Announcement • Jun 11
Racura Oncology Ltd has completed a Follow-on Equity Offering in the amount of AUD 0.999999 million. Racura Oncology Ltd has completed a Follow-on Equity Offering in the amount of AUD 0.999999 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 526,315
Price\Range: AUD 1.9
Transaction Features: Subsequent Direct Listing Announcement • Jun 05
Racura Oncology Ltd has filed a Follow-on Equity Offering in the amount of AUD 0.999999 million. Racura Oncology Ltd has filed a Follow-on Equity Offering in the amount of AUD 0.999999 million.
Security Name: Common Shares
Security Type: Common Stock
Securities Offered: 526,315
Price\Range: AUD 1.9
Transaction Features: Subsequent Direct Listing Recent Insider Transactions Derivative • May 25
CEO, MD & Director exercised options to buy AU$618k worth of stock. On the 21st of May, Daniel Tillett exercised options to buy 248k shares at a strike price of around AU$1.25, costing a total of AU$310k. This transaction amounted to 1.3% of their direct individual holding at the time of the trade. Since June 2025, Daniel's direct individual holding has increased from 17.27m shares to 19.47m. Company insiders have collectively bought AU$2.2m more than they sold, via options and on-market transactions, in the last 12 months. Announcement • May 16
Racura Oncology Receives Positive Safety Review Committee Recommendation for Ongoing Cpacs Clinical Trial Racura Oncology announced that the independent Safety Review Committee (SRC) has completed its review of safety data from Cohort 1 of the ongoing CPACS clinical trial, evaluating the safety and pharmacokinetics of RC220 alone and in combination with doxorubicin in advanced metastatic solid tumor patients. Following its review, the SRC recommended that the study continue, noting no safety concerns in patients treated with 40mg/m2 of RC220 as monotherapy, or 40mg/m2 of RC220 in combination with 60mg/m2 of doxorubicin, in the first patient cohort of this trial. Based on this positive SRC recommendation, Racura plans to proceed to screening of new eligible patients for enrolment in Cohort 2 (80mg/m2 RC220 dose level) using an updated trial protocol, which includes an initial lead-in safety monotherapy cycle of doxorubicin prior to the administration of RC220. This protocol update enables an assessment of the anthracycline-cardioprotective potential of RC220 using a blood-based molecular test. The Company has received the SRC's formal written recommendation and has promptly notified the clinical trial sites to initiate enrolment in Cohort 2, as patients present and meet the eligibility criteria. Recent Insider Transactions Derivative • May 09
CEO, MD & Director exercised options to buy AU$546k worth of stock. On the 7th of May, Daniel Tillett exercised options to buy 200k shares at a strike price of around AU$1.25, costing a total of AU$250k. This transaction amounted to 1.1% of their direct individual holding at the time of the trade. Since June 2025, Daniel's direct individual holding has increased from 17.27m shares to 18.82m. Company insiders have collectively bought AU$1.7m more than they sold, via options and on-market transactions, in the last 12 months. Announcement • May 08
Racura Oncology Reports Discovery of Primary Mechanism of Action for (E,E)-Bisantrene Racura Oncology, an Australian Phase 3 stage clinical biopharmaceutical company, reported the discovery of the primary mechanism of action (MOA) of its lead oncology asset, (E,E)-bisantrene. Bisantrene has a long clinical history of activity across a range of cancer indications, but its mechanism of action has been unknown. Preclinical studies undertaken by Racura and collaborators identified that (E,E)-bisantrene exerts its anticancer activity by binding to and stabilizing G-quadruplex (G4) DNA and RNA structures, key regulatory elements involved in controlling oncogene expression. At the American Association for Cancer Research (AACR) Annual Meeting 2026, Racura presented new preclinical data demonstrating that (E,E)-bisantrene directly binds and stabilizes G4 DNA structures within the c-MYC gene promoter region, resulting in potent suppression of c-MYC expression and broad cytotoxic activity in a wide range of cancer models. The MYC protein functions as a master regulator of gene expression, governing thousands of genes involved in cell growth, differentiation, survival, metabolic reprogramming, chemotherapy resistance, and immune surveillance. Crucially, MYC is the most commonly deregulated oncogene across human cancers, and has often been referred to as the 'holy grail' of targets due to its prevalence across many cancer indications. The promoter region of the c-MYC gene contains G4 DNA structures, which can suppress MYC expression when stabilized by drug binding. Racura is advancing a proprietary formulation of (E,E)-bisantrene (RC220) to address the high unmet needs of patients across multiple oncology indications, with a Phase 3 clinical program in acute myeloid leukemia (AML), a Phase 1a/b program in mutant epidermal growth factor receptor non-small cell lung cancer (EGFRm NSCLC), and a Phase 1a/b program in combination with the anthracycline doxorubicin, where the company aims to deliver both cardioprotection and enhanced anticancer activity for solid tumor patients. Preclinical studies have highlighted how (E,E)-bisantrene silences c-MYC gene expression via G4-DNA binding and stabilization leading to clinically relevant and broad anticancer activity. Recent Insider Transactions Derivative • Apr 07
CEO, MD & Director exercised options to buy AU$526k worth of stock. On the 2nd of April, Daniel Tillett exercised options to buy 200k shares at a strike price of around AU$1.24, costing a total of AU$249k. This transaction amounted to 1.1% of their direct individual holding at the time of the trade. Since June 2025, Daniel's direct individual holding has increased from 17.27m shares to 18.82m. Company insiders have collectively bought AU$1.4m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions Derivative • Feb 20
CEO, MD & Director exercised options to buy AU$222k worth of stock. On the 19th of February, Daniel Tillett exercised options to buy 100k shares at a strike price of around AU$1.25, costing a total of AU$125k. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. Since June 2025, Daniel's direct individual holding has increased from 17.27m shares to 18.52m. Company insiders have collectively bought AU$1.2m more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions • Feb 16
CEO, MD & Director recently bought AU$90k worth of stock On the 13th of February, Daniel Tillett bought around 63k shares on-market at roughly AU$1.44 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Daniel has been a buyer over the last 12 months, purchasing a net total of AU$160k worth in shares. Recent Insider Transactions Derivative • Jan 23
CEO, MD & Director exercised options to buy AU$1.1m worth of stock. On the 22nd of January, Daniel Tillett exercised options to buy 400k shares at a strike price of around AU$1.24, costing a total of AU$495k. This transaction amounted to 2.2% of their direct individual holding at the time of the trade. Since June 2025, Daniel's direct individual holding has increased from 17.27m shares to 18.47m. Company insiders have collectively bought AU$985k more than they sold, via options and on-market transactions, in the last 12 months. Major Estimate Revision • Dec 23
Consensus EPS estimates upgraded to AU$0.041 loss The consensus outlook for fiscal year 2026 has been updated. 2026 losses forecast to reduce from -AU$0.159 to -AU$0.041 per share. Revenue forecast unchanged from AU$2.60m at last update. Biotechs industry in Australia expected to see average net income decline 14% next year. Consensus price target up from AU$6.37 to AU$7.46. Share price rose 8.1% to AU$2.79 over the past week. Recent Insider Transactions Derivative • Dec 19
CEO, MD & Director exercised options to buy AU$813k worth of stock. On the 18th of December, Daniel Tillett exercised options to buy 300k shares at a strike price of around AU$1.25, costing a total of AU$374k. This transaction amounted to 1.7% of their direct individual holding at the time of the trade. Since June 2025, Daniel's direct individual holding has increased from 17.27m shares to 17.76m. Company insiders have collectively bought AU$490k more than they sold, via options and on-market transactions, in the last 12 months. Announcement • Dec 09
Racura Oncology Ltd has completed a Follow-on Equity Offering in the amount of AUD 3.223449 million. Racura Oncology Ltd has completed a Follow-on Equity Offering in the amount of AUD 3.223449 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 1,139,028
Price\Range: AUD 2.83
Transaction Features: Subsequent Direct Listing Recent Insider Transactions • Nov 29
CEO, MD & Director recently bought AU$59k worth of stock On the 26th of November, Daniel Tillett bought around 22k shares on-market at roughly AU$2.67 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Daniel's only on-market trade for the last 12 months. New Risk • Nov 18
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 20% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$4.6m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$12m net loss in 3 years). Revenue is less than US$5m (AU$6.0m revenue, or US$3.9m). Announcement • Oct 06
Race Oncology Limited, Annual General Meeting, Nov 24, 2025 Race Oncology Limited, Annual General Meeting, Nov 24, 2025. Location: library auditorium, state library nsw, 1 shakespeare place, sydney, new south wales Australia New Risk • Sep 25
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 13% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$4.6m free cash flow). Earnings are forecast to decline by an average of 1.0% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$12m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Revenue is less than US$5m (AU$6.0m revenue, or US$4.0m). Major Estimate Revision • Sep 24
Consensus revenue estimates decrease by 13% The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast fell from AU$3.00m to AU$2.60m. EPS estimate unchanged from -AU$0.16 per share at last update. Biotechs industry in Australia expected to see average net income decline 16% next year. Consensus price target of AU$6.37 unchanged from last update. Share price rose 31% to AU$3.38 over the past week. New Risk • Jul 01
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$820k This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$820k free cash flow). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$17m net loss in 2 years). Revenue is less than US$5m (AU$5.3m revenue, or US$3.5m). Announcement • May 05
