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Highlights
- RC220 Phase 1 Trial Progress: Ethics and regulatory submissions completed, with first patient treatment anticipated in Q1 CY2025.
- Leadership Expansion: Appointment of Dr Megan Baldwin as an independent non-executive director, along with new scientific team members.
- Financial Position: $18.78 million in cash reserves, with significant investments in R&D and drug manufacturing.
Race Oncology Ltd (ASX:RAC) has made substantial progress in the December quarter, positioning the company for the initiation of the Phase 1 clinical trial of RC220 in combination with doxorubicin. The trial targets patients with advanced solid tumors, with first patient treatment expected in the first quarter of calendar year 2025.
As part of the trial preparation, the company submitted its ethics and regulatory package to the Bellberry Human Research Ethics Committee (HREC) in early December. Following minor clarification requests from Bellberry HREC in late December, Race addressed these inquiries by mid-January 2025. With final ethics and governance approvals pending, site activation and patient recruitment are on track for Q1 CY2025.
Strengthening Leadership and Scientific Expertise
Race continued to enhance its leadership structure with the appointment of Dr Megan Baldwin as an independent non-executive director, effective January 1, 2025. Dr Baldwin, the founder and chief innovation officer of Opthea Ltd (ASX:OPT), brings extensive experience in guiding drug candidates from preclinical stages to global Phase 3 trials. Her decade-long tenure as CEO and managing director of Opthea underscores her expertise in pharmaceutical development.
Further expanding its scientific capabilities, Race appointed Dr Kirsten Curnow and Dr Sumit Shani to its research team. These appointments reinforce the company’s commitment to advancing its pipeline and accelerating drug discovery efforts.
FTO-Targeted Drug Discovery
During the quarter, Race announced a breakthrough in its FTO-targeted drug discovery program. Using state-of-the-art nuclear magnetic resonance (NMR) fragment screening, the company identified 39 unique FTO protein-binding molecules. These compounds represent confirmed FTO-binding chemical structures, forming the foundation for developing novel therapeutics targeting the m6A RNA epigenetic pathway.
This research was conducted in collaboration with the Monash University Fragment Platform (MFP), supporting Race’s broader strategy to develop innovative small-molecule inhibitors targeting key cancer-related pathways.
Financial Position and Investment in R&D
As of December 31, Race Oncology reported cash and cash equivalents of $18.78 million. The company allocated over two-thirds of its quarterly expenditure—$2.1 million—toward research and development, as well as drug manufacturing.
The quarter’s financial position was bolstered by a $5.25 million R&D Tax Incentive payment, along with the conversion of $870,000 in options. This resulted in a $4.2 million increase in cash reserves from the previous quarter, ensuring continued investment in clinical development and drug discovery initiatives.
With a strengthened leadership team, a robust financial position, and ongoing advancements in both clinical and preclinical programs, Race Oncology remains focused on progressing RC220 and expanding its portfolio of precision oncology treatments.
