CLRB — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-14

• The Company is primarily focused on the development of its radioconjugate PDC programs, also known as phospholipid radioconjugates or PRCs, designed to provide targeted delivery of a radioisotope directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiat…

• On June 4, 2025, the Company announced that the U.S Food and Drug Administration (the “FDA”) granted Breakthrough Therapy Designation for iopofosine I 131, as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM). On October 6, 2025, the Company…

• ●Iopofosine, a beta-emitting iodine-131 PRC, was studied in our CLOVER WaM Phase 2 study of iopofosine in patients with r/r WM where it was observed to result in statistically significant outcomes on both primary and secondary endpoints, and our Phase 2b studies in r/r multiple myeloma (MM) patients…

• ●CLR 125, an Auger-emitting PRC, utilizes iodine-125 as its radiation source and has been observed to show tolerability with minimal toxicities in animal models. Additionally, the Company observed CLR 125 to have good activity in multiple solid tumor models, especially in TNBC. Auger emitters provid…

• ●CLR 225, an alpha-emitting, actinium-225 based PRC has shown activity in multiple solid tumor animal models including pancreatic, colorectal and breast cancers. CLR 121225 was well tolerated in these models with the animals showing no adverse events at the highest doses tested. The compound demonst…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• The Company is primarily focused on the development of its radioconjugate PDC programs, also known as phospholipid radioconjugates or PRCs, designed to provide targeted delivery of a radioisotope directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiat…

• ●CLR 125, an Auger-emitting PRC, utilizes iodine-125 and has been observed to show tolerability with minimal toxicities in animal models. Additionally, the Company observed CLR 125 to have good activity in multiple solid tumor models, especially in triple negative breast cancer. Auger emitters provi…

• ●CLR 225, an alpha-emitting, actinium-225 based PRC has shown activity in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer. CLR 121225 was well tolerated in these models with the animals showing no adverse events at the highest doses tested. The compound demons…

• ●Iopofosine, a beta-emitting PRC, utilizes iodine-131 and was studied in our CLOVER WaM Phase 2 study of iopofosine in patients with r/r WM where it was observed to result in statistically significant outcomes on both primary and secondary endpoints, and our Phase 2b studies in r/r multiple myeloma …

• In preclinical in vivo evaluations of CLR 125 utilizing triple-negative breast cancer (TNBC) models, the compound was observed to have tumor uptake at a substantially higher rate than that of healthy tissue. Additionally, no signs of end-organ toxicity were observed including hematological toxicity.

Text added vs the prior filing · source: 10-Q · 2026-05-14

• communication and monitoring components of internal control, based on the criteria established by the COSO Framework, that constitute material weaknesses, either individually or in the aggregate.

• The process of designing and maintaining effective internal control over financial reporting is a continuous effort that requires management to anticipate and react to changes in our business, economic and regulatory environments and to expend significant resources. As our remediation efforts are on…

• Except for the identification of the material weaknesses described above, there has been no change in our internal control over financial reporting during the period ended March 31, 2026, that has materially affected, or is reasonably likely to materially affect, our internal control over financial …

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• These material weaknesses resulted in errors that required the restatement of the Company’s consolidated financial statements as of and for the fiscal years ended December 31, 2023 and December 31, 2022, as well as the restatement of the Company’s condensed consolidated financial statements as of an…

• The process of designing and maintaining effective internal control over financial reporting is a continuous effort that requires management to anticipate and react to changes in our business, economic and regulatory environments and to expend significant resources. In early 2024, the Company began …

• As our remediation efforts are still on-going, we will continue to consider the need for additional resources and implement further enhancements to our policies and procedures as necessary to further improve our internal control over financial reporting. As we work to improve our internal control ov…

• Except for the identification of the material weaknesses described above, there has been no change in our internal control over financial reporting during the period ended September 30, 2025, that has materially affected, or is reasonably likely to materially affect, our internal control over financ…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• 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.

• 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 wh…

• 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 fr…

• 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 st…

• 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 Co…