Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Investor Presentation (July 2020)
31 slides from Racura Oncology's investor presentation, Jul 15, 2020
Slide 1: ASX Announcement: Race Investor Update
ASX Announcement For personal use only Race Investor Update 15 July 2020 – Race Oncology Limited (“Race” or “the Company) (ASX: RAC) is pleased to release an updated investor presentation. It summarises significant recent news in regards the clinical development of our lead oncology drug, bisantrene
Slide 2: Investor Update | July 2020
personal use only Investor Update | July 2020 1
Slide 3: Investment highlights
personal use only Investment highlights • June 2020 RNA • Independent Phase II trial bisantrene is safe, well methylation tolerated and efficacious beyond expectations in a very hard to treat relapsed / refractory Acute deregulation Myeloid Leukaemia (R/R AML) population • Independent preclinical st
Slide 4: Corporate snapshot
personal use only SHARES ON ISSUE Shares issued1 119.8 m Options issued 36.5 m Shareholders (14 Jul ‘20) 1537 MARKET CAPITALISATION Share price (14 Jul ‘20) $1.02 Market value (14 Jul ‘20) $122.2 m Cash (14 Jul ‘20)2 $4.7 m Enterprise value (EV) $117.5 m SIGNIFICANT SHAREHOLDERS Corporate Bill Garne
Slide 5: Race management and advisors
personal use only Race management and advisors seasoned team, key opinion leaders BOARD BOARD SCIENTIFIC ADVISORS Dr John Cullity, Dr Daniel Tillett Prof Borje Andersson, Exec. Chair Exec. Dir. / CSO MD Anderson Prof Borje Andersson, Prof Jaap Boelens Dr Bill Garner NED NED MSKCC Mr Chris Ntoumenopo
Slide 6: About Bisantrene
About personal use only Bisantrene Bisantrene is a cancer chemotherapy drug developed in the 1980s by Lederle Pharmaceuticals Bisantrene was tested in more than 40 human trials and showed activity in AML (acute myeloid leukaemia), as well as breast and ovarian cancer Bisantrene was approved for AML
Slide 7: June 2020: pivotal for bisantrene & Race
personal use only June 2020 pivotal for bisantrene & race Results of the Phase II Identification by Su et al bisantrene clinical trial (City of Hope Hospital, at the Sheba Medical USA) that bisantrene is a Center (Israel) potent inhibitor of FTO 6
Slide 8: Phase II Bisantrene monotherapy in R/R AML
personal use only Phase II Bisantrene monotherapy in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) 7
Slide 9: Phase II bisantrene trial study design
personal use only Phase II bisantrene trial study design Phase II open-label single arm single center study (NCT03820908) ● 7 day 250mg/m2/day ● n=10 R/R AML patients ● Single cycle of treatment ● Study population heavily pre-treated (average of 3 prior treatments) Chaim Sheba Medical Center, Tel Av
Slide 10: Phase II bisantrene trial results
personal use only Phase II bisantrene trial results1 Of the 10 patients, one patient (10%) achieved a complete remission and three patients achieved partial remissions Overall Response Rate of 40% All 4 responders had high-risk extramedullary disease • Patient with leukaemia cutis (skin) achieved CR
Slide 11: Next steps
personal use only Next steps Bisantrene combination AML trial Follow-up study combining bisantrene with other anti-leukaemic drugs is currently in advanced planning Trial planned to begin recruitment late 2020 Trial fully funded via $3 million strategic placement to biotech investors1 1. ASX Announc
Slide 12: The critical role of RNA m6A methylation in cancer
personal use only The critical role of RNA m6A methylation in cancer 11
Slide 13: m6A RNA methylation: key pathway in cancer
personal use only m6A RNA methylation key pathway in cancer • Scientific discoveries over the last decade have identified disregulation of RNA methylation as a key driver of cancer development1,2 • Changes in m6A RNA methylation control the expression of key genes in cancer development and growth •
Slide 14: FTO: central player in cancer
personal use only FTO central player in cancer • Fat mass- and obesity-associated Protein (FTO)1 • Variations in the gene are associated with body weight differences1 • Found in 2011 to be a m6A RNA demethylase (removes methyl groups fro RNA) • Regulates the level of m6A methylation in RNA1 • Increa
Slide 15: Bisantrene is a potent inhibitor of FTO
personal use only June 2020 City of Hope Study Bisantrene is a potent inhibitor of FTO • Su et al from the City of Hope Hospital (Los Angeles) discovered that bisantrene is a potent inhibitor of FTO (IC50 = 142nM)1 • Extremely impressive and high quality work published in the top tier cancer journal
Slide 16: What does this all mean for Race?
personal use only What does this all mean for Race? • Bisantrene still works • Validation of the historical data and our 5- path strategy for commercialisation • Bisantrene has two mechanisms of action • High dose anthracycline-like chemotherapeutic (250mg/m2/d) but with greater safety with less car
Slide 17: AML: a crowded market?
personal use only AML a crowded market? • AML is increasingly a crowded market with more than 200 new treatments in development • Any new AML treatment needs to establish a market niche with less competition • Race is using three commercialisation strategies • Aim to replacing doxorubicin in high in
Slide 18: The combination opportunity
personal use only Previous research (Lederle/NCI) showed that Bisantrene has differential activity over other chemotherapy agents How does it stack up today using The combination modern research techniques? opportunity 17
Slide 19: Bisantrene adult R/R AML trial
personal use only Bisantrene adult R/R AML trial Phase I/II Bisantrene combination AML study Bisantrene plus other approved AML treatments Plan to run trial in Israel Familiar with bisantrene Does not require FDA Investigator New Drug (IND) approval Eligibility All AML patients after first relapse o
Slide 20: Bisantrene paediatric AML trial
personal use only Bisantrene paediatric AML trial Phase I/II paediatric AML Bisantrene combination study Bisantrene plus other approved AML treatments Aim is to run trial in US and Australia under IND Small trial – expect 25-40 patients Eligibility Childhood AML patients who meet ‘rare paediatric di
Slide 21: Breast cancer combination trial
personal use only Breast cancer combination trial Phase I/II proof-of-concept (POC) trial in breast cancer Will use drug combinations which preclinical data show synergise with Bisantrene (preclinical studies underway with U. Newcastle) Use optimal dosing, administration and combination of Bisantren
Slide 22: Ovarian cancer combination trial
personal use only Ovarian cancer combination trial Phase I/II proof of concept (POC) trial in ovarian cancer Preclinical trials to be performed to identify which drug combinations show synergy Use optimal dosing, administration & combinations of Bisantrene Historical non-AML cancer trials all used s
Slide 23: The MRD opportunity
personal use only Recent clinical studies have demonstrated the importance of eliminating measurable residual disease (MRD) in AML patients Why is MRD so important for curing AML patients and what can be done? The MRD opportunity 22
Slide 24: The MRD opportunity
personal use only The MRD 2-year survival and residual disease opportunity status at transplant 100 Up to 80% of AML patients who are fit enough for induction 90 chemotherapy (3+7) with go into remission (CR) and may then be candidates for a human stem cell transplant (HSCT) 80 Whether the transplan
Slide 25: Bisantrene in AML treatment for MRD
personal use only Bisantrene in AML treatment for MRD Bisantrene could transform cure rates by changing MRD status MRD(+) MRD(-) Complete Bisantrene Response Fit patients 3+7 Induction (CR) Stem Cell Chemotherapy Cure MRD(-) Transplant (HSCT) Newly Diagnosed Non- responders AML Various salvage Relap
Slide 26: Phase II MRD trial
personal use only Phase II MRD trial Phase II study of Bisantrene treatment after (7+3) induction chemotherapy to change MRD status Aim to run trial in USA and/or Israel/Australia in partnership with leading US cancer centers Eligibility Transplant eligible MRD(+) patients in CR after induction chem
Slide 27: Near term activities
personal use only Near term activities • Initiation of Phase II combination AML trial • Preclinical breast cancer results • AML drug combination publication • Sheba Phase II AML publication • ASH presentation (conference abstract) • FDA Investigation New Drug (IND) submission • Potential for other i
Slide 28: personal use only
personal use only L40 140 William St, Melbourne, VIC 3000 info@raceoncology.com +61 3 9098 8750 27
Slide 29: Selected oncology buyout transactions: leukaemia
Selected oncology buyout transaction personal use only leukaemia Company Drug Value Date Phase Forty Seven1 magrolimab US$4.9 billion 2020 I/II Ariad2 brigantinib US$5.2 billion 2017 II Celator Pharma3 CPX-351 (Vyxeos®) US$1.5 billion 2016 III Micromet4 blinatumomab US$1.16 billion 2012 II Ambit Bio
Slide 30: AML case study: ivosidenib
personal use only AML case study 1 ivosidenib Approved by the FDA in May 2019 for newly diagnosed AML with a susceptible IDH1 mutation1 Early approval from a Phase I/II open label trial of 28 patients 43% CR/CRi2 Small Market 700 – 1100 patients in the USA per year Total Sales US$300 million per yea
Slide 31: AML case study: gilteritinib
personal use only AML case study 2 gilteritinib Approved by the FDA in November 2018 for relapsed or refractory AML with a FLT3 mutation1 Early approval of gilteritinib based on an interim analysis of the ADMIRAL trial2 138 adult patients having a FLT3 ITD, D835, or I836 mutation CR/CRi ~21% Small M