Race Oncology Limited Announces Change of Chief Medical Officer, Effective May 5, 2025 Race Oncology Limited announced the appointments of Dr. Jose Iglesias, who succeeds Dr. Michelle Rashford as Chief Medical Officer (CMO), effective 5 May 2025. Dr. Jose Iglesias is an internationally recognized pharmaceutical executive with a distinguished career spanning both major and emerging pharmaceutical companies. His appointment marks a significant addition to Race's clinical leadership team. Dr. Iglesias held key leadership roles at Abraxis BioScience, including Vice President of Global Clinical Development and Chief Medical Officer, where he oversaw the global development of the reformulated chemotherapeutic agent, Abraxane® (paclitaxel) and other pipeline assets. He later served as Vice President of Clinical Development at Celgene, successfully leading several Phase 3 clinical programs for Abraxane® in pancreatic, lung, and metastatic breast cancers. Dr. Iglesias has also held senior medical leadership roles at Amgen, Bionomics, Biothera Pharmaceuticals, Apobiologix, and Eli Lilly, including as Head of Clinical Studies at Eli Lilly Australia. His has extensive experience interacting with global regulatory authorities, reimbursement agencies, oncology cooperative groups, and patient advocacy organizations. He serves as an independent oncology consultant, specializing in solid tumour oncology, immuno-oncology, and translational medicine, with a focus on early to mid-phase clinical development. A widely published expert in oncology, Dr. Iglesias's work has garnered over 12,000 citations. Announcement • Apr 03
Race Oncology Limited Announces RC220 Phase 1 Trial Opens for Patient Enrolment Race Oncology Limited (Race) announced the site activation of Southside Cancer Care Centre (Miranda, NSW) after receiving governance approval enabling the commencement of patient enrolment for its Phase 1 clinical trial of RC220 in combination with doxorubicin in advanced solid tumours patients. This follows the receipt of human ethics approval, undertaking site initiation, and completion of all documentation. The Phase 1 trial will be open label and conducted across multiple sites in Australia, Hong Kong and South Korea. The trial will use ascending doses of RC220 in up to 33 patients to determine the safety, tolerability, pharmacokinetics, maximum tolerated combined dose (MTCD) in combination with doxorubicin, and effects on a range of clinical biomarkers including m6A RNA. After an interim analysis of the data, the optimal dosage of RC220 in combination with doxorubicin will be assessed in an additional 20 patients for further safety, tolerability, and preliminary cardioprotective and anticancer efficacy signals. The Phase 1 trial will use a Bayesian design enabling greater trial flexibility and speed than traditional approaches. A recent meta-analysis of single agent doxorubicin treatment undertaken by Race Oncology has identified an anticancer response rate to doxorubicin of up to 35% in a wide range of advance and metastatic solid tumour cancers including breast cancer, small cell lung cancer, ovarian cancer, bladder cancer, liver cancer, endometrial cancer, upper gastrointestinal cancer, thyroid cancer, non-small cell lung cancer, and prostate cancer. Preclinical studies by Race Oncology have identified enhancement of the cancer killing activity of doxorubicin by the active anticancer agent in RC220 in 85% of 143 diverse cancer cell lines screened. Timing of first patient enrolment is subject to patient suitability and their interest in participating in the trial. Announcement • Mar 31
Race Oncology Limited Receives HREC Approval from Bellberry to Commence its RC220 Phase 1 Clinical Trial at Gosford and Wyong Hospitals Race Oncology Limited announced that it has received HREC approval from Bellberry to commence its RC220 Phase 1 clinical trial at Gosford and Wyong Hospitals (Central Coast Local Health District). HREC approval allows both the Gosford and Wyong Hospitals to enrol patients subject to final site approvals and activation. These approvals are expected during the month of April. The RAC-010 clinical trial is designed to assess the safety, tolerability and pharmacokinetics (PK) of RC220 alone and in combination with doxorubicin, in patients with solid tumours. This approval follows recent HREC approval for the Southside Cancer Centre (Miranda). It is expected HREC approval will be received for additional trial sites in Australia, Hong Kong and South Korea over the following months. New Risk • Feb 26
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 16% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$17m net loss in 2 years). Revenue is less than US$5m (AU$5.2m revenue, or US$3.3m). Announcement • Oct 07
Race Oncology Limited, Annual General Meeting, Nov 25, 2024 Race Oncology Limited, Annual General Meeting, Nov 25, 2024. Location: at the dixon room, state library nsw, 1 shakespeare place, new south wales, australia., sydney Australia Major Estimate Revision • Oct 01
Consensus revenue estimates increase by 12% The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from AU$4.30m to AU$4.80m. Forecast losses expected to reduce from -AU$0.079 to -AU$0.037 per share. Biotechs industry in Australia expected to see average net income growth of 4.1% next year. Consensus price target up from AU$3.22 to AU$3.67. Share price fell 3.0% to AU$1.78 over the past week. Price Target Changed • Jun 29
Price target increased by 26% to AU$3.22 Up from AU$2.56, the current price target is provided by 1 analyst. New target price is 76% above last closing price of AU$1.83. Stock is up 49% over the past year. The company is forecast to post a net loss per share of AU$0.072 next year compared to a net loss per share of AU$0.062 last year. New Risk • Jun 06
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$15m net loss in 2 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (4.0% increase in shares outstanding). Revenue is less than US$5m (AU$5.8m revenue, or US$3.9m). New Risk • May 17
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.6% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$15m net loss in 2 years). Shareholders have been diluted in the past year (2.6% increase in shares outstanding). Revenue is less than US$5m (AU$5.8m revenue, or US$3.9m). New Risk • Mar 30
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$13m free cash flow). Earnings have declined by 26% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (2.1% increase in shares outstanding). Revenue is less than US$5m (AU$5.8m revenue, or US$3.8m). New Risk • Feb 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$13m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$13m free cash flow). Earnings have declined by 26% per year over the past 5 years. Minor Risks Revenue is less than US$5m (AU$6.1m revenue, or US$4.0m). Market cap is less than US$100m (AU$128.8m market cap, or US$83.7m). Announcement • Nov 22
Race Oncology Limited Appoints Daniel Tillett as Chief Executive Officer Race Oncology Limited announced that Dr Daniel Tillett has been appointed full-time Chief Executive Officer, effective immediately. Dr Tillett will work alongside Executive Director, Dr Pete Smith, to advance the Company's strategic, clinical and commercialization plans for bisantrene. From September 2019 to March 2023, Dr Tillett was Race's Chief Scientific Officer and Executive Director. He has most recently been working with the Company in a consultancy capacity. In addition to his extensive experience with Race and bisantrene, Dr Tillett brings more than 25 years of experience in the biotech industry and is the founder and CEO of Nucleics, an Australian biotechnology company focused on DNA sequencing and genomics. He was a tenured academic (Senior Lecturer) within the School of Pharmacy and Applied Science at La Trobe University, Australia teaching and researching in the areas of phage therapy (bacterial virology), pharmacy, environmental microbiology, bioinformatics and cancer. Announcement • Oct 10
Race Oncology Limited, Annual General Meeting, Nov 27, 2023 Race Oncology Limited, Annual General Meeting, Nov 27, 2023, at 12:00 AUS Eastern Standard Time. Location: the Dixon Room, State Library NSW, 1 Shakespeare Place Sydney New South Wales Australia Agenda: To consider the re-election and appointment of Directors. New Risk • Oct 05
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Earnings have declined by 23% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (2.2% increase in shares outstanding). Revenue is less than US$5m (AU$3.1m revenue, or US$2.0m). Market cap is less than US$100m (AU$147.8m market cap, or US$93.6m). New Risk • Aug 30
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 19% per year over the past 5 years. Revenue is less than US$1m (AU$1.4m revenue, or US$892k). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Market cap is less than US$100m (AU$132.4m market cap, or US$85.8m). Announcement • Aug 22
Race Oncology Limited Announces Board Changes Race Oncology Limited announced changes to the Board and Management team structure, to ensure the company and its lead asset, bisantrene, are suitably positioned for clinical success. Effective immediately, Dr. Peter Smith will step into the role of Executive Director, taking over from Damian Clarke-Bruce, who has tendered his resignation. Non-Executive Director, Dr. John Cullity has advised his intention to retire from the Race Board, following a long and productive tenure. New Risk • Aug 15
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: AU$140.5m (US$91.4m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 19% per year over the past 5 years. Revenue is less than US$1m (AU$1.4m revenue, or US$895k). Minor Risk Market cap is less than US$100m (AU$140.5m market cap, or US$91.4m). Announcement • Jun 29
Race Oncology Limited Announces Board Changes Race Oncology Limited announced the appointment of Dr Peter Smith as a Non-Executive Director, replacing Daniel Sharp who has advised his resignation to concentrate on other personal and professional interests. Dr Peter (Pete) Smith has over 30 years of experience in a broad range of activities in the healthcare industry with a strong focus on therapeutics, especially oncology. He has been involved in projects at all stages from concept to phase III clinical studies. He is currently CEO of private company, Myrio Therapeutics (formerly Affinity Bio.) Before joining Myrio, he was CEO of publicly listed Australian companies Alchemia and AMRAD (later acquired by CSL.) Prior to moving to Australia, Pete co-founded and was CFO of Onyvax Ltd, a cancer immune-therapy company based in London. At the start of his career, he was a top-rated Pharmaceuticals Analyst with UBS and HSBC and was involved in numerous transactions including IPOs, fundraisings and M&A. His undergraduate degree and PhD are from the University of Cambridge, the latter in the field of cell-signalling. He is currently also a Director of private companies, Hula Therapeutics and Amala Therapeutics. Announcement • May 09
