Clene Inc.

Note1. Nature of the Business

Clene Inc. (the “Company,” “we,” “us,” or similar such references) is a clinical-stage pharmaceutical company pioneering the discovery, development, and commercialization of novel clean-surfaced nanotechnology therapeutics. We have developed an electro-crystal-chemistry drug development platform that enables production of concentrated, stable, highly active, clean-surfaced nanocrystal suspensions. We have multiple drug assets currently in development for applications primarily in neurology. Our efforts 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”). Our patented electro-crystal-chemistry manufacturing platform further enables us to develop very low concentration dietary supplements to advance the health and well-being of broad populations. These dietary supplements can vary greatly and include nanocrystals of varying composition, shapes and sizes as well as ionic solutions with diverse metallic constituents. Dietary supplements are marketed and distributed through our wholly-owned subsidiary, dOrbital, Inc., or through an exclusive license with4Life Research LLC (“4Life”), an international supplier of health supplements, stockholder, debt holder, and related party (see Note15).

We became a public company on* December 30, 2020 (*the “Closing Date”) when we completed a reverse recapitalization (the “Reverse Recapitalization”) with Tottenham Acquisition I Limited (“Tottenham”), Tottenham’s wholly-owned subsidiary, Chelsea Worldwide Inc., and Creative Worldwide Inc., a wholly-owned subsidiary of Chelsea Worldwide Inc. On the Closing Date, Chelsea Worldwide Inc. changed its name to Clene Inc. and listed its shares of common stock, par value $0.0001 per share (“Common Stock”) on the Nasdaq Capital Market (“Nasdaq”) under the symbol “CLNN.”

Going Concern

We incurred a loss from operations of $23.1 million and $33.1 million for the years ended* December 31, 2025and2024*, respectively. Our accumulated deficit was $308.3 million and $282.1 million as of* December 31, 2025and2024*. Our cash and cash equivalents totaled $5.2 million and $12.2 million as of* December 31, 2025and2024*, respectively, and net cash used in operating activities was $18.5 million and $21.3 million for the years ended* December 31, 2025and2024*, respectively.

We have incurred significant losses and negative cash flows from operations since our inception. We havenot generated significant revenues since our inception, and we donot 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 nexttwelve months, we willnot 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 the2024 SSCP Notes (see Note8). 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 withthird 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 onthird parties, and there isno assurance that effective implementation of our plans will result in the necessary funding to continue current operations. During the year ended* December 31, 2025*, we generated $10.6 million of gross proceeds from our equity distribution agreement and $1.5 million from the issuance of senior secured convertible promissory notes (see Note8). Subsequent to* December 31, 2025*, we generated $6.0 million of gross proceeds from the issuance of common 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 efforts, reducing employee compensation, and eliminating certain staff positions, we have concluded that our plans donot alleviate the substantial doubt about our ability to continue as a going concern beyondone year from the date the consolidated financial statements are issued.

The accompanying consolidated financial statements have been prepared assuming we will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. As a result, the accompanying consolidated financial statements donot include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amounts and classification of liabilities that* may*result should we be unable to continue as a going concern.

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Note2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying consolidated financial statements include the accounts of Clene Inc. and our wholly-owned subsidiaries, Clene Nanomedicine, Inc. (“Clene Nanomedicine”), a subsidiary incorporated in Delaware, Clene Australia Pty Ltd (“Clene Australia”), a subsidiary incorporated in Australia, Clene Netherlands B.V. (“Clene Netherlands”), a subsidiary incorporated in the Netherlands, and dOrbital, Inc., a subsidiary incorporated in Delaware, after elimination of all intercompany accounts and transactions. We have prepared the accompanying consolidated financial statements in accordance with United States (“U.S.”) Generally Accepted Accounting Principles (“GAAP”). In the opinion of management, the consolidated financial statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation.

Reverse Stock Split

Effective* July 11, 2024 (the “Effective Date”), we filed a Certificate of Amendment to our Fourth Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware, to effect a1*-for-20 reverse stock split (the “Reverse Stock Split”) of our Common Stock. Beginning with the opening of trading on the Effective Date, our Common Stock began trading on Nasdaq on a split-adjusted basis under the same symbol, “CLNN.” As a result of the Reverse Stock Split, every 20 shares of our Common Stock issued and outstanding were automatically combined and converted into1 validly issued, fully paid and non-assessable share of Common Stock. In lieu of any fractional shares, stockholders received an amount in cash (without interest) equal to: (i) the number of shares of Common Stock held by such stockholder before the Reverse Stock Split that would otherwise have been exchanged for such fractional shares multiplied by (ii) the closing price of our Common Stock on Nasdaq on the trading day immediately preceding the Effective Date.

The Reverse Stock Split didnot 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’s 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 Amended2020 Stock Plan was also appropriately adjusted. All historical share and per share data for the periods presented in these consolidated financial statements, including for periods ending prior to* July 11, 2024,has been adjusted to reflect the1*-for-20 Reverse Stock Split on a retroactive basis as if the Reverse Stock Split occurred as of the earliest period presented. As a result of the Reverse Stock Split, approximately $12,000 of par value was reclassified from Common Stock to Additional Paid-In Capital.

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and disclosure of contingent assets and liabilities, and the reported amounts of expenses. We base our estimates on historical experience and various other assumptions that we believe to be reasonable. Actual results* may*differ from those estimates or assumptions. Estimates are periodically reviewed in light of changes in circumstances, facts, and experience, and any changes in estimates will be recorded in future periods as they develop.

Risks and Uncertainties

We are subject to certain risks and uncertainties and believe that changes in any of the following areas could have a material adverse effect on future financial condition, results of operations, or cash flows: ability to obtain additional financing; regulatory approval and market acceptance of, and reimbursement for, product candidates; performance ofthird-party contract research organizations (“CROs”) and clinical vendors upon which we rely; protection of our intellectual property; litigation or claims against us based on intellectual property, patent, product, regulatory, or other factors; and our ability to attract and retain employees necessary to support our growth. The product candidates we develop require approvals from regulatory agencies prior to commercial sales. There can beno assurance that our current and future product candidates will receive the necessary approvals or be commercially successful. If we are denied approval or approval is delayed, it will have a material adverse impact on our business and our consolidated financial statements.

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Concentrations of Credit Risk

Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash. Our cash is held in financial institutions and amounts on deposit* mayat times exceed federally insured limits. We havenot* experienced any losses on our deposits of cash and donot believe that we are subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

Cash and Cash Equivalents

We consider all short-term investments with original maturities of90 days or less when purchased to be cash equivalents.

Restricted Cash

We classify cash as restricted when it is unavailable for withdrawal or use in our general operating activities. Restricted cash is classified as current and noncurrent on the consolidated balance sheets based on the nature of the restriction. Our restricted cash balance includes contractually restricted deposits related to our corporate credit card.

Accounts Receivable

Accounts receivable are stated at invoice value less estimated allowances for sales returns and doubtful accounts. We estimate the allowance for sales returns based on historical percentage of returns over a12-month trailing average of sales. We continually monitor customer payments and maintain a reserve for expected losses resulting from our customers’ inability to make required payments. We consider factors when estimating the allowance for doubtful accounts such as historical experience, age of the accounts receivable balances, geographic related risks, and economic conditions that* mayaffect a customer’s ability to pay. In cases where there are circumstances that mayimpair a specific customer’s ability to meet its financial obligations, a specific allowance is recorded against amounts due, thereby reducing the net recognized receivable to the amount reasonably believed to be collectible. Accounts receivable are written off when deemed uncollectible. Recoveries of accounts receivable previously written off are recorded when received. Historically, there have beenno* sales returns,no written-off accounts receivable, andno allowance for doubtful accounts reducing the balance of the accounts receivable.

