Latest news with #CLOVERWaM
Yahoo
04-06-2025
- Business
- Yahoo
What's Behind Cellectar Biosciences' Stock Surge? FDA Update Explained
Cellectar Biosciences, Inc. (NASDAQ:CLRB) stock is trading higher on Wednesday. As per data from Benzinga Pro, session volume stands at 361.96 million versus an average volume of 968.03k. What Happened: The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation on Wednesday for the company's iopofosine I 131, a potential first-in-class, novel cancer-targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, for relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).Why It Matters: WM is the dominant subtype of lymphoplasmacytic lymphoma. Data from the Phase 2 CLOVER WaM study, including the overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, which exceeded the agreed-upon primary endpoint of a 20% MRR, were presented during the 66th Annual American Society of Hematology Conference in December 2024. As previously announced, the FDA also granted iopofosine I 131 Fast Track Designation and Orphan Drug Designation. The European Medicines Agency (EMA) granted Orphan Drug Designation to iopofosine I 131 for r/r WM and PRIME Designation for WM. What's Next: Separately, the company has provided the EMA with a data package that includes extensive supportive preclinical, regulatory, and manufacturing data and 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. Price Action: CLRB stock is trading higher by 57.9% to $0.43 at last check Wednesday. Read Next:Photo by Tada Images via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article What's Behind Cellectar Biosciences' Stock Surge? FDA Update Explained originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
13-05-2025
- Business
- Associated Press
Cellectar Biosciences Reports First Quarter 2025 Financial Results and Provides a Corporate Update
Company Seeking Conditional Approval from European Medicines Agency (EMA) for Iopofosine I 131 in Waldenstrom Macroglobulinemia based upon CLOVER WaM Phase 2 Study Data CLOVER WaM Major Response Rate for BTKi-Treated Patients 59.0% Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., May 13, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the quarter ended March 31, 2025, and provided a corporate update on its promising portfolio of clinical and pre-clinical radiopharmaceutical therapeutics. 'Notwithstanding the need to gather additional clinical data for iopofosine I 131, as previously announced, we believe that the Phase 2 CLOVER WaM clinical trial data for this product candidate are impressive. We plan to present these data to the EMA during the second quarter of 2025 as part of the registration package seeking conditional marketing approval. We anticipate a response regarding the regulatory pathway from the European agency before the end of the third quarter of this year,' said James Caruso, president and CEO of Cellectar. 'In addition to iopofosine I 131, we have developed a pipeline of radiotherapeutic candidates, including our alpha- and Auger-emitting radioconjugates, with observed preclinical activity in solid tumor models. With cash into the fourth quarter of this year we are evaluating a variety of funding pathways to successfully advance our novel pipeline assets.' Corporate Update First Quarter 2025 Financial Highlights Conference Call & Webcast Details Cellectar management will host a conference call and webcast today, May 13, 2025, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the 'Events & Presentations' section of Cellectar's website at A recording of the webcast will be available and archived on the company's website for approximately 90 days. About Cellectar Biosciences, Inc. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company's core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company's product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 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. The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications. For more information, please visit or join the conversation by liking and following us on the company's social media channels: X, LinkedIn, and Facebook. Forward Looking Statements Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as 'may,' 'expect,' 'believe,' 'anticipate,' 'intend,' 'could,' 'estimate,' 'continue,' 'plans,' or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. 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 execute strategic alternatives, identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. 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, 2024, and our Form 10-Q for the quarterly period ending March 31, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. INVESTORS: Anne Marie Fields Precision AQ 212-362-1200 [email protected] +++ TABLES TO FOLLOW +++
Yahoo
13-05-2025
- Business
- Yahoo
Cellectar Biosciences Reports First Quarter 2025 Financial Results and Provides a Corporate Update
Company Seeking Conditional Approval from European Medicines Agency (EMA) for Iopofosine I 131 in Waldenstrom Macroglobulinemia based upon CLOVER WaM Phase 2 Study Data CLOVER WaM Major Response Rate for BTKi-Treated Patients 59.0% Company to hold webcast and conference call at 8:30 AM ET today FLORHAM PARK, N.J., May 13, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced financial results for the quarter ended March 31, 2025, and provided a corporate update on its promising portfolio of clinical and pre-clinical radiopharmaceutical therapeutics. 'Notwithstanding the need to gather additional clinical data for iopofosine I 131, as previously announced, we believe that the Phase 2 CLOVER WaM clinical trial data for this product candidate are impressive. We plan to present these data to the EMA during the second quarter of 2025 as part of the registration package seeking conditional marketing approval. We anticipate a response regarding the regulatory pathway from the European agency before the end of the third quarter of this year,' said James Caruso, president and CEO of Cellectar. 'In addition to iopofosine I 131, we have developed a pipeline of radiotherapeutic candidates, including our alpha- and Auger-emitting radioconjugates, with observed preclinical activity in solid tumor models. With cash into the fourth quarter of this year we are evaluating a variety of funding pathways to successfully advance our novel pipeline assets.' Corporate Update Announced plans to explore full range of strategic alternatives including, but not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions. The company's board of directors has engaged of Oppenheimer & Co. Inc. to serve as exclusive financial advisor to assist in the strategic evaluation process. Determined that the Phase 3 study for iopofosine I 131, for the treatment of relapsed/refractory Waldenstrom macroglobulinemia, would be a comparator, randomized controlled study with 100 patients per arm. Study initiation is dependent upon the company obtaining additional funding or a strategic collaboration. Funding dependent, the company is prepared to initiate a Phase 1b/2a dose-finding study for CLR 121125, the company's lead Auger-emitting (iodine-125) PRC, in triple-negative breast cancer. CLR 121125 is designed to provide highly precise radiotherapeutic targeting as emissions only travel a few nanometers. In a series of pre-clinical studies evaluating CLR 121225, the company's lead alpha-emitting actinium-225 PRC in refractory pancreatic models, desired pharmacokinetics, biodistribution and activity were observed, further supporting future clinical development. First Quarter 2025 Financial Highlights Cash and Cash Equivalents: As of March 31, 2025, the company had cash and cash equivalents of $13.9 million, compared to $23.3 million as of December 31, 2024. The company believes its cash balance as of March 31, 2025, is adequate to fund its basic budgeted operations into the fourth quarter of 2025. Research and Development Expenses: R&D expenses for the three months ended March 31, 2025, were approximately $3.4 million, compared to approximately $7.1 million for the three months ended March 31, 2024. The overall decrease was primarily a result of the reduction in patient follow-up activities for our CLOVER WaM Phase 2 clinical study in WM and a reduction in personnel costs. General and Administrative Expenses: G&A expenses for the three months ended March 31, 2025, were approximately $3.0 million, compared to approximately $4.9 million for the same period in 2024. The decrease was primarily driven by a reduction in pre-commercialization and personnel costs. Net Loss: The net loss attributable to common stockholders for the three months ended March 31, 2025, was $6.6 million, or $0.14 per share, compared to $26.6 million, or $0.91 per share in the three months ended March 31, 2024. Conference Call & Webcast DetailsCellectar management will host a conference call and webcast today, May 13, 2025, at 8:30 AM Eastern Time to discuss these results and answer questions. Stockholders and other interested parties may participate in the conference call by dialing 1-800-717-1738. A live webcast of the conference call can be accessed in the 'Events & Presentations' section of Cellectar's website at A recording of the webcast will be available and archived on the company's website for approximately 90 days. About Cellectar Biosciences, Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company's core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects. The company's product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. In addition, iopofosine I 131 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. The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications. For more information, please visit or join the conversation by liking and following us on the company's social media channels: X, LinkedIn, and Facebook. Forward Looking Statements Disclaimer This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. 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 execute strategic alternatives, identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. 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, 2024, and our Form 10-Q for the quarterly period ending March 31, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements. INVESTORS:Anne Marie FieldsPrecision +++ TABLES TO FOLLOW +++ CELLECTAR BIOSCIENCES, CONSOLIDATED BALANCE SHEETS(Unaudited) March 31, December 31, 2025 2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 13,905,173 $ 23,288,607 Prepaid expenses and other current assets 987,495 961,665 Total current assets 14,892,668 24,250,272 Property, plant & equipment, net 700,826 757,121 Operating lease right-of-use asset 418,916 436,874 Other long-term assets 29,780 29,780 TOTAL ASSETS $ 16,042,190 $ 25,474,047 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) CURRENT LIABILITIES: Accounts payable and accrued liabilities $ 3,874,429 $ 7,585,340 Warrant liability 2,058,000 1,718,000 Lease liability, current 88,146 84,417 Total current liabilities 6,020,575 9,387,757 Lease liability, net of current portion 386,203 409,586 TOTAL LIABILITIES 6,406,778 9,797,343 COMMITMENTS AND CONTINGENCIES (Note 7) MEZZANINE EQUITY: Series D preferred stock, 111.11 shares authorized, issued and outstanding as of March 31, 2025 and December 31, 2024 1,382,023 1,382,023 STOCKHOLDERS' EQUITY (DEFICIT): Series E-2 preferred stock, 1,225.00 shares authorized; 35.60 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 520,778 520,778 Common stock, $0.00001 par value; 170,000,000 shares authorized; 46,079,875 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively 461 461 Additional paid-in capital 261,678,642 261,115,905 Accumulated deficit (253,946,492 ) (247,342,463 ) Total stockholders' equity (deficit) 8,253,389 14,294,681 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) $ 16,042,190 $ 25,474,047 CELLECTAR BIOSCIENCES, CONSOLIDATED STATEMENTS OF OPERATIONS(Unaudited) Three Months Ended March 31, 2025 2024 OPERATING EXPENSES: Research and development $ 3,427,095 $ 7,088,042 General and administrative 2,973,896 4,913,444 Total operating expenses 6,400,991 12,001,486 LOSS FROM OPERATIONS (6,400,991 ) (12,001,486 ) OTHER INCOME (EXPENSE): (Loss) gain on valuation of warrants (340,000 ) (14,960,346 ) Interest income 136,962 319,849 Total other expense (203,038 ) (14,640,497 ) NET LOSS $ (6,604,029 ) $ (26,641,983 ) NET LOSS PER SHARE — BASIC AND DILUTED $ (0.14 ) $ (0.91 ) WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC AND DILUTED 46,079,875 29,346,679 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
14-03-2025
- Business
- Yahoo
Cellectar Biosciences Inc (CLRB) Q4 2024 Earnings Call Highlights: Strategic Restructuring and ...
