Core Insights - Cellectar Biosciences is seeking conditional marketing approval from the European Medicines Agency (EMA) for its product Iopofosine I 131 based on the promising results from the CLOVER WaM Phase 2 study, which showed a major response rate of 59.0% for BTKi-treated patients [1][2] - The company has a pipeline of radiotherapeutic candidates, including alpha- and Auger-emitting radioconjugates, and is exploring various funding pathways to advance its assets [2][5] Corporate Update - Cellectar plans to present the Phase 2 CLOVER WaM clinical trial data to the EMA in Q2 2025 and expects a response regarding the regulatory pathway by the end of Q3 2025 [2] - The company is evaluating strategic alternatives, including mergers, acquisitions, and partnerships, with Oppenheimer & Co. Inc. serving as the exclusive financial advisor [5] Financial Highlights - As of March 31, 2025, Cellectar had cash and cash equivalents of $13.9 million, down from $23.3 million as of December 31, 2024 [5][14] - Research and Development (R&D) expenses for Q1 2025 were approximately $3.4 million, a decrease from $7.1 million in Q1 2024, primarily due to reduced patient follow-up activities [5][15] - General and Administrative (G&A) expenses for Q1 2025 were approximately $3.0 million, down from $4.9 million in the same period of 2024 [5][15] - The net loss for Q1 2025 was $6.6 million, or $0.14 per share, compared to a net loss of $26.6 million, or $0.91 per share, in Q1 2024 [5][16] Product Pipeline - The company's lead assets include Iopofosine I 131, CLR 121225 (an actinium-225 based program for solid tumors), and CLR 121125 (an iodine-125 Auger-emitting program) [8][9] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and two Fast Track Designations for various cancer indications [9]

Clinical Study Results - The CLOVER-WaM Phase 2 pivotal study for iopofosine achieved a major response rate (MRR) of 58.2%, exceeding the FDA's statistical hurdle of 20%[102] - The overall response rate (ORR) in evaluable patients was 83.6%, with 98.2% of patients experiencing disease control[102] - Iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in a highly refractory Waldenstrom's macroglobulinemia population[102] - The CLOVER-WaM study reported a median duration of response not reached with 11.4 months of follow-up, and 76% of patients remained progression-free at a median follow-up of eight months[102] - The CLOVER-2 Phase 1a pediatric study for iopofosine has been conducted internationally at seven leading pediatric cancer centers[103] - The Phase 2a study reported a 100% ORR in six WM patients, with an average treatment-free survival of 330 days[128] - The Phase 2 study in triple class refractory MM patients showed a 40% ORR, with patients receiving >60 mCi typically exhibiting greater responses[129] - The Phase 1a pediatric study determined the maximum tolerated dose of iopofosine to be greater than 60 mCi/m²[118] - The CLOVER-2 Phase 1b study is evaluating two different doses of iopofosine in r/r pediatric patients with high-grade gliomas[118] - In the ongoing CLOVER-1 Phase 2 clinical study, approximately 91% of patients experienced a reduction in tumor markers, with about 73% experiencing a reduction greater than 37%[138] - In the Phase 1 study for pediatric patients, initial data showed disease control in heavily pretreated patients with ependymomas, confirming that iopofosine crosses the blood-brain barrier[140] - In the Phase 1 study of iopofosine in combination with external beam radiation therapy (EBRT) for head and neck cancer, complete remission was achieved in 64% of patients, with an ORR of 73%[143] - The overall survival rate at 12 months in the head and neck cancer study was 67%, with a progression-free survival rate of 42%[143] Financial Performance - Research and development expenses for Q1 2025 were approximately $3.43 million, a decrease of 52% from $7.09 million in Q1 2024[148] - General and administrative expenses for Q1 2025 were approximately $2.97 million, down 39% from $4.91 million in Q1 2024[149] - The company reported a net loss of approximately $6.6 million for the three months ended March 31, 2025[151] - Cash used for operations during Q1 2025 was approximately $9.4 million, with a consolidated cash balance of approximately $13.9 million as of March 31, 2025[151] - Other income (expense), net, for Q1 2025 was an expense of approximately $340,000, significantly reduced from $14.96 million in Q1 2024[150] - The company plans to secure additional capital through equity and/or debt securities to improve liquidity[151] - The company has raised substantial doubt about its ability to continue as a going concern due to ongoing operating losses[152] Strategic Initiatives - The company plans to initiate a Phase 1 imaging and dose escalation safety study for CLR 121225 in the second half of 2025, subject to financing[99] - CLR 121125 is prepared for a Phase 1b dose-finding study in the second half of 2025, also contingent on obtaining additional financing[101] - The company is exploring a full range of strategic alternatives, including mergers, acquisitions, and partnerships, to advance its platform and drug development pipeline[98] - The company is evaluating other alpha-emitting isotopes in preclinical studies and has ongoing collaborations to enhance its product pipeline[106][107] - Management is considering strategic alternatives, including mergers and acquisitions, to address liquidity concerns[151] Regulatory Designations - The company has received Fast Track Designation from the FDA for iopofosine in multiple indications, including lymphoplasmacytic lymphoma and relapsed/refractory multiple myeloma[104] - The FDA granted multiple designations for iopofosine, including Fast Track and Orphan Drug Designation (ODD) for various malignancies[119] - The FDA granted Fast Track Designation for iopofosine in WM for patients who have received two or more prior treatment regimens[134] Adverse Events - The most common grade ≥3 adverse events at the highest dose (75 mCi TBD) included thrombocytopenia (65%), neutropenia (41%), and leukopenia (30%), with no patients experiencing cardiotoxicities or neurological toxicities[133]

