Annuncio • May 19
Cellectar Biosciences, Inc., Annual General Meeting, Jul 07, 2026 Cellectar Biosciences, Inc., Annual General Meeting, Jul 07, 2026. Annuncio • May 11
Cellectar Biosciences, Inc. to Report Q1, 2026 Results on May 14, 2026 Cellectar Biosciences, Inc. announced that they will report Q1, 2026 results Pre-Market on May 14, 2026 Annuncio • May 06
Cellectar Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $4.28784 million. Cellectar Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $4.28784 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,618,053
Price\Range: $2.65
Discount Per Security: $0.212
Transaction Features: Registered Direct Offering Annuncio • Apr 23
Cellectar Biosciences Announces Subset Of Clover Clinical Trial Data Accepted For Presentation At American Society Of Clinical Oncology Conference Cellectar Biosciences, Inc. announced the acceptance of an abstract for poster presentation at the American Society of Clinical Oncology Annual Meeting taking place May 29 - June 2 in Chicago, Illinois. Details of the poster presentation are as follows: Title: “Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM subgroup efficacy and safety” Poster: 592 Date/Time: June 1, 2026, 9:00 AM-12:00 PM CDT Presenter: Jarrod Longcor. Waldenstrom’s Macroglobulinemia (WM) is a B-cell malignancy characterized by bone marrow infiltration with clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM) that remains incurable with available treatments. The prevalence in the US is approximately 26,000 with 1,500–1,900 patients being diagnosed annually. Approximately 11,500 patients require treatment in the relapsed or refractory setting and there are an estimated 4,700 patients requiring third line or greater therapy. There are also approximately 1,000 patients that have exhausted all current treatment options by third line because they are ineligible or intolerant to those existing therapies. Therefore, the total addressable market for third line or greater therapy is approximately 5,700 patients. There are no U.S. Food and Drug Administration (FDA) approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment. Non-FDA approved treatments are used in more than 60% of patients. Over 50% of patients are treated with the same or similar treatment from prior lines of therapy. There is an established unmet need for new FDA-approved treatment like iopofosine I 131 that provide a novel mechanism of action, increased deep durable responses, and time limited treatment, especially in heavily pretreated WM patients. The company’s product pipeline includes iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been tested in Phase 2b trials as a treatment for relapsed or refractory Waldenström Macroglobulinemia (WM), in relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in 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 granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation. Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth. In addition to these assets, the Cellectar team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. Annuncio • Apr 15
Cellectar Biosciences Enrolls First Patient in Clr 125 Auger-Emitting Radioconjugate Phase 1B Clinical Trial Targeting Refractory Triple Negative Breast Cancer Cellectar Biosciences, Inc. announced that the first patient has been enrolled in the Phase 1b trial of CLR 121125 (CLR 125) for the potential treatment of triple negative breast cancer (TNBC). CLR 125 is Cellectar’s proprietary Auger-emitting radioconjugate incorporating iodine-125 to achieve intracellular delivery and direct DNA-level damage in tumor cells. The molecular structure of CLR 125 is identical to that of iopofosine I 131 (CLR 131) and the demonstrated clinical activity, safety, and tumor-targeting characteristics of iopofosine I 131 provide important validation of the platform and support translational relevance. However, these radioconjugates differ in their radiobiologic behavior at the tumor level, resulting in distinct mechanisms of action and therapeutic profiles. In preclinical studies, CLR 125 showed selective tumor uptake and statistically significant activity in vivo models of TNBC with no observed end-organ or hematologic toxicity at evaluated doses. The Phase 1b clinical trial is an open-label, dose-escalation study in patients with relapsed or refractory TNBC, designed to evaluate three dose levels and dosing regimens of CLR 125 (32.75 mCi administered over 4 cycles, 62.5 mCi over 3 cycles, and 95 mCi over 2 cycles), with approximately 15 patients enrolled per treatment arm. The study incorporates imaging-based assessments to characterize tumor uptake and biodistribution, supporting prediction of safety and therapeutic activity. Clinical endpoints include safety and tolerability, as well as preliminary efficacy measures, including tumor response per RECIST criteria and progression-free survival. Price Target Changed • Mar 12
Price target decreased by 29% to US$33.33 Down from US$47.00, the current price target is an average from 3 analysts. New target price is 932% above last closing price of US$3.23. Stock is down 64% over the past year. The company is forecast to post a net loss per share of US$4.20 next year compared to a net loss per share of US$8.35 last year. Annuncio • Feb 25
Cellectar Biosciences, Inc. to Report Fiscal Year 2025 Results on Mar 04, 2026 Cellectar Biosciences, Inc. announced that they will report fiscal year 2025 results at 9:30 AM, US Eastern Standard Time on Mar 04, 2026 Annuncio • Feb 17
Cellectar Biosciences Expands Global Intellectual Property Estate Cellectar Biosciences, Inc. announced a broad expansion of its global intellectual property (IP) estate, including newly issued patents across Europe, Asia-Pacific, the Middle East, and the Americas. These additions strengthen the company's protection around iopofosine I 131, its proprietary radiotherapeutic, as well as its broader portfolio, including CLR 125, the company's Auger-emitting radiopharmaceutical in development as a treatment for triple negative breast cancer. Newly issued in Europe, China, Israel, Eurasia, and New Zealand. Fractionated Dosing of a Phospholipid Ether Analog for the Treatment of Cancer Covers proprietary iopofosine I131 dosing regimens. Newly issued in Eurasia, Israel, Turkey, Mexico, and Canada. Annuncio • Nov 06
Cellectar Biosciences, Inc. to Report Q3, 2025 Results on Nov 13, 2025 Cellectar Biosciences, Inc. announced that they will report Q3, 2025 results at 8:30 AM, US Eastern Standard Time on Nov 13, 2025 Annuncio • Oct 28
Cellectar Biosciences, Inc. Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Iopofosine I 131 in Relapsed or Refractory Pediatric High-Grade Glioma Cellectar Biosciences, Inc. announced the U.S. Food and Drug Administration (FDA) has granted rare pediatric drug designation (RPDD) for iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG). Iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The FDA previously granted Orphan Drug Designation for iopofosineI 131 for the treatment of pHGG. The FDA's Rare Pediatric Disease Designation program is intended to encourage the development of new therapies for serious and life-threatening diseases that primarily affect individuals under 18 years of age. If a New Drug Application (NDA) for iop ofosine I 131 is approved, upon reauthorization of the program Cellectar may be eligible to receive a Priority Review Voucher (PRV), which can significantly expedite the review process for future New Drug Applications or Biologic License Applications, may be redeemed to receive priority review for another marketing application or may be sold or transferred. Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively. While MRI measures of tumor volume change can be helpful and are used as a surrogate in clinical trials, they often fail to predict survival. The Phase 1b trial of iopofosine I131 consists of children, adolescents and young adults with r/r pHGG at multiple sites in the United States and Canada. Annuncio • Oct 14
Cellectar Biosciences Presents Positive Preclinical Data in Poster Presentation At the American Association for Cancer Research Special Conference on Pancreatic Cancer Research Cellectar Biosciences, Inc. announced that Jarrod Longcor, chief operating officer of Cellectar, presented positive preclinical data in a poster at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer Research that took place from September 28 through October 1, 2025, in Boston, Massachusetts. The poster highlighted preclinical data from CLR 121225 (CLR 225), the Company's novel actinium-based radio conjugate alpha-emitter for treatment in pancreatic ductal adenocarcinoma (PDAC). CLR 225 has completed Investigational New Drug (IND)-enabling studies, and the company maintains the option to advance into a Phase 1 study. Additional pharmacokinetic studies showed excellent biodistribution of CLR 225, indicating predictable behavior with dose linearity, which can assist with future estimation of a likely efficacious dose. Furthermore, in preparation for Phase 1 first-in-human studies, the poster presented data on CLR 225 in various GLP toxicity studies where no toxicities to the compound were noted. Annuncio • Oct 07
