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CLRB 10-K & 10-Q changes, risk factors and insider trading

Cellectar Biosciences, Inc. · Nasdaq · Pharmaceutical Preparations · CIK 1279704 · All filings on SEC.gov

Everything below is quoted or computed from Cellectar Biosciences, Inc.'s public SEC filings. It is not a recommendation to buy or sell. Automated comparisons can contain errors; confirm with the original filing.

At a glance

11 / 3risk-factor paragraphs added / removed in latest 10-K
4new risk-factor headings
2Form 4 filings reporting open-market purchases (last 180 days)
0Form 4 filings reporting open-market sales (last 180 days)

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What changed in the latest 10-K

Comparing 10-K filed 2026-03-04 (period ending 2025-12-31) with 10-K filed 2025-03-13 (period ending 2024-12-31).

Risk Factors (10-K Item 1A)

11new paragraphs
3removed paragraphs
23reworded paragraphs
14,934 → 15,926words in section

New heading “All of our product candidates are in clinical development or in preclinical development. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.”

New heading “We may seek Breakthrough Therapy designation by the FDA for one or more of our product candidates, which we may not receive. Such designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.”

New heading “Regulatory legislative reform measures may have a material adverse effect on our business.”

New heading “We identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and share price.”

Removed heading “We cannot assure the successful development and commercialization of our compounds in development.”

Removed heading “Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.”

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text topics: material weakness
“We identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and share price.”
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New text
“All of our product candidates are in clinical development or in preclinical development. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.”
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New text
“We may seek Breakthrough Therapy designation by the FDA for one or more of our product candidates, which we may not receive. Such designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.”
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Removed text
“Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.”
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Reworded topics: european commission

Paragraph as it now reads, with added and removed wording marked:

We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators may impede our ability to gain FDAmarketing approval from the FDA, the European Commission (based on recommendation from the EMA), or other regulatory authorities and delay or impair commercialization of any products.
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Removed text
“We cannot assure the successful development and commercialization of our compounds in development.”
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Full comparison: every changed paragraph (37)

Green = added, red = removed. Unchanged paragraphs and tables are not shown. Read the complete text in the original filing.

Reworded

We expect that we will continue to generate operating losses for the foreseeable future. As of December 31, 2024,2025, our consolidated cash balance was approximately $23.3$13.2 million. We believe our cash balance as of December 31, 2024,2025, is adequate to fund our basic budgeted operations into the fourththird quarter of 2025.2026.

Reworded

We rely on a collaborative outsourced business model, and disruptions with our third-party collaborators may impede our ability to gain FDAmarketing approval from the FDA, the European Commission (based on recommendation from the EMA), or other regulatory authorities and delay or impair commercialization of any products.

Reworded

In addition, we rely exclusively on contract research organizations to conduct research and development. Any inability of these organizations to fulfill the requirements of their agreements with us may delay or impair our ability to gain FDAmarketing approval from the FDA, European Commission (based on recommendation from the EMA), or other regulatory authorities and commercialization of our drug delivery technology and products.

Reworded

Drug manufacturers are subject to ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration, the EMA,EU nationalMember competentStates authorities(coordinated inby the EUEMA), and UKother comparable foreign regulatory authorities and other federal and state government and regulatory agencies to ensure strict compliance with cGMP and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulations and standards and they may not be able to comply. Switching manufacturers may be difficult because the number of potential manufacturers is limited. It may be difficult or impossible for us to find a replacement manufacturer quickly on acceptable terms, or at all. Additionally, if we are required to enter into new supply arrangements, we may not be able to obtain approval from the FDAFDA, the European Commission (based on recommendation from the EMA) or other comparable foreign regulatory authorities of any alternate supplier in a timely manner, or at all, which could delay or prevent the clinical development and commercialization of any related product candidates. Failure of our third-party manufacturers or us to comply with applicable regulations could result in sanctions being imposed on us, including fines, civil penalties, delays in or failure to grant marketing approval of our product candidates, injunctions, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products and compounds, operating restrictions and criminal prosecutions, warning or similar letters or civil, criminal or administrative sanctions against the company, any of which could adversely affect our business.

Reworded

We believe that we have a good working relationship with our third-party collaborators. However, should the situation change, we may be required to relocate these activities on short notice, and we do not currently have access to alternate facilities to which we could relocate our research, development and/or manufacturing activities. The cost and time to establish or locate an alternate research, development and/or manufacturing facility to develop our technology would be substantial and would delay obtaining FDA or European Commission (based on recommendation from the EMA) approval and commercializing our products.

Reworded

Furthermore, if our products are approved for commercial sale, we will need to work with our existing third-party collaborators to ensure sufficient capacity, or engage additional parties with the capacity, to commercially manufacture our products in accordance with FDAFDA, the European Commission (based on recommendation from the EMA) and other regulatory requirements. There can be no assurance that we would be able to successfully establish any such capacity or identify suitable manufacturing partners on acceptable terms.

Reworded

Risks Related to Research andResearch, Development and theRegulatory FDAApproval of Our Product Candidates

Added

All of our product candidates are in clinical development or in preclinical development. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

Removed

We cannot assure the successful development and commercialization of our compounds in development.

Reworded

Before receiving FDA approval or similar approval in the European UnionEU or other jurisdiction to market a product, we must demonstrate with substantial clinical evidence that the product is safe and effective in the patient population and the indication that will be treated. Data obtained from preclinical and clinical activities are susceptible to varying interpretations that could delay, limit or prevent regulatory approvals. Our clinical trials may fail to produce results satisfactory to the FDAFDA, the EMA, or regulatory authorities in other jurisdictions. The regulatory process also requires preclinical testing, and data obtained from preclinical and clinical activities are susceptible to varying interpretations. In connection with clinical trials of our product candidates, we may face the following risks among others:

Added

The SAWP has advised that filing for a CMA for iopofosine I 131 as a treatment for post - BTKi refractory patients with WM could be acceptable. However, there can be no guarantee that the EMA will grant CMA in the EU for iopofosine for WM patients having received two or more prior treatment regimens. 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. 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.

Reworded

Even if we do ultimately receive FDA approval or approval in the European Union for any of our products, these products will be subject to extensive ongoing regulation, including regulations governing manufacturing, labeling, packaging, testing, dispensing, prescription and procurement quotas, record keeping, reporting, handling, shipment and disposal of any such drug. Failure to obtain and maintain required registrations or to comply with any applicable regulations could further delay or preclude development and commercialization of our drugs and subject us to enforcement action.

Added

We may seek Breakthrough Therapy designation by the FDA for one or more of our product candidates, which we may not receive. Such designation may not lead to a faster development or regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.

Added

On June 4, 2025, the Company announced that the FDA granted Breakthrough Therapy Designation for iopofosine I 131, as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia. In addition, we may seek Breakthrough Therapy designation for one or more of our product candidates, which, if granted, offers the potential for a rolling review of an NDA if a number of conditions are met, which would allow data to be submitted and reviewed as they become available rather than waiting for the full data package to become available to be submitted. Rolling review is often faster than the FDA’s standard review process. The FDA has broad discretion whether or not to grant Breakthrough Therapy designations, and even if we believe a particular product candidate is eligible for such a designation, we cannot be certain that the FDA would decide to grant it. Even if we obtain such designations for one or more of our product candidates, we may not experience a faster development process, review or approval compared to non-expedited FDA review procedures. In addition, the FDA may withdraw Breakthrough Therapy designations if it believes that such designations are no longer supported. Although product candidates receiving Breakthrough Therapy designation are generally eligible for the FDA’s priority review procedures, receiving such designations does not guarantee that the NDA for such product candidates will receive priority review.

Removed

Iopofosine has received RPDD designation from the FDA for the treatment of neuroblastoma, rhabdomyosarcoma, osteosarcoma and Ewing’s sarcoma. The FDA defines a “rare pediatric disease” as a disease that affects fewer than 200,000 individuals in the U.S.

Reworded

Iopofosine has received RPDD designation from the FDA for the treatment of neuroblastoma, rhabdomyosarcoma, osteosarcoma and Ewing’s sarcoma. The FDA defines a “rare pediatric disease” as a disease that affects fewer than 200,000 individuals in the U.S. primarily under the age of 18 years old, or a patient population greater than 200,000 in the U.S. when there is no reasonable expectation that the cost of developing and making available the drug in the U.S. will be recovered from sales in the U.S. for that drug or biological product. Under the FDA’s Rare Pediatric Disease Priority Review Voucher Program, upon the approval of an NDA or a BLA for the treatment of a rare pediatric disease, the sponsor of such application could be eligible for a Rare Pediatric Disease Priority Review Voucher that can be redeemed to obtain priority review for a subsequent NDA or BLA. The sponsor of a rare pediatric disease drug product receiving a priority review voucher may transfer (including by sale) the voucher to another sponsor. The voucher may be further transferred any number of times before the voucher is used, as long as the sponsor making the transfer has not yet submitted the application.

Reworded

Furthermore, due to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine, the Company is, in addition to determining the availability of funding for such a study, pursuing strategic options for the further development and commercialization of this product candidate.

Reworded

The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subject to change, including due to judicial challenges.

Added

In addition, federal agency activities, priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles and legislative developments. For example, the current presidential administration’s commitment to significantly reduce government spending through cuts to federal healthcare programs and reductions in the workforces of key government agencies, such as HHS, FDA, and CMS. Efforts by the current administration to limit federal agency budgets or personnel may result in reductions to agency budgets, employees, and operations. The administration and agencies have also made abrupt announcements about new or changed regulatory policies, such as policies related to the use of artificial intelligence to review product applications. And, the recent federal government shutdown may prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews or other regulatory activities, and may significantly impact the ability of the FDA to timely review and process our regulatory submissions. These developments which may lead to greater uncertainty regarding FDA policies, slower response times and longer review periods, potentially affecting our ability to progress development of our product candidate or obtain regulatory approval for our product candidate.

Added

We may also not be able to maintain our ODD in the EU. In the EU, to maintain an ODD, a sponsor must demonstrate that it still satisfies the orphan designation criteria at the time of the marketing authorization. This includes a requirement for the sponsor to demonstrate ‘significant benefit’ compared with any treatments that are authorized at the time of the re-evaluation of the orphan criteria. Comparators may include products that are authorized after the sponsor has submitted its marketing authorization, but before the sponsor’s orphan designation criteria have be re-assessed.

Reworded

Regulatory approval for any approved product is limited by the FDA, the European Commission,Commission (based on recommendation from the EMA), and othercomparable regulators,foreign authorities, to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may incur significant liability if it is determined that we are promoting the “off-label” use of any of our future product candidates if approved.

Reworded

Any regulatory approval is limited to those specific diseases, indications and patient populations for which a product is deemed to be safe and effective by the FDA, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines AgencyEMA and other regulators. In addition to the FDAFDA, EMA and other regulators’ approval required for new formulations, any new indication for an approved product also requires FDA approval. If we are not able to obtain FDA approval for any desired future indications for our products and product candidates, our ability to effectively market and sell our products may be reduced and our business may be adversely affected.

Reworded

Any product for which we have obtained regulatory approval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirements by the FDA, the European Commission (based on recommendation from the EMA) and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products, our potential for generating positive cash flow may be diminished, and the capital necessary to fund our operations may be increased.

Reworded

Any product for which we have obtain regulatory approval in the future, along with the manufacturing processes and practices, post-approval clinical research, product labeling, advertising and promotional activities for such product, are subject to continual requirements of, and review by, the FDA, the European Commission (based on a recommendation from the EMA) and other comparable international regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, current good manufacturing practices (cGMP) requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians, import and export requirements and recordkeeping. If we or our suppliers encounter manufacturing, quality or compliance difficulties with respect to any of our product candidates, when and if approved, we may be unable to obtain or maintain regulatory approval or meet commercial demand for such products, which could adversely affect our business, financial conditions, results of operations and growth prospects.

Reworded

In addition, the FDA often requires post-marketing testing and surveillance to monitor the effects of products. The FDA, the European Commission (based on a recommendation from the EMA) and other comparable international regulatory agenciesauthorities may condition approval of our product candidates on the completion of such post-marketing clinical studies. These post-marketing studies may suggest that a product causes undesirable side effects or may present a risk to the patient. Additionally, the FDA may require a REMS to help ensure that the benefits of the drug outweigh its risks. A REMS may be required to include various elements, such as a medication guide or patient package insert, a communication plan to educate healthcare providers of the drug’s risks, limitations on who may prescribe or dispense the drug, requirements that patients enroll in a registry or undergo certain health evaluations or other measures that the FDA deems necessary to ensure the safe use of the drug.

Reworded

If such regulatory actions are taken, the value of our company and our operating results will be adversely affected. Additionally, if the FDA, the European Commission (based on a recommendation from the EMA) or any other comparable international regulatory agency withdraws its approval of a product that is or may be approved, we will be unable to generate revenue from the sale of that product in the relevant jurisdiction, our potential for generating positive cash flow will be diminished and the capital necessary to fund our operations will be increased. Accordingly, we continue to expend significant time, money and effort in all areas of regulatory compliance, including manufacturing, production, product surveillance, post-marketing studies and quality control.

Added

Regulatory legislative reform measures may have a material adverse effect on our business.

Added

The EU’s pharmaceutical legislation is currently changing. In December 2025, the EU legislators reached an agreement on the proposed new rules. This provisional agreement needs to be endorsed by both the Council of the EU and the European Parliament, before being formally adopted and entering into force upon publication in the EU’s Official Journal. The final text is not yet available, but key changes will include:

Added

The new legislation is expected to enter into application in 24 months. Other proposed EU acts, such as the Critical Medicines Act and the Biotech Act, may bring additional changes.

Reworded

We have restated our previously issued audited financial statements as of and for the years ended December 31, 2022 and 2023 and our interim financial statements as of and for the quarterly periods ended March 31, 2024, March 31, 2023 through September 30, 2023 and March 31, 2022 through September 30, 2022.2022 (Restatement).

Reworded

As a result of the misstatements discussed and the Restatement, we have become subject to a number of additional risks and uncertainties and unanticipated costs for accounting, legal and other fees and expenses, including risks of lawsuitlawsuits relating to securities offered by us in public and private offerings as well as claims by purchasers of our shares of common stock in the public market. Any actions, lawsuitslawsuit or other legal proceedings related to the misstatements or the Restatement could result in liabilities, reputational harm and defense and other costs, regardless of the outcome of the lawsuit or proceeding.

Added

We identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and share price.

Removed

Failure to maintain effective internal controls could adversely affect our ability to meet our reporting requirements.

Reworded

We must continue to satisfy Nasdaq continued listing requirements, including, among other things, certain corporate governance requirementsrequirements, minimum stockholders’ equity of $2.5 million, and a minimum closing bid price requirement of $1.00 per share. If a company fails for 30 consecutive business days to meet the $1.00 minimum closing bid price requirement, Nasdaq will send a deficiency notice to the company, advising that it has been afforded a “compliance period” of 180 calendar days to regain compliance with the applicable requirements.

Reworded

On January 30, 2025, we received a deficiency letter from Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on Nasdaq pursuant to the minimum closing bid price requirement. The Nasdaq deficiency letter had no immediate effect on the listing of our common stock. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have beenwere given 180 calendar days, or until July 29, 2025, to regain compliance with the minimum closing bid price requirement by causing our stock to close above $1.00 for a minimum of 10 consecutive trading days. If we do not regain compliance with the minimum closing bid price requirement by July 29, 2025, we may be afforded a second 180 calendar day period to regain compliance. To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq, except for the minimum bid price requirement. In addition, we would be required to notify Nasdaq of our intent to cure the deficiency during the second compliance period.

Added

On June 24, 2025, we effected the 1-for-30 Reverse Stock Split to regain compliance with the bid price requirement prior to the July 29, 2025 compliance deadline. On July 9, 2025, we received a letter from Nasdaq confirming that we regained compliance with the minimum bid price requirement in Nasdaq Listing Rule 5550(a)(2), as it was determined that for the last 10 consecutive business days, from June 24, 2025 to July 8, 2025, the closing bid price of our common stock was at $1.00 per share or greater. There is no assurance we will maintain compliance with Nasdaq continued listing requirements.

Reworded

If our common stock becomes subject to delisting, it would be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities. The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in our common stock. This would adversely affect the ability of investors to trade our common stock and would adversely affect the value of our common stock. These factors could contribute to lower prices and larger spreads in the bid and ask prices for our common stock. If we seek to implement a further reverse stock split in order to remain listed on Nasdaq, the announcement or implementation of such a reverse stock split could negatively affect the price of our common stock.

Management's Discussion & Analysis (MD&A) (10-K Item 7)

1new paragraphs
2removed paragraphs
8reworded paragraphs
2,147 → 2,290words in section

Largest changes (selected automatically by length and topic keywords; quoted verbatim, no commentary)

New text
“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. …”
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Removed text
“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. We believe this profile differentiates our PRCs from many traditional on-market treatments and radiotherapeutics. …”
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Reworded

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The overall decrease in research and development expenses of approximately $1,130,000,$14,637,000, or 4%,56%, was primarily a result of a reduction in clinical project costs of approximately $4,670,000, resulting from site management costs declining$6,876,000 and thea timing of patient enrollment related to the WM arm of the CLOVER-WaM study, partially offset by an increasedecrease in manufacturing and related costs related to greater production sourcing necessary to further develop commercial production capabilities of approximately $1,241,000$6,362,000, driven by the conclusion of patient enrollment and andeclining increasepatient follow-up for our WM clinical study, partially offset by increased activity in generalour research andpre-clinical development costsproject related to an increase in personnel of approximately $2,554,000.costs.
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Reworded

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Other income (expense), net. Other income (expense), net, for the year ended December 31, 2024,2025, was approximately $7,262,000$1,189,000 of income, as compared to approximately $3,870,000$7,262,000 of expenseincome for the year ended December 31, 2023.2024. A significant portion of this non-cash impact comes from changes in the valuation of the Company’s outstanding warrants. 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. Interest income improveddecreased to approximately $435,000 in 2025, compared to approximately $1,211,000 in 2024, compared to approximately $387,000 in 2023. The Company’s improved return on cash equivalents isas a productresult of higherlower average cashinvested balances and areductions higherin averagethe related interest rates.
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We are a late-stage clinical biopharmaceutical company focused on the discovery, developmentdiscovery and commercializationdevelopment 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. 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. Strategic alternatives under consideration may include, but are not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions.
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Reworded

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General and administrative. General and administrative expenses for the year ended December 31, 2024,2025, were approximately $25,641,000,$11,481,000, compared to approximately $11,694,000$25,641,000 in 2023.2024. The increasedecrease of $13,947,000,$14,160,000, or 119%55% in general and administrative costs was primarily driven by investingde-emphasizing inpre-commercialization the development of informationefforts and infrastructure to support product commercialization, including the related market preparation and personnel costs.cost reductions.
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Full comparison: every changed paragraph (11)

Green = added, red = removed. Unchanged paragraphs, 5 paragraphs where only numbers/dates changed, and tables are not shown. Read the complete text in the original filing.

Reworded

We are a late-stage clinical biopharmaceutical company focused on the discovery, developmentdiscovery and commercializationdevelopment 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. 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. 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. Our three lead programs are: CLR 121125 (CLR 125), an iodine-125 Auger-emitting program, prepared to enter a clinical trial in 2025; CLR 121225 (CLR 225), an actinium-225 based program; 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. 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 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. However, there can be no guarantee that the EMA will grant a CMA, in particular that we continue to meet the unmet needs condition. 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. 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.

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. We believe this profile differentiates our PRCs from many traditional on-market treatments and radiotherapeutics. The three lead programs are: iopofosine I 131 (iopofosine), a beta-emitting iodine-131 based program which has been studied extensively, as described below; CLR 121225, an actinium-225 based program; and CLR 121125, an iodine-125 Auger-emitting program, both prepared to enter clinical trials in 2025.

Reworded

The overall decrease in research and development expenses of approximately $1,130,000,$14,637,000, or 4%,56%, was primarily a result of a reduction in clinical project costs of approximately $4,670,000, resulting from site management costs declining$6,876,000 and thea timing of patient enrollment related to the WM arm of the CLOVER-WaM study, partially offset by an increasedecrease in manufacturing and related costs related to greater production sourcing necessary to further develop commercial production capabilities of approximately $1,241,000$6,362,000, driven by the conclusion of patient enrollment and andeclining increasepatient follow-up for our WM clinical study, partially offset by increased activity in generalour research andpre-clinical development costsproject related to an increase in personnel of approximately $2,554,000.costs.

Reworded

General and administrative. General and administrative expenses for the year ended December 31, 2024,2025, were approximately $25,641,000,$11,481,000, compared to approximately $11,694,000$25,641,000 in 2023.2024. The increasedecrease of $13,947,000,$14,160,000, or 119%55% in general and administrative costs was primarily driven by investingde-emphasizing inpre-commercialization the development of informationefforts and infrastructure to support product commercialization, including the related market preparation and personnel costs.cost reductions.

