Form 8-K
8-K — Cellectar Biosciences, Inc.
Accession: 0001104659-26-060693
Filed: 2026-05-14
Period: 2026-05-14
CIK: 0001279704
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Results of Operations and Financial Condition
Item: Financial Statements and Exhibits
Documents
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EX-99.1 — EXHIBIT 99.1 (tm2614602d1_ex99-1.htm)
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0001279704
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
May 14, 2026
Cellectar Biosciences, Inc.
(Exact name of Registrant as Specified in its
Charter)
Delaware
1-36598
04-3321804
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
100
Campus Drive, Florham Park, NJ, 07932
(Address of principal executive offices) (Zip
Code)
Registrant’s telephone number, including
area code: (608) 441-8120
N/A
(Former Name or Former Address, if Changed
Since Last Report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
General Instruction A.2. below):
¨ Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange
on which registered
Common
Stock, par value $0.00001 per share
CLRB
The Nasdaq
Capital Market
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ¨
Item 2.02.
Results of Operations and Financial Condition.
On May 14, 2026, we issued
a press release announcing our financial results for the quarter ended March 31, 2026, and provided a corporate update. A copy of
the press release is furnished as Exhibit 99.1 and is incorporated by reference herein.
Item 9.01.
Financial Statements and Exhibits
(d) Exhibits
Number
Title
99.1
Press release dated May 14, 2026, titled “Cellectar Biosciences Reports First Quarter 2026 Financial Results and Provides Corporate Updates”
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CELLECTAR BIOSCIENCES, INC.
Date: May 14, 2026
By:
/s/ Chad J. Kolean
Name:
Chad J. Kolean
Title:
Chief Financial Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2614602d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
Cellectar Biosciences
Reports First Quarter 2026 Financial Results and Provides Corporate Updates
Announced Positive
12-month Follow-on Data for Iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia (r/r WM)
Completed Financing
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
Approval
Efficacy Results
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
2026
Company to Hold
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
Highlights
· Iopofosine
I 131, the company’s Phospholipid Drug Conjugate (PDC) designed to provide targeted
delivery of iodine-131 (radioisotope)
o Reported
positive 12-month follow-up data from all patients in the Phase 2b CLOVER WaM study evaluating
iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia, which demonstrated
strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients. The minimum
12-month follow-up data aligns with the expectations set by the U.S. Food and Drug Administration
(FDA) and positions the company for accelerated approval submission and the initiation of
the confirmatory study.
§ Notably,
the primary and secondary endpoints were both achieved in the protocol study population (n=55),
with 61.8% achieving a major response rate (MRR) and a median duration of response (DoR)
of 17.8 months. Additional data points included:
· 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
o Selected
to present data from the CLOVER WaM study of iopofosine I 131 in r/r WM patients at the upcoming
American Society of Clinical Oncology Annual Meeting (ASCO) taking place May 29
- June 2, 2026. The poster presentation will highlight efficacy results from a subset
of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor
(BTKi) therapy. Details of the poster presentation are as follows:
§ Title:
“Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM
subgroup efficacy and safety”
§ Poster:
592
§ Date/Time:
June 1, 2026, 9:00 AM – 12:00pm CDT
§ Presenter:
Jarrod Longcor
o Advancing
plans to initiate a Phase 3 confirmatory trial of iopofosine I 131 as a treatment for WM
and file for accelerated approval with the U.S. FDA in alignment with the FDA requirements.
This Phase 3 study will be a comparator, randomized controlled study with approximately 100
WM patients per arm, with full patient enrollment projected within 18-24 months of the first
patient admitted to the study.
o Continuing
to work with the European Medicines Agency (EMA) to file for a Conditional Marketing Approval
(CMA) for iopofosine I 131 as a treatment option for post-BTKi refractory patients with
WM.
· CLR
121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors
o Announced
the enrollment of the first patient in the Phase 1b trial evaluating CLR 125 in refractory
triple negative breast cancer (TNBC). The Company anticipates activating additional study
sites throughout the second quarter and will provide dosimetry, safety and efficacy updates
in the second quarter and throughout the balance of 2026.
· Corporate
o In
May 2026, the Company entered into a securities purchase agreement with certain institutional
investors to issue and sell an aggregate of approximately $35 million upfront and up to $105
million of milestone-based securities in a registered direct offering of common stock and
a concurrent private placement of common stock, pre-funded warrants and milestone-based warrants.
§ The
oversubscribed financing was led by Nantahala Capital, with participation from Balyasny Asset
Management, Caligan Partners, Janus Henderson Investors, SilverArc Capital Management and
other dedicated healthcare funds. In connection with the Offering, Andrew Gu of Nantahala
Capital Management, LLC will join Cellectar’s Board of Directors.
2026 Financial Highlights
· Cash
and Cash Equivalents: As of March 31, 2026, the company had cash and cash equivalents
of $8.3 million, compared to $13.2 million as of December 31, 2025, which does not reflect
net proceeds of approximately $31 million from the May 2026 offering. The company believes
its cash balance as of March 31, 2026, along with funds from the May 2026 financing,
are adequate to fund its budgeted operations into the second quarter of 2027, including the
initiation costs for the iopofosine I 131 confirmatory study in WM.
· Research
and Development Expenses: R&D expenses for the three months ended March 31,
2026, were approximately $3.0 million, compared to approximately $3.4 million for the three
months ended March 31, 2025. The overall decrease was primarily a result of reduced
clinical and preclinical study costs, partially offset by increased spending for product
manufacturing processes.
· General
and Administrative Expenses: G&A expenses for the three months ended March 31,
2026, were approximately $2.8 million, compared to approximately $3.0 million for the same
period in 2025. The decrease was primarily a result of reduced personnel costs.
· Net
Loss: The net loss attributable to common stockholders for the three months ended March 31,
2026, was $5.7 million, or $1.33 per share, compared to $6.6 million, or $4.30 per share,
in the three months ended March 31, 2025.
Conference Call & Webcast
Details
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 Waldenström 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
tumor growth.
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.
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
+++ TABLES TO
FOLLOW +++
CELLECTAR BIOSCIENCES, INC.
CONDENSED CONSOLIDATED
BALANCE SHEETS
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
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May 14, 2026
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Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
Name:
dei_TradingSymbol
Namespace Prefix:
dei_
Data Type:
dei:tradingSymbolItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration