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]

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]

Core Viewpoint - PMV Pharmaceuticals, Inc. reported strong progress in its clinical trials and financial results for the year ended December 31, 2024, highlighting the advancement of its lead drug candidate, rezatapopt, in treating cancers with TP53 mutations [1][4]. Clinical Development - The pivotal Phase 2 portion of the PYNNACLE trial is advancing well, with enrollment on track and more than 90% of sites activated across multiple regions [3][5]. - An interim analysis of the Phase 2 monotherapy data is expected in mid-2025, with a New Drug Application submission anticipated by the end of 2026 [3][5]. - Enrollment has begun in a Phase 1b study at MD Anderson Cancer Center, evaluating rezatapopt in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome with a TP53 Y220C mutation [2][6]. Financial Performance - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $183.3 million, providing a cash runway expected to last until the end of 2026 [5][12]. - The net loss for the year ended December 31, 2024, was $58.7 million, a decrease from a net loss of $69.0 million in 2023 [12][17]. - Research and development expenses increased to $58.5 million in 2024 from $55.9 million in 2023, primarily due to clinical expenses related to rezatapopt [12][17]. Research Highlights - The Phase 1 data of rezatapopt in advanced ovarian cancer showed a confirmed partial response in 7 out of 15 patients, with a median duration of response of seven months [6]. - In advanced breast cancer, 3 out of 8 patients achieved a confirmed partial response, indicating a favorable safety profile [6]. - A paper detailing the discovery of rezatapopt was published, emphasizing its role as a first-in-class small-molecule reactivator of the p53 Y220C mutant [6][9].