RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Rare Pediatric Disease (United States)

Structure/Sequence

Molecular FormulaC29H53INO4P

InChIKeyZOAIEFWMQLYMTF-YRKXUXMHSA-N

CAS Registry873438-88-1

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Clinical Trials associated with Iopofosine I-131

NCT05610891

/ Active, not recruitingPhase 1

A Phase 1b, Open-Label, Study of a Novel Targeted Radiotherapy in Children, Adolescents and Young Adults With Inoperable Relapsed or Refractory High-Grade Glioma

The purpose of this dose finding study is to evaluate the safety and efficacy of 2 different dose levels of CLR 131 in children, adolescents and young adults with relapsed or refractory high-grade glioma (HGG).

Start Date01 Oct 2023

Sponsor / Collaborator

Cellectar Biosciences, Inc.

[+1]

NCT04105543

/ CompletedPhase 1IIT

Therapeutic Combination of CLR 131 With External Beam Radiation in Head and Neck Cancer

This is a Phase 1 study of the use of an investigational drug that selectively delivers radiation to malignant tumor cells, CLR 131, in combination with external beam radiation therapy (EBRT) in subjects with locoregionally recurrent head and neck cancer. The trial will enroll up to 12 participants who are amenable to retreatment with radiation therapy. Participants who also have distant metastatic disease may be enrolled on this clinical trial, but they must have evaluable disease that will be clinically treated with radiation therapy, as per standard of care. All participants will receive a dosimetry test dose of CLR 131 to establish drug uptake by the tumor and enable Monte Carlo dose estimation based on CLR 131 SPECT/CT imaging evaluation. Participants showing uptake will receive a cumulative tumor dose of 60-70 Gy using personalized dose calculation (via Monte Carlo methods) of CLR 131 combined with external beam radiation.

Start Date20 Dec 2019

Sponsor / Collaborator

University of Wisconsin Madison

[+2]

NCT03478462

/ Active, not recruitingPhase 1

An Open-Label, Dose Escalation, Efficacy, and Safety Study of CLR 131 in Children, Adolescents, and Young Adults With Select Solid Tumors, Lymphoma, and Malignant Brain Tumors

The study evaluates CLR 131 in children, adolescents, and young adults with relapsed or refractory malignant solid tumors and lymphoma and recurrent or refractory malignant brain tumors for which there are no standard treatment options with curative potential.

Start Date30 Apr 2019

Sponsor / Collaborator

Cellectar Biosciences, Inc.

100 Clinical Results associated with Iopofosine I-131

100 Translational Medicine associated with Iopofosine I-131

100 Patents (Medical) associated with Iopofosine I-131

Literatures (Medical) associated with Iopofosine I-131

01 Jan 2025·EBioMedicine

Safety and toxicity of Iopofosine I 131 (CLR 131) with external beam radiation therapy in recurrent or metastatic head and neck cancer: results of a phase 1 single-centre, open-label, single-arm, dose escalation and dose expansion study

Article

Author: Cho, Steve Y ; Oliver, Kate ; Harari, Paul M ; Trask, Diana ; Kimple, Randall J ; Glazer, Tiffany A ; Adam, David P ; Burr, Adam ; Bednarz, Bryan ; Yu, Menggang ; Longcor, Jarrod ; Rogus-Pulia, Nicole ; Bruce, Justine Yang ; McCulloch, Timothy M ; Hill, Patrick ; Piaskowski, Shari M ; Hartig, Gregory K ; Wieland, Aaron M

BACKGROUND:

Re-irradiation of recurrent head and neck cancer (HNC) is often limited by tumour adherence to critical structures and/or radiation tolerance of critical normal tissues. Iopofosine I 131 (CLR 131) is a targeted small molecular phospholipid ether (PLE) drug conjugate that delivers iodine-131 selectively to tumour cells. We conducted a phase 1, single-centre, open-label study to determine whether CLR 131 given with reduced dose of external beam radiation therapy (EBRT) would be tolerable and feasible.

