AI Earnings Predictions for Cellectar Biosciences Inc. (CLRB)

EX-99.1

2 tm2623056d1_ex99-1.htm

EXHIBIT 99.1

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)

oPresented 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.

oAdvanced 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.

oPublished 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 re

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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): March 4, 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 March 4, 2026, we issued a press release announcing our financial results for the year ended December 31, 2025 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 March 4, 2026, titled “Cellectar Biosciences Reports Financial Results for Year Ended 2025 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: March 4, 2026 By: /s/ Chad J. Kolean

Name: Chad J. Kolean

Title: Chief Financial Officer