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ZEVRA THERAPEUTICS INC

For the period ended Dec 31, 2024. Filed Mar 12, 2025.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Mar 12, 2025

ZVRA$12.14+4.7%Stored close · as of Nov 9, 2026

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Contents

Notes to Consolidated Financial Statements

A.Description of Business, Basis of Presentation, and Significant Transactions

Organization

Zevra Therapeutics, Inc. (the "Company") is a commercial-stage company focused on addressing unmet needs for the treatment of rare diseases. The Company has a diverse portfolio of products and product candidates, which includes clinical stage pipeline and commercial stage assets. On* September 20, 2024,the U.S. Food and Drug Administration ("FDA") approved the New Drug Application (“NDA”) for MIPLYFFA™ (arimoclomol), an orally-delivered treatment for Niemann-Pick disease type C (“NPC”), which is an ultra-rare and progressive neurodegenerative disease. MIPLYFFA, thefirst* FDA-approved treatment for NPC, is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patientstwo years of age and older. In addition, the Company received a transferable rare pediatric disease priority review voucher (“PRV”) in conjunction with the approval of MIPLYFFA. On* February 26, 2025,the Company and Zevra Denmark A/S entered into an asset purchase agreement (the “PRV Transfer Agreement”), pursuant to which the Company agreed to sell the PRV to the buyer. Pursuant to the PRV Transfer Agreement, the buyer agreed to pay the Company $150.0 million, payable in cash, upon the closing of the sale. The PRV Transfer Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of1976.* MIPLYFFA has also been granted orphan medicinal product designation for the treatment of NPC by the European Commission. OLPRUVA® (sodium phenylbutyrate) for oral suspension is approved by the FDA for the treatment of urea cycle disorders ("UCDs"). The Company also has a pipeline of investigational product candidates, including celiprolol for the treatment of vascular Ehlers-Danlos syndrome in patients with a confirmed type III collagen mutation.KP1077 is the Company's clinical development product candidate which is being developed as a treatment for idiopathic hypersomnia ("IH"), a rare neurological sleep disorder, and narcolepsy.KP1077 is comprised solely of serdexmethylphenidate (“SDX”), the Company's proprietary prodrug of d-methylphenidate ("d-MPH"). The FDA has grantedKP1077 orphan drug designation for the treatment of IH.

The Company changed its name from KemPharm, Inc. to Zevra Therapeutics, Inc. effective as of* February 21, 2023.On March 1, 2023,*following its name change, the Company's common stock began trading on the Nasdaq Global Select Market under the ticker symbol "ZVRA".

Basis of Presentation

The Company prepared the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”) and, in the Company’s opinion, reflect all adjustments, including normal recurring items that are necessary. All significant intercompany accounts and transactions have been eliminated in consolidation.

Merger

On* August 30, 2023,the Company and Aspen Z Merger Sub, Inc., a wholly-owned subsidiary of Zevra (“Merger Sub”), entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Acer Therapeutics Inc. (“Acer”), a pharmaceutical company focused on development and commercialization of therapies for rare and life-threatening diseases. On November 17, 2023 (*the "Closing Date"), the Company completed the acquisition of Acer. Pursuant to the Merger Agreement, on the Closing Date, Merger Sub was merged with and into Acer (the "Merger"), with Acer continuing as the surviving entity and as a wholly-owned subsidiary of Zevra. In connection therewith, Zevra has also purchased Acer’s secured debt from Nantahala Capital Management, LLC ("NCM”), certain of its affiliates and certain other parties (collectively with NCM, “Nantahala”) through a series of transactions and Zevra agreed to provide Acer with a bridge loan facility for up to $18.0 million ("Bridge Loan"), subject to certain terms and conditions. The Merger has expanded Zevra's rare disease portfolio, as well as increased and diversified its revenues with the addition of a U.S. commercial asset, OLPRUVA, indicated for the treatment of UCDs. See Note T for further discussion related to the Merger.

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Registration Statements on Form S-3

In connection with the Merger, Zevra and Nantahala concurrently entered into a registration rights agreement, pursuant to which Zevra agreed to file a resale registration statement with respect to the resale of the Zevra common stock issuable to Nantahala. On* February 5, 2024,Zevra filed a registration statement on Form S-3 (FileNo.* 333-276856) registering an aggregate of 2,269,721 shares of Zevra’s common stock. On* April 5, 2024,the Company filed an amendment to such registration statement, which was declared effective on April 8, 2024.*

On* June 4, 2024,the Company filed a registration statement on Form S-3 (FileNo.* 333-279941) (the* "June 2024Registration Statement") under which the Company maysell securities, including as maybe issuable upon conversion, redemption, repurchase, exchange or exercise of securities, inone* or more offerings up to a total aggregate offering price of $350.0 million, $75.0 million of which was allocated to the sale of the shares of common stock issuable under the2024 ATM Agreement (as described further below). The registration statement was declared effective on* June 13, 2024*

**** August 2024Offering**

On* August 8, 2024,the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Cantor Fitzgerald & Co. and William Blair & Company, L.L.C., as representatives of the several underwriters named therein (collectively, the “Underwriters”), in connection with the offering, issuance and sale by the Company of 9,230,770 shares of the Company’s common stock at a public offering price of $6.50 per share, pursuant to the June 2024Registration Statement and a related prospectus supplement dated August 8, 2024,filed with the SEC (the "August 2024Offering"). Under the terms of the Underwriting Agreement, the Company also granted the Underwriters an option exercisable for30* days to purchase up to an additional 1,384,615 shares of its Common Stock at the public offering price, less underwriting discounts and commissions, which the Underwriters exercised in full on* August 9, 2024.The August 2024Offering closed on August 12, 2024.Total shares issued were 10,615,385. Net proceeds from the offering were approximately$64.5 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds of the offering to support the commercial launch activities for MIPLYFFA, continued commercial support for OLPRUVA and the continued development of celiprolol andKP1077* through potential NDA filings and other general corporate purposes.

Entry into2024 ATM Agreement**

On* July 12, 2024,the Company entered into an equity distribution agreement (the"2024* ATM Agreement") with Citizens JMP Securities LLC ("Citizens JMP") under which the Company* mayoffer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $75.0 million through Citizens JMP as its sales agent. The issuance and sale, if any, of common stock by the Company under the2024* ATM Agreement will be made pursuant to the* June 2024Registration Statement, the accompanying prospectus, and the related prospectus supplement dated July 12, 2024.Citizens JMP maysell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule415* of the Securities Act. Citizens JMP will use commercially reasonable efforts to sell the common stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company* mayimpose). The Company will pay Citizens JMP a commission equal to 3.0% in the aggregate of the gross sales proceeds of any common stock sold through Citizens JMP under the2024* ATM Agreement. As of* December 31, 2024,no shares have been issued or sold under the2024* ATM Agreement.

Termination of2021 ATM Agreement**

On* July 2, 2021,the Company entered into an equity distribution agreement (the"2021* ATM Agreement") with JMP Securities LLC ("JMP") and RBC Capital Markets, LLC ("RBCCM") under which the Company* mayoffer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $75.0 million through JMP and RBCCM as its sales agents. The issuance and sale, if any, of common stock by the Company under the2021* ATM Agreement was made pursuant to the registration statement on Form S-3 (FileNo. 333-257661) which was declared effective on* July 12, 2021,the accompanying prospectus, and the related prospectus supplement dated July 12, 2021.The2021* ATM Agreement terminated on* July 11, 2024,andno shares had been issued or sold under the2021* ATM Agreement as of the termination date.

Reclassifications

Certain reclassifications were made to the2023 consolidated financial statements to conform to the classifications used in2024. These reclassifications hadno impact on the consolidated net loss, changes in stockholder's equity, or cash flows previously reported.

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B.Summary of Significant Accounting Policies

Use of Estimates

The preparation of these consolidated financial statements in conformity with U.S. GAAP requires the Company to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.

On an ongoing basis, the Company evaluates its estimates and assumptions, including those related to revenue recognition, the useful lives of property and equipment, the recoverability of long-lived assets, the incremental borrowing rate for leases, and assumptions used for purposes of determining stock-based compensation, income taxes, the fair value of the derivative and warrant liability and discount and rebate liabilities, among others. The Company bases its estimates on historical experience and on various other assumptions that it believes to be reasonable, the results of which form the basis for making judgments about the carrying value of assets and liabilities.

Concentration of Credit Risk

Financial instruments that potentially expose the Company to concentrations of credit risk consist principally of cash on deposit and investments with multiple financial institutions, the balances of which frequently exceed insured limits, and accounts receivable, which are concentrated amongst a limited number of customers.

Cash and Cash Equivalents

The Company considers any highly liquid investments with an original maturity ofthree months or less to be cash equivalents.

Investments

The Company maintains investment securities that are classified as available-for-sale securities for which the Company has elected the fair value option under Financial Accounting Standards Board("FASB") Accounting Standards Codification("ASC") Topic825, Financial Instruments. As such, these securities are carried at fair value with unrealized gains and losses included in fair value adjustment related to investments on the consolidated statements of operations. The securities primarily consist of U.S. Treasury securities and U.S. government-sponsored agency securities and are included in securities at fair value in the consolidated balance sheets. As of* December 31, 2024,and2023,* the Company held securities with an aggregate fair value of $41.7 millionand $24.7 million, respectively, that contained aggregate unrealized gains of approximately $18,000 and $0.6 million, respectively. For securities held at* December 31, 2024,$35.7 million mature withinone* year and $6.0 million mature inone tofive years. Applying fair value accounting to these debt securities more accurately represents the Company's investment strategy due to the fact that excess cash is currently being invested for the purpose of funding future operation **s.**Interest income is recognized as earned using an effective yield method giving effect to the amortization of premium and accretion of discount and is based on the economic life of the securities. Interest income is included in Interest and other income, net in the consolidated statements of operations.

Variable Interest Entities

The primary beneficiary of a variable interest entity ("VIE") is required to consolidate the assets and liabilities of the VIE. When the Company obtains a variable interest in another entity, it assesses at the inception of the relationship and upon occurrence of certain significant events whether the entity is a VIE, and if so, whether the Company is the primary beneficiary of the VIE based on its power to direct the activities of the VIE that most significantly impact the VIE's economic performance and the Company's obligation to absorb losses or the rights to receive benefits from the VIE that could potentially be significant to the VIE.

To assess whether the Company has the power to direct the activities of the VIE that most significantly impact the VIE's economic performance, the Company considers all the facts and circumstances, including the Company's role in establishing the VIE and the Company's ongoing rights and responsibilities. The assessment includes identifying the activities that most significantly impact the VIE's economic performance and identifying which party, if any, has the power to direct those activities. In general, the parties that make the most significant decisions affecting the VIE (management and representation on the Board of Directors) are deemed to have the power to direct the activities of a VIE.

To assess whether the Company has the obligation to absorb losses of the VIE or the rights to receive benefits from the VIE that could potentially be significant to the VIE, the Company considers all of its economic interests that are deemed to be variable interests in the VIE.

This assessment requires judgement in determining whether these interests, in the aggregate, are considered potentially significant to the VIE. As of* December 31, 2024,and2023,* the Company identified Acer to be the Company's sole interest in a VIE (Note T). As Zevra is the final decision maker for all of Acer's research, development, and commercialization of drug candidates that it is producing, the Company directs the activities of Acer that most significantly impact its performance. Therefore, the Company is the primary beneficiary of this VIE for accounting purposes.

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Goodwill and Intangible Assets

Goodwill represents the excess of the consideration transferred over the fair value of the net assets acquired when accounted for using the acquisition method of accounting for business combinations. Goodwill isnot amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis, during thefourth quarter, or more frequently if an event occurs or circumstances change that would more-likely-than-not reduce the fair value of the Company’s reporting unit below its carrying amount. The Company establishes its reporting units based on the organizational structure and has determined it hasone reporting unit. In performing its analysis, in accordance with ASC350, the Company has the option tofirst assess qualitatively whether it is more likely thannot that the fair value of a reporting unit is less than its carrying amount, including goodwill. In performing qualitative assessments, the Company considers, among other factors, macroeconomic conditions, the Company’s overall financial performance (including, butnot limited to, comparisons to prior periods, current period internal expectations, and comparable peer companies), broader industry and market considerations, and the trading price performance of the Company’s common stock.