METHODS:

All participants received previous curative intent treatment with radiotherapy as primary or adjuvant treatment. Eligible participants demonstrated uptake of CLR 131 as indicated via single photon emission CT/CT (SPECT/CT) imaging following CLR 131 test dose. Participants received two therapeutic doses of CLR 131 (days 1 and 8) with SPECT/CT imaging performed to quantitate the biodistribution of CLR 131. Participants subsequently received EBRT to achieve the designated radiation dose (60-70 Gy). The primary endpoint was safety. This trial was registered with ClinicalTrials.gov, NCT04105543, and enrolment and follow-up are complete.

FINDINGS:

Twelve participants completed treatment with CLR 131 and EBRT. Eight participants experienced grade 4 non-DLT haematologic toxicities (2 anaemia, 8 leukopenia, 5 thrombocytopenia) at least probably attributed to CLR 131, consistent with the expected toxicity profile. Haematologic toxicities occurred during weeks 6-8 from the first dose of CLR 131 and resolved within three weeks without sequelae. There were no treatment-related grade 3-4 non-haematologic toxicities.

INTERPRETATION:

CLR 131 in combination with EBRT did not confer any safety concerns, and was tolerable in participants with recurrent/metastatic HNC. Myelosuppression was consistent with the known toxicity profile of CLR 131.

FUNDING:

National Institutes of HealthP50 DE026787, National Cancer InstituteP30 CA014520, National Institutes of Health1UL1TR002373, Cellectar, NCT04105543.

01 Sep 2023·Cancer biotherapy & radiopharmaceuticals

Targeting of Head and Neck Cancer by Radioiodinated CLR1404 in Murine Xenograft Tumor Models with Partial Volume Corrected Theranostic Dosimetry

Article

Author: Adam, David P. ; Grudzinski, Joseph ; Li, Chunrong ; Jeffery, Justin ; Marsh, Ian R. ; Longhurst, Colin ; Bednarz, Bryan P. ; Hernandez, Reinier ; Harari, Paul M. ; Weichert, Jamey P.

Background: Delivery of radiotherapeutic dose to recurrent head and neck cancer (HNC) is primarily limited by locoregional toxicity in conventional radiotherapy. As such, HNC patients stand to benefit from the conformal targeting of primary and remnant disease achievable with radiopharmaceutical therapies. In this study, the authors investigated the tumor targeting capacity of ¹³¹I-CLR1404 (iopofosine I-131) in various HNC xenograft mouse models and the impact of partial volume correction (PVC) on theranostic dosimetry based on ¹²⁴I-CLR1404 (CLR 124) positron emission tomography (PET)/computed tomography (CT) imaging. Methods: Mice bearing flank tumor xenograft models of HNC (six murine cell line and six human patient derived) were intravenously administered 6.5-9.1 MBq of CLR 124 and imaged five times over the course of 6 d using microPET/CT. In vivo tumor uptake of CLR 124 was assessed and PVC for ¹²⁴I was applied using a novel preclinical phantom. Using subject-specific theranostic dosimetry estimations for iopofosine I-131 based on CLR 124 imaging, a discrete radiation dose escalation study (2, 4, 6, and 8 Gy) was performed to evaluate tumor growth response to iopofosine I-131 relative to a single fraction of external beam radiation therapy (6 Gy). Results: PET imaging demonstrated consistent tumor selective uptake and retention of CLR 124 across all HNC xenograft models. Peak uptake of 4.4% ± 0.8% and 4.2% ± 0.4% was observed in squamous cell carcinoma-22B and UW-13, respectively. PVC application increased uptake measures by 47%-188% and reduced absolute differences between in vivo and ex vivo uptake measurements from 3.3% to 1.0 percent injected activity per gram. Tumor dosimetry averaged over all HNC models was 0.85 ± 0.27 Gy/MBq (1.58 ± 0.46 Gy/MBq with PVC). Therapeutic iopofosine I-131 studies demonstrated a variable, but linear relationship between iopofosine I-131 radiation dose and tumor growth delay (p < 0.05). Conclusions: Iopofosine I-131 demonstrated tumoricidal capacity in preclinical HNC tumor models and the theranostic pairing with CLR 124 presents a promising new treatment approach for personalizing administration of iopofosine I-131.

01 Feb 2022·PEDIATRIC PULMONOLOGY

Does recorded oximetry utilizing a consensus‐based algorithm compare to polysomnography in discontinuing home oxygen therapy in premature infants?

Article

Author: Sobelman, Celia ; Lee, Austin ; White, Heather ; Rhein, Lawrence M. ; Kremer, Ted

Abstract:

Background:

Approximately a third of all extremely preterm infants diagnosed with bronchopulmonary dysplasia will require home oxygen therapy (HOT). Lack of consensus‐based guidelines has led to significant variability in outpatient HOT management in the United States. A common assessment performed before discontinuing oxygen is a formal polysomnogram (PSG). PSGs are potentially undesirable due to cost, lack of convenient access, and parental stress, so alternative testing to determine the optimal timing of safe oxygen discontinuation are needed.

Methods:

We compared nocturnal recorded home oximetry (RHO) with PSG data in a cohort of patients from the RHO trial for patients who had recordings performed simultaneously to or within 24 h of their PSG. The RHO trial was a randomized, unblinded, multi‐center trial comparing two oxygen management strategies. Parameters of oxygenation were compared between PSG and RHO, and nonoximegtry findings from the PSG that changed clinical management were identified.

Results:

A total of 53 infants randomized to obtain a PSG as part of the RHO trial (55%) completed a PSG, and of those, 32 (64%) completed both a PSG with comparison RHO. There were more white infants in both groups than other races and ethnicities. Bland–Altman analysis showed a strong agreement of oxygen saturation time below 90% SpO2 between PSG and RHO results (slope = 1.014, p = 0.24). Results agreed in 96% of cases.

Conclusion:

RHO is a safe and effective alternative to PSG to assist in determination of discontinuing HOT in infants with BPD without other risks for sleep‐disordered breathing.

News (Medical) associated with Iopofosine I-131

05 Jun 2025

·www.globenewswire.com

Cellectar Biosciences Enters into Common Stock Agreements to Raise $2.5 Million Priced at Market Under Nasdaq Rules

FLORHAM PARK, N.J., June 05, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the entry into definitive agreements to raise $2.5 million from the sale of shares of the company’s common stock priced at-market for Nasdaq purposes. The closing of the offering is expected to occur on or about June 6, 2025, subject to satisfaction of customary closing conditions. Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the offering. The agreements provide for the immediate exercise of certain outstanding warrants to purchase an aggregate of 8,301,322 shares of common stock, issued by the company on June 5, 2020, October 25, 2022 and July 21, 2024 (the “Existing Warrants”), at a reduced exercise price of $0.3041 per share. The shares of common stock issuable upon exercise of the Existing Warrants are all registered, or their resale is registered, pursuant to effective registration statements. The company did not issue any replacement warrants. The gross proceeds to the company from the exercise of the Existing Warrants are expected to be approximately $2.5 million, prior to deducting placement agent fees and offering expenses. The company intends to use the net proceeds for general corporate purposes, including working capital and operating expenses. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope), for which the FDA has granted Breakthrough Therapy Designation; CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications. For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Forward-Looking Statement Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarter ended March 31, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. Contacts INVESTORS:Anne Marie FieldsPrecision AQ212-362-1200annemarie.fields@precisionaq.com

Orphan DrugFast TrackPhase 2Breakthrough Therapy

04 Jun 2025

·investor.cellectar.com

Cellectar Granted U.S. FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM)

