Full Press Release Details
Cellectar Biosciences
Reports First Quarter 2026 Financial Results and Provides Corporate Updates
12-month Follow-on Data for Iopofosine I 131 in relapsed/refractory Waldenstr m Macroglobulinemia (r/r WM)
of up to $140 Million to Support Initiation of Confirmatory Study of Iopofosine I 131 in r/r WM and Subsequent U.S. FDA Filing for Accelerated
from r/r WM Patients in CLOVER-WaM Phase 2b Study Treated with Iopofosine I 131 Immediately Following BTK Inhibitor Therapy Selected
for Presentation at ASCO 2026
Dosed First Patients
in Phase 1b Dose Finding Study for CLR 125 in Triple Negative Breast Cancer with Early Dosimetry, Safety and Efficacy Data Expected Mid-year
Webcast and Conference Call at 8:30 AM ET Today
FLORHAM PARK, N.J., May 14,
2026 (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 March 31,
2026, and provided a corporate update.
"The first part of 2026 was a
pivotal period for Cellectar as we executed across our pipeline and capital strategies to position the company for value creation,"
said James Caruso, president and chief executive officer of Cellectar. "With the support of industry-leading healthcare focused
investors, we successfully completed a financing of up to $140 million, providing the necessary resources to advance iopofosine through
key U.S. regulatory milestones and potential commercialization. The recently reported positive 12-month follow-on data from our CLOVER
WaM study reinforce our confidence that iopofosine can provide meaningful patient benefits and meet regulatory expectations, supporting
our plans to initiate a Phase 3 confirmatory study and file for accelerated approval with the FDA," Mr. Caruso continued.
"In parallel, we expanded our
radio-conjugate pipeline with the enrollment of the first patients in our Phase 1b study of CLR 125 in triple negative breast cancer,
a challenging solid tumor cancer with a substantial unmet medical need. Together, these advances underscore the strength of our radiopharmaceutical
platform and potential to deliver meaningful new treatment options to patients battling a variety of difficult-to-treat cancers,"
concluded Mr. Caruso.
First Quarter 2026 and Recent Corporate
| Overall response rate (ORR): 83.6% | ||
| Median progression-free survival (PFS): 13.5 months | ||
| Very good partial response/complete response rate (VGPR/CR): 14.5% | ||
| Disease control rate (DCR):98.2 |
| Title: "Iopofosine I-131 after BTK inhibitors in Waldenstr m macroglobulinemia: CLOVER-WaM subgroup efficacy and safety" | ||
| Poster: 592 | ||
| Date/Time: June 1, 2026, 9:00 AM - 12:00pm CDT | ||
| Presenter: Jarrod Longcor |
2026 Financial Highlights
Conference Call & Webcast
Cellectar management will host a conference
call and webcast today, May 14, 2026, 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 iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been
tested in Phase 2b trials as a treatment for relapsed or refractory Waldenstr m Macroglobulinemia (WM), in relapsed or refractory
multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in 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 granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various
cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation.
Cellectar is also developing CLR 121125
(CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal
cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase
2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid
In addition to these assets, the Cellectar
team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need,
such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
For more information, please visit https://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 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 quarterly period ended March 31, 2026. 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.
CONDENSED CONSOLIDATED
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 8,347,090 | $ | 13,196,033 | ||||
| Prepaid expenses and other current assets | 920,038 | 842,432 | ||||||
| Total current assets | 9,267,128 | 14,038,465 | ||||||
| Property, plant & equipment, net | 339,697 | 549,405 | ||||||
| Operating lease right-of-use asset | 1,483,156 | 360,671 | ||||||
| Other long-term assets | 29,780 | 29,780 | ||||||
| TOTAL ASSETS | $ | 11,119,761 | $ | 14,978,321 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accrued liabilities | $ | 4,724,826 | $ | 4,423,548 | ||||
| Warrant liability | 149,000 | 226,000 | ||||||
| Lease liability, current | - | 100,189 | ||||||
| Total current liabilities | 4,873,826 | 4,749,737 | ||||||
| Lease liability, net of current portion | 1,528,825 | 309,397 | ||||||
| TOTAL LIABILITIES | 6,402,651 | 5,059,134 | ||||||
| COMMITMENTS AND CONTINGENCIES (Note 7) | ||||||||
| MEZZANINE EQUITY: | ||||||||
| Series D preferred stock, 111.11 shares authorized, issued and outstanding as of March 31, 2026 and December 31, 2025 | 1,382,023 | 1,382,023 | ||||||
| STOCKHOLDERS' EQUITY: | ||||||||
| Series E-2 preferred stock, 1,225.00 shares authorized; 35.60 shares issued and outstanding as of March 31, 2026 and December 31, 2025 | 520,778 | 520,778 | ||||||
| Common stock, $0.00001 par value; 170,000,000 shares authorized; 4,240,129 shares issued and outstanding as of March 31, 2026 and December 31, 2025 | 42 | 42 | ||||||
| Additional paid-in capital | 277,601,713 | 277,149,844 | ||||||
| Accumulated deficit | (274,787,446 | ) | (269,133,500 | ) | ||||
| Total stockholders' equity (deficit) | 3,335,087 | 8,537,164 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 11,119,761 | $ | 14,978,321 |
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| OPERATING EXPENSES: | ||||||||
| Research and development | $ | 3,007,229 | $ | 3,427,095 | ||||
| General and administrative | 2,786,713 | 2,973,896 | ||||||
| Total operating expenses | 5,793,942 | 6,400,991 | ||||||
| LOSS FROM OPERATIONS | (5,793,942 | ) | (6,400,991 | ) | ||||
| OTHER INCOME (EXPENSE): | ||||||||
| Gain (loss) on valuation of warrants | 77,000 | (340,000 | ) | |||||
| Interest income | 62,996 | 136,962 | ||||||
| Total other income (expense) | 139,996 | (203,038 | ) | |||||
| NET LOSS | $ | (5,653,946 | ) | $ | (6,604,029 | ) | ||
| NET LOSS PER SHARE - BASIC AND DILUTED | $ | (1.33 | ) | $ | (4.30 | ) | ||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING - BASIC AND DILUTED | 4,240,129 | 1,535,995 |