Core Insights - The interim analysis of RAD 101 shows that 92% of evaluable patients achieved concordance with MRI imaging, indicating significant tumor uptake in brain metastases [1][2] - The company plans to initiate a pivotal study by the end of 2026, bolstered by the positive interim data from the Phase 2b trial [3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][10] - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [10] Clinical Trial Details - The Phase 2b clinical trial is evaluating the diagnostic performance of RAD 101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [8] - The primary objective is to assess concordance between RAD 101 positive lesions and those seen in conventional MRI imaging [8] Market Opportunity - The U.S. market opportunity for RAD 101 is estimated to exceed $500 million annually, positioning it among the top three imaging agents in the market [3] - Over 300,000 patients are diagnosed with brain metastases annually in the U.S., highlighting a significant patient population for RAD 101 [4][3] Technology and Innovation - RAD 101 is a novel imaging agent targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [9] - The integration of RAD 101 PET with standard MRI could enhance patient management and treatment decisions for brain metastases [3]

Early patient data from Phase 2b clinical trial showed significant and selective tumor uptake in brain metastases compared to MRI Phase 2b clinical trial expected to complete enrollment and have topline data in 1H26 SYDNEY, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, today announced that the Phase 2b trial eval ...

Core Insights - The company has initiated the Phase 1 'HEAT' clinical trial for RAD202, targeting HER2-positive advanced solid tumors, marking a significant milestone in its transition to a clinical-stage entity [1][3][4] - The trial aims to assess the safety, tolerability, and preliminary efficacy of 177Lu-RAD202, with the first patient already dosed [2][3] - RAD202 is a proprietary nanobody that has shown promise in previous studies for treating HER2-positive cancers, including breast cancer [3][5] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [5] - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a diverse pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors [5] - The company aims to provide therapeutic options that improve clinical outcomes for patients with HER2-positive metastatic cancers [3][4]

Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [3] - The company is listed on ASX (RAD) and NASDAQ (RADX) [3] - Radiopharm has a pipeline that includes distinct and differentiated platform technologies such as peptides, small molecules, and monoclonal antibodies for cancer treatment [3] Clinical Development - The clinical program includes one Phase 2 trial and three Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain cancers [3] Upcoming Events - Management will participate in the D. Boral Capital Inaugural Global Conference on May 14, 2025, in New York City [1] - Interested parties can register for one-on-one meetings with management by contacting John Perez [2]

Core Viewpoint - Radiopharm Theranostics has initiated a Phase 2b clinical trial for 18F-RAD101, aimed at improving diagnostic accuracy for suspected recurrent brain metastases from solid tumors, highlighting the company's commitment to innovative oncology radiopharmaceuticals [1][4]. Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, listed on ASX (RAD) and NASDAQ (RADX) [5]. - The company has a diverse pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors, including lung, breast, and brain cancers [5]. Clinical Trial Details - The Phase 2b trial is a multicenter, open-label, single-arm study evaluating the diagnostic performance of 18F-RAD101 in 30 patients with confirmed recurrent brain metastases from different solid tumors [2]. - The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional imaging methods, specifically MRI with gadolinium [2]. Technology and Innovation - 18F-RAD101 is a novel imaging small molecule that targets fatty acid synthase (FASN), which is overexpressed in many solid tumors, including cerebral metastases, allowing for accurate cancer cell detection [3]. - Positive results from a previous Phase 2a trial at Imperial College London indicated significant tumor uptake of 18F-RAD101, consistent across different tumor origins [3]. Market Potential - The trial aims to enhance diagnostic precision for over 300,000 patients diagnosed with brain metastases annually in the U.S., addressing the limitations of current imaging techniques in distinguishing between tumor recurrence and radiation necrosis [4].