Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash and cash equivalents of 9.6 million as of December 31, 2023, due to funds raised from investor exercises of Tranche B warrants [21] - Net loss for the period was 0.37 per basic share, compared to a net loss of 1.55 per basic share during the same period in 2023, indicating a reduction in losses [26] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately 7.0 million in Q3 2023, primarily due to reduced clinical study costs [24] - General and administrative expenses increased to 2.4 million in Q3 2023, driven by costs associated with commercialization infrastructure development [25] Market Data and Key Metrics Changes - The U.S. market for Waldenstrom's macroglobulinemia (WM) includes approximately 26,000 patients, with 1,500 to 1,900 new diagnoses annually, and about 11,500 patients requiring treatment in the relapsed/refractory setting [44] - There are approximately 5,700 patients in the total addressable market for third-line or greater therapy, highlighting a significant unmet need for new FDA-approved treatments [45][47] Company Strategy and Development Direction - The company is focused on the NDA submission for iopofosine I 131 in WM, with a planned product launch in the second half of 2025, despite a delay in NDA submission to potentially Q2 2025 [10][14] - Expansion of iopofosine I 131 to other indolent lymphomas is viewed as a smart investment to increase overall revenue opportunities [15] - The company is also exploring collaborations for clinical development in other indications, such as mycosis fungoides, and has plans for ongoing development in pediatric high-grade gliomas [37][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of iopofosine I 131 to become a first-in-class treatment for relapsed/refractory WM patients, supported by strong clinical data [31][77] - The company remains engaged with the FDA regarding the regulatory pathway and is committed to expediting the NDA submission process [58] Other Important Information - The company has secured a second manufacturing source for iopofosine I 131, enhancing production capacity and supply redundancy [15] - A strategic master supply agreement has been signed with Northstar Medical Radioisotopes for the procurement of Actinium-225, ensuring a reliable source for future development [74] Q&A Session Summary Question: Concerns about FDA's interest in confirmatory studies - Management clarified that the FDA has indicated that a confirmatory study is not required to be ongoing prior to NDA submission [82][83] Question: Financial guidance regarding cash runway and warrant exercises - Management noted that an interim raise may be required before the first tranche of warrants is exercised, but the overall $73 million from warrant exercises should satisfy commercial launch needs [86][88]
Cellectar Biosciences(CLRB) - 2024 Q3 - Earnings Call Transcript