Race Oncology Limited Appoints Michelle Rashford Chief Medical Officer, Effective 1 July 2023 Race Oncology announced the appointment of Dr. Michelle Rashford as Chief Medical Officer (CMO), taking over from Interim CMO, Dr. Ajay Duggal. Dr. Rashford is an internationally experienced biopharmaceutical executive and former physician, with expertise in the successful development and commercialisation of pharmaceuticals across oncology, virology, and immunology. Her 25+ years of drug development experience spans large pharmaceuticals to smaller biotech companies and includes pre-clinical and clinical development, medical and regulatory affairs, and drug commercialisation. Dr. Rashford will join Race Oncology on 1 July 2023 from the Japanese Pharmaceutical company Kyowa Kirin, where she has been the Head of Global Clinical Sciences. Prior to her role at Kyowa Kirin, Dr. Rashford was the Senior Vice President of Clinical Science at Adlai Nortye Biopharma, where she successfully grew the US Clinical Development team and prepared for the company's Phase III trial. She has also held senior roles within global pharmaceutical companies, including five years at Bristol-Myers Squibb and close to 20 years at Roche in a variety of national and global clinical development roles. Dr. Rashford holds a Bachelor of Medicine & Bachelor of Surgery from the University of Tasmania, Australia. Announcement • Feb 02
Race Oncology Limited Appoints Damian Clarke-Bruce as Director Race Oncology Limited announced the appointment of Damian Clarke-bruce as Director. Date of appointment is February 1, 2023. Announcement • Feb 01
Race Oncology Limited Receives Human Ethics Approval for Observational Cardioprotection Breast Cancer Trial Race Oncology Limited announced it has received human ethics approval from the Hunter New England Human Research Ethics Committee(NSW, Australia) for the observational stage of a planned Phase 1/2b clinical trial of Zantrene (bisantrene dihydrochloride) in breast cancer patients, to be treated with doxorubicin and cyclophosphamide and who have two or more cardiovascular risk factors. Details of the trial design and purposes have been previously described. Before patients can be enrolled and treated Race must first submit and then receive research institutional governance (site budget and contracting) approval. Submission is expected to take place in the coming weeks. Governance approval is typically received within 4 to 8 weeks of submission. The study will recruit and monitor up to 50 patients being treated for breast cancer using the standard of care (SoC) regimen of doxorubicin (Adriamycin®) and cyclophosphamide - referred to as "AC chemotherapy". The aim of this study is to identify the rate and level of heart damage caused by AC chemotherapy, using modern advanced cardiac imaging and biochemical methods. In addition, the anti-cancer efficacy of AC chemotherapy will be monitored using a liquid biopsy (DNA) approach. The data from this study will be directional for the design of a subsequent Phase 1/2b interventional trial that may help patients to avoid the permanent heart damage that can be caused by AC chemotherapy as well as potentially improving anti-cancer outcomes. These human trials are fully funded from capital raised in December 2021. Announcement • Jan 19
Race Oncology Limited, Annual General Meeting, Feb 21, 2023 Race Oncology Limited, Annual General Meeting, Feb 21, 2023, at 10:30 AUS Eastern Standard Time. Location: Race Oncology Limited, Level 36, Gateway Building, 1 Macquarie Place, Sydney NSW 2000 Sydney New South Wales Australia Agenda: To consider and approve issue of options to director - Danny Sharp; to approve issue of options to director Damian Clarke-Bruce; to approve issue of options to director Mary Harney; to approve the increase in total aggregate remuneration for non-executive directors; to consider other matters if any. Recent Insider Transactions • Jan 17
Board Member recently bought AU$50k worth of stock On the 13th of January, Daniel Tillett bought around 26k shares on-market at roughly AU$1.97 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. In the last 3 months, they made an even bigger purchase worth AU$99k. Insiders have collectively bought AU$427k more in shares than they have sold in the last 12 months. Recent Insider Transactions • Dec 23
Board Member recently bought AU$99k worth of stock On the 20th of December, Daniel Tillett bought around 47k shares on-market at roughly AU$2.12 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold AU$619k more in shares than they bought in the last 12 months. Announcement • Dec 10
Race Oncology Limited Announces It Has Submitted A Human Ethics Application to Hunter New England Human Research Ethics Committee Seeking Approval to Commence the Observational Stage of A Planned Phase 1/2B Clinical Trial of Zantrene Race Oncology Limited announced it has submitted a human ethics application to the Hunter New England Human Research Ethics Committee (NSW, Australia) seeking approval to commence the observational stage of a planned Phase 1/2b clinical trial of Zantrene® (bisantrene dihydrochloride) in breast cancer patients to be treated with doxorubicin and cyclophosphamide and who have two or more cardiovascular risk factors. This study will be led by Associate Professor Aaron Svedlov, a highly credentialedcardiologist with a research focus on cardio-oncology. Dr Sverdlov was awarded the 2018 Ministerial Award for Rising Stars in Cardiovascular Research. He established and co- chairs the National Cardio-Oncology Working Group under the auspices of the AustralianCardiovascular Alliance. Dr Sverdlov has over 50 peer-reviewed publications and four book chapters in the field of cardio-oncology.The study will recruit and monitor up to 50 patients being treated for breast cancer using the standard of care (SoC) regimen of doxorubicin (Adriamycin®) and cyclophosphamide - referred to as "AC chemotherapy". The aim of this study is to identify the rate and level of heart damage caused by AC chemotherapy using modern advanced cardiac imaging and biochemical methods. In addition, the anti-cancer efficacy of AC chemotherapy will be monitored using a liquid biopsy (DNA) approach. The study is expected to fully recruit in 2023. The data from this study will be used to design a subsequent Phase 1/2b interventional trial that may help patients to avoid the permeant heart damage caused by AC chemotherapy and improve anti-cancer outcomes. These human trials are fully funded from capital raised in December 2021 (ASX Announcement: 21 December 2021). Announcement • Dec 05
Race Oncology Limited Appoints Daniel (Danny) Sharp as an Independent Non-Executive Director Race Oncology Limited announced that Mr. Daniel (Danny) Sharp has been appointed as an Independent Non-Executive Director. After commencing his career as a solicitor, Mr. Sharp has had an extensive investment banking career of more than 25 years where he has advised the boards of technology and healthcare-based organizations on global capital markets. He has an extensive network of institutional and private wealth investors. From 2012 to 2020, Mr. Sharp was an Executive Director of leading independent, financial services firm Canaccord Genuity. He is currently a Non-Executive Director of health informatics company, Alcidion Group Limited and Non-Executive Director of the dermatology-focused Botanix Pharmaceuticals Limited. He is also a member of the investment committee of the Baker Heart and Diabetes Institute Foundation. Mr. Sharp previously headed the corporate banking division of Shaw and Partners and Lodge Partners. He holds a Bachelor of Economics and Law and is a CFA Charter Holder. Announcement • Nov 23
Race Oncology Limited Receives Positive Guidance on Zantrene Via Pre-IND Meeting with US FDA Race Oncology Limited announced that it has received confidential and constructive guidance by way of a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) for Zantrene (bisantrene dihydrochloride). Race submitted a pre-IND meeting package to the FDA in September 2022, which included a summary of the preclinical and clinical data for Zantrene, an overview of the proposed clinical development plan, and specific questions on the requirements to open an Investigational New Drug (IND) application. Opening an IND is a requirement before undertaking clinical trials in the United States and is a key step in the process of obtaining a New Drug Application (NDA) and marketing approval for a new drug. In written correspondence, the FDA provided insightful and helpful feedback on the proposed clinical development plan for Zantrene and acknowledged that Acute Myeloid Leukemia (AML) continues to have significant unmet clinical needs which require new treatment solutions. Importantly, the FDA agreed that Race had adequately addressed outstanding clinical hold issues from an earlier IND application submitted in 2019 (ASX announcement: 25 April 2019). Under current US regulations, if the FDA does not place a clinical hold within 30 days of an IND submission the trial can proceed. The FDA also confirmed that the FDA505(b)(2) application pathway is a possible regulatory pathway for Zantrene, whereby some of the data from studies completed on Zantrene in the public domain can contribute to the full regulatory package required for a New Drug Application (NDA). The FDA provided guidance on the data requirements for opening an IND for Zantrene, including helpful counsel related to the AML patient populations that should be studied. While Race has no current plans to undertake any clinical trials in the US, receiving timely guidance from the FDA provides valuable commercial optionality as Race's clinical activities and partnership discussions continue to advance. Board Change • Nov 16
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 5 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Martin Tallman is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Nov 11
Race Oncology Ltd Announces Management Changes Race Oncology Ltd. announced that Dr David Fuller has resigned as Chief Medical Officer (CMO), effective 11 November 2022, to take up the role of CMO at Aucentra Therapeutics. Dr Fuller is succeeded by Dr Ajay Duggal of Adnovate Clinical who commences on 14 November 2022 as interim CMO, pending appointment of a new full time CMO. The interim CMO will work closely with Race's executive and clinical team who have been intimately involved in all aspects of the design and implementation of Race's clinical programs. All clinical programs are expected to continue without disruption. Announcement • Oct 04
Race Oncology Limited, Annual General Meeting, Nov 24, 2022 Race Oncology Limited, Annual General Meeting, Nov 24, 2022, at 12:00 E. Australia Standard Time. Location: The Press Room, Radisson Blue Plaza Sydney, 27 O'Connell Street Sydney New South Wales Australia Agenda: re-election and appointment of Directors. Announcement • Sep 28
