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Cellectar Biosciences, Inc. (CLRB)

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Previous Close1.2400
Open1.2400
Bid1.2100 x 3200
Ask1.2500 x 1000
Day's Range1.2000 - 1.2400
52 Week Range1.0100 - 3.3300
Volume190,923
Avg. Volume267,420
Market Cap32.444M
Beta (5Y Monthly)1.58
PE Ratio (TTM)N/A
EPS (TTM)-1.0070
Earnings DateNov 09, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est5.57
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  • Cellectar Reports Third Quarter 2020 Financial Results and Provides a Corporate Update
    GlobeNewswire

    Cellectar Reports Third Quarter 2020 Financial Results and Provides a Corporate Update

    FLORHAM PARK, N.J., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced financial results for the third quarter ended September 30, 2020 and provided a corporate update. Third Quarter and Recent Corporate Highlights * Held FDA Type B guidance meeting to define the registrational pathway for our priority adult hematology oncology indications and planned initiation of the pivotal study for our lead indication in the fourth quarter * Announced CLR 131 achieved a 40% overall response rate (ORR) in Triple Class Refractory Multiple Myeloma (MM) patients with an administered total body dose (TBD) of 60mCi or greater from the Phase 2 CLOVER-1 study * Interim results from the Phase 2 COVER-1 study at the American Association of Cancer Research (AACR) Virtual Meeting: Advances in Malignant Lymphoma demonstrated a 100% ORR and a 75% major response rate (MRR) in LPL/WM. Mean duration of response exceeding 17 months (8.4 – 31.7 months); duration of response continues to increase for all patients * Strengthened the management team with the appointment of Dr. John Friend, chief medical officer “We continue to make good progress towards the fourth quarter initiation of the CLR 131 pivotal study in our lead heme-oncology indication. Our recent FDA guidance meeting was most encouraging and we look forward to providing greater details in the near-term,” said James Caruso, president and CEO of Cellectar. “Additional data from our Phase 2 CLOVER-1 study remain strong, with patients in WM achieving a 100% ORR and a 75% MRR in patients failing a BTKi and a 40% ORR in the challenging to treat triple class refractory MM patient population.”Third Quarter 2020 Financial Highlights * Cash and Cash Equivalents: As of September 30, 2020, the company had cash and cash equivalents of $18.8 million compared to $10.6 million at December 31, 2019. Cash used in operating activities was approximately $10.1 million during the nine months ended September 30, 2020 as compared to $9.0 million during the nine months ended September 30, 2019. * Research and Development Expense: R&D expense for the three months ended September 30, 2020 was $2.7 million, compared to $2.7 million for the three months ended September 30, 2019. The cumulative R&D spending for the first nine months of 2020 was $7.8 million as compared to $6.8 million for the first nine months of 2019. The increase in R&D expense year-to-date in 2020 was primarily a result of higher general research and development costs resulting from increased personnel related costs and clinical study costs. Manufacturing and related costs decreased because of a reduction in materials production processes and related costs. * General and Administrative Expense: G&A expense for the three months ended September 30, 2020 was $1.2 million compared to $1.3 million for the three months ended September 30, 2019. The cumulative G&A spending for the first nine months of 2020 were of $3.7 million as compared to $4.0 million for the first nine months of 2019. The decrease in G&A expense year-to-date in 2020 was primarily a result of lower stock-based compensation expense. * Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2020 was ($3.9) million, or ($0.15) per share, compared to ($3.9) million, or ($0.42) per share, in 2019. Net loss attributable to common stockholders for the nine months ended September 30, 2020 was ($11.5) million, or ($0.69) per share, compared to ($10.7) million, or ($1.51) per share, in 2019. About Cellectar Biosciences, Inc. Cellectar Biosciences is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The company is developing proprietary drugs independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop PDCs that specifically target cancer