Racura Oncology Ltd · ASX:RAC
Racura Oncology — Race Oncology — Shareholder Meeting (November 2019)
32 slides from Racura Oncology's shareholder meeting presentation, Nov 22, 2019
Slide 1: AGM Presentation | Managing Director
For personal use only AGM Presentation | Managing Director Peter Molloy November 2019
Slide 2: Shares on issue and market capitalisation snapshot
For personal use only SHARES ON ISSUE Shares issued 109 m Options issued (excl. 4m expired 22 Nov 2019) 38 m Shareholders (at 15/11/19) 903 MARKET CAPITALISATION Share price (30-day VWAP to 15 Nov ‘19) $0.127 Market value $14.7 m Cash (15 Nov ‘19) $1.7 m Enterprise value (EV) $13.1 m SIGNIFICANT SHA
Slide 3: About Bisantrene
About For personal use only Bisantrene Bisantrene is a cancer chemotherapy drug developed in the 1980s b Lederle Pharmaceuticals Bisantrene was tested in more than 40 human trials and showed act in AML (acute myeloid leukaemia), as well as breast and ovarian can Bisantrene was approved for AML in Fr
Slide 4: Bisantrene remains an excellent cancer drug
For personal use only Bisantrene remains an excellent cancer drug with great potential in modern cancer treatment for AML and other cancers
Slide 5: Race's original plan for Bisantrene
Race’s original plan For personal use only for Bisantrene 1 Adult AML – Obtain FDA approval for Bisantrene under the 505(b)(2) pathway as a single agent for treatment of adult relapsed/refractory (R/R) AML Filed IND to support US registration trial, based on historical Phase II single agent studies;
Slide 6: How the AML landscape has changed
How the AML landscape has changed For personal use only Up to 2017, there had been no R/R AML now focused on NPP opportunities are very advances in AML treatment for at combination drug therapy, limited, due to the least 30 years. However, since 2017: not single agent abundance of clinical trials ●
Slide 7: Current AML Treatment
Current AML For personal use only Treatment Generalised overview – specific interventions vary greatly Complete Fit patients Response (CR) 7+3 Intensive Stem Cell Transplant Chemotherapy Cure (HSCT) Newly Diagnosed AML Various salvage Relapsed +/or combination +/or targeted Unfit patients Refractory
Slide 8: The new strategy for Bisantrene
The new strategy for Bisantrene For personal use only In October, Race held a company-wide strategy meeting in Houston (Texas) with consultants and advisors to develop a new strategy for Bisantrene, called the ‘5 Path’ strategy Two pillars of new strategy New preclinical data was presented showing s
Slide 9: Chief Scientific Officer Daniel Tillett
For personal use only Chief Scientific Officer Daniel Tillett November 2019
Slide 10: Why Bisantrene?
For personal use only Why Bisantrene?
Slide 11: Why Bisantrene?
Why For personal use only Bisantrene? ● Bisantrene cured two French girls with AML in the 1980 & 90s ● Both girls are alive today and have their own families
Slide 12: The MRD opportunity
For 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
Slide 13: The MRD opportunity: survival and residual disease status
The MRD For personal use only 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 trans
Slide 14: The MRD opportunity for Bisantrene
The MRD opportunity For personal use only for Bisantrene Proposed trial US Key Opinion Leaders (KOL) The MRD positioning would have indicated that this would put Bisantrene near the top of ● Patients that are still MRD(+) after represent a ‘breakthrough’ in the AML treatment pathway induction chemot
Slide 15: Bisantrene in AML treatment for MRD
Bisantrene in AML treatment For personal use only 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 R
Slide 16: The combination opportunity
For 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
Slide 17: The combination opportunity
The combination For personal use only opportunity New preclinical data from ongoing research sponsored by Race shows ● Bisantrene has excellent activity in drug resistant AML cell lines with cancer mutations associated with poor patient prognosis ● Bisantrene has synergy with cytarabine (backbone of
Slide 18: Bisantrene combinations in AML Treatment
