Oppenheimer keeps Perform rating on Cellectar Biosciences stock on recent update

EditorNatashya Angelica
Published 2025-01-13, 08:52 a/m
CLRB
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On Monday, Oppenheimer reaffirmed its Perform rating for Cellectar Biosciences (NASDAQ:CLRB) shares, a micro-cap biotech currently valued at $11.65 million, following the company's recent update on its lead Iopofosine I131 program for Waldenstrom's macroglobulinemia (WaM).

The announcement, made on Sunday, outlined the ongoing discussions with regulatory authorities and forecasted a defined regulatory pathway in the first half of 2025. According to InvestingPro data, the stock has experienced significant volatility, falling over 90% in the past year.

Cellectar Biosciences disclosed that the estimated costs for the confirmatory study of Iopofosine I131 might be lower than previously expected, with projections now set between $30-35 million. This potential reduction in costs could allow the company to manage the program internally without seeking external partnerships or support. InvestingPro analysis indicates that while the company holds more cash than debt on its balance sheet, it's quickly burning through its cash reserves.

In addition to the program cost updates, Cellectar Biosciences announced an extension of its financial runway. The company's existing funds are now expected to sustain operations into the fourth quarter of 2025, marking an extension by one quarter from prior estimates.

Oppenheimer's commentary on the update emphasized a cautious stance, suggesting that a clear direction for the Iopofosine I131 program is necessary before considering a change in the stock's rating. The firm indicated that it will remain on the sidelines until more definitive information is available regarding the program's trajectory.

Cellectar Biosciences is set to present further details at the Biotech Showcase in San Francisco, which is scheduled for Tuesday. This event may provide additional insights into the company's strategic plans and progress with its lead program.

In other recent news, Cellectar Biosciences has been making significant strides in its oncology programs. The company is exploring strategic options for the development and commercialization of its late-stage clinical program, iopofosine I 131, following discussions with the U.S. Food and Drug Administration. Meanwhile, Cellectar is shifting its focus towards advancing its radiotherapeutic assets, particularly its alpha- and Auger-emitting radioconjugates, into Phase 1 clinical studies for solid tumors.

The company has also been in ongoing discussions with the FDA regarding a possible required confirmatory trial, which is expected to delay the New Drug Application filing from late 2024 to early 2025.

Cellectar Biosciences has taken corrective action to rectify an omission in its Annual Report, ensuring compliance with Securities and Exchange Commission regulations. The company also secured a 10-year supply of actinium-225 from NorthStar Medical (TASE:PMCN) Radioisotopes, a critical component for its CLR 121225 development program.

Lastly, Cellectar is preparing a New Drug Application for its primary drug candidate, iopofosine I 131, which has demonstrated significant response rates in a pivotal trial for treating Waldenström's macroglobulinemia. These recent developments underscore the company's progress in the biopharmaceutical sector.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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