• Cash and Cash Equivalents: $23.3 million as of December 31, 2024, compared to $9.6 million as of December 31, 2023.
• Research and Development Expenses: $26.1 million for the full year 2024, down from $27.3 million in 2023.
• Selling, General, and Administrative Expenses: $25.6 million for the full year 2024, up from $11.7 million in 2023.
• Net Loss: $44.6 million for the full year ended December 31, 2024, or $1.22 per basic share and $1.40 per fully diluted share.
• Other Income and Expense Net: $7.3 million of income in 2024, compared to $3.9 million of expense in 2023.
• Cost Savings from Restructuring: Expected savings of approximately $7.5 million annually.
• Cash Runway: Extended into the fourth quarter of 2025.
• Financing Activities: $44.1 million from warrant exercises in January and $19.4 million from inducement financing in July 2024.

• Warning! GuruFocus has detected 1 Warning Sign with CLRB.

Release Date: March 13, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Cellectar Biosciences Inc (NASDAQ:CLRB) reported impressive clinical results from the CLOVER WaM study, with a 98.2% clinical benefit rate and 83.6% overall response rate for Iopofosine I-131.
• The company achieved regulatory alignment with the FDA on the design of a Phase 3 study for Iopofosine, which is expected to enroll rapidly due to high interest from the healthcare community.
• Cellectar Biosciences Inc (NASDAQ:CLRB) strengthened its balance sheet with financial transactions, including warrant exercises generating $44.1 million and inducement financing raising $19.4 million.
• The company implemented a cost-saving strategic restructuring, reducing headcount by approximately 60%, which is expected to save $7.5 million annually.
• Cellectar Biosciences Inc (NASDAQ:CLRB) is exploring non-dilutive funding opportunities and licensing deals, which could enhance the company's financial position and support its clinical programs.

Negative Points

• Cellectar Biosciences Inc (NASDAQ:CLRB) faced a regulatory setback, delaying the submission of the NDA for Iopofosine, which negatively impacted the company's stock price.
• The company had to restate its historical financial statements due to a re-evaluation of the accounting for warrants, although this did not impact cash or cash burn.
• Research and development expenses remained high at $26.1 million for 2024, despite a slight decrease from the previous year.
• Selling, general, and administrative expenses increased significantly to $25.6 million in 2024, driven by pre-commercialization initiatives.
• Cellectar Biosciences Inc (NASDAQ:CLRB) is at risk of non-compliance with NASDAQ listing requirements, and may need to consider a reverse stock split if other initiatives do not succeed.

Q & A Highlights

Q: Does the NDA acceptance for Iopofosine I-131 require data from a new study or just the CLOVER WaM study? A: The accelerated approval will require data from the additional study as well. Jarrod Longcor, Chief Operating Officer

Q: Can you share the timeline for patients to achieve and be validated for an MRR response under the study design? A: We anticipate rapid enrollment in this study. From the first patient enrolled, it would be approximately 24 months to full enrollment, with an additional month to achieve the necessary outcomes for major response rate. James Caruso, President and CEO; Jarrod Longcor, Chief Operating Officer

Q: What will the comparator arm be in the study? A: The comparator arm will include two options: rituximab monotherapy and a rituximab combination treatment. The study is designed as an investigator choice study, allowing physicians to choose between these two options. Jarrod Longcor, Chief Operating Officer

Q: Does the cash runway into the fourth quarter of 2025 include the work to complete IND filings for CLR-121225 and CLR-121125? A: Yes, it includes the cost for the IND filings. The cost to get the Phase 1 trials running is relatively modest and encompassed in the cash runway. Chad Kolean, Chief Financial Officer

Q: Why was pancreatic cancer chosen for CLR-121225? A: The choice was based on both significant market need and pre-clinical efficacy signals. The Actinium program has shown high effectiveness in pre-clinical models of pancreatic ductal adenocarcinoma. Jarrod Longcor, Chief Operating Officer

For the complete transcript of the earnings call, please refer to the full earnings call transcript.