Cellectar Biosciences Announces Iopofosine I 131 as A Treatment for Refractory (Post-Btki) Waldenstrom Macroglobulinemia (Wm) Cellectar Biosciences, Inc. announced that after a scientific advice procedure, the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) foriopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for a CMA. Cellectar's briefing document to the SAWP included iopofosine I 131's safety database, CLOVER WaM clinical study results, subset analyses, and manufacturing information. 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). 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. 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. 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. The U.S. FDA has granted iopofosine I131 Breakthrough Therapy, Fast Track and Orphan Drug Designations for the treatment of r/r WM. PRIME provides early and proactive engagement with developers to optimize clinical development plans and accelerate regulatory review, helping promising therapies reach patients sooner. Products granted PRIME status benefit from enhanced scientific advice, dedicated EMA support, and eligibility for accelerated assessment at the time of marketing authorization application. There are no U.S. Food and Drug Administration (FDA) approved treatment options for patients pro gressing on BTKi therapy. Non-FDA approved treatments are used in more than 60% of patients. There is an established unmet need for new FDA-approved treatment like iopofosine I 132 that provide a novel mechanism of action, increased deep durable responses, and time limited treatment, especially in heavily pretreated WM patients. 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. In addition, iopofosine I 130 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. Annuncio • Oct 01
Cellectar Biosciences, Inc. Presents Compelling Data in Oral Session and Panel Discussions at the American Association for Cancer Research Special Conference on Discovery and Innovation in Pediatric Cancer Cellectar Biosciences, Inc. announced that Jarrod Longcor, chief operating officer of Cellectar, delivered an oral presentation followed by a 55-minute panel discussion with other experts in the field at the American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer that took place September 25-28 in Boston, Massachusetts. The oral presentation highlighted 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). Iopofosine I 131 is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The U.S. Food and Drug Administration (FDA) previously granted Rare Pediatric Drug and Orphan Drug Designations for iopofosine I 131 for the treatment of pHGG. Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. 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. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with r/r pHGG is poor; approximately 2.25 months and 5.6 months, respectively. The interim data were delivered by Mr. Longcor in an oral presentation titled, “Precision Radiotherapy for Incurable Brain Tumors: Phase 1b Dose & Regimen Optimization Study of Iopofosine I 131 in Inoperable Relapsed or Refractory Pediatric High-Grade Glioma, Interim Data Assessment.” All patients receiving a minimum of 55 mCi total administered dose (n=7) and evaluable (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). Two case studies were highlighted in the oral presentation. Case Study 1 showed a 25-year-old male with diffuse hemispheric glioma with the H3 G34R/V mutation who had three prior therapies and who received a total administered dose of 126.6mCi of iopofosine I 131 over four doses (40mCi/m/dose) had his target lesion reduced by more than 50% approximately eight months post screening. This patient had PFS of 10.9 months and survival is ongoing at greater than 18 months as of July 25, 2025.Case Study 2 showed a 15-year-old female with ependymoma who had eight prior therapies and who received a total administered dose of 58.9mCi of iopofosine I 131 over four doses (20mCi/m/dose) had her target lesion reduced from 252mm to approximately 141mm. This patient had PFS of 11.2 months and her ongoing survival was greater than 17 months as of July 22, 2025. Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company's previously reported safety data. Importantly, patients in the study treated with iopofosine I 131 did not experience any cardiovascular, renal, or liver toxicities, peripheral neuropathy or significant bleeding. The safety profile was consistent with selective targeting of tumor sites with clinically negligible off-target effect outside the hematologic system. The most frequently reported treatment-emergent adverse events were hematologic in nature (thrombocytopenia, neutropenia and anemia) and were predictable and manageable. No treatment-related deaths were reported. Annuncio • Sep 10
Cellectar Biosciences, Inc. to Participate At Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit Cellectar Biosciences, Inc. announced that Company management will participate at the upcoming Oppenheimer 3rd Annual Targeted Radiopharmaceuticals in Oncology Summit taking place on September 11, 2025, in New York City. While participating at this radiopharmaceutical therapy summit, Cellectar management will be meeting with investors and discussing the Company's progress in recent months and future plans, including, among other topics: Progress with the European Medicines Agency's (EMA) regarding scientific advice on the company's continued preparation for a potential Conditional Market Authorization (CMA) submission. provided data to EMA data from the Phase 2b CLOVER WaM clinical trial where the company observed a statistically significant major response rate, meaningful duration of response and integrated summary of safety for all patients treated with iopofosine I 131 for hematologic malignancies. A follow-up meeting with the EMA was completed and a final decision from the EMA on their recommendation whether to submit for a CMA is expected in late third quarter or early fourth quarter 2025. Plans to pursue a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the accelerated approval of iopofosine I131 as a treatment for Waldenstrom's Macroglobulinemia (WM), subject to raising sufficient additional funding and once the confirmatory trial is underway. The submission would be supported by data from the Phase 2bCLOVER WaM clinical trial demonstrating a statistically significant major response rate compared to a null hypothesis of 20% and meaningful duration of response. 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 Bruton Tyrosine Kinase inhibitor (BTKi) treatment failures regardless of line of therapy. The Company plans to share these new data at an upcoming medical or scientific conference. Annuncio • Aug 28
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 Cellectar Biosciences, Inc. announced the acceptance of an abstract for oral presentation followed by a 55-minute panel discussion with other experts in this area at the American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer taking place September 25-28 in Boston, Massachusetts. 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). The patients enrolled in CLOVER-2 with pHGG (n=14) were diagnosed with diffuse midline gliomas (DMG), independentymomas, diffuse intrinsic pontine gliomas (DIPG), diffuse hemispheric gliomas (DHG) and anaplastic independentymomas. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively. While MRI measures of tumor volume change can be helpful and are used as a surrogate in clinical trials, they often fail to predict survival. The ongoing Phase 1b trial of iopofosineI 131 consists of children, adolescents and young adults with r/r pHGG at multiple sites in the United States and Canada. New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$35m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$35m free cash flow). Share price has been highly volatile over the past 3 months (25% average weekly change). Shareholders have been substantially diluted in the past year (167% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$18m net loss in 3 years). Market cap is less than US$100m (US$14.1m market cap). Annuncio • Aug 08
Cellectar Biosciences, Inc. to Report Q2, 2025 Results on Aug 14, 2025 Cellectar Biosciences, Inc. announced that they will report Q2, 2025 results at 8:30 AM, US Eastern Standard Time on Aug 14, 2025 Annuncio • Jul 03
Cellectar Biosciences, Inc. has completed a Composite Units Offering in the amount of $5.999997 million. Cellectar Biosciences, Inc. has completed a Composite Units Offering in the amount of $5.999997 million.