The Company's goodwill balance was $4.7 million as of* December 31, 2024,and2023.* As of* December 31, 2024,and2023,* the Company completed its annual qualitative assessment under ASC350 to determine whether the existence of events or circumstances indicated that it was more likely thannot that the fair value of its reporting unit was less than its respective carrying value. The Company concluded that based on the relevant events and circumstances, it was more likely thannot that the reporting unit’s fair value exceeded its related carrying value and thereforeno quantitative assessment was required. No goodwill impairment charges were recorded for the year ended* December 31, 2024,or2023.*

Acquired in-process research and development (“IPR&D”) that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, havenot reached technological feasibility. The amounts are capitalized and are accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each IPR&D project, the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated and begin amortization. The Company evaluates IPR&D for impairment on an annual basis, during thefourth quarter, or more frequently if impairment indicators exist. The Company’s IPR&D balancewas $2.0 million as of* December 31, 2024,and2023.* No IPR&D impairment charges were recognized for the years ended* December 31,*2024, or2023.

As of* December 31, 2024,and2023,* the Company had a definite-lived intangible asset, net related to the acquisition of OLPRUVA as a result of the Mergerof $61.3 million and $67.2 million, respectively. This asset is amortized on a straight-line basis over the OLPRUVA patent life ofthirteen years. Amortization expense is recorded as intangible asset amortization in the consolidated statements of operations and was $5.9 million and $0.8 million for the years ended* December 31, 2024,and2023,* respectively. The Company reviews the estimated useful lives of its intangible assets on an ongoing basis (Note S).

In connection with the XOMA License Agreement, the Company paid XOMA a regulatory milestone payment of $6.0 million upon approval of MIPLYFFA in* September 2024,which is included in intangible assets, net in the consolidated balance sheet. This definite-lived intangible asset is amortized on a straight-line basis over the MIPLYFFA patent life of approximately five years and is reviewed periodically for impairment. Amortization expense is recorded as intangible asset amortization in the consolidated statement of operations and was $0.3 million for the year ended December 31, 2024.*

Property and Equipment

The Company records property and equipment at cost less accumulated depreciation and amortization. Costs of renewals and improvements that extend the useful lives of the assets are capitalized. Maintenance and repairs are expensed as incurred. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three toten years. Leasehold improvements are amortized over the shorter of the useful life of the asset or the term of the related lease. Upon retirement or disposition of assets, the costs and related accumulated depreciation and amortization are removed from the accounts with the resulting gains or losses, if any, reflected in the consolidated statements of operations.

Impairment of Long-Lived Assets

Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts of the assets* may* not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying values, an impairment loss is recorded for the difference between the carrying values and fair values of the asset. No such impairment occurred for the years ended* December 31, 2024,or2023.*

Revenue Recognition

The Company recognizes revenue in accordance with ASC606, Revenue from Contracts with Customers (“ASC606”) and, as a result, follows thefive-step model when recognizing revenue:1) identifying a contract;2) identifying the performance obligations;3) determining the transaction price;4) allocating the price to the performance obligations; and5) recognizing revenue when the performance obligations have been fulfilled.

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Product Revenues, Net

Net revenues from product sales are recognized at the transaction price when the customer obtains control of the Company's product, which occurs at a point in time, typically upon receipt of the product by the customer. The Company's current single customer is a specialty pharmacy provider.

The Company's net revenues represent total revenues adjusted for discounts and allowances, including estimated cash discounts, chargebacks, rebates, returns, copay assistance, data fees and wholesaler fees for services. These adjustments represent variable consideration under ASC606 and are recorded as a reduction of revenue. These adjustments are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Adjustments for variable consideration are determined based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products.

Licensing Agreements

The terms of the Company’s licensing agreements typically includeone or more of the following: (i) upfront fees; (ii) milestone payments related to the achievement of development, regulatory, or commercial goals; and (iii) royalties on net sales of licensed products. Each of these payments* may*result in licensing revenues.

As part of the accounting for these agreements, the Company must develop estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. Generally, the estimation of the stand-alone selling price* may*include such estimates as independent evidence of market price, forecasted revenues or costs, development timelines, discount rates, and probability of regulatory success. The Company evaluates each performance obligation to determine if they can be satisfied at a point in time or over time, and it measures the services delivered to the licensee which are periodically reviewed based on the progress of the related program. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration (e.g., milestone payments) must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.

Up-front Fees: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from the transaction price allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time.

Milestone Payments: At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal wouldnot occur, the associated milestone value is included in the transaction price. Milestone payments that arenot within the Company’s or the licensee’s control, such as non-operational developmental and regulatory approvals, are generallynot considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within its or the licensee’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect collaboration revenues and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price* may*also result in negative licensing revenues and earnings in the period of adjustment.

Arimoclomol Expanded Access Program

Net revenue includes revenue from the sale of arimoclomol for the treatment of NPC under the remunerated expanded access compassionate use program in France, Accès Compassionnel (“French AC”). An expanded access compassionate use program is a program giving specific patients access to a drug, which isnot yet approved for commercial sale. Only drugs targeting serious or rare indications and for which there is currentlyno appropriate treatment are considered for expanded access compassionate use programs. Further, to be considered for the expanded access compassionate use program, the drug must have proven efficacy and safety and must either be undergoing price negotiations or seeking marketing approval.

In accordance with ASC606, the Company recognizes revenue when fulfilling its performance obligation under the Arimoclomol Expanded Access Program ("Arimoclomol EAP") by transferring control of promised goods or services to its customer, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. In determining when the customer obtains control of the product, the Company considers certain indicators, including whether the Company has a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether customer acceptance has been received. Revenue is recognized net of sales deductions, including discounts, rebates, applicable distributor fees, and revenue-based taxes.

The French Health Authorities and the manufacturer have agreed to a price for sales under the French AC, but the final transaction price depends on the terms and conditions in the contracts with the French Health Authorities, following market approval. Any excess in the price charged by the manufacturer compared to the price agreed with the health authorities once the drug product is approved in France must be repaid. The repayment is considered in the clawback liability (rebate). An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for the expected final transaction price. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar drug products. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drug products. The limited available relevant market information for directly comparable commercialized drugs within rare disease increases the uncertainty in management's estimate.

Acquired IPR&D and Milestones Expenses

In an asset acquisition, payments incurred prior to regulatory approval to acquire rights to in-process R&D projects are expensed as acquired IPR&D and milestones expense in the consolidated statements of earnings unless the project has an alternative future use. These costs include upfront and development milestone payments related to R&D collaborations, licensing arrangements, or other asset acquisitions that provide rights to develop, manufacture and/or sell pharmaceutical products. Where contingent development milestone payments are due tothird parties, prior to regulatory approval, the payment obligations are expensed when the milestone results are achieved. Regulatory and commercial milestone payments made tothird parties subsequent to regulatory approval are capitalized as intangible assets and amortized to intangible asset amortization over the remaining useful life of the related product.

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Inventories

The value of inventories is recorded at net realizable value. The Company determines the cost of its other inventories, which includes amounts related to materials and manufacturing overhead, on afirst-in,first-out basis. Inventories that arenot expected to be sold within12 months are classified as Inventories, noncurrent.

The Company* mayscale-up and make commercial quantities of its product candidates prior to the date it anticipates that such product will receive final regulatory approval. The scale-up and commercial production of pre-launch inventory involves the risk that such products maynot* be approved for marketing on a timely basis, or ever. This risk notwithstanding, the Company* mayscale-up and build pre-launch inventory of product that havenot* received final regulatory approval when the Company believes such action is appropriate in relation to the commercial value of the product launch opportunity. We capitalize inventory costs associated with our products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval. We hadno pre-approval inventory on our consolidated balance sheet as of* December31,* 2024, or2023. Inventory used in clinical trials is also expensed as research and development expense, when selected for such use. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when identified for use in a clinical manufacturing campaign. The cost of finished goods inventory that is shipped to a customer to support the Company’s patient assistance programs is expensed when those shipments take place. As of* December 31, 2024,and2023,* the Company didnot have pre-launch inventory that qualified for capitalization.

The Company performs an assessment of the recoverability of capitalized inventory during each reporting period and writes down any excess and obsolete inventory to its net realizable value in the period in which the impairment isfirst identified. Such impairment charges, should they occur, are recorded as a component of cost of product revenue in the statements of operations and comprehensive loss. The determination of whether inventory costs will be realizable requires the use of estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory* maybe required. Additionally, the Company’s product is subject to strict quality control and monitoring that it performs throughout the manufacturing process. In the event that certain batches or units of product donot* meet quality specifications, the Company will record a charge to cost of product revenue, to write-down any unsaleable inventory to its estimated net realizable value. For the year ended* December 31, 2024,the Company recognized a charge of approximately $5.7 million related to write-downs for unsaleable inventory. No such write downs were recognized for the year ended December 31, 2023.*

Cost of Product Revenue

The components of cost of product revenue are royalties and expenses directly attributable to revenue. To date, the Company has generated revenue from product sales of MIPLYFFA and OLPRUVA, the AZSTARYS License Agreement, sales of arimoclomol under the EAP, reimbursement of out-of-pocketthird-party costs and the performance of consulting services. In connection with the AZSTARYS License Agreement, the Company pays Aquestive a royalty equal to 10% of all regulatory milestone and royalty payments. In addition, the Company capitalized incremental costs directly attributable to the AZSTARYS License Agreement. These costs are amortized to royalties and contract costs as revenue is recognized.

Under the XOMA License Agreement, XOMA is entitled to a mid-single digit percentage royalty with respect to net sales of MIPLYFFA. In addition, the Company also pays a low-single digit percentage royalty to Kansas University Center for Technology Commercialization, Inc. with respect to net sales of MIPLYFFA.

Accounts and Other Receivables

Accounts and other receivables consist of receivables from MIPLYFFA and OLPRUVA product sales, receivables under the AZSTARYS License Agreement and the EAP, and income tax receivables and other receivables due to the Company. Receivables under the AZSTARYS License Agreement are recorded for amounts due to the Company related to reimbursablethird-party costs as well as milestones and royalties on product sales. Receivables under the EAP are recorded for product sales under the French AC. The Company provides reserves against receivables for estimated losses that* may*result from a customer's inability to pay. Receivables are evaluated to determine if any reserve or allowance should be recorded based on consideration of the current economic environment, expectations of future economic conditions, specific circumstances and the Company’s own historical collection experience. Amounts determined to be uncollectible are charged or written-off against the reserve.

Research and Development

Major components of research and development costs include cash compensation, stock-based compensation, depreciation and amortization expense on research and development property and equipment, costs of preclinical studies, clin ical trials and related clinical manufacturing, costs of drug development, costs of materials and supplies, facilities cost, overhead costs, regulatory and compliance costs, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Costs incurred in research and development are expensed as incurred.

The Company records nonrefundable advance payments it makes for future research and development activities as prepaid expenses. Prepaid expenses are recognized as expense in the statements of operations as the Company receives the related goods or services.

The Company enters into contractual agreements withthird-party vendors who provide research and development, manufacturing, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when an obligation has been incurred. This accrual process involves reviewing open contracts and purchase orders, communicating with the applicable personnel to identify services that have been performed and estimating the level of service performed and the associated cost when the Company hasnot yet been invoiced or otherwise notified of actual cost. The majority of the service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of the accrued expenses as of each balance sheet date based on the facts and circumstances known. The Company periodically confirms the accuracy of the estimates with the service providers and make adjustments, if necessary.

Patent Costs

Patent costs, including related legal costs, are expensed as incurred and recorded within general and administrative expenses on the statements of operations.

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Income Taxes

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the financial reporting and tax basis of assets and liabilities, as well as for operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using the tax rates that are expected to apply to taxable income for the years in which those tax assets and liabilities are expected to be realized or settled. Valuation allowances are recorded to reduce deferred tax assets to the amount the Company believes is more likely thannot to be realized.

Uncertain tax positions are recognized only when the Company believes it is more likely thannot that the tax position will be upheld on examination by the taxing authorities based on the merits of the position. The Company recognizes interest and penalties, if any, related to unrecognized income tax uncertainties in income tax expense. The Company didnot have any accrued interest or penalties associated with uncertain tax positions as of* December 31, 2024and2023*.

