CLRB Cellectar Biosciences Inc.

1.49
-0.06  -4%
Previous Close 1.55
Open 1.54
52 Week Low 1.011
52 Week High 3.33
Market Cap $35,756,488
Shares 23,997,643
Float 23,905,209
Enterprise Value $30,314,800
Volume 819,596
Av. Daily Volume 985,081
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Drug Pipeline

Drug Stage Notes
CLR 131
Multiple myeloma
Phase 1
Phase 1
Phase 1 trial has been completed - February 19, 2020.
CLR 131 - CLOVER-1
Various lymphoma
Phase 2
Phase 2
Phase 2 data update February 19, 2020. Non-Hodgkin’s lymphoma (NHL) - 42% ORR.
CLR 131 (CLOVER-2)
Solid tumors
Phase 1
Phase 1
Phase 1 trial to continue to higher dose - August 14, 2019.

Latest News

  1. FLORHAM PARK, N.J., July 01, 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 that it has appointed Dr. John Friend as chief medical officer, effective immediately.

    "We are pleased to welcome John back to Cellectar to oversee CLR 131's late-stage oncology clinical development plans and FDA engagement for our adult and pediatric programs," said Jim Caruso, president and CEO of Cellectar Biosciences. "John's understanding and prior involvement with CLR 131 combined with his extensive experience in oncology drug development will prove invaluable to our overall development…

    FLORHAM PARK, N.J., July 01, 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 that it has appointed Dr. John Friend as chief medical officer, effective immediately.

    "We are pleased to welcome John back to Cellectar to oversee CLR 131's late-stage oncology clinical development plans and FDA engagement for our adult and pediatric programs," said Jim Caruso, president and CEO of Cellectar Biosciences. "John's understanding and prior involvement with CLR 131 combined with his extensive experience in oncology drug development will prove invaluable to our overall development program and near-term pivotal study registration strategies."

    Dr. Friend returns to Cellectar bringing more than 17 years of global drug development and medical affairs expertise in hematology/oncology as well as a variety of other therapeutic indications. Most recently, he was chief medical officer of DRGT and prior to his earlier tenure at Cellectar, Dr. Friend served as Senior Vice President of Research and Development at Helsinn Therapeutics (U.S.), Inc. leading its research and development, clinical, medical affairs and regulatory affairs divisions. Prior to his time at Helsinn, Dr. Friend held executive responsibility for clinical research, medical affairs, pharmacovigilance and risk management at various pharmaceutical companies including Akros Pharma, Actavis, Alpharma, Hospira and Abbott.

    Dr. Friend noted, "I am excited to rejoin the Cellectar team and to lead the clinical development, global regulatory submission and post-approval support of CLR 131. The recent results from the company's phase 2a B-cell study demonstrating 40% plus response rates for relapsed and refractory multiple myeloma and non-hodgkin's lymphomas as well as a 100% response rate to date in Waldenstrom Macroglobulinemia validates my early belief in CLR 131 and the PDC technology platform. I look forward to working to bring CLR 131 to market for the many cancer patients that may benefit from its treatment."

    Dr. Friend completed his post-graduate residency program in family medicine and subsequently served as Clinical Director and faculty attending physician at Cabarrus Family Medicine Residency Program in North Carolina. He earned his medical degree from UMDNJ-Robert Wood Johnson Medical School (now Rutgers, RWJMS) and received his undergraduate degree in Chemistry from Southern Methodist University,

    Grant of Inducement Option

    In connection with his hiring, Cellectar has granted to Dr. Friend, effective as of his first day of employment with Cellectar, an option to purchase 100,000 shares of Cellectar's common stock at an exercise price per share equal to the closing price of Cellectar's common stock on the grant date as reported by Nasdaq. This grant was approved by the Compensation Committee of Cellectar's Board of Directors and made as an inducement material to Dr. Friend entering into employment with Cellectar as contemplated by Nasdaq Listing Rule 5635(c)(4).

    The stock option, which has a 10-year term, vests and becomes exercisable in three equal annual installments beginning on the first anniversary from the date of Dr. Friend's first day of employment.

    Cellectar provides this information in accordance with Nasdaq Listing Rule 5635(c)(4).

    Resignation of Dr. Igor Grachev

    Dr. Igor Grachev announced his resignation to pursue other opportunities. "We acknowledge and thank Igor for his contributions to our programs and wish him the very best in his future endeavors," said Jim Caruso, president and CEO of Cellectar Biosciences.

    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 r/r multiple myeloma. The 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/Waldenstrom's macroglobulinemia, 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. Most recently, the European Commission granted an ODD for r/r multiple myeloma.

    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 100mCi total body dose of CLR 131 in relapsed/refractory (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 company is also conducting a two-part Phase 1 dose-escalation with expansion arms in pediatric solid tumors and lymphomas.

    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 quarter ended March 31, 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.

    Contacts

    Investors:

    Monique Kosse

    Managing Director

    LifeSci Advisors

    646-915-3820

    Primary Logo

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  2. FLORHAM PARK, N.J., June 11, 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 that the European Patent Office has announced the intent to grant patent number EP3229810 (B1) titled "Phospholipid Ether Analogs as Cancer-Targeting Drug Vehicles." The patent provides composition of matter and use protection for the company's proprietary PLE, targeted delivery vehicle analogs in combination with a broad range of chemotherapeutics such as paclitaxel, gemcitabine, and other classes of small molecule chemotherapeutic agents. The cancer-targeting PLE delivery vehicle serves as…

    FLORHAM PARK, N.J., June 11, 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 that the European Patent Office has announced the intent to grant patent number EP3229810 (B1) titled "Phospholipid Ether Analogs as Cancer-Targeting Drug Vehicles." The patent provides composition of matter and use protection for the company's proprietary PLE, targeted delivery vehicle analogs in combination with a broad range of chemotherapeutics such as paclitaxel, gemcitabine, and other classes of small molecule chemotherapeutic agents. The cancer-targeting PLE delivery vehicle serves as the foundation for the company's lead product candidate CLR 131, which continues to advance through clinical studies in both adult and pediatric cancer indications.

    "This patent represents a key step towards the expansion of our PDC franchise into the European and the rest of the world markets. It provides intellectual property protection for many of our ongoing preclinical programs, similar to the previously granted U.S. patent," stated James Caruso president and chief executive officer of Cellectar Biosciences. "We plan to explore other therapeutic modalities with the PLE and seek partnerships with pharmaceutical and biotechnology companies interested in utilizing our technology to potentially improve the delivery and the efficacy and tolerability of their drugs."

    The combination of the PLE with a small molecule chemotherapeutic is known as a Phospholipid Drug Conjugate or PDC™. PDCs provide targeted delivery and release of therapeutic payloads inside tumor cells including primary and metastatic tumor sites as well as cancer stem cells and has also demonstrated the capacity to cross the blood-brain-barrier and target brain tumors.

    About Phospholipid Drug Conjugates™

    Cellectar's product candidates are built upon a patented delivery platform that utilizes optimized phospholipid ether-drug conjugates (PDCs™) to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads' concentration within tumor cells to be increased while reducing the concentration in normal tissue, which may enhance drug potency while reducing adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types. Compared with other targeted delivery platforms, the PDC platform's mechanism of entry does not rely upon specific cell surface epitopes or antigens which can be modified or removed by tumor cells resulting in resistance to the treatment. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types or classes of molecules that can be selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

    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 an approximate 100mCi total body dose of CLR 131 in relapsed/refractory (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 company is also conducting a two-part Phase 1 dose-escalation with expansion arms in pediatric solid tumors and lymphomas. 

    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 quarter ended March 31, 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.

    Contacts

    Investors:

    Monique Kosse

    Managing Director

    LifeSci Advisors

    646-915-3820

     

    Primary Logo

    View Full Article Hide Full Article
  3. FLORHAM PARK, N.J., June 05, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences (NASDAQ:CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the closing of its previously announced underwritten public offering for gross proceeds of $20.0 million prior to deducting underwriting discounts and commissions and estimated offering expenses.

    The offering was comprised of 14,601,628 shares of common stock, together with Series H Warrants to purchase 8,695,664 shares of common stock. The public offering price of a share of Common Stock together with one-half of a Series H Warrant to purchase one share of common stock was $1.15. Each whole Series…

    FLORHAM PARK, N.J., June 05, 2020 (GLOBE NEWSWIRE) -- Cellectar Biosciences (NASDAQ:CLRB), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the closing of its previously announced underwritten public offering for gross proceeds of $20.0 million prior to deducting underwriting discounts and commissions and estimated offering expenses.

    The offering was comprised of 14,601,628 shares of common stock, together with Series H Warrants to purchase 8,695,664 shares of common stock. The public offering price of a share of Common Stock together with one-half of a Series H Warrant to purchase one share of common stock was $1.15. Each whole Series H Warrant is exercisable to purchase one share of our common stock at an exercise price of $1.2075 per share, is exercisable upon issuance and will expire five years from the date of issuance. The shares of common stock and the accompanying Series H warrants were purchased together in this offering but were issued separately.

    Cellectar also issued 2,789,700 pre-funded warrants, in lieu of shares of common stock that would otherwise result in such purchaser's beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock. Each pre-funded warrant is exercisable for one share of our common stock. The purchase price of each pre-funded warrant and one-half of a Series H Warrant is $1.1499 and the exercise price of each pre-funded warrant will be $0.00001 per share. The pre-funded warrants are immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The pre-funded warrant and the accompanying Series H Warrants were purchased together in the offering but were issued separately.

    Oppenheimer & Co. Inc. acted as the sole book-running manager in connection with the offering and Ladenburg Thalmann & Co. Inc. and Roth Capital Partners acted as co-lead managers.

    The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-238132), which was declared effective by the Securities and Exchange Commission (SEC) on June 2, 2020 and an additional registration statement filed pursuant to Rule 462(b) (File No. 333-238892), which became effective when filed.

    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 an approximate 100mCi total body dose of CLR 131 in relapsed/refractory (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 company is also conducting a Phase 1 dose-escalation study in pediatric solid tumors and lymphomas.

