Announcement PDF Appendix 4E Preliminary final report 1. Details of reporting period Name of entity ABN Reporting Year Previous Corresponding Year 2. Race Oncology Limited 61 149 318 749 Year ended 30 June 2022 Year ended 30 June 2021 Results for announcement to the market Key information 12 months ended 30 June 2022 $ 12 months ended 30 June 2021 $ Increase/ (decrease) % 53,915 18,847 186% Amount change $ 35,068 (11,201,978) (6,340,319) (77%) ($4,861,659) (11,201,978) (6,340,319) (77%) ($4,861,659) 0.205 0.070 Revenues from ordinary activities Loss from ordinary activities after tax attributable to members Net loss for the year attributable to members Net tangible asset per share 3. Statement of profit or loss and other comprehensive income Refer to attached financial statements. 4. Statement of financial position Refer to attached financial statements. 5. Statement of cash flows Refer to attached financial statements. 6. Statement of changes in equity Refer to attached financial statements. 7. Dividends/Distributions No dividends declared in current or prior year. 8. Details of dividend reinvestment plans N/A Page | 1 9. Details of entities over which control has been gained or lost during the year N/A 10. Details of associate and joint venture entities N/A 11. Any other significant information needed by an investor to make an informed assessment of the Company’s financial performance and financial position Refer to attached financial statements. 12. Foreign entities On 6 October 2017, the Company incorporated a subsidiary in Belgium, Race Oncology, Company Number 0682664917. There were no signficant financial transactions through the subsidiary for the year ended 30 June 2022. 13. Commentary on results for period and explanatory information Race Oncology Limited incurred a net loss from operations for the financial year ended 30 June 2022 of $11,201,978 (2021: $6,340,319 loss). The net cash outflow from operating activities for the financial year was $6,257,837 (2021: $4,697,578). At 30 June 2022, the Group had a cash balance of $33,540,790 (2021: $9,322,436) and net assets of $36,107,409 (2021: $13,722,464). 14. Audit This report is based on accounts which have been audited and the audit report is included in the attached consolidated financial statements. Phillip Lynch Managing Director Authorised for release by the Board 26 August 2022 Page | 2 ASX: RAC 2022 Annual Report Novel RNA-directed therapeutics to treat cancer & protect the heart Corporate Directory DIRECTORS John Cullity – Non-Executive Chairman Phillip Lynch – Managing Director and Chief Executive Officer Daniel Tillett – Executive Director and Chief Scientific Officer Mary Harney – Non-Executive Director COMPANY SECRETARY Peter Webse REGISTERED OFFICE Level 36, Gateway, 1 Macquarie Place Sydney NSW 2000 Ph: +61 2 8051 3043 Website: www.raceoncology.com AUDITOR Hall Chadwick WA 283 Rokeby Road Subiaco WA 6008 SECURITIES EXCHANGE LISTING Race Oncology Limited’s shares are listed on the Australian Securities Exchange (ASX Code – RAC) SHARE REGISTRY Automic Registry Services Level 5, 126 Phillip Street Sydney NSW 2000 Ph: 1300 288 664 Race Oncology Limited ACN 149 318 749 Contents Chairman’s Letter 2 2022 Key Highlights 4 Directors’ Report 6 Auditor’s Independence Declaration 23 Consolidated Statement of Profit or Loss and Other Comprehensive Income 24 Consolidated Statement of Financial Position 25 Consolidated Statement of Changes in Equity 26 Consolidated Statement of Cash Flows 27 Notes to the Financial Statements 28 Directors’ Declaration 50 Independent Auditor’s Report 51 ASX Additional Information 56 Annual Report 2022 1 Chairman’s Letter It is my pleasure to share Race Oncology’s Annual Report for the period ended 30 June 2022, which was another significant year for our Company. Dear Fellow Shareholders, FY22 was marked by considerable clinical and preclinical progress and improved business prospects for Zantrene. Our pre-clinical program achievements in the year have been transformative and have prepared us well for pursuing clinical translation and assessment of Zantrene in patients. We have made considerable progress in our Acute Myeloid Leukaemia (AML) program, where we are now in the Phase 2 stage of a combination trial in relapsed or refractory (R/R) AML patients in Israel, after successfully completing the dose escalation (Phase 1b) phase. Our Australian trial of Zantrene in extramedullary (EMD) AML and highrisk Myelodysplastic Syndrome (MDS) was opened to patient recruitment. This world-first trial uses Zantrene as both a traditional high-dose chemotherapeutic, but also uniquely in a low-dose form to target FTO inhibition and the m6A RNA methylation pathway. 2 Race Oncology Limited In November 2021 we shared news of our preclinical in vitro results that showed Zantrene could both improve the anti-cancer effect and protect the heart muscle from chemotherapeutic induced damage when used with a commonly prescribed chemotherapeutic drug, doxorubicin. This significant result was further supported in an animal mouse model of chemotherapy-induced heart damage, with results reported in June 2022 demonstrating the ability of Zantrene to prevent heart damage and improve cancer treatment. This exciting and muchneeded cardioprotection opportunity is now being assessed for clinical translation. Commercialisation modelling is also underway to determine optimal clinical positioning. Race’s pursuit of the FTO-targeted opportunity remains a priority and we are pleased to see further global recognition of this approach via additional published pre-clinical studies that validate FTO’s role in treating cancer. We have demonstrated excellent preclinical results in AML, breast cancer, ovarian cancer, kidney cancer, and melanoma. Our team continues to work to determine the best cancer indication in which to clinically explore the exciting FTO opportunity. We are highly grateful of the support of our shareholders and particularly so for the robust support shown through our oversubscribed Share Purchase Plan (SPP) which raised $29.7 million in December 2021. This capital funds three core clinical program areas: EMD AML, for which we have now added European sites; cardio-protection in breast cancer (Australia); and in solid tumours where we seek to demonstrate Zantrene’s potential to target FTO in a world-first clinical trial. We have allocated smaller amounts of capital to support our drug development and formulation program which is supported by our ongoing collaboration with the University of Wollongong. Prudent financial management saw us finish FY22 with $33.5 million in cash reserves, versus $9.3 million in 2021. The financial year loss increased from $6.4 million to $11.2 million in 2022 as we purposefully increased investment in our research and development programs. The Race team has achieved many milestones this year and the Three Pillar strategy guides our focus. Looking ahead, you can expect to see continued pre-clinical progress to provide foundational support for our clinical programs. We will also report on our programs in the clinic through the remainder of FY23. I would like to take this opportunity to compliment and thank my fellow directors, management, employees, and the wider Race team for an enormous year of achievement. These results and those ahead offer cancer patients the potential for better outcomes. As we continue to move our important programs forward, we hope to see increasing interest in our activities amongst the broader global pharmaceutical industry and look forward to sharing our progress. Dr. John Cullity Non-Executive Chairman Annual Report 2022 3 2022 Key Highlights A year of major developments and clinical achievements for Zantrene® 4 September 2021 October 2021 November 2021 Preclinical results show Zantrene to be highly effective at killing a diverse range of high FTO producing melanoma cell subtypes Race enters into a research collaboration with Chaim Sheba Medical Center, Israel to analyse clinical patient samples from the ongoing Zantrene® Phase 1b/2 trial in relapsed/refractory Acute Myeloid Leukaemia (R/R AML) for FTO biomarkers A strategic collaborative research agreement with the University of Wollongong (UOW) is announced, to undertake preclinical evaluation of new Zantrene formulations November 2021 December 2021 Race announces a Share Purchase Plan (SPP) in order to raise up to $29.7 million Race extends heart protection collaboration with The University of Newcastle to explore the potential of Zantrene with additional anti-cancer drugs that can damage the heart in both cell culture and animal models October 2021 November 2021 November 2021 December 2021 Race secures a fifth and sixth patent for Zantrene in the US, further expanding the Company’s IP portfolio in the therapeutic utility of Zantrene Race enters into a collaborative preclinical research program with The University of Newcastle to develop a companion diagnostic to support the use of Zantrene® as a precision oncology treatment New preclinical research finds that Zantrene is able to protect heart muscle cells from anthracycline (specifically doxorubicin) induced cell death while improving the killing of breast cancer cells Zantrene found to protect heart muscle cells from a new class of anti-cancer drug (carfilzomib) induced cell death while improving the carfilzomib-mediated killing of cancer cells December 2021 March 2022 May 2022 June 2022 June 2022 SPP closes heavily oversubscribed and Race raises the full $29.7 million Zantrene shown to be highly effective in mouse model study of extramedullary AML US pharmaceutical veteran, Dr James Guy Breitenbucher, is appointed to Race’s Scientific Advisory Board (SAB) Race’s preclinical melanoma research program reports that Zantrene was found to enhance cancer immunotherapy in a mouse model Zantrene is found