Full Press Release Details
Cellectar Biosciences
Reports Second Quarter 2025 Financial Results and Provides a Corporate Update
an NDA Submission to the U.S. FDA under Accelerated Approval Pathway for Iopofosine I 131 for the Treatment of Waldenstrom Macroglobulinemia
(WM) Subject to Sufficient Funding and Once the Confirmatory Trial is Underway
with the EMA Toward a Potential Submission of Iopofosine I 131 for Conditional Approval in the EU; Decision expected late 3Q early 4Q
CLR 125 into Phase 1 TNBC trial 4Q 2025
Webcast and Conference Call at 8:30 AM ET Today
FLORHAM PARK, N.J., August 14, 2025
(GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery
and development of drugs for the treatment of cancer, today announced financial results for the quarter ended June 30, 2025, and
provided a corporate update on its promising portfolio of clinical and pre-clinical radiopharmaceutical therapeutics.
Second Quarter and Subsequent Corporate
"Throughout the first half of
2025 we made meaningful progress advancing our pipeline of targeted radiopharmaceuticals and are entering the second half with solid
momentum and a clear plan," said James Caruso, president and CEO of Cellectar. We are encouraged by the recent FDA Breakthrough
Therapy Designation and the totality of compelling CLOVER WaM safety and efficacy data. Importantly, our regulatory strategy aligns with
the FDA's recently stated mission to accelerate the delivery of lifesaving medicines to patients battling rare diseases, such as
"We continue our interactions
with the European Medicines Agency (EMA) and are hopeful that they will recommend that we file for a fast-track, conditional marketing
authorization approval. We expect their decision either late third or early in the fourth quarter of 2025. In parallel, we remain in
active discussions with multiple potential partners to support the NDA filing for accelerated approval of iopofosine I 131 for the treatment
of WM. Currently, we view sufficient funding or collaborations as a precursor to the confirmatory study initiation and submission of
an NDA for accelerated approval. Such partnerships may provide non-dilutive capital that preserves stockholder value and could potentially
accelerates our path to commercialization across key global markets."
"Beyond iopofosine, we are making
tremendous headway advancing our next-generation pipeline of radiopharmaceuticals targeting solid tumors, such as triple-negative breast
cancer (TNBC) and pancreatic cancer. We plan to advance CLR 125 into the clinic by late 2025 or early 2026. The FDA has received our
Phase 1 protocol submission for the CLR 125 program. We are excited by the opportunities Cellectar possesses to bring transformative
radiopharmaceutical therapies to patients in need and look forward to achieving value-creating milestones throughout the balance of the
year and beyond," concluded Mr. Caruso.
Second Quarter 2025 Financial Highlights
Conference Call & Webcast Details
Cellectar management will host a conference
call and webcast today, August 14, 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 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 121125, an
iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal; CLR 121225, an
actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and 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 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 June 30, 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.
TABLES TO FOLLOW +++
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 11,041,027 | $ | 23,288,607 | ||||
| Prepaid expenses and other current assets | 1,576,579 | 961,665 | ||||||
| Total current assets | 12,617,606 | 24,250,272 | ||||||
| Property, plant & equipment, net | 647,549 | 757,121 | ||||||
| Operating lease right-of-use asset | 400,248 | 436,874 | ||||||
| Other long-term assets | 29,780 | 29,780 | ||||||
| TOTAL ASSETS | $ | 13,695,183 | $ | 25,474,047 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 4,678,713 | $ | 7,585,340 | ||||
| Warrant liability | 1,095,926 | 1,718,000 | ||||||
| Lease liability, current | 92,022 | 84,417 | ||||||
| Total current liabilities | 5,866,661 | 9,387,757 | ||||||
| Lease liability, net of current portion | 361,487 | 409,586 | ||||||
| TOTAL LIABILITIES | 6,228,148 | 9,797,343 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 7) | ||||||||
| MEZZANINE EQUITY: | ||||||||
| Series D preferred stock, 111.11 shares authorized, issued and outstanding as of June 30, 2025 and December 31, 2024 | 1,382,023 | 1,382,023 | ||||||
| STOCKHOLDERS' EQUITY (DEFICIT): | ||||||||
| Series E-2 preferred stock, 1,225 shares authorized; 35.60 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | 520,778 | 520,778 | ||||||
| Common stock, $0.00001 par value; 170,000,000 shares authorized; 1,812,040 and 1,535,996 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | 18 | 15 | ||||||
| Additional paid-in capital | 264,958,619 | 261,116,351 | ||||||
| Accumulated deficit | (259,394,403 | ) | (247,342,463 | ) | ||||
| Total stockholders' equity (deficit) | 6,085,012 | 14,294,681 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 13,695,183 | $ | 25,474,047 |
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | $ | 2,389,801 | $ | 7,345,480 | $ | 5,816,896 | $ | 14,433,523 | ||||||||
| General and administrative | 3,647,728 | 6,358,229 | 6,621,624 | 11,271,673 | ||||||||||||
| Total operating expenses | 6,037,529 | 13,703,709 | 12,438,520 | 25,705,196 | ||||||||||||
| LOSS FROM OPERATIONS | (6,037,529 | ) | (13,703,709 | ) | (12,438,520 | ) | (25,705,196 | ) | ||||||||
| OTHER INCOME (EXPENSE): | ||||||||||||||||
| Gain (loss) on valuation of warrants | 501,598 | 12,455,431 | 161,598 | (2,504,915 | ) | |||||||||||
| Interest income | 88,020 | 328,907 | 224,982 | 648,756 | ||||||||||||
| Total other income (expense) | 589,618 | 12,784,338 | 386,580 | (1,856,159 | ) | |||||||||||
| NET LOSS | $ | (5,447,911 | ) | $ | (919,371 | ) | $ | (12,051,940 | ) | $ | (27,561,355 | ) | ||||
| NET LOSS PER SHARE - BASIC | $ | (3.39 | ) | $ | (0.77 | ) | $ | (7.66 | ) | $ | (25.38 | ) | ||||
| NET LOSS PER SHARE - DILUTED | $ | (3.39 | ) | $ | (5.43 | ) | $ | (7.66 | ) | $ | (25.38 | ) | ||||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC | 1,608,799 | 1,193,981 | 1,572,598 | 1,086,102 | ||||||||||||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - DILUTED | 1,608,799 | 1,248,210 | 1,572,598 | 1,086,102 |