Inventory

Inventory is stated at historic cost on afirst-infirst-out basis. Our inventory consisted of $23,000 in raw materials and $14,000 in finished goods as of* December 31, 2025*, and $53,000 in raw material and $15,000 in finished goods as of* December 31, 2024*. Inventory relates to our dietary supplement products.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation. Property and equipment consist of laboratory and office equipment, computer software, and leasehold improvements. Depreciation is calculated using the straight-line method over the estimated economic useful lives of the assets, which are 3 to 5 years for laboratory equipment,3 to 7 years for furniture and fixtures, and 2 to 5 years for computer software. Leasehold improvements are amortized over the lesser of the estimated lease term or the estimated useful life of the assets. Costs for capital assetsnot yet placed into service are capitalized as construction-in-progress and depreciated or amortized in accordance with the above useful lives once placed into service. Upon retirement or sale, the related cost and accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in the consolidated statements of operations and comprehensive loss. Maintenance and repairs that donot improve or extend the lives of the respective assets are expensed to operations as incurred.

We capitalize costs to obtain or develop computer software for internal use, including development costs incurred during the software development stage and costs to obtain software for access and conversion of historical data. We also capitalize costs to modify, upgrade, or enhance existing internal-use software that result in additional functionality. We expense costs incurred during the preliminary project stage, training costs, data conversion costs, and maintenance costs.

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Impairment of Long-Lived Assets

Long-lived assets are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets* may**not* be fully recoverable. Factors we consider in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends, and significant changes or planned changes in the use of assets. If an impairment review is performed to evaluate an asset group for recoverability, we compare the forecasted undiscounted cash flows expected to result from the use and eventual disposition of the asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use and eventual disposition of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value, determined based on discounted cash flows using market participant assumptions. We didnot record any impairment losses on long-lived assets during the years ended* December 31, 2025and2024*.

Debt

When debt is issued and a derivative is required to be separated (e.g., bifurcated conversion option) or another separate freestanding financial instrument (e.g., warrant) is issued, costs and fees incurred are allocated to the instruments issued (or bifurcated) in proportion to the allocation of proceeds. When some portions of the costs and fees relate to a bifurcated derivative or freestanding financial instrument that is being subsequently measured at fair value, those allocated costs are expensed immediately. Debt discounts, debt premiums, and debt issuance costs related to debt are recorded as deductions that net against the principal value of the debt and are amortized to interest expense over the contractual term of the debt using the effective interest method.

In accordance with ASC470-20, Debt with Conversion and Other Options, when we issue debt with warrants, we treat the warrants as a debt discount, recorded as a contra-liability against the debt, and amortize the balance over the life of the underlying debt as interest expense in the consolidated statements of operations and comprehensive loss. The offset to the contra-liability is recorded as additional paid-in capital in the consolidated balance sheets if the warrants arenot treated as a derivative or liability under ASC480, Distinguishing Liabilities from Equity (“ASC480”). Otherwise, the offset to the contra-liability is recorded as a warrant liability in the consolidated balance sheets and is subject to re-measurement to fair value at each balance sheet date, with any changes in fair value recognized in the consolidated statements of operations and comprehensive loss. If the debt is retired early, the associated debt discount is then recognized immediately as interest expense in the consolidated statements of operations and comprehensive loss.

Convertible Debt

In accordance with ASU2020-06, Debt—Debt with Conversion and Other Options (Subtopic470*-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity*, when we issue notes with conversion features, we evaluate if the conversion feature is freestanding or embedded. If the conversion feature is embedded, we donot separate the conversion feature from the host contract for convertible notes that arenot required to be accounted for as derivatives, or that donot result in substantial premiums accounted for as paid-in-capital. Consequently, we account for a convertible note as a single liability measured at its amortized cost as long asno other features require separation and recognition as derivatives. If the conversion feature is freestanding, or is embedded and meets the requirements to be separated, we account for the conversion feature as a derivative under ASC815, Derivatives and Hedging (“ASC815”). We record the derivative instrument at fair value at inception, and subsequently re-measure to fair value at each reporting period and immediately prior to the extinguishment of the derivative instrument, with any changes recorded in the consolidated statements of operations and comprehensive loss.

Deferred Offering Costs

We capitalize certainthird-party legal, accounting, and other fees that are directly associated with in-process equity financings until such financings are completed. After completion of the equity financing, these costs are recorded in stockholders’ deficit as a reduction of proceeds generated as a result of the offering. Should any in-process equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. As of* December 31, 2025and2024*, we didnot have any deferred offering costs.

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Leases

At inception of a contract, we determine if a contract meets the definition of a lease. We determine if the contract conveys the right to control the use of an identified asset for a period of time. We assess throughout the period of use whether we have both of the following: (i) the right to obtain substantially all the economic benefits from use of the identified asset, and (ii) the right to direct the use of the identified asset. This determination is reassessed if the terms of the contract are changed. Leases are classified as operating or finance leases based on the terms of the lease agreement and certain characteristics of the identified asset. Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of the future lease payments less any lease incentives received. At the lease commencement date, the discount rate implicit in the lease is used to discount the lease liability if readily determinable. Ifnot readily determinable or leases donot contain an implicit rate, our incremental borrowing rate is used as the discount rate. Our policy is tonot record leases with an original term oftwelve months or less within the consolidated balance sheets and we recognize lease expense for these short-term leases on a straight-line basis over the lease term.

Certain lease agreements* mayrequire us to pay additional amounts for taxes, insurance, maintenance, and other expenses, which are generally referred to as non-lease components. Such variable non-lease components are treated as variable lease payments and recognized in the period in which the obligation for these payments is incurred. Variable lease components and variable non-lease components arenot* measured as part of the right-of-use asset and liability. Only when lease components and their associated non-lease components are fixed are they accounted for as a single lease component and are recognized as part of a right-of-use asset and liability. Total contract consideration is allocated to the fixed lease and non-lease component. This policy election applies consistently to all asset classes under lease agreements.

Leases* maycontain clauses for renewal at our option. Payments to be made in option periods are recognized as part of the right-of-use lease assets and lease liabilities when it is reasonably certain that the option to extend the lease will be exercised, or isnot* at our option. We determine whether the reasonably certain threshold is met by considering contract-, asset-, market-, and entity-based factors. Operating lease expense, which is recognized on a straight-line basis over the lease term, and the amortization of finance lease right-of-use assets, which are included in property and equipment and depreciated, are included in research and development or general and administrative expenses consistent with the leased assets’ primary use. Accretion on the liabilities for finance leases is included in interest expense.

Contingent Earn-Out Liabilities

The Reverse Recapitalization provided for earn-out payments in the form of shares of Common Stock to be paid if we had achieved certain market-based milestones withinthree tofive years following the Reverse Recapitalization. The earn-out payments were to be paid to certain Clene Nanomedicine stockholders (the “Clene Nanomedicine Contingent Earn-out”) and Tottenham’s sponsor and former officers and directors (the “Initial Stockholders,” and together with the Clene Nanomedicine Contingent Earn-out, the “Contingent Earn-outs”). In accordance with ASC815, the Contingent Earn-outs werenot indexed to our own stock and were accounted for as a liability and subsequently remeasured to fair value at each reporting date, with changes recorded as a component of other income (expense), net. As of* December 31, 2024*, the Contingent Earn-outs hadno value as determined using a Monte Carlo valuation model in order to simulate the future path of our stock price over the earn-out periods. As of* December 31, 2025,the milestones hadnot* been achieved and the Contingent Earn-outs were cancelled.

Common Stock Warrants

We account for common stock warrants as either equity- or liability-classified instruments based on an assessment of the warrant terms. The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC480, meet the definition of a liability pursuant to ASC480, and whether the warrants meet all the requirements for equity classification under ASC815, including whether the warrants are indexed to our Common Stock, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and, for liability-classified warrants, at each reporting period end date while the warrants are outstanding.

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Revenue Recognition

Under ASC606, Revenue from Contracts with Customers (“ASC606”), an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC606, the entity performs the followingfive steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply thefive-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the goods or services we transfer to the customer.

Once a contract is determined to be within the scope of ASC606 at contract inception, we review the contract to determine which performance obligations we must deliver, and which performance obligations are distinct. We recognize as revenue the amount of the transaction price that is allocated to each performance obligation when that performance obligation is satisfied or as it is satisfied. We typically satisfy our performance obligations via delivery of dietary supplements to the customer. Payments are due upon receipt for commercial transactions, or a prepayment is collected for online retail sales. Our revenue during the years ended* December 31, 2025and2024* was comprised of sales of dietary supplements and royalties from sales of dietary supplements.

