Highlights

  • The first patient was treated with RC220 and osimertinib in the HARNESS-1 trial for EGFR-mutated non-small cell lung cancer, with no dose-limiting toxicities.
  • The Phase 1 CPACS trial expanded to South Korea, accelerating patient recruitment.
  • Ethics approval was received for additional HARNESS-1 sites in NSW and Victoria.
  • Cash was $30.7 million at 30 September 2026, funding all committed activities into mid-CY2028.

Racura Oncology Ltd (ASX:RAC) has released its September 2026 Quarterly Activities Report and Appendix 4C, reporting clinical progress with its lead drug candidate RC220, a proprietary formulation of (E,E)-bisantrene. Both Phase 1 trials, HARNESS-1 and CPACS, have cleared their first dose cohorts without dose-limiting toxicities, and the company says it is funded into mid-CY2028.

HARNESS-1 Lung Cancer Trial Progress

HARNESS-1 is evaluating RC220 with osimertinib in patients with EGFR-mutated non-small cell lung cancer. The first patient completed safety review with no dose-limiting toxicities, and an independent Safety Review Committee recommended enrolling another patient at the same dose before escalation. After quarter end, on 12 October 2026, the committee cleared escalation to the next planned dose of 100 mg/m², after no dose-limiting toxicities in either patient at 50 mg/m².

Bellberry ethics approval in July allowed additional Australian sites, with Chris O’Brien Lifehouse and Austin Health progressing to governance and start-up activities.

CPACS Trial and Scientific Recognition

The CPACS Phase 1 trial evaluates RC220 with doxorubicin in advanced solid tumours, aiming to deliver both cardioprotection and enhanced anticancer activity. The first South Korean site was activated on 1 September, with more to follow. Racura presented progress at the 2026 Global Cardio-Oncology Summit in Virginia on 7 October, confirming completion of the first dose cohort with no dose-limiting toxicities and progression to the next dose level, with enrolment continuing across Australia, Hong Kong and South Korea.

New preclinical data supporting RC220’s G4-binding mechanism and inhibition of MYC gene transcription were accepted for presentation at the Frontiers in Cancer Science Conference in Singapore.

Cash Position and Corporate Updates

Cash and equivalents were $30.7 million at 30 September 2026, down from $34.3 million, with net operating cash outflow of $3.5 million. About 80% of spending, or $2.46 million, went to R&D and drug manufacturing. The Appendix 4C shows an estimated 8.68 quarters of funding. Racura also received a further $117,875 R&D Tax Incentive refund, bringing its total FY2025 refund to $2,905,348.

Racura added clinical project managers and an Associate Medical Director during the quarter. Its Annual General Meeting is scheduled for 23 November 2026.

Key Takeaways

Racura is progressing through early dose escalation in two Phase 1 programs with no dose-limiting toxicities reported so far, and it has a funded runway into mid-CY2028. Early safety data is not evidence of efficacy, and results from larger trials will be needed. This article is general information only and is not financial advice.