Designation Supported by CLOVER WaM Phase 2 Study Data Which Reported an 83.6% Overall Response Rate (ORR) Seeking Guidance from EMA to Determine if CLOVER WaM Phase 2 Data Meets Criteria to Apply for Fast-Track, Conditional Marketing Authorization, Answer Expected Late July FLORHAM PARK, N.J., June 04, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for iopofosine I 131, a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM). WM is the dominant subtype of lymphoplasmacytic lymphoma and remains incurable with available therapies according to the International Waldenstrom’s Macroglobulinemia Foundation. Approved WM treatment options are limited, underscoring the need for new therapies with novel mechanisms of action. “The FDA’s Breakthrough Therapy Designation underscores the potential of iopofosine I 131 as it may offer substantial improvement on at least one clinically significant endpoint over available therapies to address the substantial unmet medical need in this life-threatening cancer,” said James Caruso, president and chief executive officer of Cellectar. “With robust clinical data, a favorable safety profile, expedited review designations in the United States and Europe and a compelling commercial market potential, we believe iopofosine I 131 represents an attractive candidate for potential collaborations or partners seeking impactful innovation and accelerated development pathways.” Data from the Phase 2 CLOVER WaM study (NCT02952508), including the overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon primary endpoint of a 20% MRR, were presented as a podium presentation during the 66th Annual American Society of Hematology Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic. As previously announced, the FDA also granted iopofosine I 131 Fast Track Designation and Orphan Drug Designation. The European Medicines Agency (EMA) granted Orphan Drug Designation to iopofosine I 131 for treatment of r/r WM, as well as PRIME Designation for WM. Separately, the company announced that it has provided the EMA with a data package that includes extensive supportive preclinical, regulatory and manufacturing data, as well as safety and efficacy data from the CLOVER WaM Phase 2b clinical trial. The EMA will review the package to determine whether there is enough clinical evidence to address the required criteria for Cellectar to apply for a fast-track, conditional marketing authorization approval. In late July 2025 the company expects a recommendation from the EMA on whether Cellectar should file a Medical Authorization Application (MAA). About Breakthrough Therapy Designation Breakthrough Therapy Designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening diseases with preliminary clinical evidence that the investigational therapy may offer substantial improvement on at least one clinically significant endpoint over available therapies. The designation provides increased interactions with the FDA and supports the possibility of receiving a six-month priority review of a New Drug Application. About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications. For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Forward Looking Statements Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarter ended March 31, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. INVESTORS: Anne Marie Fields Precision AQ 212-362-1200 annemarie.fields@precisionaq.com Released June 4, 2025

Fast TrackPhase 2Clinical ResultOrphan DrugASH

13 May 2025

·www.globenewswire.com

Cellectar Biosciences Reports First Quarter 2025 Financial Results and Provides a Corporate Update

