Radiopharm Theranostics (ASX:RAD) Q3: Positive Clinical Progress, Cash Runway Extended to 2027

Highlights 

• Radiopharm Theranostics received FDA Investigational New Drug (IND) approval for its Betabart (RV-01) program targeting B7-H3 in solid tumours. 
• RAD appointed renowned oncologist Dr Oliver Sartor to the Scientific Advisory Board. 
• In September quarter, the company raised AUD 35 through a placement, extending cash runway into 2027. 
• Closing cash balance for the quarter stood at AUD 19.04 million, supported by an R&D tax refund of AUD 4.49 million. 

Radiopharm Theranostics Limited (ASX:RAD) (NASDAQ:RADX) recently released its quarterly activities report for the period ended 30 September 2025. The company highlighted key regulatory and clinical developments across its radiopharmaceutical portfolio, including IND FDA approval to commence a Phase I study for Betabart (RV-01), along with positive progress across four ongoing trials. The quarter also featured new strategic appointments and a strengthened balance sheet following a successful capital raise. 

FDA Clears Betabart (RV-01) IND for Phase I Clinical Trial 

The company secured Investigational New Drug (IND) approval from the US Food and Drug Administration to initiate a Phase I clinical trial for Betabart (RV-01), a lutetium-177–conjugated monoclonal antibody targeting the 4Ig isoform of B7-H3. The therapy is designed for solid tumours, and the first-in-human study is planned to commence in the fourth quarter of 2025.  

Preclinical studies indicate effective tumour targeting with hepatic clearance and limited blood-related side effects. The RV-01 program is developed in collaboration with MD Anderson Cancer Centre. 

Positive Clinical Progress Across Four Key Programs 

After the quarter end, Radiopharm provided updates on four ongoing programs: 

• RAD 101 Phase 2b Imaging Study: The trial assessing Fluorine-18 labelled molecule targeting fatty acid synthase for brain metastases enrolled 12 patients in the US. Initial results demonstrated selective tumour uptake, confirming metabolic activity where MRI findings were inconclusive. The program intends to conclude enrolment in the first quarter of 2026, and topline data is expected in the first half of 2026. 

• RAD 202 Phase 1 ‘HEAT’ Trial: A Lutetium-177–labelled HER2-targeting nanobody showed higher-than-expected tumour uptake in the initial cohort. The initial 30mCi dosing has been completed. The trial has progressed to 75mCi following Data Safety and Monitoring Committee recommendations. Enrolment for the higher-dose cohort is expected to conclude by year-end 2025. 

• RAD 204 Phase 1 Study: The trial evaluating Lutetium-177–labelled PD-L1-targeting nanobody achieved stable disease in two of three late-stage metastatic non-small cell lung cancer patients at the first 30mCi dose level. Tumour uptake was observed at 30mCi and 60mCi doses across the first six patients with no dose-limiting toxicities. Dose escalation discussions are planned. 

• RAD 301 Phase 1 Program: A Gallium-68 peptide imaging agent targeting αvβ6-integrin in pancreatic cancer demonstrated data supporting its advancement into a Phase 2 trial. In the ongoing Phase 1 trial, six of the nine planned participants have been dosed, with results showing clear uptake in αvβ6-positive lesions and a positive safety profile. 

Renowned Oncologist Joins Scientific Advisory Board 

Dr Oliver Sartor, a recognised medical oncologist specialising in prostate cancer and radiopharmaceutical therapies, was appointed to Radiopharm’s Scientific Advisory Board.  

Presently, Dr Sartor, serves as Director of Radiopharmaceutical Clinical Trials and Chair of the Genitourinary Cancer Disease Group at the Mayo Clinic. With over 500 publications, he has led multiple Phase 3 trials resulting in FDA approvals for key prostate cancer therapies. 

Capital Raise 

Subsequent to the end of the quarter, the company concluded a AUD 35 million institutional placement and launched a AUD 5 million share purchase plan, with significant support from existing and new investors including Lantheus Holdings. Combined with a closing cash balance of AUD 19.04 million on 30 September 2025, the funds extend the company’s runway into 2027 to support manufacturing, clinical trials, and operational initiatives.  

The R&D tax refund for FY24 amounted to AUD 4,485,434, including interest.  

RAD shares traded at AUD 0.023 per share at the time of writing on 05 November 2025.