Cellectar Biosciences Seeks Strategic Alternatives Amid Setbacks

Cellectar Biosciences, a New Jersey-based radiopharma biotech, has announced its intention to explore strategic alternatives in an effort to maximize shareholder value. This decision comes in the wake of recent setbacks, including significant layoffs and the discontinuation of its lead clinical-stage radiotherapy program.

Strategic Review Process Initiated

The company disclosed on April 30 that it is open to a wide range of options, including mergers, acquisitions, partnerships, joint ventures, and licensing arrangements. Cellectar has not set a specific timeline for this process and plans to withhold further details until deemed necessary.

This strategic review follows a challenging period for the biotech:

• In mid-December, Cellectar implemented a 60% reduction in its workforce.
• The company halted development of its sole clinical-stage radiotherapy, iopofosine I 131.
• These actions were prompted by FDA feedback indicating the need for an additional study before potential approval.

Iopofosine I 131 Development Challenges

Cellectar had been developing iopofosine I 131, a phospholipid drug conjugate, for the treatment of Waldenström macroglobulinemia (WM), a rare cancer of the bone marrow. The company had previously conducted a phase 2 trial under the assumption that positive results for major response rate as the primary endpoint could support accelerated approval.

However, the FDA later informed Cellectar that an accelerated approval submission would also require a confirmatory study to generate data on progression-free survival. This unexpected requirement led the company to pursue strategic options for the further development and commercialization of iopofosine I 131.

Market Reaction and Future Prospects

The announcement of the strategic review has had a significant impact on Cellectar's stock price, which dropped 15% from 29 cents per share to 24 cents per share following the news.

Despite these challenges, Cellectar CEO James Caruso remains optimistic about the company's potential:

"In addition to iopofosine I 131, our platform provides exciting opportunities including our alpha- and Auger-emitting radioconjugates, CLR 225 and CLR 125, respectively, in multiple solid tumor indications as well as our small molecule and oligonucleotide conjugates," Caruso stated in the release.

The company continues to search for a partner with the resources to advance the development of iopofosine I 131 and its other pipeline assets. However, previous plans to launch clinical trials for the preclinical programs CLR 225 and CLR 125 this year have been put on hold as the company navigates its current challenges.