Interim results from Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants met the primary endpoint of MRI concordance in imaging study of patients with brain metastases Interim data from additional Cohorts of the Phase 1 clinical trial of RAD 202 and RAD 204 in advanced solid tumors are expected in mid-2026 Cash and cash equivalents of approximately $34.52 million provide runway into 2027 to advance pipeline of high value radiotherapeutic programs through key clinical and regulatory mile ...

Summary of Radiopharm Theranostics Conference Call Company Overview - **Company Name**: Radiopharm Theranostics - **Stock Symbols**: NASDAQ: RADX, ASX: RAD - **Industry**: Clinical stage radiotherapeutics - **Focus**: Development of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical needs [2][3] Core Business and Partnerships - **Core Business**: Radiopharmaceuticals, with a focus on first-in-class products [3] - **Strategic Partnerships**: - **Lantheus**: Largest shareholder with approximately 15% ownership [3] - **MD Anderson Cancer Center**: Scientific partnership for research and development [3] Pipeline and Clinical Trials - **Clinical Stage Molecules**: Five molecules currently in clinical stage [3] - **Key Products**: - **RAD101**: Imaging agent for brain metastasis, currently in Phase II with over 50% trial recruitment [4][6] - **PD-L1 Nanobody**: In Phase I, targeting multiple solid tumors [10] - **HER2 Nanobody**: In Phase I, targeting breast and gastroesophageal cancer [10] - **RV01**: Monoclonal antibody targeting B7-H3, expected to dose first patient in February [5] - **KLK3-targeting Monoclonal Antibody**: Radiolabeled with Terbium-161, also expected to dose first patient soon [5] Clinical Milestones and Data - **Upcoming Milestones**: - Completion of Phase II enrollment for RAD101 expected by March or April 2026 [14] - Full data release for Phase II anticipated before June 2026 [14] - Significant clinical data for RAD204 and RAD102 expected mid-2026 [14] - **Interim Data**: Positive interim results for RAD101, with 92% of patients achieving primary endpoint [7][8] Market Position and Competition - **Competitive Advantage**: No other radiopharmaceuticals in development for brain metastasis imaging, positioning RAD101 as a first-in-class product [16] - **Comparison with Competitors**: - **Novartis**: Established leader with commercial products but focused on different therapeutic areas [24] - **Telix**: More focused on imaging rather than therapeutics [24] - **Point Biopharma**: Acquired by Lilly, with no direct competition to Radiopharm's pipeline [25] Financial Overview - **Burn Rate**: Approximately $6 million to $7 million per quarter, with sufficient cash to reach Q1 2027 [19] - **Revenue Generation Potential**: RAD101 is closest to commercialization, with potential market launch by 2029 [21] Supply Chain and Manufacturing - **Isotope Supply Chain**: Multiple suppliers secured for Lutetium-177 to ensure reliable supply [18] Strategic Vision - **Partnership Strategy**: Focus on clinical development with openness to partnerships or licensing as trials progress [27] - **Long-term Goals**: Aim to deliver clinical data in 2026 that supports future financing needs [19][29] Conclusion - **Outlook**: 2026 is expected to be a pivotal year for Radiopharm Theranostics, with a strong focus on execution and addressing unmet medical needs in cancer treatment [29]

Core Insights - Radiopharm Theranostics has increased its ownership stake in Radiopharm Ventures, LLC from 75% to 87.5% as the joint venture progresses in its cancer therapeutic pipeline [1][2] Group 1: Joint Venture and Ownership - The increase in ownership percentage reflects the promising progress of the joint venture, particularly with the B7H3 candidate and other preclinical assets [2] - Radiopharm Ventures, LLC was launched in September 2022 in collaboration with The University of Texas MD Anderson Cancer Center to develop novel radiopharmaceutical products for cancer treatment [5] Group 2: Product Development and Clinical Trials - The lead candidate, Betabart (RV01), is a monoclonal antibody targeting B7H3, which has received Investigational New Drug clearance from the U.S. FDA and is expected to begin dosing the first patient in Q1 2026 [3][7] - Two additional preclinical candidates have shown early positive results and are moving towards final candidate selection, with applications across multiple solid tumor types [4][7] Group 3: Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs, with a pipeline that includes one Phase 2 and four Phase 1 trials in various solid tumor cancers [6]

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.

Company Overview - Radiopharm Theranostics Limited (NASDAQ:RADX) is a biotechnology company focused on developing treatments for conditions such as brain metastasis and prostate cancer [2]. Clinical Developments - The company is advancing its RAD 101 imaging agent and RAD 204 diagnostic compound, with RAD 101 currently in a Phase 2b clinical trial and having received FDA's Fast Track Designation [3]. - RAD 204's Phase 1 clinical trial for various cancers showed absorption similar to previous studies, indicating progress in its development [3]. - The market potential for RAD 101 is significant, with approximately 300,000 people diagnosed with cerebral metastases annually in the US [3]. Analyst Insights - B. Riley has lowered its price target for RADX shares from $15 to $13 while maintaining a Buy rating, reflecting a cautious optimism regarding the company's prospects [2].

Core Insights - Radiopharm Theranostics Limited (NASDAQ:RADX) is experiencing a significant increase in stock price, trading at $10.27, up 141.31%, approaching its 52-week high of $11.00 [7] Group 1: Clinical Trial Updates - The company shared interim data from its U.S. Phase 2b imaging trial of RAD 101, which targets fatty acid synthase (FASN) for diagnosing recurrent brain metastases, showing that 92% (11 out of 12) of patients achieved concordance with MRI as assessed by PET imaging [2][4] - The interim analysis indicated significant and selective tumor uptake in brain metastases, confirming metabolic activity compared to unclear MRI findings [3] Group 2: Market Potential and Future Plans - The CEO stated that the interim data strengthens confidence in the Phase II trial's success and lays a foundation for a pivotal study by the end of 2026, with independent assessments estimating RAD 101's U.S. market opportunity at over $500 million annually [4] - The company has achieved 50% patient enrollment in the Phase 2b trial evaluating RAD 101 [4] Group 3: Regulatory Designations and Additional Trials - RAD 101 has received FDA Fast Track Designation for distinguishing recurrent disease from treatment effects in brain metastases, with over 300,000 patients diagnosed annually in the U.S. [5] - Additionally, the company secured Australian approval to initiate its First-In-Human Phase 1 clinical trial of RAD 402 for metastatic or locally advanced prostate cancer [6]

Core Insights - The interim analysis of RAD 101 shows that 92% of evaluable patients achieved concordance with MRI imaging, indicating significant tumor uptake in brain metastases [1][2] - The company plans to initiate a pivotal study by the end of 2026, bolstered by the positive interim data from the Phase 2b trial [3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][10] - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [10] Clinical Trial Details - The Phase 2b clinical trial is evaluating the diagnostic performance of RAD 101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [8] - The primary objective is to assess concordance between RAD 101 positive lesions and those seen in conventional MRI imaging [8] Market Opportunity - The U.S. market opportunity for RAD 101 is estimated to exceed $500 million annually, positioning it among the top three imaging agents in the market [3] - Over 300,000 patients are diagnosed with brain metastases annually in the U.S., highlighting a significant patient population for RAD 101 [4][3] Technology and Innovation - RAD 101 is a novel imaging agent targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [9] - The integration of RAD 101 PET with standard MRI could enhance patient management and treatment decisions for brain metastases [3]

Core Viewpoint - The article discusses the best ASX stocks to buy, highlighting the impact of interest rate trends in Australia and the performance of specific biotechnology companies [1][2][3]. Interest Rate Trends - The Reserve Bank of Australia (RBA) Governor Michele Bullock indicated that there are no foreseeable interest rate cuts, suggesting a potential for rate hikes in the future [2][3]. - Bullock's comments surprised many, as she clearly signaled that further interest rate cuts are off the table, preparing the market for a possible tightening bias [3]. Company Highlights Immuron Limited (NASDAQ:IMRN) - Immuron Limited is a biotechnology company focused on preventing diarrhea and developing similar medicines [8]. - The company faced a significant setback with a 25.8% drop in share price after a clinical trial for its ETEC hyperimmune bovine colostrum product failed to meet its primary endpoint [8]. - Despite the setback, the FDA cleared Immuron's IMM-529 drug for a phase 2 clinical trial, targeting Clostridioides difficile infection, with the study expected to start in the first half of 2026 [9]. Radiopharm Theranostics Limited (NASDAQ:RADX) - Radiopharm Theranostics Limited is developing treatments for conditions such as brain metastasis and prostate cancer [10]. - B. Riley lowered its price target for Radiopharm to $13 from $15 while maintaining a Buy rating, citing important clinical progress for its RAD 101 and RAD 204 compounds [10]. - RAD 204's phase 1 clinical trial showed promising results, and RAD 101 is currently in a Phase 2b trial with FDA Fast Track Designation, targeting a market of 300,000 annual diagnoses of cerebral metastases in the US [11].

For personal use only NASDAQ: RADX / ASX: RAD Annual General Meeting NOVEMBER 20 , 2025 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, financial situa ...

Core Insights - Radiopharm Theranostics has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a First-In-Human (FIH) Phase 1 clinical trial for RAD 402, a radiotherapeutic targeting KLK3 for metastatic or locally advanced prostate cancer [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 four Phase 1 trials targeting various solid tumors, including lung, breast, and brain metastases [5] Product Details - RAD 402 is an anti-KLK3 monoclonal antibody radiolabelled with the radionuclide 161Tb, designed for the treatment of prostate cancer, with KLK3 being a key biomarker for the disease [2] - Preclinical studies have demonstrated strong tumor targeting and a favorable excretion profile for RAD 402, supporting its potential effectiveness [3] Clinical Development - The initiation of the Phase 1 trial for RAD 402 is significant as it is reportedly the first company-sponsored therapeutic trial utilizing 161Tb, highlighting the innovative approach of targeting KLK3 in advanced prostate cancer [4]