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

We currently do not have any drugs available for commercial salessale, nor do we have any drugs that have been approved for sale by theapplicable regulatory authorities. We have invested a significant portion of our efforts and financial resources in research and development of our leading drug candidate, CNM-Au8, a catalytically-active gold nanocrystal suspension, which in early-stage studies has shown potential for the treatment of patients with ALS, MS, and PD. Our ability to generate revenue and become profitable in the future depends substantially on the future sales generated by CNM-Au8 and our drug candidates, which in turn depends on the successful research and development, regulatory approval, commercialization and sale of our drug candidates presently under clinical development for the treatment of patients with neurological disorders. We are also developing new drugs based on our technology that have not yet entered into human studies. The ultimate success of our drug candidates is subject to us achieving certain milestones, including without limitation:

Even if we are able to generate revenues from any future sales of our drug candidates, we may not become profitable and may need to obtain additional funding to continue operations. Any required funding may not be available on favorable terms or at all. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and may be forced to reduce our operations. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would decrease our value significantly and could impair our ability to raise capital, expand our businessbusiness, or continue our operations, which in turn may adversely affect our business, financial condition, and results of operations.

Our main business is research and development, and, if our research and ifdevelopment activities are successful, sales of drug candidates. As all of our drug candidates are still in the research and development stage, we currently do not generate revenue from the sale of drug candidates, and we have recorded continued significant net losses. We generate an immaterial amount of revenue related to license and supply agreements for dietary (mineral) supplements; however, such revenue is not expected to be a material contributor to our revenue in the future. If we fail to commercialize our drug candidates as planned due to failures to complete clinical trials, obtain regulatory approval, conduct commercial scale manufacturing or for any other reason, we may experience significant delays or failure in generating revenue and realizing profit from the commercial sale of our drug candidates.

We expect to continue to incur losses for the foreseeable future, and we expect these losses to increase as we continue to expand our development of, and seek regulatory approvals for, our drug candidates, and we continue to build up our commercialization capabilities. Typically, it takes many years to develop one new drug from the drug discovery stage to the time it is available for treating patients. In addition, we will continue to incur costs associated with operating as a public company and in support of our growth as a development-stage or commercial-stage pharmaceutical company. The size of our future net losses will depend, in part, on the number and scope of our drug development programs and the associated costs of those programs, the cost of commercializing any approved products, our ability to generate revenues and the timing and amount of milestones and other payments we make or receive through arrangements with third parties. If any of our drug candidates fails in clinical trials or does not gain regulatory approval, or if approved, fails to achieve market acceptance, we may never become profitable. Our failure to become and remain profitable would decrease our value significantly and impair our ability to raise capital, maintain our research and development efforts, expand our businessbusiness, or continue our operations.

Our cash, cash equivalents, and marketablecash securitiesequivalents totaled $12.2$5.2 million and $35.0$12.2 million as of December 31, 20242025 and 2023,2024, respectively, and net cash used in operating activities was $21.3$18.5 million and $30.2$21.3 million for the years ended December 31, 20242025 and 2023,2024, respectively. We expect to continue to incur losses and use cash in operating activities for the foreseeable future. For details, please see “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources.” We expect that within the next twelve months, we will not have sufficient cash and other resources on hand to sustain our current operations or meet our obligations as they become due unless we obtain additional financing. Additionally, pursuant to our senior secured convertible promissory notes issued in December 2024 (the “2024 SSCP Notes”), we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes (see Note 8 to the consolidated financial statements). These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as utilizing our existing at-the-market facility and equity purchase agreement and potential proceeds from the exercise of outstanding warrants and stock options. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of our plans will result in the necessary funding to continue current operations. During the year ended December 31, 2024,2025, we generated $2.7$10.6 million of gross proceeds from our equity distribution agreement (the “ATM Agreement”), raised $3.5 million from a registered direct offering of equity securities and an additional $3.8 million from separate, concurrent private placements of equity securities, and raised $10.0$1.5 million from the issuance of thesenior 2024secured SSCPconvertible Notespromissory ofnotes which(see $7.9Note million was used8 to repay the remainingconsolidated balancefinancial ofstatements). our obligations under a term loan with Avenue Venture Opportunities Fund, L.P. Additionally, subsequentSubsequent to December 31, 2024,2025, we generated $2.5$6.0 million of gross proceeds from ourthe ATMissuance Agreement.of WeCommon Stock and warrants in a registered direct offering. While we have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization effortsefforts, reducing employee compensation, and elimination ofeliminating certain staff positions.positions, Wewe have concluded that our plans do not alleviate the substantial doubt about our ability to continue as a going concern beyond one year from the date the consolidated financial statements are issued.

Investment in biopharmaceutical product development is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential drug candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval and become commercially viable. As a relatively new business, we have not yet demonstrated an ability to manufacture drugs at a commercial scale, to arrange for a third party to do so on our behalf, or to conduct sales and marketing activities necessary for successful commercialization. We have not had any product approved for commercial sale and have not generated any revenue from pharmaceutical product sales. In addition, as a business with a limited operating history, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields. Consequently, any assessment you make about our current business or future success or viability may not be as accurate as it could be if we had a longer operating history and had been able to reduce some of the uncertainties as set out above. Further, our limited financial track record, without any revenue yet from our expected future principal business, may be of limited reference value for your assessment of our business.

In addition, the environmental, health and safety laws and regulations applicable to us and our third-party contractors may change and impose stricter requirements in the future. As a result, we may be required to incur substantial costs to comply with future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penaltiespenalties, or other sanctions, which could have a material adverse effect on our business, financial condition, results of operations, and prospects.

We could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in our information systems and networks and those of our vendors, including personal information of our employees and patients, and company and vendor confidential data. In addition, outside parties may attempt to penetrate our systems or those of our vendors or fraudulently induce our personnel or the personnel of our vendors to disclose sensitive information in order to gain access to our data and/or systems. Like other companies, we have on occasion experienced, and will continue to experience, threats to our data and systems, including malicious codes and viruses, phishing and other cyber-attacks. The number and complexity of these threats continue to increase over time. If a material breach of our information technology (“IT”) systems or those of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged. We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks.

We may also be required to comply with laws, regulations, rules, industry standards, and other legal obligations that require us to maintain the security of personal data. We may also have contractual and other legal obligations to notify customers, collaborators, or other relevant stakeholders of security incidents. Failure to prevent or mitigate cyberattacks could result in unauthorized access to data, including proprietary and personal information. Most jurisdictions have enacted laws requiring companies to notify individuals, regulatory authorities, and others of security breaches involving certain types of data. Such disclosures are costly, could lead to negative publicity, may cause our customercustomers or collaborators or other relevant stakeholders to lose confidence in the effectiveness of our security measures and require us to expend significant capital and other resources to respond to and/or alleviate problems caused by the actual or perceived security incident. In addition, the costs to respond to a cybersecurity event or to mitigate any identified security vulnerabilities could be significant, including costs for remediating the effects of such an event, paying a ransom, restoring data from backups, and conducting data analysis to determine what data may have been affected by the breach. In addition, our efforts to contain or remediate a security incident or any vulnerability exploited to cause an incident may be unsuccessful, and efforts and any related failures to contain or remediate them could result in interruptions, delays, harm to our reputation, and increases to our insurance coverage.

