent Israel trial observations AML Extramedullary Potential FDA approval via 505(b)(2) and ladder to PRV R/R Adult & Paediatric Next Steps MRD Full feasibility assessment Ovarian Ambition Multi-s
Slide 20: Extramedullary AML
ExtraMedullary AML ● Why extramedullary (EM) AML? ● Recent Israel results - 4/4 responders had EM AML ● Unmet clinical need - no clinical trials and EM AML patients excluded ● EM AML patients have a worse outcome than non-EM AML patients ● PET has shown EM AML is much more common than previously tho
Slide 21: Pillar 3: R/R AML drug combination assessing
Pillar 3 r/r aml drug combination assessing Rationale Pillar 3 Adult combination to address R/R in AML Paediatric patient need and PRV opportunity AML Extramedullary R/R Adult & Next Steps Paediatric Feasibility study: assessing drug, trial options & regulatory MRD Ovarian Ambition Combination has s
Slide 22: Feasibility studies
Feasibility Studies Combination AML ● Combination R/R AML ● Combine Bisantrene with two nucleoside analogues for R/R AML salvage in adult & paediatric MRD ● CCSA review identified potential regulatory issues with trial design so need for full review ● Next Stage - full feasibility study (underway) O
Slide 23: Key events
Key events PILLAR P R O G R AM O B J E C T I V E 2021 2022 Pillar 1 Target FTO tumours to drive cancer regression via RNA Pre-clinical POC clinical trial(s) methylation pathway (in vitro) FTO Pillar 2 Less cardiotoxic chemotherapeutic effective as POC Clinical Trial Start Clinical trial cont Breast
Slide 24: Near term activities: 1H CY 2021
Near term Activities: 1H CY 2021 • FTO pre-clinical programs • Breast cancer clinical trial design – 13 weeks • Feasibility studies to guide choice and utility on: • Adult R/R AML • Paediatric R/R AML and PRV • Extramedullary AML and PRV 24
Slide 25: Corporate overview
Corporate overview 25
Slide 26: Corporate snapshot
corporate snapshot ISSUED CAPITAL Shares 128.2m Options 28.2m Shareholders (27 November 20) 2,674 MARKET CAPITALISATION Share price (27 November 20) $2.15 Market value (27 November 20) $275.6m Cash (30 Sept 20) $5.66m Enterprise value $270m SIGNIFICANT SHAREHOLDERS Bill Garner 11% Daniel Tillett (Di
Slide 27: Transactional value observations
Transactional value observations Insights1 Plans • Value differs little between early and late stage • Phase 2 assets – primary market research and health buy outs economics • Efficacy data is largest value differentiator • Transaction comparable and sum of parts analysis • Precision oncology drivin
Slide 28: Concluding comments
concluding comments STRATEGY – capitalises on FTO insights while protecting legacy chemotherapy credentials RISK REWARD – multi leg strategy reduces executional risk and maximises potential for outsized returns TEAM – is focused on shareholder return, via sale / license to pharma partner CLINICAL PR
Slide 29: Contact us
Contact us Phil Lynch, CEO/MD Dr Daniel Tillett, CSO/ED raceoncology.com phillip.lynch@raceoncology.com daniel.tillett@raceoncology.com