Radiopharm Theranostics (ASX:RAD) Progresses Pipeline with Multiple Clinical Milestones

Highlights

• Radiopharm Theranostics is advancing multiple clinical-stage therapeutic and diagnostic programs across oncology indications.
• Lead candidate RAD204 has completed two Phase I dose cohorts, with tumour uptake confirmed in all treated participants and recruitment underway for the third cohort.
• RAD202, RAD402 and RV01 continue progressing through Phase I studies.
• The diagnostic candidate RAD101 reported ~90% concordance with MRI in its Phase 2b study and is progressing towards Phase 3 development.
• The company received ~AUD 5.89 million under Australia's R&D Tax Incentive to support ongoing clinical development and future research activities.

Radiopharm Theranostics (ASX:RAD) (Nasdaq:RADX) has expanded its clinical-stage radiopharmaceutical pipeline, with therapeutic and diagnostic candidates progressing through Phase I and Phase II studies across multiple oncology indications. As these programs continue dose-escalation and patient recruitment, the company is progressing its pipeline towards later-stage development while broadening beyond conventional radiopharmaceutical targets.

Broad Pipeline Targets Established Oncology Biomarkers

Radiopharm's research strategy centres on developing radiotherapeutics against validated oncology targets while expanding treatment approaches beyond commonly pursued targets such as PSMA and Somatostatin Receptor 2 (SSTR2).

Its technology platforms include protein-engineered molecules, antibodies, nanobodies, peptides and small molecules, supporting the development of therapies across multiple tumour types. The company currently has four clinical-stage radiotherapeutic programs targeting PD-L1, HER2, KLK3 and B7H3, alongside a diagnostic imaging portfolio.

RAD204 Leads Clinical Development

RAD204 is Radiopharm's lead therapeutic candidate targeting PD-L1, an established immuno-oncology target with potential applications across multiple tumour types, including post-immunotherapy non-small cell lung cancer (NSCLC).

The investigational therapy aims to assess tolerability and safety of ¹⁷⁷Lu-RAD204 and is currently being evaluated in a Phase I dose-escalation study on patients with history of PD-L1-positive metastatic tumours.

Clinical data from the first two dose cohorts demonstrated tumour uptake in all treated participants, while the study reported few adverse events and no treatment-related serious adverse events. Recruitment is currently underway for the third dose cohort, with completion expected during the third quarter.

Multiple Therapeutic Programs Continue Advancing

Beyond RAD204, the company is progressing several additional clinical-stage candidates targeting large oncology populations.

RAD202 is a HER2-targeted radiotherapy being evaluated in patients with HER2-positive and HER2-low/ very low cancers. The ongoing Phase I study has completed its first two dose cohorts without dose-limiting toxicities, while early biodistribution data confirmed tumour targeting across multiple cohorts. The dose-escalation program continues (up t0 130mci) to establish the recommended Phase II dose along with safety and tolerability of ¹⁷⁷ Lu-RAD202.

The company is also developing RAD402, a prostate cancer radiotherapy targeting KLK3 (PSA). The first patient was enrolled in the Phase I study in March 2026, with dose escalation continuing in patients with advanced prostate cancer. Radiopharm believes the differentiated target may address limitations of PSMA-based radiotherapy.

Another clinical-stage candidate, RV01, targets B7H3, one of the most-pursued next-gen oncology targets with applications across multiple tumour types. The ongoing Phase I basket trial is enrolling patients with cancers including lung, prostate, breast, colorectal, ovarian and head and neck tumours, evaluating the safety and tolerability of ¹⁷⁷ Lu-RV01.

Diagnostic Imaging Complements Therapeutic Development

Alongside its therapeutic pipeline, the company is advancing a clinical-stage diagnostics platform.

The imaging candidate, RAD101, is being developed as a PET imaging agent for brain metastases. Interim Phase 2b data demonstrated 90% concordance with MRI, while also improving detection in patients with equivocal cases. The study has completed recruitment and supports progression towards Phase III development along with potential commercialisation.

The company estimates an addressable U.S. market of approximately 300,000 patients annually. The company believes that the diagnostic platform may offer opportunities through commercialisation and strategic partnerships, while complementing its therapeutic pipeline without significantly increasing capital requirements.

R&D Incentive Supports Pipeline Progression

In July 2026, Radiopharm received approximately AUD 5.89 million, including interest, through the Australian Government's Research and Development (R&D) Tax Incentive for the 2025 financial year.

The proceeds will support ongoing clinical programs and future research activities.

Radiopharm Theranostics continues to expand its clinical-stage radiopharmaceutical portfolio through multiple therapeutic and diagnostic development programs. With RAD204, RAD202, RAD402, RV01 and RAD101 progressing through various stages of clinical evaluation, the company maintains a diversified approach across precision oncology. The recent AUD 5.89 million R&D tax incentive further supports continued investment in clinical development and research activities .

RAD shares were trading at AUD 0.019 per share at the time of writing on 8 July 2026.