Radiopharm (ASX:RAD, NASDAQ:RADX) Advances with New Trials, Key Partnerships and Promising Data

Highlights 

• Radiopharm secured a USD 5mn investment from Lantheus Holdings, making Lantheus the company’s largest shareholder.
• The Phase 2b trial of RAD 101 has advanced, with the first patient dosed for suspected recurrent brain metastasis.
• Radiopharm has initiated its first-in-human Phase 1 trial for RAD202 in Australia, targeting HER2-positive solid tumours.
• Positive preclinical data for RAD202 were presented at EMIM 2025, showing high accumulation in HER2-positive tumors. 

Radiopharm Theranostics Limited (ASX: RAD, NASDAQ: RADX), a clinical-stage biopharmaceutical company, is actively advancing its pipeline of distinct and highly differentiated platform technologies against cancer. The company is currently pursuing one Phase 2 and three Phase 1 trials targeting a range of solid tumours, including lung, breast, and brain cancers. 

Radiopharm recently released its March 2025 quarterly report, highlighting significant clinical and corporate achievements.  

The quarter and the subsequent period were marked by several key developments, including increased investment from Lantheus Holdings, positive imaging data for RAD 101 (18F-Pivalate) and the dosing of the first patient in its U.S. Phase 2b trial. Radiopharm also initiated a first-in-human trial for HER2-targeting candidate RAD202. In addition, the company participated in major US investment conferences and confirmed its cash flow guidance remains on track to June 2026.  

The company’s cash balance at the quarter end stood at AUD 36.86mn.  

Lantheus Becomes Radiopharm’s Largest Shareholder 

In January, Radiopharm secured USD 5mn (AUD 8mn) via a strategic placement to Lantheus Holdings Inc., issuing 133 million shares at AUD 0.060, a 150% premium to the last traded price of AUD 0.024. This transaction increased Lantheus’ stake to 12.16%, making it Radiopharm’s largest shareholder. The funds would support ongoing clinical trials of Radiopharm. 

RAD 101 Shows Promise in Brain Metastasis Imaging 

Radiopharm announced promising clinical data during the quarter, showing that its novel imaging agent, RAD 101 (18F-Pivalate), successfully detects brain metastases in a broad patient group. RAD 101 is a small-molecule radiotracer targeting fatty acid metabolism, commonly upregulated in solid tumours. A Phase 2b clinical trial (NCT06777433) is currently underway in the U.S. to assess its diagnostic potential, with patient recruitment active across three sites in Michigan. 

In April, RAD announced that it had dosed the first patient in its U.S. Phase 2b imaging study of 18F-RAD101 for suspected recurrent brain metastasis. 

RAD202 Enters First-in-Human Trials 

In March, Radiopharm announced encouraging new preclinical data for its HER2-targeting radiopharmaceutical candidate, RAD202, presented at the European Molecular Imaging Meeting (EMIM 2025).  

The study demonstrated that ⁶⁸Ga-RAD202 achieved high and specific accumulation in HER2-positive tumours, with a favourable biodistribution profile and minimal uptake in non-target tissues. 

Building on this progress, Radiopharm has initiated a First-In-Human Phase 1 dose-escalation trial in Australia using ¹⁷⁷Lu-RAD202. The study is actively recruiting patients with advanced HER2-positive solid tumours who have progressed on, or are intolerant to, existing standard-of-care therapies. The trial aims to evaluate safety, tolerability, and preliminary signals of efficacy. 

Corporate Outreach: U.S. Investment Conferences 

During the quarter, the executive team of Radiopharm participated in several prominent healthcare and investor conferences in the United States. 

RAD shares traded at AUD 0.022 at the time of writing on 6 May 2025.