Achieves alignment with U.S. Food and Drug Administration (FDA) on regulatory path for potential accelerated approval of iopofosine I 131 as a treatment for Waldenström macroglobulinemia (WM) Evaluating timing for Phase 1 solid tumor studies; Auger-emitting radioconjugate prepared for Phase 1b; plans to submit an IND for alpha-emitting radioconjugate; Company to host webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: C ...

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].

Company Overview - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for cancer treatment [2] - The company aims to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer cell-targeting treatments, enhancing efficacy and safety by reducing off-target effects [2] Product Pipeline - The company's lead assets include iopofosine I 131, designed for targeted delivery of iodine-131 (radioisotope), CLR 121225 targeting solid tumors like pancreatic cancer, and CLR 121125 aimed at other solid tumors such as triple negative breast, lung, and colorectal cancers [3] - iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is part of the CLOVER-2 Phase 1b study for pediatric patients with high-grade gliomas [4] - The FDA has granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [4] Upcoming Events - Members of Cellectar's management team will present an overview of the company at the 37th Annual Roth Conference on March 17, 2025, at 8:30 AM Eastern Time [1]

Group 1 - Cellectar Biosciences, Inc. will report financial results for the full year ended December 31, 2024, and provide a corporate update on March 13, 2025, at 8:30 a.m. Eastern Time [1] - The company is focused on the discovery, development, and commercialization of drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [3] - Cellectar's product pipeline includes lead assets such as iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors and utilizing advanced drug delivery methods [4] Group 2 - Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA upon approval [5] - The FDA has granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [5]

Core Insights - Cellectar Biosciences, Inc. is a late-stage clinical biopharmaceutical company focused on cancer treatment through drug discovery and development [2][3] - The company will present an overview at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 12, 2025 [1] Company Overview - Cellectar's primary objective is to utilize its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer treatments with improved efficacy and safety [2] - The company is engaged in independent research and development as well as collaborations to enhance its drug pipeline [2] Product Pipeline - Key assets include: - Iopofosine I 131, a PDC for targeted delivery of iodine-131, currently in Phase 2b trials for multiple myeloma and CNS lymphoma [3][4] - CLR 121225, targeting solid tumors like pancreatic cancer using actinium-225 [3] - CLR 121125, aimed at other solid tumors such as triple negative breast cancer, lung cancer, and colorectal cancer [3] - The company has multiple partnered PDC assets and preclinical PDC chemotherapeutic programs [3] Regulatory Designations - Iopofosine I 131 has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA for various cancer indications [4]

Clinical Trial Results - Iopofosine I 131 demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% in the CLOVER-WaM study, exceeding the primary endpoint of a 20% MRR [1] - The results were presented at the 66th Annual American Society of Hematology Conference in December 2024 [1] Product Pipeline - The company's lead asset is iopofosine I 131, a Phospholipid Drug Conjugate (PDC) designed for targeted delivery of iodine-131 [7] - Other pipeline assets include CLR 121225 (actinium-225 based program) and CLR 121125 (iodine-125 Auger-emitting program) targeting solid tumors [7] - The company is advancing radioconjugate PDC programs, including alpha- and Auger-emitting radioconjugates, into Phase 1/2a solid tumor studies [8] Regulatory and Market Strategy - Iopofosine I 131 has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA [4] - The company is pursuing conditional U.S. market approval through the FDA's accelerated approval process and aligning with the European Medicines Agency for global approval [5] - A confirmatory study with 40-60 patients per arm is expected to be completed within 18 months of the first patient enrollment [5] Strategic Initiatives - The company plans to advance iopofosine I 131 through internal development, strategic partnerships, and other approaches [8] - CLR 121225, an alpha-emitting actinium-225 radioconjugate, has shown activity in pancreatic, colorectal, and breast cancer animal models, with an IND application planned for Q1 2025 [9] - The company is evaluating the timing of study initiation for both CLR 121225 and CLR 121125 [6] Corporate Updates - The company will present its 2025 strategic initiatives at the Biotech Showcase during the 43rd Annual JP Morgan Healthcare Conference in January 2025 [8] - A live webcast and replay of the presentation will be available on the company's investor relations website [10]

Core Insights - Cellectar Biosciences, Inc. has announced a strategic update regarding its clinical development programs for its proprietary phospholipid ether drug conjugate platform targeting cancer [1] - The company is pursuing strategic options for the further development and commercialization of its product candidate, iopofosine I 131, following recent communications with the FDA [1][3] Group 1: Clinical Development and Regulatory Updates - The CLOVER-WaM study was conducted based on earlier FDA communications, indicating that positive results for major response rate (MRR) could support accelerated approval for iopofosine I 131 in treating Waldenstrom's macroglobulinemia (WM) [2] - A Type-C meeting with the FDA indicated that a submission for accelerated approval would need to be based on MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study focused on progression-free survival (PFS) [3] Group 2: Strategic Focus and Resource Allocation - The company plans to concentrate its resources on targeting solid tumors by advancing its actinium-225-based program CLR 121225 and iodine-125 Auger-emitting program CLR 121125 into clinical trials [4] - Cellectar expects to file Investigational New Drug applications for both CLR-121225 and CLR-121125 in the first half of 2025, initiating Phase 1 clinical studies in solid tumor cancers [5] Group 3: Financial and Operational Adjustments - The company will reduce its headcount by approximately 60%, expected to be completed by the end of the fourth quarter of 2024, to extend its cash runway into the third quarter of 2025 [5] - Following these developments, CLRB stock has seen a significant decline of 73.40%, trading at $0.34 [6]

Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash and cash equivalents of $34.3 million, a significant increase from $9.6 million as of December 31, 2023, due to funds raised from investor exercises of Tranche B warrants [21] - Net loss for the period was $14.7 million or $0.37 per basic share, compared to a net loss of $17.5 million or $1.55 per basic share during the same period in 2023, indicating a reduction in losses [26] Business Line Data and Key Metrics Changes - Research and development expenses decreased to approximately $5.5 million in Q3 2024 from approximately $7.0 million in Q3 2023, primarily due to reduced clinical study costs [24] - General and administrative expenses increased to $7.8 million in Q3 2024 from $2.4 million in Q3 2023, driven by costs associated with commercialization infrastructure development [25] Market Data and Key Metrics Changes - The U.S. market for Waldenstrom's macroglobulinemia (WM) includes approximately 26,000 patients, with 1,500 to 1,900 new diagnoses annually, and about 11,500 patients requiring treatment in the relapsed/refractory setting [44] - There are approximately 5,700 patients in the total addressable market for third-line or greater therapy, highlighting a significant unmet need for new FDA-approved treatments [45][47] Company Strategy and Development Direction - The company is focused on the NDA submission for iopofosine I 131 in WM, with a planned product launch in the second half of 2025, despite a delay in NDA submission to potentially Q2 2025 [10][14] - Expansion of iopofosine I 131 to other indolent lymphomas is viewed as a smart investment to increase overall revenue opportunities [15] - The company is also exploring collaborations for clinical development in other indications, such as mycosis fungoides, and has plans for ongoing development in pediatric high-grade gliomas [37][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of iopofosine I 131 to become a first-in-class treatment for relapsed/refractory WM patients, supported by strong clinical data [31][77] - The company remains engaged with the FDA regarding the regulatory pathway and is committed to expediting the NDA submission process [58] Other Important Information - The company has secured a second manufacturing source for iopofosine I 131, enhancing production capacity and supply redundancy [15] - A strategic master supply agreement has been signed with Northstar Medical Radioisotopes for the procurement of Actinium-225, ensuring a reliable source for future development [74] Q&A Session Summary Question: Concerns about FDA's interest in confirmatory studies - Management clarified that the FDA has indicated that a confirmatory study is not required to be ongoing prior to NDA submission [82][83] Question: Financial guidance regarding cash runway and warrant exercises - Management noted that an interim raise may be required before the first tranche of warrants is exercised, but the overall $73 million from warrant exercises should satisfy commercial launch needs [86][88]

Exhibit 99.1 Cellectar Biosciences Reports Financial Results for Q3 2024 and Provides a Corporate Update Phase 2 CLOVER-WaM pivotal study data selected for oral presentation at 66 Annual American Society of Hematology Meeting and Exposition Raised approximately $19.4 million with potential to raise up to an additional $73.3 million Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., November 18, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a latestage ...

Phase 2 CLOVER-WaM pivotal study data selected for oral presentation at 66th Annual American Society of Hematology Meeting and Exposition Raised approximately $19.4 million with potential to raise up to an additional $73.3 million Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs ...