Race Oncology Q4 FY2024 Report: Key Milestones and Financial Update
RAC (RAC) Share Update July 2024 Tuesday 23rd
Race Oncology Reports Significant Progress in Q4 FY2024
Race Oncology Limited (ASX: RAC) has released its Q4 FY2024 quarterly report, highlighting significant progress in the development of its lead asset, RC220 bisantrene, and a strong financial position.
Instant Summary:
- Completion of RC220 bisantrene non-clinical safety and pharmacology studies.
- US FDA extends Orphan Drug Designation and Rare Paediatric Disease Designation to RC220 bisantrene.
- Net cash increased to $17.19 million, up by $1.03 million from Q3 FY2024.
- Appointment of George Clinical as Clinical Research Organisation for upcoming trials.
- Significant preclinical results showing enhanced cancer cell-killing with decitabine and carfilzomib.
Key Developments in Q4 FY2024
Race Oncology Limited has made significant strides in the development of its lead asset, RC220 bisantrene, during Q4 FY2024. The completion of non-clinical safety and pharmacology studies to Good Laboratory Practice (GLP) standards marks a critical step towards initiating human clinical trials later in 2024. This achievement is complemented by the US FDA's extension of Orphan Drug Designation (ODD) for Acute Myeloid Leukemia (AML) and Rare Paediatric Disease Designation (RPDD) for paediatric AML.
Additionally, Race Oncology's financial position has strengthened, with net cash increasing to $17.19 million as of 30 June 2024. This increase is attributed to the successful exercise of bonus options by shareholders, raising $5 million in new capital.
Preclinical Success and Future Plans
Race Oncology reported impressive preclinical results, demonstrating that RC220 bisantrene, in combination with decitabine and carfilzomib, significantly enhances cancer cell-killing across a broad range of cancer types. These findings extend the potential utility of bisantrene beyond its use with anthracyclines as a cardioprotective anticancer agent.
Looking ahead, Race Oncology is preparing to initiate its first Phase 1a/1b human clinical trial of RC220 bisantrene in advanced solid tumour patients. The appointment of George Clinical as the Clinical Research Organisation (CRO) to support this trial underscores the company's commitment to advancing its clinical programs.
Management Commentary
Chief Executive Officer, Dr Daniel Tillett, expressed his satisfaction with the progress made during the quarter. 'This quarter has been highly productive with major progress made in bringing RC220 bisantrene to the clinic, aided by the extension of US FDA ODD and RPDD to RC220. We continue to discover new opportunities to use bisantrene in combination with current standard of care anticancer drugs as we advance RC220 to the clinic in 2024,' said Dr Tillett.
Dr Tillett also extended his gratitude to the shareholders who supported the company by exercising bonus options and welcomed new team members Dr Rodney Cusack and Sharon Sampath.
Financial Overview
As of 30 June 2024, Race Oncology's cash and equivalents stood at $17.19 million, up from $16.16 million at the end of Q3 FY2024. The net increase of $1.03 million is primarily due to inflows from option conversions and a reduction in administrative costs. The company continues to manage its resources effectively to support its clinical and preclinical programs.
Shareholder Support
Race Oncology has seen strong support from its shareholders, with 84% of all possible bonus options being exercised. This resulted in the issuance of 6,713,931 new RAC shares and provided over $5 million in new capital. The company's total number of shareholders increased to 9,842, reflecting renewed investor interest as Race moves closer to clinical trials with RC220 bisantrene.
The completion of non-clinical safety studies and the extension of FDA designations are significant milestones that enhance the credibility and potential of RC220 bisantrene. These developments are likely to positively impact Race Oncology's stock price as they signal progress towards clinical trials and potential market approval. The strong financial position further supports the company's ability to advance its clinical programs without immediate financial constraints.
Investor Reaction:
Investors and analysts have reacted positively to the news, highlighting the importance of the FDA designations and the successful completion of GLP studies. The strong financial position and shareholder support are also seen as positive indicators of the company's future prospects.
Conclusion:
Race Oncology's Q4 FY2024 report demonstrates significant progress in the development of RC220 bisantrene and a strong financial position. Investors should monitor upcoming clinical trial updates and assess the potential long-term impacts on their portfolios. The company's strategic advancements and strong shareholder support position it well for future success.