The Company files income tax returns in the United States for federal and various state jurisdictions. With few exceptions, the Company isno longer subject to U.S. federal and state and local income tax examinations for years prior to2015, although carryforward attributes that were generated prior to2017 maystill be adjusted upon examination by the Internal Revenue Service if used in a future period. No income tax returns are currently under examination by taxing authorities.

On* December**22,* 2017, the U.S. government enacted H.R.1, “An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year2018” ("Tax Act"). Effective* January 1, 2018,the Tax Act provides for a new global intangible low-taxed income ("GILTI") provision. Under the GILTI provision, certain foreign subsidiary earnings in excess of an allowable return on the foreign subsidiary’s tangible assets are included in U.S. taxable income. The Company hasnot* recorded any deferred taxes for future GILTI inclusions as any future inclusions are expected to be treated as a period expense and offset by net operating loss carryforwards in the U.S.

Stock-Based Compensation

The Company measures and recognizes compensation expense for all stock-based payment awards made to employees, officers and directors based on the estimated fair values of the awards as of the grant date. The Company records the value of the portion of the award that is ultimately expected to vest as expense over the requisite service period. The Company also accounts for equity instruments issued to non-employees using a fair value approach under Accounting Standards Codification ("ASC") subtopic505-50. The Company values equity instruments and stock options granted using the Black-Scholes option pricing model.

Basic and Diluted Net Loss per Share of Common Stock

The Company uses thetwo-class method to compute net loss per common share because the Company has issued securities, other than common stock, that contractually entitle the holders to participate in dividends and earnings of the Company. Thetwo-class method requires earnings for the period to be allocated between common stock and participating securities based upon their respective rights to receive distributed and undistributed earnings. Holders of each series of the Company’s convertible preferred stock and select warrants are entitled to participate in distributions, when and if declared by the board of directors, that are made to common stockholders and, as a result, are considered participating securities.

Segment and Geographic Information

Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is available and regularly reviewed by the chief operating decision maker ("CODM") in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive Officer. The Company views its operations and manages its business as a single operating and reporting segment. The Company holds long-lived assets in the United States of $13.4 million and $10.9 million as of* December 31, 2024and2023* respectively. The Company holds long-lived assets in Europe of $0.5 million as of both* December 31, 2024and2023*

Foreign currency

Assets and liabilities are translated into the reporting currency using the exchange rates in effect on the consolidated balance sheet dates. Equity accounts are translated at historical rates, except for the change in retained earnings during the year, which is the result of the income statement translation process. Revenue and expense accounts are translated using the weighted average exchange rate during the period. The cumulative translation adjustments associated with the net assets of foreign subsidiaries are recorded in accumulated other comprehensive income/loss in the accompanying consolidated statements of stockholders’ equity.

Debt Issuance Costs

Debt issuance costs incurred in connection with financing arrangements are recorded as a reduction of the related debt on the balance sheet and amortized over the life of the respective financing arrangement using the effective interest method.

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Warrants

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in FASB ASC Topic480, Distinguishing Liabilities from Equity (ASC480) and FASB ASC Topic815, Derivatives and Hedging(ASC815). 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 of the requirements for equity classification under ASC815, including whether the warrants are indexed to the Company's own stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For warrants that meet all criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital, on the consolidated statement of stockholders’ deficit at the time of issuance. For warrants that donot meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and on each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss in other expense, net, on the consolidated statement of operations. The fair value of the warrants was estimated using the Black-Scholes option pricing model.

New Accounting Pronouncements Recently Adopted

Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures*

In* November 2023,the FASB issued Accounting Standards Update ("ASU")No. 2023-07, Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures. The standard expands reportable segment disclosure requirements for public business entities primarily through expanded disclosures about significant segment expenses that are regularly provided to the chief operating decision maker ("CODM") and included within each reported measure of segment profit and loss. The Company adopted this standard for its fiscal year2024 annual financial statements and have applied this standard retrospectively for all prior periods presented in the financial statements. See Note C for further information.

New Accounting PronouncementsNot Yet Adopted**

Income Taxes (Topic740*): Improvements to Income Tax Disclosures*

In* December 2023,the FASB issued ASUNo.* 2023-09, Income Taxes (Topic740): Improvements to Income Tax Disclosures, which expands disclosures in an entity’s income tax rate reconciliation table and disclosures regarding cash taxes paid both in the U.S. and foreign jurisdictions. The update will be effective for annual periods beginning after* December 15, 2024.*The Company is currently evaluating the impact that this guidance will have on the presentation of its consolidated financial statements and accompanying notes.

C.Segment Information

Zevra manages its business activities on a consolidated basis and operates as asingle operating segment dedicated to the research and development, manufacturing, commercialization and sale of innovative medicines and therapies. The Company primarily derives its revenue from reimbursements received from the EAP, AZSTARYS License Agreement, OLPRUVA product sales, MIPLYFFA product sales, and consulting arrangements. The accounting policies of the segment are the same as those described in Note B.

Zevra's CODM is the Company's Chief Executive Officer, Neil F. McFarlane. The CODM uses net loss, as reported in the Company's Consolidated Statements of Comprehensive Loss, in evaluating performance of its segment and determining how to allocate resources of the Company as a whole, including investing in its research and development, commercialization efforts, and acquisition strategy. The CODM doesnot review assets in evaluating the results of the segment, and therefore, such information isnot presented.

The following table presents the operating results of the Company's segment:

December 31,December 31,
20242023
Total revenues$23,612$27,461
Less significant segment expenses:
Research and development directly identified to programs22,53230,083
Research and development not directly identified to programs19,5629,723
Selling, general and administrative directly identified to programs18,0947,770
Selling, general and administrative not directly identified to programs36,77526,544
Other segment items:
Income tax expense15,371-
Interest income(3,159)(4,527)
Depreciation and amortization expense6,3891,006
Interest expense7,3511,501
Other expense, net(a)6,2081,410
Segment net loss$(105,511)$(46,049)

(a) Other expense, net included in segment net loss includes foreign currency exchange gains and losses, cost of product revenue (excluding intangible asset amortization), fair value adjustment related to warrant and CVR liabilities, fair value adjustment related to investments, and other overhead expense.

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D.Inventories

The components of inventory are summarized as follows (in thousands):

December 31, 2024December 31, 2023
Raw Materials$7,928$2,938
Work in progress3,2601,884
Finished goods1,7815,019
Total inventories$12,969$9,841
E.Accounts and Other Receivables

Accounts and other receivables consist of the following (in thousands):

December 31,
20242023
Accounts receivable$10,176$16,119
Other receivables3331,258
Total accounts and other receivables$10,509$17,377
F.Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):

December 31,
20242023
Prepaid insurance$1,037$1,172
Other prepaid expenses and current assets3,015652
Total prepaid expenses and other current assets$4,052$1,824
G.Property and Equipment

Property and equipment consists of the following (in thousands):

December 31,
20242023
Laboratory equipment$463$711
Furniture and office equipment200157
Computers and hardware701643
Leasehold improvements710710
Finance lease right-of-use assets8149
Total property and equipment2,0822,370
Less: accumulated depreciation and amortization(1,726)(1,634)
Property and equipment, net$356$736

The estimated useful lives of property and equipment are as follows:

Useful Life
Asset Category · (in years)
Laboratory equipment10
Furniture and office equipment5 - 10
Computers and hardware3 - 7
Leasehold improvements9

Depreciation and amortization expense, including amounts pertaining to assets held under finance leases, was approximately$208,000 and $245,000 for the years ended* ** December 31, 2024and2023*, respectively.

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H.Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consistof the following (in thousands):

December 31,
20242023
Accrued payroll6,12610,671
Accrued professional fees863675
Accounts payable13,07513,987
Other accrued expenses5,3923,070
Total accounts payable and accrued expenses$25,456$28,403
I.Debt Obligations

Secured Promissory Note

In connection with the Merger (Note T), on * August 30, 2023,the Company and Nantahala, entered into a secured promissory note payable by Zevra to Nantahala in the original principal amount of $5.0 million (the "Nantahala Note"). The Nantahala Note initially bore interest at 9.0% per annum, payable quarterly in arrears in cash. The interest rate increased to 12.0% per annum effective March 1, 2024,as the Nantahala Note remained unpaidsix* months from its issue date. The additional 3.0% interest would have been paid in shares of Zevra's common stock based on the volume weighted average trading price ("VWAP") of Zevra's common stock during thetwenty consecutive trading days ending on the date before such interest payment date. Beginning on thefirst interest payment date following thesecond anniversary of the Nantahala Note, and on each interest payment date thereafter, Zevra was required to make $0.6 million amortization payments on the Nantahala Note until it was paid in full. All principal and unpaid interest on the Nantahala Note would have been due on* August 30, 2026,thethird* anniversary of the Nantahala Note. Zevra was entitled to prepay the Nantahala Note at any time without penalty. The Nantahala Note was secured by Zevra’s interest in (i) the loan assets under the Loan Purchase Agreement described inNote T; (ii) the note assets under the Note Purchase Agreement described in Note T;(iii) the Bridge Loan described in Note T; and (iv) the proceeds therefrom. The Company used the proceeds from the Nantahala Note, along with $12.0 million in cash and 98,683 shares of Zevra's common stock, to acquire Acer's term loans, as more fully described inNote T. In* April 2024,the Nantahala Note was repaid in full and terminated. At the time of repayment, Nantahala elected to receive a cash payment in lieu of shares of Zevra's common stock in exchange for the additional 3.0% interest accrued for the period from March 1, 2024,through April 5, 2024.*

Margin Account

On* January 26, 2023,the Company and Wells Fargo, as lender, entered into a revolving margin account agreement. The Company's investments were used as collateral for the loan and the amount the Company was able to borrow was limited to 80-90% of its outstanding investment balance held with Wells Fargo. The margin account bore interest at the Prime rate minus 225 basis-points. As of December 31, 2023,$37.7 million was outstanding under the margin account. The margin loan was included in current liabilities as of December 31, 2023,as the Company expected the outstanding balance to be due and payable in2024* based on the anticipated level of investment balance expected to be available over the course of fiscal year2024 to meet the Collateral Requirement. In* April 2024,*the Company repaid the outstanding balance under the margin account with Wells Fargo, and upon such repayment, the margin capabilities were removed from the account.

Term Loans

On* April 5, 2024 (*the "Term Loans Closing Date"), the Company entered into a credit agreement (the “Credit Agreement”) with HCR Stafford Fund II, L.P., HCR Potomac Fund II, L.P., and Perceptive Credit Holdings IV, LP (collectively, the “Lenders”), and Alter Domus (US) LLC, as administrative agent (the “Administrative Agent”).

Under the terms of the Credit Agreement, the Lenders provided a senior secured loan facility to the Company in the aggregate principal amount of $100.0 million, which is divided intothree tranches as follows: (i) $60.0 million which was funded in full on the Term Loans Closing Date; (ii) $20.0 million which is available to the Company in up totwo drawings, each in an amountnot to exceed $10.0 million, at the Company’s option until18 months following the Term Loans Closing Date; and (iii) $20.0 million which is available to the Company upon approval by the FDA of the NDA for MIPLYFFA for the treatment of NPC, at the Company’s option until* December 31, 2024 (*collectively, the “Term Loans”).

The principal amount of the Term Loans outstanding (the “Outstanding Principal Amount”) will bear interest at a rate equal to3-Month Term SOFR plus 7.00% per annum. If the net product sales for the calendar year ending* December 31, 2025,exceed $100.0 million, the Outstanding Principal Amount will bear interest at3*-Month Term SOFR plus 6.00% per annum. If the net product sales for the calendar year ending* December 31, 2025,donot* exceed $100.0 million, then for any subsequent period offour consecutive fiscal quarters ending on or after* March 31, 2026,in which net product sales exceed $125.0 million, the Outstanding Principal Amount will bear interest at3*-Month Term SOFR plus 6.50% per annum. In all cases, the3-Month Term SOFR rate will be subject to a floor of 4.00% per annum. Interest will be payable quarterly in arrears on the last day of each calendar quarter. The Company has the option to pay up to 25% of the interest in-kind beginning on the Term Loans Closing Date, through and including* June 30, 2026.The Company has recognized approximately $1.4 million of interest-in-kind as of December 31, 2024,which is included in long-term debt in the consolidated balance sheet. The Term Loans will mature on thefifth* anniversary of the Term Loans Closing Date. In connection with the Credit Agreement, the Company incurred approximately $2.2 million of costs, which primarily consisted of underwriting, legal and other professional fees, and are included as a reduction to the carrying amount of the related debt liability and are deferred and amortized over the remaining life of the financing using the effective interest method.