Race Oncology Limited Develops Improved Iv Formulation of Zantrene Race Oncology Limited announced that Race researchers, led by Dr. Benjamin Buckley in collaboration with the University of Wollongong, have developed a new formulation of Zantrene that enables peripheral (arm or leg vein) intravenous (IV) delivery to patients. This novel and improved formulation (codename RC220) provides clinicians with an easier to use alternative to the current central line formulation of Zantrene. This formulation has greater market potential and is particularly well suited to solid tumour patients. Clinical Significance; Administration of Zantrene has until now required the use of an invasive central venous catheter (central or main line) that must be performed in a hospital setting. While this is common practice for the delivery of chemotherapy drugs in patients with leukaemias, it is not optimal for patients with solid tumours (such as breast cancer, melanoma, lung cancer, kidney cancer, etc) where peripheral IV infusion in an outpatient setting is often preferred by both the patient and treating oncologist. Peripheral IV administration can provide a better quality of life for patients with less pain and lifestyle disruption as it enables patients to be treated outside of a major hospital or within their own homes. The ability to precisely match the required drug dose to the patient's need is also simpler using an IV formulation than with other delivery options, such as fixed size oral dosing. In addition, for uses where low and continuous dosing are desirable (such as inhibiting an enzyme like FTO), a peripheral IV formulation can be a better option. Commercial Significance; Peripheral IV formulations have significant commercial advantage. As central line administration requires highly skilled healthcare personnel, simpler peripheral IV formulations are attractive in resource constrained healthcare environments. An additional commercial benefit of the new peripheral IV formulation is the ability to deliver Zantrene more rapidly to the patient, minimising occupancy of expensive oncology infusion chairs and providing the patient with a better treatment experience. A more immediate impact of the RC220 IV formulation is improved patient recruitment potential for future clinical trials. Only a minority of solid tumour patients are willing to participate in clinical trials that require central line infusions. In a competitive oncology trial environment where the patient has many suitable trials to choose between, comfort and quality of life are important non-clinical factors that strongly influence patient choice of trial enrolment. Announcement • Sep 27
Race Oncology Limited Initiates New Drug Discovery Program Race Oncology Limited announced that it has contracted the Monash Fragment Platform (MFP) at Monash University to complete a fragment-based screening program aimed at discovering novel drugs that inhibit the mA RNA demethylases FTO and ALKBH5. Eminent medicinal chemist and Director of the MFP, Professor Martin Scanlon, will lead the project. All intellectual property developed in the project will be owned exclusively by Race. RNA Epitranscriptomics: Important scientific discoveries made over the last decade have identified dysregulation (loss of control) of RNA epigenetics (epitranscriptomics) as a key driver of cancer and other complex diseases. Two of the major players in this dynamic regulatory system are the Fatso/FaT and Obesity associated (FTO) and ALKBH5 proteins. FTO and ALKBH5 are the only m6A RNA demethylases found in humans and are major global regulators of the m6A RNA levels in cells. Changes in the expression of FTO or ALKBH5 has a profound impact on cancer growth, spread and resistance to treatment. Inhibiting FTO or ALKBH5 activity is able to kill or slow the growth of a wide range of cancers, including leukaemia, breast, lung, ovarian, gastric, brain, melanoma, pancreatic, kidney and many more. Race Oncology's most advanced asset Zantrene® (bisantrene dihydrochloride) is a potent inhibitor of FTO (IC50 142nM) and is the only m6A RNA demethylase inhibitor and RNA epitranscriptomic drug in the clinic. NMR Fragment Based Drug Screening: To build on success in the RNA epitranscriptomics space, Race is aiming to discover new, potent and selective inhibitors of FTO and ALKBH5 for use in cancer and other indications. To advance this program, Race has contracted the Monash Fragment Platform to complete a fragment screening campaign using the latest techniques in nuclear magnetic resonance spectroscopy (NMR). In this approach, a library of diverse small molecules (`fragments') will be tested by NMR for their ability to bind to the FTO and ALKBH5 proteins. Molecules that are found to bind to the proteins will be transformed into drug leads and ultimately clinical drug candidates in a follow-up medicinal chemistry campaign. This screening program will start immediately with results reported over the coming 12 months. The total cost of the project is $286,786 and is expected to be eligible for the ATO 43.5% R&D Tax Rebate. Recent Insider Transactions • Sep 27
Board Member recently bought AU$165k worth of stock On the 23rd of September, Daniel Tillett bought around 84k shares on-market at roughly AU$1.97 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold AU$6.0m more in shares than they bought in the last 12 months. Announcement • Jun 30
Race Oncology Limited Shares Further Interim Results from Preclinical Cardioprotection Program in Collaboration with Researchers from the University of Newcastle Race Oncology Limited shared further interim results from preclinical cardioprotection program in collaboration with researchers from the University of Newcastle. This program aimed at exploring the use of Zantrene® (bisantrene dihydrochloride) as a cardioprotective agent which offered synergy with anti-cancer treatments. Zantrene was found to protect the hearts of mice from the damaging effects of anthracyclines (specifically doxorubicin) even when the chemotherapeutic dose was increased without significant additional toxicity or bone marrow suppression. Anthracyclines are one of the most effective anti-cancer treatments developed and are used in more cancer settings than any other class of chemotherapeutic agent. These drugs are used to treat millions of cancer patients every year, including those with leukemias, lymphomas, neuroblastoma, kidney, liver, stomach, uterine, thyroid, ovarian, sarcomas, bladder, lung and breast cancers. The clinically most important anthracyclines are doxorubicin, daunorubicin, epirubicin and idarubicin. The anti-cancer efficacy of anthracyclines is known to correlate to dose with higher doses providing greater efficacy, but at the expense of higher rates of serious side-effects. In clinical practice, anthracycline chemotherapeutics such as doxorubicin are given at a level close to the patient's maximal tolerated dose (MTD) in order to maximise the anticancer efficacy. Common dose limiting toxic side-effects of anthracyclines include: cardiotoxicity, suppression of the immune system and red blood cell production (myelosuppression), hair loss (alopecia), and gastrointestinal toxicity that can cause serious nausea and weight loss. While highly effective anti-cancer drugs, the anthracyclines can cause serious and permanent damage to the heart in many patients. Some studies have estimated that over half of patients exposed to anthracyclines will develop some form of heart disease within 6 years of treatment. Anthracyclines, such as doxorubicin and epirubicin, can lead to either acute or late onset cardiotoxicity. Acute toxicity is associated with increased inflammation and can lead to a pericarditis-myocarditis syndrome. Flaccid dilative cardiomyopathy is the predominant form of late onset anthracycline cardiotoxicity and can occur months to years after anthracycline exposure. Announcement • Jun 22
Race Oncology Limited Announces Interim Results from its Preclinical Melanoma Research Program 22 June 2022 - Race Oncology Limited shared further interim results from its preclinical melanoma research program. The program's objective was to explore the use of Zantrene® (bisantrene dihydrochloride) in novel drug combinations for the treatment of drug and immunotherapy resistant melanomas using cell and animal models. Used at low concentrations, Zantrene was found to enhance cancer immunotherapy in three distinct and complementary ways: (1) direct killing of melanoma cells; (2) activation of immune cells targeting the tumour, and (3) reducing the expression of immune evasion genes in the tumour. Checkpoint inhibitors immune therapies such as anti-PD-1 antibodies have emerged as a front-line treatment for many types of cancer, including melanoma. While these immune drugs have revolutionised the treatment of advanced melanoma, only a minority of patients show a long-term response to therapy and the five-year survival rate remains low due to treatment resistance.1 Zantrene showed significant historical in vitro activity against fresh human melanoma samples taken from patients in human tumor clonogenic assays.2,3 In a subsequent historic Phase I trial of Zantrene administered weekly, one of four treated patients with metastatic melanoma achieved a complete response (complete shrinkage of tumour) which lasted 6 months.4 Despite these early successes, four subsequent historic Phase 2 studies of Zantrene in 100 melanoma patients using far longer dosing intervals and higher dosing levels (one maximally tolerated dose every three or four weeks) did not achieve any significant clinical responses.5-8 Seventeen patients achieved disease stabilization, but no further complete responses were observed in any of these Phase 2 trials. Zantrene has been identified as a potent, targeted inhibitor of the Fat Mass and Obesity associated protein (FTO).9 Previous studies have observed that FTO is over-produced in approximately 50% of metastatic melanomas10 and that inhibition of FTO can overcome PD-1 immune checkpoint resistance in the B16-F10 (known to over-produce FTO) mouse melanoma model.10,11 Further supporting these animal and cell studies, human genetic research has identified variations within the FTO gene that are associated with an increased risk of developing melanoma, with this increased risk being independent of body mass index. 12,13 On the basis that Zantrene is a potent FTO inhibitor (IC50 142 nM)9, it was hypothesised that Zantrene and anti-PD-1 antibodies may synergise to overcome checkpoint inhibitor resistance in a treatment resistant mouse model of melanoma. The murine B16 melanoma model is the most commonly used metastatic melanoma model for preclinical studies.14 The B16-F10 cell line was generated as the 10th serial passage sub-clone of the B16 parent tumour line in C57BL/6 mice.15 B16-F10 melanoma cells implanted subcutaneously into C57BL/6 mice result in highly aggressive (fast growing) tumours that double in size approximately every two days, although with significant variation between individual animals. Announcement • Jun 09
