Cellectar Biosciences(CLRB) - 2025 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended 2025 with cash and cash equivalents of $13.2 million, down from $23.3 million as of December 31, 2024 [7] - Net loss for the full year 2025 was $21.8 million or $8.35 per basic and diluted share, compared to a net loss of $44.6 million or $36.52 per basic share and $41.89 per diluted share in 2024 [9] - Research and development expenses for Q4 2025 were approximately $11.5 million, a decrease from approximately $26.6 million for the year ended December 31, 2024 [8] Business Line Data and Key Metrics Changes - The company advanced its lead asset, Iopofosine I 131, and is on track to submit a conditional marketing authorization application in Q3 2026 [4] - CLR 125, a new asset for triple-negative breast cancer, has initiated a phase 1b study, with early interim data expected in mid-2026 [5][6] - The company raised approximately $15.2 million throughout the year, extending its cash runway for ongoing pipeline advancements [7] 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, which is just below 12,000 patients [54] - The conditional marketing authorization in Europe is expected to target a third line or later post-BTKI patient population, with plans to shift to a second line setting upon completion of the confirmatory study [54][55] Company Strategy and Development Direction - The company is focused on advancing its regulatory position in both Europe and the U.S. for Iopofosine I 131, with a clear strategy for market approval [4][10] - Strengthening supply chain infrastructure and expanding the global intellectual property estate are key components of the company's strategy [6][7] - The company aims to deliver transformative therapies to patients with difficult-to-treat cancers, supported by robust science and regulatory engagement [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the regulatory paths for Iopofosine I 131, highlighting the strength of the clinical data and the unmet medical need [5][10] - The company anticipates a milestone-rich 2026, with multiple value-creating milestones expected throughout the year [17] - Management noted high interest from physicians and patients in participating in upcoming trials, indicating a strong market demand for their therapies [41][42] Other Important Information - The company has made significant progress in its clinical development pipeline, including the initiation of new studies and strengthening partnerships for isotope supply [6][16] - The company has expanded its global patent estate, providing long-term protection for its key assets [6] 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-initiation of the confirmatory study? - Management indicated that they expect to submit the NDA to the FDA about one to two months after initiating the study, with a response expected within 7 to 9 months [25][27] Question: What is the expected progression-free survival (PFS) compared to standard care? - Management provided insights into historical data, indicating that the median PFS for standard therapies is around 8 months, and they expect Iopofosine to perform better based on their data [29][40] 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 [53][54]