Cellectar Biosciences Conference Call Summary Company Overview - **Company**: Cellectar Biosciences - **Stock Symbol**: CLRB (NASDAQ) - **Focus**: Oncology, platform technology, and radiopharmaceuticals, specifically phospholipid radioconjugates (PRCs) [2][3] Key Points and Arguments Product Development and Clinical Trials - **Lead Product**: CLR 131 (iodine-131) for Waldenstrom's macroglobulinemia - Achieved a major response rate of 58.2% in a highly relapsed, refractory patient population, exceeding the FDA's primary endpoint of 20% [3] - Overall response rate of 84% and disease control rate of nearly 99% [3] - **Regulatory Designations**: - Received FDA breakthrough designation and EMA's PRIME designation [4] - Anticipated submission for conditional marketing authorization to EMA in early Q3 2026 [4] - Preparing for U.S. FDA accelerated application [4] Future Studies and Market Opportunities - **Upcoming Studies**: - Initiated study for CLR 125 in triple-negative breast cancer in Q1 2026 [5] - CLR 225 for pancreatic cancer is phase 1 ready [5] - **Market Potential**: - Significant unmet medical need in relapsed, refractory patient populations, particularly in triple-negative breast cancer [5][20] - Approximately 11,500 patients in the U.S. for second-line treatment, with 1,000 patients not seeking treatment due to lack of options [20] - 60% of treatments are off-label, indicating high unmet medical need [20] Financial and Operational Insights - **Financial Position**: - As of September 30, the company had $12.6 million, with an additional $5.2 million added in October, totaling just under $18 million [26] - 4 million-plus shares of common stock outstanding, fully diluted at 7.5 million [26] - **Study Costs**: - Estimated study cost for CLR 225 is $42 million, with approximately $15 million needed to reach approval [12] Mechanism of Action and Technology - **Delivery Technology**: - Utilizes phospholipid ether (PLE) delivery moiety to target cancer cells while sparing healthy tissue, enhancing therapeutic window [2][13] - Demonstrated CNS penetration and ability to treat various malignant brain tumors [13] Clinical Data and Efficacy - **Efficacy in Challenging Populations**: - CLR 131 showed a disease control rate of 98% in a highly refractory patient population [17] - Average duration of response (DOR) and progression-free survival (PFS) reported at 11.4 months [17] - Minimal adverse events, with all patients recovering from cytopenias [18] Competitive Landscape - **Market Dynamics**: - The EU market is approximately 30% larger than the U.S. in terms of patient population [21] - Only one class of approved agents (BTK inhibitors) currently available, indicating a significant opportunity for Cellectar's products [21] Additional Important Information - **Pipeline Expansion**: - Ongoing discussions for partnerships to maximize the potential of WM and iopofosine in both the EU and U.S. [6] - **Upcoming Data Releases**: - Expecting imaging data and initial response data for CLR 125 in the first half of the year [9][10] This summary encapsulates the critical insights from the Cellectar Biosciences conference call, highlighting the company's focus on innovative oncology treatments, regulatory progress, and market opportunities.

Financial Data and Key Metrics Changes - The company ended 2024 with cash and cash equivalents of $23.3 million, compared to $9.6 million as of December 31, 2023, indicating a significant increase in liquidity [20] - The net loss for the full year ended December 31, 2024, was $44.6 million or $1.22 per basic share, compared to a net loss of $42.8 million or $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 $26.1 million, a decrease from $27.3 million in the prior year, primarily due to the timing of expenditures for the WM Phase 2 study [20][21] - Selling, general and administrative expenses for the full year 2024 were $25.6 million, compared to $11.7 million in the prior year, driven by pre-commercialization initiatives [21] Market Data and Key Metrics Changes - The company highlighted the significant market potential for iopofosine in the relapsed/refractory setting, driven by its novel mechanism of action and fixed dosing regimen [12][13] Company Strategy and Development Direction - The company is focused on advancing its Alpha and Auger radioisotopes solid tumor programs and is evaluating non-dilutive funding opportunities [8] - A strategic restructuring was implemented to reduce headcount by approximately 60%, expected to drive annual savings of about $7.5 million [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential value of iopofosine for patients with relapsed/refractory Waldenstrom's macroglobulinemia, despite regulatory setbacks [10][11] - The company is optimistic about achieving rapid enrollment in upcoming studies due to strong interest from the healthcare community [60] Other Important Information - The company is preparing for Phase 1 studies for both CLR 121225 and CLR 121125 in the first half of 2025, with estimated costs for these studies around $4.5 million each [72] 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: Can you share the timeline for patients to achieve and be evaluated for an MRR response? - The company anticipates approximately 24 months to full enrollment, with major response rate outcomes expected 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] Question: Does the cash runway include the cost for IND filings for CLR 121225 and 125? - Yes, the runway includes the cost for IND filings, which is 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 observed in animal models [90]