Grant Funding

We* maysubmit applications to receive grant funding from governmental and non-governmental entities. We account for grants by analogizing to the grant accounting model under IAS20,* Accounting for Government Grants and Disclosure of Government Assistance (“IAS20”). We recognize grant funding without conditions or continuing performance obligations, including certain research and development tax credits, as other income in the consolidated statements of operations and comprehensive loss. We accrue certain research and development tax credits receivable in other current assets (see Note4) in an amount equal to the qualifying expenses incurred in each period multiplied by the applicable reimbursement percentage and we recognize other income in the consolidated statements of operations and comprehensive loss. After submission of our tax returns, we receive a cash refund of certain research and development tax credits and relieve the receivable.

We recognize grant funding with conditions or continuing performance obligations as a reduction in research and development or general and administrative expenses in the period during which the related qualifying expenses are incurred and as the conditions or performance obligations are fulfilled. Any amount received in advance of fulfilling such conditions or performance obligations is recorded in accrued liabilities (see Note6) if the conditions or performance obligations are expected to be met within the nexttwelve months. We recognized grant funding as a reduction of research and development expenses totaling $8.5 million and $3.3 million during the years ended* December 31, 2025and2024*, respectively. We recognized grant funding as a reduction of general and administrative expenses totaling $0.4 million and $0.1 million during the years ended* December 31, 2025and2024*, respectively.

In* October 2023we were awarded a grant (“the NIH Grant”) in collaboration with New York University (“NYU”) as prime awardee (formerly Columbia University), and Synapticure, a neurology specialty health clinic, from the National Institutes of Health (“NIH”). The NIH Grant was awarded pursuant to the Accelerating Access to Critical Therapies for ALS Act to support up to afour*-year Expanded Access Program (the “ACT-EAP”) for CNM-Au8® treatment of ALS. The NIH Grant totaled $45.1 million and subawards to us* maytotal up to $30.9 million in aggregate and mayextend to August 31, 2027.Subawards are awarded annually and subaward funds are paid to us as reimbursement for expenditures to support the ACT-EAP. Subawards for the first, second, andthird* year of the ACT-EAP totaled $7.3 million, $8.0 million, and $8.0 million, respectively. We recognized grant revenue totaling $8.6 million and $3.0 million during the years ended* December 31, 2025and2024*, respectively, which we recognized as a reduction of research and development and general and administrative expenses.

Fair Value of Financial Instruments

Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed inone of the followingthree levels of the fair value hierarchy:

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We review the fair value hierarchy classification of our applicable assets and liabilities on a quarterly basis. Changes in the observability of valuation inputs* mayresult in a reclassification for certain financial assets or liabilities. Reclassifications impacting all levels of the fair value hierarchy are reported as transfers in or out of the Level1,* 2, or3 categories as of the beginning of the period during which the reclassifications occur.

Foreign Currency Translation and Transactions

Our functional and reporting currency is the U.S. dollar (“USD”). Clene Australia and Clene Netherlands determined their functional currencies to be the Australian dollar and Euro, respectively. The results of our foreign currency operations are translated into USD at the average exchange rates during the period, assets and liabilities are translated using the exchange rate as of the balance sheet date, and stockholders’ deficit is translated using historical rates. Adjustments from the translation of the results of our foreign currency operations are excluded from net loss and are accumulated in a separate component of stockholders’ deficit. We also incur foreign exchange transaction gains and losses for purchases denominated in foreign currencies. Foreign exchange transaction gains and losses are included in other income (expense), net, as incurred.

Comprehensive Loss

Comprehensive loss includes net loss as well as other changes in stockholders’ deficit that result from transactions and economic events other than those with stockholders. The only elements of other comprehensive loss in any periods presented were the translation of foreign currency denominated balances of Clene Australia and Clene Netherlands to USD for consolidation and the unrealized loss on available-for-sale securities.

Net Loss Per Share Attributable to Common Stockholders

Basic net loss per share attributable to common stockholders is calculated using our weighted-average outstanding common shares. Shares issuable for little orno cash consideration, such as pre-funded warrants, shall be considered outstanding common shares upon the satisfaction of any contingent conditions or when there areno contingent conditions. Diluted net loss per share attributable to common stockholders is calculated using our weighted-average outstanding common shares including the dilutive effect of securities as determined under the treasury stock method, except for the dilutive effect of convertible notes payable, which is calculated under the if-converted method, even if the embedded conversion option is out-of-the-money. In periods in which we report a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares arenot assumed to have been issued if their effect is anti-dilutive.

Segment Information

We report segment information based on ASC280 Segment Reporting (“ASC280”), which defines operating segments as components of a company that engage in activities from which it* mayrecognize revenues and incur expenses, and for which operating results are regularly reviewed by the entity’s chief operating decision maker (“CODM”) to make decisions regarding resource allocation and assess performance, and for which discrete financial information is available. We determined that the Company is a single operating and reportable segment (“Products”) focused on treating central nervous system disorders through discovery, development, and commercialization of our novel CSN therapeutics. Our chief executive officer acts as the CODM and allocates resources and assesses performance at a consolidated level. Segment information is further described in Note16*.

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Income Taxes

We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in our tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statement basis and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.

We recognize deferred tax assets to the extent we believe these assets are more likely thannot to be realized. In making such a determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and recent results of operations. If we determine that we would be able to realize any deferred tax assets in the future in excess of their net recorded amount, we would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes.

We record uncertain tax positions in accordance with ASC740, Income Taxes, on the basis of atwo-step process to (i) determine whether it is more likely thannot that the tax positions will be sustained on the basis of the technical merits of the position, and (ii) for those tax positions that meet the more-likely-than-not recognition threshold, we recognize the largest amount of tax benefit that is more than50% likely to be realized upon ultimate settlement with the related tax authority.

We recognize interest and penalties related to unrecognized tax benefits within income tax expense in the consolidated statements of operations and comprehensive loss. Any accrued interest and penalties related to uncertain tax positions will be reflected as liabilities in the consolidated balance sheets.

Stock-Based Compensation

We account for stock-based compensation arrangements using a fair value-based method for costs related to all share-based payments including stock options and stock awards. Stock-based compensation expense is recorded in research and development and general and administrative expenses based on the classification of the work performed by the grantees. The fair value is recognized over the period during which a grantee is required to provide services in exchange for the option award and service-based stock awards, known as the requisite service period (usually the vesting period), on a straight-line basis. For stock awards with market conditions, the fair value is recognized over the period based on the expected milestone achievement dates as the derived service period (usually the vesting period), on a straight-line basis. For stock awards with performance conditions, the grant-date fair value of these awards is the market price on the applicable grant date, and compensation expense will be recognized when the conditions become probable of being satisfied. We recognize a cumulative true-up adjustment once the conditions become probable of being satisfied as the related service period had been completed in a prior period. We generally grant stock options with afour-year requisite service period. Certain stock options* mayvest based upon performance conditions instead of service conditions, such as the achievement of regulatory milestones or financial performance measures. For the grant-date fair value, we estimate the expected term of stock options with performance conditions based upon the nature of the conditions. If the expected term isnot* estimable and the achievement of performance conditions isnot probable, we use the contractual term as the expected term. We elect to account for forfeitures as they occur, rather than estimating expected forfeitures. We determine the fair value of stock option awards using a Black-Scholes option pricing model based on the closing price of our Common Stock as reported by Nasdaq on the date of grant. The fair value of stock awards with market conditions are determined using a Monte Carlo valuation model.

Research and Development

Research and development costs are expensed as incurred. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the goods have been received or when the service has been performed. Research and development expenses consist of costs incurred for the discovery and development of our product candidates. Research and development costs include, but arenot limited to, payroll and personnel expenses including stock-based compensation, clinical trial supplies, fees for clinical trial services, consulting costs, and allocated overhead, including rent, equipment, and utilities.

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Clinical Trial Accrual

Our clinical trial accrual process accounts for expenses resulting from obligations under contracts with CROs, consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations that vary from contract to contract and* mayresult in payment flows that donot* match the periods over which materials or services are provided to us under such contracts. We estimate accruals for the progress of contract completion at each reporting date based upon the facts and circumstances known to us at that time and through discussion and reporting from applicable personnel and service providers. Clinical trial costs are charged to research and development expense in the period in which services and efforts are expended. In the event advance payments are made to a CRO, the payments will be recorded as a prepaid asset that will be amortized to research and development expense over the period the contracted services are performed. CRO contracts generally include pass-through costs including, butnot limited to, regulatory expenses, investigator fees, travel costs, shipping costs, printing fees, and other miscellaneous costs. In addition to pass-through costs, we generally incur costs in clinical trials infour distinct groups as follows:

Recently Adopted Accounting Pronouncements

In* December 2023,the FASB issued ASU2023*-09, Income Taxes (Topic740*): Improvements to Income Tax Disclosures* (“ASU2023-09”). ASU2023-09 requires incremental income tax disclosures that increase the transparency and usefulness of income tax disclosures, including that public entities disclose specific categories and greater disaggregation within the tax rate reconciliation, disaggregation of income taxes paid, and modifications of other income tax-related disclosures. The guidance is effective for annual periods beginning after* December 15, 2024.We adopted ASU2023*-09 prospectively effective* January 1, 2025.The adoption impacted the presentation and disclosure of income taxes (see Note10*) but didnot have a material impact on our consolidated financial statements.

Recent Accounting PronouncementsNot Yet Adopted**

In* November 2024,the FASB issued ASU2024*-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220*-40): Disaggregation of Income Statement Expenses* (“ASU2024-03”). ASU2024-03 requires that public entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. In* January 2025,the FASB clarified the effective date of ASU2024*-03 with the issuance of ASU2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220*-40): Clarifying the Effective Date* (“ASU2025-01”). The guidance is effective for annual periods beginning after* December 15, 2026,and interim periods within annual periods beginning after December 15, 2027,with early adoption permitted. We are currently evaluating the impact of ASU2024*-03.

In* September 2025,the FASB issued ASU2025*-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic350*-40)* (“ASU2025-06”). ASU2025-06 requires that entities start capitalizing software costs when funding is authorized and committed and it is probable that the project will be completed and the software will be used to perform its intended function. The guidance is effective for annual periods beginning after* December 15, 2027,and interim periods within those annual periods, with early adoption permitted. We are currently evaluating the impact of ASU2025*-06.

F-15

In* December 2025,the FASB issued ASU2025*-10, Government Grants (Topic832*): Accounting for Government Grants Received by Business Entities* (“ASU2025-10”). ASU2025-10 establishes authoritative guidance on how to recognize, measure, and present government grants received by business entities. The guidance is effective for annual periods beginning after* December 15, 2028,and interim periods within those annual periods, with early adoption permitted. We are currently evaluating the impact of ASU2025*-10.

Note3. Cash and Cash Equivalents

Cash and cash equivalents as of* December 31, 2025* were as follows:

Cash and cash equivalents as of* December 31, 2024* were as follows:

Note4. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets as of* December 31, 2025and2024* were as follows:

Note5. Property and Equipment, Net

Property and equipment, net, as of* December 31, 2025and2024* were as follows:

F-16

Depreciation expense recorded in research and development expense and general and administrative expense during the years ended* December 31, 2025and2024* was as follows:

Note6. Accrued Liabilities

Accrued liabilities as of* December 31, 2025and2024* were as follows:

Note7. Leases

We lease laboratory and office space and certain laboratory equipment under non-cancellable operating leases. The carrying value of our right-of-use lease assets is substantially concentrated in our real estate leases, while the volume of lease agreements is primarily concentrated in equipment leases. We expect that, in the normal course of business, the existing leases will be renewed or replaced by similar leases.

We have leases forthree real estate properties: (i) a laboratory and manufacturing facility lease that commenced in* September 2021with aten-year term and an option to extend fortwo five-year periods, (ii) a laboratory and manufacturing facility lease that commenced in February 2022with aseven-year term and an option to extend fortwo five-year periods, and (iii) our corporate office lease that commenced in April 2020forseven years with an option to extend forfive years. We didnot* recognize the payments to be made in the option periods as part of the right-of-use asset or lease liability because the exercise of the option isnot reasonably certain.

As of* December 31, 2025and2024*, our operating lease obligations had a weighted-average discount rate of 9.6% and 9.6%, respectively, and a weighted-average remaining term of 4.6 years and 5.5 years, respectively.

Maturity Analysis of Lease Obligations

The maturity analysis of our operating lease obligations as of* December 31, 2025* was as follows:

F-17

Components of Lease Cost

The components of lease costs for the years ended* December 31, 2025and2024* were as follows:

Supplemental Cash Flow Information

Note8. Notes Payable and Convertible Notes Payable

Our notes payable and convertible notes payable as of* December 31, 2025and2024* were as follows:

F-18

Our interest expense on notes payable and convertible notes payable for the years ended* December 31, 2025and2024*, was as follows:

Maryland Loans

In* April 2019,we entered into a term loan agreement (the“2019* Cecil Loan”) with Cecil County, Maryland, for $0.1 million bearing simple interest at an annual rate of 8.00%. The2019 Cecil Loan established “Phantom Shares” based on 1,199 shares of Common Stock. The2019 Cecil Loan matures in full on* April 30, 2034,with the repayment amount equal to the greater of (i) principal plus accrued interest or (ii) the Phantom Shares multiplied by the closing price of our Common Stock on Nasdaq on the trading day prior to the maturity date. As of December 31, 2025and2024*, the2019 Cecil Loan was recorded at principal plus accrued interest as it was greater than the value of the Phantom Shares.

In* February 2019,we entered into a term loan agreement (the“2019* MD Loan”) with the Department of Housing and Community Development (“DHCD”), a principal department of the State of Maryland, for $0.5 million bearing simple interest at an annual rate of 8.00%. We are subject to covenants until maturity, including limitations on our ability to retire, repurchase, or redeem our stock, options, and warrants other than per the terms of the securities; and limitations on our ability to pay dividends. We arenot in violation of any covenants. The2019 MD Loan established “Phantom Shares” based on 5,995 shares of Common Stock. The2019 MD Loan matures in full on* February 22, 2034,with the repayment amount equal to the greater of (i) principal plus accrued interest or (ii) the Phantom Shares multiplied by the closing price of our Common Stock on Nasdaq on the trading day prior to the maturity date. As of December 31, 2025and2024*, the2019 MD Loan was recorded at principal plus accrued interest as it was greater than the value of the Phantom Shares.

In* May 2022,we entered into a term loan agreement (the“2022* MD Loan”) with DHCD for up to $3.0 million bearing simple interest at an annual rate of 6.00% for the purchase of certain manufacturing equipment (the “Assets”). We drew a total of $1.0 million and our ability to draw the remaining $2.0 million expired in* May 2024.Thefirst* 12 payments, commencing* July 1, 2022,are deferred, followed by18* monthly installments of interest-only based on the outstanding principal, each up to$15,000 maximum; followed by monthly installments of principal and interest in the amount of $33,306, payable for the lesser of30 months or until the principal and accrued and unpaid interest is fully repaid, with a balloon payment of all remaining principal and unpaid interest due on the maturity date of* July 1, 2027.As of December 31, 2025and2024*, the balance of accrued and unpaid interest was $50,000 and $50,000, respectively, and is recorded as part of the carrying amount of the loan. We recorded debt issuance costs of $31,000 as a debt discount.

In* December 2022,we entered into a term loan agreement (the“2022* DHCD Loan”) with DHCD for $5.0 million bearing simple interest at an annual rate of 6.00%. Thefirst 12 payments, commencing* January 1, 2023,are deferred, followed by48* monthly installments of interest-only, with a balloon payment of all principal and unpaid interest due on the maturity date of* January 1, 2028.As of December 31, 2025and2024*, the balance of accrued and unpaid interest was $0.3 million and $0.3 million, respectively, and is recorded as part of the carrying amount of the loan. We recorded debt issuance costs of $0.1 million as a debt discount. At any time after* December 8, 2023,DHCD may,in its sole discretion, convert up to $5.0 million of principal into Common Stock in increments of $1.0 million, at a price equal to the greater of: (i)97% of the30*-day trailing VWAP of our Common Stock; or (ii) $80.00 per share (the “DHCD Conversion Feature”). The DHCD Conversion Feature didnot meet the requirements for derivative accounting. The effective interest rate is 5.99%.

