Radiopharm Theranostics (ASX:RAD) unveiled promising clinical data across multiple radiopharmaceutical programs while securing A$40 million in new funding to accelerate its growing oncology pipeline.
The company is advancing six clinical-stage programs targeting some of the most challenging cancers to treat.
At the centre of the update is RAD101, a first-in-class PET imaging agent designed to detect recurrent brain metastases. Interim data from the ongoing Phase 2b trial show clear metabolic signals in cases where standard MRI results were ambiguous, demonstrating early clinical utility for identifying relapse following stereotactic radiosurgery. Enrollment is expected to be completed in early 2026.
The company also reported strong progress for RAD202, a HER2-targeted radiotherapeutic for patients with advanced HER2-positive tumours. Early Phase 1 data show high tumour uptake and a favourable safety profile, with no serious adverse events reported. Cohort 2 dosing at 75 mCi has now commenced, marking a key milestone in advancing this treatment for patients who have exhausted standard options.
Equally notable are the findings from RAD204, a PD-L1–targeted nanobody therapy. Interim data from the first two cohorts indicate disease stabilisation in 67 per cent of patients at the lowest dose level, exceeding historical progression-free survival benchmarks in late-line non-small cell lung cancer. The safety profile has so far been favourable, with only low-grade adverse events and no related SAEs observed.
For diagnostics, RAD301, an αvβ6 integrin-targeting imaging agent, is showing early proof of concept in pancreatic cancer. Preliminary Phase 1 results indicate the ability to detect primary and metastatic lesions as small as one centimetre, supporting its potential as a companion diagnostic for multiple tumour types.
Beyond clinical data, Radiopharm announced a A$40 million capital raising to fund its programs into 2027 fully. The raise includes strategic participation from Lantheus Holdings, which has already invested in the company and entered a co-development agreement to accelerate Australian radiopharmaceutical innovation.
The pipeline is anchored in clinically validated isotopes such as fluorine-18, gallium-68, lutetium-177, and terbium-161, and backed by secured isotope supply chains. With six molecules expected to be in clinical development by year’s end, the company is positioning itself as a leading player in a rapidly expanding radiopharmaceutical market.
“This is a transformative moment for Radiopharm,” said CEO Riccardo Canevari. “Our clinical data show the real potential of targeted radiopharmaceuticals to change outcomes for patients with hard-to-treat cancers. With strong funding and partnerships in place, we are well-positioned to deliver meaningful milestones in 2026 and beyond.”
The company expects Phase 2b readouts for RAD101 and further dose escalation data for RAD202 and RAD204 in the first half of 2026, with a Phase 3 launch of the RAD101 imaging program anticipated in the second half of the year.