Cellectar Biosciences, Inc.

Current report

Our 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 process and may find that iopofosine I 131 does not meet approval requirements. In addition, we may not be able to raise additional funds required to execute our regulatory strategy.

Current report

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 authorities 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 CLOVER 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 information are insufficient for approval. They may also disagree with the design of our proposed confirmatory study. They may require additional preclinical, clinical or other studies.

Current report

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

Current report

We may not be able to raise additional funds. If we are able to raise additional funds, such funds may not be sufficient to execute our regulatory strategy. Even if we raise funds that we believe are sufficient to 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, financial position, results of operations, prospects 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, a wind-down of operations and/or filing for 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 introduction or sale of proposed products and result in failure to achieve revenues or maintain our ongoing business” in our Annual Report on Form 10-K for the year ended December 31, 2024.

Current report

Our existing cash and cash equivalents will not be sufficient to progress CLR 125 through a Phase 1b dose finding study preliminary data readout and we will require additional funding to do so. If no additional sources of funding materialize, the Company may be required to seek other alternatives which may include, among others, the sale of assets, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection.

Current report

We do not expect that our existing cash and cash equivalents will be sufficient to progress CLR 125 through a Phase 1b dose-finding study. As such, our ability to progress through final data readout and our current operating plan will continue to depend on our ability to obtain additional funding from the sale of equity and/or debt securities, strategic transactions or other sources of capital.

Current report

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 Company is not expected to have any readouts of its 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.

Current report

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

Previous report

If the Company’s exploration of strategic alternatives is unsuccessful, its financial condition and results of operations may be materially adversely affected.