In addition, regulatory response or litigation resulting from security breaches may adversely affect our business. Unauthorized access to our information technologyIT systems could result in litigation with our customers, collaborators, or other relevant stakeholders, or regulatory actions by government entities. These proceedings could force us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, or adversely affect our reputation. We could be required to fundamentally change our business activities and practices in response to such litigation, which could have an adverse effect on our business. If a security breach were to occur and the confidentiality, integrity or availability of our data or the data of our collaborators were disrupted, we could incur significant liability, which could negatively affect our business and damage our reputation.

Our manufacturing facilities will be subject to ongoing, periodic inspection by various regulatory authorities, including the FDA, EMA, China’s National Medical Products Administration (“NMPA”), Health Canada, and the Australian Therapeutics Goods Administration (“TGA”) or other comparable regulatory agencies to ensure compliance with GMP. Our failure to follow and document our adherence to such GMP or other regulatory requirements may lead to significant delays in the availability of products for clinical or, if approved, commercial use, and may result in the termination of or a hold on a clinical trial, or may delay or prevent filing or approval of marketing applications for our drug candidates or the commercialization of our drugs, if approved. We also may encounter problems with the following:

In addition, currentCurrent or future tax treatments, tax concessions, tax allowances and financial incentives applicable to us may be changed, terminated, or otherwise become unavailable due to many factors, including changes in government policy or administrative decisions by the relevant government authorities. Due to potential changes in government policies, we cannot be certain of the level of government grants we will receive in the future. Our post-tax profitability and cash flows may be adversely affected as a result of one or more of these or other factors.factors.''

Changes in tax laws may adversely affect us, and the Internal Revenue Service or a court may disagree with tax positions taken by us, which may resultadversely in adverse effects inaffect our financial condition or the value of our Common Stock.

The ultimate impact of potential future epidemics or pandemics is highly uncertain and subject to continued change. These effects could have a material adverse impact on our business and operations, or the businesses and operations of third parties on which we rely.

If we are not able to obtain, or experiencesexperience delays in obtaining, required regulatory approvals, we will not be able to commercialize our drug candidates, and our ability to generate revenue will be materially impaired.

Disruptions at the FDA and other government agencies may slow the time necessary for new product candidates to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. If a prolonged government shutdown occurs, as it did from October 1, 2025 to November 12, 2025, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Further, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Since March 2020, when foreign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume pre-COVID-19 pandemic levels of inspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections. Should the FDA determine that an inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel, and the FDA does not determine a remote interactive evaluation to be adequate, the FDA has stated that it generally intends to issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed. During the COVID-19 pandemic, a number of companies announced receipt of complete response letters due to the FDA’s inability to complete required inspections for their applications. Regulatory authorities outside the U.S. may adopt similar restrictions or other policy measures in response to future health epidemics or pandemics and may experience delays in their regulatory activities. Further, with the change in presidential administrations in 2025, there isremains substantial uncertainty as to how, if at all, the newsecond Trump administration will seek to modify or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates. There is also uncertainty as to how other measures being implemented by the newsecond Trump administration across the government will impact our activities and those of the FDA and its operations. For example, the potentialmass losslayoffs of FDA personnel as part of the administration’s efforts to reduce the size of the federal workforce could lead to further disruptions and delays in FDA review of our product candidates. Similarly, efforts by the new administration to substantially reduce research funding by the NIH of medical research could have substantial direct or indirect impacts on our research activities.

We do not currently have Fast Track Designation or Breakthrough Therapy Designation,Designation for any of our drug candidates, but may seek one or more of such designations in the future.

Regulatory bodies that enforce laws and regulations to prohibit off-label use may investigate whether our products are being used off-label. Even though we take steps to prevent off-label promotion of our products, this would not necessarily prevent regulatory or prosecuting agencies from investigating and taking action against us as if we were engaged in off-label promotion. Such actions could result in significant harm to our reputation and financial condition.

We may face difficulties from changes to current regulations and future legislation.legislation, including relating to healthcare reform efforts.

Although we do not currently own issued patents or pending patent applications that have been generated through the use of U.S. government funding, we may acquire or license in the future intellectual property rights that have been generated through the use of U.S. government funding or grants. Pursuant to the Bayh-Dole Act of 1980, the U.S. government may have certain rights in inventions developed with government funding. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (1) adequate steps have not been taken to commercialize the invention; (2) government action is necessary to meet public health or safety needs; or (3) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). Such “march-in” rights can apply to new subject matter arising from the use of such government funding or grants and should not extend to pre-existing subject matter or subject matter arising from funds unrelated to the government funding or grants If the U.S. government exercised its march-in rights in our future intellectual property rights that are generated through the use of U.S. government funding or grants, we could be forced to license or sublicense intellectual property developed by us or that we license on terms unfavorable to us, and there can be no assurance that we would receive compensation from the U.S. government for the exercise of such rights. The U.S. government also has the right to take title to these inventions if we fail to disclose the invention to the government or fail to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products covered by such intellectual property.grants.

We have incurredincur significant increased expenses and administrative burdens as a public company, which could have an adverse effect on our business, financial condition and results of operations.

As a public company, and particularly after we are no longer a smaller reporting company, we have faced and will continue to face increased legal, accounting, administrative and other costs and expenses as a public company that we did not incur as a private company. The Sarbanes-Oxley Act, including the requirements of Section 404, as well as rules and regulations subsequently implemented by the U.S. Securities and Exchange Commission (“SEC”), the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010 and the rules and regulations promulgated and to be promulgated thereunder, the Public Company Accounting Oversight Board and the securities exchanges, impose additional reporting and other obligations on public companies. Compliance with public company requirements hasis increased costscostly and mademakes certain activities more time-consuming. A number of those requirements have required us to carry out activities we have not done previously. Our management and other personnel also have devoted and will continue to devote a substantial amount of time to these compliance initiatives. In addition, additional expenses associated with SEC reporting requirements have been incurred. Furthermore, if any issuesnoncompliance in complying with those requirements areis identified (for example, if theour auditors identify a material weakness or significant deficiency in theour internal control over financial reporting), we could incur additional costs rectifyingto thosecorrect issues, and the existence of those issuesnoncompliance could adversely affect our reputationreputation. orOther investor perceptionschallenges of it.operating Itas isa alsopublic morecompany expensiveinclude, tobut obtainare not limited to, the increased costs of director and officer liability insurance. Risks associated with our status as a public company may make it more difficult to attractinsurance and retainfinancial and legal services, attracting and retaining qualified persons to serve on theour board of directors or as executive officers.officers, Theand additionaladvocacy efforts by stockholders and third parties that may prompt changes in governance, reporting andrequirements otheror obligations imposed by these rulesregulations and regulationsthereby hasfurther increasedincrease legal and financial compliance costs and the costs of related legal, accounting and administrative activities.costs. These increased costs require us to divert a significant amount of time and money that could otherwise be used to expand our business and achieve strategic objectives. Advocacy efforts by stockholders and third parties may also prompt additional changes in governance and reporting requirements, which could further increase costs.

Future offerings of debt or equity securities by us may dilute the economic and voting rights of our existing stockholders or adversely affect the market price of our Common Stock.

There can be no assurance that we will be able to maintain compliance with any of the Nasdaq continued listing requirements. If Nasdaq delists our shares of Common Stock or warrants from trading on its exchange for failure to meet Nasdaq’s listing requirements, we and our stockholders could face significant material adverse consequences including:

Our patent-protected, proprietary position affords us the potential to develop a broad and deep pipeline of novel CSN therapeutics to address a range of diseases with high impact on human health. We innovated an electro-crystal-chemistry drug development platform that draws from advances in nanotechnology, plasma and quantum physics, materialmaterials science, and biochemistry. Our platform process results in nanocrystals with faceted structures and surfaces that are free of the chemical surface modifications that accompany other production methods. Many traditional methods of nanoparticle synthesis involve the unavoidable deposition of potentially toxic organic residues and stabilizing surfactants on the particle surfaces. Synthesizing stable nanocrystals that are both nontoxic and highly catalytic has overcome this significant hurdle in harnessing transition metal catalytic activity for therapeutic use. Our clean-surfaced nanocrystals exhibit catalytic activities many-fold higher than other commercially available nanoparticles, produced using various techniques, that we have comparatively evaluated.

