FLORHAM PARK, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced positive results from its CLOVER WaM pivotal study evaluating iopofosine I 131, a potential first-in-class, targeted radiotherapeutic candidate for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia (WM) patients that received at leas ...

56.4% major response rate exceeded 20% primary endpoint 98.2% disease control rate achieved in heavily pretreated patients Responses shown in difficult-to-treat, high-needs patient populations with approximately 27% of patients refractory to all available therapies and 40% dual-class refractory (BTKi and rituximab) FLORHAM PARK, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commerci ...

Core Viewpoint - Cellectar Biosciences, Inc. has announced the issuance of new warrants that could generate significant gross proceeds, which will support the commercialization of its lead asset, iopofosine I 131, for cancer treatment [1][2][7]. Group 1: New Warrants and Financial Proceeds - The new warrants consist of Tranche A, B, and C, with potential gross proceeds of approximately $73.3 million if fully exercised [1][7]. - Tranche A warrants can generate up to $17.0 million at an exercise price of $2.52, triggered by the FDA's assignment of a review date for iopofosine I 131 [1]. - Tranche B warrants can yield approximately $32.9 million at an exercise price of $4.00, triggered by FDA approval of iopofosine I 131 [1]. - Tranche C warrants can provide about $23.5 million at an exercise price of $5.50, triggered by domestic quarterly revenue from iopofosine I 131 exceeding $10.0 million [1]. - The exercised Tranche B warrants and newly purchased warrants will generate gross proceeds of approximately $19.4 million [7]. Group 2: Product Pipeline and Development Plans - Cellectar is focused on the development of iopofosine I 131, a small-molecule PDC designed for targeted delivery of iodine-131 for cancer treatment [3][10]. - The company plans to file a New Drug Application (NDA) for iopofosine I 131 for the treatment of Waldenstrom's macroglobulinemia in Q4 2024, seeking priority review [2].

Group 1 - Cellectar Biosciences, Inc. has announced the exercise of the majority of Tranche B warrants for Series E preferred stock, generating gross proceeds of approximately $19.4 million, with potential additional proceeds of up to $73.3 million from newly purchased warrants [1][2][11] - The company plans to file a New Drug Application (NDA) for iopofosine I 131 for the treatment of Waldenstrom's macroglobulinemia in Q4 2024, seeking priority review [2] - Cellectar focuses on the development of proprietary drugs for cancer treatment using its Phospholipid Drug Conjugate™ (PDC) delivery platform, aiming for improved efficacy and safety [3][13] Group 2 - The new warrants include Tranche A, B, and C, with Tranche A potentially generating approximately $17.0 million, Tranche B approximately $32.9 million, and Tranche C approximately $23.5 million based on specific exercise triggers [11] - The company's product pipeline features lead asset iopofosine I 131, designed for targeted delivery of iodine-131, along with other preclinical PDC chemotherapeutic programs and partnered assets [13]

The event will feature both company leadership and key investigators, who will discuss the CLOVER WaM study (NCT02952508) and full results. Details are as follows: A replay of the conference call will be available on the Events section of the company's investor relations website. Waldenstrom's macroglobulinemia is a B-cell malignancy characterized by bone marrow infiltration of clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments. T ...

Group 1: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [3][4]. - The company's product pipeline includes its lead asset, iopofosine I 131, designed for targeted delivery of iodine-131, along with other preclinical PDC chemotherapeutic programs and partnered assets [3]. Group 2: Industry Context - Waldenstrom's macroglobulinemia is a B-cell malignancy with approximately 26,000 prevalent cases in the US, with 1,500-1,900 new diagnoses annually [2]. - There is a significant unmet need for new FDA-approved treatments for patients with Waldenstrom's macroglobulinemia, particularly those who have progressed on BTKi therapy, as current options do not provide complete response rates and require continuous treatment [2]. - Approximately 50% of third-line patients not receiving treatment are likely to consider new treatment options, indicating a demand for innovative therapies that offer novel mechanisms of action and improved patient outcomes [2]. Group 3: Upcoming Events - Cellectar Biosciences will host an event on July 24, 2024, at 8:00 a.m. EDT to discuss recent data from its pivotal trial of iopofosine I 131 in Waldenstrom's macroglobulinemia, the current treatment landscape, and opportunities to improve patient outcomes [4][5].

Opportunity for Iopofosine Expansion Within Areas of High Unmet Need in Non-Hodgkin's Lymphoma Establishes Partnership With One of the Largest Cancer Research and Treatment Organizations in the U.S. "We are excited to partner with Cellectar Biosciences to evaluate iopofosine in patients with mycosis fungoides," said Dr. Steven T. Rosen, executive vice president and director emeritus, Comprehensive Cancer Center and Beckman Research Institute of City of Hope. "Its unique delivery platform targeting all tumor ...

Topline Summary and Update Financial Overview As of their Q1 filing, CLRB held $41.4 million in current assets, made up mostly of $40.0 million in cash and equivalents. Their operating expenses, or cash burn, for the quarter reached $12.0 million. After recognizing an addition $9.9 million in losses due to valuation of their warrants, the net loss for the quarter was $21.6 million. Cellectar Biosciences, Inc. (NASDAQ:CLRB) is a radiopharmaceutical-focused developmental biotech training their sites on a firs ...

Market Overview - The U.S. Waldenstrom's Macroglobulinemia (WM) market is valued at approximately $2.1 billion[18] - The Relapsed/Refractory (R/R) market within WM is currently valued at around $1.05 billion[18] - Approximately 50% of patients in the 3rd line or greater setting have been retreated after prior exposure to the same therapy[20] - The 3rd line + market could grow to approximately 5,700 patients[11] Iopofosine I 131 Positioning - Iopofosine demonstrates a meaningful treatment option for R/R patients due to its novel MOA, demonstrated clinical benefit, and fixed therapy[19] - Iopofosine has a 61% advantage with potential FDA approval and a major response rate[21] - Iopofosine shows a 75.6% overall response rate and 7.3% complete responses[21] Market Share & Treatment Landscape - Over 60% of the drug share across all lines of therapy is non-FDA approved[20] - BCL2 (venetoclax) inhibitor utilization is between 1-4% across all lines of treatment[20] - In the 3rd line setting, BTKi patients who received a BTKi in the 2nd line account for 52%[20] Manufacturing and Logistics - The existing supply maximum is approximately 1,000 units per week, with additional sites potentially increasing this by approximately 50%[2] - The novel formulation provides a 17-day shelf-life[2] - The company aims to provide US sites with drug product within 24 hours[2]

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]