Racura Oncology Ltd · ASX:RAC
Racura Oncology — Investor Presentation (November 2023)
51 slides from Racura Oncology's investor presentation, Nov 22, 2023
Slide 1: Updated Strategy and Investor Presentation (ASX Announcement)
ASX Announcement Updated Strategy and Investor Presentation ● Updated corporate strategy focused on clinical development within Australia to achieve commercial goals using available resources ● Program designed to establish anthracycline cardioprotection and clinical effects on the m6A RNA pathway u
Slide 2: About Race Oncology
About Race Oncology (ASX: RAC) Race Oncology (ASX: RAC) is an ASX-listed clinical stage biopharmaceutical company with a dedicated mission to be at the heart of cancer care. Race’s lead asset, bisantrene, is a small molecule chemotherapeutic. Bisantrene has a rich and unique clinical history with de
Slide 3: At the Heart of Cancer Care
N O V E M B E R 2 0 2 3 AT THE HEART OF CANCER CARE I N V E S T O R U P D A T E 0 1 ASX: RAC | RACE ONCOLOGY LIMITED | ABN 61 149 318 749
Slide 4: Important Notice and Disclaimer
Important Notice and Disclaimer A T T H E The material in this presentation has been prepared by Race Oncology Limited (ACN 149 318 749) (Company). H E A R T THIS IS NOT A PROSPECTUS This presentation is not a prospectus, product disclosure statement or disclosure document for the purposes of the Co
Slide 5: Strategy Principles
Strategy Principles A T T H E H E A R T Shareholders first while meeting patient needs O F C A N C E R Major commercial opportunities for Race are cardioprotection + anticancer activity in solid tumours, m6A RNA & AML C A R E Phase 2 data demonstrating clinical efficacy provides maximum return on sh
Slide 6: Overview: Race Oncology & Bisantrene
Overview Race Oncology & Bisantrene A T T H E H E A R T O F C A N C E R C A R E 4
Slide 7: Race Oncology
Race Oncology A T Mission - advance bisantrene T H E with the aim of demonstrating clinical efficacy in anthracycline H E A R T cardioprotection, m6A RNA & AML with a commercial focus on pharma partnering & O F transactions C A N C E R 2022 – reformulated bisantrene to generate new C A R E IP & over
Slide 8: Bisantrene
Bisantrene A T T H E Small molecule chemotherapeutic with clinical efficacy in a diverse range of solid and H E A R T hematological cancers O F C A N C E R Studied in over 50 clinical trials, 166 peer-reviewed publications. Approved for use in AML in France in 1988 C A R E Used in >1500 cancer patie
Slide 9: Bisantrene + Anthracycline Improved Anticancer Activity
Bisantrene + Anthracycline A T Improved Anticancer Activity1 T H E H E A R T Bisantrene shows potent cell-killing activity against Bisantrene significantly improves the cancer O F a diverse range of human cancers cell killing activity of doxorubicin C A N C E R 10000 Bisantrene IC50 (nM) C A R E 100
Slide 10: Bisantrene + Anthracycline Protecting the Heart
Bisantrene + Anthracycline Protecting the Heart1 A T T H E H E A R T O F C A N C E R Bisantrene protects the hearts of mice from permanent damage caused by the anthracycline doxorubicin Vehicle Heart protection was achieved using higher levels of C A R E Bisantrene chemotherapy treatment with no ext
Slide 11: New Bisantrene Formulation - RC220
New Bisantrene Formulation - RC2201 A T T H E H E A R T RC220 – a high value reformulation O F • Proprietary formulation for peripheral and central line IV use C A N C E R • Designed to avoid drug precipitation issues whilst maintaining the activity and PK/PD properties of prior bisantrene formulati
Slide 12: Opportunities
Opportunities Bisantrene’s commercial potential in context A T T H E H E A R T O F C A N C E R C A R E 10
Slide 13: Anthracyclines - Effective & Enduring
