Race Oncology (ASX:RAC) has described the past year as one of the most defining in its history, marked by scientific progress, strengthened clinical capability and decisive steps toward realising the full potential of its lead asset, RC220.
Addressing shareholders at the company’s 2025 Annual General Meeting, Executive Chair Dr Pete Smith outlined a year of execution and strategic evolution as the company positions itself for multiple pivotal readouts in the coming years.
At the centre of Race’s momentum is RC220, the proprietary bisantrene formulation designed to overcome decades-old delivery challenges.
Dr Smith highlighted the initiation of the company’s Phase 1a/b trial combining RC220 with doxorubicin for advanced solid tumours, an advance he described as “a milestone many years in the making,” noting that the first patients have been successfully and safely dosed. With clinical sites now open in Hong Kong and South Korean sites preparing to come online, the program has rapidly expanded into Asia, reflecting Race’s increasing global orientation.
Dr Smith said the appointments of internationally recognised oncologist Professor Daniel Von Hoff to the Clinical Advisory Board and senior pharmaceutical executives Dr Jose Iglesias and Dr Simon Fisher to key medical leadership roles have “already had a tangible impact” on operational readiness and the speed with which the company can advance its programs.
Dr Smith emphasised a second significant development in a trio of newly filed composition-of-matter patent applications covering the single active isomer of bisantrene. These filings, he said, represent the strongest form of pharmaceutical IP protection and could extend exclusivity to around 2045 if granted. The discoveries underpinning these filings, including the role of RC220 as a potent G-quadruplex binder that can silence MYC, have opened a pathway to addressing one of oncology’s most persistent challenges. This is the acquired resistance that limits the long-term effectiveness of many targeted treatments.
Race is now preparing to commence a Phase 1a/b trial in EGFR-mutated non-small cell lung cancer, targeting resistance to market-leading tyrosine kinase inhibitors such as osimertinib. Investigators are engaged, leading Australian sites are ready, and the protocol is finalised pending final site approvals. Dr Smith said the science suggests that RC220 may ultimately delay resistance to multiple classes of targeted oncology drugs, significantly expanding its commercial and clinical reach.
Alongside this, Race has charted a rapid regulatory pathway for relapsed or refractory acute myeloid leukaemia (AML), creating a bridging Phase 3 strategy that links historical bisantrene clinical data with the RC220 formulation. Designed to align with the FDA’s Project Optimus expectations, this program provides what Dr Smith called “the potential for earlier value realisation in an area of clear unmet need.”
Dr Smith reiterated that the RC220 plus doxorubicin combination program remains central to Race’s mission of solving clinically significant problems, including preventing chemotherapy-induced heart damage.
Race also remains well-funded through to the end of 2027, with deliberate guardrails ensuring that significant expenditure on new trials will commence only once defined funding thresholds are met. The Board is actively assessing capital and partnering opportunities as the company transitions into a period of potentially transformative clinical readouts.
Dr Smith announced a proposal to change the company’s name to Racura Oncology, a shift intended to reflect both the organisation’s heritage and its sharpened mission focused on care. He said the company today is “substantially different to the Race of only a couple of years ago,” underscoring its rapid maturation.