Core Insights - The FDA has granted clearance for Radiopharm Theranostics to initiate a first-in-human Phase 1 clinical trial of RV-01, a Lu177-B7H3 monoclonal antibody targeting the 4Ig isoform of B7-H3, which is overexpressed in tumors [1][2] - RV-01 is expected to provide a novel treatment option for patients with aggressive solid tumors, with the first patient dosing anticipated later in 2025 [2][5] 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) [6] - The company has a diverse pipeline that includes distinct technologies such as peptides, small molecules, and monoclonal antibodies, with ongoing clinical trials for various solid tumors [6] Product Details - RV-01 is the first radiopharmaceutical therapeutic agent developed through a joint venture with MD Anderson Cancer Center, demonstrating tumor shrinkage and prolonged survival in preclinical studies [5] - The unique hepatic clearance of RV-01 may minimize adverse effects compared to other radiotherapeutics, which often have renal excretion pathways associated with higher toxicity risks [2][3] Scientific Significance - B7-H3 is an immune checkpoint molecule linked to tumor aggressiveness and poor clinical outcomes, making it a compelling target for antibody-based cancer immunotherapy [4] - The high affinity of RV-01 for the 4Ig isoform allows for enhanced targeting of tumors while avoiding immune complex formation in circulation [3][4]

Core Insights - Radiopharm Theranostics has appointed Dr. Oliver Sartor to its Scientific Advisory Board, enhancing its expertise in oncology radiopharmaceuticals [1][5]. Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][5]. - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain metastases [5]. Dr. Oliver Sartor's Background - Dr. Sartor is a recognized expert in prostate cancer and radiopharmaceutical therapies, currently serving as Director of Radiopharmaceutical Clinical Trials at Mayo Clinic [2][3]. - He has authored over 500 peer-reviewed publications and led pivotal Phase 3 trials that resulted in FDA approvals for several therapies [4]. Strategic Importance - The addition of Dr. Sartor to the Scientific Advisory Board is expected to provide invaluable insights and leadership as the company advances its radiopharmaceutical pipeline [5].

Core Insights - Radiopharm Theranostics has completed the preclinical data package for RAD 402, an anti-Kallikrein Related Peptidase 3 (KLK3) monoclonal antibody radiotherapeutic, and is preparing to initiate a Phase 1 clinical trial for prostate cancer in the second half of 2025 [1][2][3] 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] Partnership and Development - A supply agreement has been signed with Cyclotek to radiolabel RAD 402 with Terbium-161 (Tb), which is crucial for the upcoming Phase 1 clinical trial [1][3] - Cyclotek, a leading radiopharmaceutical manufacturer in Australia and New Zealand, will produce and provide doses of Tb-labeled RAD 402 [6][4] Therapeutic Focus - RAD 402 is designed to target KLK3, which is highly expressed in prostate tissue, potentially leading to improved therapeutic efficacy due to the unique properties of Tb compared to other radionuclides [2][4] - The partnership aims to enhance patient outcomes by improving the accessibility of radiopharmaceuticals [7][8]

Core Insights - The FDA has granted Fast Track Designation for RAD101, a novel imaging small molecule developed by Radiopharm Theranostics, aimed at distinguishing between recurrent disease and treatment effects in brain metastases from solid tumors [1][3] - RAD101 targets fatty acid synthase (FASN), which is overexpressed in many solid tumors, including cerebral metastases, potentially improving diagnostic precision for over 300,000 patients diagnosed annually in the U.S. [2][3] 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) [6] - The company has a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain metastases [6] Clinical Trial Details - The Phase 2b clinical trial of RAD101 is a multicenter, open-label study evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases [4] - The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional imaging (MRI with gadolinium) [4] - Secondary endpoints include the accuracy, sensitivity, and specificity of RAD101 in differentiating tumor recurrence from radiation necrosis in previously treated brain metastases [4] Product Information - RAD101 is designed to allow for more accurate detection of cancer cells by targeting FASN activity, representing a clinically relevant method for imaging brain metastases [5] - Positive data from a Phase 2a imaging trial indicated significant tumor uptake independent of the tumor's origin, suggesting potential for non-invasive prediction of overall survival [5]

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]

Core Insights - ITM Isotope Technologies Munich SE and Radiopharm Theranostics have signed a supply agreement for non-carrier-added Lutetium-177 (n.c.a. Lu) to support Radiopharm's clinical and potential commercial development of Lu-based molecules [1][2] Company Overview - ITM is a leading radiopharmaceutical biotech company focused on developing therapeutics and diagnostics for hard-to-treat tumors, with a commitment to improving patient outcomes through high-quality radioisotopes [4] - Radiopharm Theranostics is a clinical-stage company developing innovative radiopharmaceutical products for diagnostic and therapeutic applications, with a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors [5] Agreement Details - The supply agreement allows Radiopharm to utilize ITM's n.c.a. Lu in key clinical programs, including RAD 204, RAD 202, and RV01, aimed at treating solid tumors [2][3] - ITM's n.c.a. Lu is a highly pure beta-emitting radioisotope that can be linked to tumor-specific targeting molecules, enhancing the precision of cancer treatment [3] Strategic Importance - The agreement is seen as a critical step for Radiopharm to ensure the quality and reliability of its clinical development plans, particularly for its advanced assets [3] - ITM emphasizes its commitment to supplying high-quality medical radioisotopes to both its partners and its own pipeline, reflecting a shared dedication to improving cancer treatment options [4]

Core Insights - The Data and Safety Monitoring Committee (DSMC) has approved the continuation of the Phase 1 clinical trial for 177Lu-RAD204 without modifications, allowing the company to proceed to the next dose level [1][2] - The company aims to complete enrollment of the first two cohorts by mid-2025, with an expansion to multiple tumor types beyond Non-Small Cell Lung Cancer (NSCLC) [2][3] 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) [6] - The company has a pipeline that includes one Phase 2 and three Phase 1 trials targeting various solid tumors, including lung, breast, and brain cancers [6] Clinical Trial Details - The first cohort of the Phase 1 study involved four patients treated with 30mCi of 177Lu-RAD204, showing positive safety and pharmacokinetic data, leading to the decision to increase the dose for the second cohort to 60mCi [2][4] - The second cohort will include patients with various PD-L1-driven cancers, such as SCLC, Triple-negative Breast Cancer (TNBC), Cutaneous Melanoma, head and neck squamous cell carcinoma (HNSCC), and Endometrial Cancer [2][4] Product Information - 177Lu-RAD204 is a single-domain monoclonal antibody targeting PD-L1, which is overexpressed in many solid tumors, making it a promising therapeutic target [4][5] - Previous Phase I imaging data indicated that the diagnostic compound is safe and associated with acceptable dosimetry [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].