Race Oncology Limited Expands FTO Targeting Phase 1b/2a Extramedullary AML & MDS Trial to Europe Race Oncology Limited announced it is expanding the FTO-targeted BISECT (RAC-006) clinical trial in extramedullary Acute Myeloid Leukaemia (EMD AML) and Myelodysplastic Syndromes (MDS) to include five additional trial sites in Spain and Italy and has signed a new clinical support agreement with global Clinical Research Organisation, Parexel International to support the additional trial monitoring activities. BISECT (RAC-006) is an open label Phase 1b/2a clinical trial in patients with EMD AML and MDS which recently received Ethics and Governance approval to commence patient recruitment at the Calvary Mater Hospital Newcastle. The intention to expand the BISECT trial to Europe was announced at the 2021 Race Annual General Meeting. The total study costs are expected to be in the range of AUD 7.7 million to a maximum of AUD 15.4 million. The final cost is dependent on the location and number of patients screened and enrolled in the trial. Due to the adaptive (Bayesian) design of this study, the total study costs cannot be precisely determined, but are expected to be lower than the maximum cited here. Payments will be made to Parexel throughout the study upon reaching key milestones as patients are recruited and other operational variables are achieved. Extramedullary AML occurs when leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain, or other organs. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have the extramedullary form1. Extramedullary AML patients have no clinically approved treatments and limited experimental treatment options, with many clinical trials explicitly excluding this difficult to treat form of AML. MDS are a group of blood cancers that affect the production of normal blood cells in the bone marrow. These include chronic myelomonocytic leukaemia (CMML), atypical chronic myeloid leukaemia (aCML) and myelodysplastic/myeloproliferative neoplasms unclassifiable (MDS/MPN)2. MDS has a very high risk (1 in 3) of the patient progressing to AML and high risk MDS is considered to be an earlier stage of AML. There are more than 10,000 patients diagnosed with MDS each year in the USA, which is approximately half the rate of AML. This open label Phase 1b trial with a Phase 2a dose expansion phase will recruit up to 60 patients with 18F-FDG PET/CT imaging-identified extramedullary AML at 10 clinical sites using a two-stratum (arm) design. The first stratum will utilise Zantrene as a high dose, single agent treatment over 7 days in patients with extramedullary AML who are able to tolerate high intensity chemotherapy, followed by one or more cycles of consolidation treatment of Zantrene in combination with Ara-C, a standard of care drug. The second stratum will use Zantrene as a low dose FTO-targeted agent in combination with the oral hypomethylating agent, ASTX727 for MDS or AML patients unwilling, or unable to tolerate high intensity chemotherapy. Published preclinical data from City of Hope Hospital /Beckman Research Institute (Los Angeles, California), by Professor Chen's Laboratory identified that inhibition of FTO synergizes with decitabine to better kill AML cells3. Subsequent preclinical work by Race in collaboration with the Verrills' Laboratory (Newcastle, Australia) validated these findings in the EMD setting. Using a mouse model of EMD AML, Associate Professor Verrills demonstrated that optimal dosing of decitabine and Zantrene can synergistically target extramedullary AML tumours as well as AML lesions in the bone marrow and spleen. The trial primary endpoint will be complete response (CR) and complete response with incomplete haematological recovery (CRi), with the clinical aim of bridging the patient to an allogeneic hematopoietic stem cell transplant (Stratum 1), and safety and tolerability of the decitabine/Zantrene regimen (Stratum 2). Key secondary endpoints include safety and tolerability of Zantrene, overall and event-free survival, and the correlation of FTO expression or other biomarkers with response to treatment. Announcement • May 27
Race Oncology Limited Announces the Dose Escalation Phase 1b Stage of the Relapsed or Refractory Acute Myeloid Leukaemia (R/R AML) Trial Running At the Chaim Sheba Medical Centre, Israel Race Oncology Limited announced the dose escalation Phase 1b stage of the relapsed or refractory Acute Myeloid Leukaemia (R/R AML) trial running at the Chaim Sheba Medical Centre, Israel has successfully completed after the treatment of the first six patients. The six patients were heavily pre-treated and had received a median of four prior lines of AML treatment (range 2-8). By design, the primary endpoint of the initial phase of this 2-stage clinical trial is establishing the recommended dose to be used in the subsequent Phase 2 expansion (efficacy) stage. This first stage requires identifying the treatment dose level that achieves two or fewer dose-limiting toxicities (DLTs) from six consecutively treated patients. In the initial six patients treated, two DLTs were reported (one Grade 3 elevated liver enzymes and one Grade 5 infection). Both DLTs occurred in the most heavily pre-treated patients who had received five and eight prior lines of treatment, respectively. Efficacy results in this refractory patient population were very encouraging, with one patient showing a complete response (CR) based on morphology, two patients having a partial response (PR) including one with extramedullary disease, two showing no response (NR), and one patient not assessable (NA) due to death from infection. Infection is a known side effect of all intensive chemotherapeutic regimens and is one of the leading causes of death in AML patients1. Three patients (1 CR and 2 PR) were bridged to an allogeneic stem cell transplant. Bridging a patient to transplant is an important positive outcome in AML treatment as it offers the patient the potential of long-term remission. Of note, these three patients had all received less than five prior lines of treatment. Poor or no response to known efficacious treatments is common and expected in heavily pre-treated cancer patients2. The trial will now progress to the Phase 2 efficacy (expansion) stage using a 4-day schedule of Zantrene® (bisantrene dihydrochloride) in combination with fludarabine and clofarabine. Announcement • May 19
Race Oncology Limited Appoints Guy Breitenbucher to Its Scientific Advisory Board Race Oncology Limited announced that it has appointed Dr James Guy Breitenbucher to its Scientific Advisory Board (SAB). Dr Breitenbucher brings to Race an extensive drug discovery and clinical development history, having spent more than 26 years in scientific leadership positions at a range of large and small pharmaceutical companies, including Johnson & Johnson Pharmaceuticals, Convelo Therapeutics, Libra Therapeutics, Dart Neuroscience, Axys Pharmaceuticals, and Bristol Myers Squibb. Dr Breitenbucher is an exceedingly successful drug discovery and development researcher, having advanced numerous pharmaceutical projects from concept to the clinic. He is highly skilled in solving complex drug discovery problems, including those surrounding formulations, DMPK, structure biology, pharmacology, biomarkers, IP and safety. While VP of Chemistry at Convelo Therapeutics, he led a major industrial research partnership with Genentech1. At Johnson & Johnson, Guy led multiple pain and CNS drug development programs and delivered 11 compounds into the J&J clinical pipeline, 3 of which are currently in clinical development. Guy has published more than 59 peer reviewed scientific papers, is a named inventor on 39 patents and has given numerous invited scientific presentations at international conferences. His deep scientific and pharmaceutical industry knowledge will be exceptionally valuable to Race as it advances the development of improved Zantrene® formulations and explores the development of new m6A RNA focused molecules. Dr Breitenbucher joins eminent m6A RNA researcher and discoverer of Zantrene's role as a potent FTO inhibitor, Professor Jianjun Chen of the City of Hope Hospital (USA), on the Race SAB. Announcement • May 12
Race Oncology Limited Receives Governance Approval for AML EMD & MDS Trial Race Oncology Limited announced it has received Research Governance Office (RGO) approval from the Calvary Mater Newcastle Hospital for its open label clinical trial of Zantrene (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS). Human ethics approval for this trial has been granted. Representatives of the Race Oncology clinical team, the contract research organization Paraxel, and associated clinical teams of the Calvary Mater Hospital are scheduled to meet for site initiation and training on the 31 May 2022. Completion of this site training will enable the first patient to be recruited into the trial. This open label Phase 1 trial with a dose expansion Phase 2 stage will recruit up to 60 patients with extramedullary AML or MDS using a two-stratum (arm) design at trial sites in Australia and Europe. Extramedullary AML occurs when the leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain and others. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have the extramedullary form1. Extramedullary AML patients have no clinically approved treatments and limited experimental treatment options, with many clinical trials explicitly excluding this difficult to treat form of AML.MDS are a group of blood cancers that affect the production of normal blood cells in the bone marrow. These include chronic myelomonocytic leukaemia (CMML), atypical chronic myeloid leukaemia (aCML) and myelodysplastic/myeloproliferative neoplasms unclassifiable (MDS/MPN)2. MDS has a very high risk (1 in 3) of the patient progressing to AML and high risk MDS is considered to be an earlier stage of AML. The annual rate of MDS is 40 to 50 clinical cases per million people2, which is approximately half the case rate of AML. This open label Phase 1 trial with a Phase 2 dose expansion phase will recruit up to 60 patients with 18F-FDG PET/CT imaging-confirmed extramedullary AML at up to 10 clinical sites in Australia and Europe using a two-stratum (arm) design. The first stratum will utilise Zantrene as a high dose, single agent treatment over 7 days in patients with extramedullary AML who are able to tolerate high intensity chemotherapy, followed by one or more cycles of consolidation treatment using Zantrene in combination with Ara- C, a standard of care AML drug. The second stratum will use Zantrene as a low dose FTO-targeted agent in combination with the oral hypomethylating agent, ASTX727, for MDS or AML patients unwilling, or unable to tolerate high intensity chemotherapy. Published preclinical data from City of Hope Hospital /Beckman Research Institute by Professor Chen's Laboratory identified that FTO inhibition synergized with decitabine in leukaemic cells3. Subsequent preclinical work by Race in collaboration with the Verrill's Laboratory validated these findings in the EMD in vivo setting. Using a mouse model of EMD AML, A/Prof Verrills demonstrated that optimal dosing of decitabine and Zantrene is able to synergistically target extramedullary AML tumours as well as AML lesions in the bone marrow and spleen. The trial primary endpoint will be complete response (CR) and complete response with incomplete haematological recovery (CRi), with the clinical aim of bridging the patient to an allogeneic hematopoietic stem cell transplant (Stratum 1), and safety and tolerability of the decitabine/Zantrene regimen (Stratum 2). Key secondary endpoints include safety and tolerability of Zantrene, overall and event-free survival, and the correlation of FTO expression or other biomarkers with response to treatment. Indicative Timelines and Reporting The trial is expected to take 36 to 40 months with full patient recruitment completed over approximately 18 months. This trial is open label in nature, so patient outcome results are obtained soon after patients are treated. The company intend to announce progress updates on the trial on a regular basis, but not at the individual patient level. The first patient is expected to be recruited soon after site initiation. Board Change • Apr 27
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 4 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Martin Tallman is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Apr 06