to protect the hearts of mice from the damaging effects of chemotherapeutic anthracycline, doxorubicin March 2022 April 2022 June 2022 June 2022 Compelling preclinical research finds Zantrene on its own, and in combination with known kidney cancer drugs, can kill kidney cancer cells at clinically relevant concentrations Human ethics approval received for Race’s phase 2 extramedullary AML & MDS trial Race expands its FTO-targeting phase 1b/2a trial in extramedullary AML MDS to include five additional trial sites in Spain and Italy, and signs a new clinical support agreement with global CRO, Parexel International Race’s preclinical melanoma research program shows that Zantrene, in combination with BRAF and MEK protein kinase inhibitors, improves the killing of human melanoma cells Race Oncology Limited Annual Report 2022 5 Race Oncology Limited ABN: 61 149 318 749 Directors’ Report Director’s Report For the Year Ended 30 June 2022 Your directors present their report, together with the financial statements of Race Oncology Limited (the Company, Race or RAC), for the financial year ended 30 June 2022. Information on directors Directors have been in office since the start of the financial year to the date of this report unless otherwise stated. John Cullity Qualifications Experience Non-Executive Chairman (appointed as a Director 6 April 2018) MBBS, MRCP, MSc(Econs), MBA Dr Cullity is Managing Director at BioSynergy Partners, a New York and Melbourne based advisory recently spun out of Torreya – the renowned life sciences investment bank. He additionally serves on the Boards of several life sciences companies including Ceramedix (seeded by Torreya). At Torreya, he provided strategic advisory on Mergers and Acquisitions, Partnering and Financing to life-science companies worldwide. Prior to joining Torreya, he was a senior member of the Business Development team at Sanofi Pharmaceuticals, where he led buy side transactions in oncology and diabetes. Earlier in his career, Dr Cullity was Head of Strategic Pricing and Reimbursement at Sanofi, Director of Health Economics at Schering-Plough, and Consultant at A.T. Kearney. He has also worked at the World Bank and the World Health Organisation. Dr Cullity graduated in Medicine and sub-specialised in haematology-oncology at QE II Medical Centre, Perth. He holds a Bachelor of Medicine, Bachelor of Surgery from The University of Western Australia; Membership of the Royal College of Physicians; Masters in Health Economics from London School of Economics & Political Science, and MBA from The Wharton School, University of Pennsylvania. Interest in shares and options Directorships held in listed entities Personal & related party relevant interests: • Biosynergy Partners Pty Ltd - 6,102,194 Fully Paid Ordinary Shares • Craganorig Holdings, LLC - 2,000,000 Fully Paid Ordinary Shares None 2 6 Race Oncology Limited Race Oncology Limited ABN: 61 149 318 749 Director’s Report For the Year Ended 30 June 2022 Information on directors (continued) Phillip Lynch Qualifications Experience Managing Director and Chief Executive Officer (appointed as a Director 1 June 2020) Graduate of Monash University with a Bachelor of Business in Marketing. Completed postgraduate studies at University of Virginia’s Darden Business School (USA). Graduate of the Australian Institute of Company Directors. Mr Lynch has a career spanning more than 30 years in the Asia Pacific region with Johnson & Johnson. He is an experienced executive and board director, with a diverse background across corporate development, strategy, financial performance, marketing and governance. In his former role as Vice President of Commercial Growth and Innovation at Johnson & Johnson Asia Pacific (J&J AP), 2016 - 2019, Mr Lynch partnered with the Mergers and Acquisitions team to drive the integration and growth of acquired businesses. He retired from J&J AP in December 2019 following the >$2b acquisition and integration of a significant Japanese business. He is currently the Chair of Consumer Health Products Australia. Interest in shares and options Personal & related party relevant interests: • 2,000,000 Options exercisable at $2.65 expiring 29/11/2025 • Lynch Eventide Holdings Pty Ltd <Lynch Family A/C> 429,149 Fully Paid Ordinary Shares Directorships held in listed entities None Daniel Tillett Executive Director and Chief Scientific Officer (appointed as a Director 17 September 2019) Ph.D in Molecular Genetics & Biochemistry Dr Tillett is the CEO and founder of Nucleics Pty Ltd, a private biotechnology company in the genomics space. He was previously a Senior Lecturer within the School of Pharmacy at La Trobe University where he lectured on biochemistry, biotechnology, pharmacy, microbiology and virology. Dr Tillett’s Ph.D on the molecular genetics and biochemistry of microcystin toxin production was awarded by the University of New South Wales in 2000. Personal & related party