Security Name: Class A Units
Security Type: Equity/Derivative Unit
Securities Offered: 865,000
Price\Range: $5
Discount Per Security: $0.4
Security Name: Class B Units
Security Type: Equity/Derivative Unit
Securities Offered: 335,000
Price\Range: $4.99999
Discount Per Security: $0.4 New Risk • Jul 02
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$8.81m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$8.81m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Annuncio • Jun 24
Cellectar Biosciences Submits Phase 1b Clinical Trial Protocol to US Food and Drug Administration for CLR 125 to Treat Triple-Negative Breast Cancer (TNBC) Cellectar Biosciences, Inc. announced that the company has submitted a protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1b Dose Finding study of its Auger emitting radiopharmaceutical, CLR 125, for the treatment of relapsed TNBC. CLR 125 is an iodine-125 Auger-emitting drug candidate targeting solid tumors, such as triple negative breast, lung and colorectal cancers. In the U.S., approximately 12% of breast cancer diagnoses are TNBC. Studies suggest that approximately 25% (40,540) of TNBC cases relapse after standard treatments like surgery, chemotherapy, and radiation.2 Due to its high recurrence rate and poor prognosis, there is a critical need for innovative, targeted therapies to improve outcomes for patients facing this difficult diagnosis. New Risk • Jun 22
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 52% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (24% average weekly change). Shareholders have been substantially diluted in the past year (52% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$28m net loss in 3 years). Market cap is less than US$100m (US$15.9m market cap). Annuncio • Jun 11
Cellectar Biosciences Provides Update on Clover-2 Phase 1 Clinical Trial of Iopofosine I 131 in Pediatric Patients with Relapsed/Refractory High-Grade Glioma Cellectar Biosciences, Inc. announced initial results as of June 10, 2025, from the CLOVER-2 Phase 1 clinical trial evaluating iopofosine I 131 in relapsed/refractory pediatric high-grade glioma (pHGG) patients. Rare Pediatric Drug and Orphan Drug Designations for pHGG have previously been granted for iopofosine I 131. Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. 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. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively. While MRI measures of tumor volume change can be helpful and are used as a surrogate in clinical trials, they often fail to predict survival. 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). Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company's previously reported safety data. Importantly, patients on iopofosine I 131 did not experience any cardiovascular, renal, or liver toxicities, and no peripheral neuropathy or significant bleeding. The safety profile was consistent with selective targeting of tumor sites with clinically negligible off-target effect outside the hematologic system. The most frequently reported treatment emergent adverse events were hematologic in nature (thrombocytopenia, neutropenia and anemia) and were predictable and manageable. All patients recovered from cytopenias. Price Target Changed • Jun 10
Price target decreased by 48% to US$4.00 Down from US$7.67, the current price target is an average from 2 analysts. New target price is 993% above last closing price of US$0.37. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$0.53 next year compared to a net loss per share of US$1.22 last year. Annuncio • Jun 05
Cellectar Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $2.5 million. Cellectar Biosciences, Inc. has filed a Follow-on Equity Offering in the amount of $2.5 million.
