Core Viewpoint - SpectronRx and Cellectar Biosciences have entered into a commercial supply agreement for the manufacture of iopofosine I 131, a novel cancer therapy aimed at treating advanced cancers, particularly Waldenstrom's macroglobulinemia [1][2][3] Company Overview - SpectronRx specializes in radiopharmaceutical contract development and manufacturing, with capabilities in isotope production and clinical trial support [5][6] - Cellectar Biosciences focuses on the discovery and commercialization of cancer treatments, leveraging its proprietary Phospholipid Drug Conjugate delivery platform [7][8] Partnership Details - The partnership aims to enhance Cellectar's supply network and manufacturing capabilities for iopofosine I 131, which has shown promising efficacy in clinical studies [2][3] - SpectronRx will utilize its facilities in Indiana and Belgium for the production of iopofosine I 131, facilitating global market distribution [2][3] Product Development - Iopofosine I 131 has demonstrated impressive results in the CLOVER-WaM pivotal study for patients with relapsed or refractory Waldenstrom's macroglobulinemia, with a New Drug Application submission planned soon [2][3] - The drug is also being evaluated in Phase 2 studies for relapsed or refractory multiple myeloma and central nervous system lymphoma, as well as in a Phase 1b study targeting pediatric patients with high-grade gliomas [2][3] Regulatory Status - Iopofosine I 131 is currently investigational and has received Orphan Drug and Fast Track Designations from the FDA for various cancer indications [3]

FLORHAM PARK, N.J., Nov. 11, 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 that the company will report financial results for the three months ended September 30, 2024, and provide a corporate update on November 18, 2024, at 8:30 a.m. Eastern Time. Conference Call & Webcast Details:Date:Monday, November 18, 2024Time:8:30 am E ...

FLORHAM PARK, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company, announced today it received a letter dated October 31, 2024, from Nasdaq, Inc. informing the Company that it had regained compliance with Nasdaq Listing Rule 5250(c)(1). The Company filed the following on October 29, 2024, with the Securities and Exchange Commission: (i) restated audited consolidated financial statements for the fiscal years ended December 31, 20 ...

Clinical Study Results - The CLOVER-WaM Phase 2 pivotal study for iopofosine achieved a median response rate (MRR) of 61% in patients with relapsed/refractory Waldenstrom's macroglobulinemia, exceeding the statistical hurdle of 20%[98] - The overall response rate (ORR) in evaluable patients was 75.6%, with 100% of patients experiencing disease control[98] - The CLOVER-1 Phase 2 study has met its primary efficacy endpoints and is now enrolling an expansion cohort for multiple myeloma and CNS lymphoma patients[99] - The CLOVER WaM study achieved a major response rate (MRR) of 61% among patients, exceeding the statistical hurdle of 20%[104] - The overall response rate (ORR) in evaluable patients was 75.6%, with 100% of patients experiencing disease control[104] - The study reported a 7.3% complete remission (CR) rate in a highly refractory Waldenstrom's macroglobulinemia population[104] - The Phase 2 CLOVER-1 study reported a 40% ORR in triple class refractory multiple myeloma patients receiving 60 mCi or greater[109] - In the r/r non-Hodgkin's lymphoma cohort, patients receiving <60mCi and >60mCi had ORRs of 42% and 43%, respectively[111] - Approximately 91% of patients in the CLOVER-1 study experienced a reduction in tumor markers, with about 73% showing a reduction greater than 37%[119] - The pooled median overall survival (mOS) data from the first four cohorts of the iopofosine study was reported at 22.0 months[117] - In the Phase 1 study of iopofosine for head and neck cancer, complete remission was achieved in 64% of patients, with an overall response rate (ORR) of 73%[123] Adverse Events - Adverse events included fatigue (39%) and various cytopenias, with thrombocytopenia occurring in 75% of patients[96] - The rates of Grade 3 or greater treatment-related adverse events included thrombocytopenia (55%), neutropenia (37%), and anemia (26%)[104] - Adverse events in the iopofosine studies included thrombocytopenia (75%), lymphopenia (75%), and neutropenia (67%) in head and neck cancer patients[123] Regulatory Designations - Iopofosine has received Fast Track Designation from the FDA for multiple indications, including lymphoplasmacytic lymphoma and relapsed/refractory multiple myeloma[90] - The FDA granted Fast Track Designation for iopofosine in WM for patients having received two or more prior treatment regimens[114] - The FDA granted Fast Track Designation for iopofosine in fourth line or later relapsed/refractory multiple myeloma in May 2019[119] Financial Performance - Research and development expenses for Q2 2024 were approximately $7,345,000, a 20% increase from $6,135,000 in Q2 2023, primarily due to increased clinical project costs[129] - General and administrative expenses for Q2 2024 were approximately $6,358,000, a 194% increase from $2,159,000 in Q2 2023, driven by infrastructure development costs for anticipated NDA approval[130] - Other income for Q2 2024 was approximately $12,784,000, compared to an expense of approximately $1,885,000 in Q2 2023, mainly due to changes in warrant valuation[131] - Research and development expense for the six months ended June 30, 2024, was approximately $14,434,000, an increase of $1,940,000 or 16% compared to $12,494,000 for the same period in 2023[133] - General and administrative expense for the six months ended June 30, 2024, was approximately $11,272,000, reflecting an increase of $6,767,000 or 150% compared to $4,505,000 in 2023[134] - The company incurred a net loss of approximately $27.6 million during the six months ended June 30, 2024, and used approximately $27.5 million in cash for operations[136] - As of June 30, 2024, the company's consolidated cash balance was approximately $25.9 million, with available liquidity limited to approximately $34.3 million of unrestricted cash and cash equivalents[136] - Clinical project costs for the six months ended June 30, 2024, were $6,644,000, an increase of $1,735,000 compared to $4,909,000 in 2023[138] - Manufacturing and related costs for the same period were $5,941,000, up by $1,766,000 from $4,175,000 in 2023[138] - Other income (expense), net, for the first six months of 2024 was an expense of approximately $1,856,000, compared to $370,000 in 2023[135] - Interest income for the year-to-date in 2024 was approximately $649,000, an increase from approximately $197,000 in 2023[135] Company Developments - The company is developing a PDC-based targeted alpha-emitter therapy (CLR121225) currently in IND enabling studies, alongside evaluating other alpha-emitting isotopes[92] - The CLOVER-2 Phase 1a study for pediatric cancers has concluded, with a Phase 1b study currently enrolling patients with high-grade gliomas[89] - The company has established three ongoing collaborations featuring four unique payloads to accelerate product candidate development[93] - The European Medicines Agency granted Small and Medium-Sized Enterprise (SME) status, allowing for significant financial incentives including a 90% to 100% fee reduction for regulatory services[91] - The company plans to secure additional outside capital via the sale of equity and/or debt securities to improve liquidity[136] - There are substantial doubts about the company's ability to continue as a going concern, necessitating potential asset sales or other measures if liquidity plans are not effectively implemented[137]

