Summary of Radiopharm Theranostics (NasdaqCM:RADX) Update / Briefing December 15, 2025 Company Overview - **Company**: Radiopharm Theranostics - **Ticker**: RADX - **Focus**: Development of imaging agents for brain metastases, specifically RAD-101 targeting fatty acid synthase Key Industry Insights - **Target Market**: Brain metastases primarily from lung cancer, breast cancer, and melanoma, which account for approximately 90% of cases [3][4] - **Current Treatment Challenges**: Difficulty in differentiating between tumor recurrence and treatment-related effects post-stereotactic radiosurgery (SRS) [4][11] - **Unmet Medical Need**: High demand for effective imaging solutions to accurately assess brain metastases and guide treatment decisions [11][19] Core Findings and Data - **RAD-101 Performance**: Preclinical data shows RAD-101 has superior uptake and tumor-to-brain ratios compared to traditional imaging agents like 18F FTG in various cancer models [2] - **Phase IIB Study**: Currently recruiting 30 patients in the U.S. to evaluate RAD-101's effectiveness in patients with suspected brain metastases post-SRS [4][5] - **Survival Correlation**: Patients with a standardized uptake value (SUV) greater than 2 showed significantly shorter overall survival, indicating the potential prognostic value of RAD-101 [6][8] - **Market Potential**: Estimated market size of $500 million in the U.S. for RAD-101, with a projected price of $4,800-$5,000 per dose [46][56] Competitive Landscape - **Lack of Competition**: Currently, no other imaging agents specifically targeting brain metastases are in clinical development, providing RAD-101 a unique market position [49][50] - **Differentiation from Other Agents**: RAD-101 targets fatty acid metabolism, while competitors focus on amino acid metabolism, addressing different patient populations [48][50] Future Plans - **Phase III Study**: Anticipated to include around 150 patients, focusing on sensitivity and specificity as primary endpoints [40][41] - **Longitudinal Studies**: Plans to conduct longitudinal scans to establish a truth standard for imaging efficacy [77] - **Potential for Therapeutic Version**: Exploration of developing a therapeutic isotope version of RAD-101 is underway [64] Additional Considerations - **Combination with MRI**: Initial strategy involves using RAD-101 in conjunction with MRI to enhance diagnostic accuracy [45][68] - **Patient Management Improvement**: Aim to enable earlier diagnosis and treatment of tumor recurrence, potentially improving patient outcomes [54][56] - **Safety Concerns**: Emphasis on the importance of accurate imaging to avoid unnecessary SRS procedures, which carry risks of side effects [65][67] Conclusion Radiopharm Theranostics is positioned to address a significant unmet need in the imaging of brain metastases with RAD-101, showing promising preclinical results and a clear path towards clinical development. The company is focused on establishing its market presence while ensuring patient safety and improving treatment outcomes through innovative imaging solutions.