F-19

Avenue Loan

In* May 2021,we entered into a term loan agreement (the“2021* Avenue Loan”) with Avenue Venture Opportunities Fund, L.P. (“Avenue”) for up to $30.0 million, bearing interest at a variable rate equal to (i) the greater of (a) the prime rate or (b)3.25%, plus (ii)6.60%. We borrowed $15.0 million in* May 2021plus $5.0 million in September 2021 (“Tranche1”), and the remaining $10.0 million (“Tranche2”) wasnot* drawn and expired. At inception, we incurred $0.8 million of debt issuance costs of which $47,000 related to liability-classified warrants was expensed immediately and the remainder was recorded as a debt discount. Payments were interest-only for thefirst 12 months and the interest-only period was extended for (i)12 months due to our achievement of certain clinical trial milestones, plus (ii) an additional12 months (through* June 30, 2024),pursuant to an amendment in June 2023 (the “Second Amendment”), due to our receipt of at least $35.0 million from the sale and issuance of Common Stock in a public offering in June 2023 (“Equity Milestone1”). Following the interest-only period, from July 2024to September 2024,*we made equal monthly principal installments of $3.3 million plus interest at the variable rate then in effect.

On* September 30, 2024,we entered into an amendment (the “Third Amendment”) that (i) reduced the October 2024principal installment from $3.3 million to $2.0 million, plus interest at the applicable variable rate, (ii) reduced the November 2024and December 2024principal installments from $3.3 million to $0.5 million each, plus interest at the applicable variable rate, and (iii) delayed the maturity date of the loan from December 1, 2024to April 1, 2025.However, we repaid the2021* Avenue Loan in full on* December 20, 2024 (the “Termination Date”) with the proceeds from the2024* SSCP Notes (discussed below). The total repayment amount was approximately $7.9 million and included (i) the total outstanding balance of principal and accrued interest, (ii) a final payment of 4.25% of funded principal, equal to $0.9 million (the “Final Payment”), which was previously recorded as a debt premium at the inception of the2021 Avenue Loan, and (iii) an early termination fee of 1% of the balance of outstanding principal. We recorded a loss on extinguishment of $0.2 million during the year ended* December 31, 2024.*

Avenue had the right to convert up to $5.0 million of principal into Common Stock (the “Avenue Conversion Feature”), which expired in* May 2024and wasnot* exercised. During the year ended* December 31, 2024*, the effective interest rate was 17.56%.

At the inception of the2021 Avenue Loan, we issued a warrant to Avenue to purchase Common Stock (the*“2021* Avenue Warrant”). A portion of the net proceeds at issuance of the2021 Avenue Loan were allocated to the2021 Avenue Warrant in an amount equal to its fair value of $1.5 million and were recorded as a debt discount. Pursuant to the Second Amendment, the2021 Avenue Warrant was cancelled and a new warrant to purchase 150,000 shares of Common Stock was issued (the*“2023* Avenue Warrant”). At issuance, the2023 Avenue Warrant was recorded as a liability and debt discount in amount equal to its fair value of $0.7 million. The Second Amendment, including the revised terms, cancellation of the2021 Avenue Warrant, and issuance of the2023 Avenue Warrant was accounted for as a debt modification. Additionally, pursuant to the Third Amendment, the exercise price of the2023 Avenue Warrant was reduced from $16.00 per share to $4.6014 per share, with the resulting change in fair value of $0.1 million recorded as a debt discount. The Third Amendment was accounted for as a debt modification that also met the requirements as a troubled debt restructuring under ASC470, Debt (“ASC470”), withno restructuring gain required to be recognized as the future cash payments were greater than the carrying amount of the2021 Avenue Loan.

Senior Secured Convertible Promissory Notes

In* December 2024,we entered into a note purchase agreement pursuant to which we sold the2024* SSCP Notes in a principal amount totaling $10.0 million and bearing interest at an annual rate of 12.00%, which we amended in* August 2025 (the“2024* SSCPN Amendment”). The2024 SSCP Notes were sold to related parties, including: (i) an entity controlled by a member of our board of directors, (ii)4Life, and (iii) an entity controlled by the chairman of4Life who is also a board member of a subsidiary of Clene. Wefirst used the2024 SSCP Note proceeds to satisfy our obligations under the2021 Avenue Loan. Pursuant to the2024 SSCPN Amendment, the maturity date of the2024 SSCP Notes was extended to the earlier of (i)* February 13, 2027or (ii) upon a change in control transaction. Payments were interest-only for thefirst* 12 months, and, pursuant to the2024 SSCPN Amendment, interest will be capitalized monthly and added to the balance of the2024 SSCP Notes beginning in* August 2025.Pursuant to the2024* SSCPN Amendment, monthly payments totaling $1.0 million per month will commence in* September 2026and continue until the maturity date and will be applied pro rata to principal and any accrued interest. We recorded debt issuance costs of $1.5 million as a debt discount at the issuance date and an additional $0.7 million at the date of the2024* SSCPN Amendment. As of* December 31, 2025and2024*, the balance of accrued and unpaid interest was $0.5 million and $37,000, respectively, and is recorded as part of the carrying amount of the2024 SSCP Notes. The2024 SSCPN Amendment was accounted for as a troubled debt restructuring under ASC470, withno restructuring gain required to be recognized as the future cash payments were greater than the carrying amount of the2024 SSCP Notes.

F-20

In* August 2025,we entered into a note purchase agreement pursuant to which we sold senior secured convertible promissory notes (the“2025* SSCP Notes,” and together with the2024 SSCP Notes, the “SSCP Notes”) in a principal amount totaling $1.5 million and bearing interest at an annual rate of 12.00%. The2025 SSCP Notes mature on the earlier of (i)* February 13, 2027or (ii) upon a change in control transaction. Interest will be capitalized monthly and added to the balance of the2025* SSCP Notes. Monthly payments totaling $150,000 per month will commence in* September 2026and continue until the maturity date and will be applied pro rata to principal and any accrued interest. We recorded debt issuance costs of $0.2 million as a debt discount. As of December 31, 2025*, the balance of accrued and unpaid interest was $0.1 million and is recorded as part of the carrying amount of the notes.

We are subject to covenants until maturity, including a requirement to maintain unrestricted cash and cash equivalents of at least $2.0 million pursuant to the2024 SSCP Notes. We arenot in violation of any covenants. If certain events of default occur and are continuing, the holders of a majority of the outstanding principal balance* mayaccelerate all obligations under the SSCP Notes, plus a penalty equal to 10% of all outstanding principal and accrued and unpaid interest (the “SSCPN Default Feature”). The SSCP Notes are collateralized by substantially all our tangible and intangible property and rights (the “Collateral”). During the continuance of an event of default, if the Collateral is sold or otherwise disposed of and the proceeds thereof are insufficient to satisfy our obligations under the SSCP Notes, we shall be liable for any deficiency, together with additional interest thereon at the rate of 10% per annum (the “SSCPN Collateral Deficiency Fee”). We account for the SSCPN Collateral Deficiency Fee as a contingent liability (see Note9*).

The holders of SSCP Notes* may,in their sole discretion, convert up to (i)65% of the outstanding balance of principal and accrued interest of the2024* SSCP Notes into the number of shares of our Common Stock equal to the amount to be converted divided by (A) $5.668 for principal or (B) $4.44 for accrued interest, and (ii)65% of the outstanding principal balance of the2025 SSCP Notes into the number of shares of our Common Stock equal to the amount to be converted divided by $4.44 (the “SSCPN Conversion Feature”). Notwithstanding, in the event a holder declines to convert its pro rata share, the remaining holders* mayconvert additional amounts, provided thatno* aggregate converted amount exceeds (i)65% of the outstanding balance of principal and accrued interest for the2024 SSCP Notes or (ii) $975,000 for the2025 SSCP Notes. In the event of a change in control or any bankruptcy, liquidation, or other restructuring process, the holders* may,at their option, (i) convert up to 65% of outstanding balance of principal and accrued interest for the2024* SSCP Notes and up to 65% of the outstanding principal for the2025 SSCP Notes into Common Stock, (ii) receive a cash payment equal to 115% of the outstanding balance of principal and accrued interest for the2024 SSCP Notes and 115% of the outstanding principal for the2025 SSCP Notes, or (iii) any combination thereof, prior to such monetization event, before any security or claim junior to the SSCP Notes shall receive any proceeds from such monetization event (the “SSCPN Redemption Feature,” collectively with the SSCPN Conversion Feature and SSCPN Default Feature, the “SSCPN Derivative Liabilities”). The SSCPN Derivative Liabilities met the requirements to be separated as derivative instruments and measured at fair value (see Note12). The issuance date fair value of the SSCPN Derivative Liabilities was (i) $1.4 million for the2024 SSCP Notes and (ii) $0.2 million for the2025 SSCP Notes and was recorded as a debt discount. During the years ended* December 31, 2025and2024*, the effective interest rate of the2024 SSCP Notes was 24.17% and 24.65%, respectively. During the year ended* December 31, 2025*, the effective interest rate of the2025 SSCP Notes was 24.65%.

We are required to file and maintain an effective registration statement covering the resale of the shares underlying the SSCPN Conversion Feature or we shall pay the holders a penalty equal to 2% of the face value of the2024 SSCP Notes or2025 SSCP Notes, as applicable, upon the occurrence of any such failure and for each30-day period during which such failure is continuing (the “SSCPN Registration Fee”). The aggregate penalty will inno event exceed 10% of the face value of the2024 SSCP Notes or the2025 SSCP Notes, as applicable. We account for the SSCPN Registration Fee as a registration payment arrangement to be evaluated as a contingent liability (see Note9).

F-21

Debt Maturities

Future debt payments, net of unamortized discounts and debt issuance costs, without giving effect to any potential future exercise of equity conversion features, are as follows:

Note9. Commitments and Contingencies

Commitments

We enter into agreements in the normal course of business with CROs for clinical trials and with vendors for preclinical studies and other services and products for operating purposes, which are cancelable at any time by us, subject to payment of our remaining obligations under binding purchase orders and, in certain cases, nominal early termination fees. These commitments arenot deemed significant.

As of* December 31, 2025and2024*, we had commitments under various agreements for capital expenditures totaling $0.2 million and $0.2 million, respectively, related to the construction of our manufacturing facilities.

Contingencies

From time to time, we* mayhave certain contingent legal liabilities that arise in the ordinary course of business activities. We accrue a liability for such matters when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. We arenot* aware of any current material pending legal matters or claims.

We receivedtwo grants from the National Multiple Sclerosis Society (“NMSS”): (i) $0.3 million in* September 2019 (the“2019* Grant”) for our VISIONARY-MS clinical trial, and (ii) $0.7 million in* May 2023 (the“2023* Grant”) for our REPAIR-MS clinical trial. Pursuant to the grants, if we make future commercial sales of CNM-Au8 for MS, we will repay: (i)50% of the grants upon thefirst commercial sale, (ii) an additional 50% of the grants upon cumulative sales of $10.0 million, (iii) an additional 150% of the grants upon cumulative sales of $50.0 million, and (iv) an additional 200% of the grants upon cumulative sales of $100.0 million, with the maximum repayment of 450% of the grants if all milestones are achieved. If NMSS hasnot yet received aggregate repayments equal to 300% of the2019 Grant or 150% of the2023 Grant, then the following events will trigger repayment of 300% of the2019 Grant, or $1.0 million, and 150% of the2023 Grant, or $1.0 million, less any amounts previously paid: (i) sale of all or substantially all of our assets and business, (ii) sale of any portion of our assets and business including CNM-Au8 for MS treatment, (iii) exclusive licensing of our intellectual property claiming CNM-Au8 for MS treatment, (iv) a collaboration with athird-party to develop CNM-Au8 for MS treatment (2019 Grant only), or (v) licensing of our commercialization rights to CNM-Au8 for MS treatment (2023 Grant only). As of* December 31, 2025*, we havenot met any of the above milestones. We account for these provisions in accordance with ASC450, Contingencies (“ASC450”). We assessed the likelihood of each event as less than probable and thereforeno contingent liability is recognized. Our estimate of the possible range of loss is between the minimum and maximum repayment amounts, equal to 50% and 450% of each grant, or approximately $0.2 million and $1.5 million for the2019 Grant, respectively; and approximately $0.3 million and $3.0 million for the2023 Grant, respectively. However, it is at least reasonably possible that our estimate of the likelihood of each contingent event and the possible range of loss will change in the near term.

F-22

We account for the SSCPN Collateral Deficiency Fee and SSCPN Registration Fee (see Note8) as contingent liabilities in accordance with ASC450 that werenot probable as of* December 31, 2025*, and thereforeno contingent liabilities were recorded. Our estimate of the possible range of loss for the SSCPN Registration Fee is between $0.2 million, which is equal to the loss upon initial failure to register the SSCPN Conversion Feature underlying shares, and $1.2 million, which is equal to the contractually-limited maximum loss upon continued failure to register the SSCPN Conversion Feature underlying shares. We arenot able to estimate a possible range of loss for the SSCPN Collateral Deficiency Fee. It is at least reasonably possible that our estimate of the likelihood of each contingent event and the possible range of loss will change in the near term.

Note10. Income Taxes

The components of loss before income taxes for the years ended* December 31, 2025and2024* were as follows:

We hadno income tax expense or benefit for the years ended* December 31, 2025and2024*. Pursuant to our prospective adoption of ASU2023-09 (see Note2), the following table presents a reconciliation of income tax computed at the U.S. federal statutory rate of 21.00% to expense for income taxes for the year ended* December 31, 2025* as follows:

A reconciliation of income tax computed at the U.S. federal statutory rate of 21.00% to expense for income taxes for the years ended* December 31, 2024*, prior to the adoption of ASU2023-09, was as follows:

F-23

Our effective tax rate was 0.00% and 0.00% during the years ended* December 31, 2025and2024*, respectively. The primary difference between the effective tax rate and the federal statutory tax rate relates to the full valuation allowance on our net operating losses and other deferred tax assets. Significant components of deferred tax assets (liabilities) as of* December 31, 2025and2024* were as follows:

In assessing the realizability of deferred tax assets, we consider whether it is more likely thannot that some portion or all of the deferred tax assets willnot be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during periods in which those temporary differences become deductible. We consider the scheduled reversal of deferred tax liabilities, projected future taxable income, carry back opportunities and tax planning strategies in making the assessment. We believe it is more likely thannot that we willnot realize the benefits of these deductible differences and have applied a full valuation allowance against them.

We have federal and state net operating losses (“NOLs”) of approximately $195.7 million and $136.3 million as of* December 31, 2025*, respectively that, subject to limitation,* maybe available in future tax years to offset taxable income. Of the available federal NOLs, approximately $162.3 million can be carried forward indefinitely but utilization is limited to80%* of our taxable income in any given tax year based on current federal tax laws. The remaining balance of $33.4 million will begin to expire after2034. Of the available state NOLs, approximately $123.4 million can be carried forward indefinitely but utilization is limited to80% of our taxable income in any given tax year based on current tax laws. The remaining balance of $12.9 million will begin to expire after2032. Additionally, we had approximately $6.7 million of research and development credit carryforwards that will begin to expire after2034 ifnot utilized.

Under the provisions of Section382 of the Internal Revenue Code of1986, substantial changes in our ownership* mayresult in limitations on the amount of NOL carryforwards and research and development credits that can be utilized in future years. NOL carryforwards and research and development credits are subject to examination in the year they are utilized regardless of whether the tax year in which they are generated has been closed by statute. The amount subject to disallowance is limited to the amount utilized. Accordingly, we may*be subject to examination for prior NOLs and credits generated as such tax attributes are utilized.

We havenot recorded any amounts for unrecognized tax benefits as of* December 31, 2025and2024*. We recognize interest and penalties related to income tax matters in income tax expense. We haveno accrual of interest and penalties on the consolidated balance sheets and havenot recognized interest and penalties in the consolidated statements of operations and comprehensive loss for the years ended* December 31, 2025and2024*.

We are subject to taxation in the U.S., Australia, Netherlands, and various state jurisdictions. Our tax returns from2015 to present are subject to examination by U.S. and state authorities due to the carry forward of unutilized net operating losses and research and development credits. We currently haveno pending examinations.

F-24

Note11. Benefit Plans

401(k) Plan

Our401(k) plan is a deferred salary arrangement under Section401(k) of the Internal Revenue Code. We match 100% of a participating employee’s deferral contributions up to 3% of annual compensation, limited to $4,500 of matching contributions. Our contributions to the401(k) plan totaled $0.2 million and $0.2 million for the years ended* December 31, 2025and2024*, respectively.

Stock Compensation Plans

The Clene Nanomedicine, Inc.2014 Stock Plan (the*“2014* Plan”) was adopted in* July 2014.Effective as of the closing of the Reverse Recapitalization,no additional awards maybe granted under the2014* Plan. As of* December 31, 2025*, a total of 109,324 stock options remained outstanding under the2014 Plan.

The Clene Inc.2020 Amended Stock Plan (the*“2020* Plan”) was adopted in* December 2020and amended in May 2023,** May 2024,and May 2025.Currently,3,220,000 shares of Common Stock are reserved for issuance thereunder. As of December 31, 2025*, a total of 2,694,216 stock options and other stock awards had been granted under the2020 Plan and 525,784 shares remained available for future grant.

Stock-Based Compensation Expense

Stock-based compensation expense recorded in research and development expense and general and administrative expense during the years ended* December 31, 2025and2024* was as follows:

Stock-based compensation expense by award type during the years ended* December 31, 2025and2024* was as follows:

Stock Options

Outstanding stock options and related activity during the year ended* December 31, 2025* was as follows:

F-25

As of* December 31, 2025and2024*, we had approximately $4.8 million and $8.3 million, respectively, of unrecognized stock-based compensation costs related to unvested stock options that is expected to be recognized over a weighted-average period of 1.52 years and 1.70 years, respectively. Our unrecognized stock-based compensation cost excludes $2.8 million of stock options that vest based on performance conditions that we assessed as less than probable as of* December 31, 2025and2024*.

The weighted-average grant-date fair value of stock options granted during the year ended* December 31, 2025and2024* was $3.95 and $5.95, respectively. The assumptions used to calculate the fair value of stock options granted during the year ended* December 31, 2025and2024* were as follows:

Stock Awards

Stock awards include rights to restricted stock awards with market-based vesting conditions and restricted stock units with service-based vesting conditions. Outstanding stock awards and related activity during the year ended* December 31, 2025* was as follows:

As of* December 31, 2025and2024*, we hadno unrecognized stock-based compensation cost related to unvested stock awards.

Note12. Fair Value

Cash and cash equivalents are carried at fair value. Financial instruments, including accounts receivable, accounts payable, and accrued expenses are carried at cost, which approximates fair value given their short-term nature. Our remaining fair value measures are discussed below.

Financial Instruments with Fair Value Measurements on a Recurring Basis

The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of* December 31, 2025* was as follows:

F-26

The fair value hierarchy for financial instruments measured at fair value on a recurring basis as of* December 31, 2024* was as follows:

There wereno transfers between Level1, Level2, or Level3 during any of the periods above.

Changes in the fair value of our Level3 financial instruments during the year ended* December 31, 2025* were as follows:

Changes in the fair value of our Level3 financial instruments during the year ended* December 31, 2024* were as follows:

Valuation of Notes Payable and Convertible Notes Payable

Our notes payable and convertible notes payable are categorized within Level3 of the fair value hierarchy. The2019 MD Loan and2019 Cecil Loan are carried at the greater of principal plus accrued interest or the value of the Phantom Shares (see Note8) which approximates fair value. The2022 MD Loan,2022 DHCD Loan, and2025 SSCP Notes are carried at amortized cost, which approximates fair value due to our credit risk and market interest rates.

The2024 SSCP Notes are carried at their amortized cost of $9.3 million and $8.6 million as of* December 31, 2025and2024*, respectively. As of* December 31, 2024*, amortized cost approximated fair value but as of* December 31, 2025*, amortized cost didnot approximate fair value and the fair value of the2024 SSCP Notes, excluding the SSCPN Derivative Liabilities pertaining to the2024 SSCP Notes, was approximately $8.2 million.

F-27

The SSCPN Derivative Liabilities met the requirements to be separated from the SSCP Notes as derivative instruments measured at fair value. 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) dissolution of the Company, or (iii) held to maturity. These estimates require significant judgment. The carrying amount* mayfluctuate significantly and the actual settlement amount may*be materially different from the estimated fair value. The unobservable valuation inputs were as follows:

Valuation of the Common Stock Warrant Liabilities

The2023 Avenue Warrant, as amended, is classified as a liability and carried at fair value. 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 carrying amount* mayfluctuate significantly and the actual settlement amount may*be materially different from the estimated fair value. The unobservable valuation inputs were as follows:

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Pursuant to an underwritten public offering in* June 2023,we issued warrants to purchase 2,500,000 shares of Common Stock at $22.00 per share (the “Tranche A Warrants”). The Tranche A Warrants are classified as a liability and carried at fair value. We estimate the fair value using a Black-Scholes option-pricing model with probability weights for the occurrence of (i) acceptance of a new drug application (“NDA”) by the U.S. Food and Drug Administration (“FDA”) for CNM-Au8, (ii) settlement upon a fundamental transaction, (iii) dissolution of the Company, and (iv) held to expiration. These estimates require significant judgment. The carrying amount mayfluctuate significantly and the actual settlement amount may*be materially different from the estimated fair value. 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 Common Stock at $4.82 per share (the“2024* Common Warrants”). The2024 Common Warrants are classified as a liability and carried at fair value. 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 carrying amount* mayfluctuate significantly and the actual settlement amount may*be materially different from the estimated fair value. The unobservable valuation inputs were as follows:

Note13. Capital Stock

As of* December 31, 2025and2024*, our amended and restated certificate of incorporation authorized us to issue 600,000,000 shares of Common Stock, par value $0.0001 per share; and 1,000,000 shares of Preferred Stock, par value $0.0001 per share. As of* December 31, 2025and2024*, we had 10,849,974 and 8,089,565 shares of Common Stock issued and outstanding, respectively, andno shares of Preferred Stock issued or outstanding.

Our common stockholders are entitled toone vote per share and to notice of any stockholders’ meeting. Voting, dividend, and liquidation rights of the holders of Common Stock are subject to the prior rights of holders of all classes of stock and are qualified by the rights, powers, preferences, and privileges of the holders of Preferred Stock.No distributions shall be made with respect to Common Stock until all declared dividends to Preferred Stock have been paid or set aside for payment. Common Stock isnot redeemable at the option of the holder.

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Common Stock Warrants

We have issued the following outstanding warrants and pre-funded warrants to purchase shares of Common Stock:

Public Offerings

In* October 2024,pursuant to a placement agency agreement with Canaccord Genuity LLC (“Canaccord”), we sold 725,000 shares of Common Stock and2024* Pre-Funded Warrants to purchase up to 17,626 shares of Common Stock. The aggregate gross proceeds were approximately $3.5 million, excluding the proceeds, if 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 number333-264299), declared effective on* April 26, 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,2024 Pre-Funded Warrants to purchase up to 424,358 shares of Common Stock, and2024 Common Warrants to purchase up to 1,546,914 shares of Common Stock. The aggregate gross proceeds from the private placements was 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 the2024 Pre-Funded Warrants and2024 Common Warrants. The2024 Pre-Funded Warrants were exercisable immediately at a price of $0.001 per share and expired when exercised in full. The2024 Common Warrants were exercisable immediately at a price of $4.82 per share and expire five years from issuance. The total fair value of the Common Stock,2024 Pre-Funded Warrants, and2024 Common Warrants sold in the offerings exceeded the offering proceeds by $2.1 million, therefore pursuant to ASC815, we recognized this amount as a loss on the initial issuance of equity during the year ended* December 31, 2024.The placement agent fees and offering expenses were allocated to the Common Stock,2024 Pre-Funded Warrants, and2024* Common Warrants sold in the offering based on their relative fair values, with the amount allocated to the liability-classified2024 Common Warrants recorded as an expense and the amounts allocated to the Common Stock and2024 Pre-Funded Warrants as a reduction to their initial carrying values.

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Common Stock Sales Agreement

In* April 2022,we entered into an equity distribution agreement (the“2022* ATM Agreement”), which we amended in* December 2022.In April 2025,we entered into an equity distribution agreement (the“2025* ATM Agreement,” and collectively with the2022 ATM Agreement, the “ATM Agreements”). Canaccord acts as placement agent under the ATM Agreements and we* mayoffer and sell shares of Common Stock from time to time through Canaccord. The issuance and sale of Common Stock by us under the2022* ATM Agreement was made pursuant to our2022 S-3, which expired on* April 26, 2025,and a related prospectus supplement. The issuance and sale of Common Stock by us under the2025* ATM Agreement was made pursuant to our registration statement on Form S-3 (file number333-286058), declared effective by the SEC on* April 25, 2025 (the“2025* S-3”), and a related prospectus supplement.

Pursuant to the ATM Agreements, Canaccord isnot required to sell any specific number or dollar amount of Common Stock but will act as our placement agent to sell, on our behalf, all of the Common Stock requested by us to be sold, consistent with Canaccord’s normal trading and sales practices, on terms mutually agreed between Canaccord and us, for a fixed commission from each sale of Common Stock, if any. During the years ended years ended* December 31, 2025and2024*, we sold 2,300,804 and 504,292 shares of Common Stock, respectively, generated gross proceeds of $10.6 million and $2.7 million, respectively, and paid commissions of $0.2 million and $0.1 million, respectively.

Common Stock Purchase Agreement

On* March 3, 2023,we entered into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant to which Lincoln Park committed to purchase up to $25.0 million of shares of Common Stock at our sole discretion and subject to certain daily limitations based on our prior day purchase history and the volume and closing price of our Common Stock on Nasdaq, from time to time over a 36-month period commencing on March 7, 2023.The issuance and sale of Common Stock under the Purchase Agreement was made pursuant to our2022* S-3. On* June 16, 2023,we suspended and terminated the prospectus supplement related to the offering with respect to the unsold shares of Common Stock issuable pursuant to the Purchase Agreement. We willnot* make any further sales of our securities pursuant to the Purchase Agreement, unless and until a new prospectus supplement is filed. Other than the termination of the prospectus supplement related to the offering with respect to future sales by us, the Purchase Agreement remains in full force and effect.

On the date of the Purchase Agreement, we issued 16,633 shares of Common Stock (the “Initial Commitment Shares”) to Lincoln Park as an initial fee for its commitment under the Purchase Agreement. We recorded the fair value of the Initial Commitment Shares on the date of issuance in other income (expense), net. We* mayfurther issue up to 8,317 additional shares of Common Stock (the “Additional Commitment Shares,” and, together with the Initial Commitment Shares, the “Commitment Shares”) on a pro rata basis upon each purchase by Lincoln Park under the Purchase Agreement. Under applicable Nasdaq listing rules, the total number of shares of Common Stock that we maysell to Lincoln Park is limited to 765,506 shares (including the Commitment Shares), representing 19.99% of the outstanding shares of our Common Stock immediately prior to the execution of the Purchase Agreement, unless we (i)first obtain stockholder approval in accordance with applicable Nasdaq listing rules or (ii) the average price paid by Lincoln Park for all shares of Common Stock issued by us under the Purchase Agreement is equal to or greater than $24.8080. The Purchase Agreement prohibits us from directing Lincoln Park to purchase any shares of Common Stock that would result in Lincoln Park having beneficial ownership of greater than 4.99% of our outstanding Common Stock, which Lincoln Park may,in its sole discretion, increase up to 9.99% of our outstanding Common Stock by delivering written notice thereof to us, which shallnot* be effective until the61st day after such written notice is delivered to us. We* mayterminate the Purchase Agreement at any time, for any reason and without any payment or liability to us, by giving Lincoln Park a termination notice with effectone* business date after the notice has been received by Lincoln Park.

We evaluated the Purchase Agreement under ASC815-40 Derivatives and Hedging—Contracts on an Entity's Own Equity as it represents the right to require Lincoln Park to purchase shares of Common Stock in the future, similar to a put option. We concluded it represents a freestanding derivative instrument that doesnot qualify for equity classification and therefore requires fair value accounting. We analyzed the terms of the contract and concluded the derivative instrument hasno value as of* December 31, 2025and2024*. We didnot effect any sales during the periods presented herein.

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Note14. Net Loss Per Share

The computation of basic and diluted net loss per share attributable to common stockholders for the years ended* December 31, 2025and2024* was as follows:

The following shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the years ended* December 31, 2025and2024* because they were antidilutive, out-of-the-money, or the issuance of such shares is contingent upon certain conditions that werenot satisfied by the end of the period:

Note15. Related Party Transactions

Supply and License Agreements

In* August 2018,we entered into an exclusive supply agreement (the “Supply Agreement”) and license agreement (the “License Agreement”) in conjunction with4Life’s* investment in the Series C preferred stock and warrants of our predecessor. On* April 25, 2024,we entered into an amendment to the Supply Agreement and License Agreement (the “Amended4Life* Agreements”). The Amended4Life Agreements contain the following terms:

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We currently provide (i) an aqueous zinc-silver ion dietary (mineral) supplement on a non-exclusive basis to4Life that is sold under the trade name Zinc Factor™, and (ii) an aqueous gold dietary (mineral) supplement of very low-concentration gold nanoparticles on an exclusive basis to4Life that is sold under the tradename Gold Factor™ and is subject to royalties. Total revenue under the Amended4Life Agreements during the years ended* December 31, 2025and2024* was as follows:

Note16. Geographic and Segment Information

Geographic Information

All of our long-lived assets, composed of property and equipment, net by location, were held in the U.S. and all of our revenues from external customers were generated in the U.S.

Segment Information

Our Products segment measures of profit and loss is consolidated loss from operations, and its measure of total assets is consolidated total assets. Our CODM uses loss from operations predominantly in the annual budget and forecasting process to monitor variances in budget versus actual results along with consolidated total assets to determine resource allocation. Segment revenues from external customers, significant segment non-cash items, and other significant segment expense categories included within the measure of profit and loss and provided to our CODM were all based on their consolidated amounts. During the years ended* December 31, 2025and2024*, these items were as follows:

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Our revenues during the years ended* December 31, 2025and2024* were predominantly with a single customer,4Life, through our Amended4Life Agreements (see Note15). A reconciliation of the total of the Products segment loss from operations to consolidated net loss before income taxes for the years ended* December 31, 2025and2024* was as follows:

Products segment assets exclude corporate assets, such as cash, restricted cash, and corporate facilities. Total assets as of* December 31, 2025and2024* were as follows:

Additions to long-lived assets during the years ended* December 31, 2025and2024* were as follows:

Note17. Subsequent Events

On* January 13, 2026,we closed a public equity offering pursuant to which we sold, directly to certain institutional investors, existing stockholders of the Company, and certain of the Company’s directors, (i)928,333 shares of Common Stock, (ii) warrants to purchase up to 1,114,000 shares of Common Stock (the “Series A Warrants”) and (iii) warrants to purchase up to 2,599,333 shares of Common Stock (the “Series B Warrants”). Each unit, consisting ofone share of Common Stock, one Series A Warrant, andone Series B Warrant, was sold at a price of $6.50. The aggregate gross proceeds to the Company was approximately $6.0 million, before deducting placement agent fees and expenses and other offering expenses payable by us. The offering was made pursuant to our2025* S-3 and a prospectus supplement relating to the offering. We are currently evaluating the accounting for the proceeds from the offering and the classification of the associated equity securities.

On* March 13, 2026,we entered into a subaward agreement with NYU pursuant to which NIH Grant funds totaling up to $8.0 million maybe paid to us as reimbursement for expenditures to support thethird* year of the ACT-EAP, from* September 1, 2025to August 31, 2026.*

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