Financial Data and Key Metrics Changes - The company ended the quarter with cash and cash equivalents of $11 million, down from $23.3 million as of December 31, 2024, indicating a significant decrease in liquidity [11] - Research and development expenses for the quarter were approximately $2.4 million, a decrease from $7.3 million in the same period last year, reflecting a conclusion of patient enrollment and follow-up for a significant clinical study [12] - General and administrative expenses decreased to $3.6 million from $6.4 million year-over-year, primarily due to reduced pre-commercialization efforts [12] - The net loss for the quarter was $5.4 million, or $3.39 per share, compared to a net loss of $900,000, or $0.77 per share, in the same period last year [13] Business Line Data and Key Metrics Changes - The lead asset, iapofacine I-131, is positioned for accelerated approval with the FDA, reflecting a strategic shift in regulatory approach [5][6] - The company is advancing its next-generation radiopharmaceutical pipeline, with CLR125 and CLR225 expected to enter clinical trials in late 2025 or early 2026 [9][10] Market Data and Key Metrics Changes - The company anticipates a response from the EMA regarding conditional marketing authorization for iapofacine I-131 late in Q3 or early Q4 2025, indicating ongoing engagement with European regulatory bodies [7] - The market potential for iapofacine I-131 is considered compelling, supported by robust clinical data and a well-understood safety profile [9] Company Strategy and Development Direction - The company is focused on delivering innovative, life-extending therapies for cancer patients, with a clear regulatory strategy for accelerated approval in the US and conditional marketing authorization in Europe [21][22] - Active discussions with potential partners are underway to secure non-dilutive capital and expertise, which will support the company's strategic initiatives [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the new regulatory strategy for iapofacine I-131, highlighting the importance of the twelve-month follow-up data and the shift to earlier lines of therapy [29] - The company remains committed to advancing its clinical programs and regulatory milestones, with a focus on expanding its impact into solid tumors [21][22] Other Important Information - The company raised nearly $10 million in recent financings to support clinical programs and regulatory milestones [10] - The anticipated costs for the confirmatory study related to iapofacine I-131 are estimated to be between $40 million and $45 million [40] Q&A Session Summary Question: Status of the WM program and EU approval path - Management is finalizing the protocol for an accelerated approval confirmatory study and expects to submit the NDA later this year or early next year, pending sufficient capital [27][29] Question: Concerns regarding preclinical biodistribution data - The biodistribution data indicates approximately 25% to 30% of the infused drug reaches the tumor, with off-target activity generally below 5% in other tissues, primarily the liver [32] Question: Timing and costs associated with NDA submission - The estimated cost for the confirmatory study is approximately $40 million to $45 million, with $20 million to $25 million needed for full enrollment and necessary data [40][41]