The Credit Agreement contains customary affirmative and negative covenants by the Company, which among other things, will require the Company to provide certain financial reports to the Lenders within60 days after the end of each of thefirst three fiscal quarters of each fiscal year and105 days after the end of each fiscal year, meet certain minimum net product sales amounts, and limit the ability of the Company to incur or guarantee additional indebtedness, engage in certain transactions, and effect a consolidation or merger without consent. In addition, as long as the line of credit remains active, the Company must maintain a minimum cash balance of $20.0 million to ensure the Company can meet its immediate capital needs. The obligations of the Company under the Credit Agreement* maybe accelerated upon customary events of default, including non-payment of principal, interest, fees and other amounts, covenant defaults, insolvency, material judgments, or inaccuracy of representations and warranties. The Term Loans are secured by afirst* priority perfected lien on, and security interest in, substantially all current and future assets of the Company. The proceeds of the Term Loans were used to refinance certain existing indebtedness of the Company and its subsidiaries. The Company will use the remaining proceeds to pay fees and expenses related to the debt financing and fund the development and commercialization of OLPRUVA and MIPLYFFA.

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Long-term debt consisted of the following (in thousands):

December 31, 2024December 31, 2023
Notes payable$61,552$—
Secured promissory note—5,000
Unamortized original issue (discount) premium(921)148
Less: debt issuance costs(1,127)(82)
$59,504$5,066

Future minimum principal payments under the secured promissory note as of* December 31, 2024,*were as follows (in thousands):

Year Ending December 31, 2024December 31, 2024
2025$—
2026—
2027—
2028—
202961,552
Total minimum payments61,552
Less: unamortized debt discount and debt issuance costs(2,048)
Long-term debt$59,504
J.Revenue, net

Licensing Agreements

AZSTARYS License Agreement

The Company entered into a Collaboration and License Agreement (the “AZSTARYS License Agreement”) with Commave Therapeutics SA (formerly known as Boston Pharmaceutical S.A.) ("Commave"), an affiliate of Gurnet Point Capital, L.P., dated* September 3, 2019.*Under the AZSTARYS License Agreement, as amended, the Company granted to Commave an exclusive, worldwide license to develop, manufacture and commercialize the Company’s product candidates containing SDX and d-MPH, including AZSTARYS, or any other product candidates containing SDX and developed to treat ADHD or any other central nervous system disorder. Corium Inc. was tasked by Commave to lead all commercialization activities for AZSTARYS under the AZSTARYS License Agreement. Pursuant to the AZSTARYS License Agreement, Commave agreed to pay milestone payments up to an aggregate of $590.0 million upon the occurrence of specified regulatory milestones related to AZSTARYS, additional fixed payments upon the achievement of specified U.S. sales milestones, and quarterly, tiered royalty payments based on a range of percentages of net sales (as defined in the AZSTARYS License Agreement). Commave is obligated to make such royalty payments on a product-by-product basis until expiration of the royalty term for the applicable product.

The Company concluded that these regulatory milestones, sales milestones and royalty payments each contain a significant uncertainty associated with a future event. As such, these milestone and royalty payments are constrained at contract inception and arenot included in the transaction price as the Company couldnot conclude that it is probable a significant reversal in the amount of cumulative revenue recognized willnot occur surrounding these milestone payments. At the end of each reporting period, the Company updates its assessment of whether the milestone and royalty payments are constrained by considering both the likelihood and magnitude of the potential revenue reversal. For the year ended* December 31, 2024,the Company recognized $4.3 million of revenue under the AZSTARYS License Agreement, respectively, primarily related to royalties. For the year ended December 31, 2023,the Company recognized revenue under the AZSTARYS License Agreement of $18.5 million, which includes $15.0 million in net sales milestone payments earned during the year then ended. There wasno deferred revenue related to this agreement as of December 31, 2024,and2023.* All revenues recognized under this agreement derived in the United States.

In accordance with the terms of the Company’s Termination Agreement with Aquestive Therapeutics ("Aquestive") dated* March 20, 2012,Aquestive has the right to receive an amount equal to 10% of any royalty or milestone payments made to the Company related to AZSTARYS orKP1077* under the AZSTARYS License Agreement.

The AZSTARYS License Agreement is within the scope of ASC606, as the transaction represents a contract with a customer where the participants function in a customer / vendor relationship and arenot exposed equally to the risks and rewards of the activities contemplated under the AZSTARYS License Agreement.

Relief Exclusive License Agreement

As a condition to entering into the Merger Agreement, Acer and Relief Therapeutics SA ("Relief") entered into an exclusive license agreement on* August 30, 2023 (the “Relief License Agreement”). Pursuant to the Relief License Agreement, Relief will hold exclusive development and commercialization rights for OLPRUVA in the European Union, Liechtenstein, San Marino, Vatican City, Norway, Iceland, Principality of Monaco, Andorra, Gibraltar, Switzerland, United Kingdom, Albania, Bosnia, Kosovo, Montenegro, Serbia and North Macedonia ("Geographical Europe"). The Company will have the right to receive a royalty of up to 10% of the net sales of OLPRUVA in Geographical Europe. For the year ended December* 31, 2024, the Company didnot recognize any revenue under the Relief License Agreement. There wasno deferred revenue related to this agreement as of* December 31, 2024,and2023.* For further discussion of the Relief License Agreement, see Note T.

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Product Revenues, Net

Expanded Access Program

Net revenue includes revenue from the sale of arimoclomol for the treatment of NPC under the remunerated expanded access compassionate use program in France, Accès Compassionnnel (“French AC”). An expanded access compassionate use program is a program giving specific patients access to a drug, which isnot yet approved for commercial sale. Only drugs targeting serious or rare indications and for which there is currentlyno appropriate treatment are considered for expanded access compassionate use programs. Further, to be considered for the expanded access compassionate use program, the drug must have proven efficacy and safety and must either be undergoing price negotiations or seeking marketing approval.

In accordance with ASC606, the Company recognizes revenue when fulfilling its performance obligation under the Expanded Access Program ("EAP") by transferring control of promised goods or services to its customer, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. In determining when the customer obtains control of the product, the Company considers certain indicators, including whether the Company has a present right to payment from the customer, whether title and/or significant risks and rewards of ownership have transferred to the customer and whether the customer acceptance has been received. Revenue is recognized net of sales deductions, including discounts, rebates, applicable distributor fees, and revenue-based taxes.

The French Health Authorities and the manufacturer have agreed to a price for sales under the French AC, but the final transaction price depends on the terms and conditions in the contracts with the French Health Authorities and is subject to price negotiations with the French Health Authorities following market approval. Any excess in the price charged the manufacturer compared to the price agreed with the health authorities once the drug product is approved in France must be repaid. The repayment is considered in the clawback liability (rebate). An estimate of net revenue and clawback liability are recognized using the ‘expected value’ method. Accounting for net revenue and clawback liability requires determination of the most appropriate method for the expected final transaction price. This estimate also requires assumptions with respect to inputs into the method, including current pricing of comparable marketed products within the rare disease area in France. Management has considered the expected final sales price as well as the price of similar drug products. The Company is operating within a rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drugs products. The limited available relevant market information for directly comparable commercialized drugs within rare disease increases the uncertainty in management's estimate.

For the years ended* December 31, 2024,and2023,* the Company recognized revenue related to the EAP in France of $9.1 million and$8.7 million, respectively, which is net of a clawback liability of $5.7 million and$5 .1 million, respectively, and other gross to net adjustments. The total estimated reserve liability as of* December 31, 2024,and2023* was$12 .6 million and $12.2 million, respectively. As of* December 31, 2024,and2023,* this estimated reserve liability is recorded as discount and rebate liabilities in the consolidated balance sheets and is separated into current and long-term based upon the timing of the expected payment to the French regulators.

Product Sales

On* December 27, 2022,the FDA approved OLPRUVA (sodium phenylbutyrate), a prescription medicine used along with certain therapy, including changes in diet, for the long-term management of adults and children with UCDs weighing44* pounds (20 kg) or greater and with a body surface area of1.2m2 or greater. On* November 17, 2023,the Company acquired OLPRUVA in connection with the Merger (Note T). For the year ended December 31, 2024,sales of OLPRUVA were $0.1 million. For the year ended December 31, 2023,*there wereno sales of OLPRUVA.

On* September 20, 2024,the NDA for MIPLYFFA, an orally-delivered treatment for NPC, which is an ultra-rare and progressive neurodegenerative disease, was approved. For the year ended December 31, 2024,*net sales of MIPLYFFA were $10.1 million.

The Company currently utilizes a single specialty pharmacy provider as its sole distributor for both OLPRUVA and MIPLYFFA. The Company also enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates with respect to the purchase of its products. To commercialize OLPRUVA for oral suspension and MIPLYFFA in the U.S., the Company has built marketing, sales, medical affairs, distribution, managerial and other non-technical capabilities or is making arrangements withthird parties to perform these services. All revenues derived from sales of OLPRUVA and MIPLYFFA are in the United States.

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K.Commitments and Contingencies

Legal Matters

From time to time, the Company is involved in various legal proceedings arising in the normal course of business. For some matters, a liability isnot probable, or the amount cannot be reasonably estimated and, therefore, an accrual hasnot been made. However, for such matters when it is probable that the Company has incurred a liability and can reasonably estimate the amount, the Company accrues and discloses such estimates.

Stockholder Litigation Related to the Merger

On* October 12, 2023,Brodsky & Smith, purporting to act as counsel for Jerry Beavee, who was asserted to be a stockholder of Acer, filed a complaint entitled Jerry Beavee v. Acer Therapeutics Inc., et al.,No. 1:23-cv-08995 in the United States District Court for the Southern District of New York (the "Action") alleging that defendants violated Section14*(a) and20(a) of the Securities Exchange Act of1934 by filing the Preliminary Merger Registration Statement which allegedly omitted certain information that such counsel asserts is material to Acer’s required disclosure.

On* October 30, 2023,Acer filed with the SEC a ScheduleDEF14A* that contained additional information regarding the Merger, which mooted the disclosure claims alleged in the Action. On* December 8, 2023,*Jerry Beavee filed with the court a notice of dismissal of the Action without prejudice.

On* October 20, 2023,Long Law, LLC and Acocelli Law, PLLC, purporting to act as counsel for Kevin Turner, who was asserted to be a stockholder of Acer, filed a complaint entitled Kevin Turner v. Acer Therapeutics Inc., et al.,No. 1:23-cv-01185 in the United States District Court for the District of Delaware alleging that defendants violated Section14*(a) and20(a) of the Securities Exchange Act of1934 as well as SEC Rule14a-9 by filing the Definitive Proxy Statement which allegedly omitted certain information that such counsel asserts is material to Acer’s required disclosure. The complaint prays that, if asserted omissions arenot adequately corrected, then Turner will seek to enjoin Acer from holding a stockholder meeting to approve the Merger and, if the Merger closes, will seek to rescind it and seek an award of damages.

On* October 20, 2023,Long Law, LLC, purporting to act as counsel for Matthew Jones, who was asserted to be a stockholder of Acer, filed a complaint entitled Matthew Jones v. Acer Therapeutics Inc., et al.,No. 1:23-cv-01186 in the United States District Court for the District of Delaware alleging that defendants violated Section14*(a) and20(a) of the Securities Exchange Act of1934 as well as SEC Rule14a-9 by filing the Definitive Proxy Statement which allegedly omitted certain information that such counsel asserts is material to the Acer’s required disclosure. The complaint prays that, if asserted omissions arenot adequately corrected, then Jones will seek to enjoin Acer from holding a stockholder meeting to approve the Merger and, if the Merger closes, will seek to rescind it and seek an award of damages.

