Financial Data and Key Metrics Changes - The company ended 2024 with cash and cash equivalents of $23.3 million, compared to $9.6 million as of December 31, 2023, indicating a significant increase in liquidity [20] - The net loss for the full year ended December 31, 2024, was $44.6 million or $1.22 per basic share, compared to a net loss of $42.8 million or $3.50 per basic and fully diluted share during 2023 [23] Business Line Data and Key Metrics Changes - Research and development expenses for the full year 2024 were approximately $26.1 million, a decrease from $27.3 million in the prior year, primarily due to the timing of expenditures for the WM Phase 2 study [20][21] - Selling, general and administrative expenses for the full year 2024 were $25.6 million, compared to $11.7 million in the prior year, driven by pre-commercialization initiatives [21] Market Data and Key Metrics Changes - The company highlighted the significant market potential for iopofosine in the relapsed/refractory setting, driven by its novel mechanism of action and fixed dosing regimen [12][13] Company Strategy and Development Direction - The company is focused on advancing its Alpha and Auger radioisotopes solid tumor programs and is evaluating non-dilutive funding opportunities [8] - A strategic restructuring was implemented to reduce headcount by approximately 60%, expected to drive annual savings of about $7.5 million [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential value of iopofosine for patients with relapsed/refractory Waldenstrom's macroglobulinemia, despite regulatory setbacks [10][11] - The company is optimistic about achieving rapid enrollment in upcoming studies due to strong interest from the healthcare community [60] Other Important Information - The company is preparing for Phase 1 studies for both CLR 121225 and CLR 121125 in the first half of 2025, with estimated costs for these studies around $4.5 million each [72] Q&A Session Summary Question: Does the NDA acceptance require data from the confirmatory study or just the CLOVER study? - The accelerated approval will require data from the additional study as well [56] Question: Can you share the timeline for patients to achieve and be evaluated for an MRR response? - The company anticipates approximately 24 months to full enrollment, with major response rate outcomes expected about one month after enrollment [62] Question: What would be the comparator in the study? - The study will have an investigator choice design with two comparators, one being rituximab monotherapy [66] Question: Does the cash runway include the cost for IND filings for CLR 121225 and 125? - Yes, the runway includes the cost for IND filings, which is relatively modest [71] Question: Why is pancreatic cancer chosen for CLR 121225? - The choice is based on significant market need and strong preclinical efficacy signals observed in animal models [90]