Full Press Release Details
Cellectar Biosciences
Reports Financial Results for Year Ended 2024 and Provides a Corporate Update
with U.S. Food and Drug Administration (FDA) on regulatory path for potential accelerated approval of iopofosine I 131 as a treatment
for Waldenstr m macroglobulinemia (WM)
for Phase 1 solid tumor studies; Auger-emitting radioconjugate prepared for Phase 1b; plans to submit an IND for alpha-emitting radioconjugate;
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.
the company showcased the efficacy and safety of iopofosine I 131 for the treatment of relapsed/refractory Waldenstr m 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
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.
CELLECTAR BIOSCIENCES, INC.
| 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.
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 |