Anthracyclines* – Effective & Enduring A T T H E H E A R T For most cancer patients, a therapy targetable Highly effective chemotherapeutics across a wide mutation cannot be identified, & immunotherapy is O F range of cancers ineffective C A N C E R C A R E Can cause serious adverse reactions, inclu
Slide 14: Anthracycline Cancer Indications
Anthracycline* Cancer Indications A T T H E H E A R T FDA On Label Use1 Off Label Use1 O F Advanced Endometrial Cancer C A N C E R Acute lymphocytic leukemia Ewing sarcoma Uterine Sarcoma Acute nonlymphocytic leukemia Soft tissue sarcoma Metastatic Hepatocellular Cancer C A R E Acute myelogenous leu
Slide 15: Global Anthracycline Use
Global Anthracycline Use1 A T T H E H E A R T O F 1.1M C A N C E R 1.2M C A R E Russia EU-5 12.1M 739K China + Japan United States 434K 85K India Australia 1. Estimated number of anthracycline doses used per year – Triangle Insights (ASX Announcement: 14 April 2023) 13
Slide 16: Anthracycline Cardiotoxicity
Anthracycline Cardiotoxicity A T T H E H E A R T An under-appreciated problem in oncology O F Anthracyclines cause permanent damage to the hearts of patients C A N C E R Current solution – exclude use in high-risk patients and reduce lifetime dosing so that the acute, clinically- defined cardiotoxic
Slide 17: Anthracyclines in the USA
Anthracyclines in the USA1 A T T H E H E A R T Anthracyclines continue to be widely used in the There is strong US clinician interest in new agents USA despite cardiotoxicity risks 2 able to reduce anthracycline cardiotoxicity 3 O F C A N C E R Q. On a scale from 1 to 7, with one being ‘not at all c
Slide 18: Key Opinion Leaders
Key Opinion Leaders A T T H E H E A R T It depends how carefully Toxicity is highest in the Scope for new cardio- 9-14% of patients on you look, but at least first year, but risk of O F protective therapy in anthracycline regimens 30% of patients who are heart failure remains addition to doxorubicin
Slide 19: FDA Project Optimus
FDA Project Optimus1 A T T H E H E A R T “The goal of Project Optimus is to educate, innovate, and collaborate with companies, academia, professional societies, international regulatory authorities, and patients to O F C A N C E R move forward with a dose-finding and dose optimization paradigm acros
Slide 20: Bisantrene Market Potential - USA
Bisantrene Market Potential – USA1 A T T H E Annual Revenue – Cardioprotection alone in Annual Revenue - Cardioprotection + anticancer H E A R T breast cancer indications activity in breast cancer indications O F $1,687M $1,646M $2,000M $2,000M C A N C E R $1,606M $1,567M $1,529M $1,492M Note: All f
Slide 21: Bisantrene Market Potential - World
Bisantrene Market Potential – World1 A T T H E H E A R T Annual Revenue – Cardioprotection Only Annual Revenue - Cardioprotection + Anticancer Note: All forecasted revenues O F reflect a 50% reduction to the C A N C E R physician-stated adoption rate C A R E USD$4,000 base price/cycle for 4 cycles w
Slide 22: m6A RNA dysregulation underlies many diseases
m6A RNA dysregulation underlies many diseases A T T H E H E A R T Ribonucleic acid (RNA) is the key information O F messenger that translates genetic instructions from C A N C E R DNA (genes) to cell proteins CELL CARDIAC C A R E Targeting RNA regulation CANCER VIRAL pathways, like m 6A methylation,
Slide 23: m6A RNA Opportunity
m6A RNA Opportunity A T T H E FTO – important role in human cancers? H E A R T Scientific discoveries over the last decade have identified dysregulation O F (loss of control) of RNA methylation as a key driver of cancer development 1 C A N C E R Changes in m 6A RNA methylation control the expression
Slide 24: AML Opportunity
AML Opportunity A T T H E Bisantrene approved for AML in France in 1988, although it was never H E A R T marketed O F Sheba 1 (2020) – 40% response rate in 10 AML salvage patients using C A N C E R bisantrene as a single agent – 4/4 clinical response in EMD AML 1 C A R E Sheba 2 (2023) – 40% respons
Slide 25: FDA Fast Track & Breakthrough Designation
FDA Fast Track & Breakthrough Designation A T T H E FDA Fast Track Designation (see Appendix) H E A R T More frequent communication with FDA Eligibility for Accelerated Approval and Priority Review O F C A N C E R Rolling Review of NDA FDA Breakthrough Designation (see Appendix) C A R E All Fast Tra
Slide 26: Challenges
Challenges Issues facing Race Oncology A T T H E H E A R T O F C A N C E R C A R E 24
Slide 27: Challenges and Solutions
Challenges Solutions A T T H E H E A R T Efficient project management to ensure spending is within available resources O F C A N C E R Biotech sector in a Many recent pharma Build a robust, high-quality, clinical efficacy data C A R E funding/valuation deals have been slow to “nuclear winter” with c
Slide 28: Updated Strategy
Updated Strategy Addressing the challenges A T T H E H E A R T O F C A N C E R C A R E 26
Slide 29: Strategy Overview
Strategy Overview A T T H E H E A R T Position bisantrene as a cardioprotective supportive care drug in early clinical trials with prudent, value-building investment O F C A N C E R Aim to generate robust, high-quality clinical efficacy data for the cardioprotection, m6A RNA & AML opportunities that
Slide 30: Clinical Strategy
Clinical Strategy Generating clinical evidence of efficacy for c a r d i o p r o t e c t i o n , m 6A R N A & A M L A T T H E H E A R T O F C A N C E R C A R E 28
Slide 31: RC220 Phase 1a/b Trial - Fully Funded
RC220 Phase 1a/b Trial – Fully Funded1 A T T H E H E A R T An ‘all comers’ Bayesian dose escalation Phase 1a trial of RC220 in any solid tumour patient where anthracycline use is indicated O F Size: 25-50 patients; up to 10 sites in Australia and internationally C A N C E R Sponsor: Race Oncology Pr
Slide 32: RC220 Phase 1a/b Trial Outcomes
RC220 Phase 1a/b Trial Outcomes A T T H E H E A R T Leverages an Australian-focused Phase 1a/1b trial design to ensure trial can be fully funded O F C A N C E R from existing cash resources C A R E Phase 1a establishes optimal bisantrene anthracycline dosing and safety Phase 1b generates proof-of-co
Slide 33: Cardioprotection & m6A RNA Phase 2 Trial
Cardioprotection & m6A RNA Phase 2 Trial1 A T T H E H E A R T A placebo-controlled, double-blinded, umbrella Bayesian combination trial of RC220. Focus on breast cancer plus any cancer or patient population that shows exceptional response to treatment in Phase 1 O F C A N C E R Size: 80-120 patients
Slide 34: AML Phase 1/2 Investigator Initiated Trial
AML Phase 1/2 Investigator Initiated Trial1 A T T H E H E A R T A low intensity salvage treatment for patients unable or unwilling to tolerate high intensity chemotherapy who have failed standard of care AML treatments. O F C A N C E R Size: 40-60 patients; up to 10 sites in Australia Sponsor: Inves
Slide 35: Preclinical Activities
Preclinical Activities A T T H E H E A R T O F C A N C E R C A R E Continue studies to determine the Develop the next generation Continue building the preclinical data Generate data to enable an cardioprotection mechanism of action bisantrene with a focus on the package needed to support pharma FDA
Slide 36: Advantages of Expanded Program
Advantages of Expanded Program A T T H E H E A R T Provides supportive cardioprotection data from Generates robust Phase 2 clinical efficacy data for the Phase 1 in a variety of cancer types and cardioprotection, m6A RNA & AML opportunities. O F treatment protocols maximising the commercial C A N C
Slide 37: Expanded Clinical Program
Expanded Clinical Program A T T H E H E A R T O F C A N C E R Preclinical Solid Tumour Solid Tumour AML Phase 1/2 studies & IND C A R E Phase 1a/b Trial Phase 2 Trial Trial submission Allows the generation of Phase 2 efficacy data for the AML, solid tumour cardioprotection + anticancer & m6A RNA com
Slide 38: Bonus Option Offer
Bonus Option Offer A T T H E H E A R T O F C A N C E R C A R E 36
Slide 39: Bonus Option Offer
Bonus Option Offer A T T H E H E A R T Race is issuing Bonus Options to reward existing shareholders and provide shareholders the O F opportunity to support the next steps of our highly promising clinical program C A N C E R The Bonus Options will be issued for nil consideration to Eligible Sharehol
Slide 40: Prospectus Use of Funds
Prospectus Use of Funds A T T H E H E A R T O F Proposed Expenditure C A N C E R Solid Tumour Phase 2 Solid Tumour (Phase 2) $32 million C A R E AML Phase 1/2 AML (Phase 1/2) $4 million Preclinical + IND $3 million Preclinical Corp. costs + Contingency $5 million Corp + Contingency R&D Tax Rebate1 (
Slide 41: Bonus Option Timetable
Bonus Option Timetable A T T H E H E A R T Date Item O F Announce Bonus Option Plan Wednesday, 22 November 2023 Lodge Appendix 3B and issue Cleansing Notice C A N C E R Ex Date of the Bonus Options Offer Monday, 29 November 2023 C A R E Record Date for Bonus Options Offer 7:00 pm AEDT Wednesday, 30
Slide 42: Conclusion
Conclusion Race Oncology A T T H E H E A R T O F C A N C E R C A R E 40
Slide 43: Summary
Summary A T T H E H E A R T Phase 1a/1b Australian trial fully funded from existing cash O F C A N C E R A clear and fully funded plan (subject to shareholder support) to generate C A R E Phase 2 efficacy data for the AML, solid tumour cardioprotection + anticancer & m6A RNA commercial opportunities
Slide 44: Questions
Questions Race Oncology A T T H E H E A R T O F C A N C E R C A R E 42
Slide 45: Contact
Contact DANIEL TILLETT Chief Executive Officer JANE LOWE Investor & Media Relations +61 2 8051 3043 +61 411 117 774 daniel.tillett@raceoncology.com jane.lowe@irdepartment.com.au ASX: RAC | RACE ONCOLOGY LIMITED | ABN 61 149 318 749
Slide 46: Appendix
Appendix A T T H E H E A R T O F C A N C E R C A R E 44
Slide 47: Race Oncology Board and Financials
Race Oncology Board and Financials A T T H E H E A R T ISSUED CAPITAL O F Shares1 163.1m C A N C E R Options1 10.7m Shareholders2 8,486 C A R E MARKET CAPITALISATION Share price1 $0.955 Mary Harney Dr Peter Smith Philip Lynch Non-Executive Board Chair Executive Director Non-Executive Director Market
Slide 48: Race Oncology Management Team
Race Oncology Management Team A T T H E H E A R T O F C A N C E R C A R E Dr Daniel Tillett, PhD Dr Michelle Rashford, MBBS Dr Sophia Moscovis, PhD Prof Michael Kelso, PhD Dr Marinella Messina, PhD Chief Executive Officer Chief Medical Officer Program Management, Principal Scientist Clinical Directo
Slide 49: FDA Fast Track Designation
FDA Fast Track Designation1 A T T H E Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an H E A R T unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad r
Slide 50: FDA Breakthrough Therapy Designation
FDA Breakthrough Therapy Designation1 A T T H E H E A R T Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improv
Slide 51: VO2Peak Measures of Cardiac Damage
VO2Peak Measures of Cardiac Damage A T T H E Left ventricular ejection fraction (LVEF) and global longitudinal strain (GLS) have been the standard of care measures for H E A R T evaluating chemotherapy-associated cardiotoxicity O F VO 2Peak can be simply assessed in minutes using a continuous ramp p
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