cells, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s PDC platform possesses the potential for the discovery and development of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations.The company’s lead PDC therapeutic, CLR 131, is currently in two clinical studies. The CLOVER-1 Phase 2 study and the Phase 1 pediatric safety study. The CLOVER-1 study met the primary efficacy endpoints from the Part A dose-exploration portion, conducted in r/r B-cell malignancies, and is now enrolling in expansion cohorts evaluating in triple class refractory multiple myeloma and BTK inhibitor failed Waldenstrom’s macroglobulinemia patients. The dosing regimen is designed to provide the optimal dose identified in Part A of >60mCi total body dose. The data from the Part A portion were announced on February 19, 2020.The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of CLR 131 in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin’s lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.The company’s product pipeline includes one preclinical PDC chemotherapeutic program (CLR 1900) and multiple partnered PDC assets.For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.Forward-Looking Statement Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations of the impact of the COVID-19 pandemic. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of CLR 131, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for CLR 131, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2019, our Form 10-Q for the quarter ended March 31, 2020, our Form 10-Q for the quarter ended June 30, 2020 and our Form 10-Q for the quarter ended September 30, 2020, when filed. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.ContactsInvestors: Monique Kosse Managing Director LifeSci Advisors, LLC 646-915-3820 monique@lifesciadvisors.comCELLECTAR BIOSCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS  September 30, 2020 (Unaudited)  December 31, 2019  ASSETS         CURRENT ASSETS:         Cash and cash equivalents $18,841,944  $10,614,722  Prepaid expenses and other current assets  960,906   770,951  Total current assets  19,802,850   11,385,673  Fixed assets, net  374,697   435,083  Right-of-use asset, net  299,982   348,841  Long-term assets  219,121   75,000  Other assets  —   6,214  TOTAL ASSETS $20,696,650  $12,250,811            LIABILITIES AND STOCKHOLDERS’ EQUITY         CURRENT LIABILITIES:         Accounts payable and accrued liabilities $3,839,318  $2,663,873  Lease liability  116,257   105,885  Total current liabilities  3,955,575   2,769,758  LONG-TERM LIABILITIES:         Lease liability  333,375   421,644  Loan payable  184,000   —  Total long-term liabilities  517,375   421,644  TOTAL LIABILITIES  4,472,950   3,191,402  COMMITMENTS AND CONTINGENCIES (Note 7)         STOCKHOLDERS’ EQUITY:         Preferred stock, $0.00001 par value; 7,000 shares authorized; Series C preferred stock: 215 issued and outstanding as of September 30, 2020 and December 31, 2019  1,148,204   1,148,204  Common stock, $0.00001 par value; 80,000,000 shares authorized; 26,813,593 and 9,386,689 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively  268   94  Additional paid-in capital  138,235,579   119,592,366  Accumulated deficit  (123,160,351)  (111,681,255) Total stockholders’ equity  16,223,700   9,059,409  TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $20,696,650  $12,250,811   CELLECTAR BIOSCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)  Three Months Ended September 30,  Nine Months Ended September 30,    2020  2019  2020  2019  COSTS AND EXPENSES:                 Research and development $2,683,944  $2,703,831  $7,765,673  $6,821,775  General and administrative  1,225,993   1,260,048   3,725,153   3,972,275  Total costs and expenses  3,909,937   3,963,879   11,490,826   10,794,050                    LOSS FROM OPERATIONS  (3,909,937)  (3,963,879)  (11,490,826)  (10,794,050)                   OTHER INCOME:                 Gain on revaluation of derivative warrants  —   46,000   —   43,000  Interest income, net  374   14,072   11,730   38,041  Total other income  374   60,072   11,730   81,041  NET LOSS $(3,909,563) $(3,903,807) $(11,479,096) $(10,713,009) BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE $(0.15) $(0.42) $(0.69) $(1.51) SHARES USED IN COMPUTING BASIC AND DILUTED NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS PER COMMON SHARE  26,326,782   9,386,703   16,539,183   7,098,285