Core Insights - Cellectar Biosciences, Inc. will report its financial results for Q1 2025 and provide a corporate update on May 13, 2025, at 8:30 a.m. Eastern Time [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] Product Pipeline - The company's product pipeline includes lead assets such as iopofosine I 131, CLR 225, and CLR 125, targeting various solid tumors and leveraging advanced drug delivery technologies [4] - Iopofosine I 131 is currently in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA [5] Regulatory Designations - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug, four Rare Pediatric Drug, and two Fast Track designations, as well as two Orphan Drug designations and PRIME designation from the EMA [5]

Core Viewpoint - Cellectar Biosciences, Inc. is exploring a full range of strategic alternatives to enhance stockholder value, including potential mergers, acquisitions, partnerships, and licensing arrangements [1][2]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [4]. Product Pipeline - The company's lead product, iopofosine I 131, is designed for targeted delivery of iodine-131 and has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma [5][6]. - Other significant assets include CLR 225, targeting solid tumors like pancreatic cancer, and CLR 125, aimed at triple negative breast, lung, and colorectal cancers [5]. Strategic Evaluation Process - The company has engaged Oppenheimer & Co. Inc. as its exclusive financial advisor to assist in evaluating strategic alternatives, with no set timetable for completion [1][3]. - There are no guarantees that any transaction will result from this evaluation process [3].

Company Performance - Cellectar Biosciences, Inc. (CLRB) has gained approximately 12.6% year-to-date, outperforming the average gain of 4.9% in the Medical sector [4] - The Zacks Consensus Estimate for CLRB's full-year earnings has increased by 6.5% over the past quarter, indicating improving analyst sentiment [3] - Cellectar Biosciences, Inc. is currently ranked 2 (Buy) in the Zacks Rank system, suggesting a favorable outlook for the stock [3] Industry Comparison - Cellectar Biosciences, Inc. belongs to the Medical - Products industry, which has seen an average gain of 7.5% year-to-date, indicating that CLRB is performing better than its industry peers [5] - Another stock in the Medical sector, Cencora (COR), has also outperformed the sector with a year-to-date gain of 16.2% [4] - The Medical sector as a whole is ranked 4 in the Zacks Sector Rank, which evaluates the strength of various groups within the sector [2]

Financial Data and Key Metrics Changes - The company ended 2024 with cash and cash equivalents of $23.3 million, up from $9.6 million as of December 31, 2023 [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, down from $27.3 million in the prior year, primarily due to 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][22] Market Data and Key Metrics Changes - The company is focused on the relapsed/refractory Waldenstrom's macroglobulinemia (WM) market, with iopofosine showing a significant clinical benefit rate of 98.2% and an overall response rate of 83.6% in the CLOVER-WaM study [9][10] - The company is also advancing its solid tumor-focused radioisotope programs, including alpha emitters for pancreatic cancer and Auger emitters for triple-negative breast cancer [15] Company Strategy and Development Direction - The company aims to address its NASDAQ status and future funding through non-dilutive funding opportunities and collaborations [8][15] - A strategic restructuring was implemented to reduce headcount by approximately 60%, expected to save about $7.5 million annually [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential value of iopofosine for patients with relapsed/refractory WM, despite regulatory setbacks delaying the NDA submission [11][12] - The company anticipates rapid enrollment in the upcoming Phase 3 study for iopofosine, with a clear regulatory pathway established with the FDA [28][47] Other Important Information - The company is preparing for Phase 1 studies for both CLR 121225 and CLR 121125 in 2025, targeting pancreatic cancer and triple-negative breast cancer respectively [49][42] - The company is exploring various deal types for licensing iopofosine, including global partnerships and regional rights [81][84] 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: What is the timeline for patients to achieve and be evaluated for an MRR response? - Enrollment is expected to take approximately 24 months, with major response rate outcomes assessed 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][67] Question: Does the cash runway include costs for IND filings for CLR 121225 and 125? - Yes, the runway includes costs for IND filings, estimated to be 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 [90]

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]

Financial Performance - Cellectar Biosciences achieved a net loss of $44.6 million or $1.22 per basic share for the year ended December 31, 2024, compared to a net loss of $42.8 million or $3.50 per basic share in 2023[12]. - Other income and expense netted approximately $7.3 million in 2024, compared to a net expense of approximately $3.9 million in 2023, primarily due to non-cash items related to equity securities[12]. - Total operating expenses for 2024 were approximately $51.8 million, compared to $39.0 million in 2023, reflecting increased costs associated with the company's growth initiatives[18]. Cash Position - Cash and cash equivalents increased to $23.3 million as of December 31, 2024, up from $9.6 million at the end of 2023, supported by $44.1 million from warrant exercises and $19.4 million from inducement financing[6]. Research and Development - Research and Development expenses decreased to approximately $26.1 million in 2024 from approximately $27.3 million in 2023, primarily due to the timing of expenditures for the WM Phase 2 study[6]. - The company finalized a study design for the potential FDA accelerated approval of iopofosine I 131, with a total study cost expected to be between $40 million and $45 million[4]. - Cellectar plans to submit an IND application for its alpha-emitting radioconjugate in the first half of 2025, with Phase 1 clinical studies expected to begin by mid-2025[3]. - The company is preparing to initiate a Phase 1b/2a dose-finding study with CLR 121125 in triple-negative breast cancer, targeting significant unmet needs[6]. Clinical Study Results - The Phase 2 CLOVER-WaM study demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, exceeding the FDA's primary endpoint of 20% MRR[6]. General and Administrative Expenses - General and Administrative expenses rose significantly to approximately $25.6 million in 2024 from approximately $11.7 million in 2023, driven by costs related to commercialization infrastructure[6].

Core Viewpoint - Cellectar Biosciences has achieved alignment with the FDA on the regulatory path for the accelerated approval of iopofosine I 131 as a treatment for Waldenström macroglobulinemia, showcasing its efficacy and safety in clinical studies [1][2][3] Corporate Updates - The company plans to submit an IND for an alpha-emitting radioconjugate and is preparing for Phase 1 clinical studies for both CLR 121225 and CLR 121125 targeting triple negative breast cancer and pancreatic cancer, respectively [2][3] - Cellectar has finalized the study design for a randomized, controlled trial of iopofosine I 131, expecting to enroll 100 patients per arm and complete enrollment within 24 months [3] - The total cost for the study is estimated to be between $40 million and $45 million, with approximately $30 million allocated for full enrollment [3] Clinical Data Highlights - The Phase 2 CLOVER-WaM study demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, significantly exceeding the FDA's primary endpoint of 20% MRR [3] - The treatment was well tolerated with a manageable toxicity profile across various patient subgroups [3] - An investigator-led study published in eBioMedicine reported a 63.6% complete response rate among patients treated with iopofosine I 131 in combination with external beam radiation [3] Financial Highlights - As of December 31, 2024, the company reported cash and cash equivalents of $23.3 million, a significant increase from $9.6 million in 2023 [8] - Research and development expenses for 2024 were approximately $26.1 million, a decrease from $27.3 million in 2023, primarily due to the timing of expenditures [8] - General and administrative expenses rose to approximately $25.6 million in 2024 from $11.7 million in 2023, driven by commercialization infrastructure development [8] - The net loss for the year ending 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 share in 2023 [8][8]

Financial Position and Performance - As of December 31, 2024, the company's consolidated cash balance was approximately $23.3 million, which is expected to fund basic operations into the fourth quarter of 2025[193]. - The company has incurred significant losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern[379]. - The company reported a net loss of $44.58 million in 2024, compared to a net loss of $42.77 million in 2023, with a basic net loss per share of $1.22[394]. - The company's accumulated deficit increased to $(247.34) million in 2024 from $(202.76) million in 2023, indicating ongoing financial challenges despite capital raises[391]. - Cash used in operating activities for 2024 was approximately $47.58 million, an increase from $32.38 million in 2023[399]. - The company expects to continue incurring significant losses and using net cash until product candidates are approved and commercialized[403]. - The company has restated its previously issued financial statements for the years ended December 31, 2022, and 2023, exposing it to additional risks and uncertainties[317]. - The restatement has led to potential liabilities and reputational harm, as well as increased costs related to accounting and legal fees[318]. Capital and Funding - The company expects to require additional capital to continue operations and may have difficulty raising such capital, impacting its ability to execute its operating plan[194]. - Management plans to secure additional outside capital to fund operations, with available liquidity limited to approximately $14.9 million as of the issuance date[405]. - Proceeds from the exercise of warrants amounted to approximately $61.41 million in 2024, compared to $0.79 million in 2023[399]. - The company entered into a warrant exercise inducement transaction, resulting in gross proceeds of $19.4 million and net proceeds of $17.5 million from the exercise of 1,610 shares of Series E-4 preferred stock, convertible to 6,739,919 shares of common stock at a price of $2.52 per share[385]. Research and Development - The company is focused on the discovery, development, and commercialization of drugs for cancer treatment using its PDC platform, which can target nearly all tumor cells[212]. - The company may need to delay, scale back, or eliminate research and development programs if it cannot secure adequate financing when needed[199]. - The company has engaged AtomVie and SpectronRx as sources to supply drug products for ongoing research and clinical studies[202]. - The company has received orphan drug designation (ODD) in the U.S. for iopofosine, which is intended for the treatment of multiple myeloma and other conditions[252]. - The FDA has granted rare pediatric disease designation to iopofosine for treating neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, and osteosarcoma, but the company may not realize value from this designation[189]. - Clinical studies are lengthy and expensive, with uncertain outcomes, and earlier study results may not predict future results[238]. Regulatory and Compliance Risks - The company must comply with extensive regulations governing the testing, manufacturing, and marketing of its products, which can delay or limit product introduction[229]. - The company may face significant challenges in obtaining sufficient quantities of its products at reasonable prices, even if they are shown to be safe and effective[213]. - The company must demonstrate substantial clinical evidence for safety and efficacy to obtain FDA approval, which can take many years and require significant resources[217]. - The company may face litigation from third parties claiming infringement of intellectual property rights, which could result in substantial costs[258]. - Regulatory changes and increased litigation scrutiny could negatively impact the company's business and financial condition[247]. Market and Competitive Landscape - The market for the company's proposed products is rapidly changing and competitive, which could impair its ability to develop its business[191]. - The potential for widespread acceptance of alternative therapies may limit market acceptance of the company's products, even if they are commercialized[294]. - The commercial success of the company's products will depend significantly on reimbursement from third-party payors, with ongoing trends to reduce costs impacting revenue[304]. - Market acceptance of the company's products is uncertain, and failure to achieve this could delay revenue generation[270]. Internal Controls and Governance - The company is required to establish and maintain effective internal controls over financial reporting, with evolving and complex standards that may incur significant expenses[322]. - There are identified material weaknesses in the company's internal controls that have previously resulted in restatements of historical financial statements[322]. - The company has experienced high volatility in its stock price, which may be affected by the issuance of additional shares or convertible securities[327]. - The company has received a deficiency letter from Nasdaq due to the closing bid price of its common stock being below the minimum requirement of $1.00 per share for 30 consecutive business days[324]. Personnel and Intellectual Property - The company's success significantly relies on the continued services of key personnel, including the CEO, James V. Caruso, and the ability to attract and retain highly skilled personnel[266]. - The company faces risks related to the protection of trade secrets and proprietary information, which could adversely affect its competitive position[267]. - The patent positions for biotechnology products are often uncertain, and the company may not be able to adequately protect its intellectual property rights[260].