Cellectar Biosciences, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001410578-25-001778
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001104659-25-110827
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 13 previous paragraphs and 15 current paragraphs.
10 unchanged; 2 reworded; 2 added; 0 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (2)
Current report
Although we have obtained feedback from the EMA through their scientific advice procedure, this feedback does not guarantee any particular outcome with respect to regulatory approval of iopofosine I 131.
Current report
Although during the scientific advice procedure SAWP advised that filing a CMA for iopofosine I 131 as a treatment for post-BTKi refractory patients with WM could be acceptable, this feedback is not a guarantee of final CMA approval, and we do not know how the EMA will interpret the data and results from our clinical trials and other elements of our development program. The EMA may raise issues of, for example, safety, efficacy, study conduct, bias, deviation from the protocol, statistical power and analyses, patient demographics, patient completion rates, changes in scientific or medical parameters or internal inconsistencies in the data prior to making its final decision. There is no guarantee that the EMA will not require that we conduct one or more additional clinical trials or nonclinical studies to support potential CMA approval, or that iopofosine I 131 will receive any regulatory approvals in the EU. Scientific advice is legally non-binding with regard to any future CMA application and it is beyond the remit of the SAWP to determine whether the data shows sufficient safety and efficacy for a CMA. Companies which have been provided with positive scientific advice by SAWP have ultimately failed to obtain approval of a CMA or marketing authorization for their drugs. If we do not
Reworded paragraphs (2)
Previous wording
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.
Current wording
We are including the following additional risk factors, 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 factors 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.
Previous wording
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
Current wording
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 include, among others, the sale of Company or its assets, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
obtain approval of a CMA or marketing authorization for iopofosine I 131, our business, financial position, results of operations, prospects and stock price may be materially adversely affected.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
include, among others, the sale of Company or its assets, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection.