Highlights

• Bellberry Human Research Ethics Committee has approved Racura Oncology's HARNESS-1 lung cancer trial.

• The approval allows additional Australian clinical trial sites to participate in the study.

• Chris O'Brien Lifehouse and Austin Health will progress to governance and site start-up activities.

• HARNESS-1 is evaluating RC220 in combination with osimertinib for EGFR-mutant non-small cell lung cancer.

• Additional Australian clinical sites are expected to join the study as further governance approvals are obtained.

Racura Oncology Ltd (ASX:RAC) has announced that Bellberry Human Research Ethics Committee (HREC) has approved its HARNESS-1 lung cancer clinical trial, allowing the company to expand the study across additional Australian clinical trial sites. The approval represents another step in progressing the Phase 1a/b clinical program evaluating RC220 in combination with osimertinib for patients with epidermal growth factor receptor-mutant non-small cell lung cancer (EGFRm NSCLC).

Racura Oncology shares were trading at AUD 2.23, down 2.19% during the afternoon session on 3 July 2026. Despite the day's decline, the stock remains up 87.39% over the past year. The latest announcement relates to the expansion of the company's clinical trial network and does not include new clinical efficacy or safety results.

Racura Oncology is a clinical-stage biopharmaceutical company focused on developing therapies for cancer treatment. Its lead product candidate, RC220 ((E,E)-bisantrene), is being investigated across multiple oncology programs, including a Phase 3 study in acute myeloid leukaemia (AML), a Phase 1a/b study in EGFR-mutant non-small cell lung cancer and a separate Phase 1a/b combination study with doxorubicin for solid tumours.

Ethics Approval Supports Expansion of HARNESS-1 Trial

The company confirmed that Bellberry Human Research Ethics Committee has approved the HARNESS-1 clinical trial, enabling additional Australian hospitals to participate in the study.

This approval follows an earlier ethics approval granted by the St Vincent's Hospital (Melbourne) Human Research Ethics Committee for the lead trial site, Monash Health, which was announced in November 2025.

According to Racura, Bellberry's approval applies to Australian private hospitals as well as eligible public hospital sites located outside Victoria.

The latest approval expands the potential network of participating clinical centres as the company continues advancing patient recruitment for the study.

Additional Trial Sites Move Towards Activation

Following the Bellberry approval, Chris O'Brien Lifehouse will now move into governance and site start-up activities before patient recruitment can commence.

In addition, St Vincent's Hospital (Melbourne) Human Research Ethics Committee has approved the inclusion of Austin Health in Victoria.

Austin Health will also progress through governance and site start-up processes before participating in the clinical study.

Racura stated that additional Australian clinical trial sites are expected to be incorporated into HARNESS-1 over the coming months as further governance approvals are obtained.

The company continues to build the study network progressively through the required ethics and governance processes.

HARNESS-1 Evaluates RC220 Combination Therapy

HARNESS-1 is a multi-centre Phase 1a/b clinical trial involving patients with EGFR-mutant non-small cell lung cancer who are receiving osimertinib (Tagrisso®, AstraZeneca).

The study is evaluating the safety, tolerability and pharmacokinetics (PK) of RC220 when administered in combination with standard-of-care osimertinib.

Before patients enter the treatment stage, the study includes an observational screening phase.

During this stage, circulating tumour DNA (ctDNA), a blood-based marker used to assess cancer activity and tumour growth, is used to identify eligible patients for enrolment into the treatment portion of the trial.

The use of ctDNA is intended to assist in selecting suitable participants before treatment begins.

Dose Escalation Forms the First Treatment Stage

Following screening, eligible patients enter the first treatment stage of the study.

This phase evaluates increasing dose levels of RC220 administered by intravenous infusion on Day 1 of each 21-day treatment cycle alongside maintenance osimertinib therapy.

According to the company, this stage has been designed to assess safety while determining an appropriate dose for future clinical evaluation.

Racura expects between 12 and 40 patients to participate in the dose-escalation phase.

Safety and pharmacokinetic information collected during this stage will be reviewed before the study advances further.

Phase 1b Expansion Planned After Dose Selection

Once a recommended RC220 dose has been established and assessed using available safety and pharmacokinetic data, HARNESS-1 will progress into a randomised, double-blind Phase 1b expansion stage.

Approximately 40 patients are expected to participate in this part of the study.

Participants will receive one of two RC220 dose levels together with osimertinib.

The company said patients will be monitored for safety, pharmacokinetics and early measures of clinical activity.

These assessments will include progression-free survival, overall survival, changes in circulating tumour DNA levels and changes in cancer-specific mutations.

Clinical Trial Listed on Public Registry

Racura noted that HARNESS-1 is registered on the Australian and New Zealand Clinical Trials Registry.

The study is listed under trial registration number ACTRN12626000325303.

The registry provides details regarding participating sites as they become active, together with other publicly available trial information.

The company also confirmed that enquiries relating to the study can be directed to its dedicated clinical trials email address.

Management Comments on the Milestone

Principal Scientist Dr Rodney Cusack described the Bellberry approval as another important milestone for the HARNESS-1 clinical program.

Management noted that Chris O'Brien Lifehouse and Austin Health are established cancer treatment centres with the clinical expertise and patient access required to support the study.

The company stated that it looks forward to activating both sites and continuing patient enrolment as RC220 is evaluated in combination with osimertinib.

About Racura Oncology

Racura Oncology is a clinical-stage biopharmaceutical company focused on developing therapies targeting cancer.

Its lead product candidate, RC220 ((E,E)-bisantrene), is designed to bind G4-DNA and RNA structures, with the aim of silencing the MYC cancer growth regulator.

The company is advancing RC220 across multiple clinical programs, including a Phase 3 trial in acute myeloid leukaemia, a Phase 1a/b trial in EGFR-mutant non-small cell lung cancer and a Phase 1a/b combination study with doxorubicin for solid tumours.

Racura has also collaborated with organisations including Astex, Emory University, Purdue University, MD Anderson Cancer Center, Sheba City of Health, the University of North Carolina School of Medicine, the University of Wollongong and the University of Newcastle.

What Could Investors Watch Next?

Investors are likely to monitor governance approvals that will allow Chris O'Brien Lifehouse and Austin Health to begin participating in the HARNESS-1 study.

Further additions of Australian clinical sites, progress in patient enrolment and updates from the Phase 1a/b trial may also remain key areas of interest as the clinical program advances.

Market participants may also watch for future updates across Racura's broader RC220 development programs, including its ongoing studies in acute myeloid leukaemia and solid tumours.