iopofosine I-131 (CLR 131) / Cellectar - LARVOL DELTA

Cellectar Biosciences Reports Third Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Raised approximately $12.7 million. These funds will be used to advance the Company’s TNBC study and to complete the EMA Conditional Marketing Authorization application for iopofosine I 131 for WM."

Financing • Triple Negative Breast Cancer • Waldenstrom Macroglobulinemia

Iopofosine I 131 in Previously Treated Patients with Waldenstrom Macroglobulinemia (WM): Efficacy and Safety Results from the International, Multicenter, Open-Label Phase 2 Study (CLOVER-WaM) (ASH 2024) - P2 | "The treatment was well-tolerated with a manageable toxicity profile across broad biologic and clinical subgroups, irrespective of risk stratification. Based on the results of this trial, iopofosine I 131 shows promise as a novel treatment for WM patients."

Clinical • P2 data • Anemia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Lymphoma • Lymphoplasmacytic Lymphoma • Neutropenia • Septic Shock • Thrombocytopenia • Waldenstrom Macroglobulinemia • CXCR4 • MYD88

Interim data from CLOVER-2...were highlighted in an oral presentation at the recent American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer that took place in late September 2025. (GlobeNewswire) - "...showed that all patients receiving a minimum of 55 mCi total administered dose (n=6) experienced an average of 5.4 months of PFS and 8.6 months of OS, ongoing. All patients experienced disease control, which according to the committee for the Response Assessment in Pediatric Neuro-Oncology (RAPNO) does correlate with survival benefit. Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response (ORR)."

P1 data • High Grade Glioma

Cellectar Biosciences Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Iopofosine I 131 in Relapsed or Refractory Pediatric High-Grade Glioma (GlobeNewswire)

FDA event • High Grade Glioma

Cellectar Biosciences, Inc…announced that…the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for a CMA. (GlobeNewswire) - "Cellectar’s briefing document to the SAWP included iopofosine I 131’s safety database, CLOVER WaM clinical study results, subset analyses, and manufacturing information...'we are rapidly proceeding toward a potential European approval and commercial availability in 2027'..."

EMA filing • Launch Europe • Waldenstrom Macroglobulinemia

The U.S. NDA will be submitted once the confirmatory trial is underway and will be supported by data from the Phase 2b CLOVER WaM clinical trial that demonstrated a statistically significant major response rate compared to a null hypothesis of 20% and meaningful duration of response. (GlobeNewswire) - "The data set now includes the FDA-requested 12-month follow-up results on all patients from the trial and new subset analysis of data from patients immediately following BTKi treatment failures regardless of line of therapy."

FDA filing • Waldenstrom Macroglobulinemia

The Optimal Management of Waldenström Macroglobulinemia (SOHO 2025) - "Standard treatment options include alkylating agents (eg, bend-amustine or cyclophosphamide) or proteasome inhibitors (eg, bortezomib, carfilzomib, or ixazomib) in combination with anti-CD20 monoclonal antibody rituximab, covalent Bruton tyrosine kinase (BKT) inhibitors (eg ibrutinib, acalabrutinib, or zanubrutinib), BCL2 antagonists (eg, venetoclax), and non-covalent BTK inhibitors (eg, pirtobrutinib) 13–23...The combination of bendamustine and rituximab showed superior progression-free survival (PFS) to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in a study by the STiL group 13...The all-oral, non-chemo, fixed-duration combination of pirtobrutinib and venetoclax has shown promise in early relapse 29.Inlate relapse, multiple agents are under active development, including second-generation BCL2 antagonists (eg, sonrotoclax), BTK degraders (eg, BGB-16673 30, NX-5948), conjugated radioisotopes (eg, iopofosine I-131 31), antibody-drug conjugates..."

IO biomarker • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia • B2M • BCL2 • CXCR4 • MYD88 • TP53

Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit (GlobeNewswire) - "Provided data to EMA data from the Phase 2b CLOVER WaM clinical trial....Initiation of Phase 1b Dose Finding study of the company’s Auger-emitting radiopharmaceutical, CLR 125, for the treatment of relapsed triple-negative breast cancer (TNBC), planned for the fourth quarter 2025."

New P1 trial • Trial status • Triple Negative Breast Cancer • Waldenstrom Macroglobulinemia

Cellectar to Submit NDA for Iopofosine I-131 in WM by Early 2026, Focuses on Accelerated Approval (AInvest) - "The submission will be supported by data from the Phase 2b CLOVER WaM clinical trial. The company is also working with the European Medicines Agency (EMA) towards a potential submission for conditional approval in the EU. The EMA expects to make a decision late in the third quarter or early in the fourth quarter of 2025."

EMA approval • FDA filing • Waldenstrom Macroglobulinemia

Cellectar Biosciences to Present Data in Oral Session and Panel Discussions at the American Association for Cancer Research Special Conference on Discovery and Innovation in Pediatric Cancer (GlobeNewswire) - "The oral presentation will highlight interim data from the Phase 1b dose and regimen optimization study of iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG)."

P1 data • Glioma

Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring (GlobeNewswire) - "Due to recent communications with the...FDA...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....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 PFS....The Company will now focus its resources on targeting solid tumors by advancing CLR 121225...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."