relevant interests: • 13,500,301 Fully Paid Ordinary Shares Qualifications Experience Interest in shares and options Directorships held in listed entities • 2,500,000 Options exercisable at $0.19 expiring 25/11/2022 • 2,000,000 Options exercisable at $2.65 expiring 29/11/2025 Simble Solutions Limited (Non-executive director appointed 16 February 2022) 3 Annual Report 2022 7 Race Oncology Limited ABN: 61 149 318 749 Directors’ Report Director’s Report For the Year Ended 30 June 2022 Information on directors (continued) Mary Harney Qualifications Experience Non- Executive Director (appointed 8 February 2021) BSc, BA (Fine Arts), AICD Ms Harney is the Director of specialist consulting firm Mary Harney Advisory providing leadership, governance and strategic advice across innovation industries such as health, biotech and agriculture. She currently also serves as Chairman of private Australian biotech Oncology One Pty Ltd, a cancer drug discovery company. Ms Harney was formerly the CEO of Royal Australasian College of Surgeons; CEO of Gardiner Research Foundation; COO and Director of Office of Cancer Research for Peter MacCallum Hospital, and; COO of Cerylid Biosciences. Other former roles were with CSL, Amrad, BIOPROPERTIES and Royal Melbourne Hospital. Interest in shares and options Personal & related party relevant interests: • Mary Celicia Harney <MAA Super Fund A/C> - 23,400 Fully Paid Ordinary Shares Directorships held in listed entities None Peter Webse Qualifications Experience Company Secretary B.Bus, FGIA, FCIS, FCPA, MAICD. Mr Webse has over 28 years' company secretarial experience and is the director of Governance Corporate Pty Ltd, a company specialising in providing company secretarial, corporate governance and corporate advisory services. Meetings of directors During the financial year, eleven meetings of directors (including committees of directors) were held. Attendances by each director during the year were as follows: Directors' Meetings Number eligible to attend Number attended 11 11 11 11 11 11 11 11 John Cullity Phillip Lynch Daniel Tillett Mary Harney Principal activities Race Oncology is an ASX listed precision oncology company with a Phase 2/3 cancer drug called Zantrene® (bisantrene dihydrochloride). Zantrene is a potent inhibitor of the Fatso/Fat mass and obesity-associated (FTO) protein. Overexpression of FTO has been shown to be the genetic driver of a diverse range of cancers. Race is exploring the use of Zantrene as a new therapy for melanoma, breast cancer, and clear cell renal cell carcinoma, all of which are both frequent FTO overexpressing cancers. In breakthrough preclinical research, Race has also discovered that Zantrene protects the heart from anthracycline-induced damage, while acting in tandem with anthracyclines and proteasome inhibitors to improve their ability to target cancer. Race is advancing this discovery in the laboratory with plans to move to the clinic in 2023. 4 8 Race Oncology Limited Race Oncology Limited ABN: 61 149 318 749 Director’s Report For the Year Ended 30 June 2022 Principal activities (continued) The Company has compelling clinical data for Zantrene as a chemotherapeutic agent and is currently undertaking two Phase 1/2 clinical trials in Acute Myeloid Leukaemia (AML). Race is pursuing outsized commercial returns for shareholders via its ‘Three Pillar’ strategy for the clinical development of Zantrene. Outlook Race Oncology is focused on using its Three Pillar strategy, as outlined at the 2021 Annual General Meeting, to achieve contemporary use of Zantrene by clinicians and regulatory approval for its use in a range of cancers. Shareholders supported this updated strategy through the subsequent Shareholder Purchase Plan (SPP) that raised $29.7 million to fund our strategy (ASX announcement: 23 November 2021). The SPP funding supports the Company to progress the following programs: a Phase 1b/2 FTO solid tumour clinical trial ($8.0 million); a cardioprotection Phase 2b clinical trial in breast cancer patients ($7.5m); expansion of the Phase 2 Extramedullary AML and high-risk Myelodysplastic syndrome (MDS) clinical trial to Europe ($9.2 million); enhanced formulations of Zantrene ($3.2 million); preclinical cardioprotection studies ($1.0 million); and the development of new molecules ($0.8 million). Clinical progress saw the Israel R/R AML combination trial move from Phase 1b to Phase 2 in FY22. Further progress is expected through FY23. The EMD AML trial in Australia is recruiting and the additional European expansion has been confirmed, extending the EMD AML study to Italy and Spain. All current clinical trials are open-label, so we look forward to reporting results on patient groups as they progress. The cardioprotection program has seen in vitro cell data now replicated via an in vivo animal study, providing confirmation that Zantrene, when combined with doxorubicin, improves cancer efficacy, while also mitigating cardiac damage, even at higher, more effective dosing. Plans to translate this to clinical evaluation are underway, as are commercial evaluations of how best to position this opportunity. Preclinical findings both within Race and globally continue to identify FTO and the broader m6A pathway as an exciting and novel means of targeting many different cancer types. Race will assess and determine the best proof of concept solid cancer type to target and identify approaches that will help to qualify its clinical application. Race has additional programs underway to expand Zantrene’s application and intellectual property through chemical, manufacturing, and formulation initiatives. We expect continued expansion of our patent portfolio based on these initiatives over the coming year. Overview of company performance The table below sets out information about Race's earnings and movements in shareholder wealth for the past five years up to and including the current financial year. NPAT($'m) Share price at year end ($) Basic EPS (cents) Total dividends (cents per share) 2022 2021 2020 2019 2018 (11.20) (6.34) (3.85) (3.66) (6.31) 1.95 3.67 0.70 0.05 0.21 (7.28) - (4.84) - (3.60) - (4.60) - (9.40) - Operating results The operating loss after providing for income tax amounted to $ 11,201,978 (2021: loss of $ 6,340,319); net cash used in operating activities was $ 6,257,837 (2021: $ 4,697,578) 5 Annual Report 2022 9 Race Oncology Limited ABN: 61 149 318 749 Directors’ Report Director’s Report For the Year Ended 30 June 2022 Dividends paid or recommended No dividends were paid or are payable for the financial year (2021: Nil). Review of operations On 9 August 2021, Race announced that the first patient had been dosed in its Phase 1b/2 AML clinical trial at the Chaim Sheba Medical Center Israel under Principal Investigator, Professor Arnon Nagler. Treating the first patient is an important step in any trial and builds upon earlier Phase 2 trial results, where a 40% overall clinical response rate was observed (ASX announcement: 16 June 2020). On 30 September 2021, Race announced that Zantrene kills melanoma cancer cells that overproduce FTO. The preclinical program led by University of Newcastle researchers Professor Zhang and Associate Professor Jin identified that Zantrene sensitivity is correlated with FTO levels and that high FTO producing cells show up to 60x greater sensitivity than low FTO producing cells. The results support future melanoma clinical trials for Zantrene, in combination with standard of care treatments. On 30 September 2021, Race shared an update on its preclinical and clinical programs, noting some COVID-19-related slowdowns in NSW, with significant progress occurring outside of the state. On 6 & 19 October 2021, Race announced that it had been granted its fifth and sixth USA patents, providing additional protection around the use, formulation, and compositions of Zantrene for improving the efficacy of related treatments. On 27 October 2021, Race announced an FTO biomarker research collaboration with Chaim Sheba Hospital, Israel. This research program will see an analysis of clinical patient samples by Dr Dom Dominissini, to assess the FTO biomarker and m6A RNA methylation status in patients treated with Zantrene. On 1 November 2021, Race announced the submission of its human ethics application to enable the commencement of a Phase 1b/2 extramedullary AML & MDS trial. This clinical program underpins future registration trials in the EU and US for Zantrene. The study is led by Associate Professor Anoop Enjeti (Calvary Mater Hospital, Newcastle) with the support of the Contract Research Organisation, Parexel. On 3 November 2021, Race initiated a collaboration study to develop a genomics-based companion diagnostic for Zantrene to support its use as a precision oncology drug. This study will be led by the experienced genomics researcher Professor Murray Cairns at the University of Newcastle. It will utilise the latest RNA genomics tools to identify genetic biomarkers associated with cancer’s sensitivity to Zantrene at the patient- specific level. On 9 November 2021, Race announced the initiation of a strategic collaboration with The University of Wollongong, focused on the optimisation of new formulations to support long-acting peripheral intravenous delivery of Zantrene. This collaboration will also pursue the development of an oral formulation of Zantrene. It will be led by experienced oncology formulator, Professor Marie Ranson, in collaboration with Race’s Principal Scientist, Professor Michael Kelso. This research is further supported by the appointment of Dr Ben Buckley as a Senior Scientist. On 22 November 2021, Race announced a preclinical breakthrough heart protection discovery for Zantrene. While anthracyclines are effective anti-cancer drugs, they carry a serious risk of causing permanent heart damage. Zantrene was shown to protect heart muscle cells from anthracycline-induced death when used in combination with anthracyclines. Furthermore, the combination of Zantrene and the anthracycline doxorubicin was found to better kill cancer cells. This cardioprotective effect was independent of the FTO inhibiting activity of Zantrene and provides Race with an entirely novel and significant, new commercial opportunity. 6 10 Race Oncology Limited Race Oncology Limited ABN: 61 149 318 749 Director’s Report For the Year Ended 30 June 2022 Review of operations (continued) On 23 November 2021, Race announced an update to its “Three Pillar Strategy” at the Company’s AGM, along with a Share Purchase Plan (SPP), designed to fund execution of the new strategy and to capitalise on the expanded commercial potential of Zantrene, by pursuing the following activities: • Pillar 1 – Current Zantrene, expanding the EMD AML & FTO clinical programs, initiating a US IND, and progressing the cardio-protective opportunity. • Pillar 2 – Optimising Zantrene, development to improve utility via improved IV, and oral formulations, and associated IP. • Pillar 3 – Beyond Zantrene, utilises team capabilities to pursue new RNA targeting molecules, via internal development, partnership, and/or acquisition. The SPP was announced with three levels of potential funding to support an expanded FTO-targeted clinical program in solid tumours, improved formulations, a cardioprotection clinical program, new drug development, and expansion of the Phase 1b/2 EMD AML program into Europe. The SPP was launched at $3.00 per share to shareholders of record on 22 November 2021, and closed on 17 December 2021, with the maximum raise capped at $29.7 million. On 8 December 2021, Race announced an additional heart protection preclinical discovery. Zantrene was found to protect heart muscle cells from damage caused by the Multiple Myeloma drug, carfilzomib (Kyprolis®) while synergising to improve its anti-cancer effects. This cardioprotective observation broadens the formulation and potential commercial opportunities for Zantrene via the development of new Zantrene / carfilzomib formulations. On 10 December 2021, Race announced an extension to its heart protection collaboration with the University of Newcastle. This program extension plans to assess the cardioprotective potential of Zantrene with additional anti-cancer drugs where heart damage is a known treatment risk. On 21 December 2021, Race announced raising the full $29.7 million target in a heavily oversubscribed SPP. This enables the progression of the FTO solid tumour Phase 1b/2 clinical trial, cardioprotective preclinical and clinical Phase 2b trial, expansion of the EMD AML Phase 1b/2 trial into Europe, improved Zantrene formulations, and new molecule development. On 18 January 2022, Race announced that it had received a $707,557 R&D tax refund for the financial year ended 30 June 2021. This reflects investment in Australian-based R&D projects and encourages us to utilise Australian-based research resources, where possible. On 23 February 2022, Race announced that MD Anderson Cancer Centre collaborators had published an AML preclinical study on Zantrene in the Journal of Leukemia & Lymphoma. The study identified that Zantrene, when used in combination with the AML drugs venetoclax, panobinostat, decitabine, and olaparib synergised in killing AML cells. This work supports our extramedullary AML trial plans where Zantrene will be used in combination with decitabine and cytarabine. On 10 March 2022, Race announced the results of a preclinical study that confirmed compelling kidney cancer results for Zantrene, both on its own and in combination with known cancer agents. Cell Killing synergies were observed when Zantrene was combined with either lenvatinib, cabozantinib, or pazopanib. These results support advancing Zantrene into human kidney cancer trials. On 17 March 2022, Race announced results from an extramedullary AML mouse model which showed high efficacy for Zantrene when used in combination with decitabine, to target extramedullary tumours, as well as AML cells in the bone marrow and spleen. These results support our Extramedullary AML clinical trial. On 30 March 2022, Race announced it had signed a clinical trial collaboration and supply agreement with Astex Pharmaceuticals, to supply ASTX727 (oral decitabine and cedazuridine) for Race’s Phase 1b/2 EMD AML study, entitled BISantrene Extramedullary ChemoTherapy (BISECT) (RAC-006). 7 Annual Report 2022 11 Race Oncology Limited ABN: 61 149 318 749 Directors’ Report Director’s Report For the Year Ended 30 June 2022 Review of operations (continued) On 6 April 2022, Race announced that it had received human ethics approval for its open- label, BISECT clinical trial of Zantrene in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS). This is the first clinical trial in the world to investigate the targeting of FTO and m6A RNA methylation a