Company Seeking Conditional Approval from European Medicines Agency (EMA) for Iopofosine I 131 in Waldenstrom Macroglobulinemia based upon CLOVER WaM Phase 2 Study Data CLOVER WaM Major Response Rate for BTKi-Treated Patients 59.0% Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., May 13, 2025 (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 March 31, 2025, and provided a corporate update on its promising portfolio of clinical and pre-clinical radiopharmaceutical therapeutics. “Notwithstanding the need to gather additional clinical data for iopofosine I 131, as previously announced, we believe that the Phase 2 CLOVER WaM clinical trial data for this product candidate are impressive. We plan to present these data to the EMA during the second quarter of 2025 as part of the registration package seeking conditional marketing approval. We anticipate a response regarding the regulatory pathway from the European agency before the end of the third quarter of this year,” said James Caruso, president and CEO of Cellectar. “In addition to iopofosine I 131, we have developed a pipeline of radiotherapeutic candidates, including our alpha- and Auger-emitting radioconjugates, with observed preclinical activity in solid tumor models. With cash into the fourth quarter of this year we are evaluating a variety of funding pathways to successfully advance our novel pipeline assets.” Corporate Update Announced plans to explore full range of strategic alternatives including, but not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions. The company’s board of directors has engaged of Oppenheimer & Co. Inc. to serve as exclusive financial advisor to assist in the strategic evaluation process.Determined that the Phase 3 study for iopofosine I 131, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia, would be a comparator, randomized controlled study with 100 patients per arm. Study initiation is dependent upon the company obtaining additional funding or a strategic collaboration.Funding dependent, the company is prepared to initiate a Phase 1b/2a dose-finding study for CLR 121125, the company’s lead Auger-emitting (iodine-125) PRC, in triple-negative breast cancer. CLR 121125 is designed to provide highly precise radiotherapeutic targeting as emissions only travel a few nanometers.In a series of pre-clinical studies evaluating CLR 121225, the company’s lead alpha-emitting actinium-225 PRC in refractory pancreatic models, desired pharmacokinetics, biodistribution and activity were observed, further supporting future clinical development. First Quarter 2025 Financial Highlights Cash and Cash Equivalents: As of March 31, 2025, the company had cash and cash equivalents of $13.9 million, compared to $23.3 million as of December 31, 2024. The company believes its cash balance as of March 31, 2025, is adequate to fund its basic budgeted operations into the fourth quarter of 2025.Research and Development Expenses: R&D expenses for the three months ended March 31, 2025, were approximately $3.4 million, compared to approximately $7.1 million for the three months ended March 31, 2024. The overall decrease was primarily a result of the reduction in patient follow-up activities for our CLOVER WaM Phase 2 clinical study in WM and a reduction in personnel costs.General and Administrative Expenses: G&A expenses for the three months ended March 31, 2025, were approximately $3.0 million, compared to approximately $4.9 million for the same period in 2024. The decrease was primarily driven by a reduction in pre-commercialization and personnel costs.Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2025, was $6.6 million, or $0.14 per share, compared to $26.6 million, or $0.91 per share in the three months ended March 31, 2024. Conference Call & Webcast DetailsCellectar management will host a conference call and webcast today, May 13, 2025, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the “Events & Presentations” section of Cellectar’s website at www.cellectar.com. A recording of the webcast will be available and archived on the company’s website for approximately 90 days. About Cellectar Biosciences, Inc.Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications. For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook. Forward Looking Statements Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to execute strategic alternatives, identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarterly period ending March 31, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. INVESTORS:Anne Marie FieldsPrecision AQ212-362-1200annemarie.fields@precisionaq.com +++ TABLES TO FOLLOW +++ CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited) March 31, December 31, 2025 2024ASSETS CURRENT ASSETS: Cash and cash equivalents $13,905,173 $23,288,607 Prepaid expenses and other current assets 987,495 961,665 Total current assets 14,892,668 24,250,272 Property, plant & equipment, net 700,826 757,121 Operating lease right-of-use asset 418,916 436,874 Other long-term assets 29,780 29,780 TOTAL ASSETS $16,042,190 $25,474,047 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) CURRENT LIABILITIES: Accounts payable and accrued liabilities $3,874,429 $7,585,340 Warrant liability 2,058,000 1,718,000 Lease liability, current 88,146 84,417 Total current liabilities 6,020,575 9,387,757 Lease liability, net of current portion 386,203 409,586 TOTAL LIABILITIES 6,406,778 9,797,343 COMMITMENTS AND CONTINGENCIES (Note 7) MEZZANINE EQUITY: Series D preferred stock, 111.11 shares authorized, issued and outstanding as of March 31, 2025 and December 31, 2024 1,382,023 1,382,023 STOCKHOLDERS’ EQUITY (DEFICIT): Series E-2 preferred stock, 1,225.00 shares authorized; 35.60 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 520,778 520,778 Common stock, $0.00001 par value; 170,000,000 shares authorized; 46,079,875 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 461 461 Additional paid-in capital 261,678,642 261,115,905 Accumulated deficit (253,946,492) (247,342,463)Total stockholders’ equity (deficit) 8,253,389 14,294,681 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) $16,042,190 $25,474,047 CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) Three Months Ended March 31, 2025 2024OPERATING EXPENSES: Research and development $3,427,095 $7,088,042 General and administrative 2,973,896 4,913,444 Total operating expenses 6,400,991 12,001,486 LOSS FROM OPERATIONS (6,400,991) (12,001,486) OTHER INCOME (EXPENSE): (Loss) gain on valuation of warrants (340,000) (14,960,346)Interest income 136,962 319,849 Total other expense (203,038) (14,640,497)NET LOSS $(6,604,029) $(26,641,983)NET LOSS PER SHARE — BASIC AND DILUTED $(0.14) $(0.91)WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC AND DILUTED 46,079,875 29,346,679