On* June 19, 2024,the Company entered into a confidential fee agreement (the "Fee Agreement") to settle the above stockholder litigation matters related to the Merger. The parties to the Fee Agreement were entitled to an aggregate payment of approximately $0.3 million, which was paid during thesecond* quarter of2024.

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Litigation Related to the AZSTARYS License Agreement

In* September 2024,the Company became engaged in a legal dispute regarding the AZSTARYS License Agreement. The litigation is in its early stages. The Company cannot predict with certainty the timing or ultimate outcome of this litigation or its potential impact on the Company's business, financial condition, or results of operations. At this time, the Company hasnot recorded any accrual for contingent liability associated with this matter. The AZSTARYS License Agreement remains in effect during this litigation, and both parties continue to perform their respective obligations thereunder. However, there can beno* assurance that this dispute willnot have an adverse impact on the Company's relationship with Commave or on the Company's business. The Company will continue to monitor developments in this matter and will assess the potential impact on the Company's financial statements in future periods. The Company expects to incur significant legal expenses in connection with this litigation, which* may*materially affect its results of operations in future periods.

As of* December 31, 2024,and December 31, 2023,*no accruals were made related to commitments and contingencies.

L.Stock and Warrants

Authorized, Issued, and Outstanding Common Shares

As of* December 31, 2024,and2023,* the Company had authorized shares of common stock of 250,000,000 shares. Of the authorized shares,55,246,401 and 43,110,360 shares of common stock were issued as of* December 31, 2024,and2023,* respectively, and 53,670,709 and 41,534,668 shares of common stock were outstanding as of* December 31, 2024,and2023,* respectively.

As of* December 31, 2024,and2023,* the Company had reserved authorized shares of common stock for future issuance as follows:

December 31,
20242023
Outstanding awards under equity incentive plans7,789,6588,023,142
Outstanding common stock warrants5,483,5375,603,729
Possible future issuances under equity incentive plans5,383,1651,728,885
Possible future issuances under employee stock purchase plan1,148,0121,340,172
Total common shares reserved for future issuance19,804,37216,695,928

Common Stock Activity

The following table summarizes common stock activity for the years ended* ** December 31, 2024and2023*:

Shares of
Common Stock
Balance as of January 1, 202334,540,304
Common stock issued as compensation to third-parties44,791
Common stock issued as a result of stock warrants exercised110
Common stock issued as a result of stock options exercised7,500
Common stock repurchased as a result of the Stock Repurchase Program(665,739)
Common stock issued in connection with the Merger (Note T)7,530,509
Common stock issued as a result of the Employee Stock Purchase Plan77,193
Balance as of December 31, 202341,534,668
Common stock issued in connection with the Public Offering (Note B)10,615,385
Common stock issued in connection with restricted stock units218,000
Common stock issued as compensation to third-parties92,988
Common stock issued in connection with vesting of performance-based awards547,945
Common stock issued as a result of stock options exercised469,563
Common stock issued as a result of the Employee Stock Purchase Plan192,160
Balance as of December 31, 202453,670,709

Authorized, Issued, and Outstanding Preferred Stock

As of* December 31, 2024,and2023,* the Company had 10,000,000 shares of authorized, unallocated and unissued preferred stock. As of* December 31, 2024,and2023,* no shares of preferred stock were designated, issued or outstanding.

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Warrants to Purchase Common Stock

The Company has issued warrants to purchase common stock to variousthird parties, of which 5,483,537 remain outstanding as of* December 31, 2024,and are immediately exercisable. These warrants qualify as participating securities under ASC Topic260,* Earnings per Share, and are treated as such in the net loss per share calculation (Note P). The Company* may*be required to redeem these warrants for a cash amount equal to the Black-Scholes value of the portion of the warrants to be redeemed (the “Put Option”).

In connection with the Merger (Note T), in* November 2023,the Company directly issued to certain investors an aggregate of 1,382,489 shares of its common stock, par value $0.0001 per share, and accompanying warrants to purchase up to 1,382,489 shares of its common stock (the"2023* Warrants") at a combined offering price of $4.34 per share of common stock and the Warrants and an aggregate of 917,934 shares of its common stock in exchange for the cancellation of a warrant to purchase 2,920,306 shares of common stock of Acer. The Warrants are immediately exercisable and expire on* November 22, 2028.The Company used the net proceeds of approximately $6.0 million from the offering for general corporate purposes. These warrants are separately exercisable by the warrant holders. While the warrants are outstanding (but unexercised), the warrant holders will participate in any dividend or other distribution of the Company’s assets to its common stockholders by way of return of capital or otherwise. As of December 31, 2024,and December 31, 2023,none of the warrants have been exercised. The warrants have been evaluated to determine the appropriate accounting and classification pursuant to ASC480* and ASC815. Generally, freestanding warrants should be classified as (i) liabilities if the warrant terms allow settlement of the warrant exercise in cash and (ii) equity if the warrant terms only allow settlement in shares of common stock.

The Company determined that its outstanding warrants and the Put Option should be recorded as a liability and stated at fair value at each reporting period. Changes to the fair value of the warrant liability are recorded through the consolidated statements of operations as a fair value adjustment related to warrant and CVR liability. As of* December 31, 2024,and December 31, 2023,the fair value of the liability associated with these warrants and the Put Option was approximately $17.8 million and $16.1 million, respectively. The fair value adjustment related to these warrants and the Put Option was approximately$1.7 million of loss and ($1.4) million of income for the years ended December 31, 2024,and2023,* respectively.

M.Stock-Based Compensation

The Company maintains a stock-based compensation plan (the “Incentive Stock Plan”) that governs stock awards made to employees and directors prior to completion of the IPO.

In* November 2014,the Board of Directors of the Company ("the Board"), and in April 2015,the Company’s stockholders, approved the Company’s2014* Equity Incentive Plan (the*“2014* Plan”), which became effective in* April 2015.The2014* Plan provides for the grant of stock options, other forms of equity compensation, and performance cash awards. In* June 2021,the Company's stockholders approved an Amended and Restated2014* Equity Incentive Plan (the "A&R2014 Plan"), following its adoption by the Board in* April 2021,which among other things added 4,900,000 shares to the maximum number of shares of common stock to be issued under the plan and extended the annual automatic increases (discussed further below) until January 1, 2031and eliminated individual grant limits that applied under the2014* Plan to awards that were intended to comply with the exemption for "performance-based compensation" under Code Section162(m). The maximum number of shares of common stock that* maybe issued under the A&R2014* Plan was 9,932,883 as of* December 31, 2024.The number of shares of common stock reserved for issuance under the A&R2014* Plan will automatically increase on* January 1of each year, beginning on January 1, 2016,and ending on and including January 1, 2031,by 4% of the total number of shares of the Company’s capital stock outstanding on December 31of the preceding calendar year, or a lesser number of shares determined by the Board. Pursuant to the terms of the A&R2014* Plan, on* January 1, 2025,the common stock reserved for issuance under the A&R2014* Plan automatically increased by 2,146,828 shares.

During the years ended* December 31, 2024,and2023,* 1,177,545 and 7,500 stock options were exercised, respectively.

In* January 2023,the Board approved the2023* Employment Inducement Award Plan (as amended, the*“2023* Plan”). The maximum number of shares of common stock that* maybe issued under the2023* Plan is 4,500,000 as of* December 31, 2024.*

Stock-based compensation expense recorded under the Incentive Stock Plan, A&R2014 Plan, and2023 Plan is included in the following line items in the accompanying consolidated statements of operations (in thousands):

Year ended December 31,
20242023
Research and development$5,819$2,664
General and administrative9,0873,290
Total stock-based compensation expense$14,906$5,954

There was $2.5 million of stock-based compensation expense related to performance-based awards recognized during the year ended* December 31, 2024.There wasno stock-based compensation expense related to performance-based awards recognized during the year ended December 31,*2023.

As a result of transition agreements entered into with certain former employees, the vesting for certain stock options was accelerated, resulting in a net increase in stock-based compensation expense of $2.4 million for the year ended* December 31, 2024.*The effects of this accelerated vesting are reflected in the table above within research and development expenses.

As a result of transition agreements entered into with certain former employees, certain stock options were modified, resulting in a net decrease in stock-based compensation expense of $1.2 million for the year ended* December 31, 2023.*The effects of those modifications are reflected in the table above within selling, general, and administrative expenses.

In* June 2021,the Company's stockholders approved an Employee Stock Purchase Plan (the "ESPP"), following its adoption by the Board in April 2021.The maximum number of shares of common stock that maybe issued under the ESPP is 1,500,000. Thefirst* offering period under the ESPP began on* October 1, 2021,and thefirst* purchase date occurred on* May 31, 2022.As of December 31, 2024,*351,988 shares have been issued under the ESPP.

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Stock Option Awards

The Company estimates the fair value of stock options using the Black-Scholes option-pricing model, which requires the use of subjective assumptions, including the expected term of the option, the expected stock price volatility, expected dividend yield and the risk-free interest rate for the expected term of the option. The expected term represents the period of time the stock options are expected to be outstanding. Due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected term of the stock options, the Company uses the simplified method to estimate the expected term for its “plain vanilla” stock options. Under the simplified method, the expected term of an option is presumed to be the mid-point between the vesting date and the end of the contractual term. Some options, for example those that have exercise prices in excess of the fair value of the underlying stock, arenot considered “plain vanilla” stock options. For these options, the Company uses an expected term equal to the contractual term of the option. Expected volatility is based on the Company’s historical volatility over the estimated expected term of the stock options. The Company assumesno dividend yield because dividends arenot expected to be paid in the near future, which is consistent with the Company’s history ofnot paying dividends.

The Company recognizes compensation expense related to stock-based payment transactions upon satisfaction of the requisite service or vesting requirements. Forfeitures are estimated at the time of grant and revised based on actual forfeitures, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

Using the Black-Scholes option-pricing model, the weighted-average fair value of awards granted during the years ended* December 31, 2024,and2023,* fair value was$5.74 and $3.65 per share, respectively. The assumptions used to estimate fair value are as follows:

Year Ended December 31,
20242023
Risk-free interest rate3.82% - 4.50%3.34% - 4.79%
Expected term (in years)5.50 - 6.255.50 - 10.00
Expected volatility89.85% - 91.32%89.48% - 93.67%
Expected dividend yield00

The activity under the Incentive Stock Plan, A&R2014 Plan, and2023 Planfor the year ended* ** December 31, 2024**,*is summarized as follows:

Weighted · Weighted Avg · Aggregate
Number ofAverageRemainingIntrinsic
OptionsExercise PriceContractual TermValue
Outstanding balance at January 1, 20247,275,197$8.408.68$11,089
Granted962,700$5.74--
Exercised or released1,162,705$5.30-$1,966
Canceled or forfeited314,250$4.90--
Expired809,542$22.52--
Outstanding balance at December 31, 20245,951,400$7.256.79$17,448
Exercisable at December 31, 20242,399,305$10.254.47$6,302
Vested and expected to vest at December 31, 20245,764,1666.75$16,783

Information regarding currently outstanding and exercisable options as of* December 31, 2024**,*is as follows:

Options Outstanding · Options Exercisable
Weighted Avg · Weighted Avg
Number of · Remaining · Number of · Remaining
Exercise Price · Shares · Contractual Term · Shares · Contractual Term
$2.848 to $10.005,841,2576.912,289,1624.69
$10.01 to $30.001,8754.311,8754.37
$30.01 to $50.0039,2182.6739,2182.71
$50.01 to $70.0021,9581.6021,9581.63
$70.01 to $327.2047,0921.3647,0928.34
5,951,4002,399,305

The total fair value of stock options vested during the years ended* ** December 31, 2024and2023*, was$8.1 million and $9.2 million, respectively.

Unvested stock options as of* ** December 31, 2024and2023*, were as follows:

Number of Unvested Shares
December 31,
Exercise Price20242023
$2.848 to $10.003,552,0955,614,977
Total number of unvested stock options3,552,0955,614,977

As of* December 31, 2024* there was$9.5 million of total unrecognized compensation cost related to unvested share-based compensation arrangements granted under the A&R2014 Plan and2023 Plan.

