On May 14, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, reported financial results for the quarter ended March 31, 2026, and provided a corporate update.
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"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)
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
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 (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) 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
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.
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
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
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.
(Press release, Cellectar Biosciences, MAY 14, 2026, View Source [SID1234665700])