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 1

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 CLR-131

100 Translational Medicine associated with CLR-131

100 Patents (Medical) associated with CLR-131

Literatures (Medical) associated with CLR-131

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 ; White, Heather ; Lee, Austin ; Kremer, Ted ; Rhein, Lawrence M

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.

12 May 2021·Leukemia & lymphoma

Targeted treatment of multiple myeloma with a radioiodinated small molecule radiopharmaceutical

Letter

Author: Marino, Roberta ; Baiu, Dana C. ; Weiss, Gerald E. ; Callander, Natalie S. ; Pula, Taner ; Otto, Mario ; Shahi, Ankita ; Asimakopoulos, Fotis ; Bhattacharya, Saswati

Despite recent advances in the therapy of multiple myeloma (MM), this blood cancer is characterized by initial response to treatment.MM is a very radiosensitive malignancy and ionizing radiation was one of the first therapeutic modalities investigated in the treatment of MM patients.However, limited by the infiltrative bone marrow distribution pattern throughout the body and toxicity associated with treatment of large areas, radiotherapy is now primarily reserved for disease palliation and prescribed in the context of emergencies.CLR 131 is a clin.-stage, radioactive isostere of CLR 127 (18-(p-iodo-phenyl) octadecyl phosphocholine), a tumor-selective alkyl phosphocholine (APC) analog that belongs to the family of anti-tumor alkyl phospholipid (APL) drugs.We determined CLR1501 uptake by flow cytometry in MM cells from 5 sep. patient bone marrow aspirate samples and compared the uptake to non-MM bone marrow cell populations from the same sample.

News (Medical) associated with CLR-131

10 Dec 2024

·www.globenewswire.com

Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring

Evaluating strategic options for iopofosine I 131 a late-stage clinical program with compelling Phase 2 data and a substantial market opportunity Focusing on advancing radiotherapeutic assets including alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies FLORHAM PARK, N.J., Dec. 10, 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 announces a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform that delivers a broad array of therapeutic modalities to target cancers. Due to recent communications with the U.S. Food and Drug Administration (FDA, or the Agency) regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the Company has decided to pursue strategic options for the further development and commercialization of this product candidate. The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end of Phase 2 meeting and from a meeting in early 2024, during which the Company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 as a treatment for Waldenstrom’s macroglobulinemia (WM). Based upon a recent Type-C meeting with the FDA, the Company now believes that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS). “While iopofosine I 131’s positive WM data along with the high unmet medical need for these patients support further investment, we have determined that such a program may best be brought to market by a larger organization with greater resources. Importantly, partnering or divesting this program supports our commitment to providing this potentially life-saving drug to the patients who need it as quickly as possible,” stated James Caruso, president and CEO of Cellectar. “We believe iopofosine I 131 represents a compelling opportunity as it has shown strong efficacy and good tolerability based on our clinical studies. Moreover, the commercial work we conducted demonstrates iopofosine I 131’s substantial market opportunity based upon the product profile, which includes off-the-shelf global distribution, orphan pricing and existing unmet medical need.” Cellectar remains confident in the potential of its phospholipid ether drug conjugate platform and the targeted radiotherapies in its development pipeline. Iopofosine I 131’s clinical success validates the platform’s ability to target cancers and Cellectar will leverage its experience to focus on the development of its earlier clinical programs. Specifically, Cellectar will focus on those assets it believes have the highest therapeutic potential and opportunity for value creation. As highlighted by recent acquisitions and collaborations within the radiopharmaceutical sector, precision isotopes like alpha- and Auger-emitters have emerged as the leading therapeutics of interest. Consequently, the Company will now focus its resources on targeting solid tumors by advancing CLR 121225, its actinium-225 based program, and CLR 121125, its iodine-125 Auger-emitting program into the clinic. Cellectar expects to file Investigational New Drug applications in the first half of 2025 for both CLR-121225 and CLR-121125, which will allow the initiation of Phase 1 clinical studies in solid tumor cancers. Both programs have demonstrated robust in vivo activity, tolerability, excellent targeting and uptake in preclinical solid tumor models. The Company believes this approach will provide an expedited timeframe to achieve safety and proof-of-concept data in patients. The Company’s strategic reprioritization will impact all departments and result in an immediate reduction in headcount of approximately 60%, which should be complete by the end of the fourth quarter 2024. The Company anticipates that the implementation of the restructuring will extend its cash runway into the third quarter of 2025. “We are being methodical in our efforts to reorganize the company with the goal of conserving cash while maintaining the flexibility to execute immediate priorities and build for long-term growth and value creation. This reorganization is difficult but necessary for the future growth potential of Cellectar,” said Mr. Caruso. “I want to extend my deepest gratitude to our departing employees for their significant contributions to our work and their dedication to making a difference in the lives of patients.” 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 ConjugateTM (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 lead asset, iopofosine I 131, a small-molecule 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, CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 is under evaluation in Phase 2b studies for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, alongside 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 Orphan Drug and Fast Track Designations for various cancer indications. New data from the CLOVER-WaM Phase 2 clinical trial were recently presented in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition (ASH 2024). For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, 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 raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to obtain regulatory exclusivities, the availability of priority review vouchers, our ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. 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/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended September 30, 2024. 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 MEDIA: Christy MaginnBliss Bio Health 703-297-7194 cmaginn@blissbiohealth.com INVESTORS: Anne Marie FieldsPrecision AQ212-362-1200annemarie.fields@precisionaq.com

Fast TrackPhase 2ASHOrphan DrugPhase 1

18 Nov 2024

·www.globenewswire.com

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 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 for the treatment of cancer, today announced financial results for the quarter ended September 30, 2024, and provided a corporate update. “We achieved important clinical, operational and commercial corporate objectives during the quarter. We reported topline results from the CLOVER-WaM pivotal study in WM and look forward to filing our NDA submission with a request for accelerated regulatory approval in the coming months,” said James Caruso, president and CEO of Cellectar Biosciences. “In addition to our lead iopofosine I 131 program, we plan to further advance the value of our phospholipid radioconjugate pipeline and are preparing alpha and Auger PRCs for initiation of solid tumor clinical studies as business conditions allow.” Third Quarter and Recent Corporate Highlights Reported positive results from the Phase 2 CLOVER-WaM pivotal study evaluating iopofosine I 131, the company’s potentially first-in-class, targeted radiotherapeutic candidate, for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM). These results support the company’s planned filing of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the near term.Selected to present data from the CLOVER-WaM study evaluating iopofosine I 131 in patients with WM at the upcoming 66th Annual American Society of Hematology Meeting and Exposition (ASH), in an oral presentation session. Details of the oral presentation are as follows: Abstract Title: Iopofosine I 131 in Previously Treated Patients with Waldenström Macroglobulinemia (WM): Efficacy and Safety Results from the International, Multicenter, Open-Label Phase 2 Study (CLOVER-WaM™)Session Name: 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Clinical Trials for Marginal Zone Lymphoma, Waldenstrom's Macroglobulinemia and Hairy Cell LeukemiaSession Date: Monday, December 9, 2024Presentation Time: 3:15 PM PST Delivered oral and poster presentations at the 12th International Workshop on Waldenstrom’s Macroglobulinemia (IWWM) in October 2024 that highlighted the activity of iopofosine I 131 in WM. Oral presentation: Session XXII Clinical Trials in Progress for WM: Multi-center trial of iopofosine I-131 in relapsed/refractory WMPoster presentation: Treatment With iopofosine I 131 in a Patient With Bing-Neel Syndrome, A Rare Manifestation of Waldenström Macroglobulinemia: A Case Report Advanced sales, marketing and medical planning activities to support iopofosine I 131 commercializationPartnered with key national and regional community cancer networks to better understand the WM disease landscape, to advance iopofosine I 131 for WM patients in the community settingEstablished collaboration with the City of Hope Cancer Center to evaluate iopofosine I 131 in mycosis fungoides, a cutaneous T-cell lymphomaExecuted supply and manufacturing agreements, further strengthening our multi-sourced supply network: Commercial finished product supply of iopofosine I 131 with SpectronRxPre-clinical and clinical supply of alpha-emitting actinium 225 isotope with Northstar Medical Radioisotopes Raised $19.4 million through warrant exercises and issued new milestone-based warrants with the potential to raise up to an additional $73.3 million. Funds generated from the execution of these new warrants will further advance the company’s commercialization plans for iopofosine I 131 in the treatment of WM and support future clinical development. Third Quarter 2024 Financial Highlights Cash and Cash Equivalents: As of September 30, 2024, the company had cash and cash equivalents of $34.3 million, including 19.4 million ($17.5 million, net) raised through investor exercises of Tranche B warrants and the purchase of new warrants in July 2024, compared to $9.6 million as of December 31, 2023. The company believes its cash balance as of September 30, 2024, is adequate to fund its basic budgeted operations into the second quarter of 2025.Research and Development Expenses: R&D expenses for the three months ended September 30, 2024, were approximately $5.5 million, compared to approximately $7.0 million for the three months ended September 30, 2023. The overall decrease was primarily a result of the conclusion of patient enrollment in our WM pivotal study having occurred earlier in the year, partially offset by increased activity in our ongoing pediatric trial and an increase in personnel.General and Administrative Expenses: G&A expenses for the three months ended September 30, 2024, were approximately $7.8 million, compared to approximately $2.4 million for the same period in 2023. The increase was primarily driven by costs associated with the development of infrastructure necessary to support commercialization upon anticipated NDA approval, including the related marketing and personnel cost. Conference Call & Webcast DetailsCellectar management will host a conference call and webcast today, November 18, 2024, 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, development, and commercialization 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 lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. 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 including our expectations regarding the CLOVER-WaM pivotal trial. 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 raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. 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/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended September 30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. MEDIA:Claire LaCagninaBliss Bio Health315-765-1462clacagnina@blissbiohealth.com INVESTORS:Anne Marie FieldsPrecision AQ212-362-1200annemarie.fields@precisionaq.com +++ TABLES TO FOLLOW +++ CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited) September 30, December 31, 2024 2023 ASSETS CURRENT ASSETS: Cash and cash equivalents $34,263,371 $9,564,988 Prepaid expenses and other current assets 1,635,818 888,225 Total current assets 35,899,189 10,453,213 Property, plant & equipment, net 910,131 1,090,304 Operating lease right-of-use asset 454,166 502,283 Other long-term assets 29,780 29,780 TOTAL ASSETS $37,293,266 $12,075,580 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) CURRENT LIABILITIES: Accounts payable and accrued liabilities $8,304,311 $9,178,645 Warrant liability 11,929,242 16,120,898 Lease liability, current 80,821 58,979 Total current liabilities 20,314,374 25,358,522 Long-term lease liability, net of current portion 431,929 494,003 TOTAL LIABILITIES 20,746,303 25,852,525 COMMITMENTS AND CONTINGENCIES MEZZANINE EQUITY: Series D preferred stock, 111.11 shares authorized, issued and outstanding as of September 30, 2024 and December 31, 2023 1,382,023 1,382,023 STOCKHOLDERS’ EQUITY (DEFICIT): Series E-2 preferred stock, 1,225.00 shares authorized; 149.60 and 319.76 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 2,188,434 4,677,632 Series E-3 preferred stock, 2,205.00 shares authorized; 202.50 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 4,369,317 — Series E-4 preferred stock, 1,610.00 shares authorized; 714.00 and 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 7,057,793 — Common stock, $0.00001 par value; 170,000,000 shares authorized; 40,566,534 and 20,744,110 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 406 207 Additional paid-in capital 246,536,080 182,924,210 Accumulated deficit (244,987,090) (202,761,017)Total stockholders’ equity (deficit) 15,164,940 (15,158,968)TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) $37,293,266 $12,075,580 CELLECTAR BIOSCIENCES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 OPERATING EXPENSES: Research and development $5,493,496 $7,034,656 $19,927,019 $19,528,898 General and administrative 7,834,181 2,378,804 19,105,853 6,883,866 Total operating expenses 13,327,677 9,413,460 39,032,872 26,412,764 LOSS FROM OPERATIONS (13,327,677) (9,413,460) (39,032,872) (26,412,764) OTHER INCOME (EXPENSE): Warrant issuance expense (7,743,284) (470,000) (7,743,284) (470,000)Gain (loss) on valuation of warrants 6,088,355 (7,688,028) 3,583,440 (8,254,649)Interest income 317,887 51,110 966,643 247,925 Total other income (expense) (1,337,042) (8,106,918) (3,193,201) (8,476,724)NET LOSS $(14,664,719) $(17,520,378) (42,226,073) $(34,889,488)NET LOSS PER SHARE — BASIC $(0.37) $(1.55) (1.21) $(3.09)NET LOSS PER SHARE — DILUTED $(0.40) $(1.55) (1.39) $(3.09)WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC 39,335,924 11,308,738 34,850,441 11,277,231 WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED 39,794,220 11,308,738 35,545,500 11,277,231

Clinical ResultASHPhase 2Financial StatementOrphan Drug

12 Nov 2024

·www.globenewswire.com

Cellectar Biosciences and SpectronRx Partner to Manufacture Novel Phospholipid Radioconjugate for the Treatment of Cancer

Cellectar broadens global manufacturing network in preparation for potential commercialization of Iopofosine I 131 in 2025INDIANAPOLIS 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 network, ensuring patients with advanced cancers in need of novel therapeutic options gain access to what we believe is a best-in-class treatment for Waldenstrom's macroglobulinemia (WM). This partnership is part of our multi-sourced global supply strategy, which is key for Cellectar’s commercialization plans for iopofosine I 131," said James Caruso, president and CEO of Cellectar. "SpectronRx's expertise and strategically located facilities offer significant logistical benefits for global market distribution while expanding our manufacturing capabilities for iopofosine I 131.” SpectronRx will utilize its state-of-the-art facilities in Indiana and Belgium to produce iopofosine I 131, a promising therapeutic that has shown impressive efficacy, surpassing primary and secondary endpoints in the CLOVER-WaM pivotal study for patients with relapsed or refractory WM with a planned New Drug Application submission in the near term. Furthermore, iopofosine I 131 is under evaluation in Phase 2 studies for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, alongside the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas. John Zehner, CEO of SpectronRx, expressed enthusiasm about the collaboration, stating, "Our partnership with Cellectar aligns with our commitment to support innovative radiopharmaceutical developers in delivering life-changing treatments globally. By integrating our advanced manufacturing capabilities with Cellectar's groundbreaking therapies, we are poised to address the unmet needs of cancer patients worldwide." Iopofosine I-131 is still investigational and not yet approved. The FDA has granted it Orphan Drug and Fast Track Designations for various cancer indications. For more information about Cellectar, please visit Cellectar.com. To learn more about SpectronRx, visit SpectronRx.com. About SpectronRx SpectronRx is a diagnostic and therapeutic radiopharmaceutical developer and manufacturer with three distinct specialties: Radiopharmaceutical Contract Development (RCDMO), Radiopharmaceutical Contract Manufacturing (RCMO), and Isotope Production. The company performs all scales of development, from initial conjugations through scale-up and commercial distribution. It also has the capacity to run clinical trials. Additionally, SpectronRx's deep industry knowledge, technical prowess and state-of-the-art facilities enable the company to significantly condense the timeline for bringing new medicines to market, which has the dual benefit of saving lives and driving greater profitability for clients. With a large staff of radiochemists, radiopharmacists, scientists and engineers, dozens of qualified clean rooms, and over 200,000 sq. ft. of production space in Indiana, with additional facilities in Danbury, Connecticut and Europe, SpectronRx now supplies therapeutic and diagnostic radiopharmaceuticals to 29 countries. The company has been EMA and FDA inspected and can produce and procure any currently used radioisotopes, including actinium-225. For more information visit SpectronRx.com, or follow the company on LinkedIn. About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of novel 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 ConjugateTM (PDCTM) 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 lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, 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 including our expectations regarding the CLOVER WaM pivotal trial. 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 raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. 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/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended June 30, 2024. 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 MEDIA: Christy MaginnBliss Bio Health 703-297-7194 cmaginn@blissbiohealth.com INVESTORS:Anne Marie FieldsPrecision AQ (formerly Stern IR)annemarie.fields@precisionaq.com

