Financial Data and Key Metrics Changes - The company ended 2024 with cash and cash equivalents of 9.6 million as of December 31, 2023 [20] - The net loss for the full year ended December 31, 2024, was 1.22 per basic share, compared to a net loss of 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 27.3 million in the prior year, primarily due to timing of expenditures for the WM Phase 2 study [20][21] - Selling, general and administrative expenses for the full year 2024 were 11.7 million in the prior year, driven by pre-commercialization initiatives [21][22] Market Data and Key Metrics Changes - The company is focused on the relapsed/refractory Waldenstrom's macroglobulinemia (WM) market, with iopofosine showing a significant clinical benefit rate of 98.2% and an overall response rate of 83.6% in the CLOVER-WaM study [9][10] - The company is also advancing its solid tumor-focused radioisotope programs, including alpha emitters for pancreatic cancer and Auger emitters for triple-negative breast cancer [15] Company Strategy and Development Direction - The company aims to address its NASDAQ status and future funding through non-dilutive funding opportunities and collaborations [8][15] - A strategic restructuring was implemented to reduce headcount by approximately 60%, expected to save about $7.5 million annually [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential value of iopofosine for patients with relapsed/refractory WM, despite regulatory setbacks delaying the NDA submission [11][12] - The company anticipates rapid enrollment in the upcoming Phase 3 study for iopofosine, with a clear regulatory pathway established with the FDA [28][47] Other Important Information - The company is preparing for Phase 1 studies for both CLR 121225 and CLR 121125 in 2025, targeting pancreatic cancer and triple-negative breast cancer respectively [49][42] - The company is exploring various deal types for licensing iopofosine, including global partnerships and regional rights [81][84] 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: What is the timeline for patients to achieve and be evaluated for an MRR response? - Enrollment is expected to take approximately 24 months, with major response rate outcomes assessed 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][67] Question: Does the cash runway include costs for IND filings for CLR 121225 and 125? - Yes, the runway includes costs for IND filings, estimated to be 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 [90]
Cellectar Biosciences(CLRB) - 2024 Q4 - Earnings Call Transcript