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Cellectar Biosciences Reports Financial Results for Year Ended 2024 and Provides a Corporate Update

Achieves alignment with U.S. Food and Drug Administration (FDA) on regulatory path for potential accelerated approval of iopofosine I 131 as a treatment for Waldenström macroglobulinemia (WM)

Evaluating timing for Phase 1 solid tumor studies; Auger-emitting radioconjugate prepared for Phase 1b; plans to submit an IND for alpha-emitting radioconjugate;

Company to host webcast and conference call at 8:30 AM ET today

FLORHAM PARK, N.J., March 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 year ended December 31, 2024, and provided a corporate update.

“In 2024 the company showcased the efficacy and safety of iopofosine I 131 for the treatment of relapsed/refractory Waldenström macroglobulinemia. We recently completed a productive meeting with the FDA that established a clear regulatory pathway for the accelerated approval of this promising drug. Based upon this regulatory clarity, the quality of the CLOVER-WaM data, and a robust global market opportunity, we continue to evaluate inbound inquiries regarding a range of collaborations for iopofosine I 131, which we view as an attractive, non-dilutive funding approach.” said James Caruso, president and CEO of Cellectar. “In addition, the company received clearance for an IND for our Auger-emitting radioconjugate and will be submitting an IND application for our alpha-emitting radioconjugate. By the middle of 2025 we will be prepared to advance into phase 1 clinical studies for both compounds, in triple negative breast cancer and pancreatic cancer indications, respectively.”

2024 and Recent Corporate Highlights

2024 Financial Highlights

Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, March 13, 2024, 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 www.cellectar.com. 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 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 www.cellectar.com 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 raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, 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 iopofosine, 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, 2024. 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
annemarie.fields@precisionaq.com

+++ TABLES FOLLOW +++

CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED BALANCE SHEETS
             
    December 31,    December 31, 
       2024        2023  
ASSETS            
CURRENT ASSETS:            
Cash and cash equivalents   $ 23,288,607     $ 9,564,988  
Prepaid expenses and other current assets     961,665       888,225  
Total current assets     24,250,272       10,453,213  
Property, plant & equipment, net     757,121       1,090,304  
Operating lease right-of-use asset     436,874       502,283  
Other long-term assets     29,780       29,780  
TOTAL ASSETS   $ 25,474,047     $ 12,075,580  
             
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY            
CURRENT LIABILITIES:            
Accounts payable and accrued liabilities   $ 7,585,340     $ 9,178,645  
Warrant liability     1,718,000       16,120,898  
Lease liability, current     84,417       58,979  
Total current liabilities     9,387,757       25,358,522  
Lease liability, net of current portion     409,586       494,003  
TOTAL LIABILITIES     9,797,343       25,852,525  
COMMITMENTS AND CONTINGENCIES (Note 10)            
MEZZANINE EQUITY:            
Series D convertible preferred stock, 111.11 shares authorized; 111.11 shares issued and outstanding as of December 31, 2024 and 2023     1,382,023       1,382,023  
STOCKHOLDERS’ (DEFICIT) EQUITY:            
Series E-2 preferred stock, 1,225.00 shares authorized; 35.60 and 319.76 shares issued and outstanding as of December 31, 2024 and 2023, respectively     520,778       4,677,632  
Common stock, $0.00001 par value; 170,000,000 shares authorized; 46,079,875 and 20,744,110 shares issued and outstanding as of December 31, 2024 and 2023, respectively     461       207  
Additional paid-in capital     261,115,905       182,924,210  
Accumulated deficit     (247,342,463 )     (202,761,017 )
Total stockholders’ (deficit) equity     14,294,681       (15,158,968 )
TOTAL LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY   $ 25,474,047     $ 12,075,580  
CELLECTAR BIOSCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
             
    Year Ended December 31, 
       2024        2023  
             
OPERATING EXPENSES:            
Research and development   $ 26,136,246     $ 27,266,276  
General and administrative     25,641,452       11,694,367  
Total operating expenses     51,777,698       38,960,643  
             
LOSS FROM OPERATIONS     (51,777,698 )     (38,960,643 )
             
OTHER INCOME (EXPENSE):            
Warrant issuance expense     (7,743,284 )     (470,000 )
Gain (loss) on valuation of warrants     13,794,683       (3,787,114 )
Interest income     1,210,853       387,147  
Total other income (expense), net     7,262,252       (3,869,967 )
LOSS BEFORE INCOME TAXES     (44,515,446 )     (42,830,610 )
             
INCOME TAX PROVISION (BENEFIT)     66,000       (60,000 )
             
NET LOSS   $ (44,581,446 )   $ (42,770,610 )
NET LOSS PER SHARE — BASIC   $ (1.22 )   $ (3.50 )
NET LOSS PER SHARE — DILUTED   $ (1.40 )   $ (3.50 )
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC     36,622,474       12,221,571  
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED     37,143,769       12,221,571  


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