Highlights

• RAD204 Phase 1 Trial expands to multiple cancer types, showing promising tumour-targeting capabilities and safety.
• Preclinical studies of RAD402 demonstrated significant tumour regression and minimal off-target toxicity in prostate cancer models.
• RAD101 receives FDA IND approval for its Phase 2b trial, targeting brain metastases with high imaging sensitivity.
• Ethics approval secured for Phase 1 trial of 177Lu-RAD202 in HER2-positive cancers, including gastric and breast cancers.
• Lantheus expanded its partnership with Radiopharm, funding a Phase 1 imaging trial .
• Radiopharm listed its ADSs on Nasdaq under the ticker - RADX in November 2024.
• The company has raised its ownership in Radiopharm Ventures from 51% to 75%.

Radiopharm Theranostics Limited (ASX:RAD) achieved notable progress in its mission to develop next-generation radiopharmaceuticals during the six-month period ended 31 December 2024 (1HFY25). The company made strides in clinical trials, regulatory approvals, and strategic partnerships.

A key milestone during the period was the listing of the company’s American Depositary Shares (ADSs) on Nasdaq under the ticker code “RADX”, with each ADS representing 300 ordinary shares. This move enhances the company’s access to U.S. investors and boosts its global profile.

 RAD204 Phase 1 Trial Expands to Multiple Cancer Types

The company’s Phase 1 clinical trial of RAD204, a radiotherapeutic targeting PD-L1, advanced across several Australian sites in collaboration with GenesisCare CRO. Initially focused on non-small cell lung cancer (NSCLC), the trial has been expanded to include five additional cancer types, further exploring RAD204's potential efficacy in targeting PD-L1-expressing tumours.

The company has accelerated patient recruitment to meet study targets. Initial data has shown promising tumour-targeting capabilities, favourable biodistribution, and encouraging safety profile. Insights from the initial NSCLC cohort are being used to refine therapeutic outcomes and dosing strategies across the expanded indications.

Interim data are expected in mid-2025, with full results anticipated in Q4 2025/ Q1 2026.

RAD101 – Advancing Brain Metastases Imaging

The Phase 2b trial of RAD101 (F18-Pivalate), focusing on brain metastases, has secured FDA Investigational New Drug (IND) approval. This follows positive Phase 2a results that demonstrated high tumour uptake and strong imaging contrast.

The Phase 2b study aims to evaluate RAD101’s imaging performance in identifying brain metastases with high specificity and sensitivity and assessing lesion detectability along with uptake consistency. The trial is enrolling 30 patients across multiple sites in the U.S. .

The study will assist in gathering data for a future registrational Phase 3 trial, a key step towards regulatory approval and commercialisation of RAD101 for clinical use.

Ethics Approval Secured for Phase 1 Trial of RAD202

Radiopharm has secured ethics approval to initiate a Phase 1 trial of 177Lu-RAD202 for HER2-positive cancers, including gastric and breast cancers. The trial will take place across several Australian sites.

Diagnostic and preclinical studies have demonstrated tumour uptake and therapeutic potential. Meanwhile, preclinical models have shown significant tumour growth inhibition and prolonged survival when labelled with 177Lu.

The first set of interim data is expected in 2HFY25.

RAD301 – Promising Results for Pancreatic Cancer Imaging

Clinical results for 68Ga-Trivehexin (68Ga-RAD301) were recently published in Frontiers in Nuclear Medicine. The study, which is the largest cohort of RAD301 imaging to date, included 44 cancer patients and demonstrated that RAD301 is a safe and effective diagnostic tool for αvβ6-integrin expression in pancreatic cancer.

The phase I IND-approved imaging study in pancreatic cancer patients is being conducted in New York, with full results anticipated by June this year.

RAD402 – KLK3-Targeting Radiotherapeutic for Prostate Cancer

Preclinical studies of RAD402, targeting advanced prostate cancer patients, have yielded promising results. Models demonstrating minimal off-target toxicity and substantial tumour regression. Radiopharm is now collaborating with regulatory agencies to finalise the clinical development pathway, with GMP manufacturing expected to be concluded in 1H2025.

A Phase I study is planned for 2H 2025.

Strategic Developments

• Lantheus Co-Development Agreement: Lantheus Holdings has expanded its partnership with Radiopharm and will fund a Phase 1 imaging trial for solid tumours, committing up to USD 2 million in milestone payments. Lantheus has also increased its equity stake to 12.16% following an AUD8 million strategic placement.
• BAMF Health Partnership: RAD has established a partnership with BAMF Health in order to manufacture and dose 18F-RAD101 for the Phase 2b brain metastases imaging trial.
• Increased Ownership in Radiopharm Ventures: RAD has raised its shareholding in Radiopharm Ventures, LLC from 51% to 75%. The joint venture, established with MD Anderson Cancer Centre, focuses on advancing radiopharmaceutical cancer treatments. RAD has invested additional USD4 million to fund future development.

RAD shares were trading 13.33% higher at AUD 0.034 per share at the time of writing on 06 March 2025.