Company Overview - Cellectar Biosciences, Inc. (CLRB) announced two presentations regarding the treatment of Bing-Neel Syndrome (BNS) with iopofosine I 131 and a review of the CLOVER WaM pivotal study of iopofosine I 131, to be presented at the 12th International Workshop on Waldenstrom's Macroglobulinemia (IWWM) on October 17, 2024, in Prague, Czech Republic [1][3] Product Information - Iopofosine I 131 is a potential first-in-class cancer-targeting agent that can cross the blood-brain barrier and has shown clinical activity in multiple hematologic malignancies, including relapsed/refractory primary CNS lymphoma [2] - The treatment of BNS, a rare and life-threatening complication of Waldenstrom's Macroglobulinemia (WM), requires agents that can penetrate the blood-brain barrier [4] Clinical Developments - At the IWWM, a case study will be presented demonstrating complete CNS clearance in a relapsed/refractory BNS patient treated with iopofosine I-131 [3] - The CLOVER WaM pivotal study, which is the first and largest WM study in a highly refractory patient population, has shown a 98% disease control rate and an 80% overall response rate with just four doses of iopofosine monotherapy [7] Strategic Partnerships - In July 2024, Cellectar Biosciences entered into a strategic partnership with City of Hope Cancer Center to focus on the clinical development of iopofosine I 131 in mycosis fungoides, a rare form of non-Hodgkin's lymphoma [8] Market Prospects - The WM treatment market is expected to grow at a CAGR of 5.2% from 2022 to 2027, driven by increasing prevalence of WM cases, drug approvals, and a rising geriatric population [5][6]

Jorge Castillo, M.D. to Present Iopofosine I 131 Activity in Bing-Neel Syndrome Andrei Shustov, M.D. to Review CLOVER WaM Pivotal Study FLORHAM PARK, N.J., Aug. 26, 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 two presentations: one regarding the treatment of a patient with Bing-Neel Syndrome (BNS), and a review of the compa ...

Cellectar Biosciences, Inc. (NASDAQ:CLRB) Q2 2024 Earnings Conference Call August 13, 2024 8:30 AM ET Company Participants Jim Caruso – President and Chief Executive Officer Andrei Shustov – Senior Vice President-Medical Jarrod Longcor – Chief Operating Officer Shane Lea – Chief Commercial Officer Chad Kolean – Chief Financial Officer Conference Call Participants Jonathan Aschoff – ROTH Jeff Jones – Oppenheimer Ted Tenthoff – Piper Sandler Operator Good morning, and welcome to Cellectar Biosciences Second Q ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): August 13, 2024 Cellectar Biosciences, Inc. (Exact name of Registrant as Specified in its Charter) Delaware (State or other jurisdiction of incorporation) | --- | --- | --- | |-------|-------------|-------| | | | | | | | | | | | | | | | | | | | | | | 1-36598 | | | | | | | | (Commission | | | | ...

FLORHAM PARK, N.J., Aug. 13, 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 financial results for the quarter ended June 30, 2024, and provided a corporate update. "With our recent positive data announcement from the CLOVER WaM pivotal study evaluating iopofosine I 131 in Waldenstrom's macroglobulinemia, we remain focused on ...

FLORHAM PARK, N.J., Aug. 08, 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 that the company will provide a corporate update for the three months ended June 30, 2024, on Tuesday, August 13, 2024. Management will also host a conference call with investors to discuss financial results and provide an overview at 8:30 am Eastern ...