  • Cellectar Biosciences’ CLR 131 Demonstrates Preliminary Activity in Phase I Study for Pediatric Brain and Solid Tumors
    GlobeNewswire

    Cellectar Biosciences’ CLR 131 Demonstrates Preliminary Activity in Phase I Study for Pediatric Brain and Solid Tumors

    CLR 131 crosses blood brain barrier delivering drug directly to brain tumorsFLORHAM PARK, N.J., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced CLR 131 has demonstrated preliminary activity in inoperable brain tumors in a Phase 1 study. The study is an international, open-label, dose escalation, safety study of CLR 131 in children and adolescents with relapsed or refractory cancers, specifically high grade gliomas (HGGs), high risk neuroblastomas and select soft tissue sarcomas. Highlights from the study: * Four dose levels (15, 30, 45 and 60mCi/m2 ) have been evaluated to date with all deemed safe and tolerated by the independent Data Monitoring Committee; patients are currently being evaluated at the 75mCi/m2 dose level * Initial activity was expected to occur at doses of 60mCi/m2 and higher; activity has been noted at lower dose levels * CLR 131 has been measured in tumors, confirming that systemic administration of CLR 131 crosses the blood brain barrier and is delivered into tumors * Disease control has been exhibited in heavily pretreated patients with ependymomas“CLR 131’s ability to cross the blood brain barrier along with the initial responses in pediatric brain tumors are most encouraging. CLR 131 may provide an attractive new treatment option for these patients beyond the current paradigms of external beam radiation and/or systemic targeted radiation as standards of care,” said Dr. John Friend, CMO of Cellectar. “These ultra-orphan pediatric indications align with the development and regulatory strategy that we have successfully employed with our lead program in heme-oncology. We look forward to providing feedback from our recent FDA Guidance meeting, outlining the registrational pathway for our priority adult hematology indications and planned initiation of our pivotal trial later in the fourth quarter.”Similar to previous CLR 131 studies in adults, this study demonstrated that 20-40% of the infused CLR 131 is delivered to the tumors. Additionally, the study demonstrated that systemic administration of CLR 131 results in a sufficient proportion of infused drug crossing the blood brain barrier and is delivered to different types of malignant brain tumors. CLR 131 has achieved disease control at multiple dose levels in rapidly progressing, heavily pretreated patients, including two patients at distinct dose levels with rapidly growing ependymomas. Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes (i.e. diffuse intrinsic pontine gliomas, glioblastomas, astrocytomas, ependymomas, etc.) with about 400 new pediatric cases diagnosed annually in the United States. Children with these tumors have a poor prognosis and limited 5 year survival.It is noteworthy that CLR 131 is currently being dosed at 75mCi/m2 and when compared to another targeted radiotherapeutic, MIBG-Iodine-131 (second line standard of care in neuroblastoma), CLR 131 achieves a nearly 16 fold increase in the amount of radiation delivered to the tumor. This enhanced delivery suggests that doses of CLR 131 between 60 and 75mCi/m2 would be predicted to achieve similar responses in patients as an MIBG-Iodine-131 dose of up to 1,300mCi. Neuroblastoma is a cancer type that occurs in immature nerve cells of the adrenal gland, neck, chest or spinal cord with approximately 800 new cases diagnosed per year in the United States. Over 60% of the newly diagnosed cases of neuroblastoma are advanced with at least one site of metastasis resulting in a poor patient prognosis.About CLR 131 CLR 131 is a small-molecule Phospholipid Drug Conjugate™ designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company’s lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in relapsed/refractory (r/r) multiple myeloma. The U.S. Food and Drug Administration (FDA) granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large B-cell lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia (WM), neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Earlier this year, the European Commission granted an ODD for r/r multiple myeloma and most recently, the FDA granted Fast Track Designation for CLR 131 in LPL/WM in patients having received two prior treatment regimens or more.About Cellectar Biosciences, Inc. Cellectar Biosciences is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The company is developing proprietary drugs independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop PDCs that specifically target cancer cells, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s PDC platform possesses the potential for the discovery and development of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations.The company’s lead PDC therapeutic, CLR 131, is currently in two clinical studies. The CLOVER-1 Phase 2 study and the Phase 1 pediatric safety study. The CLOVER-1 study met the primary efficacy endpoints from the Part A dose-exploration portion, conducted in r/r B-cell malignancies, and is now enrolling in expansion cohorts evaluating in triple class refractory multiple myeloma and BTK inhibitor failed Waldenstrom’s macroglobulinemia patients. The dosing regimen is designed to provide the optimal dose identified in Part A of >60mCi total body dose. The data from the Part A portion were announced on February 19, 2020.The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of CLR 131 in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin’s lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.The company’s product pipeline includes one preclinical PDC chemotherapeutic program (CLR 1900) and multiple partnered PDC assets.For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.Forward-Looking Statement Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations of the impact of the COVID-19 pandemic. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of CLR 131, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for CLR 131, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2019 and our Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. These forward looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.ContactsInvestors:Monique Kosse Managing Director LifeSci Advisors 212-915-3820 monique@lifesciadvisors.com

  • GlobeNewswire

    Cellectar Biosciences to Present at Two Upcoming Investor Conferences

    FLORHAM PARK, N.J., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced James Caruso, president and CEO, will present at the following investor conferences in September and be available for 1x1 meetings: H.C. Wainwright 22nd Annual Global Investment Conference Date:        Tuesday, September 15, 2020 Time: 3:30 pm Eastern Time Format: Virtual Presentation and 1x1 meetings     Oppenheimer Fall Healthcare Life Sciences & MedTech Summit Date: Monday, September 21, 2020 Time: 4:10 pm Eastern Time Format: Virtual Presentation and 1x1 meetings     A replay of the presentation and webcast will be on the Investor Relations section of the company’s website available for 90 days here.  About Cellectar Biosciences, Inc. Cellectar Biosciences is focused on the discovery, development and commercialization of drugs for the treatment of cancer. The company is developing proprietary drugs independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop PDCs that specifically target cancer cells, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s PDC platform possesses the potential for the discovery and development of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations.The company’s lead PDC therapeutic, CLR 131, is currently in two clinical studies. The CLOVER-1 Phase 2 study completed the Part A dose-exploration portion, conducted in relapsed/refractory (r/r) B-cell malignancies, and is now enrolling in the Part B expansion cohorts evaluating a two cycle dosing regimen that provides approximately 100 mCi total body dose of CLR 131 in r/r multiple myeloma (MM) and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM). The data from the Part A portion was announced on February 19, 2020.The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of CLR 131 in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin’s lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.The company’s product pipeline includes one preclinical PDC chemotherapeutic program (CLR 1900) and multiple partnered PDC assets.For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.Forward-Looking Statement Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes including our expectations of the impact of the recent COVID-19 pandemic. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of CLR 131, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for CLR 131, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2019 and our Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. These forward looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.ContactsInvestors:Monique Kosse Managing Director LifeSci Advisors 212-915-3820 monique@lifesciadvisors.com