AUS
NZ
UK
CA
USA
IND
Highlights
- Radiopharm Theranostics has completed enrolment in its Phase 2b trial of RAD101, with interim results showing concordance with MRI imaging.
- The company signed a supply agreement with Siemens Healthineers to radiolabel and distribute RAD101 using Fluorine-18.
- Early clinical data from the Phase 0/1 study of RAD202 demonstrated tumour uptake, acceptable radiation levels, and no dose-limiting toxicities.
- RAD204 advanced to higher dosing cohorts in its Phase 1 study after initial findings showed tumour uptake and no treatment-related adverse events.
- Radiopharm initiated two First-In-Human trials for RV-01 and RAD402, while continuing enrolment in the Phase 1 study of pancreatic cancer imaging agent RAD301.
Radiopharm Theranostics (ASX:RAD) (NASDAQ:RADX) has outlined significant progress across its clinical-stage oncology portfolio in its quarterly update for the period ended 31 March 2026. The company reported advancements in multiple diagnostic and therapeutic programs, alongside the initiation of new early-stage trials targeting a range of cancers with limited treatment options.
Progress in Brain Metastases Imaging
In March quarter, the company confirmed the completion of patient enrolment in its US Phase 2b trial evaluating RAD101, an imaging agent designed for recurrent brain metastases. Interim findings from the study showed concordance with MRI imaging in the majority of evaluable participants, meeting the primary endpoint criteria.
The trial, conducted in the United States, focuses on assessing diagnostic accuracy in patients with confirmed brain metastases originating from various solid tumours. Following the confirmation of interim results, the company will prepare for a larger, multi-centre Phase 3 trial.
RAD101 has received Fast Track designation from the U.S. Food and Drug Administration, enabling an expedited review process.
In April 2026, the company inked a supply agreement with Siemens Healthineers, which will distribute and radiolabel RAD101 with Fluorine-18 (18F).
Advances in Targeted Radiotherapeutics
New data from the ongoing Phase 0/1 ‘HEAT’ study of RAD202 were presented at the American Association for Cancer Research in April 2026. The therapy, which targets HER2-positive tumours, demonstrated positive uptake of RAD 202, showed no dose-limiting toxicities and organ-level observed radiation doses with the acceptable ranges.
A Data Safety Monitoring Committee has recommended progression to a higher dose level in the study. Further data from additional cohorts are expected by mid-2026, as the trial continues to evaluate safety and distribution patterns in patients with advanced solid tumours.
Meanwhile, RAD204, therapeutic candidate targeting PD-L1-driven cancers, continues to progress through Phase 1 evaluation. Early findings from the first two cohorts indicated tumour uptake in relevant lesions and no treatment-related adverse events. The study has advanced to higher dosing cohorts (90mCi), with further results anticipated later in the year.
Expansion Through New Clinical Trials
Radiopharm has initiated two First-In-Human studies to broaden its therapeutic portfolio. The first involves RV-01, a monoclonal antibody targeting the B7H3 protein, currently being tested across multiple tumour types. In February 2026, under Phase 1/2a trial, the first patient was dosed.
The second focuses on RAD402, developed for advanced prostate cancer, with the trial assessing safety, distribution, and preliminary activity. In March 2026, as part of Phase 1 trial, first patient received the dose.
Additionally, RAD301, an imaging agent for pancreatic cancer, continues enrolment in a Phase 1 study. Early data from this program have shown uptake in targeted lesions, supporting plans to advance into Phase 2 trials.
Financial Overview
The company reported a cash balance of AUD 19.2 million at the end of the quarter and net operating cash outflows totalled AUD 14.9 million, largely driven by research, development, and staffing costs.
Radiopharm Theranostics continues to advance its clinical programs across both diagnostic and therapeutic applications in oncology. With multiple trials progressing and new studies underway, the company is moving forward with its development strategy focused on addressing unmet needs in cancer care. Upcoming data from ongoing studies are expected to further inform the next stages of clinical development.
RAD shares were trading 4.76% higher at AUD 0.022 per share at the time of writing on 23 April 2026.