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Restricted stock units

The following table summarizes the restricted stock unit activity under the A&R2014 and2023 Plan:

SharesWeighted-average grant date fair value
Unvested balance at December 31, 2023747,945$4.33
Granted2,012,9585.52
Vested765,9454.77
Forfeited156,7005.83
Unvested balance at December 31, 20241,838,258$5.32

As of December 31, 2024 there was$7.1 million of total unrecognized compensation cost related to restricted stock units.

N.Fair Value of Financial Instruments

The accounting standard for fair value measurements provides a framework for measuring fair value and requires disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, based on the Company’s principal or, in absence of a principal, most advantageous market for the specific asset or liability.

The Company uses athree-tier fair value hierarchy to classify and disclose all assets and liabilities measured at fair value on a recurring basis, as well as assets and liabilities measured at fair value on a non-recurring basis, in periods subsequent to their initial measurement. The hierarchy requires the Company to use observable inputs when available, and to minimize the use of unobservable inputs, when determining fair value. Thethree tiers are defined as follows:

●Level 1—Observable inputs that reflect quoted market prices (unadjusted) for identical assets or liabilities in active markets;
●Level 2—Observable inputs other than quoted prices in active markets that are observable either directly or indirectly in the marketplace for identical or similar assets and liabilities; and
●Level 3—Unobservable inputs that are supported by little or no market data, which require the Company to develop its own assumptions.

The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts and other receivables, accounts payable and accrued expenses, the Nantahala Note, and the margin account approximate their respective fair values due to the short-term nature of such instruments.

Assets and Liabilities Measured at Fair Value on a Recurring Basis

The Company evaluates its financial assets and liabilities subject to fair value measurements on a recurring basis to determine the appropriate level in which to classify them for each reporting period. This determination requires significant judgments to be made. The following table summarizes the conclusions reached regarding fair value measurements as of* December 31, 2024,and2023* (in thousands):

Quoted Prices · Significant
in Active · Other · Significant
Balance at · Markets for · Observable · Unobservable
December 31, · Identical Assets · Inputs · Inputs
2024 · (Level 1) · (Level 2) · (Level 3)
CVR liability (Note T)$3,500$-$-$3,500
Warrant liabilities17,804--17,804
Total liabilities$21,304$-$-$21,304
Securities:
U.S. Treasury securities$35,711$35,711$-$-
Corporate bonds6,010-6,010-
Total assets$41,721$35,711$6,010$-
Quoted Prices · Significant
in Active · Other · Significant
Balance at · Markets for · Observable · Unobservable
December 31, · Identical Assets · Inputs · Inputs
2023 · (Level 1) · (Level 2) · (Level 3)
CVR liability (Note T)$7,262$-$-$7,262
Warrant liabilities16,100--16,100
Total liabilities$23,362$-$-$23,362
Securities:
U.S. Treasury securities$24,688$24,688-$-
Total assets$24,688$24,688$-$-

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The common stock warrant liabilities were recorded at fair value using the Black-Scholes option pricing model. The following assumptions were used in determining the fair value of the warrant liabilities valued using the Black-Scholes option pricing model as of* December**31,* 2024, and2023:

December 31, 2024 · December 31, 2023
Risk-free interest rate4.08%-4.23%3.76%-4.12%
Volatility62.14%-68.68%62.01%-92.42%
Dividend yield—%—%
Expected term (years)1.02-3.892.0-4.9
Weighted average fair value$3.25$2.94

The following table is a reconciliation for the common stock warrant liabilities measured at fair value using Level3 unobservable inputs (in thousands):

Balance at December 31, 2023$16,100
Change in fair value measurement1,704
Balance at December 31, 2024$17,804

For the year ended* December 31, 2024,*the changes in fair value of the warrant liabilities primarily resulted from the volatility of the Company's common stock and the change in the risk-free interest rates.

O.Income Taxes

The Company didnot recognize any state tax expense during the years ended* December 31, 2024,and2023.* A reconciliation of the difference between the (expense)/benefit for income taxes at the statutory U.S. federal income tax rate is as follows (in thousands, except amounts pertaining to rate which are shown as a percentage):

Year ended December 31,
20242023
Federal statutory rate21.00%21.00%
Effect of:
Foreign rate differential0.04-
Change in valuation allowance(13.17)(23.29)
Return to provision and deferred true-up(4.40)(2.41)
Federal research and development credit-4.09
Change in rate-(0.01)
State tax benefit (net of federal)5.055.19
Stock-based compensation(0.55)(0.20)
Global intangible low-taxed income credit(0.02)(3.41)
Officers compensation(0.23)-
Expiration of net operating loss deferred tax asset(3.01)-
Deferred adjustment and rate change(4.27)-
Foreign research and development excess benefit-(0.86)
Uncertain tax position(17.88)-
Other0.39(0.10)
Federal income tax provision effective rate(17.05)%0.00%

The components of deferred tax assets and liabilities are as follows (in thousands):

December 31,
20242023
Deferred tax assets relating to:
Net operating loss carryforwards$100,552$90,743
Research and development tax carryforward19,15320,670
Stock-based compensation5,7115,154
174 expenses33,94130,241
Right-of-use liability108265
Property and equipment7923
Other deferred tax assets3,6521,951
Total gross deferred tax assets163,196149,047
Deferred tax liabilities relating to:
Right-of-use asset82249
Intangibles17,85914,473
Total gross deferred tax liabilities17,94114,722
Deferred tax assets less liabilities145,256134,324
Valuation allowance(146,359)(134,488)
Net deferred tax liability$(1,103)$(164)

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In assessing the realizability of deferred tax assets, management considers 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 the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income and tax planning strategies in making this assessment. Based upon the level of historical taxable income (losses) and projections for future taxable income (losses) over the periods in which the deferred tax assets are deductible, management believes it is more likely thannot that the Company willnot realize the benefits of these deductible differences in the future.

The Company recorded refundable research and development tax credit as other income andnot income tax under ASC740 in the consolidated statement of operations for the year ended* December 31, 2023.These refundable tax credits are a result of increased qualified research and development spending in certain jurisdictions which allow for a refundable credit even when the Company hasno* current period income tax expense. The Company has analyzed their tax positions under the principles of ASC740-10, Accounting for Uncertainty in Income Taxes.

In accordance with the Tax Cuts and Jobs Act of2017, the Company evaluated its plans for reinvestment or repatriation of current and future earnings of foreign operations and determined to indefinitely reinvest current and future earnings of foreign operations in the foreign operation. The Company hasnot repatriated funds to the U.S. to satisfy domestic liquidity needs, nor does the Company anticipate the need to do so. If in the foreseeable future, the Company canno longer demonstrate that these earnings are indefinitely reinvested, a deferred tax liability will be recognized.

The Company has federal operating loss carryforwards totaling $381.3 million, $118.5 million of which, ifnot utilized, will begin to expire in2027 and $262.8 million of which haveno expiration date. The Company also has certain state net operating loss carryforwards totaling $428.6 million, which, ifnot utilized, will begin to expire in2027. The Company also has Denmark net operating loss carryforwards totaling $7.7 million which has indefinite carryforward period in Denmark. Due to potential ownership changes that* mayhave occurred or would occur in the future, Internal Revenue Code Section382* * may*place additional limitations on the Company’s ability to utilize the net operating loss carryforward.

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P.Net Loss Per Share

For all periods presented herein, the Company didnot use thetwo-class method to compute net loss attributable to common stockholders per share of common stock, even though it had issued securities, other than common stock, that contractually entitled the holders to participate in dividends and earnings, because these holders arenot obligated to participate in a loss. Thetwo-class method requires earnings for the period to be allocated between common stock and participating securities based upon their respective rights to receive distributed and undistributed earnings.

Under thetwo-class method, for periods with net income attributable to common stockholders, basic net income attributable to common stockholders per share of common stock is computed by dividing the undistributed net income attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period. Undistributed net income attributable to common stockholders is computed by subtracting from net income the portion of current period earnings that participating securities would have been entitled to receive pursuant to their dividend rights had all of the period’s earnings been distributed and subtracting the actual or deemed dividends declared.No such adjustment to earnings is made during periods with a net loss as the holders of the participating securities haveno obligation to fund losses. Diluted net income attributable to common stockholders per share of common stock is computed under thetwo-class method by using the weighted average number of shares of common stock outstanding plus the potential dilutive effects of stock options and warrants. In addition to analyzing under thetwo class method, the Company analyzes the potential dilutive effect of stock options and warrants, under the treasury-stock method when calculating diluted income (loss) attributable to common stockholders per share of common stock, in which it is assumed that the stock options and warrants convert into common stock at the beginning of the period or date of issuance, if the stock option or warrant was issued during the period. The Company reports the more dilutive of the approaches (two-class or treasury-stock/if-converted) as its diluted net income (loss) attributable to common stockholders per share of common stock during the period.

As noted above, for all periods presented herein, the Company didnot utilize thetwo-class approach as the Company was in a net loss position and the holders of the participating securities haveno obligation to fund losses. The Company did analyze diluted net loss attributable to common stockholders per share of common stock under the treasury-stock/if-converted method and noted that all outstanding stock options and warrants were anti-dilutive for the periods presented. For all periods presented, basic net loss attributable to common stockholders per share of common stock was the same as diluted net loss attributable to common stockholders per share of common stock.

The following securities, presented on a common stock equivalent basis, have been excluded from the calculation of weighted average number of shares of common stock outstanding because their effect is anti-dilutive:

December 31,
20242023
Awards under equity incentive plans1,148,0121,728,885
Common stock warrants5,483,5375,603,729
Total securities excluded from the calculation of weighted average number of shares of common stock outstanding6,631,5497,332,614

A reconciliation from net loss to basic net loss attributable to common stockholders per share of common stock and diluted net loss attributable to common stockholders per share of common stock for the years ended* December 31,*2024, and2023, is as follows (in thousands):

December 31,
20242023
Basic and diluted net loss per share of common stock:
Net loss, basic and diluted$(105,511)$(46,049)
Weighted average number of shares of common stock outstanding, basic and diluted46,25135,452
Basic and diluted net loss per share of common stock$(2.28)$(1.30)

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Q.Leases

The Company has operating and finance leases for office space, laboratory facilities and various laboratory equipment, furniture and office equipment and leasehold improvements. The Company determines if an arrangement is a lease at contract inception. Lease assets and lease liabilities are recognized based on the present value of lease payments over the lease term at the commencement date. The Company doesnot separate lease and non-lease components. Leases with a term of12 months or less at commencement arenot recorded on the consolidated balance sheets. Lease expense for these arrangements is recognized on a straight-line bases over the lease term. The Company’s leases have remaining lease terms of less than 1 year to approximately 4 years, some of which include options to extend the leases for up to 5 years, and some which include options to terminate the leases within 1 year.

Effective* June 1, 2021,the Company agreed to sublease office space in Florida, comprised ofone* of thetwo contiguous suites, under a non-cancelable operating lease, which expires in* February 2026.*

The components of lease expense were as follows (in thousands):

Year Ended December 31,
Lease Cost20242023
Finance lease cost:
Amortization of right-of-use assets$44$102
Interest on lease liabilities--
Total finance lease cost44102
Operating lease cost330437
Short-term lease cost177171
Variable lease cost3940
Less: sublease income(128)(157)
Total lease costs$462$593

Supplemental cash flow information related to leases was as follows (in thousands):

Year Ended December 31,
2024 · 2023
Cash paid for amounts included in the measurement of lease liabilities:
Financing cash flows from finance leases-5
Operating cash flows from operating leases405552
Operating cash flows from short-term leases225171
Operating cash flows from variable lease costs3940
Right-of-use assets obtained in exchange for lease liabilities:
Finance leases$-$-
Operating leases419-

124

Supplemental balance sheet information related to leases was as follows (in thousands, except weighted average remaining lease term and weighted average discount rate):

December 31,
20242023
Finance Leases
Property and equipment, at cost$1,031$1,031
less: accumulated depreciation and amortization(1,023)(882)
Property and equipment, net$8$149
Operating Leases
Operating lease right-of-use assets$657$790
Total operating lease right-of-use assets$657$790
Current portion of operating lease liabilities$420$543
Operating lease liabilities, less current portion372456
Total operating lease liabilities$792$999
Weighted Average Remaining Lease Term
Operating leases (in years)32
Weighted Average Discount Rate
Finance leases-14.3%
Operating leases9.9%7.6%

Maturities on lease liabilities were as follows (in thousands):

Operating
Year Ending December 31,Leases
2025$481
2026138
2027127
2028150
202938
Thereafter10
Total lease payments944
Less: future interest expense(152)
Lease liabilities$792
R.Employee Benefit Plan

The Company has a401(k) retirement plan (the*“401*(k) Plan”) that covers substantially all employees. The Company* mayprovide a discretionary match with a maximum amount of 4% of the participant’s compensation, which vests immediately. The Company made matching contributions under the401*(k) Plan of approximately $0.5 millionand $0.3 million for the years ended* December 31, 2024,and2023,* respectively.