Race Oncology Limited Receives Human Ethics Approval for Its Open Label Clinical Trial of Zantrene in Patients with Extramedullary Acute Myeloid Leukaemia or High-Risk Myelodysplastic Syndrome Race Oncology Limited (Race) announced it has received human ethics approval for its open label clinical trial of Zantrene® (bisantrene dihydrochloride) in patients with extramedullary Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome (MDS). Before patients can be enrolled and treated at the lead site - Calvary Mater Newcastle Hospital - Race must receive Research Governance Office (RGO) (site budget and contracting) approval. All required documentation has now been submitted to enable this outcome. Governance approval is typically received within 4 to 8 weeks from submission. This open label Phase 1 trial with a dose expansion Phase 2 stage will recruit up to 60 patients with extramedullary AML or MDS using a two-stratum (arm) design. Extramedullary AML: Extramedullary AML occurs when the leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain and others. A 2020 prospective positron imaging trial identified that up to 22% of AML patients have the extramedullary form3. Extramedullary AML patients have no clinically approved treatments and limited experimental treatment options, with many clinical trials explicitly excluding this difficult to treat form of AML. Myelodysplastic Syndromes (MDS): MDS are a group of blood cancers that affect the production of normal blood cells in the bone marrow. These include chronic myelomonocytic leukaemia (CMML), atypical chronic myeloid leukaemia (aCML) and myelodysplastic/myeloproliferative neoplasms unclassifiable (MDS/MPN). MDS has a very high risk (1 in 3) of the patient progressing to AML and high risk MDS is an earlier stage of AML. There are more than 10,000 patients diagnosed with MDS each year in the USA, which is approximately half the rate of AML. Clinical Trial Design: This open label Phase 1 trial with a Phase 2 dose expansion phase will recruit up to 60 patients with 18F-FDG PET/CT imaging-identified extramedullary AML at 10 clinical sites using a two-stratum (arm) design. The first stratum will utilise Zantrene as a high dose, single agent treatment over 7 days in patients with extramedullary AML who are able to tolerate high intensity chemotherapy, followed by one or more cycles of consolidation treatment of Zantrene in combination with Ara-C, a standard of care drug. The second stratum will use Zantrene as a low dose FTO-targeted agent in combination with the oral hypomethylating agent, ASTX727 for MDS or AML patients unwilling, or unable to tolerate high intensity chemotherapy. Published preclinical data from City of Hope Hospital /Beckman Research Institute, by Professor Chen's Laboratory identified that FTO inhibition synergized with decitabine in leukaemic cells. Subsequent preclinical work by Race in collaboration with the Verrill's Laboratory validated these findings in the EMD setting. Using a mouse model of EMD AML, A/Prof Verrills demonstrated that optimal dosing of decitabine and Zantrene is able to synergistically target extramedullary AML tumours as well as AML lesions in the bone marrow and spleen. The trial primary endpoint will be complete response (CR) and complete response with incomplete haematological recovery (CRi), with the clinical aim of bridging the patient to an allogeneic hematopoietic stem cell transplant (Stratum 1), and safety and tolerability of the decitabine/Zantrene regimen (Stratum 2). Key secondary endpoints include safety and tolerability of Zantrene, overall and event-free survival, and the correlation of FTO expression or other biomarkers with response to treatment. Indicative Timelines and Reporting: The trial is expected to take 36 to 40 months to complete with full patient recruitment over approximately 18 months. This trial is open label in nature, so patient outcome results are obtained as patients are treated. Company intend to announce progress updates on a regular basis, but not at the individual patient level. The first patient is expected to begin treatment soon after governance approval is obtained. Announcement • Mar 31
Race Oncology Limited Announces Preclinical & Clinical Programs Update Race Oncology Limited announced an update on clinical and preclinical programs, which were committed to in the Expected News in December 2021 Quarterly Activity report. While the impact of COVID-19 has slowed some programs, the company continue to make significant preclinical and clinical progress in Australia and internationally. Preclinical: Cellular Programs: Race shared results of preclinical kidney cancer program earlier this month. This study found Zantrene was able to kill a range of kidney cancer cells, both on its own and in combination with existing cancer treatments, and that when used in combination with the current kidney cancer treatment drugs lenvatinib, cabozantinib and pazopanib, greatly improved cell killing (synergy) was observed. Race shared interim results of collaborative extramedullary acute myeloid leukaemia (EMD AML) preclinical program in collaboration with Associate Professor Nikki Verrills. This program identified that Zantrene alone was able to kill a genetically diverse range of AML cells at low drug concentrations and that Zantrene in combination with decitabine showed significantly greater cell killing across a genetically diverse panel of AML cell lines and in mice than either drug on its own (synergy). New cell-based studies exploring the potential of Zantrene in breast cancer, multiple myeloma, melanoma and kidney cancer, as well as further cardioprotection studies are underway with results expected in second quarter and third quarter of current year 2022. Preclinical: Animal Programs: Race shared the results of a mouse model study of AML EMD where Zantrene in combination with decitabine was found to target extramedullary AML tumours as well as kill AML cells present in the bone marrow and spleen. Race is currently exploring Zantrene as a potential immunotherapeutic and treatment enhancer for existing oncology drugs in mouse models of melanoma. The melanoma animal studies are nearing completion with results expected in early second quarter of current year 2022. Results from these studies will be shared once the IP protection process is complete. Animal studies exploring the cardioprotection potential of Zantrene against anthracycline and carfilzomib induced heart damage are underway. These studies are technically complex and time consuming with first results expected in second quarter of current year 2022 New animal model studies in multiple myeloma and kidney cancer are in advanced planning and are expected to be initiated in second quarter of current year 2022. Clinical Programs: The Phase 1b/2 clinical trial of Zantrene in combination with fludarabine and clofarabine to treat relapsed/refractory (R/R) Acute Myeloid Leukaemia is progressing to expectation and is continuing to recruit patients. The study is being led by Professor Arnon Nagler of the Chaim Sheba Medical Center, Israel, who previously conducted the Phase 2 single agent Zantrene R/R AML trial, where a 40% clinical response was observed. Race will update investors on progress upon completion of the Phase 1 dose-finding stage. Progress on Australian extramedullary AML-focused trial (RAC-006) is advancing with the support of the Contract Research Organisation (CRO), Parexel. While COVID-19 in New South Wales (Australia) has impeded this trial, Race expects to be able to update investors on human ethics and governance approval in early second quarter of current year 2022. Race announced that it has signed a clinical trial collaboration and supply agreement with Astex Pharmaceuticals Inc. ("Astex"), a subsidiary of Otsuka Pharmaceutical of Japan, to supply ASTX727 (oral decitabine and cedazuridine) for Race's EMD AML & MDS trial RAC-006. Recent Insider Transactions • Mar 06
Board Member recently bought AU$56k worth of stock On the 4th of March, Daniel Tillett bought around 20k shares on-market at roughly AU$2.75 per share. In the last 3 months, they made an even bigger purchase worth AU$59k. Despite this recent purchase, insiders have collectively sold AU$22m more in shares than they bought in the last 12 months. Announcement • Feb 24
Race Oncology Limited Announces MD Anderson Cancer Center Collaborators Publish Peer Reviewed AML Preclinical Study on Zantrene Race Oncology Limited announced a researcher team, led by Professor Borje Andersson and Associate Professor Ben Valdez of the MD Anderson Cancer Center (Texas, USA), have identified a number of additional clinically translatable drug combinations that showed synergy with Zantrene when tested in Acute Myeloid Leukaemia (AML) cells. This study, sponsored by Race, has been published in the Journal Leukemia & Lymphoma and is entitled "Enhanced cytotoxicity of bisantrene when combined with venetoclax, panobinostat, decitabine and olaparib in acute myeloid leukemia cells." The MD Anderson team identified synergism of Zantrene and venetoclax in combination with panobinostat, decitabine, or olaparib, known inhibitors of BCL2, histone deacetylase, DNA methyltransferase, and poly (ADP-ribose) polymerase, respectively, in AML cells. These combinations were found to enhance DNA damage, cleavage of Caspase 3 and PARP1, DNA fragmentation, increased ROS, and potent apoptosis activation in AML cells. Similar results were observed using mononuclear cells isolated from leukaemia patients, but not from healthy donors. The SAPK/JNK signalling pathway was strongly activated by the combination treatments, whereas the PI3K/mTOR and Wnt/b-catenin pro-survival pathways were inhibited. Announcement • Jan 31
Race Oncology Limited Appoints Christina Manfre as Chief Financial Officer Race Oncology Limited announced the appointment of Christina Manfre, as Chief Financial Officer. Christina is employed as a partner at PKF Sydney Pty Ltd. and will via PKF provide leadership to Race Oncology's financial analysis, reporting and strategic financial needs. Christina has a wealth of experience working with a diverse range of clients. Her professional affiliations and experience include a Bachelor of commerce with Appliedfinance, member of Chartered accountants (ANZ) and is a member of the Australian Institute of Company Directors (AICD). Recent Insider Transactions • Jan 11
Non-Independent Non-Executive Chairman recently sold AU$995k worth of stock On the 10th of January, John Cullity sold around 300k shares on-market at roughly AU$3.32 per share. In the last 3 months, there was an even bigger sale from another insider worth AU$4.4m. John has been a seller over the last 12 months, reducing personal holdings by AU$478k. Recent Insider Transactions • Dec 17
Board Member recently bought AU$59k worth of stock On the 10th of December, Daniel Tillett bought around 18k shares on-market at roughly AU$3.34 per share. In the last 3 months, there was an even bigger purchase from another insider worth AU$710k. Despite this recent purchase, insiders have collectively sold AU$23m more in shares than they bought in the last 12 months. Recent Insider Transactions • Nov 30
Insider recently sold AU$4.4m worth of stock On the 22nd of November, William Garner sold around 1m shares on-market at roughly AU$3.45 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of AU$23m more than they bought in the last 12 months. Announcement • Nov 22
Race Oncology Limited Announces Interim Results from the Zantrene® Preclinical Heart Safety Research Program Led by Eminent Cardiotoxicity Researchers, Associate Professors Aaron Sverdlov and Doan Ngo Race Oncology Limited announced interim results from the Zantrene® preclinical heart safety research program led by eminent cardiotoxicity researchers, Associate Professors Aaron Sverdlov and Doan Ngo, in collaboration with cancer scientist Associate Professor Nikki Verrills, at The University of Newcastle. This research has found that Zantrene is able to protect heart muscle cells from anthracycline (specifically doxorubicin) induced cell death while improving the killing of breast cancer cells. Anthracyclines are one of the most effective anti-cancer treatments developed and are used in more cancer settings than any other class of chemotherapeutic agent1. These drugs are used to treat millions of cancer patients every year, including those with leukemias, lymphomas, neuroblastoma, kidney, liver, stomach, uterine, thyroid, ovarian, sarcomas, bladder, lung and breast cancers. The clinically most important anthracyclines are doxorubicin, daunorubicin, epirubicin and idarubicin. While highly effective anti-cancer drugs, the anthracyclines cause serious and permanent damage to the heart in many patients. Zantrene® (bisantrene dihydrochloride) was originally developed as a heart-safer alternative to the anthracyclines particularly with respect to preservation of heart muscle3. While Zantrene's improved heart safety was proven in more than 50 clinical trials4,, the question as to whether Zantrene could help prevent the heart damage caused by anthracyclines has never been addressed. Recent Insider Transactions Derivative • Nov 14
Non-Independent Non-Executive Chairman exercised options to buy AU$9.8m worth of stock. On the 12th of November, John Cullity exercised options to buy 3m shares at a strike price of around AU$0.24, costing a total of AU$710k. This transaction amounted to 56% of their direct individual holding at the time of the trade. Since June 2021, John's direct individual holding has increased from 3.79m shares to 5.40m. Company insiders have collectively sold AU$21m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Nov 08
Non-Independent Non-Executive Chairman recently bought AU$710k worth of stock On the 4th of November, John Cullity bought around 218k shares on-market at roughly AU$3.26 per share. This was the largest purchase by an insider in the last 3 months. John has been a buyer over the last 12 months, purchasing a net total of AU$517k worth in shares. Recent Insider Transactions • Sep 07
Non-Executive Chairman recently sold AU$193k worth of stock On the 2nd of September, John Cullity sold around 62k shares on-market at roughly AU$3.12 per share. In the last 3 months, there was an even bigger sale from another insider worth AU$4.3m. This was John's only on-market trade for the last 12 months. Recent Insider Transactions Derivative • Aug 25
Non-Executive Chairman exercised options to buy AU$5.7m worth of stock. On the 23rd of August, John Cullity exercised options to buy 2m shares at a strike price of around AU$0.099, costing a total of AU$187k. This transaction amounted to 50% of their direct individual holding at the time of the trade. Since September 2020, John's direct individual holding has increased from 3.79m shares to 5.68m. Company insiders have collectively sold AU$22m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • Aug 04
Insider recently sold AU$4.3m worth of stock On the 29th of July, William Garner sold around 1m shares on-market at roughly AU$3.55 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of AU$18m more than they bought in the last 12 months. Announcement • Jun 23
Race Oncology Limited Executes Contract to Commence Phase 1b/2 AML Trial at Chaim Sheba Israel Race Oncology Limited announced it has executed an agreement with The Sheba Fund for Health Services and Research, Chaim Sheba Medical
Center to commence a Phase 1b/2 trial in relapsed/refractory Acute Myeloid Leukaemia (R/R AML). This investigator-led trial will be supervised by Professor Arnon Nagler, who was the Principal Investigator on the Phase 2 investigator-initiated trial which reported an impressive 40% response rate as a single agent in R/R AML. This Phase 1b/2 trial will use Bisantrene in a novel three drug combination which in preclinical studies showed superior efficacy in AML cells. The trial has received human ethics approval and the first patient is expected to be treated in quarter 3 CY 2021. The trial will run in parallel with a separate Australian Phase 2 trial in patients with extramedullary AML that is expected to begin treating patients in Fourth Quarter CY 2021. Relapsed or Refractory Acute Myeloid Leukemia: Primary refractory or relapsed acute myeloid leukemia is associated with poor prognosis and remains a major therapeutic challenge. Primary refractory AML is defined by the absence of complete remission (CR), manifested by blast count of 5% in bone marrow after one or two cycles of intense induction chemotherapy. Up to 30% of adults with newly diagnosed AML fail to achieve CR after two courses of intensive chemotherapy. Even when CR is achieved through intense chemotherapy, approximately half of the younger and 80% of the older patients relapse. In both clinical situations, refractory and/or relapsed AML, active disease remains a major therapeutic challenge despite recent advances. Clinical Trial Design: An open-label, Phase 1b/2 study of intravenous FluCloXan (Fludarabine, Clofarabine, Bisantrene dihydrochloride (Xan)) in cohorts of adult patients with R/R AML using a Simon's 2-stage design: a Phase 1b lead-in dose escalation stage to establish the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of FluCloXan and a Phase 2 expansion stage to determine efficacy and confirm safety of the FluCloXan regimen at the RP2D in up to 17 subjects. Phase 1b, Dose-Escalation (Lead-in Stage): A two-cohort dose escalation schema using a 3 + 3 design will be employed. Cohort 1 will enroll three subjects to receive the FluCloXan regimen for four consecutive days. If no dose limiting toxicities (DLTs) have occurred in the first three subjects by day 30 of their first cycle of treatment, then dose escalation to Cohort 2 will occur. Phase 2, Expansion (Efficacy Stage): Up to 17 subjects will be enrolled into a Phase 2 expansion efficacy cohort using a 2-stage Simon design. Initially, 9 subjects will be enrolled and treated with the recommended dose of FluCloXan regimen determined in Stage 1. If no subject responds according to the response criteria outlined in the European Leukemia Net (ELN) guidelines, in the first 9 subjects, the study will be terminated for futility. If at least one subject shows a response, 8 more subjects will be enrolled and treated. If three or more of subjects treated in Stage 2 respond, the null hypothesis can be rejected. Efficacy assessments will be based on bone marrow examination at a minimum of two time points on Day 21 and on Day 30. A further bone marrow examination may be performed on Day 42 at the investigator's discretion, based on the patient's disease and performance status and/or on peripheral blood hematology results during the treatment course and between Day 21 to 42. Treatment will be terminated upon any sign of progressive/recurrent disease and/or referral for starting pre-transplant conditioning therapy for (allogeneic) stem cell transplantation. Subjects who do not progress or experience any dose limiting toxicities may receive a second course of treatment for the same duration as in their first cycle. All subjects will be actively followed up every three months for a further 12 months following completion of Cycle 1 for disease free survival (DFS) and overall survival (OS). While the focus of this trial is not aimed at targeting FTO driven cancers, the FTO expression status will be examined for each patient as part of an exploratory trial endpoint. Recent Insider Transactions • Apr 27
Insider recently sold AU$4.8m worth of stock On the 22nd of April, William Garner sold around 1m shares on-market at roughly AU$3.76 per share. In the last 3 months, they made an even bigger sale worth AU$6.6m. Insiders have been net sellers, collectively disposing of AU$13m more than they bought in the last 12 months. Recent Insider Transactions • Mar 16
Insider recently sold AU$6.6m worth of stock On the 12th of March, William Garner sold around 2m shares on-market at roughly AU$4.00 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of AU$8.7m more than they bought in the last 12 months. Announcement • Mar 10
Race Oncology Limited Announces Compelling Preclinical Breast Cancer Results Race Oncology Limited announces the final results of collaborative preclinical research program with the eminent cancer researcher, Associate Professor Nikki Verrills of The University of Newcastle and Hunter Medical Research Institute. The aim of this research program was to identify combinations of existing breast cancer drugs which when paired with Bisantrene show equivalent or better efficacy to existing treatment options, but with reduced side effects. Activity of Bisantrene alone against a range of breast cancer genetic subtypes, including those resistant to standard of care drug treatments, was also explored. The interim results demonstrated that Bisantrene was an effective chemotherapeutic agent across a wide range of genetically distinct breast cancer subtypes. Bisantrene was able to kill some cancer subtypes that were resistant to the currently used anthracyclines doxorubicin and epirubicin. Importantly, Bisantrene showed near identical additive benefit when used in combination with cyclophosphamide to that seen with either doxorubicin or epirubicin. Final results showed Bisantrene to be an effective chemotherapeutic agent across a diverse panel of genetically defined breast cancer subtypes and to also kill breast cancer cells resistant to a wide range of breast cancer treatment drugs. Anthracyclines agents such as doxorubicin and epirubicin are routinely combined with cyclophosphamide for the management of breast cancer. This is often followed by taxane based therapy. Bisantrene was the subject of a large Phase III single agent clinical trial in the USA in advanced breast cancer patients in the late 1980s and early 1990s. This Phase III trial showed that Bisantrene had efficacy comparable to standard of care treatment, doxorubicin, but caused significantly less damage to the patient's heart. Some 23% of the patients who received doxorubicin had serious heart failure compared to just 4% with Bisantrene. Sixteen breast cancer cell lines were screened for their sensitivity to Bisantrene and other common anti-cancer drugs used in breast cancer patients. These cell lines were selected from a range of different breast cancers to cover all the common breast cancer sub-types and to span both drug sensitive and drug resistant cancers.
