Announcement PDF ASX Announcement Race to Present at E&P Small Caps Healthcare Conference 26 September 2024 – Race Oncology Limited (“Race”) is pleased to share a copy of the presentation that will be given by Race’s Executive Chair, Dr Pete Smith, at the E&P Small Cap Healthcare Conference in Sydney today. The presentation provides an overview of Race’s lead oncology drug RC220 bisantrene, an update on development progress, and the latest clinical plans. A copy of the presentation is appended to this announcement. -ENDSAbout 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 demonstrated therapeutic benefits in both adult and paediatric patients, a wellcharacterised safety profile, and compelling clinical data demonstrating an anticancer effect and less cardiotoxicity over certain anthracyclines, such as doxorubicin. Race is advancing a reformulated bisantrene (RC220) to address the high unmet needs of patients across multiple oncology indications, with a clinical focus on anthracycline combinations, where we hope to deliver cardioprotection and enhanced anticancer activity in solid tumours. Race is also exploring RC220 as a low intensity treatment for acute myeloid leukaemia. Race is investigating the effect of bisantrene on the m6A RNA pathway, following independent research published by the City of Hope identifying bisantrene as a potent inhibitor of FTO (Fat mass and obesityassociated protein). Dysregulation of the m6A RNA pathway has been described in numerous peer reviewed studies to be a driver of a diverse range of cancers. Race Oncology has collaborated with Astex, City of Hope, MD Anderson, Sheba City of Health, UNC School of Medicine, University of Wollongong and University of Newcastle, and is actively exploring partnerships, licence agreements or a commercial merger and acquisition to accelerate access to bisantrene for patients with cancer across the world. Learn more at www.raceoncology.com. If you have any questions on this announcement or any past Race Oncology announcements, please go to the Interactive Announcements page in our Investor Hub https://announcements.raceoncology.com Race Oncology Ltd • ABN 61 149 318 749 L36, 1 Macquarie Place Sydney NSW 2000 • T. +61 2 8051 3043 • E. info@raceoncology.com • www.raceoncology.com Race encourages all investors to go paperless by registering their details with the Company’s share registry, Automic Registry Services, at www.automicgroup.com.au. Release authorised by: Media contact: Pete Smith, Executive Chair info@raceoncology.com Jane Lowe +61 411 117 774 jane.lowe@irdepartment.com.au Race Oncology Ltd • ABN 61 149 318 749 L36, 1 Macquarie Place Sydney NSW 2000 • T. +61 2 8051 3043 • E. info@raceoncology.com • www.raceoncology.com S e p t e m b e r 2 0 2 4 AT THE HEART OF CANCER CARE Pete Smith PhD, Executive Chair E&P Small Cap Healthcare Conference 0 1 ASX: RAC | RACE ONCOLOGY LIMITED | ABN 61 149 318 749 NOT FINANCIAL PRODUCT ADVICE C A R E This presentation does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States . Any securities described in this presentation have not been, and will not be, registered under the US Securities Act of 1933, as amended (Securities Act) or the securities laws of any state or other jurisdiction of the United States and may not be offere d or sold in the United States except in transactions exempt from, or not subject to, registration under the Securities Act and applicable US state securities laws. This presentation may not be released to US wire services or distributed in the United S tates. The distribution of this presentation in other jurisdictions outside Australia may also be restricted by law and any such restrictions should be observed. C A N C E R Statements in this presentation are made only as of the date of this presentation unless otherwise stated and the information in this presentation remains subject to change without notice. No representation or warranty, express or implied, is made as to the fairness, accuracy or completeness of the information, opinions and conclusions contained in this presentation or any other information the Company or any other person otherwise provides to you. O F This presentation is not a prospectus, product disclosure statement or disclosure document for the purposes of the Corporatio ns Act 2001 (Cth) (Corporations Act). It has not been lodged with the Australian Securities and Investments Commission, or otherwise. H E A R T THIS IS NOT A PROSPECTUS T H E The material in this presentation has been prepared by Race Oncology Limited (ACN 149 318 749) (Company). A T Important Notice and Disclaimer No attempt has been made to independently verify the information contained in this presentation. The information in this pres entation is of a general nature and does not constitute financial product advice, investment advice or any recommendation. Nothing in this presentation constitutes legal, financial, tax or other advice. The information in this presentation does not take into account your particular investment objectives, financial situation or needs, or those of any other person. You should make your own assessment of an investment in the Company and should not rely on this presentation. In all cases, you should c onduct your own investigations and analysis of the financial condition, assets and liabilities, financial position and performance, profits and losses, prospects and business affairs of the Company and its business, and the contents of this pre sentation. You should seek legal, financial, tax and other advice appropriate to your jurisdiction. THIS PRESENTATION DOES NOT CONSTITUTE AN OFFER OR ADVERTISEMENT This presentation does not constitute an invitation, offer or recommendation to apply for or purchase Shares and does not con tain any application form for Shares. This presentation does not constitute an advertisement for an offer or proposed offer of Shares. NO LIABILITY The Company has prepared this presentation based on information available to it at the time of preparation, from sources beli eved to be reliable and subject to the qualifications in this presentation. No representation or warranty, express or implied, i s made as to the fairness, accuracy, completeness or correctness of the information, opinions and conclusions contained in this presentation. To the maximum extent permitted by law, none of the Company or its subsidiaries or affiliates or the directors, employees, agents, representatives or advisers of any such party, nor any other person accepts any liability for any loss ari sing from the use of this presentation or its contents or otherwise arising in connection with it, including without limitation, any liability arising from fault or negligence on the part of the Company or its subsidiaries or affiliates or the directors, emp loyees, agents, representatives or advisers of any such party. FORWARD-LOOKING STATEMENTS This presentation may contain forward-looking statements that are subject to risk factors associated with an oncology company. F orward looking statements can be identified by the use of forward-looking terminology, including, without limitation, the terms “believes”, “estimates”, “anticipates”, “expects”, “predicts”, “intends”, “plans”, “goals”, “targets”, “aims”, “outlook ”, “guidance”, “forecasts”, “may”, “will”, “would”, “could” or “should” or, in each case, their negative or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. By their nature, for ward-looking statements involve known and unknown risks, uncertainties and other factors because they relate to events and depend on circumstances that may or may not occur in the future and may be beyond the Company’s ability to control or predict which may cause the actual results or performance of the Company to be materially different from the results or performance expressed or implied by such forward -looking statements. Forward looking statements are based on assumptions and are not guarantees or predictions of future performance. No representation is made that any of these statements or projections will come to pass or that any forecast result will be achieved, nor as to their accuracy, completeness or correct ness. Similarly, no representation is given that the assumptions upon which forward looking statements may be based are reasonable. 2 A T Corporate snapshot T H E H E A R T Race Oncology is an ASX-listed, clinical stage biopharmaceutical company with a dedicated mission to be at the heart of cancer care. O F RAC Share price $1.74 1 Market capitalisation $296.5m 1 Cash at bank $17.2m 2 Debt Nil Enterprise value $279.3m 1 Shares on issue 170,423,606 1 Options on issue 35,176,756 1 1. As at 23 September 2024 2. As at 30 June 2024 C A R E ASX code C A N C E R Race 12-month trading history Key Data Current Options On 22 November 2023, Race issued a 1 for 20 bonus and piggyback option series to existing shareholders. The conversion of bonus options ($0.75) raised $5m and the 19.9m piggyback options ($1.25) could raise an additional $25m before expiry 29 May 2026 3 A T Race Oncology Board T H E H E A R T O F C A N C E R C A R E • Former CSO and Executive Director of Race Oncology (2019-2023) • Responsible for development of RC220 & cardioprotection discoveries • >25 years of biotech management experience (Nucleics) • Largest Race Oncology shareholder (>10%) Dr Serge Scrofani, PhD MBA Non-Executive Director Dr Peter Smith, PhD Executive Chair Dr Daniel Tillett, PhD Managing Director / CEO • >30 years' experience in healthcare with focus on therapeutics / oncology • >28 years’ experience in healthcare including research, strategy, licensing, M&A • Non-Executive Director at MycRx, and Founder and CEO of Amala. • • Former top-rated pharma analyst with UBS and HSBC Principal at Poplar Advisory Pty Ltd, Executive Director at FinCap Pty Ltd, Non-Executive Director at Burnet Institute & The Centre for Eye Research Australia • Former Vice President of Strategy & Corporate Development at CSL. 4 A T Race Oncology Management Team T H E H E A R T O F C A N C E R C A R E Dr Daniel Tillett, PhD Managing Director / CEO Dr Michelle Rashford, MBBS Chief Medical Officer • Former CSO and Executive Director of Race Oncology (2019-2023) • Responsible for development of RC220 & cardioprotection discoveries • >25 years of biotech management experience (Nucleics) • Largest Race Oncology shareholder (>10%) • Former physician, with >25 years expertise in the successful development and commercialization of pharmaceuticals across oncology, virology, and immunology • Former Head of Global Clinical Sciences with Kyowa Kirin, 5 years BMS and 20 years with Roche Dr Sophia Moscovis, PhD Vice President of Operations & Strategy • >20 years experience in healthcare with 10+ years in the pharmaceutical industry • Scientist with a PhD in Immunogenetics • >10 years with Novartis across a range of areas including cardiology and business transformation Prof Michael Kelso, PhD Vice President of Research Dr Marinella Messina, PhD Vice President of Clinical Development • Internationally experienced researcher, with >25 years R&D experience across a wide range of areas in medicinal chemistry, incl. oncology, antimicrobial drug development and drug formulation • 69 scientific research papers, 7 patents and 18 grants achieved • Highly experienced oncology clinical trials specialist, having managed a wide range of clinical trials over >10 years, across all development phases (I, II, III and IV) • Former Noxopharm Clinical Operations Manager and Clinical Program Manager 5 A T T H E H E A R T O F C A N C E R C A R E Cancer survivorship 6 A T Cancer survivorship – life after treatment T H E Ageing In 2022, there were 18m cancer survivors in the US, growing to 22.5m by 2032 1 O F 1. www.cancer.gov 2. Florido R, et al. J Am Coll Cardiol, 2022 Heart damage + other effects C A R E Cardiovascular toxicity is permanent 4 and can be profound for certain groups, e.g. children Race. C A N C E R Patients receiving chemotherapy have a 37% increased risk of cardiovascular disease 2 Clinician interest H E A R T New specialties such as cardiooncology are focused on reducing damage caused by treatments Better diagnosis + therapy A single dose of chemotherapy can cause cardiotoxicity 3 and muscle atrophy 4 3. Dillon HJ, et al. J Am Coll Cardiol, 2024 4. Mallard J, et al. J Cachexia Sarcopenia Muscle, 2024 7 A T Chemotherapy needs improvement T H E H E A R T O F Issue – patients not given full effective dose, and heart damage with serious long-term health consequences remains Opportunity – if the cardiovascular toxicity could be reduced, more patients could be treated and more effective regimens delivered C A R E Current solution – exclude use in high-risk patients and limit dosing of the drugs C A N C E R Anthracyclines* are the most widely used class of chemotherapeutics. They are highly effective, but can cause permanent damage to the cardiovascular system “Cardiotoxicity, which includes heart failure, is one of the main side effects limiting the use of these effective therapies.” Professor Aaron Sverdlov, University of Newcastle * Approved anthracyclines include doxorubicin, daunorubicin, epirubicin, idarubicin and valrubicin 8 A T Anthracycline use is growing1, 2, 3 T H E H E A R T Estimated number of anthracycline doses used per year1 O F 22.98 18.97 16.69 20.22 17.79 According to Data Bridge Market Research, global anthracycline usage is expected to increase by a CAGR of 6.60% between 2023 and 2030 C A R E 21.55 • C A N C E R 24.49 15.66 2023 2024 2025 China & Japan 2026 EU-5 Russia 2027 United States 2028 India 2029 Australia 2030 1. IQVIA MIDAS AUDITED US VOLUME Anthracycline Data, Triangle Insights (ASX Announcement, slide 16: 14 April 2023) 2. Daunorubicin, doxorubicin, liposomal doxorubicin (Doxil), epirubicin, idarubicin, mitoxantrone, and valrubicin 3. Triangle Insights (ASX Announcement: 14 April 2023) 9 Anthracyclines continue to be widely used Lymphoma ABVD, CHOP/R-CHOP, DA-EPOCH-R, others Breast cancer AC/AC-T, FAC/CAF, FEC, others Small-cell lung cancer CAV Oesophageal cancer ECF, EOX Acute myeloid leukemia 7+3/DA, ADE Acute lymphoblastic leukemia Hyper-CVAD, others Bladder cancer Mono (Epi), ECM, Dox + cisplatin/gemcitabine, MVAC Legend: therapy type​s Various advanced or metastatic cancers Mono = monotherapy, Dox = doxorubicin, Epi = epirubicin, AI = Dox + ifosfamide, DTIC = Dox + dacarbazine, ECM = Epi +cisplatin + methotrexate, MVAC = Methotrexate + Vinblastine + Dox + Cisplatin, CAV = cyclophosphamide + Dox + vincristine, ECF = Epi + cisplatin + 5FU, EOF = Epi + oxaliplatin + 5FU, AC/ACT = Dox + cyc;lophosphamide +/- taxane, FAC = 5FU + Dox + cyclophosphamide, FEC = 5FU + Epi + cyclophosphamide, ABVD = Dox + bleomycin + vinblastine + dacarbazine, R-CHOP = rituximab + cyclophosphamide + Dox + vincristine + prednisone, DA-EPOCH-R = etoposide + prednisone + vincristine + cyclophosphamide + Dox + rituximab, 7+3/DA = cytarabine + daunorubicin, ADE = cytarabine + daunorubicin + etoposide, Hyper-CVAD = cyclophosphamide + vincristine + Dox + dexamethasone Neoadjuvant​ Soft tissue sarcoma Induction​ Mono, AI, DTIC Consolidation​ Adjuvant​ Combination chemotherapy​ Maintenance​ Palliative​ A T T H E H E A R T O F C A N C E R C A R E Clinical development of bisantrene 11 A T Bisantrene’s history of clinical success T H E H E A R T Acute Myeloid Leukaemia 471 patients across 9 Phase 2 & 3 clinical trials Approved in France in 1988, but Lederle (Pfizer) ended commercial development of bisantrene due to solubility issues Less toxic than standard-of-care doxorubicin - reduced myelosuppression - reduced alopecia (hair loss) - no cardiac failures Complete response rates above 40% as a salvage agent for Acute Myeloid Leukaemia (AML) O F Breast cancer 1 C A N C E R C A R E Phase 3. Overall patient survival greater in bisantrene treated patients (HR 0.92 95%CI = 0.7-1.21) Bisantrene cured two French girls with r/rAML in the 1980 & 90s. Both women are alive today and have their own families Complete responses with bisantrene in paediatric and adult Acute Myeloid Leukaemia patients 80% 70% 60% 50% 40% 30% 20% 10% 0% 1. Cowan, J. D. et al. . Natl. Cancer Inst. 83, 1077–1084 (1991) 72% 50% 46% 50% 40% 23% Marty et al 19851 Phase I, Adult (N=17) Marty et al 19872 Phase II, Leblanc et al 19943 Phase II, Adult (N=40) Pediatric (N=22) Tosi et al 19894 Phase II, Adult (N=10) Bezwoda and Seymour Spadea et al 19936 Phase II, 19895 Phase II, Adult (N=15) Adult (N=7) 12 H E A R T • Created new intellectual property with a long lifespan (20 years) • Leveraged new science to understand bisantrene’s anti-cancer and cardioprotective mechanism of action 2 • Built on the >1,500 patients’ worth of clinical data across a broad range of cancer indications, and generated new Phase 2 clinical data in AML • RC220 is a new drug product, requiring a full non-clinical toxicology & safety data package – delivered in June 2024 3 C A R E RC220 preserves the PK/PD properties of the earlier clinically validated formulations of bisantrene C A N C E R • O F Created RC220, a new formulation of bisantrene which is more soluble and can be delivered intravenously 1 T H E Race has… • A T Building on bisantrene’s history RC220 is a clinically and commercially attractive formulation with long IP life 1. ASX Announcement: 9 November 2023 | 2. ASX Announcement: 21 September 2023 | 3. ASX Announcement 27 June 2024 13 Large addressable patient population IP protection Data from 1,500 patients in 50 trials, Approved in France ✓ ✓ ✓ ✓ Can be delivered by central line or intravenously Data from 1,500 patients in 50 trials, Approved in France C A R E Able to treat solid cancers ✓ ✓ ✓ C A N C E R Ease of delivery ✓ ✓ ✓ O F Able to treat haematological cancers Comment H E A R T Clinical safety established RC220 T H E Clinical efficacy established Bisantrene/RC110 A T RC220 overcomes significant challenges Must be delivered by central line Intravenous delivery needed to treat solid tumours Solid cancer market presents much larger opportunity New formulation = new IP 14 A T Bisantrene + doxorubicin = improved anti-cancer activity 1 T H E O F 79% of cell lines show IC50 below 500 nM Bisantrene improves doxorubicin anti-cancer activity in 85% C A R E 500 Increasing potency C A N C E R Bisantrene IC50 (nM) H E A R T Bisantrene shows potent cell-killing activity against a diverse range of human cancers when used alone and in combination with doxorubicin, the most commonly used anthracycline of all cancers2 Type Bisantrene shows broad anti-cancer activity. The half-maximal inhibitory concentration (IC50) was determined for bisantrene against 143 cancer cell lines derived from diverse human tumour types. Boxes show the 25%-75% range, with the line within each box representing the median IC50 value. The upper and lower edges of the box represent the 75th and 25th percentiles, respectively. Whiskers show the minimum and maximum IC50 values observed for each cancer cell type. 1. ASX Announcement: 21 September 2023 | 2. 143 cancer cell lines screened. 15 T H E Vehicle Doxorubicin Dox + Bis 1:2 C A R E Data supports using bisantrene with anthracyclines to protect the hearts of patients from chemotherapy Cardiac output of C57BL/6 mice treated with either vehicle control (blue), bisantrene alone (orange), doxorubicin alone (grey), 1:1 molar ratio doxorubicin + bisantrene (yellow), or 1:2 molar ratio doxorubicin + bisantrene (red) at Day 0 and Day 42. All mice were dosed intravenously weekly with either: vehicle control, 7.33 mg/kg bisantrene, 5 mg/kg of doxorubicin, 5 mg/kg of doxorubicin + 3.67 mg/kg of bisantrene, 5 mg/kg of doxorubicin + 7.33 mg/kg of bisantrene. n=12 per group. Error bars = SEM. **p < 0.01. Promise of better cancer treatment with reduced side effects Dox/Bis Dox Normal Strong protection from anthracycline-induced cardiomyopathy No Fibrosis 1. ASX Announcement: 30 June 2022 Extensive Fibrosis C A N C E R Dox + Bis 1:1 Heart protection was achieved using higher levels of chemotherapy treatment with no extra toxicity observed O F Bisantrene H E A R T Bisantrene protects the hearts of mice from permanent damage caused by the anthracycline, doxorubicin A T Bisantrene + doxorubicin = protecting the heart 1 Minimal Fibrosis In vitro studies in human primary cardiomyocytes and in vivo studies in mice have demonstrated cardioprotection for the bisantrene + doxorubicin combinations, including increased cardiac function and reduced fibrosis when compared to doxorubicin alone 16 A T Clinical pipeline T H E H E A R T Discovery Acute Myeloid Leukaemia Chaim Sheba Medical Centre, Israel Phase 2 RC220 Cardioprotection + m6A RNA + anticancer efficacy - solid tumours Race Oncology2 Phase 1a/b H2 CY24 RC220 Acute Myeloid Leukaemia Investigator sponsored2 Phase 1/2 H2 CY24 m6A RNA molecule development Next generation bisantrene Race Oncology Preclinical RC110 Phase 1 Phase 2 Phase 3 Next milestone Successfully concluded in July 20241 2026 C A R E Sponsor C A N C E R IND enabling Indication O F Asset Ethics / governance approvals First