Racura Oncology Ltd (ASX:RAC) earlier this week confirmed it has secured AU$3.22 million to fully fund its Harness-1 Phase 1/1B lung cancer trial. The company said the study will test its proprietary drug RC220 in combination with osimertinib, targeting EGFR-mutant lung cancer.
The company told investors that the trial is designed in two stages. The first is a dose escalation phase, followed by a dose expansion phase. The aim is to determine whether RC220 can delay the onset of resistance to third-generation EGFR tyrosine kinase inhibitors.
Racura said the $3.2 million raise, supported by existing shareholders, will ensure the trial is completed without delay. The CEO has also committed to convert $3.0 million in options to strengthen the company’s cash position.
Dr. Peter Smith, Executive Director and Chairman, said the company expects to begin patient recruitment in the first quarter of next calendar year, pending final institutional approvals.
Racura added that data from the Harness-1 trial will be released progressively, given the open-label design. It also noted that data from a second study — investigating RC220 in combination with doxorubicin — will be published throughout 2026.
Proactive:
Welcome back to Proactive Newsroom. I'm now joined by Racura Oncology Executive Director and Chairman, Dr. Peter Smith. Pete, it's good to have you back on with me today.
Dr. Peter Smith:
Nice to be with you. Thank you.
Proactive:
You've raised just over $3.2 million to fund the Harness-1 Phase 1/1B lung cancer trial. Before we dive into the use of those funds, can you give investors a refresher on what Harness-1 is and where you're at with trials?
Dr. Peter Smith:
Yes, so the origin of this trial comes from understanding the mechanism of action of our drug, RC220. Through published literature, we developed the idea of using RC220 — our proprietary version of entry inhibition — to prevent resistance to third-generation EGFR tyrosine kinase inhibitors, which are a vital class of lung cancer drugs.
EGFR mutations drive a portion of lung cancer, and drugs like Tagrisso from AstraZeneca are highly effective at blocking those mutations. What we’ve found is that RC220 blocks a key protein called MEK downstream of that mutation, which may prevent resistance from developing via other pathways.
The trial has two parts: Phase 1A, a dose-escalation study where RC220 is added on top of osimertinib, and Phase 1B, an expansion phase to determine whether the selected dose can delay resistance. This is crucial because once resistance develops, patients have very limited treatment options and very short survival times.
Proactive:
It sounds like a fairly extensive trial. Now that you’ve secured $3.22 million, what exactly will those funds be used for?
Dr. Peter Smith:
The total cost of the trial is about $11.5 million. We had about that amount in cash at the end of September this year, and we also had piggyback options available. What this new $3.2 million allows us to do is move ahead confidently with the trial and know we can complete it.
Daniel, our CEO, is also converting $3 million in options, which further strengthens our funding. With this, we’re fully funded for the trial. We've been doing preparatory work all through 2025, and this enables us to begin patient recruitment as soon as final institutional approvals are received. We expect to enrol the first patients very early in the first quarter of next calendar year.
Proactive:
Where did this $3.22 million in funding come from?
Dr. Peter Smith:
We were approached by existing shareholders who realised that without this funding, the trial might be delayed. I want to emphasise — we would never start a trial without having the resources to finish it. So we were delighted and a bit surprised that shareholders offered more support voluntarily. It reflects their confidence in the company and in this study. Many of them are also converting their piggyback options early, which is helping us move forward.
Proactive:
That shows real trust in the company and this trial, doesn’t it?
Dr. Peter Smith:
Yes, absolutely. We talk a lot about being investor-friendly, and we mean it. We always remember whose money we're spending, and that’s a key part of our approach.
Proactive:
You’ve mentioned that patient enrolment is expected as early as January. What can investors expect as we head into the new year?
Dr. Peter Smith:
This is an open-label study, so we’ll be reporting on each cohort as we escalate the dose of RC220 in combination with osimertinib. There will be a steady flow of data throughout 2026. We're also conducting another study evaluating the cardioprotective and anti-cancer effects of RC220 combined with doxorubicin, so we expect data from multiple studies over the year. Everything kicks off in January.
Proactive:
Racura Oncology Executive Director and Chairman, Dr. Peter Smith, it's been great to have you back on. Thanks for those updates.
Dr. Peter Smith:
Great to be here. Thank you.