Our development and clinical efforts are dedicated to revolutionizing the treatment of neurodegenerative diseases to restore and protect neuronal health and function. Our nanotherapeutics target cellular energy impairments that are common to many diseases and we are currently focused on addressing the high unmet medical needs in central nervous system disorders including amyotrophic lateral sclerosis (“ALS”), multiple sclerosis (“MS”), and Parkinson’s disease (“PD”). We currently have no drugs approved for commercial sale and have not generated any revenue from drug sales. We have never been profitable and have incurred operating losses in each year since inception. We generate revenue from sales of dietary supplements through our wholly ownedwholly-owned subsidiary, dOrbital, Inc., or through an exclusive license with 4Life Research LLC (“4Life”), an international supplier of health supplements, stockholder, debt holder, and related party. We anticipate these revenues to be small compared to our operating expenses and to the revenue we expect to generate from potential future sales of our drug candidates, for which we are currently conducting clinical trials.

The Reverse Stock Split did not reduce the total number of authorized shares of Common Stock or preferred stock, par value $0.0001 per share (“Preferred Stock”), or change the par values of the Company’sour Common Stock or Preferred Stock. All outstanding stock options, warrants, rights to restricted stock awards, convertible debt, and contingent earn-out shares entitling their holders to purchase or receive shares of Common Stock were adjusted as a result of the Reverse Stock Split, in accordance with the terms of each such security. In addition, the number of shares reserved for issuance pursuant to our Amended 2020 Stock Plan was also appropriately adjusted. All historical share and per share data for the periods presented in our consolidated financial statements, including for periods ending prior to July 11, 2024, has been adjusted to reflect the 1-for-20 Reverse Stock Split on a retroactive basis as if the Reverse Stock Split occurred as of the earliest period presented.

The FDA noted that whether NfLdisease-specific biomarkers can serve as a reasonably likely surrogate endpoint for the effects of CNM-Au8 in ALS and whether the magnitude of change observed on NfL or other related disease-specific biomarkers in patients treated with CNM-Au8 iscan reasonably likely to predict clinical benefit for ALS would be a matter of review.

The discovery and development of novel drug candidates requires a significant investment of resources over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. As a result of this commitment, our pipeline of drug candidates has been advancing, with substantially all our research and development expenses relating to CNM-Au8, our lead asset, with the remainder spent on our CNM-ZnAg asset.CNM-Au8.

General and administrative expenses consist primarily of payroll and personnel expenses for salaries, benefits, and stock-based compensation; fees for legal, finance, accounting, tax, and information technology services; insurance costs; expenses for public and investor relations; rent, utilities, depreciation, and facilityother costs.costs related to our facilities.

We anticipate that our general and administrative expenses in future periods will be contingent upon our discussions with the FDA. If we are able to file an NDA with the FDA under an accelerated approval pathway, we anticipate our general and administrative expenses would increase in future periods to support increases in our drug development activities and as we build our commercial capabilities in advance of receiving regulatory approval. This potential increase will likely include increased headcount, increased stock-based compensation expenses, expanded infrastructure including certain sales and marketing activities performed ahead of regulatory approval, and increased insurance expenses. If we are unable to file an NDA with the FDA under an accelerated approval pathway, we would need to continue investing in clinical research activities and we anticipate our general and administrative expenses would decrease in future periods as we decrease commercial manufacturing expansion projects, including at our Elkton, Maryland facility, and as we implement cost-saving initiatives, such as a reduction in compensation, a hiring freeze, and elimination of certain staff positions.

Total other income (expense), net, consists primarily of (i) interest income and interest expense, (ii) commitment share expense from shares of Common Stock issued as a commitment fee, (iii) issuance costs for common stock warrant liabilities, (iv) a loss on initial issuance of equity from the fair value in excess of proceeds from public equity offerings, (v) changes in the fair value of our common stock warrant liabilities,liabilities and derivative liabilities, and Contingent Earn-outs, (viiii) research and development tax credits, unrestricted grants, and conditional grants for which applicable conditions have been met, and (vii) realized gains and losses on foreign currency transactions and other miscellaneous income and expense items.met.

Product revenue relates to our dietary supplement products and consists of (i) sales of an aqueous zinc-silver ion dietary (mineral) supplement sold by our wholly-owned subsidiary, dOrbital, Inc., under the trade name “rMetx™ ZnAg Immune Boost,” or under a supply agreement with 4Life under the trade name “Zinc Factor™,” and (ii) sales of KHC46, an aqueous gold dietary (mineral) supplement of very low-concentration, sold under a supply agreement with 4Life under the trade name “Gold Factor™.” Royalty revenue relates to our dietary supplement products and consists of proceeds under an exclusive and royalty-bearing license agreement with 4Life relating to the sale of Gold Factor. During the years ended December 31, 20242025 and 2023,2024, changes in product and royalty revenues were due to the timing of purchases and sales of Zinc Factor and Gold Factor by 4Life under the supply and license agreements.

We are incorporated in the state of Delaware and subject to statutory U.S. federal corporate income tax at a rate of 21.00%. We are also subject to state income tax in Maryland at a rate of 8.25%, and in Utah at a rate of 4.55% and 4.65% for the years ended December 31, 2024 and 2023, respectively.4.50%. As of December 31, 20242025 and 2023,2024, we recorded a full valuation allowance against our net deferred tax assets due to the uncertainty as to whether such assets will be realized resulting from our three-year cumulative loss position and the uncertainty surrounding our ability to generate pre-tax income in the foreseeable future.

We incurred a loss from operations of $33.1$23.1 million and $40.5$33.1 million for the years ended December 31, 20242025 and 2023,2024, respectively. Our accumulated deficit was $282.1$308.3 million and $242.7$282.1 million as of December 31, 20242025 and 2023.2024. Our cash,cash and cash equivalents, and marketable securitiesequivalents totaled $12.2$5.2 million and $35.0$12.2 million as of December 31, 20242025 and 2023,2024, respectively, and net cash used in operating activities was $21.3$18.5 million and $30.2$21.3 million for the years ended December 31, 20242025 and 2023,2024, respectively.