The Company has a discretionary profit-sharing plan (the “Profit Sharing Plan”) that covers all employees. Employees become eligible participants in the Profit Sharing Plan once they have provided three years of service to the Company. The Company madeno contributions to the Profit Sharing Plan in2024 or2023.

125

S.Goodwill & Intangible Assets

The Company's goodwill balance was $4.7 million as of* December 31, 2024,and2023.*

As of* December 31, 2024,and2023,* non-amortizable intangible assets include IPR&D of $2.0 million.

As of* December 31, 2024,and2023,* the Company had a definite-lived intangible asset, net related to the acquisition of OLPRUVA as a result of the Merger of$61.3 million and$67.2 million, respectively. This is amortized on a straight-line basis over the OLPRUVA patent life of 13 years and is reviewed periodically for impairment. Amortization expense is recorded as intangible asset amortization in the consolidated statements of operations and was $6.2 million and $0.8 million for the years ended* December 31, 2024,and2023.*

The Company's review of the estimated useful lives of its intangible assets indicated that based on recent facts and circumstances, including detailed analysis on sales experience and prospective product strategy, the actual life of the definite-lived intangible asset related to OLPRUVA was longer than the estimated useful life previously established at the acquisition of the asset. As a result, effective* September 30, 2024,the Company changed its estimate of the useful life of this intangible asset to better reflect the estimated periods during which this asset will remain in service. The estimated useful life was previously 11 years and was increased to 13 years. The change in estimate was applied prospectively and decreased intangible asset amortization expense by $0.2 million for the year ended December 31, 2024.*Consequently, there was an increase to intangible assets, net of $0.2 million at year end. The impact of this change in estimate to net income and basic and diluted earnings per share was de minimis.

In connection with the XOMA License Agreement, the Company owed XOMA a regulatory milestone payment of $6.0 million upon approval of MIPLYFFA, which was paid in* October 2024.*

This definite-lived intangible asset is amortized on a straight-line basis over the MIPLYFFA patent life of approximately five years and is reviewed periodically for impairment. Amortization expense is recorded as intangible asset amortization in the consolidated statements of operations and was $0.3 million for the year ended* December 31, 2024.*

The definite-lived Intangible assets that are subject to amortization have been reviewed for impairment whenever events or changes in circumstances have indicated that their carrying amounts* may**not* be recoverable. The Company’s historical sales experience related to OLPRUVA resulted in management preparing an estimate of future cash flows used to assess the recoverability of such asset. Future cash flows specific to OLPRUVA, which most significantly includes an estimate of forecasted revenues, are based on reasonable and supportable assumptions regarding the cash flows expected to result from the use of the asset and its eventual disposition. As a result of the Company’s analysis, the asset was fully recoverable andno impairments were recorded by the Company as of and for the year’s ended* December 31, 2024,and2023.*

For intangible assets subject to amortization, estimated amortization expense for thefive fiscal years subsequent to* December 31, 2024,*is expected to be as follows:

2025$6,461
2026$6,461
2027$6,461
2028$6,461
2029$5,830

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T.Merger

On* August 30, 2023,*in connection with the Merger Agreement with Acer, the following transactions occurred prior to Closing:

●Bridge Loan - Zevra and Acer entered into a bridge loan agreement (the “Bridge Loan Agreement”), providing for Zevra to make loans (collectively, the “Bridge Loan”) to Acer up to an aggregate principal amount of $16.5 million. The Bridge Loan was provided to Acer to support its termination agreement with Relief Therapeutics Holding SA (“Relief”) and to provide Acer with working capital, including for payments of accounts payable to support the commercial launch of OLPRUVA and the development of celiprolol pending the Merger’s closure. On October 31, 2023, the Company and Acer entered into an amendment to the Bridge Loan Agreement, which increased the aggregate principal amount available under the loan from $16.5 million to $18.0 million.
●Purchase of Acer’s Term Loans - Zevra purchased certain indebtedness of Acer held by Nantahala Capital Management, LLC ("Nantahala). Under the loan purchase with Nantahala, certain of its affiliates and certain other parties (collectively with Nantahala, "Nantahala Holders") Zevra purchased (i) an original senior secured term loan facility made available to Acer in an aggregate amount of $6.5 million and funded on March 14, 2022, and (ii) an additional senior secured term loan made to Acer in an aggregate amount of $7.0 million in a single borrowing which funded on January 31, 2023 for (1) $12.0 million in cash; (2) 98,683 shares of Zevra Common Stock; and (3) a secured Promissory Note payable by Zevra to Nantahala in the original principal amount $5.0 million. These were recorded as receivables form Acer and were treated as a settlement of a preexisting relationship in connection with the closing of the transaction and recorded as a component of purchase consideration.
●Purchase of Acer’s Convertible Notes (“Marathon Convertible Notes”)- Under the Note Purchase Agreement with the Nantahala Holders, Zevra purchased the Marathon Convertible Notes that Nantahala had acquired on June 16, 2023. Zevra acquired the Marathon Convertible Notes in exchange for the issuance of 2,171,038 shares of Zevra Common Stock at $5.0667 per share for a total purchase price of $11.0 million.
●Amendment to IP License Agreement and IP Termination Agreement: As a condition to entering into the Merger Agreement, Acer and Relief Therapeutics Holding AG ("Relief") entered into the Exclusive License Agreement and the Termination Agreement terminating the collaboration and license agreement, dated March 19, 2021, by and between Acer and Relief. Pursuant to the Exclusive License Agreement, Relief holds exclusive development and commercialization rights for OLPRUVA in Geographical Europe. Acer has the right to receive a royalty of up to 10.0% of the net sales of OLPRUVA in Geographical Europe. In accordance with the terms of the Termination Agreement, Relief received an upfront payment from Acer of $10.0 million (which payment was funded with the Bridge Loan described above) with an additional payment of $1.5 million due on the first-year anniversary of the $10.0 million payment. Acer also agreed to pay a 10.0% royalty on net sales of OLPRUVA worldwide, excluding Geographical Europe, and 20.0% of any value received by Acer from certain third parties relating to OLPRUVA licensing or divestment rights, all of the foregoing which are capped at $45.0 million, for total payments to Relief of up to $56.5 million.

In connection with the closing of the Merger on* November 17, 2023,each share of common stock of Acer was converted into the right to receive (i)0.1210 fully paid and non-assessable shares of common stock of Zevra, par value $0.0001 per share , and (ii)one non-transferable contingent value right (“CVR”) to be issued by Zevra, which will represent the right to receiveone* or more contingent payments up to an additional $76 million upon the achievement, if any, of certain commercial and regulatory milestones for Acer’s OLPRUVA and celiprolol products within specified time periods. Certain additional cash payments are also possible pursuant to the CVRs with respect to milestones involving Acer’s early-stage program ACER-2820 (emetine).

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The assets acquired and liabilities assumed were recorded based on their acquisition date fair values. Consideration for the Merger was $72.6 million and consists of (i) approximately 2.96 million shares of Zevra common stock valued at $12.8 million, (ii) the Bridge Loan advances of $17.8 million, (iii) $12.0 million in cash paid to Nantahala; (iv)2.27 million shares of Zevra Common Stock issued to Nantahala valued at $11.5 million based on the VWAP of shares of Zevra Common Stock during the 20 consecutive trading days ending on the trading date prior to* August 30, 2023; (*v) a secured promissory note payable by Zevra to Nantahala in the original principal amount of $5.0 million, as disclosed in Note I, (vi) $8.5 million in the estimated fair value of contingent consideration related to the CVRs, (vii) approximately 0.9 million shares of Zevra Common Stock issued to a former holder of Acer warrants valued at $4.0 million based on Zevra's common stock price on the Effective Date and (viii) $1.0 million in notes payable paid by the Company on Acer's behalf. In addition, effective as of immediately prior to the Effective Time, all of the outstanding and unexercised Acer stock options were automatically cancelled and ceased to exist without any cash or other consideration being paid or provided in respect thereof. The following purchase price allocation reflects the preliminary estimates of and assumptions related to the fair values of assets acquired and liabilities assumed:

Assets
Cash$575
Prepaid expenses278
Other current assets11
Inventory9,376
Property, plant, and equipment35
Other noncurrent assets209
Approved product - OLPRUVA68,000
IPR&D - celiprolol2,000
Goodwill acquired4,538
Liabilities
Accounts payable and accrued expenses$10,718
Deferred collaboration funding1,500
Operating lease liabilities175
Fair Value of Net Assets Acquired$72,629

128

The fair values assigned to the tangible and intangible assets acquired and liabilities assumed were determined using an income approach based on management’s estimates and assumptions, as well as other information compiled by management, includingthird-party valuations that utilize customary valuation procedures and techniques. These preliminary fair values are subject to change within theone-year measurement period. The estimated fair values were developed by discounting future net cash flows to their present value at market-based rates of return. The goodwill acquired represents the excess of the purchase price and related costs over the value assigned to the net tangible and identifiable intangible assets of the business acquired. The useful lives of the intangible assets for amortization purposes were determined by considering the period of expected cash flows used to measure the fair values of the intangible assets adjusted as appropriate for entity-specific factors including legal, regulatory, contractual, competitive, economic and other factors that* maylimit the useful life. The marketed product asset is amortized on a straight-line basis over its estimated useful life. As of December**31,* 2023, the IPR&D project hadnot been completed or abandoned and, therefore, the IPR&D intangible asset isnot currently subject to amortization.

Cancellation of Acer Warrant

On* November 22, 2023,*the Company sold an aggregate of 917,934 shares of its common stock to a healthcare focused investment fund (the "Investor") to cancel a warrant held by the Investor to purchase 2,920,306 shares of common stock of Acer. The shares of common stock were offered and sold to the Investor in a registered direct offering without an underwriter or placement agent.

Contingent Consideration

Contingent consideration liabilities relate to the Company's liabilities arising in connection with the CVRs issued as a result of the Merger. The contingent consideration is classified as Level3 in the fair value hierarchy. The fair value is measured based on a Monte Carlo simulation or a scenario-based method, depending on the earn-out achievement objectives, utilizing projections about future performance. Significant inputs include volatility and projected financial information, including projections representative of a market participant's view of the expected cash payments associated with the agreed upon regulatory milestones based on probabilities of technical success, timing of the potential milestone events for the compounds, and estimated discount rates.

The following table provides a reconciliation of the beginning and ending balances related to the contingent consideration liabilities for the CVRs (dollars in thousands):

Balance at December 31, 2023$7,262
Change in fair value recognized in earnings(3,762)
Balance at December 31, 2024$3,500

For the year ended* December**31,* 2024, the Company recorded a $3.7 million gain on the change in fair value of contingent consideration, primarily due to changes in market data and revenue projections.

129

U.Subsequent Events

The Company evaluated events and transactions occurring subsequent to* December 31, 2024,through March**12*,2025, the date the accompanying financial statements were issued. During this period, other than the sale of the PRV, which is disclosed in Note A, there wereno subsequent events that required recognition in the accompanying consolidated financial statements, nor were there any additional non-recognized subsequent events that required disclosure.

