Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million at the end of 2024 [8] - Net loss for the full year 2025 was $21.8 million or $8.35 per share, compared to a net loss of $44.6 million or $36.52 per share in 2024 [10] - Research and development expenses decreased to approximately $11.5 million in Q4 2025 from $26.6 million in 2024, primarily due to the conclusion of patient enrollment in the CLOVER-WaM clinical study [9] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and initiated a Phase 1b study of CLR 125 in Triple-Negative Breast Cancer [4][6] - CLR 125 is designed for precise tumor targeting, with early interim data expected in mid-2026 [7] - CLR 225, another asset, is ready to initiate a Phase 1 trial pending funding [16] Market Data and Key Metrics Changes - The European market for the second line setting is estimated to be over 12,000 patients, slightly higher than the U.S. market [53] - The company plans to submit a conditional marketing authorization application for Iopofosine in Europe in Q3 2026, targeting potential approval as early as 2027 [4][5] Company Strategy and Development Direction - The company aims to submit a conditional marketing authorization application for Iopofosine I 131 in Europe and pursue an NDA under the Accelerated Approval pathway in the U.S. [4][11] - The focus is on expanding the clinical development pipeline of radiopharmaceuticals and strengthening regulatory positions in both Europe and the U.S. [4][11] - The company is engaged in partnering conversations to support global program development [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory and clinical progress made in 2025, positioning the company for a milestone-rich 2026 [11][18] - The strength of the CLOVER-WaM data set and the unmet medical need for Iopofosine were highlighted as key factors for future success [5][14] - Management anticipates multiple value-creating milestones in the coming months and remains committed to delivering transformative therapies [18] Other Important Information - The company raised approximately $15.2 million in 2025, extending its cash runway [7] - Significant expansion of the global intellectual property estate was achieved with new patents issued across various regions [7] Q&A Session Summary Question: Can the same submission package for EMA be used for FDA? - Management confirmed that while the formats differ, much of the data is similar and can be applied to both submissions [22][23] Question: What is the expected timeline for FDA submission post Phase III trial initiation? - Management indicated that they expect to submit the NDA within 1-2 months after initiating the confirmatory study, with a response from the FDA expected within 7-9 months [27][28] Question: What is the current environment for enrollment in the trial? - Management noted high interest from physicians and patients, emphasizing the significant need for the drug in the marketplace [40][41] Question: What are the plans for distribution in Europe? - The company plans to partner with various parties for commercialization in Europe, with a unique competitive advantage due to the longer shelf life of their product [52][53]