FDA event • IND • Pipeline update • Hematological Malignancies • Oncology • Solid Tumor

Cellectar Biosciences Provides Update on CLOVER-2 Phase 1 Clinical Trial of Iopofosine I 131 in Pediatric Patients with Relapsed/Refractory High-Grade Glioma (GlobeNewswire) - P1 | N=30 | CLOVER-2 (NCT03478462) | Sponsor: Cellectar Biosciences, Inc. | "The patients enrolled in CLOVER-2 with pHGG (n=14) were diagnosed with diffuse midline gliomas (DMG), ependymomas, diffuse intrinsic pontine gliomas (DIPG), diffuse hemispheric gliomas (DHG) and anaplastic ependymomas....All patients receiving a minimum of 55 mCi total administered dose (n=7) experienced an average of 5.4 months of PFS and 8.6 months of OS, ongoing. All patients experienced disease control, which according to the committee for the Response Assessment in Pediatric Neuro-Oncology (RAPNO) does correlate with survival benefit. Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response (ORR)."

P1 data • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioma

Cellectar Granted U.S. FDA Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia (WM) (GlobeNewswire) - "Cellectar Biosciences, Inc...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)....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."

Breakthrough therapy • European regulatory • Waldenstrom Macroglobulinemia

Cellectar Biosciences Reports First Quarter 2025 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Company Seeking Conditional Approval from European Medicines Agency (EMA) for Iopofosine I 131 in Waldenstrom Macroglobulinemia based upon CLOVER WaM Phase 2 Study Data....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."

EMA approval • P2 data • Waldenstrom Macroglobulinemia

CLOVER-WaM: Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Cellectar Biosciences, Inc. | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial primary completion date • B Cell Lymphoma • Chronic Lymphocytic Leukemia • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

Dose Escalation Study of CLR 131 in Children, Adolescents, and Young Adults With Relapsed or Refractory Malignant Tumors Including But Not Limited to Neuroblastoma, Rhabdomyosarcoma, Ewings Sarcoma, and Osteosarcoma (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Cellectar Biosciences, Inc. | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Sep 2022 ➔ Dec 2025

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Ewing Sarcoma • Glioma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Neuroblastoma • Oncology • Osteosarcoma • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor • CD34

Novel Targeted Radiotherapy in Pediatric Patients With Inoperable Relapsed or Refractory HGG (clinicaltrials.gov) - P1 | N=50 | Active, not recruiting | Sponsor: Cellectar Biosciences, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • CNS Tumor • Glioma • Malignant Glioma • Oncology • Pediatrics • Solid Tumor • CD34

Cellectar Biosciences to Highlight 2025 Strategic Initiatives at Upcoming Biotech Showcase during the JP Morgan Healthcare Conference (GlobeNewswire) - "Iopofosine I 131 (iopofosine) is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy....The Company expects the confirmatory study to be a comparator, randomized controlled study with 40-60 patients per arm and full patient enrollment projected within 18 months of the first patient admitted to the study. The Company anticipates alignment with the FDA in the first half of 2025."

New trial • Hematological Malignancies

Cellectar Biosciences to Highlight 2025 Strategic Initiatives at Upcoming Biotech Showcase during the JP Morgan Healthcare Conference (GlobeNewswire) - P2 | N=120 | CLOVER-WaM (NCT02952508) | Sponsor: Cellectar Biosciences, Inc. | "Iopofosine I 131 (iopofosine) is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The CLOVER-WaM study (NCT02952508) results demonstrated an 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. These data 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."

P2 data • Waldenstrom Macroglobulinemia

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. (PubMed, EBioMedicine) - P1 | "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."

Journal • Metastases • P1 data • Head and Neck Cancer • Leukopenia • Oncology • Solid Tumor • Thrombocytopenia

Cellectar Biosciences Reports Financial Results for Q3 2024 and Provides a Corporate Update (GlobeNewswire) - "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."

Financing • Waldenstrom Macroglobulinemia

Phase 1 Dose Finding Study Evaluating the Safety, Tolerability, and Efficacy of Iopofosine I 131 in Children, Adolescents, and Young Adults With Inoperable Relapsed or Refractory High-Grade Gliomas: A Trial-in-Progress (SNO 2024) - P1 | "Efficacy analyses use the Response Assessment in Pediatric Neuro-Oncology criteria and the Kaplan-Meier method to detect a median PFS of 5 months compared to a historical control of 2 months. For 90% power by a 1-sided, 1-sample log-rank test: ≥10 evaluable patients must be enrolled (≤90) across ≤15 sites."

Clinical • P1 data • Brain Cancer • CNS Tumor • Ependymoma • Glioma • Malignant Glioma • Oncology • Pediatrics • Solid Tumor

Cellectar Biosciences and SpectronRx Partner to Manufacture Novel Phospholipid Radioconjugate for the Treatment of Cancer (GlobeNewswire) - "SpectronRx...have signed a commercial supply agreement for the manufacture of Cellectar’s first-in-class cancer therapy, iopofosine I 131...SpectronRx will utilize its state-of-the-art facilities in Indiana and Belgium to produce iopofosine I 131."

Commercial • B Cell Lymphoma • CNS Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

Cellectar Selected to Present New Data from Phase 2 CLOVER-WaM Study in Oral Session at ASH 2024 (GlobeNewswire) - "Cellectar Biosciences, Inc...announced that new data from the company’s open-label Phase 2 CLOVER-WaM study of iopofosine I 131 as a potential treatment for Waldenstrom’s macroglobulinemia (WM) will be highlighted in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition (ASH 2024) taking place from December 7–10, 2024, in San Diego, California."

P2 data • Waldenstrom Macroglobulinemia

CLOVER-WaM: Study of Iopofosine I 131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) and Pivotal Expansion in Waldenstrom Macroglobulinemia (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Cellectar Biosciences, Inc. | Trial completion date: Jun 2025 ➔ Dec 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Chronic Lymphocytic Leukemia • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia