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].

As filed with the Securities and Exchange Commission on December 5, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Radiopharm Theranostics Limited (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Australia 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) Lev ...