130

EXHIBITS

Exhibit No.Description
2.1***Agreement and Plan of Merger dated as of August 30, 2023, by and among Zevra Therapeutics, Inc., Aspen Z Merger Sub, Inc., and Acer Therapeutics Inc. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on August 31, 2023).
3.1Amended and Restated Certificate of Incorporation of Zevra Therapeutics, Inc. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on April 21, 2015)
3.1.1Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Company, effective as of December 23, 2020 (incorporated herein by reference to Registrant's Current Report on Form 8-K as filed with the SEC on December 28, 2020).
3.1.2Certificate of Elimination of Series A Convertible Preferred Stock of Zevra Therapeutics, Inc. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on June 23, 2021).
3.1.3Certificate of Elimination of Series B-1 Convertible Preferred Stock of Zevra Therapeutics, Inc. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on June 23, 2021).
3.1.4Certificate of Elimination of Series B-2 Convertible Preferred Stock of Zevra Therapeutics, Inc. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on June 23, 2021).
3.1.5Certificate of Amendment of Amended and Restated Certificate of Incorporation of Zevra Therapeutics, Inc. (incorporated herein by reference to the Registrant’s Current Report on Form 8-K as filed with the SEC on February 24, 2023).
3.2Amended and Restated Bylaws, as currently in effect, of Zevra Therapeutics, Inc. (incorporated herein by reference to the Registrant’s Current Report on Form 8-K as filed with the SEC on February 28, 2024).
4.1Specimen stock certificate evidencing shares of Common Stock (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 12, 2021).
4.2Form of Common Stock Purchase Warrant and schedule of holders (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on January 13, 2021).
4.3Form of Inducement Warrant (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on January 26, 2021).
4.4Form of Inducement Warrant (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on June 23, 2021).
4.5*Description of the Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934.
4.6Form of Common Stock Purchase Warrant (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on November 20, 2023).
10.1+Material Supply Agreement, by and between the Registrant and Johnson Matthey, Inc., dated as of November 2, 2009 (incorporated by reference Registrant’s Amendment No. 1 to Registration Statement on Form S-1/A (File No. 333-202660) as filed with the SEC on April 3, 2015).
10.2Payoff letter, dated as of February 8, 2021, by and among the Company and the lenders named therein (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on February 9, 2021).
10.3Second Amendment to Senior Secured Convertible Note and Warrant, by and between Registrant and Deerfield Private Design Fund III, L.P., dated January 6, 2016 (incorporated by reference to the Registrant’s Current Report on Form 8-K as filed with the SEC on January 11, 2016).
10.3.1Fourth Amendment to Senior Secured Convertible Note and Warrant, effective as of October 3, 2016, by and between the Registrant and Deerfield Private Design Fund III, L.P. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on October 3, 2016).
10.3.2Amendment to Convertible Note and Warrant Agreement, dated November 20, 2018, between the Company and Deerfield Private Design Fund III, L.P. (as incorporated herein by reference to the Company's Current Report on Form 8-K filed with the SEC on November 20, 2018).
10.3.3Seventh Amendment to Senior Secured Convertible Note and Sixth Amendment to Warrant, dated February 28, 2019, between the Company and Deerfield Private Design Fund III, L.P. (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 1, 2019).
10.3.4Amendment to Senior Secured Convertible Notes and Amendment to Warrant, dated as of February 17, 2020, by and among Registrant and the noteholders party thereto (incorporated herein by reference to the Registrant’s Current Report on Form 8-K as filed with the SEC on February 18, 2020)
10.3.5Amendment to Senior Secured Convertible Notes and Amendment to Warrant, dated as of January 12, 2021, by and among the Company, Deerfield Private Design Fund III, L.P. and Deerfield Special Situations Fund, L.P. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on January 13, 2021)
10.4Warrant to Purchase Shares of Series D Preferred Stock issued to Deerfield Private Design Fund III, L.P., dated as of June 2, 2014 (incorporated herein by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.4.1Form of Stock Purchase Warrant to purchase shares of Series D Convertible Preferred Stock issued in bridge financing, along with a schedule of warrant holders (incorporated herein by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
Exhibit No.Description
10.5Amended and Restated Investors’ Rights Agreement, dated as of February 19, 2015, by and among the Registrant and certain of its stockholders (incorporated herein by reference to the Registrant’s Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.6+Agreement to Terminate CLA, by and between MonoSol Rx, LLC and the Registrant, dated as of March 20, 2012 (incorporated herein by reference to the Registrant's Amendment No. 1 to Registration Statement on Form S-1/A (File No. 333-202660) as filed with the SEC on April 3, 2015).
10.7#Incentive Stock Plan, as amended to date (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.7.1#Form of Incentive Stock Option Agreement under Incentive Stock Plan (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.7.2#Form of Nonqualified Stock Option Agreement under Incentive Stock Plan (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.7.3#Amended and Restated 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 13, 2021).
10.7.4#Form of Stock Option Grant Notice and Stock Option Agreement under 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 File No. 333-202660) as filed with the SEC on March 11, 2015).
10.7.5#Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement under 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 File No. 333-202660) as filed with the SEC on March 11, 2015).
10.7.6#Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under 2014 Equity Incentive Plan (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on May 14, 2019).
10.7.7#2021 Employee Stock Purchase Plan (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 13, 2021).
10.7.82023 Employment Inducement Award Plan and forms of award agreements thereunder (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on April 1, 2024).
10.8#Ninth Amended and Restated Non-Employee Director Compensation Policy effective May 3, 2023 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 14, 2023).
10.9#Form of Indemnification Agreement with the Registrant's directors and executive officers (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.10#Amended and Restated Employment Agreement by and between the Registrant and R. LaDuane Clifton, dated as of June 25, 2015 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 14, 2015).
10.10.1#Amendment to Amended and Restated Employment Agreement by and between the Registrant and R. LaDuane Clifton, dated as of October 13, 2015 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on November 13, 2015).
10.11#Employment Agreement by and between the Registrant and Christal M.M. Mickle, dated as of May 30, 2014 (incorporated herein by reference to the Registrant's Registration Statement on Form S-1 (File No. 333-202660) as filed with the SEC on March 11, 2015).
10.11.1#Amendment to Employment Agreement by and between the Registrant and Christal M.M. Mickle, dated as of October 13, 2015 (incorporated herein by reference to Exhibit 10.1 to the Registrant's Quarterly Report on Form 10-Q filed with the SEC on November 13, 2015).
10.11.2#Agreement Regarding Employment Terms, dated as of May 13, 2023, between the Registrant and Christal M.M. Mickle (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on May 15, 2023).
10.12#Amended and Restated Employment Agreement by and between the Registrant and Sven Guenther, dated as of April 13, 2016 (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on May 13, 2016).
Exhibit No.Description
10.13#*Employment Agreement by and between the Registrant and Adrian Quartel, dated as of January 3, 2024.
10.14#*Employment Agreement by and between the Registrant and Joshua Schafer, dated as of January 6, 2023.
10.15#Employment Agreement by and between the Registrant and Rahsaan Thompson, dated as of June 21, 2024 (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q as filed with the SEC on August 13, 2024).
10.16#Employment Agreement, effective as of October 10, 2023, between the Registrant and Neil F. McFarlane (incorporated herein by reference to the Registrant's Current Report on 8-K as filed with the SEC on October 10, 2023).
10.16.1#*Amendment to the Employment Agreement by and between the Registrant and Neil F. McFarlane, dated as of May 7, 2024.
10.17Lease Agreement, by and between the Registrant and BRE/COH FL LLC, dated as of November 3, 2014 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.18.1First Amendment to the Lease Agreement, by and between the Registrant and BRE/COH FL LLC, dated as of April 21, 2015 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.18.2Second Amendment to the Lease Agreement, by and between the Registrant and BRE/COH FL LLC, dated as of December 22, 2015 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.18.3Third Amendment to the Lease Agreement, by and between the Registrant and BRE/COH FL LLC, dated as of July 15, 2016 (incorporated herein by reference to the Registrant's Annual Report on Form 10-K as filed with the SEC on March 10, 2017).
10.19Purchase Agreement, dated February 17, 2020, by and between the Registrant and Lincoln Park Capital Fund, LLC. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on February 18, 2020).
10.20+Collaboration and License Agreement, dated as of September 3, 2019, by and between the Registrant and Boston Pharmaceuticals Holdings SA (incorporated herein by reference to the Registrant’s Current Report on Form 8-K as filed with the SEC on September 4, 2019).
10.21+Amendment No. 1 to Collaboration and License Agreement, effective as of April 8, 2021, by and between the Company and Commave Therapeutics SA (formerly known as Boston Pharmaceuticals Holdings SA) (incorporated herein by reference to the Registrant’s Quarterly Report on Form 10-Q as filed with the SEC on August 13, 2021).
10.22Form of Inducement Letter (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on January 26, 2021).
10.23Form of Inducement Letter (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on June 23, 2021).
10.24Equity Distribution Agreement, dated July 2, 2021, by and among the Company, JMP Securities LLC and RBC Capital Markets, LLC (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on July 2, 2021).
10.25†Asset Purchase Agreement by and among the Registrant, Zevra Denmark A/S and Orphazyme A/S, in restructuring, dated May 15, 2022 (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on May 16, 2022).
10.26Revolving Loan Agreement dated May 31, 2022, by and among the Registrant and Ameris Bank, as lender (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on June 1, 2022).
10.27Bridge Loan Agreement dated as of August 30, 2023, by and between the Registrant and Acer Therapeutics Inc. (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on August 31, 2023).
10.27.1First Amendment to the Bridge Loan Agreement by and between the Registrant and Acer Therapeutics Inc. (incorporated herein by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on April 1, 2024).
10.28***Loan Purchase Agreement dated as of August 30, 2023, by and among the Registrant and Nantahala Capital Management, LLC and the other sellers party thereto (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on August 31, 2023).
10.29***Note Purchase Agreement dated as of August 30, 2023, by and among the Registrant and Nantahala Capital Management, LLC and the other sellers party thereto (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on August 31, 2023).
10.30Registration Rights Agreement dated as of August 30, 2023, by and among the Registrant and each of the sellers party thereto (incorporated herein by reference to the Registrant's Current Report on Form 8-K as filed with the SEC on August 31, 2023).
10.31Ninth Amended and Restated Non-Employee Director Compensation Policy (incorporated herein by reference to the Registrant's Quarterly Report on Form 10-Q as filed with the SEC on August 14, 2023).
10.32Contingent Value Rights Agreement, dated as of November 17, 2023, by and among Zevra Therapeutics, Inc., Computershare, Inc., and Computershare Trust Company, N.A. (incorporated by reference to the Registrant's Current Report on 8-K as filed with the SEC on November 20, 2023).
10.33 †+Credit Agreement dated as of April 5, 2024, by and among Zevra Therapeutics, Inc. and HCR Stafford Fund II, L.P., HCR Potomac Fund II, L.P., and Perceptive Credit Holdings IV, LP (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q as filed with the SEC on May 9, 2024).
19*Zevra Therapeutics, Inc. Amended and Restated Insider Trading and Window Period Policy.
21.1Subsidiaries of the Company (incorporated by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on April 1, 2024).
23.1*Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
24.1*Power of Attorney (included on signature page).
31.1*Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
31.2*Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended.
32.1**Certification of the Principal Executive Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**Certification of the Principal Financial Officer pursuant to Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1#Zevra Therapeutics, Inc. Policy for Recovery of Erroneously Awarded Compensation, Effective October 2, 2023 (incorporated by reference to the Registrant’s Annual Report on Form 10-K as filed with the SEC on April 1, 2024).
99.1Securities Purchase Agreement, dated as of November 20, 2023, by and between the Registrant and Armistice Capital Master Fund Ltd. (incorporated herein by reference to the Registrant's Current Report on 8-K as filed with the SEC on November 20, 2023).
Exhibit No.Description
101.INS*Inline XBRL Instance Document.
101.SCH*Inline XBRL Taxonomy Extension Schema Document.
101.CAL*Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF*Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB*Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE*Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104Cover Page Interactive Data File (embedded within the Inline XBRL and contained in Exhibit 101)
*Filed herewith
**Furnished herewith
***Pursuant to Item 601(b)(2) of Regulation S-K, schedules and similar attachments have been omitted. The registrant hereby agrees to furnish a copy of any omitted schedule or similar attachment to the SEC upon request.
#Indicates management contract or compensatory plan.
+Certain portions of the exhibit, identified by the mark, “[*]”, have been omitted because such portions contained information that is both (i) not material and (ii) the type that the Registrant treats as private or confidential.
†Schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule will be furnished to the Securities and Exchange Commission upon request; provided, however, that the parties may request confidential treatment pursuant to Rule 24b-2 of the Exchange Act for any document so furnished.
ContentsView on SEC.gov

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