Phase 2Fast TrackOrphan DrugFinancial StatementPhase 1

100 Deals associated with Iopofosine I-131

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Waldenstrom Macroglobulinemia	Phase 3	United States	Cellectar Biosciences, Inc.	-
Chronic Lymphocytic Leukemia	Phase 2	United States	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	Australia	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	Brazil	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	Czechia	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	Finland	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	France	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	Greece	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	Israel	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	Spain	Cellectar Biosciences, Inc.	26 Jul 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02952508 (ASH2024) Manual	Phase 2	Waldenstrom Macroglobulinemia Third line	65	Iopofosine I 131 15 mCi/m2	ifksafusaw(rqzhkxcykp) = occurred in 1 patient due to bacterial sepsis eaqkbqsyom (ptessokxof ) View more	Positive	09 Dec 2024
NCT02952508 (CLOVER-WaM, Corporate Publications) Manual	Phase 2	Waldenstrom Macroglobulinemia	50	Iopofosine I 131	wutpqhsapy(rdohhebcne) = gurcgnydzv yxrltvlhrs (nqlnjqfmgf, 44.5 - 75.8) Met View more	Positive	08 Jan 2024
NCT02952508 (CLOVER-1, Literature) Manual	Phase 2	Relapse multiple myeloma Last line	7	CLR-131+dexamethasone (total dose ≥60 mCi)	oojkrwohnu(sapuwspnrk) = obxkcqcbay nozgeovani (jxakfopuld ) View more	Positive	06 Sep 2022
NCT02952508 (CLOVER-1, Literature) Manual	Phase 2	Relapse multiple myeloma Last line	7	CLR-131+dexamethasone (total dose <60 mCi)	-	Positive	06 Sep 2022
NCT02952508 (CLOVER-1, ASCO2021)	Phase 2	Lymphoplasmacytic Lymphoma \| Mantle-Cell Lymphoma \| Chronic Lymphocytic Leukemia ... View more	6	CLR 131	qtwijafccz(uggmujydyd) = anaemia (66%) etbwqejvjy (dkcobdottd ) View more	-	28 May 2021
NCT02952508 (ESMO2019) Manual	Phase 2	Diffuse large B-cell lymphoma recurrent	6	CLR-131	xcrlnltsqn(vgavlzvjxa) = fusvruvuqv pjrzudpgqm (iczfausgcn ) View more	Positive	28 Sep 2019
AACR2018	Phase 2	-	-	Fractionated injections of CLR 131	haliazwayj(fboxlihlfv) = ckmtrhqvim hbwekwmote (uohnxtohfj )	-	01 Jul 2018
AACR2018	Phase 2	-	-	Standard dosing of bortezomid	haliazwayj(fboxlihlfv) = jgffbsqjgn hbwekwmote (uohnxtohfj )	-	01 Jul 2018
NCT02278315 (ASH 12016 \| ASH 22016) Manual	Phase 1	Multiple Myeloma	8	dexamethasone+I-131-CLR1404	nedumjhqmj(fdnjwnhkrg) = jjrwxjebzx oszwxodbve (vwxslsknqu )	Positive	02 Dec 2016
NCT02278315 (ASH 12016 \| ASH 22016) Manual	Phase 1	Multiple Myeloma	8	dexamethasone+I-131-CLR1404	ohwakdmihr(ixqcjvlgsu) = bltmzbotms nxplkuwvox (tywhquccpp ) View more	Positive	02 Dec 2016
NCT00925275 (Pubmed \| PLoS One)	Phase 1	Advanced Malignant Solid Neoplasm	8	131I-CLR1404	auxboqfhyl(fvgwukqhrh) = jceuhpqhpp vxaozwpnjq (etktovrpic ) View more	-	17 Nov 2014
NCT01495663 (ASCO2014)	Phase 1	HR-positive/HER2-low Solid Tumors	12	Phospholipid ether [<sup>131</sup>I]-CLR1404	iboeilcjag(iedfjmcezf) = lpurpnmqzb erdsqyqcew (nylxpvxxqu )	-	20 May 2014
AACR2013	Not Applicable	Squamous Cell Carcinoma of Head and Neck	-	131I-CLR1404	kngfijewpi(opbneixbmb) = isfrczztxh osczpquxmv (kwpvfewovo ) View more	-	15 Apr 2013

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