Cash and Cash Equivalents: $23.3 million as of December 31, 2024, compared to $9.6 million as of December 31, 2023. Research and Development Expenses: $26.1 million for the full year 2024, down from $27.3 million in 2023. Selling, General, and Administrative Expenses: $25.6 million for the full year 2024, up from $11.7 million in 2023. Net Loss: $44.6 million for the full year ended December 31, 2024, or $1.22 per basic share and $1.40 per fully diluted share. Other Income and Expense Net: $7.3 million of income in 2024, compared to $3.9 million of expense in 2023. Cost Savings from Restructuring: Expected savings of approximately $7.5 million annually. Cash Runway: Extended into the fourth quarter of 2025. Financing Activities: $44.1 million from warrant exercises in January and $19.4 million from inducement financing in July 2024. Warning! GuruFocus has detected 1 Warning Sign with CLRB. Release Date: March 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Cellectar Biosciences Inc (NASDAQ:CLRB) reported impressive clinical results from the CLOVER WaM study, with a 98.2% clinical benefit rate and 83.6% overall response rate for Iopofosine I-131. The company achieved regulatory alignment with the FDA on the design of a Phase 3 study for Iopofosine, which is expected to enroll rapidly due to high interest from the healthcare community. Cellectar Biosciences Inc (NASDAQ:CLRB) strengthened its balance sheet with financial transactions, including warrant exercises generating $44.1 million and inducement financing raising $19.4 million. The company implemented a cost-saving strategic restructuring, reducing headcount by approximately 60%, which is expected to save $7.5 million annually. Cellectar Biosciences Inc (NASDAQ:CLRB) is exploring non-dilutive funding opportunities and licensing deals, which could enhance the company's financial position and support its clinical programs. Cellectar Biosciences Inc (NASDAQ:CLRB) faced a regulatory setback, delaying the submission of the NDA for Iopofosine, which negatively impacted the company's stock price. The company had to restate its historical financial statements due to a re-evaluation of the accounting for warrants, although this did not impact cash or cash burn. Research and development expenses remained high at $26.1 million for 2024, despite a slight decrease from the previous year. Selling, general, and administrative expenses increased significantly to $25.6 million in 2024, driven by pre-commercialization initiatives. Cellectar Biosciences Inc (NASDAQ:CLRB) is at risk of non-compliance with NASDAQ listing requirements, and may need to consider a reverse stock split if other initiatives do not succeed. Q: Does the NDA acceptance for Iopofosine I-131 require data from a new study or just the CLOVER WaM study? A: The accelerated approval will require data from the additional study as well. Jarrod Longcor, Chief Operating Officer Q: Can you share the timeline for patients to achieve and be validated for an MRR response under the study design? A: We anticipate rapid enrollment in this study. From the first patient enrolled, it would be approximately 24 months to full enrollment, with an additional month to achieve the necessary outcomes for major response rate. James Caruso, President and CEO; Jarrod Longcor, Chief Operating Officer Q: What will the comparator arm be in the study? A: The comparator arm will include two options: rituximab monotherapy and a rituximab combination treatment. The study is designed as an investigator choice study, allowing physicians to choose between these two options. Jarrod Longcor, Chief Operating Officer Q: Does the cash runway into the fourth quarter of 2025 include the work to complete IND filings for CLR-121225 and CLR-121125? A: Yes, it includes the cost for the IND filings. The cost to get the Phase 1 trials running is relatively modest and encompassed in the cash runway. Chad Kolean, Chief Financial Officer Q: Why was pancreatic cancer chosen for CLR-121225? A: The choice was based on both significant market need and pre-clinical efficacy signals. The Actinium program has shown high effectiveness in pre-clinical models of pancreatic ductal adenocarcinoma. Jarrod Longcor, Chief Operating Officer For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
