Highlights

  • Radiopharm Theranostics (ASX:RAD) traded at AUD 0.010, down 4.76% during the afternoon Trading session on 26 August 2026.
  • The company dosed the first patient in the second cohort of its Phase 1/2a RV-01 clinical trial.
  • The trial has advanced to the 70 mCi dose level following a positive Safety and Monitoring Committee recommendation.
  • RV-01 is the first therapeutic radiopharmaceutical developed through Radiopharm’s joint venture with MD Anderson Cancer Center.
  • Initial clinical data from the trial is expected later in 2026.

Radiopharm Theranostics Limited (ASX:RAD) has announced progress in its BetaBart (RV-01) clinical program, with the first patient dosed in the second cohort of its Phase 1/2a clinical trial targeting B7-H3 expressing solid tumours.

The company traded at AUD 0.010, down 4.76% during the afternoon trading session on 26 August 2026. Over the past year, Radiopharm Theranostics’ share price has declined 66.67%.

The latest milestone follows a recommendation from the Safety and Monitoring Committee (SMC), an independent multidisciplinary committee, to progress the trial to the 70 mCi dose level.

RV-01 Trial Progress

Radiopharm has commenced dosing in the second cohort of its First-In-Human Phase 1/2a clinical trial of RV-01, also known as 177Lu-Betabart.

RV-01 is a radiopharmaceutical therapeutic designed to target B7-H3 expressing tumours.

The Phase 1/2a study is a dose escalation and expansion trial evaluating the safety profile, biodistribution, radiation dosimetry and preliminary anti-tumour activity of RV-01.

The trial is being conducted across clinical centres in the United States and is designed to determine the recommended dose for future studies.

BetaBart Technology

RV-01 is a 177Lutetium-tagged engineered monoclonal antibody developed to target the 4Ig isoform of B7-H3.

B7-H3 is an immune checkpoint molecule that is overexpressed across several tumour types and has become a target of interest for antibody-based cancer therapies.

Radiopharm said preclinical studies of RV-01 have demonstrated tumour shrinkage and prolonged survival in animal models treated with the radiotherapeutic agent.

The company is developing RV-01 as part of its broader radiopharmaceutical pipeline focused on oncology applications.

Joint Venture Program

RV-01 is the first therapeutic radiopharmaceutical developed through Radiopharm Ventures, a joint venture between Radiopharm Theranostics and The University of Texas MD Anderson Cancer Center.

The program represents the first therapeutic candidate from the collaboration to progress through clinical development.

Radiopharm’s pipeline includes radiopharmaceutical technologies based on peptides, small molecules and monoclonal antibodies for diagnostic and therapeutic applications in cancer.

Clinical Trial Design

The Phase 1/2a trial is designed to establish the safety profile, biodistribution, pharmacokinetics and radiation dosimetry of RV-01.

The study aims to enrol 61 eligible participants with a range of solid tumour cancers.

Eligible patient groups include individuals with castrate-resistant prostate cancer, colorectal cancer, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell cancer, ovarian cancer, cervical cancer, endometrial cancer, triple negative breast cancer and oesophageal squamous cell carcinoma.

The trial is expected to provide data to support evaluation of RV-01’s potential therapeutic application.

Management Commentary

Radiopharm CEO and Managing Director Riccardo Canevari said dosing the first patient in the second cohort represented a clinical and operational milestone for the company.

Mr Canevari said progression to the 70 mCi dose level followed the Safety and Monitoring Committee’s recommendation and supported continued advancement of the RV-01 development program.

Chief Medical Officer Dimitris Voliotis said B7-H3 remains a target of interest due to its expression across multiple solid tumour types.

He added that the company remains focused on enrolling patients in the current cohort and expects to report initial clinical data later in 2026.

Company Pipeline

Radiopharm Theranostics is a clinical-stage radiotherapeutics company developing diagnostic and therapeutic radiopharmaceutical products for areas of high unmet medical need.

The company’s clinical programs include one Phase 2 trial and five Phase 1 trials across a range of solid tumour cancers, including lung, breast, prostate and brain cancers.

RV-01 is one of the company’s key therapeutic programs as Radiopharm continues advancing its oncology-focused pipeline.

Investor Takeaway

Radiopharm Theranostics’ latest update highlights continued advancement of the RV-01 BetaBart program, with the first patient dosed in the second cohort of its Phase 1/2a clinical trial. The company is progressing dose escalation activities following Safety and Monitoring Committee support and remains focused on generating clinical data from the trial later in 2026. Investors may continue watching trial enrolment, safety data and future development milestones for RV-01.