Phase 1License out/inOrphan DrugFast TrackPhase 2

100 Deals associated with CLR-131

External Link

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-	-	-	DB15244

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Lymphocytic Leukemia	Phase 2	US	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	AU	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	BR	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	CZ	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	FI	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	FR	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	GR	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	IL	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	ES	Cellectar Biosciences, Inc.	26 Jul 2017
Chronic Lymphocytic Leukemia	Phase 2	TR	Cellectar Biosciences, Inc.	26 Jul 2017

Clinical Result

Indication

Phase

Evaluation

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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	pkzonsdwlt(gsrlacnwlf) = occurred in 1 patient due to bacterial sepsis guoxvmqbfk (uhdodhwmnz ) View more	Positive	09 Dec 2024
NCT02952508 (CLOVER-WaM, Corporate Publications) Manual	Phase 2	Waldenstrom Macroglobulinemia	50	Iopofosine I 131	pnqpdnixuu(xzfkquevdl) = bdmbrrcqlx rznvbywvac (ohqvnjtzbt, 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)	timiautfhq(tejzzwrdtw) = cwhvgqtyse mshmclkgku (jqfrhzezgc ) 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	lrnebltkuk(hdajincmnh) = anaemia (66%) kqfikwzlpf (qufgjlrjnk ) View more	-	28 May 2021
NCT02952508 (ESMO2019) Manual	Phase 2	Diffuse large B-cell lymphoma recurrent	6	CLR-131	gwlzsfmdns(cuhbkwfhya) = chrgcpirau zpnsrxkoji (vaotleodrw ) View more	Positive	28 Sep 2019
AACR2018	Phase 2	-	-	Fractionated injections of CLR 131	knbsersqjl(sgubxvuvho) = vpprikjrhb ngnurawcwr (gyfkwiglpb )	-	01 Jul 2018
AACR2018	Phase 2	-	-	Standard dosing of bortezomid	knbsersqjl(sgubxvuvho) = rpjhurcqbr ngnurawcwr (gyfkwiglpb )	-	01 Jul 2018
NCT01540513 (CTgov)	Not Applicable	Glioblastoma Multiforme \| Brain metastases	12	NM404	wqdpttxgao(ihdtgiaxgm) = asoxiauymz qhotoulvuy (sxzyznlbcm, awbbmvkkws - dkwsztgmwn) View more	-	11 Dec 2017
NCT02278315 (ASH2016) Manual	Phase 1	Multiple Myeloma	8	dexamethasone+I-131-CLR1404	cvhowytsaz(koepqobnlf) = srqzulshbj gfinolizsb (jxuywjtmjd )	Positive	02 Dec 2016
NCT02278315 (ASH2016) Manual	Phase 1	Multiple Myeloma	8	dexamethasone+I-131-CLR1404	zrnbrhguvn(wcasnrsbep) = zdckmwhueh budeiphkgy (vxtxrxvzff ) View more	Positive	02 Dec 2016
NCT00925275 (Pubmed \| J Biol Chem)	Phase 1	Advanced Malignant Solid Neoplasm	8	131I-CLR1404	hfaeyzywnx(ffjtodmrvb) = zudqkivobb iwtarlecgf (rqkegqefxj ) View more	-	01 Jan 2014
AACR2013	Not Applicable	Squamous Cell Carcinoma of Head and Neck	-	131I-CLR1404	izottouxcy(wfwttfhyyn) = pnjwqqvjot sddcfqgezg (djwsbfvpsd ) View more	-	15 Apr 2013

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