Bisantrene combinations For personal use only in AML Treatment Bisantrene could transform R/R AML treatment Complete Fit patients Response (CR) Stem Cell 3+7 Induction Chemotherapy Transplant Cure (HSCT) Newly Diagnosed Non- responders AML Relapsed +/or Bisantrene Combinations Refractory AML
Slide 19: Bisantrene's new Path strategy
Bisantrene’s For personal use only new 5 Path strategy 1 2 3 4 5 Phase II MRD trial to Phase I/II Phase I/II Phase I/II Phase I/II advance Bisantrene combination trial combination trial for combination trial combination trial towards FDA approval for adult R/R AML paediatric R/R AML for breast cance
Slide 20: Phase II MRD trial
For personal use only 1 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 in partnership with a leading US cancer center Eligibility MRD(+) patients in CR after induction chemotherapy Study Design Open label 7-da
Slide 21: Bisantrene adult R/R AML trial
Bisantrene adult For personal use only 2 R/R AML trial Phase I/II Bisantrene combination AML study Bisantrene plus other approved AML treatments Aim to run trial in Australia Lower cost Does not require IND R&D Tax credits (43.5% cash rebate) Eligibility All AML patients after first relapse Endpoint
Slide 22: Bisantrene paediatric AML trial
3 Bisantrene paediatric For personal use only 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 – expected 25-40 patients Eligibility Childhood AML patients who meet ‘rare paedi
Slide 23: Bisantrene other cancers
Bisantrene For personal use only other cancers
Slide 24: Breast cancer combination trial
Breast cancer For personal use only 4 combination trial Phase I/II proof-of-concept (POC) trial in breast cancer Will use drug combinations which preclinical data show synerg Bisantrene (studies ongoing) Uses optimal dosing and administration of Bisantrene Historical breast cancer trials used sub-op
Slide 25: Ovarian or other cancer trial
Ovarian or other For personal use only 5 cancer trial Phase I/II proof of concept (POC) trial in ovarian or other cancer Preclinical trials to be performed to identify those cancers that respond most to Bisantrene and which drug combinations show synergy Uses optimal dosing and administration of Bis
Slide 26: Case study: ivosidenib
Case study For personal use only ivosidenib Approved by the FDA in May 2019 for newly diagnosed AML with a susceptible IDH1 mutation [1] Early approval from a Phase I/II open label trial of 28 patients 43% CR/CRi [2] Small Market 700 – 1100 patients in the USA per year Total Sales US$300 million per
Slide 27: Case study: gilteritinib
Case study For personal use only gilteritinib Approved by the FDA in November 2018 for relapsed or refractory AML with a FLT3 mutation [1] Approval of gilteritinib based on an interim analysis of the ADMIRAL trial [2] 138 adult patients having a FLT3 ITD, D835, or I836 mutation CR/CRi ~21% Small Mar
Slide 28: Benefits of the Path plan
Benefits of the 5 Path plan For personal use only $ $ RAC value driver Partnering value Clinical focus Australia • Faster (early-stage) • Expands the market for • Larger market expands clinical outcomes Bisantrene by up to 20x pool of potential without IND barriers partners • Early approval potentia
Slide 29: Expanded market potential for Bisantrene
Expanded market potential For personal use only Approx. Annual Cases for Bisantrene US + EU 850,000 AML remains key market for Bisantrene • Around 50,000 new cases p.a. and growing due to aging • Now Bisantrene will target 3 AML segments AML Segment Annual Cases (US+EU) Post-induction CR with MRD+ 1
Slide 30: Partnering is our long term goal
Partnering is our long term goal For personal use only US remains our key target market • US has <5% of world population but 47% of global 2018 Global Pharma Sales US$ pharmaceutical sales, due to higher pricing (and consumption) • Partnering deal values are driven by potential in US market All othe
Slide 31: Path plan: Valuable, affordable, fundable
5 Path plan For personal use only Valuable, affordable, fundable • Bisantrene’s role in cancer has been enhanced and expanded • Potential for early licensing deal and even early approval after in MRD or one of the proof-of- concept combination trials • Race is seeking funding from US partners or US
Slide 32: For personal use only
For personal use only L40 140 William St, Melbourne, VIC 3000 info@raceoncology.com +61 3 9098 8750