Security Name: Common Stock
Security Type: Common Stock Annuncio • Jun 04
Cellectar Biosciences, Inc. Grants U.S. Fda Breakthrough Therapy Designation for Iopofosine I 131 in Waldenstrom Macroglobulinemia 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). 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. 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 I131 Fast Track Designation and Orphan Drug Designation. The European Medicines Agency (EMA) granted Orphan Drug Designation to iopofosine I 130 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). 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. Annuncio • May 07
Cellectar Biosciences, Inc. to Report Q1, 2025 Results on May 13, 2025 Cellectar Biosciences, Inc. announced that they will report Q1, 2025 results on May 13, 2025 Annuncio • Apr 29
Cellectar Biosciences, Inc., Annual General Meeting, Jun 13, 2025 Cellectar Biosciences, Inc., Annual General Meeting, Jun 13, 2025. New Risk • Mar 13
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$48m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$48m free cash flow). Shareholders have been substantially diluted in the past year (51% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$14.6m market cap). Annuncio • Mar 05
Cellectar Biosciences, Inc. to Report Fiscal Year 2024 Results on Mar 13, 2025 Cellectar Biosciences, Inc. announced that they will report fiscal year 2024 results on Mar 13, 2025 Price Target Changed • Feb 13
Price target decreased by 26% to US$5.67 Down from US$7.67, the current price target is an average from 3 analysts. New target price is 1,917% above last closing price of US$0.28. Stock is down 92% over the past year. The company is forecast to post a net loss per share of US$1.57 next year compared to a net loss per share of US$3.50 last year. Board Change • Feb 13
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 3 highly experienced directors. Independent Director Asher Chanan-Khan was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • Feb 01
Cellectar Biosciences Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price On January 30, 2025, Cellectar Biosciences, Inc. (the Company") received notice from Nasdaq which indicated that under Nasdaq Listing Rule 5550(a)(2), the Company is required to maintain a minimum bid price for its common stock of $1.00 for continued listing. The notice does not have any immediate impact on the listing of the Company's stock on the Nasdaq exchange. The Company's common stock remains listed on the Nasdaq Capital Market. In accordance with the Nasdaq Listing Rules, the Company has 180 calendar days, or until July 29, 2025, to regain compliance with the bid price requirement. In the event the Company does not regain compliance within 180 calendar days, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If Nasdaq believes that the Company meets these requirements and can cure the deficiency, Nasdaq will inform the Company that it has been granted an additional 180 calendar days. There can be no assurance that the Company will attain compliance with continued listing requirements during any initial or extension period that Nasdaq may grant. If the Company is unable to regain compliance within any period granted by Nasdaq, then the result would be the issuance of a delisting determination. The Company would at that time have the option to request a hearing before a Nasdaq Hearings Panel to present its plan to regain compliance and to request a further extension period to regain compliance. The request for a hearing would stay any delisting action. Annuncio • Dec 11
Cellectar Biosciences Provides Strategic Update on Clinical Development, Pipeline Programs and Corporate Restructuring Cellectar Biosciences, Inc. announced 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 ofiopofosine 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). 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. Annuncio • Nov 14
Cellectar Biosciences, Inc. announced delayed 10-Q filing On 11/13/2024, Cellectar Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Annuncio • Nov 12
Cellectar Biosciences, Inc. to Report Q3, 2024 Results on Nov 18, 2024 Cellectar Biosciences, Inc. announced that they will report Q3, 2024 results on Nov 18, 2024 Annuncio • Nov 08
Cellectar Biosciences, Inc. to Present New Data from Phase 2 CLOVER -WaM Study in Oral Session at ASH 2024 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. Cellectar's lead product candidate, iopofosine I 131, is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate. This highlights the need for novel class therapies for an often-overlooked patient population affected by this rare disease in which iopofosine I131 has the potential to establish itself as the standard-of-care for relapsed/refractory patients. Therefore, the total addressable market for third line or greater therapy is approximately 5,700 patients. There are no U.S. Food and Drug Administration (FDA) approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment. Non-FDA approved treatments are used in more than 60% of patients. Over 50% of patients are treated with the same or similar treatment from prior lines of therapy. There is an established unmet need for new FDA-approved treatment like Iopofosine I-131 that provide a novel mechanism of action, increased deep durable responses, and time limited treatment, especially in heavily pretreated WM patients. Annuncio • Nov 02
Cellectar Biosciences Regains Compliance with Nasdaq Listing Rule 5250(c)(1) Regarding Filing of Form 10-Q Cellectar Biosciences, Inc. announced it received a letter dated October 31, 2024, from Nasdaq, Inc. informing the Company that it had regained compliance with Nasdaq Listing Rule 5250(c)(1). The Company filed the following on October 29, 2024, with the Securities and Exchange Commission: (i) restated audited consolidated financial statements for the fiscal years ended December 31, 2023 and 2022 and restated quarterly financial statements for the periods ended March 31, 2023; June 30, 2023; September 30, 2023; March 31, 2022, June 30, 2022, and September 30, 2022 on Form 10-K/A; (ii) restated quarterly consolidated financial statements for the three months ended March 31, 2024 on Form 10-Q/A; and (iii) quarterly financial statements for the three and six months ended June 30, 2024 on Form 10-Q. The letter from Nasdaq noted that the matter is now closed. Annuncio • Aug 25
Cellectar Biosciences Announces Receipt of Expected Delinquency Notification Letter from Nasdaq Cellectar Biosciences, Inc. announced that the Company had received an expected delinquency notification letter (the Notice) from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (Nasdaq) on August 20, 2024. The Notice indicated that the Company is not in compliance with the periodic financial report filing requirement set forth in Nasdaq Listing Rule 5250(c)(1) as a result of the Company's delay in filing its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 (the Second Quarter 10-Q), by the applicable due date. The delay in filing the Second Quarter 10-Q is a result of the Company’s need to restate certain previously filed financial statements. As was previously reported on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) on August 9, 2024, after engaging Deloitte & Touche LLP as the Company’s independent registered accounting firm the Company determined that it was necessary to re-evaluate its accounting treatment for warrants issued as part of a financing completed in October 2022. The financial statement changes are all expected to be non-cash and non-operating. The Company expects to restate the previously issued (i) audited consolidated financial statements for the fiscal years ended December 31, 2023 and 2022, contained in its Annual Reports on Form 10-K and (ii) unaudited interim condensed consolidated financial statements for the periods ending March 31, 2023, June 30, 2023, September 30, 2023, and March 31, 2024, contained in its Quarterly Reports on Form 10-Q (the Previously Issued Statements). Restating and filing the Previously Issued Statements must be completed prior to filing the Second Quarter 10-Q. The Company has 60 calendar days, or until October 21, 2024, to submit a plan (Plan) to Nasdaq to regain compliance. If Nasdaq accepts the Plan, Nasdaq may grant an exception of up to 180 calendar days from the Form 10-Qs due date, or until February 17, 2025, to regain compliance. If Nasdaq does not accept the Plan, the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel. The Notice does not impact the Company’s listing of its common stock on The Nasdaq Capital Market at this time. The Company expects the process of restating and filing the Previously Issued Statements will require approximately six weeks to complete, immediately after which it expects to file its Second Quarter 10-Q. Annuncio • Aug 15
Cellectar Biosciences, Inc. announced delayed 10-Q filing On 08/14/2024, Cellectar Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Breakeven Date Change • Aug 13
No longer forecast to breakeven The 4 analysts covering Cellectar Biosciences no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$21.4m in 2026. New consensus forecast suggests the company will make a loss of US$12.4m in 2026. Annuncio • Aug 09
Cellectar Biosciences, Inc. to Report Q2, 2024 Results on Aug 13, 2024 Cellectar Biosciences, Inc. announced that they will report Q2, 2024 results on Aug 13, 2024 Annuncio • Jul 23
Cellectar Biosciences, Inc. Announces Positive Results Data from its Ongoing CLover WaM Pivotal Study Evaluating Iopofosine I 131 for the Treatment of Relapsed/Refractory Waldenstrom's Macroglobulinemia Cellectar Biosciences, Inc. announced positive results data from its ongoing CLOVER WaM pivotal study evaluating iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia ("WM") patients that have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors ("BTKi"). The data presented was as of an May 31, 2024 data cut. As of May 31, 2024, results in the CLOVER WaM study had an overall response rate ("ORR") of 80% and a major response rate ("MRR") of 56.4% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon primary endpoint of a 20% MRR. Median age was 70 years (range, 50-88) in the modified intent to treat ("mITT") population (n=55). The median number of prior lines of therapy was 4 (range, 2-14), with approximately 27% of patients refractory to all available therapies (BTKi, anti-CD20 antibody, chemotherapy), and 40% of patients dual-class refractory (BTKi and rituximab). CLOVER WaM is the first and largest WM study to date in a highly refractory patient population, including patients who are refractory to all available treatment categories. As of May 31, 2022, results in the CLOVERWaM study (NCT02952508) had an overall response rate (ORR) of 80% and a major Response rate (MRR) of 56.4% (95% CI, 0.42 To 0.67), which exceeded The agreed-upon primary endpoint of an 20% MRR. Median ages was 70 years (range,50-88) in the modified Intent to treat (mITT) population (n=55). Therefore, the total addressable market for 3 line or greater therapy is approximately 5,700 patients. There are no FDA approved treatment options for patients progressing on BTKi therapy. BTKi therapies do not demonstrate complete response rates and require continuous treatment. Approximately 50% of 3rd line patients not receiving treatment are likely to consider new treatment options because greater than 50% of patients are treated with the same or similar treatment from prior lines of therapy. Greater than 60% of treatments utilized are non-FDA approved therapies. There is an established unmet need for new FDA approved treatments that provide a novel mechanism of action, increased deep durable responses, and time limited treatment, especially in heavily pretreated WM patients. Board Change • Jul 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 3 highly experienced directors. Independent Director Asher Chanan-Khan was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Annuncio • May 09
Cellectar Biosciences, Inc. to Report Q1, 2024 Results on May 14, 2024 Cellectar Biosciences, Inc. announced that they will report Q1, 2024 results on May 14, 2024 Annuncio • Apr 28
Cellectar Biosciences, Inc., Annual General Meeting, Jun 14, 2024 Cellectar Biosciences, Inc., Annual General Meeting, Jun 14, 2024, at 10:00 US Eastern Standard Time. Agenda: To vote upon the election of two Class I directors named in this proxy statement; to approve an increase in the number of shares of common stock available for issuance under our 2021 Stock Incentive Plan by 7,000,000 shares; to ratify the appointment of Baker Tilly US, LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2024; to hold a non-binding advisory vote to approve named executive officer compensation; and to transact such other business as may properly come before the Annual Meeting. New Risk • Apr 19
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$98.1m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$33m free cash flow). Negative equity (-US$1.4m). Shareholders have been substantially diluted in the past year (231% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (11% average weekly change). Market cap is less than US$100m (US$98.1m market cap). New Risk • Mar 27
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$33m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$33m free cash flow). Negative equity (-US$1.4m). Shareholders have been substantially diluted in the past year (213% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$24m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Price Target Changed • Mar 27
Price target increased by 23% to US$14.75 Up from US$12.00, the current price target is an average from 4 analysts. New target price is 306% above last closing price of US$3.64. Stock is up 162% over the past year. The company is forecast to post a net loss per share of US$2.83 next year compared to a net loss per share of US$4.05 last year. Annuncio • Mar 21
Cellectar Biosciences, Inc. to Report Fiscal Year 2023 Results on Mar 27, 2024 Cellectar Biosciences, Inc. announced that they will report fiscal year 2023 results on Mar 27, 2024 Annuncio • Mar 05
Cellectar Biosciences, Inc. Reports High Rate of Complete Remission in Investigator Initiated Phase I Study of iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer Cellectar Biosciences, Inc. announced that iopofosine I 131 in combination with external beam radiation therapy (EBRT) was safe and tolerated in a SPORE Grant supported investigator-initiated Phase 1 clinical trial. The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%). The data were presented in a poster at the 2024 Multidisciplinary Head and Neck Cancers Symposium held February 29-March 2, 2024, in Phoenix, AZ. Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11). Prior to treatment with iopofosine I 131, six patients had multiple recurrence and one had metastatic disease both of which are indicative of poor outcomes. Additionally, the study demonstrated durability of tumor control with an overall survival of 67% and progression free survival of 42% at 12 months. The patients received two therapeutic doses of iopofosine I 131 at a fixed fractionated dose of 15.6 mCi/m2 (days 1 and 8) with SPECT/CT imaging performed to quantitate the biodistribution of iopofosine I 131. Patients subsequently received EBRT to complete the designated radiation dose outlined in the reirradiation plan, which was 60-70 Gray. Overall, eleven patients (92%) experienced a treatment-related adverse event. The most common treatment-related adverse events of any grade were thrombocytopenia (92%), lymphopenia (75%), neutropenia (75%), and anemia (92%). Observed adverse events were consistent with the known toxicity profile of iopofosine I 131, with cytopenias being the most common with all patients recovering. New Risk • Feb 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 224% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (224% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$3.2m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Annuncio • Jan 31
Cellectar Biosciences, Inc. Announces Enrollment of the First Patient in Pediatric High-Grade Gliomas Phase 1B Clinical Study Cellectar Biosciences, Inc. announced the first patient has been enrolled in its Phase 1b clinical trial evaluating iopofosine I 131, a novel phospholipid radiotherapeutic conjugate, in pediatric patients with relapsed or refractory malignant high-grade gliomas (pHGG). The open-label study (NCT05610891) will assess two dosing regimens to identify the optimal iopofosine I 131 Phase 2 recommended dose and schedule in pHGG patients and evaluate safety and tolerability. The study is supported by a $2 million Fast Track SBIR grant from the National Institute of Health’s National Cancer Institute (NCI), which was awarded based in part on the promising Phase 1a trial data. Pediatric high-grade gliomas are aggressive malignant tumors that form in the brain or spinal cord of children, adolescents, and young adults. Comprising a small but devastating portion of childhood cancers with an approximate incidence rate of 1,300 patients in the US (1.1-1.178 per 100,000 children), these tumors originate in the glial cells of the brain and spinal cord and are known for their rapid growth and resistance to conventional treatments. They are also responsible for over 40% of childhood brain tumor death and are the more common cause of tumor related death for children. The current standard of care for pediatric high-grade gliomas typically involves a combination of extensive brain surgery, radiation therapy, and chemotherapy at the time of initial diagnosis. However, the outcomes remain unsatisfactory for newly diagnosed patients and are dismal for relapsed or progressive disease. The five-year overall survival rate for high-grade gliomas in children is less than 20% and limited improvements were seen over the years. The disease's aggressive clinical nature and inherent genomic resistance often leads to significant challenges in achieving long-term remission and therapies with new mechanisms of action are urgently needed. Annuncio • Jan 23
Cellectar Biosciences, Inc. Reports Complete Central Nervous System (CNS) Clearance in Relapsed/Refractory Waldenstrom’s Macroglobulinemia Patient Cellectar Biosciences, Inc. announced that its novel phospholipid radiotherapeutic conjugate, iopofosine I 131, demonstrated a pathological response with complete clonal clearance in a relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patient with CNS involvement, also known as Bing-Neel Syndrome (BNS), enrolled in its Phase 2b CLOVER WaM pivotal trial. As part of the CLOVER WaM pivotal trial, the patient with BNS received the standard WM dosing regimen of two treatment cycles with two doses per cycle for a total of four fixed doses of iopofosine I 131 over 75 days. The patient received the recommended total administered dose of greater than 60mCi. Cerebrospinal fluid flow cytometry showed no evidence of clonal B-cells, and molecular analysis did not detect the MYD88 mutation. Cellectar previously announced a complete response in a patient with relapsed/refractory primary central nervous system lymphoma (CNSL) as part of its ongoing Phase 2a trial of iopofosine I 131. Currently, there are no approved therapies available to CNSL patients.Additionally, with the support of a $2 million grant from the National Institute of Health’s National Cancer Institute (NCI), during the third quarter of 2023, Cellectar initiated a Phase 1b study in pediatric high-grade gliomas (pHGGs), which is currently enrolling. The study objective is to identify the recommended iopofosine I 131 Phase 2 dose in pHGG patients. The NCI funding was in part granted due to the Phase 1a trial data demonstrating five months of progression free survival, which is substantially greater than what is typically observed in relapsed/refractory patients. Breakeven Date Change • Jan 16
Forecast to breakeven in 2026 The 3 analysts covering Cellectar Biosciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$3.04m in 2026. Average annual earnings growth of 56% is required to achieve expected profit on schedule. Annuncio • Jan 16
Cellectar Biosciences Broadens Pipeline with Targeted Alpha Therapy for Solid Tumors and Releases Promising Preclinical Data Cellectar Biosciences, Inc. announced promising preclinical data for its proprietary novel alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225 (225Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in pancreatic cancer models. The development of this compound will expand the company’s clinical pipeline of PLE cancer targeting compounds to include targeted alpha therapies (TATs), complementing its beta-emitting phospholipid radiotherapeutic conjugate, iopofosine I 131, which achieved its primary endpoint in the CLOVER WaM pivotal study in highly refractory Waldenstrom’s macroglobulinemia patients. Cellectar’s PLE platform may provide unique advantages which overcome the issues experienced by existing TAT delivery platforms. While current TAT platforms, such as antibodies and peptides, possess the potential to be effective for treating cancers with low tumor volume, they are challenged to treat higher volume or bulky tumors due to insufficient penetration and the need for high quantities of the target epitope. Cellectar’s PLE’s possess biochemical properties that enable penetration of the TAT payload deep into the tumor mass and the abundance of lipid rafts on tumor cells provides near universal delivery and enhanced outcomes. In preclinical studies, CLR 121225 demonstrated potent anti-tumor activity in refractory pancreatic cancer mouse xenograft models. A single administration at each dose level (100nCi, 250nCi and 500nCi) resulted in tumor volume reduction in a dose dependent manner with the highest dose providing near complete eradication of the tumor. Additionally, it was shown that CLR 121225 demonstrated excellent biodistribution; approximately 15 – 20% of the infused drug accumulated in the tumor within four hours and continued to accumulate over 72 – 96 hours. The mice had no end organ toxicities demonstrating good tolerability. The data are consistent with experiments using other alpha emitters conjugated to the company’s proprietary PLE targeted delivery platform. Annuncio • Jan 08
Cellectar Biosciences Announces Positive Topline Data Achieving Primary Endpoint in Pivotal Clinical Study of Iopofosine I 131 in Waldenstrom's Macroglobulinemia Cellectar Biosciences, Inc. announced data from its CLOVER WaM pivotal study, evaluating iopofosine I 131, a potential first-in-class, targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom’s macroglobulinemia (WM) patients that have received at least two prior lines of therapy, including Bruton tyrosine kinase inhibitors (BTKi). CLOVER WaM is the largest study to date in relapsed or refractory WM patients post-BTKi therapy and represents the most refractory population ever tested in clinical studies based upon a review of published literature. The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]). The overall response rate (ORR) in evaluable patients was 75.6%, and 100% of patients experienced disease control. Responses were durable, with median duration of response not reached and 76% of patients remaining progression free at a median follow-up of eight months. These outcomes exceed real world data, which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and less refractory to multiple classes of drugs. Notably, iopofosine monotherapy achieved an 8% stringent complete remission (sCR) in this highly refractory WM population. CLOVER WaM is a single-arm registration study with a target enrollment of 50 patients. The study is fully enrolled and topline safety data is being reported on 45 patients meeting criteria for modified intent to treat (mITT) with a data cut-off date of January 3, 2024. Topline efficacy evaluable population (41) is defined as patients who have received a total administered dose of greater than 60 mCi and had follow up of at least 60 days post last dose. Among mITT patients, median age was 71 years, median IgM level prior to treatment with iopofosine was 2,185, 90% were refractory to either a BTKi (18/36 50%) or anti-CD20 therapy (18/41 40%), with 26.7% multiclass refractory, and 80% of patients were previously treated with a BTKi therapy. Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company's previously reported safety data. There were no treatment-related adverse events (TRAEs) leading to discontinuation. The rates of Grade 3 or greater TRAEs observed in more than 10% of patients included thrombocytopenia (55%), neutropenia (37%), and anemia (26%). All patients recovered from cytopenias with no reported aplastic sequalae. Importantly, there were no clinically significant bleeding events, and the rate of febrile neutropenia was 2%. There were no treatment related deaths in the study. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 3 analysts covering Cellectar Biosciences expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$5.41m in 2026. Average annual earnings growth of 59% is required to achieve expected profit on schedule. New Risk • Nov 17
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$38m Forecast net loss in 3 years: US$1.5m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$1.5m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (5.9% increase in shares outstanding). Market cap is less than US$100m (US$19.9m market cap). Annuncio • Oct 28
Nasdaq Grants Cellectar Biosciences an Extension to Take Action to Evidence Compliance with Nasdaq Listing Rule 5550(b), on or Before January 4, 2024 As previously reported in a Current Report on Form 8-K filed on August 21, 2023, the Cellectar Biosciences, Inc. received notice from Nasdaq indicating that it was not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on Nasdaq to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing. In accordance with Nasdaq Listing Rules, the Company had 45 calendar days, or until September 30, 2023, to submit a plan to regain compliance. The Company timely submitted a plan of compliance addressing how it intends to regain compliance with Nasdaq Listing Rule 5550(b). On October 25, 2023, Nasdaq notified the Company of approval of the compliance plan, and Nasdaq granted the Company an extension to take action to evidence compliance with Nasdaq Listing Rule 5550(b), which requires that, among other things, on or before January 4, 2024, the Company provide Nasdaq with an update on the timeline for the exercise of the warrants the Company issued to certain investors in connection with the financing announced on September 8, 2023 and that, on or before February 12, 2024, the Company must provide to Nasdaq evidence of compliance with Nasdaq Listing Rule 5550(b). Further, if the Company fails to demonstrate compliance upon filing its periodic report for the quarter ending March 31, 2024, the Company may be subject to delisting. The Company is diligently working to timely evidence compliance with the terms of the Staff’s decision and remain listed on Nasdaq. However, there can be no assurance that the Company will attain compliance with the stockholders’ equity continued listing requirement during the extension period granted by Nasdaq. Annuncio • Oct 25
Cellectar Biosciences, Inc. to Report Q3, 2023 Results on Nov 02, 2023 Cellectar Biosciences, Inc. announced that they will report Q3, 2023 results on Nov 02, 2023 Annuncio • Sep 19
Cellectar Biosciences, Inc. Receives European Medicines Agency Priority Medicines (PRIME) Designation for Iopofosine for Waldenstrom's Macroglobulinemia Cellectar Biosciences, Inc. announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to iopofosine I 131, the company's lead small-molecule drug candidate, for Waldenstrom's macroglobulinemia (WM) in patients who have received two or more prior treatment regimens. The PRIME program aims to optimize development plans and speed up evaluation of medicines that may offer a major therapeutic advantage over existing treatments or benefit patients without treatment options. These medicines are considered priority medicines by the EMA and are intended to reach patients earlier. To be accepted for PRIME, new therapies must demonstrate the potential to significantly address an unmet medical need in clinical trials. The U.S. Food and Drug Administration (FDA) has granted Cellectar's lead asset iopofosine I 131, a small-molecule Phospholipid Drug Conjugate(TM) (PDC) designed to provide targeted delivery of iodine-131 (radioisotope), Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as relapsed (or refractory) multiple myeloma and relapsed (or refractory) diffuse large B-cell lymphoma (DLBCL). The company expects to complete ongoing Phase 2b WM pivotal trial (NCT02952508) in the second half of 2023 and assuming an FDA Priority Review and approval, remains on target for a 2024 US product launch. Price Target Changed • Sep 12
Price target decreased by 7.7% to US$12.00 Down from US$13.00, the current price target is an average from 4 analysts. New target price is 453% above last closing price of US$2.17. Stock is down 55% over the past year. The company is forecast to post a net loss per share of US$2.18 next year compared to a net loss per share of US$4.05 last year. Annuncio • Sep 06
Cellectar Biosciences, Inc. announced that it expects to receive $102.9 million in funding from Aigh Capital Management, LLC, ADAR1 Capital Management, LLC, Second Line Capital, LLC, Nantahala Capital Management, LLC, AuGC Partners LLC, Rosalind Advisors, Inc. and other investors Cellectar Biosciences, Inc. announced that it has entered into a securities purchase agreement to issue 24,500,000 series E-1 preferred stock and warrants for the gross proceeds of up to $102.9 million led by, Rosalind Advisors, Inc. on September 5, 2023. The transaction will include participation from new investors, Aigh Capital Management, LLC, ADAR1 Capital Management, LLC, Second Line Capital, LLC, Nantahala Capital Management, LLC, returning investor, AuGC Partners LLC and other investors. The preferred stocks will be convertible into common stock of the company at a conversion price of $1.82 per share. The warrants will consist of Tranche A warrants for an aggregate exercise price of approximately $44.1 million that are exercisable for Series E-3 Preferred Stock until the earlier of September 6, 2026, or 10 days following the company's announcement and Tranche B warrants for an aggregate exercise price of approximately $34.3 million that are exercisable for Series E-3 Preferred Stock until the earlier of September 6, 2028, or 10 days following disclosure. Annuncio • Aug 22
Cellectar Biosciences Receives Notice from Nasdaq Regarding Non-Compliance with Minimum Stockholders’ Equity Requirement Pursuant to Nasdaq Listing Rule 5550(b)(1) On August 16, 2023, Cellectar Biosciences, Inc. received notice from Nasdaq which indicated that under Nasdaq Listing Rule 5550(b)(1), the Company is required to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing. In the Company’s Form 10-Q for the period ended June 30, 2023, the Company reported stockholders’ equity was $(467,004). The notice does not have any immediate impact on the listing of the Company’s stock on Nasdaq. In accordance with the Nasdaq Listing Rules, the Company has 45 calendar days, or until September 30, 2023, to submit a plan to regain compliance with the stockholders’ equity requirement, which the Company expects submit for Nasdaq’s consideration in a timely manner. If the plan is accepted, Nasdaq may grant the Company an extension period of up to 180 calendar days from the date of the deficiency notice, or until February 12, 2024, to regain compliance. There can be no assurance that the Company’s plan to regain compliance will be accepted, or if accepted, that the Company will attain compliance with the stockholders' equity continued listing requirement during any extension period that Nasdaq may grant. If the Nasdaq chooses not to accept the Company’s plan, or if the Company is unable to regain compliance within any extension period granted by Nasdaq, then the result would be the issuance of a delisting determination. The Company would at that time have the option to request a hearing before a Nasdaq Hearings Panel to present its plan to regain compliance and to request a further extension period to regain compliance. The request for a hearing would stay any delisting action. New Risk • Aug 16
