Management’s Discussion and Analysis of Financial Condition and Results of Operations.
−Removed: We are a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer.
+Added: We are a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer.
Our core objective is to leverage our proprietary phospholipid ether drug conjugate™ (PDC™) delivery platform to develop PDCs that are designed to specifically target cancer cells and deliver improved efficacy and better safety as a result of fewer off-target effects.
We believe that our PDC platform possesses the potential for the discovery and development of the next generation of cancer-targeting treatments, and we plan to develop PDCs both independently and through research and development collaborations.
−Removed: We are primarily focused on the development of our 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.
+Added: On April 30, 2025, we announced that we will explore a full range of strategic alternatives to advance our platform and radiopharmaceutical drug development pipeline.
+Added: Strategic alternatives under consideration may include, but are not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions.
+Added: 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 differentiates our PRCs from many traditional on-market treatments and radiotherapeutics.
−Removed: The three lead programs are:
−Removed: iopofosine I 131 (iopofosine), a beta-emitting iodine-131 based program which has been studied extensively, as described below;
−Removed: CLR 121225, an actinium-225 based program;
−Removed: and CLR 121125, an iodine-125 Auger-emitting program, both prepared to enter clinical trials in 2025.
−Removed: ● Iopofosine, the beta-emitting PRC, utilizes iodine-131 and was studied in our CLOVER-WaM Phase 2 pivotal study of iopofosine in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), and our Phase 2b studies in r/r multiple myeloma (MM) patients and r/r central nervous system lymphoma (CNSL) are ongoing.
+Added: Our three lead programs are:
+Added: CLR 121125 (CLR 125), an iodine-125 Auger-emitting program, prepared to enter a clinical trial in 2025;
+Added: CLR 121225 (CLR 225), an actinium-225 based program;
+Added: and iopofosine I 131 (iopofosine I 131, or simply iopofosine), a beta-emitting iodine-131 based program which has been studied extensively, as described below.
+Added: 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).
+Added: On October 6, 2025, the Company announced that after a scientific advice procedure, the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 as a treatment for post - Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable.
+Added: However, there can be no guarantee that the EMA will grant a CMA, in particular that we continue to meet the unmet needs condition.
+Added: Even if we are granted a CMA in the EU, we will be required to undergo annual renewal assessments to determine whether the risk-benefit balance remains positive.
+Added: During or in between such assessments, it may be determined that we do not meet the conditions, which would mean that the CMA is revoked, or that there is a need for additional or modified conditions and/or specific obligations.
+Added: ● CLR 125, an Auger-emitting PRC, utilizes iodine-125 and has been observed to show tolerability with minimal toxicities in animal models.
+Added: Additionally, the Company observed CLR 125 to have good activity in multiple solid tumor models, especially in triple negative breast cancer.
+Added: Auger emitters provide the greatest precision in targeted radiotherapy as the
+Added: emission can only travel a few nanometers.
+Added: The Company believes that to cause the necessary breakage of the tumor cell DNA, the isotope must get inside the cell and near the cell nucleus to be effective.
+Added: The Company believes that CLR 125 achieves this condition because of the Company’s novel phospholipid ether drug conjugate platform.
+Added: CLR 125 is the subject of a Phase 1b dose finding study as described below.
+Added: ● CLR 225, an alpha-emitting, actinium-225 based PRC has shown activity in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer.
+Added: CLR 121225 was well tolerated in these models with the animals showing no adverse events at the highest doses tested.
+Added: The compound demonstrated excellent biodistribution and uptake by the tumor.
+Added: Furthermore, in multiple models of pancreatic adenocarcinoma, including highly refractory pancreatic cancer, we have observed proportional dose response with a single dose of CLR 225 providing either tumor stasis at the lowest dose tested or tumor volume reduction at the higher doses.
+Added: The Company is currently prepared to initiate a Phase 1 imaging and dose escalation safety study subject to our ability to obtain additional financing.
+Added: ● 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 (MM) patients and r/r central nervous system lymphoma (CNSL) are ongoing.
The CLOVER-2 Phase 1a study for a variety of pediatric cancers has concluded and a Phase 1b study in pediatric patients with high grade glioma is enrolling.
−Removed: Additionally, a Phase 1 Investigator-initiated study conducted by the University of Wisconsin Madison of iopofosine I 131 in combination with external beam radiation in patients with recurrent head and neck cancer has also completed.
−Removed: As with all clinical trials, adverse events, serious adverse events or fatalities may arise during a clinical trial resulting from medical problems that may not be related to clinical trial treatments.
−Removed: ● CLR 121225, the alpha-emitting, actinium-225 based PRC has demonstrated activity in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer.
−Removed: CLR 121225 has been shown to be well tolerated in these models with the animals showing no adverse events at the highest doses tested.
−Removed: It was also shown that the compound has excellent biodistribution and uptake by the tumor.
−Removed: Furthermore, in multiple models of pancreatic adenocarcinoma, including highly refractory pancreatic cancer, the compound demonstrated a proportional dose response with a single dose providing either tumor stasis at the lowest dose tested or tumor volume reduction at the higher doses.
−Removed: We are currently prepared to initiate a Phase 1 imaging and dose escalation safety study in the first half of 2025.
−Removed: ● CLR 121125, the Auger-emitting PRC, utilizes iodine-125 and has demonstrated excellent tolerability with no toxicities in animal models.
−Removed: Additionally, CLR 121125 has been shown to have good activity in multiple solid tumor models, especially in triple negative breast cancer.
−Removed: Auger emitters provide the greatest precision in targeted radiotherapy as the emission can only travel a few nanometers.
−Removed: This means that to cause the necessary breakage of the tumor cell DNA, the isotope most get inside the cell and near the cell nucleus to be effective.
−Removed: CLR 121125 achieves this due to our novel phospholipid ether drug conjugate platform.
−Removed: CLR 121125 is currently projected to be the subject of a Phase 1b dose finding study in the first half of 2025.
+Added: Additionally, a Phase 1 investigator-initiated study conducted by the University of Wisconsin-Madison of iopofosine in combination with external beam radiation in patients with recurrent head and neck cancer has also been completed.
+Added: The Company plans to submit a New Drug Application (NDA) to the U.S.
+Added: Food and Drug Administration (FDA) for the accelerated approval of iopofosine I 131 as a treatment for WM once the confirmatory trial is underway, which is subject to sufficient funding.
+Added: As part of our previous announcement to seek a full range of strategic alternatives, we have initiated a process that includes identifying a strategic partner with the resources to develop iopofosine I 131.
Results of Operations
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General research and development costs
−Removed: The overall decrease in research and development expenses of approximately $1,130,000, or 4%, was primarily a result of a reduction in clinical project costs of approximately $4,670,000, resulting from site management costs declining and the timing of patient enrollment related to the WM arm of the CLOVER-WaM study, partially offset by an increase in manufacturing and related costs related to greater production sourcing necessary to further develop commercial production capabilities of approximately $1,241,000 and an increase in general research and development costs related to an increase in personnel of approximately $2,554,000.
+Added: The overall decrease in research and development expenses of approximately $14,637,000, or 56%, was primarily a result of a reduction in clinical project costs of approximately $6,876,000 and a decrease in manufacturing and related costs of approximately $6,362,000, driven by the conclusion of patient enrollment and declining patient follow-up for our WM clinical study, partially offset by increased activity in our pre-clinical development project costs.
General and administrative.
General and administrative expenses for the year ended December 31, 2025, were approximately $11,481,000, compared to approximately $25,641,000 in 2024.
−Removed: The increase of $13,947,000, or 119% in general and administrative costs was primarily driven by investing in the development of information and infrastructure to support product commercialization, including the related market preparation and personnel costs.
+Added: The decrease of $14,160,000, or 55% in general and administrative costs was primarily driven by de-emphasizing pre-commercialization efforts and related personnel cost reductions.
Other income (expense), net .
−Removed: Other income (expense), net, for the year ended December 31, 2024, was approximately $7,262,000 of income, as compared to approximately $3,870,000 of expense for the year ended December 31, 2023.
+Added: Other income (expense), net, for the year ended December 31, 2025, was approximately $1,189,000 of income, as compared to approximately $7,262,000 of income for the year ended December 31, 2024.
A significant portion of this non-cash impact comes from changes in the valuation of the Company’s outstanding warrants.
−Removed: Warrant valuation consists of several
−Removed: aspects, but the most significant driver is the price of the Company’s common stock at the end of each reporting period.
−Removed: Interest income improved to approximately $1,211,000 in 2024, compared to approximately $387,000 in 2023.
−Removed: The Company’s improved return on cash equivalents is a product of higher average cash balances and a higher average interest rates.
+Added: Warrant valuation consists of several aspects, but the most significant driver is the price of the Company’s common stock at the end of each reporting period.
+Added: Interest income decreased to approximately $435,000 in 2025, compared to approximately $1,211,000 in 2024, as a result of lower invested balances and reductions in the related interest rates.
Liquidity and Capital Resources
Year ended December 31, 2025, Compared to Year Ended December 31, 2024
−Removed: As of December 31, 2024, we had cash and cash equivalents of $23.3 million, compared to $9.6 million as of December 31, 2023, an increase of $13.7 million.
−Removed: Net cash proceeds from the issuance of common stock, preferred stock and warrants during 2024 were approximately $61.4 million.
+Added: As of December 31, 2025, we had cash and cash equivalents of $13.2 million, compared to $23.3 million as of December 31, 2024, a decrease of $10.1 million.
+Added: Net cash proceeds from the issuance of common stock and warrants during 2025 were approximately $13 million.
The cash used in operating activities during the twelve months ended December 31, 2025, was approximately $23.1 million.
−Removed: Investing activities consist exclusively of fixed asset purchases, which declined in 2024 as compared to 2023 due to our having completed the establishment of redundancy in each aspect of our product manufacturing supply chain, ensuring product availability upon commercialization.
−Removed: Net cash proceeds from financing activities was exclusively the exercise of warrants by investors during 2024 for approximately $61.4 million, as compared to approximately $22.9 million primarily for preferred stock issued in 2023.
+Added: Investing activities consist exclusively of fixed asset purchases, which declined in 2025 as compared to 2024 as a result of our completing the establishment of redundancy in each aspect of our product manufacturing supply chain.
Our cash requirements have historically been for our research and development activities, finance and administrative costs, capital expenditures and overall working capital.
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As of the date the accompanying consolidated financial statements were issued (the “issuance date”), the Company’s available liquidity to fund the Company’s operations over the next twelve months beyond the issuance date was limited to approximately $9.7 million of unrestricted cash and cash equivalents.
−Removed: Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the fourth quarter of 2025.
+Added: Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the third quarter of 2026.
To improve the Company’s liquidity, management plans to secure additional outside capital via the sale of equity and/or debt securities or execute a strategic transaction.
8 unchanged sentences
Management bases its estimates and judgments on historical experience, knowledge of current conditions and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
−Removed: Actual results could differ from those
+Added: Actual results could differ from those estimates.
We review these estimates and assumptions periodically and reflect the effects of revisions in the period that they are determined to be necessary.
12 unchanged sentences
As such, fair value is a market-based measurement that is determined based on assumptions that a market participant would use in pricing an asset or liability.
−Removed: In conjunction with the financings conducted in July 2024, September 2023 and October 2022, we recorded the preferred stock and warrants separately based on their estimated fair values.
+Added: We recorded the preferred stock and warrants separately based on their estimated fair values.
Subsequent to issuance, to the extent that such securities are liability classified, they are marked to market, with the change in value reflected in the statement of operations at each reporting date.
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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.