Form 8-K

8-K — Cellectar Biosciences, Inc.

Accession: 0001104659-26-095460

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0001279704

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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2026-08-13

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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):

August 13, 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 August 13, 2026, we issued

a press release announcing our financial results for the quarter ended June 30, 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 August 13, 2026, titled “Cellectar Biosciences Reports Second 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: August 13, 2026

By:

/s/ Chad J. Kolean

Name:

Chad J. Kolean

Title:

Chief Financial Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2623056d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Cellectar Biosciences

Reports Second Quarter 2026 Financial Results and Provides Corporate Updates

Site Activation Initiated for Confirmatory Phase 3 Study of Iopofosine

I 131 with New Drug Application Submission Planned for mid-2027 under the FDA's Accelerated Approval Program

Presented Data from CLOVER WaM Trial of Iopofosine

I 131 in relapsed/refractory Waldenström Macroglobulinemia (r/r WM) at the American Society of Clinical Oncology 2026 Annual Meeting

Initiated Enrollment and Dosed First Patients

in Phase 1b Clinical Trial of CLR 125 in Triple Negative Breast Cancer

Announced Publication of Phase 1 Data in Peer-Reviewed

Journal Cancers

Company to Hold Webcast and Conference Call

at 8:30 AM ET Today

FLORHAM PARK, N.J., August 13, 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 June 30, 2026, and provided a corporate

update.

“Our second quarter marked another period of significant execution

as we continued to advance multiple programs across our oncology pipeline while laying the foundation for several important near-term

catalysts,” said James Caruso, president and chief executive officer of Cellectar. “Most notably, we progressed our regulatory

strategy for iopofosine I 131 in Waldenström macroglobulinemia, including initiation of site activation activities for our confirmatory

Phase 3 trial, which is an important first step toward our accelerated approval application in the U.S., which we plan to submit in mid-2027.

The compelling data we continue to generate from the Phase 2b CLOVER WaM study reinforce our belief that iopofosine has the potential

to address a critical unmet need for WM patients, including those previously treated with BTK inhibitors and prior to off-label salvage

therapies.”

“At the same time, we continued to expand the clinical validation

of our proprietary PDC platform, achieving key enrollment and dosing milestones in our CLR 125 Phase 1b trial in triple-negative breast

cancer and advancing our broader radiopharmaceutical portfolio. Supported by a strengthened balance sheet and a clear operational roadmap,

we are entering the second half of 2026 with strong momentum, multiple anticipated data and development milestones, and a steadfast commitment

to creating long-term value for patients and stockholders.”

Second 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 Presented data from the CLOVER WaM study of iopofosine I 131 in relapsed/refractory Waldenström macroglobulinemia (r/r WM)

patients at the American Society of Clinical Oncology 2026 Annual Meeting (ASCO). The poster presentation highlighted efficacy results

from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor (BTKi) therapy, which consisted

of two cycles administered at 15 mCi/m2 on days 1 and 15 of each 57-day cycle. Major response rate (MRR) was the primary efficacy

endpoint, while the subset analysis also assessed a modified intent-to-treat (mITT) population who were immediately post-BTKi treatment.

§ Efficacy from the evaluable patients (n=24) included:

· 100% clinical benefit rate

· 87.5% overall response rate (ORR)

· 79.2% MRR, partial response (PR) or better

· Median duration of response (DOR) of 16 months

(range: 7.3-25.4 months)

· 20% of patients exceeded 30 months DOR

§ Treatment was well-tolerated with a manageable toxicity profile with cytopenias

as the only Grade 3 or greater adverse event.

o Advanced preparations for the Phase 3 confirmatory trial of iopofosine I 131 and began site initiation activities. Sites are

expected to begin opening in the coming months with first patient to be dosed in early 2027.

§ The Phase 3 study will be a comparator, randomized controlled study with

approximately 100 WM patients per arm; full patient enrollment is projected within 18-24 months of the first patient admitted to the study.

§ The New Drug Application is planned for submission in mid-2027 under the

FDA’s Accelerated Approval Program. Based on the Breakthrough Therapy Designation awarded to iopofosine I 131 for r/r WM, an approximate

6-month review is anticipated.

o Published results from a Phase 1 dose-escalation study of iopofosine I 131 in combination with low-dose dexamethasone in patients

with heavily pretreated relapsed/refractory multiple myeloma (r/r MM) in the peer-reviewed journal, Cancer.

§ Among 26 efficacy-evaluable patients, iopofosine I 131 achieved disease control

in 84.6% of patients and an ORR of 15.4%, including four partial responses, with evidence of enhanced clinical activity at higher administered

doses and a 30% ORR among evaluable patients receiving at least 60 mCi.

§ Treatment was generally well tolerated, with a favorable safety profile consisting

primarily of predictable and reversible hematologic toxicities, no new safety signals, and mostly low-grade non-hematologic adverse events.

§ Given that iopofosine I 131’s mechanism of action is not dependent

on a single target or mutation, the company believes these and other data underscore its potential to address a broad range of B-cell-mediated

malignancies, including WM, MM, diffuse large B-cell lymphoma and other difficult-to-treat hematologic cancers where new therapeutic options

are needed.

· CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for

solid tumor

o Initiated enrollment and dosing of the first patients in the Phase 1b trial evaluating CLR 125 in refractory triple negative breast

cancer (TNBC).

