Cellectar Biosciences Inc

Item 1A. Risk Factors

We are including the following additional risk factor, which should be read in conjunction with our description of risk factors provided in Part I, Item 1A. Risk Factors in our Annual Report on Form 10-K filed with the SEC on March 13, 2025.. The risk factor below and the risk factors in our Annual Report on Form 10-K filed with the SEC on March 13, 2025 should be considered carefully, together with other information in this report and other reports and materials we file with the SEC.

If the Companys exploration of strategic alternatives is unsuccOur regulatory strategy may not result in the approval of iopofosine I 131 by the FDA, EMA or any other regulatory authority. Regulatory authorities have substantial discretion in the approval processful, its financial cond and may find that iopofosine I 131 does not meet approval requirements. In addition, we may not be able to raise addition andal funds results of operations may be materially adverselquired to execute our regulatory strategy.

We plan to submit an NDA to the FDA for accelerated approval of iopofosine I 131 for the treatment of WM patients that have received two prior lines of therapy, including a BTKi. We are also continuing our dialogue with the EMA regarding a possible conditional marketing approval submission. FDA, EMA and other regulatory affected.

As previously announced,uthorities have substantial discretion in the drug approval process. They may refuse to file, refuse to review, or reject our NDA, or equivalent application, for a variety of reasons. They may determine that the Company has engaged a financial advisor to assist itLOVER WaM trial or our other clinical trials for iopofosine I 131 did not meet safety and efficacy endpoints, even if we believe the trials did. They may decide that our data, sample size, trial design and other in eformation are insufficient for approvaluating potential. They may also disagree with the design of our proposed confirmatory strategic alternatives to enhance stockholder value. Sudy. They may require additional preclinical, clinical or other studies.

Our existing cash and cash equivalents are not sufficient to execute our regulatory strategic alternatives y. We view raising additional funds as a precursor to submission of an NDA and initiation of our proposed confirmatory study. Additional funder s will also be required to consideration tinue our potential EMA approval process.

We may not be able to raise additional funds. If we are able to raise additional funds, such funds may include, but are not limitednot be sufficient to execute our regulatory strategy. Even if we raise funds that we believe are sufficient to mergers, acquisitions, execute our regulatory strategy, the FDA, EMA and other regulatory authorities may not approve iopofosine I 131. If we are unable to execute our regulatory strategy, our business combin, financial position, results of operations, partnerships, joint venturerospects and stock price may be materially adversely affected and we may be required to seek other alternatives which may include, among others, the sale of the Company or its assets, discontinuance of certain operations, licensia wind-down of operations and/or filing arrangements or other strategic transafor bankruptcy protection. See also Failure to complete the development of our technologies, obtain government approvals, including required FDA approvals, or comply with ongoing governmental regulations could prevent, delay or limit introductions. The Company  or sale of proposed products and its financiresult in failure to achieve revenues or maintain our ongoing business in our Annual advisor have engaged in Report on Form 10-K for the year ended December 31, 2024.

Our existing cash and cash equivalents will not be sufficient to progress CLR 125 through a Phase 1b dose finding study preliminary discussions with potentiata readout and we will require additional funding to do so. If no additional counsources of funding materpartiialize, the Company may be required to seek other alternatives but which may include, among othere is nos, the sale of assurets, discontinuance that the potential strategic alternativeof certain operations, a wind-down of operations and/or filing for bankruptcy protection.

We do not expect that our existing cash and cash equivalents will lead to a debe sufficient to progress CLR 125 through a Phase 1b dose-finitive ading study. As such, our ability to progreement. If the Company is unabless through final data readout and our current operating plan will continue to depend on our ability to consummate a stobtain additional funding from the sale of equity and/or debt securities, strategic transaction,s or if othere is any significant delay in closing such a transaction, sources of capital.

Our ability to obtain additional funding on acceptable terms or at all is subject to a variety of risks and uncertainties outside of our control. Those risks and uncertainties are further exacerbated since the Companys financial condition and is not expected to have any resuladouts of operations may be materially adits data from the Phase 1b dose finding study of CLR 125 in close proximity to the time when it may need to seek additional funding.

The Company plans to continue actively pursuing additional funding, howeversely affect, there can be no assurance that such additional funding can be obtained. Inf no additional sources of funding materialize, the Company may be required to seek other alternatives which may

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include, among others, the sale of the Company or its assets, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection.