How Race Oncology’s RC220 Trial Milestones Are Narrowing Its FY2025 Loss
Race Oncology Limited reported a significantly reduced loss for FY2025, driven by key clinical trial progress and strategic leadership changes. The company advances its RC220 program with promising Phase 1 dosing milestones and strengthens its governance to support future growth.
- Loss narrowed to $4.79 million from $13.82 million in FY2024
- Successful first dosing of RC220 and combination with doxorubicin in Phase 1 trial
- Board renewal with new appointments including Executive Chair and independent directors
- Termination of global IP license with City of Hope to consolidate intellectual property
- Cash reserves of $13.67 million, funding operations through 2026
Financial Performance and Operational Highlights
Race Oncology Limited (ASX – RAC) has reported a marked improvement in its financial results for the year ended 30 June 2025, reducing its net loss to $4.79 million from $13.82 million the previous year. This improvement reflects the company’s focused investment in clinical development and operational efficiencies amid ongoing research and development activities.
The company’s cash position remains robust at $13.67 million, providing a solid runway to fund its clinical and preclinical programs through calendar year 2026. Notably, over 83% of Race’s Q4 2025 expenditure was allocated to research and development and drug manufacturing, underscoring its commitment to advancing its oncology pipeline.
Clinical Progress – RC220 Phase 1 Trial Milestones
A pivotal highlight for Race Oncology during FY2025 was the initiation and successful dosing milestones in its Phase 1 clinical trial of RC220, a novel formulation of bisantrene, in combination with doxorubicin for patients with advanced solid tumours. Following ethics and regulatory approvals in early 2025, trial sites in New South Wales were activated, with the first patient dosed safely on 30 April 2025.
Subsequently, the company announced the safe combination dosing of RC220 with doxorubicin, with no treatment-related dose-limiting adverse effects observed. This milestone addresses a historical challenge in delivering bisantrene intravenously, positioning RC220 as a potentially safer and more effective anticancer agent with cardioprotective properties.
Race Oncology has also expanded the trial to Asia, securing approvals to commence dosing at leading hospitals in Hong Kong, signaling its intent to broaden patient access and accelerate clinical data generation.
Leadership and Governance Enhancements
The company undertook significant board renewal during the year, with the retirement of long-serving directors Mary Harney and Phillip Lynch. Dr Peter Smith was appointed Executive Chair, while Dr Daniel Tillett transitioned from CEO to CEO and Managing Director. The board was further strengthened by the appointments of Dr Serge Scrofani and Dr Megan Baldwin as Independent Non-Executive Directors, bringing expertise in global deal-making, biotechnology, and clinical development.
Race also bolstered its clinical leadership by appointing internationally recognised oncologist Professor Daniel Von Hoff to its Clinical Advisory Board, alongside key senior clinical appointments including Dr Jose Iglesias as Chief Medical Officer and Dr Simon Fisher as Vice President of Medical. These strategic hires enhance the company’s capability to navigate complex clinical development pathways.
Intellectual Property and Strategic Focus
In a strategic move to consolidate its intellectual property portfolio, Race Oncology terminated its global license agreement with the City of Hope National Medical Center in June 2025. This decision followed expert legal advice that the license no longer provided value relative to future maintenance costs. The company retains full freedom to operate and utilise bisantrene in all planned applications, supported by a strong patent estate including seven patent families and five granted US patents.
Corporate and Subsidiary Updates
During the year, Race Oncology dissolved its wholly owned Belgian subsidiary, Race Oncology SRL/BV, completing the process in line with corporate regulations. The subsidiary held a nominal cash balance at dissolution, which the company is seeking to recover, though receipt remains uncertain.
Race Oncology’s inclusion in the S&P/ASX All Ordinaries Index in March 2025 reflects its growing market presence and investor interest as it advances its clinical programs.
Outlook
Looking forward, Race Oncology is well-positioned to continue progressing its RC220 clinical trials across multiple jurisdictions, with a focus on achieving key clinical endpoints and exploring strategic partnerships. The company remains committed to delivering shareholder value through clinical innovation and potential commercialisation pathways.
Bottom Line?
Race Oncology’s FY2025 results and clinical milestones set the stage for critical upcoming data readouts and strategic partnerships that could reshape its growth trajectory.
Questions in the middle?
- When will initial efficacy and safety data from the expanded RC220 Phase 1 trial in Asia be available?
- What are the company’s plans for securing additional capital to support late-stage clinical development?
- How will the termination of the City of Hope license impact Race Oncology’s IP strategy and potential collaborations?
