Table of Contents U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [mark one] ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 1-36598 CELLECTAR BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) ...

NorthStar to provide Cellectar with non-carrier-added Ac-225 for its expanded portfolio of clinical programs FLORHAM PARK, N.J., Nov. 14, 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 the signing of a strategic supply agreement with NorthStar Medical Radioisotopes, LLC, for the procurement of NorthStar’s non-carrier added (n.c ...

INDIANAPOLIS and FLORHAM PARK, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- SpectronRx, a leading radiopharmaceutical contract developer and manufacturer, and 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, have signed a commercial supply agreement for the manufacture of Cellectar’s first-in-class cancer therapy, iopofosine I 131. "We continue strengthening our supply netw ...

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]

Cellectar Biosciences, Inc. (CLRB) announced two presentations. The first presentation is regarding the treatment of Bing-Neel Syndrome ("BNS") with iopofosine I 131 and the second is the review of the company's CLOVER WaM pivotal study of iopofosine I 131. The company will present these data at the 12thInternational Workshop on Waldenstrom's Macroglobulinemia (IWWM) on Oct. 17, 2024, in Prague, Czech Republic. About Cellectar Biosciences' Iopofosine I 131 Iopofosine I 131 is a potential first-in-class, nov ...

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 | | | | ...