We have incurred significant losses and negative cash flows from operations since our inception. We have not generated significant revenues since our inception, and we do not anticipate generating significant revenues unless we successfully complete development and obtain regulatory approval for commercialization of a drug candidate. We expect to incur additional losses in the future, particularly as we advance the development of our clinical-stage drug candidates, continue research and development of our preclinical drug candidates, and initiate additional clinical trials of, and seek regulatory approval for, these and other future drug candidates. We expect that within the next twelve months, we will not have sufficient cash and other resources on hand to sustain our current operations or meet our obligations as they become due unless we obtain additional financing. Additionally, pursuant to our senior secured convertible promissory notes issued in December 2024 (the “2024 SSCP Notes,Notes”), we are required to maintain unrestricted cash and cash equivalents of at least $2.0 million to avoid acceleration of the full balance of the 2024 SSCP Notes (see Note 8 to the consolidated financial statements). These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as utilizing our existing at-the-market facility and equity purchase agreement and potential proceeds from the exercise of outstanding warrants and stock options. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of our plans will result in the necessary funding to continue current operations. During the year ended December 31, 2024,2025, we generated $2.7$10.6 million of gross proceeds from our equity distribution agreement (the “ATM Agreement”), raised $3.5 million from a registered direct offering of equity securities and an additional $3.8 million from separate, concurrent private placements of equity securities, and raised $10.0$1.5 million from the issuance of thesenior 2024secured SSCPconvertible Notespromissory ofnotes which(see $7.9Note million was used8 to repay the remainingconsolidated balancefinancial ofstatements). our obligations under a term loan with Avenue. Additionally, subsequentSubsequent to December 31, 2024,2025, we generated $2.5$6.0 million of gross proceeds from ourthe ATMissuance Agreement.of Wecommon stock and warrants in a registered direct offering. While we have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization effortsefforts, reducing employee compensation, and elimination ofeliminating certain staff positions.positions, Wewe have concluded that our plans do not alleviate the substantial doubt about our ability to continue as a going concern beyond one year from the date the consolidated financial statements are issued.

For at least the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; and general and administrative costs to support our drug development and pre-commercial activities in advance of receiving regulatory approval for our drug candidates.candidates; and principal and interest payments on our notes payable and convertible notes payable. Firm commitments for funds include approximately $1.4$1.2 million of payments under operating lease obligations, payment of principal and interest on notes payable and convertible notes payable totaling $1.9$5.3 million, and a commitment for capital expenditures totaling $0.2 million related to the construction of our manufacturing facilities. We expect to meet our short-term liquidity requirements primarily through cash on hand. Additional sources of funds include equity financing, debt financing, or other capital sources.

Beyond the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; and general and administrative costs to support our drug development activities in advance of receiving regulatory approval for our drug candidates.candidates; and principal and interest payments on our notes payable and convertible notes payable. Additional funds may be spent to initiate new clinical trials, at our discretion. Known obligations beyond the next twelve months include $5.2$3.9 million of payments under operating lease obligations, and interest and principal repayment of notes payable and convertible notes payable of $18.0$15.9 million. We expect to meet our long-term liquidity requirements primarily through equity financing, debt financing, or other capital sources.

Net cash used in operating activities was $21.3$18.5 million for the year ended December 31, 2024,2025, which resulted from a net loss of $39.4$26.2 million, adjusted for non-cash items totaling $14.9$11.0 million and a net change in operating assets and liabilities of $3.2$3.4 million. Significant non-cash items included: (i) depreciation expense of $1.7$1.5 million relatingrelated to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.5$0.6 million, (iii) issuance costs of $0.2 million from a public equity offering allocated to liability-classified warrants, (iv) a loss on initial issuance of equity of $2.1 million from the fair value in excess of proceeds from a public equity offering, (v) stock-based compensation expense of $8.0$6.4 million, (vi) a loss on extinguishment of notes payable of $0.2 million from the repayment in full of the 2021 Avenue Loan, (vii) a loss on disposal of property and equipment of $0.2 million, (viiiiv) accretion of debt discount of $1.1$1.0 million, (ix) non-cash interest income on marketable securities of $0.2 million, (xv) non-cash interest expense on notes payable of $0.1$0.6 million due to amortization of debt discounts on notes payable,million, (xivi) a change in fair value of our common stock warrant liabilities of $0.7 million due to changes in the price of our Common Stock on Nasdaq and changes in valuation model inputs, (xii) a change in fair value of our derivative liabilities of $0.4$0.5 million due to changes in the price of our Common Stock on Nasdaq and changes in valuation model inputs, and (xiiivii) a change in fair value of theour Clenederivative Nanomedicine and Initial Stockholders Contingent Earn-outsliabilities of $0.1$0.4 million and $10,000, respectively, due to changes in the price of our Common Stock on Nasdaq and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to: (Ai) a decrease in accounts receivable of $0.1 million and a decrease in accounts payable of $0.3 million due to the timing of vendor invoicing and payments, (Bii) ana increasedecrease in prepaid expenses and other current assets of $0.2$0.1 million due to the(A) timinga ofdecrease vendorin invoicingprepaid clinical and payments,CRO expenses from the timing of receiptACT-EAP ofinvoicing, payments, and reimbursements, partially offset by (B) an increase in metals to be used in research and development,development due to the timing of invoicing, payments, and deliveries from suppliers, and (C) an increase in prepaid ACT-EAP expenses, partially offset by a decrease in research and development tax credits receivable,receivable due to the timing of refund payments, (Ciii) ana increasedecrease in accrued liabilities of $4.1$2.2 million primarily due to increased(A) a decrease in accrued compensation and benefits,benefits increasedresulting from payments of deferred grants,employee bonuses in cash and anequity, increase(B) a decrease in deferred grants due to satisfaction of grant conditions or performance obligations, and (C) a decrease in accrued CRO and clinical fees,fees partiallydue offsetto bythe atiming decreaseof ininvoicing otherand miscellaneous accrued liabilities,payments, and (Div) a decrease in operating lease obligations of $0.4$1.0 million.

Net cash used in operating activities was $30.2$21.3 million for the year ended December 31, 2023,2024, which resulted from a net loss of $49.5$39.4 million, adjusted for non-cash items totaling $19.5$14.9 million and a net change in operating assets and liabilities of $0.2$3.2 million. Significant non-cash items included: (i) depreciation expense of $1.7$1.6 million relating to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.4$0.5 million, (iii) commitment share expense of $0.4 million related to the shares of Common Stock issued to Lincoln Park as an initial fee for Lincoln Park’s commitment to purchase Common Stock under a purchase agreement with the Company, (iv) issuance costs of $0.3$0.2 million from a public equity offering allocated to liability-classified warrants, (viv) a loss on initial issuance of equity of $14.8$2.1 million from the fair value in excess of proceeds from a public equity offering, (viv) stock-based compensation expense of $9.1$8.0 million, (vi) a loss on extinguishment of notes payable of $0.2 million from the repayment in full of the 2021 Avenue Loan, (vii) a loss on disposal of property and equipment of $0.2 million, (viii) accretion of debt discount of $1.2$1.1 million, (viiiix) non-cash interest income on marketable securities of $0.2 million, (x) non-cash interest expense on notes payable of $0.1 million due to amortization of debt discounts on notes payable, (xi) a change in fair value of our common stock warrant liabilities of $0.7 million due to changes in the price of our Common Stock on Nasdaq and changes in valuation model inputs, (xii) a change in fair value of our derivative liabilities of $0.4 million,million due to changes in the price of our Common Stock on Nasdaq and changes in valuation model inputs, and (ixxiii) a change in fair value of the Clene Nanomedicine and Initial Stockholders Contingent Earn-outs of $2.2$0.1 million and $0.3 million,$10,000, respectively, due to the decreasechanges in price of our Common Stock on Nasdaq, and (x) a change in fair value of our common stock warrant liabilities of $6.3 million due to the decrease in price of our Common Stock on Nasdaq and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to the following: (AI) a decrease in accounts receivable of $46,000$0.1 million and a decrease in accounts payable of $1.5$0.3 million due to the timing of vendor invoicing and payments, (Bii) aan decreaseincrease in prepaid expenses and other current assets of $2.0$0.2 million due to the timing of vendor invoicing and payments, the timing of receipt of metals to be used in research and development, and an increase in prepaid ACT-EAP expenses, partially offset by a decrease in research and development tax credits receivable, (Ciii) aan decreaseincrease in accrued liabilities of $0.1$4.0 million primarily due to aincreased decreaseaccrued compensation and benefits, increased deferred grants, and an increase in accrued CRO and clinical fees, partially offset by ana increasedecrease in accrued compensation and benefits and other miscellaneous accrued liabilities, and (Div) a decrease in operating lease obligations of $0.6$0.4 million.

