Financial Data and Key Metrics Changes - The cash and cash equivalent balance as of March 31, 2024, was $40.0 million, compared to $9.6 million as of December 31, 2023, indicating a significant increase in liquidity [28] - The net loss attributable to common stockholders for Q1 2024 was $21.4 million or $0.74 per share, compared to $8.6 million or $0.76 per share in the same period last year [30] - General and administrative (G&A) expenses for Q1 2024 were $4.6 million, up from $2.1 million in the previous year, driven by preparations for a product launch in 2025 [29] Business Line Data and Key Metrics Changes - The company reported a high rate of complete remission in a Phase 1 study of iopofosine in combination with external beam radiotherapy for recurrent head and neck cancer, with a complete remission rate of 64% and overall response rate of 73% [27] - Iopofosine has been positioned to capture share in the existing relapsed refractory market, with approximately 4700 patients currently in the third line or greater setting, which could expand to 5700 patients [69] Market Data and Key Metrics Changes - The total U.S. Waldenstrom's macroglobulinemia (WM) market is approximately $2.1 billion, with the current relapse refractory market valued at $1 billion [4] - Claims data indicates that over 60% of therapies used in the WM market are not FDA approved, highlighting a significant unmet need [34] Company Strategy and Development Direction - The company announced a strategic partnership with the American Oncology Network to advance the treatment of WM and ensure patient access to iopofosine I 131 [12] - The focus is on establishing iopofosine as a market share leader in WM, with ongoing preparations for a potential commercial launch upon FDA approval [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data announcement for the fully enrolled study patient population in June, which is expected to provide insights into treatment durability [2][17] - The company is optimistic about the potential of iopofosine I 131 in pediatric high-grade gliomas and plans to provide updates on its Phase 1b study in the second half of 2024 [76] Other Important Information - The company has implemented a modular manufacturing strategy to enhance scalability and reduce costs, allowing for rapid increases in supply to meet market demands [5][51] - The company is evaluating pricing strategies based on market research and analogs, with expectations for premium pricing due to the high unmet need in the WM market [35][102] Q&A Session Summary Question: What is the FDA filing timeline and have any sales members been hired? - The company expects to submit its NDA in the second half of the year, anticipating a six-month review period [78] - A highly talented sales team is being assembled to drive awareness and adoption of iopofosine [79] Question: Can you provide more details on pricing? - The company is confident in its ability to set a premium price based on market research and the high value of the treatment [102] Question: What are the company's plans for ex-U.S. negotiations? - The company is engaged in discussions with various parties for regional partnerships while also considering broader global strategies [90]
Cellectar Biosciences(CLRB) - 2024 Q1 - Earnings Call Transcript