Reworded

Other income (expense), net. Other income (expense), net, for the year ended December 31, 2024,2025, was approximately $7,262,000$1,189,000 of income, as compared to approximately $3,870,000$7,262,000 of expenseincome for the year ended December 31, 2023.2024. A significant portion of this non-cash impact comes from changes in the valuation of the Company’s outstanding warrants. 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. Interest income improveddecreased to approximately $435,000 in 2025, compared to approximately $1,211,000 in 2024, compared to approximately $387,000 in 2023. The Company’s improved return on cash equivalents isas a productresult of higherlower average cashinvested balances and areductions higherin averagethe related interest rates.

Reworded

As of December 31, 2024,2025, we had cash and cash equivalents of $23.3$13.2 million, compared to $9.6$23.3 million as of December 31, 2023,2024, ana increasedecrease of $13.7$10.1 million. Net cash proceeds from the issuance of common stock, preferred stock and warrants during 20242025 were approximately $61.4$13 million. The cash used in operating activities during the twelve months ended December 31, 2024,2025, was approximately $47.6$23.1 million.

Reworded

Investing activities consist exclusively of fixed asset purchases, which declined in 20242025 as compared to 20232024 dueas toa result of our having completedcompleting the establishment of redundancy in each aspect of our product manufacturing supply chain, ensuring product availability upon commercialization.chain.

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.

Reworded

We have incurred losses since inception in devoting substantially all of our efforts toward research and development. During the year ended December 31, 2024,2025, we generated a net loss of approximately $44.6$21.8 million and used approximately $47.6$23.1 million in cash for operations. We expect that we will continue to generate operating losses for the foreseeable future. As of December 31, 2024,2025, our consolidated cash balance was approximately $23.3$13.2 million. 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 $14.9$9.7 million of unrestricted cash and cash equivalents. Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the fourththird quarter of 2025.2026. 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. Management also plans to preserve liquidity, as needed, by implementing cost saving measures. While management believes their plans will be successful, no assurance can be provided such plans will be effectively implemented over the next twelve months beyond the issuance date. In the event management’s plans are not effectively implemented, the Company will 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.

Reworded

Fair value measurements. We account for certain financial assets at fair value, defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., exit price) in the principal, most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. 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. In conjunction with the financings conducted in July 2024, September 2023 and October 2022, weWe 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. If management made different assumptions or judgments, material differences in measurements of fair value could occur.

What changed in the latest 10-Q

Comparing 10-Q filed 2026-08-13 (period ending 2026-06-30) with 10-Q filed 2026-05-14 (period ending 2026-03-31).

Risk Factors (10-Q Part II, Item 1A)

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Management's Discussion & Analysis (MD&A) (10-Q Part I, Item 2)

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New heading “Six Months Ended June 30, 2026 and 2025”

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“Six Months Ended June 30, 2026 and 2025”
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“Recent Developments”
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OnThe MarchCompany 6,initiated 2025,activities related to the CompanyPhase conducted3 itsconfirmatory study in June of 2026. These activities include, but are not limited to, selection of and finalizing the contract with the lead CRO, finalizing the protocol and statistical analysis plan, site feasibility and qualification visits. The study is designed based upon a series of communications with the FDA, starting with an End-of-Phase-2 (EOP2) meeting withwhich occurred on March 6, 2025. Following the U.S.FDA Food and Drug Administration (FDA). As a result of the meeting, and clarified by subsequent written correspondence,guidance, the Company believes that it understands a path forward for potential accelerated and full approval of iopofosine I 131131will be based upon the CLOVER WaM study and the initiation of a comparator controlledcomparator-controlled Phase 3 confirmatory trial assessing progression free survival as the primary endpoints in WM patients. Full approval of iopofosine will be based upon the demonstration of superior progression free survival of iopofosine against a comparator in an earlier line of therapy than was tested in the CLOVER WaM patients and would be granted if the accelerated approval is accepted. The submission for accelerated approval utilizing the CLOVER WaM study data can occur at the time of or after the initiation of a Phase 3 randomized controlled confirmatory study and patient enrollment must be ongoing at the time of decision on the accelerated NDA. The confirmatoryCompany is currently preparing a Phase 3 study that will be executeda incomparator, anrandomized earliercontrolled linestudy with approximately 100 WM patients per arm; full patient enrollment is projected within 18-24 months of therapythe thanfirst waspatient testedadmitted into the CLOVER WaM patients.study.
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“Other income (expense), net. Other income (expense), net, for the six months ended June 30, 2026, was approximately $405,000, as compared to approximately $387,000 of income in the same period of 2025, resulting from changes in warrant valuation and interest income. The changes in warrant valuation impacts are non-cash in nature and are largely driven by fluctuations in the Company’s common stock price. Interest income decreased to approximately $196,000 in the six months ended June 30, 2026, as compared to approximately $225,000 for the same period in 2025. …”
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“The overall increase in research and development expense of approximately $1,748,000, or 30%, was primarily a result of increased clinical project costs and manufacturing and related costs of approximately $1,418,000 and 942,000, respectively, resulting from the initiation of the confirmatory and triple-negative breast cancer studies, offset in part by decreased pre-clinical project costs of approximately $(517,000), driven by reduced activity in the pediatric study.”
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The CLOVER WaM study was designed as a pivotal registration study evaluating iopofosine in WM patients that were r/r to at least two prior lines of therapy including having failed or had a suboptimal response to a BTKi. The study completed enrollment in the fourth quarter of 2023, and initial top line data from the study was reported in January 2024. CLOVER-WaM was a single-arm study with a target enrollment of 50 patients. Based upon the data from September 2024, the CLOVER WaM study enrolled a total of 55 patients in the modified Intent to Treat (mITT) population and met its primary endpoint with a major response rate (MRR) of 58.2%61.8% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]) exceeding the FDA agreed-upon statistical hurdle of 20%. The overall response rate (ORR) in evaluable patients was 83.6%, and 98.2% of patients experienced disease control. Responses were durable, with median duration of response notof reached at 11.417.8 months of follow-up and 76%a median of patients remaining progression free at a median follow-upsurvival of eight13.5 months. These outcomes exceed historic real world data which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and not refractory to multiple classes of drugs. Notably, iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population. Overall, 45 (69.2%) patients had prior exposure to at least 3 drug classes and 19 (29.2%) patients had prior exposure to at least 4 drug classes of anti-cancer therapies. Forty-eight (73.8%) patients had prior exposure to a BTKi of which 37 (77.1%) were deemed to be refractory to BTKis. Forty-three (66.2%) patients were exposed to BTKi and anti-CD20 antibody with 25 (58.1%) being refractory to both BTKi and anti-CD-20 antibodies. Thirty-seven (56.9%) patients had prior exposure to BTKi, anti-CD20 antibody, and chemotherapy and 18 (48.6%) patients were refractory to all three classes of drugs, BTKi, anti-CD20 antibody, and chemotherapy. Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data. The safety population was 65 patients which was composed of patients that received at least a single dose of iopofosine I 131 but did not receive enough drug to be assessed for efficacy.131. There were 35 (4.6%7.7%) patients that experienced treatment-relatedtreatment-emergent adverse events (TRAEsTEAEs) leading to discontinuation.discontinuation of which 2 (3.6%) were treatment related. The rates of greaterAny TRAEsGrade TEAEs observed in more than 10% of patients included thrombocytopenia (56 [86.2%] patients), neutropenia (52 [80.0%] patients), anemia (42 [64.6%] patients) and decreased white blood cell count (21 [32.3%] patients) among hematologic toxicities and fatigue (22 [33.8%] patients), nausea (19 [29.2%] patients) and diarrhea (13 [20.0%] patients) among non-hematologic toxicities. The rates of Grade 3 or greater TRAEsTEAEs observed in more than 10% of patients included thrombocytopenia (53 [81.5%] patients), neutropenia (43 [66.2%] patients), anemia (31 [47.7%] patients), decreased white blood cell count (18 [27.7%]), decreased lymphocyte count 8 (12.3%). All patients recovered from cytopenias with no reported aplastic sequalae. Importantly, there were no clinically significant bleeding events, and the rate of febrile neutropenia was 10.8%. There were no treatment-related deaths in the study.
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Reworded

You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited financial information and notes thereto included in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business, include forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2025, our actual results could differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Reworded

The CLOVER WaM study was designed as a pivotal registration study evaluating iopofosine in WM patients that were r/r to at least two prior lines of therapy including having failed or had a suboptimal response to a BTKi. The study completed enrollment in the fourth quarter of 2023, and initial top line data from the study was reported in January 2024. CLOVER-WaM was a single-arm study with a target enrollment of 50 patients. Based upon the data from September 2024, the CLOVER WaM study enrolled a total of 55 patients in the modified Intent to Treat (mITT) population and met its primary endpoint with a major response rate (MRR) of 58.2%61.8% (95% confidence interval [44.50%, 75.80%, two-sided p value < 0.0001]) exceeding the FDA agreed-upon statistical hurdle of 20%. The overall response rate (ORR) in evaluable patients was 83.6%, and 98.2% of patients experienced disease control. Responses were durable, with median duration of response notof reached at 11.417.8 months of follow-up and 76%a median of patients remaining progression free at a median follow-upsurvival of eight13.5 months. These outcomes exceed historic real world data which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and not refractory to multiple classes of drugs. Notably, iopofosine I 131 monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population. Overall, 45 (69.2%) patients had prior exposure to at least 3 drug classes and 19 (29.2%) patients had prior exposure to at least 4 drug classes of anti-cancer therapies. Forty-eight (73.8%) patients had prior exposure to a BTKi of which 37 (77.1%) were deemed to be refractory to BTKis. Forty-three (66.2%) patients were exposed to BTKi and anti-CD20 antibody with 25 (58.1%) being refractory to both BTKi and anti-CD-20 antibodies. Thirty-seven (56.9%) patients had prior exposure to BTKi, anti-CD20 antibody, and chemotherapy and 18 (48.6%) patients were refractory to all three classes of drugs, BTKi, anti-CD20 antibody, and chemotherapy. Iopofosine I 131 was well tolerated and its toxicity profile was consistent with the Company’s previously reported safety data. The safety population was 65 patients which was composed of patients that received at least a single dose of iopofosine I 131 but did not receive enough drug to be assessed for efficacy.131. There were 35 (4.6%7.7%) patients that experienced treatment-relatedtreatment-emergent adverse events (TRAEsTEAEs) leading to discontinuation.discontinuation of which 2 (3.6%) were treatment related. The rates of greaterAny TRAEsGrade TEAEs observed in more than 10% of patients included thrombocytopenia (56 [86.2%] patients), neutropenia (52 [80.0%] patients), anemia (42 [64.6%] patients) and decreased white blood cell count (21 [32.3%] patients) among hematologic toxicities and fatigue (22 [33.8%] patients), nausea (19 [29.2%] patients) and diarrhea (13 [20.0%] patients) among non-hematologic toxicities. The rates of Grade 3 or greater TRAEsTEAEs observed in more than 10% of patients included thrombocytopenia (53 [81.5%] patients), neutropenia (43 [66.2%] patients), anemia (31 [47.7%] patients), decreased white blood cell count (18 [27.7%]), decreased lymphocyte count 8 (12.3%). All patients recovered from cytopenias with no reported aplastic sequalae. Importantly, there were no clinically significant bleeding events, and the rate of febrile neutropenia was 10.8%. There were no treatment-related deaths in the study.

Reworded

The U.S. Food and Drug Administration (FDA) granted iopofosine Break-throughBreakthrough Therapy Designation for r/r Waldenstrom’s macroglobulinemia (WM), Fast Track Designation for lymphoplasmacytic lymphoma (LPL) and WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for LPL/WM, MM, neuroblastoma, soft tissue sarcomas including rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted PRIME designation and ODD to iopofosine for treatment of r/r MM and WM.

Reworded

OnThe MarchCompany 6,initiated 2025,activities related to the CompanyPhase conducted3 itsconfirmatory study in June of 2026. These activities include, but are not limited to, selection of and finalizing the contract with the lead CRO, finalizing the protocol and statistical analysis plan, site feasibility and qualification visits. The study is designed based upon a series of communications with the FDA, starting with an End-of-Phase-2 (EOP2) meeting withwhich occurred on March 6, 2025. Following the U.S.FDA Food and Drug Administration (FDA). As a result of the meeting, and clarified by subsequent written correspondence,guidance, the Company believes that it understands a path forward for potential accelerated and full approval of iopofosine I 131131will be based upon the CLOVER WaM study and the initiation of a comparator controlledcomparator-controlled Phase 3 confirmatory trial assessing progression free survival as the primary endpoints in WM patients. Full approval of iopofosine will be based upon the demonstration of superior progression free survival of iopofosine against a comparator in an earlier line of therapy than was tested in the CLOVER WaM patients and would be granted if the accelerated approval is accepted. The submission for accelerated approval utilizing the CLOVER WaM study data can occur at the time of or after the initiation of a Phase 3 randomized controlled confirmatory study and patient enrollment must be ongoing at the time of decision on the accelerated NDA. The confirmatoryCompany is currently preparing a Phase 3 study that will be executeda incomparator, anrandomized earliercontrolled linestudy with approximately 100 WM patients per arm; full patient enrollment is projected within 18-24 months of therapythe thanfirst waspatient testedadmitted into the CLOVER WaM patients.study.

Reworded

The Phase 2 CLOVER-1 study was an open-label study designed to determine the efficacy and safety of CLR 131 in select B-cell malignancies (multiple myeloma (MM), indolent chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia (WM), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), DLBCL, and central nervous system lymphoma (CNSL) who have been previously treated with standard therapy for their underlying malignancy. As of March 2022, the study arms for CLL/SLL, LPL/WM, MZL, MCL, and DLBCL were closed. Dosing of patients varied by disease state cohort and was measured in terms of TBD.total body dose (TBD).

Reworded

Patients in the r/r WM cohort all received TBD of ≥ 60 mCi (25 mCi/m2 single bolus, 31.25 mCi/m2 fractionated, 37.5 mCi/m2 fractionated, or two cycles of40 mCi/m2 fractionated) either as a bolus dose or fractionated. Current data from our Phase 2a CLOVER-1 clinical study show a 100% ORR in six WM patients and an 83.3% major response rate with one patient achieving a complete response (CR), which reached 39 months post-last treatment. While median treatment free survival (TFS), also known as treatment free remission (TFR), and DOR have not been reached, the average treatment TFS/TFR is currently at 330 days. We believe this may represent an important improvement in the treatment of r/r WM as we believe no approved or late-stage development treatments for second- and third-line patients have reported a CR to date. Based on study results, iopofosine was well tolerated, with the most common adverse events being cytopenias and fatigue.

Reworded

The most frequently reported adverse events in all patients were cytopenias, which followed a predictable course and timeline. The frequency of adverse events did not increase as doses were increased and the profile of cytopenias remained consistent. Importantly, our assessment is that these cytopenias have had a predictable pattern to initiation, nadir and recovery and are treatable. The most common grade ≥3 events at the highest dose (75mCi TBD) were hematologic toxicities including thrombocytopenia (65%), neutropenia (41%), leukopenia (30%), anemia (24%) and lymphopenia (35%). No patients experienced cardiotoxicities, neurological toxicities, infusion site reactions, peripheral neuropathy, allergic reactions, cytokine release syndrome, keratopathy, renal toxicities, or changes in liver enzymes. The safety and tolerability profile in patients with r/r NHL was similar to r/r MM patients except for fewer cytopenias of any grade. Based upon iopofosine being well tolerated across all dose groups, the observed response rate, and especially in difficult to treat patients such as high risk and triple class refractory or penta-refractory, and corroborating data showing the potential to further improve upon current ORRs and durability of those responses, the study has been expanded to test a two-cycle dosing optimization regimen with a target TBD >60 mCi/m2 of iopofosine.