Net cash used in investing activities was $39,000 for the year ended December 31, 2025, which consisted of purchases of property and equipment. Net cash provided by investing activities was $6.3 million for the year ended December 31, 2024, which consisted of proceeds from maturities of marketable securities of $12.5 million, partially offset by purchases of marketable securities of $6.2 million and purchases of property and equipment of $15,000. Net cash used in investing activities was $1.5 million for year ended December 31, 2023, which consisted of purchases of marketable securities of $6.2 million and purchases of property and equipment of $0.3 million, partially offset by proceeds from maturities of marketable securities of $5.0 million.

Net cash used in financing activities was $1.5 million for the year ended December 31, 2024, which consisted of payments of finance lease obligations of $27,000 and payments of notes payable principal of $20.8 million due to principal repayments and the ultimate payoff of the 2021 Avenue Loan,Loan and payments of finance lease obligations of $27,000, partially offset by proceeds from the exercise of stock options of $0.1 million, proceeds from the issuance of common stock, warrants, and pre-funded warrants, net of offering costs, of $9.2 million, and proceeds from the issuance of notes payable and convertible notes payable of $9.9 million. Net cash provided by financing activities was $42.2 million for the year ended December 31, 2023, which consisted of proceeds from the issuance of common stock and warrants, net of offering costs, of $42.1 million, and proceeds from the issuance of notes payable of $0.4 million, partially offset by payments of finance lease obligations of $0.1 million and payments of notes payable modification fees of $0.2 million.

In October 2024, pursuant to a placement agency agreement with Canaccord,Canaccord Genuity LLC (“Canaccord”), we sold 725,000 shares of Common Stock and pre-funded warrants to purchase up to 17,626 shares of Common Stock at an exercise price of $0.001 per share. The aggregate gross proceeds were approximately $3.5 million, excluding the proceeds, ofif any, from the exercise of the pre-funded warrants and before deducting placement agent fees and expenses and other expenses payable by us. We paid Canaccord a placement agent fee of 6.00% of the aggregate gross proceeds of the offering. The offering was made pursuant to our registration statement on Form S-3 (file number 333-264299), declared effective by the Securities and Exchange Commission (“SEC”) on April 26, 2022,2022 (the ”2022 S-3”), and a related prospectus supplement. Additionally, in separate, concurrent private placements, we also sold 379,930 shares of Common Stock, pre-funded warrants to purchase up to 424,358 shares of Common Stock at an exercise price of $0.001 per share, and warrants to purchase up to 1,546,914 shares of Common Stock at an exercise price of $4.82 per share. The aggregate gross proceeds from the private placements were approximately $3.8 million, of which $1.3 million was contributed by certain of our directors, executive officers and their affiliated entities, and excludes the proceeds, if any, from the exercise of the warrants and pre-funded warrants.

During the years ended December 31, 20242025 and 2023,2024, we sold 504,2922,300,804 and 144,755504,292 shares of Common Stock, respectively, under our April 2022 equity distribution agreement (the “2022 ATM Agreement”) and April 2025 equity distribution agreement (the “2025 ATM Agreement,” and collectively with the 2022 ATM Agreement, the “ATM Agreements”) with Canaccord, generated gross proceeds of $2.7$10.6 million and $4.5$2.7 million, respectively, and paid commissions of $0.1$0.2 million and $0.1 million, respectively. The issuance and sale of Common Stock by us under the 2022 ATM Agreement was made pursuant to our 2022 S-3, which expired on April 26, 2025, and a related prospectus supplement. The issuance and sale of Common Stock by us under the 2025 ATM Agreement was made pursuant to our registration statement on Form S-3 (file number 333-264299333-286058), declared effective by the SEC on April 26,25, 2022,2025, and a related prospectus supplement.

In accordance with ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, we classified a portion of the 20212022 AvenueDHCD Loan as convertible notes payable in the consolidated balance sheets as of December 31, 2023 and did not separate the conversion option from the host contract as it did not meet the requirements for accounting as a derivative instrument. We accountedaccount for the convertible note as a single liability measured at its amortized cost as of December 31, 2023,2025 and 2024, with a carrying value of $4.9$5.3 million.million Asand of$5.3 Decembermillion, 31, 2024, the 2021 Avenue Loan was repaid in full.respectively.

We classified a portion of the 2024senior secured convertible promissory notes (the “SSCP Notes”) as convertible notes payable in the consolidated balance sheets and separated three features from the host contract as derivative instruments measured at fair value: (i) the conversion option (the “SSCPN Conversion Feature”), (ii) the redemption option upon a change of control or any bankruptcy, liquidation, or other restructuring process consisting of a cash payment equal to 115% of the outstanding principal (the “SSCPN Redemption Feature”), and (iii) the acceleration option plus a penalty equal to 10% of all outstanding principal and accrued and unpaid interest upon the occurrence and continuation of certain events of default (the “SSCPN Default Feature,” collectively with the SSCPN Conversion Feature and SSCPN Redemption Feature, the “SSCPN Derivative Liabilities”). We accounted for the remainder of the 2024 SSCP Notes as liabilities measured at their amortized costcost, with carrying values of (i) $9.3 million and $8.6 million for the 2024 SSCP Notes as of December 31, 2025 and 2024, withrespectively, aand carrying(ii) value$1.4 ofmillion $8.6 million. We remeasurefor the SSCPN2025 DerivativeSSCP Liabilities at each reporting date and record the change in fair valueNotes as a component of other income (expense), net in the consolidated statements of operations and comprehensive loss. During the year ended December 31, 2024, the change in fair value of the SSCPN Derivative Liabilities resulted in a loss of $0.4 million. We estimate the fair value of the 2024 SSCP Notes with and without the SSCPN Derivative Liabilities and calculate the difference as the implied fair value of the SSCPN Derivative Liabilities. The valuation model consists of a discounted cash flow model and a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) a change of control transaction, (ii) dissolution of the Company, or (iii) another outcome outside of (i)-(ii). These estimates require significant judgment. The unobservable valuation inputs were as follows:2025.

Pursuant to amendments to the 2021 Avenue Loan in June 2023 and September 2024, we issued a warrant to purchase 150,000 shares of Common Stock at $4.6014 per share (the “2023 Avenue Warrant”). The change in fair value of the 2023 Avenue Warrant resulted in a loss of $49,000$51,000 and a gainloss of $0.5 million$49,000 during the years ended December 31, 20242025 and 2023,2024, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) settlement of the instrument upon a change of control transaction, (ii) dissolution of the Company, or (iii) anotherheld outcometo outside of (i)-(ii).expiration. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Pursuant to an underwritten public offering in June 2023, we issued the Tranche A Warrantswarrants to purchase 2,500,000 shares of Common Stock at $22.00 per share.share (the “Tranche A Warrants”). The change in fair value of the Tranche A Warrants resulted in a gain of $0.6$0.3 million and a gain of $5.8$0.6 million during the years ended December 31, 20242025 and 2023,2024, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) FDA acceptance of an NDA for CNM-Au8, (ii) settlement upon a fundamental transaction, (iii) dissolution of the Company, and (iv) anotherheld outcometo outside of (i)-(iii).maturity. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Pursuant to a registered direct public offering in October 2024, we issued the 2024 Common Warrantswarrants to purchase 1,546,914 shares of Common Stock at $4.82 per share.share (the “2024 Common Warrants”). The change in fair value of the 2024 Common Warrants resulted in a loss of $0.8 million and a loss of $1.3 million during the yearyears ended December 31, 2024.2025 and 2024, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of the following events: (i) dissolution of the Company and (ii) anotherheld outcometo outside of (i).maturity. These estimates require significant judgment. The unobservable valuation inputs were as follows:

We estimate the fair value of stock options using a Black-Scholes option-pricing model, which requires significant judgment. The unobservable inputs include the expected price volatility, risk-free interest rate, expected dividend yield, and expected term. The unobservable valuation inputs were as follows:

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report. Unless the context otherwise requires, for purposes of this section, the terms the “Company,” “we,” “us,” or “our” are intended to mean the business and operations of Clene Inc. and its consolidated subsidiaries.

