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Risk Factors in our Annual Report on Form 10-K filed with the SEC on March 4, 2026.
−Removed: 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.
+Added: The risk factor below and the risk factors in our Annual Report on Form 10-K filed with the SEC on March 4, 2026 should be considered carefully, together with other information in this report and other reports and materials we file with the SEC.
Our regulatory strategy may not result in the approval of iopofosine I 131 by the FDA, EMA or any other regulatory authority.
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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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: The Company plans to continue actively pursuing additional funding, however, there can be no assurance that such additional funding can be obtained.
−Removed: 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.
+Added: If we do not 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.
Unregistered Sales of Equity Securities and Use of Proceeds
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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.