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Cellectar Biosciences’ Phospholipid Drug Conjugate Platform with its Unique Mechanism of Action Targets Lipid Rafts and Specialized Microdomains Prevalent Across Virtually All Cancer Cell Typed
Jim Caruso, President/CEO
Cellectar Biosciences, Inc.
NASDAQ: CLRB
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Interview conducted by:
Lynn Fosse, Senior Editor
CEOCFO Magazine
Published – August 17, 2026
CEOCFO: Tell me a bit about Cellectar Biosciences and what you think the key driver of value is over time—both near-
Mr. Caruso: Cellectar is focused on the research & development of rare adult & pediatric oncology diseases. The Foundation of our strategy is our proprietary Phospholipid Ether or PLE delivery platform. This platform has been validated in both pre-
One of the most important findings from our work to date is that, regardless of the oncology payloads attached, whether therapeutic or imaging, our conjugates consistently retain their unique tumor-
Given our extensive experience with and confidence in the platform, we believe the PLE technology represents the Company’s significant long-
In terms of near-
Beginning with iopofosine, the therapeutic payload is iodine 131, a beta-
Our lead clinical development program is in Waldenstrom’s Macroglobulinemia (WM), where we are actively preparing for the initiation of a Phase 3 confirmatory study, which we expect to begin in the fourth quarter of this year.
We are also very excited about CLR 125, our Auger-
As a result, this study should generate highly informative data that will validate CLR 125’s TNBC targeting capabilities while helping define the optimal dose and regimen for future Phase 2 development.
Finally, I would also mention CLR 225, our actinium-
CEOCFO: Please share the topline performance of CLR 131 in the Phase 2b study and the status of the CLR 131 confirmatory study in WM along with key milestones and timeline to a potential FDA approval?
Mr. Caruso: Simply put, the Phase 2b results for iopofosine were exceptional and generated considerable enthusiasm within the WM community. Importantly, this was a very difficult-
The primary study endpoint was Major Response Rate (MRR) and the FDA established an MRR target of 20%. Impressively, iopofosine nearly tripled that benchmark, achieving an MRR of just under 60%. Just as importantly, both the duration of response and progression-
Today, our focus is on the WM confirmatory study. We are actively engaged in start-
From a timeline perspective, we anticipate enrolling the first patient in early 2027. We are also planning to submit our New Drug Application (NDA) under the accelerated approval pathway during the first half of 2027. Given iopofosine’s FDA Breakthrough Therapy designation in WM, we believe the review period could be approximately six months, potentially supporting approval in late 2027 or early 2028.
CEOCFO: In recent years, radiopharmaceuticals have been “hot” with multiple big pharma buyouts and the transition to some very successful commercial products, how is Cellectar different from and better than some of these successful therapeutic approaches?
Mr. Caruso: I agree. Interest in radiopharmaceuticals remains extremely strong, both among investors and across the pharmaceutical industry. While current radiotherapeutics have demonstrated meaningful clinical impact, there is also considerable excitement surrounding the next generation of targeted radiotherapeutics.
What differentiates Cellectar is our Phospholipid Drug Conjugate platform and its unique mechanism of action. Our technology targets lipid rafts, specialized microdomains that are highly prevalent across virtually all cancer cell types. As lipid rafts are broadly expressed in cancer, they represent a potentially universal targeting mechanism.
This universal targeting capability allows Cellectar to utilize the same delivery platform across multiple cancer types. Rather than redesigning the targeting component for every indication, we can optimize the therapeutic payload for a specific disease. This approach has the potential to reduce development timelines, lower costs and mitigate clinical development risk.
With respect to commercially successful radiotherapeutics, we believe iopofosine has the potential to become an important future treatment option for patients with WM.
Waldenström's macroglobulinemia is a rare, incurable blood cancer affecting approximately 26,000 patients in the United States. The disease is typically diagnosed in patients in their mid-
CEOCFO: Over the years, radiopharmaceuticals have had issues with manufacturing and supply chain constraints. How is Cellectar positioned in terms of supply and what are you doing to ensure your ongoing supply chain?
Mr. Caruso: That is a very fair observation. We have been highly focused on addressing the manufacturing and supply chain challenges that have affected portions of the radiopharmaceutical industry. To mitigate those risks, we have established a manufacturing and supply chain strategy built around redundancy and flexibility. We have secured supply agreements with multiple vendors for critical raw materials and key components required for finished product manufacturing.
In addition, we utilize several contract manufacturing organizations strategically located across major geographic regions. This distributed network is designed to support global product distribution and enable delivery of finished product within approximately 48 hours.
CEOCFO: What’s next for Cellectar beyond the three key oncology programs and why should investors pay attention?
Mr. Caruso: First and foremost, we believe our current clinical programs already represent significant opportunities for shareholder value creation. Our top priority is the successful execution of the Phase 3 confirmatory study in WM. An approval in WM would be transformative for Cellectar, establishing our first commercial product and validating our platform in a meaningful way.
Following approval, we believe iopofosine’s differentiated product profile, combined with the significant unmet need in WM and the scalable nature of the market opportunity, could support rapid physician adoption and patient utilization.
Beyond WM, we see compelling opportunities to expand iopofosine into related B-
We also view the ongoing CLR 125 study in triple-
Ultimately, while investors are likely to recognize the value potential associated with iopofosine and CLR 125, we believe the greatest long-
As our resources and timing allow, we intend to expand beyond radioisotopes and explore additional payload classes, including small molecules, mRNA, siRNA, protein degraders, and peptides. By combining these therapeutic modalities with our targeted delivery technology, we believe we have the potential to unlock a much broader oncology opportunity and fully realize the promise of our platform.
Cellectar Biosciences, Inc. | Phospholipid Drug Conjugate | PDC | NASDAQ: CLRB | Jim Caruso | Cellectar Biosciences’ Phospholipid Drug Conjugate Platform with its Unique Mechanism of Action Targets Lipid Rafts and Specialized Microdomains Prevalent Across Virtually All Cancer Cell Typed | CEO Interviews 2026 | Medical Companies | Public Company | Clinical Trial Opportunity for Triple-