New major risk - Negative shareholders equity The company has negative equity. Total equity: -US$467k This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$29m free cash flow). Negative equity (-US$467k). Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (US$16.7m market cap). New Risk • Aug 07
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.8% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$28m free cash flow). Shareholders have been substantially diluted in the past year (59% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$1.7m net loss in 3 years). Share price has been volatile over the past 3 months (9.8% average weekly change). Market cap is less than US$100m (US$17.7m market cap). Annuncio • Jun 13
Cellectar Biosciences, Inc. Provides an Update for Its iopofosine I 131 Clinical Program and Guidance Related to Its Proprietary Phospholipidether Drug Conjugate Platform Cellectar Biosciences, Inc. provided an update for its iopofosine I 131 clinical program and guidance related to its Waldenstrom's macroglobulinemia (WM) CLOVER-WaM pivotal trial, as well as preclinical advancements to its proprietary phospholipid ether drug conjugate platform. WM CLOVER-WaM pivotal study The company now expects to release top-line data from the WM CLOVER-WaM trial in the second half of 2023 and assuming FDA approval, remains on target for a 2024 product launch. Cellectar experienced delays with trial start-up activities, such as site contracting and country regulatory responses, which slowed the initial pace of site initiations resulting in lower-than-expected patient enrollment. The company now has all 49 sites up and running and patient enrollment rates have accelerated. As has been previously reported, and in agreement with the FDA, WM CLOVER-WaM is a single arm, open label trial with a target enrollment of 50 patients. The company's COO, Jarrod Longcor, will deliver an oral presentation of iopofosine I131 in multiple myeloma at the Society of Nuclear Medicine and Molecular Imaging Annual Conference. The presentation is on June 26(th) (#P1243, Using targeted radiotherapy in highly refractory multiple myeloma). Phospholipid ether cancer targeting platform Development of the company's phospholipid ether cancer targeting platforms continues to demonstrate its broad utility to provide targeted intracellular delivery of multiple cancer treatment modalities. Preclinical data recently presented at several conferences demonstrate the broad utility of the platform, including: multip e alpha-emitter radiotherapeutic programs targeting solid tumor; the activity of multiple cytotoxic smamall molecule payloads in triple negative breast cancer mouse models including eradication of the tumors with no subsequent regrowth; the successful delivery, uptake, and gene knockdown in a mouse model of pancreatic cancer with siRNA-phospholipid ether when given intravenously; and the conjugation and use of peptides against intracellular targets where small molecules may not be effective. Annuncio • Feb 16
Cellectar Biosciences Hires Dr. Andrei Shustov as New Senior Vice President, Medical Cellectar Biosciences, Inc. announced that it has hired Andrei Shustov, M.D., as its new Senior Vice President, Medical reporting to Mr. James Caruso, president and CEO. In this role, Dr. Shustov will lead and provide oversight on all aspects of the Company’s clinical development program, medical affairs, and medical communications. Dr. Shustov, brings over three decades of research, clinical, development, and academic experience in hematology. He most recently served as Senior Medical Director, Late-Stage Clinical Development at Seagen, Inc. where he provided clinical expertise and oversight of regulatory submissions and activities of the Global Development Team. Prior to Seagen, Dr. Shustov spent 15 years on faculty in the Division of Hematology, Department of Medicine at the University of Washington and Fred Hutchinson Cancer Research Center in Seattle, finishing his academic career as full Professor of Medicine. Dr. Shustov is author or co-author on over 100 research papers; author of 10 hematology/oncology chapters in medical textbooks; and has been principal or lead investigator in over 40 clinical studies investigating new therapies in hematology for companies such as Bristol-Myers Squibb, Celegene, Merck, Gilead, Seattle Genetics, Millennium, AstraZeneca, and Pfizer among others, several of which resulted in regulatory approvals. Dr. Shustov completed his residency in internal Medicine in 2003 at WellSpan Health in York, PA, and his fellowship in hematology/medical oncology in 2006 at the University of Washington School of Medicine in Seattle, Washington. He received his Doctor of Medicine in 1987 from the Crimea Medical Institute, Simferopol, Ukraine. Price Target Changed • Nov 16
Price target decreased to US$12.60 Down from US$37.38, the current price target is an average from 5 analysts. New target price is 567% above last closing price of US$1.89. Stock is down 76% over the past year. The company is forecast to post a net loss per share of US$3.91 next year compared to a net loss per share of US$4.35 last year. Price Target Changed • Nov 03
Price target decreased to US$33.63 Down from US$39.38, the current price target is an average from 4 analysts. New target price is 1,548% above last closing price of US$2.04. Stock is down 80% over the past year. The company is forecast to post a net loss per share of US$3.50 next year compared to a net loss per share of US$4.35 last year. Price Target Changed • Jul 22
Price target decreased to US$39.38 Down from US$51.00, the current price target is an average from 4 analysts. New target price is 695% above last closing price of US$4.95. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$4.25 next year compared to a net loss per share of US$4.35 last year. Price Target Changed • May 26
Price target increased to US$5.88 Up from US$5.38, the current price target is an average from 4 analysts. New target price is 1,369% above last closing price of US$0.40. Stock is down 75% over the past year. The company is forecast to post a net loss per share of US$0.41 next year compared to a net loss per share of US$0.43 last year. Price Target Changed • Sep 16
Price target decreased to US$5.38 Down from US$5.98, the current price target is an average from 5 analysts. New target price is 443% above last closing price of US$0.99. Stock is down 19% over the past year. Board Change • Jul 31
High number of new directors Independent Director Asher Chanan-Khan was the last director to join the board, commencing their role in 2021. Is New 90 Day High Low • Mar 05
New 90-day low: US$1.74 The company is down 15% from its price of US$2.04 on 04 December 2020. The American market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$82.27 per share. Is New 90 Day High Low • Dec 22
New 90-day high: US$2.66 The company is up 108% from its price of US$1.28 on 22 September 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 19% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$57.57 per share. Is New 90 Day High Low • Dec 02
New 90-day high: US$1.52 The company is up 34% from its price of US$1.13 on 02 September 2020. The American market is up 5.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 13% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$16.17 per share. 
