Radiopharm Theranostics (ASX:RAD) Advances Clinical Pipeline with Key Trial Progress and Funding Boost

Highlights

• Radiopharm Theranostics is advancing multiple radiopharmaceutical programs across clinical stages
• RAD 101 has reported 92% concordance with MRI in a Phase 2b brain metastases study
• RAD 202 and RAD 204 have progressed dose escalation studies with early tumour uptake observed
• BetaBart (RV-01) has entered clinical trials with the first patient dosed following FDA clearance
• The company has strengthened its funding position to support new patient dosing, regulatory milestones, and pipeline expansion through 2026

Radiopharm Theranostics Limited (ASX:RAD) continues advancing its clinical-stage radiopharmaceutical pipeline, with multiple programs across diagnostic and therapeutic applications. The company’s recent activities reflect ongoing investment in research, clinical trials, and strategic initiatives aimed at expanding its oncology-focused portfolio, supported by a diversified pipeline progressing through early- and mid-stage development.

RAD 101 Shows Imaging Concordance

The company’s 18F-RAD 101 program, targeting fatty acid synthase (FASN), reported interim results from its Phase 2b trial in patients with recurrent brain metastases. Data from the first twelve participants showed 92% of evaluable participants achieved concordance with MRI imaging, meeting the primary endpoint.

The study is designed to evaluate diagnostic performance across multiple tumour types, with findings indicating the ability of RAD 101 to detect metabolically active tumour tissue. The program also demonstrated potential utility in cases where MRI results are inconclusive. Enrolment is expected to complete in the first quarter of 2026, with further data anticipated thereafter.

RAD 202 Advances in HER2-Targeted Therapy

The 177Lu-RAD 202 program continued its Phase 1 ‘HEAT’ study in HER2-positive cancers. Initial dosing has been completed, with early data indicating tumour uptake and target engagement.

Following review by the Data Safety Monitoring Committee, the study progressed to a higher dose cohort. The program is focused on evaluating safety and biodistribution in patients with advanced HER2-positive tumours, including breast cancer.

RAD 204 Demonstrates Early Clinical Activity

Radiopharm’s 177Lu-RAD 204, targeting PD-L1, advanced through its Phase 1 study across multiple cancer types. Initial findings confirmed tumour uptake in PD-L1-positive lesions and a consistent safety profile.

In a small cohort of patients with metastatic non-small cell lung cancer, two participants achieved stable disease for 5.5 months. The study has since progressed to higher dosing levels following completion of earlier cohorts.

New Clinical Entry and Preclinical Progress

BetaBart (RV-01) Enters Clinical Stage: The company’s B7-H3-targeted monoclonal antibody, Lu177-RV 01 (BetaBart), has transitioned from preclinical development into clinical evaluation. The program received Investigational New Drug clearance from the U.S. FDA in July 2025.

First patient has been dosed in a Phase 1/2a trial designed to assess safety, biodistribution, and preliminary anti-tumour activity.

RAD 402 Targets Prostate Cancer: The Tb161-RAD 402 program, targeting KLK3 in prostate cancer, progressed toward first-in-human studies. Regulatory approval was received in Australia to initiate a Phase 1 trial in patients with advanced or metastatic disease.

RAD 301 Continues Imaging Study: The Ga68-RAD 301 imaging agent, targeting αvβ6-integrin in pancreatic cancer, has continued enrolment in its Phase 1 study. Early data confirmed safety and tumour uptake, supporting its diagnostic potential in a high-mortality cancer type.

Financial Position and Capital Activity

The company has secured approximately A$35 million through an institutional placement, alongside a Share Purchase Plan that raised additional funds. An At-the-Market (ATM) facility was also established in the United States, providing flexibility to raise up to US$18.9 million through the issuance of American Depositary Shares.

Radiopharm Theranostics looks forward to advance clinical trials and progress key assets toward later-stage development. Strengthened funding is set to support new patient dosing, regulatory milestones, and pipeline expansion through 2026.

Shares of RAD traded at AUD 0.021 at the time of writing on 18 March 2026.