We intend to submit our NDA in early fourth quarter of 2026, which will remain a matter of FDA review. The planned NDA submission will be supported by NfL biomarker and clinical data from the Phase 2 HEALEY ALS Platform Trial and its open-label extension, as well as the Phase 2 RESCUE-ALS Trial, and the National Institutes of Health-sponsored expanded access protocol for CNM-Au8. Supporting data include reductions in plasma NfL associated with longer survival in the open-label extension and additional clinical outcomes. CNM-Au8 has previously received Orphan Drug Designation from the FDA for the treatment of ALS. We plan to initiate oura Phase 3 RESTORE-ALS trial during the firstsecond quarter of 20272027, andwhich servingwill serve as the post-approval confirmatory study.

We met with the FDA in a Type B end of Phase 2 meeting during the third quarter of 2025 to review results from the Phase 2 VISIONARY-MS trial and discuss a planned Phase 3 study focusing on cognition improvement as an adjunct to standard-of-care MS therapies, addressing a critical unmet medical need for people struggling with MS. The FDA aligned with Clenethe Company acknowledging the limitations of the Expanded Disability Status Scale, a global measure of MS disease severity, and expressed openness to considering other potential primary endpoints, including cognition, to evaluate broader treatment effects. We plan to work closely with regulatory health authorities from the FDA, European Medicines Agency and other international regulatory bodies, MS experts, and patient representatives to determine the proper path to advance CNM-Au8 into Phase 3 and potential future approval. We also believe that once CNM-Au8 receives regulatory approval in another indication, licensing opportunities for the MS indication will improve.

Total other income (expense), net, consists primarily of (i) interest income and interest expense, (ii) changes in the fair value of our common stock warrant liabilities and derivative liabilities, and (iii) research and development tax credits, unrestricted grants, and conditional grants for which applicable conditions have been met.met, (iv) issuance costs for common stock warrant liabilities, and (v) losses on initial issuances of equity if the fair value exceeds the proceeds from public equity offerings.

Our results of operations for the three and six months ended MarchJune 31,30, 2026 and 2025 were as follows:

Product revenue relates to our dietary supplement products and consists of (i) sales of an aqueous zinc-silver ion dietary (mineral) supplement sold by our wholly-owned subsidiary, dOrbital, Inc., under the trade name “rMetx™ ZnAg Immune Boost,” or under a supply agreement with 4Life under the trade name “Zinc Factor™,” and (ii) sales of KHC46, an aqueous gold dietary (mineral) supplement of very low-concentration, sold under a supply agreement with 4Life under the trade name “Gold Factor™.” Royalty revenue relates to our dietary supplement products and consists of proceeds under an exclusive and royalty-bearing license agreement with 4Life relating to the sale of Gold Factor. During the three and six months ended MarchJune 31,30, 2026 and 2025, changes in product and royalty revenue was due to the timing of purchases and sales of Zinc Factor and Gold Factor by 4Life under the supply and license agreements.

Research and development expenses during the three and six months ended MarchJune 31,30, 2026 and 2025 was as follows:

General and administrative expenses during the three and six months ended MarchJune 31,30, 2026 and 2025 were as follows:

Total other income (expense), net, during the three and six months ended MarchJune 31,30, 2026 and 2025 was as follows:

We are incorporated in the state of Delaware and subject to statutory U.S. federal corporate income tax at a rate of 21.00%. We are also subject to state income tax in Maryland at a rate of 8.25%, and in Utah at a rate of 4.50%. As of MarchJune 31,30, 2026 and December 31, 2025, we recorded a full valuation allowance against our net deferred tax assets due to the uncertainty as to whether such assets will be realized resulting from our three-year cumulative loss position and the uncertainty surrounding our ability to generate pre-tax income in the foreseeable future.

Our wholly-owned subsidiary, Clene Australia Pty Ltd (“Clene Australia”), was established in Australia in March 2018 and is subject to corporate income tax at a rate of 30.00%. Clene Australia had no taxable income or provision for income taxes for the threesix months ended MarchJune 31,30, 2026 and 2025. We recorded other income of $36,000$64,000 and $24,000$40,000 for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively, for research and development tax credits pertaining to Clene Australia for the 2026 and 2025 tax years, respectively.

Our wholly-owned subsidiary, Clene Netherlands B.V. (“Clene Netherlands”), was established in the Netherlands in April 2021 and is subject to corporate income tax at a rate of 19.00% up to €200,000 of taxable income and 25.80% for taxable income in excess of €200,000 for the threesix months ended MarchJune 31,30, 2026 and 2025. Clene Netherlands had no taxable income or provision for income taxes for the threesix months ended MarchJune 31,30, 2026 and 2025.

We incurred a loss from operations of $2.1$5.3 million and $4.1$5.9 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively; and $7.4 million and $9.9 million for the six months ended June 30, 2026 and 2025, respectively. Our accumulated deficit was $316.4$329.8 million and $308.3 million as of MarchJune 31,30, 2026 and December 31, 2025, respectively. Our cash and cash equivalents totaled $5.9$9.7 million and $5.2 million as of MarchJune 31,30, 2026 and December 31, 2025, respectively, and net cash used in operating activities was $4.5$7.1 million and $5.0$9.8 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.

To mitigate our funding needs, we plan to raise additional funding, including exploring equity financing and offerings, debt financing, licensing or collaboration arrangements with third parties, as well as utilizing our existing at-the-market facility and potential proceeds from the exercise of outstanding warrants and stock options. These plans are subject to market conditions and reliance on third parties, and there is no assurance that effective implementation of our plans will result in the necessary funding to continue current operations. During the three and six months ended MarchJune 31,30, 2026, we raised $6.0$7.0 million and $13.0 million, respectively, of gross proceeds from a registered direct offeringofferings of equity securities (see Note 13 to the condensed consolidated financial statements), and subsequent to March 31, 2026, we raised $7.0 million of gross proceeds from a registered direct offering of equity securities (see Note 17 to the condensed consolidated financial statements). While we have implemented cost-saving initiatives, including delaying and reducing certain research and development programs and commercialization efforts, reducing employee compensation, and eliminating certain staff positions, we have concluded that our plans do not alleviate the substantial doubt about our ability to continue as a going concern beyond one year from the date the condensed consolidated financial statements contained in this report are issued.

