Radiopharm Theranostics (NasdaqCM:RADX) Update / briefing March 24, 2026 06:00 PM ET Company ParticipantsDimitris Voliotis - CMOHarshad Kulkarni - Chief Medical AdvisorRiccardo Canevari - Managing Director and CEORiccardo CanevariThanks a lot, Ben, and thanks to everybody for joining and for listening to us. We have decided to run this workshop after the press release of yesterday. A little bit of history. We were together mid-December when we reported the first interim analysis of the phase II-B trial of R ...

Radiopharm Theranostics (NasdaqCM:RADX) Conference March 24, 2026 05:30 PM ET Company ParticipantsMatt Wright - Director of Media and Investor RelationsRiccardo Canevari - CEOMatt WrightBy popular demand, has been around some of the best investing conferences in Australia across various sectors. Again, encourage everyone to check out those. Without further ado, the first presenter today, we have Radiopharm Theranostics, and the CEO, Riccardo Canevari. Radiopharm is a clinical-stage radiopharmaceutical compa ...

RAD 101 is Radiopharm’s novel, small-molecule imaging agent targeting fatty acid synthase (FASN) and radiolabelled with Fluorine-18 for the diagnosis of suspected recurrent brain metastases from solid tumors of different origins.Phase 2b Interim Data Shows 90% MRI ConcordanceThe second interim analysis revealed that 90% of patients dosed with RAD 101 achieved concordance with MRI imaging, meeting the primary endpoint of the trial.The results showed significant and selective tumor uptake in the brain metasta ...

90% of patients dosed with RAD 101 and evaluable at interim analysis achieved concordance with MRI imaging (the primary endpoint) First five patients with available data from six-month follow-up and biopsy show encouraging trend for Sensitivity and Specificity (secondary objective) Company to host webinar on March 25 at 9:00 am AEDT (Sydney, Melbourne) / Tuesday, March 24 at 6:00 pm EST (U.S.) SYDNEY, Australia, March 24, 2026 (GLOBE NEWSWIRE) -- Radiopharm Theranostics (ASX: RAD, “Radiopharm” or the “Compa ...

Core Insights - The interim results from the Phase 2b clinical trial of RAD 101 indicate that 92% of evaluable participants met the primary endpoint of MRI concordance in patients with brain metastases [1][5] - The company has approximately $34.52 million in cash and cash equivalents, providing a financial runway into 2027 to advance its pipeline of radiotherapeutic programs [1][19] - The CEO emphasized a focus on advancing radiopharmaceutical assets and delivering meaningful data across multiple programs in 2026 [2] Clinical Pipeline Updates - RAD 101 is currently in a Phase 2b clinical trial for patients with recurrent brain metastases, with enrollment expected to complete in Q1 2026 [3] - RAD 202 is being evaluated in a Phase 1 'HEAT' clinical trial for HER2-positive advanced solid tumors, with a recent recommendation to escalate dosing to 75mCi [4][6] - RAD 204 is in a Phase 1 study for PD-L1-driven cancers, with initial data showing stable disease in 2 out of 3 patients for 5.5 months, compared to 3.5 months with standard care [12] Financial Performance - The company reported a net cash outflow of $22.67 million for the six months ending December 31, 2025, with a cash balance increase from $29.12 million to $34.52 million [19] - In October 2025, the company secured commitments to raise approximately $35 million through a private placement [19] Strategic Developments - The company increased its ownership in Radiopharm Ventures from 75% to 87.5%, indicating progress in its cancer therapeutic pipeline [13] - RAD 402 received ethics committee approval to initiate a Phase 1 clinical trial for metastatic or locally advanced prostate cancer, expected to start in Q1 2026 [14]

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]