patient dosed Confirmation of trial Preliminary results 1. https://announcements.raceoncology.com/announcements/6454612 | 2. https://announcements.raceoncology.com/announcements/6429352 17 A T T H E RC220 cardioprotection clinical program 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 C A N C E R Size: 25-50 patients; up to 10 sites in Australia and internationally Sponsor: Race Oncology C A R E Primary endpoints: Safety & optimal Phase 2 dose Exploratory endpoints: Standard & advanced cardiac markers including VO2Peak, m6A RNA levels, & anticancer efficacy Start: First patient H2 CY2024 (subject to RC220 availability) Timeline: 12–18 months due to Bayesian design uncertainty around total patient number (patient recruitment) Expands market potential of bisantrene beyond breast cancer to all cancers where anthracyclines are used Effect of bisantrene on the m6A RNA system will be collected by using a lead-in dose of bisantrene given 7 days prior to the first anthracycline combination dose – provides ‘clean’ PK/PD, m6A RNA & single-agent anticancer efficacy data Cost: A$11 million, fully funded (based on 50 patients) VO2Peak offers a clinically relevant endpoint that can provide clear evidence of cardioprotection and improvement in patient Quality of Life 18 A T Typical risks in drug development (illustrative) T H E Chance of a drug making it to market PHASE III NDA Lack of preclinical efficacy or toxicity Toxic in man Lack of efficacy Lack of efficacy, emerging toxicity Data insufficient Preclinical efficacy and toxicity known for combination Known toxicity as single agent and in other combinations Efficacy established for single agent and other combinations Efficacy and safety established for single agent MKT C A R E PHASE II C A N C E R Bisantrene Known molecule PHASE I O F Key risks Failure to find suitable molecule PRECLINICAL H E A R T DISCOVERY 96% 80% 50% 25% 10% 1% 1 3% 2 3 4 5 6 7 8 9 10 11 12 13 14 Years 19 US$1.5b US$7b C A N C E R cardioprotection + anti-cancer2 O F doxorubicin - 20231 H E A R T Annual revenue bisantrene T H E Annual revenue generic A T Bisantrene market potential – world C A R E Note: Forecasted revenue reflect a 50% reduction to the physician-stated adoption rate USD$100 base price/cycle for 4 cycles 1. https://www.theinsightpartners.com/reports/doxorubicin-market 2. Triangle Insights (ASX Announcement: 14 April 2023) USD$15,000 base price/cycle for 4 cycles with a 3% yearly net price increase after launch 20 T H E H1 CY2025 ✓ Interim results released from Sheba 2 study of bisantrene RC110 in AML patients – 40% response rate ✓ Distinguished Oncologist Daniel Von Additional preclinical results on bisantrene mechanism of action O F ✓ Proposal received for investigator led study of RC220 in AML patients Ethics submission for Phase 1a/1b trial in solid tumours File Investigational New Drug (IND) application with US Food and Drug Administration for RC220 cGMP RC220 manufacturing Governance approval for Phase 1a/1b trial in solid tumours First patient treated in Phase 1/2 AML study First patient treated in the RC220 solid tumour (all comers) Phase 1a/b Trial Initial results from RC220 Phase 1 solid tumour trial ✓ Leading cardiorespiratory expert, A/Prof Erin Bowden joins SAB cGMP RC220 released by Ardena for Updates on new molecules to target the m6A RNA pathway Bisantrene shows potent anti-cancer activity in AML models Publication of results from Sheba Phase 2 clinical study in AML ✓ safety and toxicology studies Completion of RC220 non-clinical Updates on clinical trial progress for RC220 cardioprotection study ✓ Appoints George Clinical as CRO Commence Phase 1/2 AML study ✓ use in human clinical trials ✓ 1. All dates are estimates and subject to change C A R E ✓ campaign completes Hoff Joins as Consultant C A N C E R H2 CY2024 H E A R T H2 CY2023 / H1 CY2024 A T Recent & upcoming milestones1 21 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 22 Contact PETE SMITH JANE LOWE Executive Chairman Investor & Media Relations +61 2 8051 3043 +61 411 117 774 peter.smith@raceoncology.com jane.lowe@irdepartment.com.au www.raceoncology.com Authorised for release by the Board ASX: RAC | RACE ONCOLOGY LIMITED | ABN 61 149 318 749