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]

Core Insights - Radiopharm Theranostics is advancing its RV01 program towards a first-in-human therapeutic basket study targeting solid tumor cancers, with an Investigational New Drug submission planned for mid-2025 and Phase 1 study initiation expected in Q4 2025 [1][7] Group 1: RV01 Program Development - The RV01 therapy is a B7-H3-targeted radiopharmaceutical designed to target solid tumors expressing the B7-H3 protein, which is associated with poor prognosis in various cancers [2] - Preclinical data indicates that RV01 demonstrates favorable biodistribution and high tumor uptake, with modifications in the Fc region leading to a shorter half-life compared to traditional monoclonal antibodies [1][3] - The antibody's faster liver excretion allows for effective tumor targeting while potentially reducing associated toxicities, offering advantages over traditional excretion methods [4] Group 2: Preclinical Data and Efficacy - New preclinical data supports earlier findings of RV01's strong affinity for the cancer-specific 4Ig isoform of the B7-H3 receptor, showing complete regression of established solid tumors and evidence of immune system stimulation [6] - The biodistribution study is the final preclinical work required for the IND application with the U.S. FDA, confirming the timeline for submission and study initiation [7] Group 3: Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals, with a diverse pipeline including peptides, small molecules, and monoclonal antibodies for cancer treatment [9]

ITM's n.c.a. Lu is a market-approved, highly pure form of the beta-emitting radioisotope, Lutetium-177, that can be linked to tumor-specific targeting molecules for the treatment of various cancers and has been successfully used in numerous clinical and commercial radiopharmaceutical cancer treatments. ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. Lu and has marketing authorization in the EU (brand name EndolucinBeta). "Ensuring supply of key isotopes continu ...

DSMC concluded that Phase 1 study may continue as planned without any modifications On track to complete the enrollment of the first two cohorts by mid-2025 SYDNEY, May 12, 2025 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, Nasdaq: RADX, "Radiopharm" or the "Company"), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, announced today that it has achieved a key milestone in its ongoing clinical development ...

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].