On November 10, 2026 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of cancer therapies, reported financial results for the quarter ended September 30, 2026, and provided a corporate update.
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"We remain focused on executing the clinical, regulatory and operational activities necessary to position iopofosine I 131 for potential registration and commercialization in Waldenström macroglobulinemia, and we believe our third quarter progress represents a significant step toward that goal," said James Caruso, president and chief executive officer of Cellectar Biosciences. "The new sub-analysis efficacy data presented at the International Workshop for Waldenström Macroglobulinemia (IWWM) further strengthen our confidence in the clinical profile of iopofosine I 131, demonstrating high response rates, durable outcomes and a favorable safety profile in a difficult-to-treat post-BTK inhibitor patient population, which is the same patient population being evaluated in our Phase 3 confirmatory clinical trial."
"To further maximize the long-term value of the program, we have initiated our Phase 1b dosimetry trial, which we believe offers an important opportunity to further characterize iopofosine I 131 across WM treatment settings, including first and second line. With these trials underway, a planned NDA submission in the first half of 2027, and continued advancement of our broader PDC pipeline, we believe Cellectar is entering a period of significant value creation with multiple meaningful milestones in 2027," continued Mr. Caruso.
Third 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)
Presented additional Phase 2b CLOVER-WaM data supporting the clinical profile of iopofosine I 131 in patients with relapsed/refractory Waldenström macroglobulinemia (r/r WM) following Bruton Tyrosine Kinase inhibitor (BTKi) therapy at the International Workshop for Waldenström Macroglobulinemia (IWWM). The poster presentation highlighted efficacy results from a subset of patients treated with iopofosine I 131 immediately following BTKi therapy. Patients in the analysis received a median of three prior lines of therapy (range: 2-7), including patients with TP53 mutations (17%) and MYD88 wild-type disease (29%), both of which have demonstrated lower response rates and shorter duration of response when it occurs.
Key findings from the immediately post-BTKi evaluable patients (n=24) include:
Overall Response Rate (ORR): 87.5%
Major Response Rate (MRR): 79.2%
Median Duration of Response (DoR): 16.0 months
Treatment Free Survival (TFS): 19.1 months
Clinical Benefit Rate (CBR): 100%
Safety: Treatment emergent adverse events (TEAE) occurred in less than 10% of patients, with the only Grade 3 or higher TEAE being cytopenias.
Reported plans to present three posters highlighting the durable clinical activity of iopofosine I 131 in WM at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH 2026).
The presentations will feature updated 12-month follow-up data from the Phase 2b CLOVER WaM clinical trial, including a new analysis demonstrating significantly longer duration of response among patients treated after only two prior lines of therapy compared with more heavily pretreated patients.
These findings further support the potential of iopofosine I 131 to address a substantial unmet need in relapsed or refractory WM and may support future evaluation in earlier treatment settings.
The Company will also present, for the first time, the detailed design of its confirmatory Phase 3 trial in WM patients previously treated with BTKi.
Advanced preparations for the planned Phase 3 confirmatory trial of iopofosine I 131, including activation of initial clinical trial sites.
The Phase 3 confirmatory clinical trial will be a comparator, randomized controlled trial in post-first line, post-BTKi patients (100 WM patients per arm) evaluating progression-free survival as the primary endpoint.
Remains on track to dose the first patient in the first quarter of 2027 and to submit in 1H27 a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking accelerated approval.
Initiated preparations for Phase 1b dosimetry clinical trial of iopofosine I 131 in all treatment lines in WM patients as requested by the FDA.
Supports uptake of iopofosine I 131 into cancer cells while sparing healthy tissue and organs.
The Phase 1b trial will also measure clinical activity, which is expected to provide data from 20-30 newly diagnosed and relapsed WM patients, potentially validating its potential to treat earlier lines of disease.
Reported a case study highlighting a complete response lasting more than eight years following treatment with iopofosine I 131 in a heavily pretreated patient with diffuse large B-cell lymphoma (DLBCL).
The case study described a 53-year-old patient with high-grade, double-hit DLBCL who had received four prior lines of therapy. Treatment with iopofosine I 131 resulted in a complete response by Day 85 that has been maintained for more than eight years without disease progression or additional anticancer therapy.
The Company plans to submit these findings for journal publication or presentation at a future medical meeting.
CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumor
The dose-finding Phase 1b trial evaluating CLR 125 in refractory triple-negative breast cancer (TNBC) continues to enroll. Initial dosimetry, and safety data from the dose-escalation Phase 1b trial are expected to be shared in the fourth quarter of 2026 at a medical meeting.
Phospholipid Drug Conjugate (PDC) Platform
Hosted a virtual educational webinar highlighting Cellectar’s validated PDC platform. The webinar, titled "The Platform Behind the Pipeline: Unlocking the Full Potential of Cellectar’s Phospholipid Drug Conjugate Technology" focused on the broader potential of the phospholipid ether (PLE) platform and its combinability with a wide variety of therapeutic molecules, including small-molecule chemotherapeutics, radiotherapeutics, and other molecules that utilize alternative therapeutic approaches.
A replay of the webinar can be accessed in the "News & Events" section of Cellectar’s website or accessible here.
2026 Financial Highlights
Cash and Cash Equivalents: As of September 30, 2026, the company had cash and cash equivalents of $24.6 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 September 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 September 30, 2026, were approximately $5.4 million, compared to approximately $2.5 million for the three months ended September 30, 2025. The initiation of our Phase 3 confirmatory trial of iopofosine I 131 in WM and increased activity in our ongoing Phase 1b trial of CLR 125 in TNBC were the primary drivers of the increase.
General and Administrative Expenses: G&A expenses for the three months ended September 30, 2026, were approximately $2.7 million, compared to approximately $2.3 million for the same period in 2025. The modest increase was primarily a result of increased professional fees and personnel costs.
Net Loss: The net loss attributable to common stockholders for the three months ended September 30, 2026, was $8.0 million, or $0.46 per share, compared to $4.4 million, or $1.41 per share, in the three months ended September 30, 2025.
Conference Call & Webcast Details
Cellectar management will host a conference call and webcast today, November 10, 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, NOV 10, 2026, View Source [SID1234674555])