· Phospholipid Drug Conjugate (PDC) Platform

o On August 18th, Cellectar management will host a virtual educational webinar highlighting its validated PDC platform.

The webinar will highlight the company’s Phospholipid Drug Conjugates’ (PDCs)™ ability to target and gain intracellular

access to most primary tumors, metastatic sites, and cancer stem cells and will underscore how this approach may enhance drug efficacy

and simultaneously minimize side effects for patients.

o The event will showcase how this next-generation proprietary PLE delivery platform was engineered to be conjugated (combined) with

a wide variety of therapeutic molecules, such as small-molecule chemotherapeutics, radiotherapeutics, and other molecules that utilize

alternative therapeutic approaches.

o Details of the webinar are below:

§ Date: August 18th, 2026

§ Time: 11:30 am – 12:30 pm ET

§ Registration

Link: HERE

· Corporate

o In May 2026, the company entered into a securities purchase agreement with certain institutional investors and members of executive

management to issue and sell an aggregate of approximately $35 million upfront and up to $105 million 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. Proceeds from this financing will primarily be used to fund the Phase 3 confirmatory study of iopofosine I 131 in WM.

2026 Financial Highlights

· Cash and Cash Equivalents: As of June 30, 2026, the company

had cash and cash equivalents of $34.0 million, compared to $13.2 million as of December 31, 2025, which reflects net proceeds of

approximately $31.7 million from the May 2026 offering. The company believes its cash balance as of June 30, 2026, is adequate

to fund its budgeted operations into the second quarter of 2027.

· Research and Development Expenses: R&D expenses for the three

months ended June 30, 2026, were approximately $4.6 million, compared to approximately $2.4 million for the three months ended June 30,

2025. The initiation of the WM confirmatory iopofosine I 131 and CLR 125 Triple Negative Breast Cancer studies drove the increase.

· General and Administrative Expenses: G&A expenses for the

three months ended June 30, 2026, were approximately $2.6 million, compared to approximately $3.6 million for the same period in

2025. The decrease was primarily a result of reduced commercialization efforts, professional fees, and lower personnel costs.

· Net Loss: The net loss attributable to common stockholders for the

three months ended June 30, 2026, was $6.9 million, or $0.57 per share, compared to $5.4 million, or $3.39 per share, for the three

months ended June 30, 2025.

Conference Call & Webcast Details

Cellectar management will host a conference call and webcast today,

August 13, 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 year ended December 31, 2025, and our Form 10-Q

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 FOLLOW +++

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

June 30,

December 31,

2026

2025

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

$ 33,993,982

$ 13,196,033

Prepaid expenses and other current assets

883,659

842,432

Total current assets

34,877,641

14,038,465

Property, plant & equipment, net

304,173

549,405

Operating lease right-of-use asset

1,433,706

360,671

Other long-term assets

23,566

29,780

TOTAL ASSETS

$ 36,639,086

$ 14,978,321

LIABILITIES AND STOCKHOLDERS’ EQUITY

CURRENT LIABILITIES:

Accounts payable and accrued liabilities

$ 5,218,681

$ 4,423,548

Warrant liability

17,000

226,000

Lease liability, current

2,030

100,189

Total current liabilities

5,237,711

4,749,737

Lease liability, net of current portion

1,529,542

309,397

TOTAL LIABILITIES

6,767,253

5,059,134

COMMITMENTS AND CONTINGENCIES (Note 7)

MEZZANINE EQUITY:

Series D preferred stock, 111.11 shares authorized, 0.00 and 111.11 issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

—

1,382,023

STOCKHOLDERS’ EQUITY:

Series E-2 preferred stock, 1,225 shares authorized; 0.00 and 35.60 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

—

520,778

Common stock, $0.00001 par value; 170,000,000 shares authorized; 8,252,108 and 4,240,129 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

Additional paid-in capital

311,589,849

277,149,844

Accumulated deficit

(281,718,099 )

(269,133,500 )

Total stockholders’ equity

29,871,833

8,537,164

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$ 36,639,086

$ 14,978,321

CELLECTAR BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

Three Months Ended June 30,

Six Months Ended June 30,

2026

2025

2026

2025

OPERATING EXPENSES:

Research and development

$ 4,557,383

$ 2,389,801

$ 7,564,612

$ 5,816,896

General and administrative

2,638,629

3,647,728

5,425,341

6,621,624

Total operating expenses

7,196,012

6,037,529

12,989,953

12,438,520

LOSS FROM OPERATIONS

(7,196,012 )

(6,037,529 )

(12,989,953 )

(12,438,520 )

OTHER INCOME (EXPENSE):

Gain (loss) on valuation of warrants

132,000

501,598

209,000

161,598

Interest income

133,359

88,020

196,355

224,982

Total other income (expense)

265,359

589,618

405,355

386,580

NET LOSS

$ (6,930,653 )

$ (5,447,911 )

$ (12,584,598 )

$ (12,051,940 )

NET LOSS PER SHARE — BASIC

$ (0.57 )

$ (3.39 )

$ (1.52 )

$ (7.66 )

NET LOSS PER SHARE — DILUTED

$ (0.57 )

$ (3.39 )

$ (1.52 )

$ (7.66 )

WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — BASIC

12,231,851

1,608,799

8,258,067

1,572,598

WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING — DILUTED

12,231,851

1,608,799

8,258,067

1,572,598

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Namespace Prefix:

dei_

Data Type:

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Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

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:

Period Type:

duration

- 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:

Period Type:

duration