Full Press Release Details
Biosciences Reports First Quarter 2025 Financial Results and Provides a Corporate Update
Seeking Conditional Approval from European Medicines Agency (EMA) for Iopofosine I 131 in Waldenstrom Macroglobulinemia based upon CLOVER
WaM Phase 2 Study Data
WaM Major Response Rate for BTKi-Treated Patients 59.0%
to hold webcast and conference call at 8:30 AM ET today
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.
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."
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 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
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 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 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.
+++ TABLES TO FOLLOW
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| 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, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| 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 |