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Recent Developments

Reworded

Three Months Ended MarchJune 31,30, 2026 and 2025

Reworded

Research and Development. Research and development expenses for the three months ended MarchJune 31,30, 2026, were approximately $3,007,000,$4,557,000, compared to approximately $3,427,000$2,390,000 for the three months ended MarchJune 31,30, 2025.

Reworded

The following table is a summary comparison of approximate research and development costs for the three months ended MarchJune 31,30, 2026 and 2025:

Added

The overall increase in research and development expense was approximately $2,167,000, or 91%. The increase in spending was composed primarily of increased clinical project costs and manufacturing and related costs resulting from the initiation of the confirmatory and triple-negative breast cancer studies, offset in part by reduced activity in the pediatric study.

Removed

The overall decrease in research and development expense of approximately $420,000, or 12%, was primarily a result of decreased clinical project costs of approximately $348,000 driven by the conclusion of patient enrollment in our WM and pre-clinical project costs of approximately $446,000 offset by an increase in manufacturing and related costs of approximately $536,000 for further development of pre-clinical assets.

Reworded

General and administrative. General and administrative expense for the three months ended MarchJune 31,30, 2026, was approximately $2,787,000,$2,639,000, compared to approximately $2,974,000$3,648,000 for the same period in 2025. The overall decrease in general and administrative expense of approximately $184,000,$1,009,000, or 6%,28%, was driven by costs associated with a decrease in pre-commercialization activities, professional fees, and personnel costs.

Reworded

Other income (expense), net. Other income (expense), net, for the three months ended MarchJune 31,30, 2026, was income of approximately $140,000,$265,000, as compared to approximately $203,000 of expense$590,000 in the same period of 2025, resulting almost exclusively from changes in warrant valuation.valuation, Fluctuationswhich are non-cash in nature, and are primarily impacted by fluctuations in the Company’s common stock price are the primary aspect of warrant valuation changes.price. Interest income decreasedincreased year-over-year to approximately $63,000$133,000 in 2026 as compared to approximately $137,000$88,000 in 2025. The Company’s reducedhigher cashamounts onof handinvested funds drove the reduction.increase.

Added

Six Months Ended June 30, 2026 and 2025

Added

Research and Development. Research and development expenses for the six months ended June 30, 2026, were approximately $7,565,000, compared to approximately $5,817,000 for the six months ended June 30, 2025.

Added

The following table is a summary comparison of approximate research and development costs for the six months ended June 30, 2026 and 2025:

Added

The overall increase in research and development expense of approximately $1,748,000, or 30%, was primarily a result of increased clinical project costs and manufacturing and related costs of approximately $1,418,000 and 942,000, respectively, resulting from the initiation of the confirmatory and triple-negative breast cancer studies, offset in part by decreased pre-clinical project costs of approximately $(517,000), driven by reduced activity in the pediatric study.

Added

General and administrative. General and administrative expense for the six months ended June 30, 2026, was approximately $5,425,000, compared to approximately $6,622,000 for the same period in 2025. The overall decrease in general and administrative expense of approximately $1,196,000, or 18%, was driven by lower costs associated with a decrease in professional fees, pre-commercialization and personnel costs.

Added

Other income (expense), net. Other income (expense), net, for the six months ended June 30, 2026, was approximately $405,000, as compared to approximately $387,000 of income in the same period of 2025, resulting from changes in warrant valuation and interest income. The changes in warrant valuation impacts are non-cash in nature and are largely driven by fluctuations in the Company’s common stock price. Interest income decreased to approximately $196,000 in the six months ended June 30, 2026, as compared to approximately $225,000 for the same period in 2025. Lower average amounts of invested funds in the current year were the primary driver of the reduction.

Reworded

We have incurred losses since inception in devoting substantially all of our efforts toward research and development of drug candidates for which we are seeking FDA approval. During the threesix months ended MarchJune 31,30, 2026, we generated a net loss of approximately $5.7$12.6 million and used approximately $4.8$10.9 million in cash for operations. We expect that we will continue to generate operating losses for the foreseeable future. As of MarchJune 31,30, 2026, our consolidated cash balance was approximately $8.3$34.0 million. 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 $37$29 million of unrestricted cash and cash equivalents. Absent further action taken by management to increase its liquidity, the Company may be unable to fund its operations under normal course beyond the second quarter of 2027. 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. Management also plans to preserve liquidity, as needed, by implementing temporary cost saving measures. While management believes their plans will be successful, no assurance can be provided such plans will be effectively implemented over the next twelve months beyond the issuance date. In the event management’s plans are not effectively implemented, the Company will be required to seek other alternatives which may include, among others, strategic alternatives such as mergers, acquisitions, partnerships, joint ventures, licensing arrangements or other strategic transactions, the sale of assets, discontinuance of certain operations, and/or filing for bankruptcy protection.

CLRB insider buying and selling (Form 4)

Since 2026-04-11, insiders reported open-market purchases in 2 Form 4 filings (2 insiders, 1 trade date, 17,360 shares, about $50.0K) and open-market sales in 0 filings. Net open-market shares: 17,360 (purchases minus sales); net value about $50.0K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.

Trade dateInsiderTransactionSharesPriceValueOwned afterFiling
2026-05-07Longcor Jarrod
Chief Operating Officer
Open-market purchase 8,680$2.88 $25.0K20,451 SEC
2026-05-07Caruso James V
Director, Chief Executive Officer
Open-market purchase 8,680$2.88 $25.0K20,318 SEC

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