Radiopharm Theranostics (ASX:RAD) Prepares for Multiple 2026 Readouts with Firm Cash Position

Highlights

• Interim results from the Phase 2b trial of RAD 101 showed that 92% of evaluable patients with brain metastases met the primary endpoint of concordance with MRI imaging.
• Enrolment in the RAD 101 study is ongoing and expected to be completed in the first quarter of 2026, with results set to inform a Phase 3 registrational study.
• Phase 1 trials of RAD 202 and RAD 204 continue to progress, with dose escalation approved by the DSMC and additional cohort data expected by mid-2026.
• First-in-human Phase 1 trials for RV-01, RAD 402, and RAD 301 are expected to commence in early 2026.
• The company reported a cash position of AUD 34.52 million at the end of December 2025.

Radiopharm Theranostics Limited (ASX:RAD) (Nasdaq:RADX) reported a constructive December 2025 quarter, highlighting positive interim clinical data from its lead program, continued progress across multiple Phase 1 and Phase 2 oncology trials, and a strengthened funding position. The update underscores the company’s momentum as it advances a diversified radiopharmaceutical pipeline toward key milestones in 2026.

RAD 101 Delivers Interim Phase 2b Imaging Data

RAD 101 is currently being evaluated in a single-arm Phase 2b diagnostic trial in the US, targeting patients with recurrent brain metastases. The study aims to enrol 30 participants with metastases from diverse solid tumors. RAD 101 has earned Fast Track Designation from the US FDA.

Interim results reported in December 2025, based on the first 12 patients, revealed that 92% of evaluable participants met the primary endpoint of alignment with MRI imaging.

Currently, patients’ enrolment is underway and is expected to be completed in the first quarter of 2026, with confirmation of results expected to support preparation for a Phase 3 registrational study.

Dose Escalation and Enrolment Progress in RAD 202 and RAD 204

RAD 202 continues evaluation in patients with HER2-positive advanced solid tumours under the Phase 1 HEAT trial. Dosing at the 30mCi level has been completed, and the study is progressing to the 75mCi dose following approval from the Data Safety Monitoring Committee. Initial data from the first cohort showed considerable tumour uptake in HER2-positive tumours, with enrolment in higher-dose cohorts slated to wrap up in the first half of 2026.

RAD 204, targeting PD-L1, is advancing through a Phase 1 study in multiple cancer types. The second cohort has completed enrolment, allowing progression to a third cohort at a 90mCi dose (as approved by the DSMC). Early data across two cohorts indicate tumour uptake in PD-L1-positive lesions, with no drug-related adverse events reported.

Radiopharm Ventures Programs Enter First-In-Human Studies

RV-01, a Lutetium-177–labelled monoclonal antibody targeting the 4Ig isoform of B7H3, received FDA Investigational New Drug clearance in July 2025 to advance first-in-human Phase 1 trial. In January 2026, Radiopharm increased its ownership in Radiopharm Ventures to 87.5%. First patient dosing in the Phase 1 trial is expected in the Q1 2026.

RAD 402 and RAD 301 Advance to Next Stages of Evaluation

RAD 402, targeting KLK3 for the treatment of prostate cancer, received approval from the Bellberry Human Research Ethics Committee in Australia in November 2025, with a Phase 1 trial anticipated to commence in Q1 2026. RAD 301 continues enrolment in a Phase 1 imaging study for pancreatic cancer, with initial data supporting progression toward Phase 2 evaluation.

Financial Update

As of 31 December 2025, the company reported a closing cash balance of AUD 34.52 million, up from AUD 29.12 million at the end of the prior period. In October 2025, the company received commitments to raise approximately AUD 35 million via private placement.

Radiopharm Theranostics has entered 2026 with a well-funded and actively advancing pipeline, marked by positive interim data from RAD 101, ongoing dose escalation in RAD 202 and RAD 204, and the upcoming first-in-human trials for RV-01, RAD 402, and RAD 301. The company’s cash position of AUD 34.52 million supports continued progress across multiple radiopharmaceutical programs toward key clinical and regulatory milestones. The company’s cash position provide runway into 2027 to advance its pipeline of high value radiotherapeutic programs through key clinical and regulatory milestones.

RAD shares were trading at AUD 0.021 per share at the time of writing on 30 January 2026.