For at least the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; general and administrative costs to support our drug development and pre-commercial activities in advance of receiving regulatory approval for our drug candidates; and principal and interest payments on our notes payable and convertible notes payable. Firm commitments for funds include approximately $1.1 million of payments under operating lease obligations, payment of principal and interest on notes payable and convertible notes payable totaling $2.5$0.7 million, and a commitment for capital expenditures totaling $0.2$1.6 million related to the construction of our manufacturing facilities. We expect to meet our short-term liquidity requirements primarily through cash on hand. Additional sources of funds include equity financing, debt financing, or other capital sources. However, there can be no assurance that we will be able to secure such financing on favorable terms, or at all.

Beyond the next twelve months, our primary capital requirements are to fund our operations, including research and development, personnel, regulatory, and other clinical trial costs related to development of our lead drug candidate, CNM-Au8; general and administrative costs to support our drug development activities in advance of receiving regulatory approval for our drug candidates; and principal and interest payments on our notes payable and convertible notes payable. Additional funds may be spent to initiate new clinical trials, at our discretion. Known obligations beyond the next twelve months include $3.6$3.4 million of payments under operating lease obligations, and interest and principal repayment of notes payable and convertible notes payable of $18.6$21.2 million. We expect to meet our long-term liquidity requirements primarily through equity financing, debt financing, or other capital sources. However, there can be no assurance that we will be able to secure such financing on favorable terms, or at all.

Our cash flows for the threesix months ended MarchJune 31,30, 2026 and 2025 were as follows:

Net cash used in operating activities was $4.5$7.1 million for the threesix months ended MarchJune 31,30, 2026, which resulted from a net loss of $8.1$21.5 million, adjusted for non-cash items totaling $7.8$17.5 million and a net change in operating assets and liabilities of $4.3$3.1 million. Significant non-cash items included: (i) depreciation expense of $0.4$0.7 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.2$0.3 million, (iii) stock-based compensation expense of $1.3$2.4 million, (iv) accretion of debt discount of $0.3$0.5 million, (v) non-cash interest expense on notes payable of $0.4$0.8 million, (vi) issuance costs for common stock warrant liabilities of $0.4 million, (vii) a loss on initial issuance of equity from the fair value in excess of proceeds from a public equity offering of $4.6 million, (viii) a change in fair value of our common stock warrant liabilities of $1.1$5.2 million due to changes in the price of our Commoncommon Stockstock and changes in valuation model inputs, and (ix) a change in fair value of our derivative liabilities of $0.7$2.6 million due to changes in the price of our Commoncommon Stockstock and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to: (i) an increase in accounts receivable of $43,000 and an increase in accounts payable of $0.4$0.3 million due to the timing of vendor invoicing and payments, (ii) an increase in prepaid expenses and other current assets of $3.3$1.4 million due to (A) the timing of vendor invoicing and payments, (B) an increase in metals to be used in research and development due to the timing of invoicing, payments, and deliveries from our supplier, and changes in the commodity price of gold during reprocessing by our supplier compared to the original purchase price, and (C) an increase in grants receivable related to ACT-EAP reimbursements, and (D) an increase in prepaid clinical and CRO expenses related to the ACT-EAP, partially offset by (DE) a decrease in research and development tax credits receivable due to the timing of refund payments, and (EF) a decrease in miscellaneous prepaids and other current assets, (iii) a decrease in accrued liabilities of $1.2$1.4 million primarily due to (A) a decrease in accrued compensation and benefits resulting from payments of deferred employee bonuses in cash and equityequity, and(B) a decrease in deferred grants due to satisfaction of grant conditions or performance obligations, partially offset byand (C) ana increasedecrease in other miscellaneous accrued liabilities, partially offset by (D) an increase in accrued CRO and clinical fees related to our ongoing clinical programs, and (iv) a decrease in operating lease obligations of $0.2$0.4 million.

Net cash used in operating activities was $5.0$9.8 million for the threesix months ended MarchJune 31,30, 2025, which resulted from a net loss of $0.8$8.2 million, adjusted for non-cash items totaling $0.9$2.2 million and a net change in operating assets and liabilities of $3.3$3.8 million. Significant non-cash items included: (i) depreciation expense of $0.4$0.8 million related to laboratory and office equipment and leasehold improvements, (ii) non-cash lease expense of $0.1$0.3 million, (iii) stock-based compensation expense of $1.9$3.3 million, (iv) accretion of debt discount of $0.2$0.5 million, (v) non-cash interest expense on notes payable of $12,000,$24,000, (vi) a change in fair value of our common stock warrant liabilities of $2.5$2.0 million due to changes in the price of our Commoncommon Stockstock and changes in valuation model inputs, and (vii) a change in fair value of the our derivative liabilities of $1.1$0.7 million due to changes in the price of our Commoncommon Stockstock and changes in valuation model inputs. The net change in operating assets and liabilities was primarily attributable to: (i) a decrease in accounts receivable of $0.1 million and ana increasedecrease in accounts payable of $0.2$0.4 million due to the timing of vendor invoicing and payments, (ii) a decrease in inventory of $30,000 (iii) an increase in prepaid expenses and other current assets of $0.9$0.8 million due to (A) the timing of vendor invoicing and payments, (B) the timing of receipt of metals to be used in research and development, (C) an increase in prepaid ACT-EAP expenses, and (DC) an increase in research and development tax credits receivable, partially offset by (ivD) a decrease in prepaid clinical and CRO expenses related to the ACT-EAP, (iii) a decrease in accrued liabilities of $2.5$2.3 million primarily due to (A) a decrease in deferred grants, (B) a decrease in accrued CRO and clinical fees, and (CB) a decrease in other miscellaneous accrued liabilities, partially offset by (DC) an increase in accrued compensation and benefits, and (viv) a decrease in operating lease obligations of $0.2$0.3 million.

Net cash used in investing activities for the six months ended June 30, 2026 consisted of purchases of property and equipment of $1,000. We had no net cash provided by or used in investing activities during the threesix months ended MarchJune 31, 2026 and30, 2025.

Net cash provided by financing activities was $5.2$11.6 million for the threesix months ended MarchJune 31,30, 2026, which consisted of proceeds from the issuance of common stock and warrants, net of offering costs, of $5.3$11.7 million, partially offset by payments of notes payable of $0.1$0.2 million. Net cash provided by financing activities was $2.7$4.8 million for the threesix months ended MarchJune 31,30, 2025, which consisted of proceeds from the issuance of common stock of $2.7$5.0 million, partially offset by payments of notes payable of $0.2 million.

In January 2026, pursuant to a placement agency agreement with BTIG, LLC (“BTIG”), we sold 928,333 shares of Commonour Stock,common Seriesstock, A Warrantswarrants to purchase up to 1,114,000 shares of Commonour Stock,common stock (the “Series A Warrants”), and Series B Warrantswarrants to purchase up to 2,599,333 shares of Commonour Stock.common stock (the “Series B Warrants”). The aggregate gross proceeds were approximately $6.0 million, of which $0.3 million was contributed by certain of our directors and their affiliated entities, excluding the proceeds, of any, from the exercise of the Series A Warrants and Series B Warrants and before deducting placement agent fees and expenses and other expenses payable by us. We paid BTIG a placement agent fee of 6.00% of the aggregate gross proceeds of the offering. The offering was made pursuant to our registration statement on Form S-3 (file number 333-286058), declared effective on April 25, 2025,2025 (the “2025 S-3”), and a related prospectus supplement. The total fair value of the Common Stock, Series A Warrants, and Series B Warrants sold in the offerings exceeded the offering proceeds by $4.6 million, therefore pursuant to ASC 815, we recognized this amount as a loss on the initial issuance of equity during the three months ended March 31, 2026. The placement agent fees and offering expenses were allocated to the Common Stock, Series A Warrants, and Series B Warrants sold in the offering based on their relative fair values, with the amounts allocated to the liability-classified Series A and Series B Warrants recorded as an expense and the amounts allocated to the Common Stock as a reduction to its initial carrying value.

In accordance with ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, we classified the 2022 DHCD Loan as convertible notes payable in the condensed consolidated balance sheets and did not separate the conversion option from the host contract as it did not meet the requirements for accounting as a derivative instrument. We account for the convertible note as a single liability measured at its amortized cost as of MarchJune 31,30, 2026 and December 31, 2025, with a carrying value of $5.3 million and $5.3 million, respectively.

We classified a portion of the senior secured convertible promissory notes (the “SSCP Notes”) as convertible notes payable in the consolidated balance sheets and separated three features from the host contract as derivative instruments measured at fair value: (i) the conversion option (the “SSCPN Conversion Feature”), (ii) the redemption option upon a change of control or any bankruptcy, liquidation, or other restructuring process consisting of a cash payment equal to 115% of the outstanding principal (the “SSCPN Redemption Feature”), and (iii) the acceleration option plus a penalty equal to 10% of all outstanding principal and accrued and unpaid interest upon the occurrence and continuation of certain events of default (the “SSCPN Default Feature,” collectively with the SSCPN Conversion Feature and SSCPN Redemption Feature, the “SSCPN Derivative Liabilities”). We accounted for the remainder of the SSCP Notes as liabilities measured at their amortized cost, with carrying values of (i) $9.9$10.4 million and $9.3 million for the 2024 SSCP Notes as of MarchJune 31,30, 2026 and December 31, 2025, respectively, and (ii) $1.5 million and $1.4 million for the 2025 SSCP Notes as of MarchJune 31,30, 2026 and December 31, 2025, respectively.

We remeasure the SSCPN Derivative Liabilities at each reporting date and record the change in fair value as a component of other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The change in fair value of the SSCPN Derivative Liabilities resulted in a gainloss of $0.7$3.3 million and a gainloss of $1.1$0.4 million during the three months ended MarchJune 31,30, 2026 and 2025, respectively; and a loss of $2.6 million and a gain of $0.7 million during the six months ended June 30, 2026 and 2025, respectively. We estimate the fair value of the SSCP Notes with and without the SSCPN Derivative Liabilities and calculate the difference as the implied fair value of the SSCPN Derivative Liabilities. The valuation model consists of a discounted cash flow model and a Black-Scholes option-pricing model with probability weights for the occurrence of (i) a change of control transaction, (ii) dissolutiondefault of the Company, or (iii) held to maturity. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Pursuant to a loan with Avenue Venture Opportunities Fund, L.P. (“Avenue”), which we repaid in 2024, we issued a warrant to purchase 150,000 shares of Commonour Stockcommon stock at $4.6014 per share (the “2023 Avenue Warrant”). The change in fair value of the 2023 Avenue Warrant resulted in a gainloss of $0.1 million and a loss of $25,000 during the three months ended June 30, 2026 and 2025, respectively; and a loss of $0.1 million and a gain of $0.2$0.1 million during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of (i) settlement of the instrument upon a change of control transaction, (ii) dissolution of the Company, or (iii) held to expiration. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Pursuant to an underwritten public offering in June 2023, we issued warrants to purchase 2,500,000 shares of Commonour Stockcommon stock at $22.00 per share (the “Tranche A Warrants”). The Tranche A Warrants expired unexercised in June 2026. The change in fair value prior to the expiration of the Tranche A Warrants resulted in a loss of $30,000 during the three months ended June 30, 2025, and a gain of $0.4 million and a gain of $0.6 million during the threesix months ended MarchJune 31,30, 2026 and 2025, respectively. We estimateestimated the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of (i) acceptance of an NDA by the FDA for CNM-Au8, (ii) settlement upon a fundamental transaction, (iii) dissolution of the Company, and (iv) held to expiration. These estimates requirerequired significant judgment. The unobservable valuation inputs were as follows:

Pursuant to a registered direct public offering in October 2024, we issued warrants to purchase 1,546,914 shares of Commonour Stockcommon stock at $4.82 per share (the “2024 Common Warrants”). The change in fair value of the 2024 Common Warrants resulted in a gainloss of $0.7$1.0 million and a gainloss of $1.8$0.5 million during the three months ended MarchJune 31,30, 2026 and 2025, respectively; and a loss of $0.3 million and a gain of $1.3 million during the six months ended June 30, 2026 and 2025, respectively. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of (i) dissolution of the Company and (ii) held to maturity. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Pursuant to a registered direct public offering in January 2026, we issued Series A Warrants to purchase 1,114,000 shares of Commonour Stockcommon stock at $6.00 per share. The exercise price of the Series A Warrants will increase to $7.00 per share if (i) the Series A Warrant is exercised prior to our public announcement of the FDA’s posted action date under the Prescription Drug User Fee Act for our NDA for CNM-Au8 (the “Series A Trigger Announcement”), or (ii) the volume weighted average price (“VWAP”) of our Commoncommon Stockstock equals or exceeds $10.00 on the Series A Price Measurement Date, as defined below. The “Series A Price Measurement Date” means (A) the trading day on which the Series A Trigger Announcement is made, if such announcement is made prior to 9:00 a.m. (New York City time) on such trading day, or (B) the first trading day immediately following the day on which the Series A Trigger Announcement is made, if such announcement is made at or after 9:01 a.m. (New York City time) on a trading day or on a day that is not a trading day.

The change in fair value of the Series A Warrants resulted in a loss of $0.3$0.6 million and a loss of $0.9 million during the three and six months ended MarchJune 31,30, 2026. We estimate the fair value using a Monte Carlo simulation with estimates for (i) the probability of the Series A Trigger Announcement (ii) the expected stock price increase if the Series A Trigger Announcement occurs, and (iii) the expected stock price decrease if the Series A Trigger Announcement does not occur. These estimates require significant judgment. The unobservable valuation inputs were as follows:

Pursuant to a registered direct public offering in January 2026, we issued Series B Warrants to purchase 2,599,333 shares of Commonour Stockcommon stock at $6.00 per share. The exercise price of the Series B Warrants will increase to (i) $10.00 per share if the VWAP of our Commoncommon Stockstock equals or exceeds $20.00 on the Series B Price Measurement Date, or (ii) $12.50 per share if (A) the VWAP of our Commoncommon Stockstock equals or exceeds $25.00 on the Series B Price Measurement Date, or (B) the Series B Warrant is exercised prior to our public announcement of receipt of written approval from the FDA of our NDA for CNM-Au8 in ALS, which announcement shall be made promptly after receipt of such approval (the “Series B Trigger Announcement”). The “Series B Price Measurement Date” means (A) the trading day on which the Series B Trigger Announcement is made, if such announcement is made prior to 9:00 a.m. (New York City time) on such trading day, or (B) the first trading day immediately following the day on which the Series B Trigger Announcement is made, if such announcement is made at or after 9:01 a.m. (New York City time) on a trading day or on a day that is not a trading day.

The change in fair value of the Series B Warrants resulted in a loss of $1.9$2.4 million and a loss of $4.3 million during the three and six months ended MarchJune 31,30, 2026. We estimate the fair value using a Monte Carlo simulation with estimates for (i) the probability of the Series B Announcement (ii) the expected stock price increase if the Series B Trigger Announcement occurs, and (iii) the expected stock price decrease if the Series B Trigger Announcement does not occur. These estimates require significant judgment. The unobservable valuation inputs were as follows: