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 ...

Summary of Radiopharm Theranostics Conference Call Company Overview - **Company Name**: Radiopharm Theranostics - **Ticker Symbols**: ASX (Australia), NASDAQ: RADX - **Founded**: 2021 in Australia - **Core Business**: Radiopharmaceutical imaging and therapies - **Management Team**: Primarily U.S.-based, located on the East Coast - **Public Listing**: Dual-listed on ASX and NASDAQ since December 2024 [2][4] Key Business Strategies - **Differentiation**: Focus on unique mechanisms of action in radiopharmaceuticals, avoiding common targets like PSMA, SSTR2, and FAP [3] - **Clinical Development**: Four therapeutic molecules and one imaging molecule currently in clinical stages [2][5] - **Supply Chain**: Established a secure and redundant supply chain, with strategic partnerships [4] Strategic Partnerships - **Lantheus**: Co-development agreement and largest shareholder (12% stake) [4] - **MD Anderson Cancer Center**: Joint venture for developing new radiopharmaceuticals [4][21] Product Pipeline - **RAD101**: Imaging agent for brain metastasis, currently in Phase IIB trials with 12 out of 30 patients enrolled. Expected completion by Q1 2026 [5][6][10] - **RAD204**: Therapeutic targeting PD-L1, in dose escalation trials, with promising early results [6][15] - **RAD202**: Therapeutic targeting HER2, also in dose escalation trials, showing significant tumor uptake [18][19] - **B7-H3**: Emerging mechanism for multiple solid tumors, IND approval received, expected to start Phase I soon [8][9] - **KLK3**: Prostate cancer drug using Tb-161 isotope, expected to start Phase I soon [9] Market Potential - **RAD101 Market Assessment**: Estimated total addressable market of $500 million to $700 million in the U.S. alone, with a projected market share of 94% due to lack of competition in brain metastasis imaging [26][27] - **Patient Population**: 300,000 new patients diagnosed annually with brain metastasis [10] Financials and Capital Raise - **Recent Capital Raise**: Conducted to extend cash runway into Q1 2027, following a previous raise in June 2024 [5][20] - **Cash Position**: Current cash runway is eight months, prompting the recent capital raise [20][27] Clinical Trial Updates - **RAD101**: Primary endpoint focuses on concordance with MRI, with secondary endpoints assessing additional lesion detection [23] - **RAD204 and RAD202**: Expected readouts in mid-2026 and end of 2026, respectively [25] Conclusion - **Outlook**: Positive early signals from clinical trials, with a strong focus on expanding the use of radiopharmaceuticals in oncology [25]

NASDAQ: RADX / ASX: RAD CLINICAL UPDATE AND CAPITAL RAISING OCTOBER 20th , 2025 For personal use only Notice & Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Radiopharm Theranostics Ltd ACN 647 877 889 (Company). In preparing this presentation, the Company did not take into account the investment objectives, f ...

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]