    The company's product pipeline includes one preclinical PDC chemotherapeutic program (CLR 1900) and several 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 quarter ended March 31, 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.

    Contacts

    Investors:

    Monique Kosse

    Managing Director

    LifeSci Advisors

    646-915-3820

     

    Primary Logo

    View Full Article Hide Full Article
  4. FLORHAM PARK, N.J., June 03, 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 the pricing of an underwritten public offering for gross proceeds of $20.0 million, prior to deducting underwriting discounts and commissions and estimated offering expenses.

    The offering is priced at a public offering price of $1.15 per share of common stock and one-half of a Series H Warrant. Each whole Series H Warrant is exercisable to purchase one share of our common stock at an exercise price of $1.21 per share, will be exercisable upon issuance and will expire five years from the date…

    FLORHAM PARK, N.J., June 03, 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 the pricing of an underwritten public offering for gross proceeds of $20.0 million, prior to deducting underwriting discounts and commissions and estimated offering expenses.

    The offering is priced at a public offering price of $1.15 per share of common stock and one-half of a Series H Warrant. Each whole Series H Warrant is exercisable to purchase one share of our common stock at an exercise price of $1.21 per share, will be exercisable upon issuance and will expire five years from the date of issuance. The shares of common stock and Series H warrants can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance.

    We are also offering to certain purchasers whose purchase of shares of common stock in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses, pre-funded warrants, in lieu of shares of common stock that would otherwise result in such purchaser's beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock. Each pre-funded warrant will be exercisable for one share of our common stock. The purchase price of each pre-funded warrant and the accompanying Series H Warrant will be equal to the price at which a share of common stock and accompanying Series H Warrant are sold to the public in this offering, minus $0.00001, and the exercise price of each pre-funded warrant will be $0.00001 per share. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. This offering also relates to the shares of common stock issuable upon exercise of any pre-funded warrants sold in this offering. Each pre-funded warrant is being sold together with one-half of a Series H Warrant. Each whole Series H Warrant is exercisable to purchase one share of our common stock at an exercise price of $1.21 per share, will be exercisable upon issuance and will expire five years from the date of issuance.

    The offering is expected to close on or about June 5, 2020, subject to the satisfaction or waiver of customary closing conditions.

    Oppenheimer & Co. Inc. acted as the sole book-running manager in connection with the offering and Ladenburg Thalmann & Co. Inc. and Roth Capital Partners acted as co-lead managers.

    The securities will be offered pursuant to a registration statement on Form S-1 (File No. 333-238132), which was declared effective by the Securities and Exchange Commission (SEC) on June 2, 2020 and an additional registration statement filed pursuant to Rule 462(b) (File No. 333-238892), which became effective when filed.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The offering is being made solely by means of a prospectus. A final prospectus relating to this offering will be filed by Cellectar with the SEC. When available, copies of the final prospectus can be obtained at the SEC's website at www.sec.gov or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at .

    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 an approximate 100mCi total body dose of CLR 131 in relapsed/refractory (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 company is also conducting a Phase 1 dose-escalation study in pediatric solid tumors and lymphomas.

    The company's product pipeline includes one preclinical PDC chemotherapeutic program (CLR 1900) and several 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 quarter ended March 31, 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.

    Contacts

    Investors:
    Monique Kosse
    Managing Director
    LifeSci Advisors
    646-915-3820

    Primary Logo

    View Full Article Hide Full Article
  5. FLORHAM PARK, N.J., June 01, 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 that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency's (EMA) Micro, Small and Medium-sized Enterprise (SME) office.

    The newly granted SME status allows Cellectar to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities and fee waivers for selective EMA pre and post-authorization…

    FLORHAM PARK, N.J., June 01, 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 that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency's (EMA) Micro, Small and Medium-sized Enterprise (SME) office.

    The newly granted SME status allows Cellectar to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities and fee waivers for selective EMA pre and post-authorization regulatory filings, including orphan drug and PRIME designations. Cellectar is also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.

    "The receipt of our SME status is timely as we prepare to engage the EMA for discussions to harmonize CLR 131's pivotal study," stated James Caruso, president and chief executive officer. "SME status from the EMA, will allow Cellectar to pursue EU marketing authorization in a more efficient and cost-effective manner and will greatly benefit our company as we advance CLR 131 to commercialization."

    The EMA plays a central role in facilitating the development and authorization of medicines across Europe. The SME initiative promotes innovation from smaller companies like Cellectar to ensure Europe continues to be a favorable environment for preclinical and clinical development of promising new therapeutic options like CLR 131. Detailed information on SME status can be found 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 an approximate 100mCi total body dose of CLR 131 in relapsed/refractory (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 company is also conducting a Phase 1 dose-escalation study in pediatric solid tumors and lymphomas.

    The company's product pipeline includes one preclinical PDC chemotherapeutic program (CLR 1900) and several 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 quarter ended March 31, 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.

    Contacts

    Investors:
    Monique Kosse
    Managing Director
    LifeSci Advisors
    646-915-3820

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