Bisantrene was compared to doxorubicin and epirubicin as both a single agent and in combination with cyclophosphamide. Building on the data presented in the interim report which showed that Bisantrene can kill breast cancer cells resistant to doxorubicin the study was extended to a range of drug resistant MCF7 cell lines developed by repeated treatment with the DNA damaging topoisomerase II inhibitor, etoposide (VP16); the cyclin-dependent kinase 4/6 inhibitor palbocicclib (PalbR); the selective estrogen receptor degrader (SERD), fulvestrant (FasR); or the estrogen receptor modulator (SERM), tamoxifen (TamR). These are informative cellular models to investigate if Bisantrene is likely to be clinically useful in patients who have developed resistance to standard therapies. As expected, the MCF7/VP16 cells were more resistant to doxorubicin and epirubicin than the parental MCF7 cells, due at least in part to their expression of the multidrug resistant protein 1 (MRP1; ABCC1) and MRP6 (ABCC6). Intriguingly, the MCF7/VP16 cells were more sensitive to Bisantrene (1.9x) than the parental MCF7 cells. This result suggests that Bisantrene is not a substrate for the multi-drug resistance proteins, MRP1 and MRP6, which are commonly overexpressed in cancers that develop resistance to treatment. The observation that Bisantrene is even more effective in these resistant cells than the parental line is supportive for the use of Bisantrene as a salvage treatment. In addition to reduced drug accumulation from MRP overexpression, the topoisomerase II drug target in these resistant cells was less sensitive to drug-induced, cleavable complex formation than the parental MCF7 cells. It is possible that the altered topoisomerase II may mediates hyper-sensitivity to Bisantrene. All breast cancer cell lines tested displayed a very similar additive cell death response when cyclophosphamide was combined with Bisantrene, doxorubicin or epirubicin. To determine the effects of the combined drug treatments, three different approaches were used. Webb analysis revealed that the vast majority of doses of cyclophosphamide and Bisantrene were additive across all the cell lines. There were a few doses of cyclophosphamide and Bisantrene in the ZR-75-1, MDA-MB-468, SKBR3, HMT-3522-S2
and MCF7 (parental and resistant) cell lines that were at the cut-off for synergy (0.1). Chou-Talalay analysis indicated additivity between Bisantrene and cyclophosphamide, similar to that seen for doxorubicin or epirucibin and cyclophosphamide at the inhibitory concentration 50% (IC50) and 25% (IC25) doses. Recent Insider Transactions • Mar 08
Insider recently sold AU$2.1m worth of stock On the 3rd of March, William Garner sold around 663k shares on-market at roughly AU$3.23 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of AU$2.1m more than they bought in the last 12 months. Is New 90 Day High Low • Feb 25
New 90-day high: AU$3.29 The company is up 53% from its price of AU$2.15 on 27 November 2020. The Australian market is up 4.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 12% over the same period. Announcement • Feb 23
Race Oncology Limited Announces Positive Early Preclinical Ovarian Cancer Results Race Oncology Limited shared further interim results of continuing collaborative preclinical research program with The University of Newcastle. Eminent cancer researcher, Associate Professor Nikki Verrills of the Hunter Medical Research Institute is leading the project. The aim of this recent preclinical research program is to explore Bisantrene efficacy in ovarian cancer. Bisantrene was the subject of two-Phase II clinical trials in the USA in advanced ovarian cancer patients in the 1980s. These trials showed that Bisantrene was able to induce a clinical response in heavily pre-treated ovarian cancer patients, including those resistant to doxorubicin and other standard of care drugs of the period. Early results show Bisantrene to be an effective chemotherapeutic agent in patient-derived ovarian cancer cell lines. Bisantrene was able to kill these cancer cells that were resistant to the current standard of care ovarian drugs, cisplatin, 5-fluorouracil and chlorambucil. PEO1 is an adherent ovarian cancer cell line derived from malignant peritoneal ascites in a patient with a poorly differentiated serous adenocarcinoma. PEO4 was derived from the same patient after relapse and treatment with cisplatin, 5-fluorouracil and chlorambucil and is the cell line resistant to these three drugs. Bisantrene was compared to doxorubicin, epirubicin and cisplatin as a single agent in both PEO1 and PEO4. Cell viability was determined using the resazurin metabolic assay and confirmed by visual inspection under light microscopy. All experiments were replicated a minimum of three times. Announcement • Feb 19
Professor Borje Andersson to Resign as Chief Medical Officer of Race Oncology Limited Race Oncology Limited announced that Professor Borje Andersson has given notice that he will resign as Race's Chief Medical Officer (CMO) to enable Race to recruit a new Australian-based CMO to drive the Company's Three Pillar strategy forward in a full-time capacity. Prof. Andersson will remain the Chair of Race's Clinical Advisory Board. Race has commenced the recruitment process for an Australian based CMO. Professor Andersson will transition out of the role over a three-month duration. Announcement • Feb 08
Race Oncology Limited Appoints Mary Harney as Non-Executive Director Race Oncology Limited announced that Ms Mary Harney has been appointed Non-Executive Director. Ms Harney currently also serves as Chairman of CTxONE Pty Ltd. Is New 90 Day High Low • Feb 05
New 90-day high: AU$2.48 The company is up 132% from its price of AU$1.07 on 06 November 2020. The Australian market is up 11% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 8.0% over the same period. Announcement • Dec 10
Race Oncology Limited Announces Borje Andersson Resigns as an Executive Director Race Oncology Limited announced that Borje Andersson has resigned as an Executive Director in order to focus on his roles of Chief Medical Officer and Chair of the Race Clinical Advisory Board. Prof. Andersson joined the Race Board as Non-Executive Director on 28 January 2020 prior to his appointment to the executive team. Announcement • Nov 27
Race Oncology Limited Announces Breast Cancer Clinical Trial Program Initiated Race Oncology announced that it has appointed the clinical research organisation (CRO), George Clinical, to scope and cost a proof-of-concept Phase I/II breast cancer clinical trial of Bisantrene in combination with cyclophosphamide. This program will enable the Race Oncology Board to make a fully informed and costed decision on this important clinical pathway before expending significant shareholder funds. Bisantrene was the subject of a series of Phase II and III clinical trials in the USA in advanced breast cancer patients in the late 1980s and early 1990s. The Phase III trial showed that Bisantrene had the same efficacy as the standard of care treatment, doxorubicin, but caused significantly less damage to the patient's heart1. Recent preclinical data from Race and the University of Newcastle's Hunter Medical Research Institute has shown that Bisantrene has additive cytotoxicity when paired with cyclophosphamide, similar to doxorubicin or epirubicin (ASX Release: 24 November 2020). The first stage of the signed Master Service Agreement (MSA) between Race Oncology and George Clinical has the following key deliverables: Establish, support and manage an Australian Clinical Advisory Board (CAB) of Key Opinion Leaders (KOL) in breast cancer clinical research. Select suitable Principle Investigators. Select qualified trial sites. Develop a full clinical protocol under the supervision of the CAB. Statistical analysis to ensure a robust trial design. Detailed trial costs and timelines. Report on the practicability of the trial and any possible regulatory hurdles. The MSA will start immediately with an estimated completion time of 13 weeks. Is New 90 Day High Low • Nov 09
New 90-day high: AU$1.30 The company is up 51% from its price of AU$0.86 on 11 August 2020. The Australian market is up 3.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 7.0% over the same period. Announcement • Nov 06
Race Oncology Limited Reports Phase II Bisantrene Trial Data to be presented at ASH 2020 Race Oncology Limited reported the clinical data from the investigator initiated Phase II clinical trial of Bisantrene in relapsed and refractory Acute Myeloid Leukaemia (R/R AML), conducted at Israel's Sheba Medical Centre has been accepted for presentation at the American Society for Haematology 2020 Conference (ASH 2020). This open label, single agent trial, led by Professor Arnon Nagler, studied patients (n=10) with relapsed or refractory Acute Myeloid Leukaemia (R/R AML) who on average had failed three prior lines of treatment. Bisantrene was found to be well tolerated, and after only a single course of treatment, had an overall clinical response rate of 40% (ASX Announcement: June 16 2020).