Cellectar Biosciences Advances Iopofosine I 131 for WM, CLR 125 for TNBC.

• Cellectar Biosciences pursuing NDA submission for iopofosine I 131 in Waldenstrom Macroglobulinemia • FDA submission under accelerated approval pathway • EMA submission for conditional approval in EU expected late 3Q early 4Q 2025 • Advancing CLR 125 into Phase 1 TNBC trial in 4Q 2025 • On track with clinical trials for cancer treatment

Cellectar Biosciences, Inc. (NASDAQ: CLRB) has made significant strides in its pursuit of regulatory approval for iopofosine I 131 and CLR 125, two key radiopharmaceuticals in its pipeline. The company reported its second-quarter 2025 financial results and provided a corporate update on August 14, 2025.

Regulatory Milestones:

- FDA Submission: Cellectar is planning to submit an NDA to the FDA under the accelerated approval pathway for iopofosine I 131, a treatment for Waldenstrom Macroglobulinemia (WM). The submission will be supported by data from the Phase 2b CLOVER WaM clinical trial, which demonstrated a statistically significant major response rate compared to a null hypothesis of 20% [1]. The company expects to share new data from this trial at an upcoming medical or scientific conference.

- EMA Submission: Cellectar continues to work with the EMA toward a potential submission for conditional approval of iopofosine I 131 in the EU. The decision is expected by late in the third quarter or early in the fourth quarter of 2025 [1].

Clinical Trial Progress:

- CLR 125: Cellectar has submitted a trial protocol with the FDA for a Phase 1b Dose Finding study of CLR 125, an iodine-125 Auger-emitting drug candidate targeting solid tumors such as triple-negative breast, lung, and colorectal cancers. The company plans to advance CLR 125 into the clinic by late 2025 or early 2026 [1].

- Positive Data from iopofosine I 131: The company reported positive initial data from the Phase 1 clinical trial of iopofosine I 131 in pediatric patients with relapsed/refractory high-grade glioma (pHGG). The trial showed an average progression-free survival (PFS) of 5.4 months and an overall survival (OS) of 8.6 months, with two patients achieving an objective response [1].

Funding and Partnerships:

Cellectar raised nearly $9.5 million through separate June and July 2025 financings. The funds will be used to advance its pipeline and continue regulatory engagement and partnership discussions for iopofosine I 131. The company is also in active discussions with multiple potential partners for the regional or global licensing of iopofosine I 131 [1].

Financial Results:

- Cash and Cash Equivalents: As of June 30, 2025, Cellectar had approximately $11.0 million in cash and cash equivalents, compared to $23.3 million as of December 31, 2024. The company believes its cash balance is adequate to fund its basic budgeted operations into the second quarter of 2026 [1].

- R&D Expenses: R&D expenses for the three months ended June 30, 2025, were approximately $2.4 million, a decrease from approximately $7.3 million in the same period in 2024. This reduction was primarily driven by decreased clinical project costs and manufacturing and related costs [1].

- Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2025, was $5.4 million, compared to $0.9 million in the same period in 2024 [1].

Conclusion:

Cellectar Biosciences continues to make progress in advancing its radiopharmaceutical pipeline, with significant milestones expected in the coming quarters. The company's regulatory strategy aligns with the FDA's mission to accelerate the delivery of lifesaving medicines to patients battling rare diseases. Investors should closely monitor Cellectar's regulatory submissions and clinical trial progress for further updates.

References:
[1] https://www.globenewswire.com/news-release/2025/08/14/3133335/29076/en/Cellectar-Biosciences-Reports-Second-Quarter-2025-Financial-Results-and-Provides-a-Corporate-Update.html